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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 PLUS year tenure till date June 2021, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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Tixagevimab


(Heavy chain)
QMQLVQSGPE VKKPGTSVKV SCKASGFTFM SSAVQWVRQA RGQRLEWIGW IVIGSGNTNY
AQKFQERVTI TRDMSTSTAY MELSSLRSED TAVYYCAAPY CSSISCNDGF DIWGQGTMVT
VSSASTKGPS VFPLAPSSKS TSGGTAALGC LVKDYFPEPV TVSWNSGALT SGVHTFPAVL
QSSGLYSLSS VVTVPSSSLG TQTYICNVNH KPSNTKVDKR VEPKSCDKTH TCPPCPAPEF
EGGPSVFLFP PKPKDTLYIT REPEVTCVVV DVSHEDPEVK FNWYVDGVEV HNAKTKPREE
QYNSTYRVVS VLTVLHQDWL NGKEYKCKVS NKALPASIEK TISKAKGQPR EPQVYTLPPS
REEMTKNQVS LTCLVKGFYP SDIAVEWESN GQPENNYKTT PPVLDSDGSF FLYSKLTVDK
SRWQQGNVFS CSVMHEALHN HYTQKSLSLS PGK
(Light chain)
EIVLTQSPGT LSLSPGERAT LSCRASQSVS SSYLAWYQQK PGQAPRLLIY GASSRATGIP
DRFSGSGSGT DFTLTISRLE PEDFAVYYCQ HYGSSRGWTF GQGTKVEIKR TVAAPSVFIF
PPSDEQLKSG TASVVCLLNN FYPREAKVQW KVDNALQSGN SQESVTEQDS KDSTYSLSST
LTLSKADYEK HKVYACEVTH QGLSSPVTKS FNRGEC
(Disulfide bridge: H22-H96, H101-H106, H150-H206, H216-L216, H232-H’232, H235-H’235, H267-H327, H373-H431, H’22-H’96, H’101-H’106, H’150-H’206, H’226-L’216, H’267-H’327, H’373-H’431, L23-L89, L136-L196, L’23-L’89, L’136-L’196)

Tixagevimab

FDA 2021, 2021/12/8

ANTI VIRAL, CORONA VIRUS, PEPTIDE

Monoclonal antibody
Treatment and prevention of SARS-CoV-2 infection

FormulaC6488H10034N1746O2038S50
CAS2420564-02-7
Mol weight146704.817
  • 2196
  • AZD-8895
  • AZD8895
  • COV2-2196
  • Tixagevimab
  • Tixagevimab [INN]
  • UNII-F0LZ415Z3B
  • WHO 11776
  • OriginatorVanderbilt University
  • DeveloperAstraZeneca; INSERM; National Institute of Allergy and Infectious Diseases
  • ClassAntivirals; Monoclonal antibodies
  • Mechanism of ActionVirus internalisation inhibitors
  • RegisteredCOVID 2019 infections
  • 24 Dec 2021Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by AstraZeneca
  • 16 Dec 2021Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by AstraZeneca
  • 10 Dec 2021Registered for COVID-2019 infections (In the elderly, Prevention, In adults) in USA (IM) – Emergency Use Authorization

Tixagevimab/cilgavimab is a combination of two human monoclonal antibodiestixagevimab (AZD8895) and cilgavimab (AZD1061) targeted against the surface spike protein of SARS-CoV-2[4][5] used to prevent COVID-19. It is being developed by British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca.[6][7] It is co-packaged and given as two separate consecutive intramuscular injections (one injection per monoclonal antibody, given in immediate succession).[2]

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Development

In 2020, researchers at Vanderbilt University Medical Center discovered particularly potent monoclonal antibodies, isolated from COVID-19 patients infected with a SARS-CoV-2 circulating at that time. Initially designated COV2-2196 and COV2-2130, antibody engineering was used to transfer their SARS-CoV-2 binding specificity to IgG scaffolds that would last longer in the body, and these engineered antibodies were named AZD8895 and AZD1061, respectively (and the combination was called AZD7442).[8]

To evaluate the antibodies’ potential as monoclonal antibody based prophylaxis (prevention), the ‘Provent’ clinical trial enrolled 5,000 high risk but not yet infected individuals and monitored them for 15 months.[9][10] The trial reported that those receiving the cocktail showed a 77% reduction in symptomatic COVID-19 and that there were no severe cases or deaths. AstraZeneca also found that the antibody cocktail “neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta variant“.[7]

In contrast to pre-exposure prophylaxis, the Storm Chaser study of already-exposed people (post-exposure prophylaxis) did not meet its primary endpoint, which was prevention of symptomatic COVID-19 in people already exposed. AZD7442 was administered to 1,000 volunteers who had recently been exposed to COVID.[9]

Regulatory review

In October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of tixagevimab/cilgavimab, which is being developed by AstraZeneca AB, for the prevention of COVID-19 in adults.[11]

Also in October 2021, AstraZeneca requested Emergency Use Authorization for tixagevimab/cilgavimab to prevent COVID-19 from the U.S. Food and Drug Administration (FDA).[12][13]

Emergency use authorization

On 14 November 2021, Bahrain granted emergency use authorization.[14]

On 8 December 2021, the U.S. Food and Drug Administration (FDA) granted emergency use authorization of this combination to prevent COVID-19 (before exposure) in people with weakened immunity or who cannot be fully vaccinated due to a history of severe reaction to coronavirus vaccines.[15] The FDA issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain people aged 12 years of age and older weighing at least 40 kilograms (88 lb).[2] The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2.[2]

References

  1. ^ “Evusheld- azd7442 kit”DailyMed. Retrieved 4 January 2022.
  2. Jump up to:a b c d “Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals”U.S. Food and Drug Administration (FDA) (Press release). 8 December 2021. Retrieved 9 December 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ O’Shaughnessy, Jacqueline A. (20 December 2021). “Re: Emergency Use Authorization 104” (PDF). Food and Drug Administration. Letter to AstraZeneca Pharmaceuticals LP | Attention: Stacey Cromer Berman, PhD. Archived from the original on 29 December 2021. Retrieved 18 January 2022.
  4. ^ “IUPHAR/BPS Guide to PHARMACOLOGY”IUPHAR. 27 December 2021. Retrieved 27 December 2021.
  5. ^ “IUPHAR/BPS Guide to PHARMACOLOGY”IUPHAR. 27 December 2021. Retrieved 27 December 2021.
  6. ^ Ray, Siladitya (21 August 2021). “AstraZeneca’s Covid-19 Antibody Therapy Effective In Preventing Symptoms Among High-Risk Groups, Trial Finds”ForbesISSN 0015-6914Archived from the original on 21 August 2021. Retrieved 18 January 2022.
  7. Jump up to:a b Goriainoff, Anthony O. (20 August 2021). “AstraZeneca Says AZD7442 Antibody Phase 3 Trial Met Primary Endpoint in Preventing Covid-19”MarketWatchArchived from the original on 21 August 2021. Retrieved 18 January 2022.
  8. ^ Dong J, Zost SJ, Greaney AJ, Starr TN, Dingens AS, Chen EC, et al. (October 2021). “Genetic and structural basis for SARS-CoV-2 variant neutralization by a two-antibody cocktail”. Nature Microbiology6 (10): 1233–1244. doi:10.1038/s41564-021-00972-2ISSN 2058-5276PMC 8543371. PMID 34548634.
  9. Jump up to:a b Haridy, Rich (23 August 2021). “”Game-changing” antibody cocktail prevents COVID-19 in the chronically ill”New Atlas. Retrieved 23 August 2021.
  10. ^ “AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19”AstraZeneca (Press release). 20 August 2021. Retrieved 15 October 2021.
  11. ^ “EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)”European Medicines Agency. 14 October 2021. Retrieved 15 October 2021.
  12. ^ “AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US”AstraZeneca US (Press release). 5 October 2021. Retrieved 15 October 2021.
  13. ^ “AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US”AstraZeneca (Press release). 5 October 2021. Retrieved 15 October 2021.
  14. ^ Abd-Alaziz, Moaz; Elhamy, Ahmad (14 November 2021). Macfie, Nick (ed.). “Bahrain authorizes AstraZeneca’s anti-COVID drug for emergency use”ReutersArchived from the original on 23 November 2021. Retrieved 18 January 2022.
  15. ^ Mishra, Manas; Satija, Bhanvi (8 December 2021). Dasgupta, Shounak (ed.). “U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail”ReutersArchived from the original on 13 January 2022. Retrieved 18 January 2022.

“Tixagevimab”Drug Information Portal. U.S. National Library of Medicine.

  • “Cilgavimab”Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT04625972 for “Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post-exposure Prophylaxis of COVID-19 in Adults (STORM CHASER)” at ClinicalTrials.gov
  • Clinical trial number NCT04625725 for “Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (PROVENT)” at ClinicalTrials.gov
Tixagevimab (teal, right) and cilgavimab (purple, left) binding the spike protein RBD. From PDB7L7E.
Combination of
TixagevimabMonoclonal antibody
CilgavimabMonoclonal antibody
Clinical data
Trade namesEvusheld
Other namesAZD7442
License dataUS DailyMedTixagevimab
Routes of
administration
Intramuscular
ATC codeJ06BD03 (WHO)
Legal status
Legal statusUS: ℞-only via emergency use authorization[1][2][3]
Identifiers
KEGGD12262
Clinical data
Drug classAntiviral
ATC codeNone
Identifiers
CAS Number2420564-02-7
DrugBankDB16394
UNIIF0LZ415Z3B
KEGGD11993
Chemical and physical data
FormulaC6488H10034N1746O2038S50
Molar mass146706.82 g·mol−1
Clinical data
Drug classAntiviral
ATC codeNone
Identifiers
CAS Number2420563-99-9
DrugBankDB16393
UNII1KUR4BN70F
KEGGD11994
Chemical and physical data
FormulaC6626H10218N1750O2078S44
Molar mass149053.44 g·mol−1

/////////////////Tixagevimab, ANTI VIRAL, CORONA VIRUS, PEPTIDE, Monoclonal antibody,  SARS-CoV-2 , WHO 11776, 2196, AZD-8895, AZD 8895, COV2-2196, COVID 19

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4-Hydroxy-TEMPO, TEMPOL, MBM-02, MTS 01


Skeletal formula of 4-hydroxy-TEMPO
ChemSpider 2D Image | 4-Hydroxy-TEMPO | C9H18NO2

4-Hydroxy-TEMPO, TEMPOL, MBM-02, MTS 01

  • Molecular FormulaC9H18NO2
  • Average mass172.245 Da

2,2,6,6-Tetramethyl-4-hydroxypiperidinooxy
2,2,6,6-Tetramethyl-4-hydroxypiperidinooxy radical
2,2,6,6-Tetramethyl-4-piperidinol 1-oxyl
CAS 2226-96-2[RN]
4-hydroxy-1-oxyl-2,2,6,6-tetramethylpiperidine
4-Hydroxy-2,2,6,6-tetramethyl-1-piperidin-1-yloxy, free radical
4-Hydroxy-2,2,6,6-tetramethylpiperidine N-oxide
4-Hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
TEMPOLCAS Registry Number: 2226-96-2 
CAS Name: 4-Hydroxy-2,2,6,6-tetramethyl-1-piperidinyloxy 
Additional Names: 4-hydroxy-TEMPO; 4-hydroxy-2,2,6,6-tetramethyl piperidine N-oxide; 4-hydroxy-2,2,6,6-tetramethylpiperidinooxy 
Molecular Formula: C9H18NO2, Molecular Weight: 172.24 
Percent Composition: C 62.76%, H 10.53%, N 8.13%, O 18.58% 
Literature References: Stable nitroxyl radical; water-soluble analogue of TEMPO, q.v. Functions as a membrane-permeable radical scavenger. Prepn: E. G. Rozantsev, Bull. Acad. Sci. USSR Div. Chem. Sci.12, 2085 (1964). Energy transfer studies: N. N. Quan, A. V. Guzzo, J. Phys. Chem.85, 140 (1981). IR conformation study: W. A. Bueno, L. Degrève, J. Mol. Struct.74, 291 (1981).Solid state NMR spectra: C. J. Groombridge, M. J. Perkins, J. Chem. Soc. Chem. Commun.1991, 1164. LC/MS/MS determn: I. D. Podmore, J. Chem. Res. Synop.2002, 574. Use as a phase transfer catalyst: X.-Y. Wang et al.,Synth. Commun.29, 157 (1999). Review of effects in animal models for shock, ischemia-reperfusion injury, and inflammation: C. Thiemermann, Crit. Care Med.31, S76-S84 (2003). 
Properties: Crystals from ether + hexane, mp 71.5°. uv max (hexane): 240, 450-500 (e ~1800, ~5). uv max (ethanol): 242, 435-455 (e ~3800, ~10). Sol in water. 
Melting point: mp 71.5° 
Absorption maximum: uv max (hexane): 240, 450-500 (e ~1800, ~5); uv max (ethanol): 242, 435-455 (e ~3800, ~10) 
Use: Spin label for EPR studies; phase transfer dehydration catalyst; antioxidant; inhibitor of olefin free radical polymerization.Topical PiperidineNitroxide MTS-01 is a topical gel containing a cell permeable hydrophilic piperidinenitroxide with potential radioprotective and antioxidant activity. As a stable, free radical compound, MTS-01 may be able to protect cells against the damaging effects of reactive oxygen species (ROS), upon exposure to ionizing radiation and oxidative stress. The topically applied MTS-01 may protect normal tissue from radiation-induced toxicity, such as radiation dermatitis, during radiation therapy. 
4-Hydroxy-TEMPO is a member of aminoxyls and a member of piperidines. It has a role as a radical scavenger and a catalyst. It derives from a TEMPO.

4-Hydroxy-TEMPO or TEMPOL, formally 4-hydroxy-2,2,6,6-tetramethylpiperidin-1-oxyl, is a heterocyclic compound. Like the related TEMPO, it is used as a catalyst and chemical oxidant by virtue of being a stable aminoxyl radical. Its major appeal over TEMPO is that is less expensive, being produced from triacetone amine, which is itself made via the condensation of acetone and ammonia. This makes it economically viable on an industrial scale.[3]

Example synthesis of 4-Hydroxy-TEMPO from phorone, which is itself made from acetone and ammonia

In biochemical research, 4-hydroxy-TEMPO has been investigated as an agent for limiting reactive oxygen species. It catalyzes the disproportionation of superoxide, facilitates hydrogen peroxide metabolism, and inhibits Fenton chemistry.[4] 4-Hydroxy-TEMPO, along with related nitroxides, are being studied for their potential antioxidant properties.[5]

On an industrial-scale 4-hydroxy-TEMPO is often present as a structural element in hindered amine light stabilizers, which are commonly used stabilizers in plastics, it is also used as a polymerisation inhibitor, particularly during the purification of styrene.

It is a promising model substance to inhibit SARS-CoV-2 RNA-dependent RNA polymerase.[6]

SYN

SYN

Inorganica Chimica Acta, 370(1), 469-473; 2011

IR(KBr)vmax/cm-1: 3413 (m(O-H))
Crystal Structure DataEmpirical formula C25H26NO8F6Cu; Formula weigh 646.02; T (K) 293(2); λ/Å 0.71073; Crystal system monoclinic; Space group P21/c; a (Å) 10.132(2); b (Å) 25.103(5); c (Å) 13.578(5); α (°) 90; β (°) 121.67(2); γ (°) 90; V (Å3) 2939.2(14); Z = 4

SYN

Bioorganic & Medicinal Chemistry Letters, 22(2), 920-923; 2012

SYN

https://pubs.acs.org/doi/10.1021/ol0712024

SYN

https://pubs.acs.org/doi/10.1021/es302157j

PAT

CN 113429392

SYN

 Journal of the American Chemical Society, 138(29), 9069-9072; 2016

https://pubs.acs.org/doi/10.1021/jacs.6b05421

file:///C:/Users/Inspiron/Downloads/ja6b05421_si_001.pdf

1H NMR(400 MHz, CDCl3) δH 3.89 (1H, tt, J = 11.4, 4.3 Hz, H4), 1.82.-.1.77 (2H, m, H3, H5), 1.43 (2H, t, J = 11.9 Hz, H3, H5), 1.14 (6H, s, 2 ×CH3), 1.07 (6H, s, 2 ×CH3);
13C NMR(100 MHz, CDCl3) δH 63.1, 47.5, 31.6, 20.6.
IR(thin film, νmax / cm-1) 3407, 1472, 1376, 1174, 1161, 1066;
Rf0.22 (ethyl acetate / petroleum ether (1:1));
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Thursday, June 3, 2021

NIH researchers identify potential new antiviral drug for COVID-19

Compound targets essential viral enzyme and prevents replication in cells.https://www.nih.gov/news-events/news-releases/nih-researchers-identify-potential-new-antiviral-drug-covid-19Novel Coronavirus SARS-CoV-2small spherical structures in the center of the image are SARS-CoV-2 virus particles. The string-like protrusions extending from the cells are cell projections or pseudopodium. NIAID

The experimental drug TEMPOL may be a promising oral antiviral treatment for COVID-19, suggests a study of cell cultures by researchers at the National Institutes of Health. TEMPOL can limit SARS-CoV-2 infection by impairing the activity of a viral enzyme called RNA replicase. The work was led by researchers at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study appears in Science.

“We urgently need additional effective, accessible treatments for COVID-19,” said Diana W. Bianchi, M.D., NICHD Director. “An oral drug that prevents SARS-CoV-2 from replicating would be an important tool for reducing the severity of the disease.”

The study team was led by Tracey A. Rouault, M.D., head of the NICHD Section on Human Iron Metabolism. It discovered TEMPOL’s effectiveness by evaluating a more basic question on how the virus uses its RNA replicase, an enzyme that allows SARS-CoV-2 to replicate its genome and make copies of itself once inside a cell.

Researchers tested whether the RNA replicase (specifically the enzyme’s nsp12 subunit) requires iron-sulfur clusters for structural support. Their findings indicate that the SARS-CoV-2 RNA replicase requires two iron-sulfur clusters to function optimally. Earlier studies had mistakenly identified these iron-sulfur cluster binding sites for zinc-binding sites, likely because iron-sulfur clusters degrade easily under standard experimental conditions.

Identifying this characteristic of the RNA replicase also enables researchers to exploit a weakness in the virus. TEMPOL can degrade iron-sulfur clusters, and previous research from the Rouault Lab has shown the drug may be effective in other diseases that involve iron-sulfur clusters. In cell culture experiments with live SARS-CoV-2 virus, the study team found that the drug can inhibit viral replication.

Based on previous animal studies of TEMPOL in other diseases, the study authors noted that the TEMPOL doses used in their antiviral experiments could likely be achieved in tissues that are primary targets for the virus, such as the salivary glands and the lungs.

“Given TEMPOL’s safety profile and the dosage considered therapeutic in our study, we are hopeful,” said Dr. Rouault. “However, clinical studies are needed to determine if the drug is effective in patients, particularly early in the disease course when the virus begins to replicate.”

The study team plans on conducting additional animal studies and will seek opportunities to evaluate TEMPOL in a clinical study of COVID-19.

NIH authors on the study include researchers from the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the National Institute of Neurological Disorders and Stroke. Authors from the Pennsylvania State University are funded by NIH’s National Institute of General Medical Sciences.

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health®

Article

Maio N, et al. Fe-S cofactors in the SARS-CoV-2 RNA-dependent RNA polymerase are potential antiviral targets. Science DOI: 10.1126/science.abi5224(link is external) (2021)

References

  1. ^ Zakrzewski, Jerzy; Krawczyk, Maria (1 January 2011). “Reactions of Nitroxides. Part XII [1]. – 2,2,6,6-Tetramethyl-1-oxyl- 4-piperidyl Chloroformate – A New Reactive Nitroxyl Radical. A One-pot Synthesis of 2,2,6,6-Tetramethyl-1-oxyl-4-piperidyl N,N-Dialkyl-carbamates”. Zeitschrift für Naturforschung B66 (5). doi:10.1515/znb-2011-0509.
  2. Jump up to:a b c d Sigma-Aldrich Co.4-Hydroxy-TEMPO. Retrieved on 2015-08-24.
  3. ^ Ciriminna, Rosaria; Pagliaro, Mario (15 January 2010). “Industrial Oxidations with Organocatalyst TEMPO and Its Derivatives”. Organic Process Research & Development14 (1): 245–251. doi:10.1021/op900059x.
  4. ^ Wilcox, C. S.; Pearlman, A. (2008). “Chemistry and Antihypertensive Effects of Tempol and Other Nitroxides”Pharmacological Reviews60 (4): 418–69. doi:10.1124/pr.108.000240PMC 2739999PMID 19112152.
  5. ^ Lewandowski, M; Gwozdzinski, K. (2017). “Nitroxides as Antioxidants and Anticancer Drugs”International Journal of Molecular Sciences18 (11): 2490. doi:10.3390/ijms18112490PMC 5713456.
  6. ^ Maio, N.; Lafont, B.A.P.; Sil, D.; Li, Y.; Bollinger, M.; Krebs, C. (2021). “Fe-S cofactors in the SARS-CoV-2 RNA-dependent RNA polymerase are potential antiviral targets”Science373 (6551): 236–241. doi:10.1126/science.abi5224.
Names
Preferred IUPAC name(4-Hydroxy-2,2,6,6-tetramethylpiperidin-1-yl)oxyl
Other namestempol; tanol; TMPN; 4-Oxypiperidol; nitroxyl 2; HyTEMPO
Identifiers
CAS Number2226-96-2 
3D model (JSmol)Interactive image
ChEBICHEBI:180664
ChEMBLChEMBL607023 
ChemSpider121639 
ECHA InfoCard100.017.056 
PubChem CID137994
UNIIU78ZX2F65X 
CompTox Dashboard (EPA)DTXSID4041280 
showInChI
showSMILES
Properties
Chemical formulaC9H18NO2
Molar mass172.248 g·mol−1
AppearanceOrange crystals
Melting point71–73 °C (160–163 °F; 344–346 K)[1]
Solubility in water629.3 g/l (20 °C)
Hazards
GHS labelling:
Pictograms[2]
Signal wordWarning[2]
Hazard statementsH302, H315, H319, H335[2]
Precautionary statementsP261, P305+P351+P338[2]
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
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Infobox references

//////////////////4-Hydroxy-TEMPO,  TEMPOL, MBM-02, MTS 01, ZJ 701, CORONA VIRUS, COVID 19

https://www.clinicaltrials.gov/ct2/show/NCT04729595

CC1(CC(CC(N1[O])(C)C)O)C

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MVC COVID-19 vaccine, Taiwan’s covid vaccine


Taiwan's president gets jabbed with first domestic COVID-19 vaccine to stamp personal approval

Medigen vaccine

MVC COVID-19 vaccine

  • MVC-COV1901

track it https://covid19.trackvaccines.org/vaccines/24/

MVC-COV1901 is a vaccine candidate developed and commercialized by Medigen Vaccine Biologics Corporation. The vaccine candidate contains a perfusion form of the SARS-Cov2 recombinant spike protein. Medigen has combined forces with Dynavax, which offers an advanced adjuvant, CpG 1018 (also known as ISS-1018), for use with its vaccine. As of September 2020, the vaccine candidate is in Phase 1 clinical trials to assess its safety and immunogenicity (NCT04487210).

The MVC COVID-19 vaccine, designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine, is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation [zh] in Taiwan, American company Dynavax Technologies and the U.S. National Institute of Health.[1][2]

This vaccine is made by the recombinant S-2P spike protein adjuvanted with CpG 1018 supplied by Dynavax.[3] Preliminary results from Phase I trials on 77 participants were published in June 2021, indicating what the authors described as “robust” immune system response elicited by the vaccine.[4]

The study authors have assessed the humoral immune response by measuring quantities of binding IgG to S protein, and also the cellular immune response by measuring the quantities of IFN-γ and IL-4 secreting T cells.[4]

Taiwan-based Medigen Vaccine Biologics Corporation (MVC) and Dynavax Technologies Corporation, in the US, have announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week.

Ryan Spencer, Chief Executive Officer of Dynavax commented, “We are pleased that Medigen’s vaccine is now available for the people of Taiwan. We are very excited for this first, of hopefully multiple, EUAs and approvals for COVID-19 vaccines that include CpG 1018 adjuvant. Considering the limitations of current vaccines and the global vaccine shortage, we believe adjuvanted vaccines can contribute significantly to current vaccination efforts.”

In July, MVC received Taiwan Emergency Use Authorization and approval for inclusion in Taiwan’s COVID-19 vaccine immunization program, MVC-COV1901.

MVC COVID-19 vaccine is indicated for adults over 20 years old and is administered in two doses 28 days apart for prevention of COVID-19.

The Advisory Committee recommended that MVC should submit safety monitoring report monthly during the declared EUA period and should submit a vaccine effectiveness report within one year after obtaining EUA approval.

(CNN)Taiwan’s President Tsai Ing-wen received her first shot of the island’s homegrown Covid-19 vaccine on Monday, a public show of support for the new drug which is central to plans for inoculation self sufficiency amid low immunization rates and struggles to obtain vaccines from overseas.Monday’s island-wide rollout of the Medigen Covid-19 vaccine, developed by Taipei-based Medigen Vaccine Biologics Corporation, comes after the drug was approved for emergency use last month by Taiwanese authorities for anyone above 20 years old, with at least 28 days between the two doses.The vaccine has yet to complete phase 3 clinical trials and no efficacy data is available.  Paul Torkehagen, Medigen’s director of overseas business development, told CNN in May that the company designed a “very large” phase 2 clinical trial to ensure the vaccine’s safety and effectiveness, with 3,800 participants. Normally, a stage 2 clinical trial only involves several hundred people. Data from the trials showed that 99.8% of participants were able to form antibodies against Covid-19 after taking two doses of the vaccine, Medigen’s CEO Charles Chen said.   Taiwanese President Tsai Ing-wen, center, receives her first shot of the island's first domestically developed coronavirus vaccine at the Taiwan University Hospital in Taipei, Taiwan on Monday, August 23.
Taiwanese President Tsai Ing-wen, center, receives her first shot of the island’s first domestically developed coronavirus vaccine at the Taiwan University Hospital in Taipei, Taiwan on Monday, August 23.   
Taiwan’s Centers for Disease Control said in a July 19 statement that the vaccine posed no serious health effects. Taiwan has ordered 5 million doses of the vaccine from Medigen and more than 700,000 people have already signed up to receive it, according to Reuters.In a Facebook post after receiving the vaccine at a hospital in Taipei, Tsai said she hadn’t suffered from any post-vaccination pain and thanked the health care workers who had administered the shot.”Taking the vaccine can protect yourself, your family, as well as medical staff,” Tsai wrote. “Let’s do our part in boosting Taiwan’s collective defense against the virus!”With its borders sealed to most travelers and strict measures enacted to contain local outbreaks, Taiwan has so far been largely successful in containing Covid-19, reporting fewer than 16,000 total confirmed infections and 828 deaths. But the island has struggled to vaccinate its more than 23 million population, partly due to difficulties obtaining doses from international suppliers.Taiwan’s government has only managed to import around 10 million Covid-19 vaccines, according to Reuters. In July it ordered another 36 million doses of the Moderna shot.Fewer than 5% of Taiwan’s population has received both doses of their Covid-19 vaccine, according to Reuters, as the island delays second dose vaccinations so more people can receive a first shot.On Monday, Taiwan reported four new Covid-19 cases, according to the Central Epidemic Command Center (CECC). Authorities announced on the weekend they would ease virus prevention measures to allow for larger gatherings and the opening of study centers and indoor amusement parks.But Health and Welfare Minister Chen Shih-chung said current Covid-19 restrictions — which include the closure of bars and nightclubs — would remain in place until at least September 6, with the possibility of an extension if the global outbreak continued to grow.Taiwan could become increasingly isolated if it keeps pursuing its “Covid zero” strategy, with both Australia and New Zealand hinting they might abandon the approach once vaccinations reach a certain level.In an opinion piece published on Sunday, Australian Prime Minister Scott Morrison said that while lockdowns to prevent Covid-19 transmission were “sadly necessary for now,” they may not be once vaccination rates increased to the targets of 70% and 80%.”This is what living with Covid is all about. The case numbers will likely rise when we soon begin to open up. That is inevitable,” he said.In neighboring New Zealand, which has also attempted to eliminate the virus within its borders, Covid-19 response minister Chris Hipkins told local media the highly-contagious Delta variant raised “some pretty big questions about what the long-term future of our plans are.”“At some point we will have to start to be more open in the future,” he said.

History

On 16 February 2020, Medigen Vaccine Biologics Corp. (MVC) signed a collaboration agreement with National Institutes of Health (NIH) for COVID-19 vaccine development. The partnership will allow MVC to obtain NIH’s COVID-19 vaccine and related biological materials to conduct animal studies in Taiwan.[5]

On 23 July 2020, Medigen Vaccine Biologics (MVC) announced collaboration with Dynavax Technologies to develop COVID-19 vaccine. The COVID-19 candidate vaccine will have the combination of SARS-CoV2 spike protein created by MVC and Dynavax’s vaccine adjuvant CpG 1018, which was used in a previously FDA-approved adult hepatitis B vaccine.[6][7]

Clinical trials

On 13 October 2020, Medigen Vaccine Biologics received Taiwan’s government subsidies for the initiation of Phase 1 Clinical Trial in Taiwan starting early October. The Phase 1 Clinical Trial was held at National Taiwan University Hospital with 45 participants ranging the age of 20-50.[8][9]

On 25 January 2021, Medigen Vaccine Biologics initiated Phase 2 Clinical Trial for its COVID-19 vaccine candidate MVC-COV1901 with the first participant being dosed. The Phase 2 Clinical Trial for the MVC COVID-19 vaccine was a randomized, double-blinded, and multi-center clinical trial, planned to enroll 3,700 participants of any age 20 above.[3][10][11]

On 10 June 2021, Medigen Vaccine Biologics released its COVID-19 vaccine Phase 2 interim analysis results, which demonstrates good safety profile in participants. The Phase 2 Clinical Trial in the end included 3,800 participants with all participants receiving second dose by 28 April 2021. Medigen Vaccine Biologics announced that it will request Emergency Use Authorization (EUA) with the concluding of the Phase 2 Clinical Trial.[12]

On 20 July 2021, Medigen Vaccine Biologics filed a Phase 3 Clinical Trial IND application with Paraguay’s regulatory authority, which was later approved. The Phase 3 Clinical Trial, however, was different from regular Phase 3 Clinical Trial, which uses immune-bridging trial to compare the performance of MVC COVID-19 vaccine with the Oxford-AstraZeneca COVID-19 vaccine.[13] The decision was a controversial announcement as immune-bridging trials were not fully approved or widely accepted by health authorities. In addition, the accuracy of immune-bridging trials were also been questioned for years.[citation needed]

Adolescents trial

In July 2021, Medigen commenced phase II trials for adolescents aged 12-18.[14]

Authorization

   Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § Medigen

On July 19, 2021, MVC COVID-19 vaccine obtained Emergency Use Authorization (EUA) approval from the Taiwanese government after fulfilling EUA requirements set by Taiwanese authority.[15] The EUA, however, was met with controversy due to the lack of efficacy data and Phase 3 Clinical Trial. On August 23, 2021, President Tsai Ing-Wen was among the first Taiwanese to receive a dose of the vaccine. [16]

References

  1. ^ “Dynavax and Medigen Announce Collaboration to Develop a Novel Adjuvanted COVID-19 Vaccine Candidate”. GlobeNewswire. 23 July 2020. Retrieved 7 June 2021.
  2. ^ 黃驛淵 (10 June 2021). “【獨家】【國產疫苗解盲1】高端實體疫苗針劑首曝光 「每天9萬劑」生產基地直擊” (in Chinese). Mirror Media.
  3. Jump up to:a b “Medigen Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax’s CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in Taiwan”http://www.medigenvac.com. Retrieved 7 August 2021.
  4. Jump up to:a b Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, Chen C, Janssen R, Shih SR, Huang CG, Tai IC, Chang SC (25 June 2021). “Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVCCOV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study”EClinicalMedicine: 100989. doi:10.1016/j.eclinm.2021.100989ISSN 2589-5370PMC 8233066PMID 34222848.
  5. ^ “MVC and NIH Collaborate to Develop COVID-19 Vaccine”http://www.medigenvac.com. Retrieved 7 August 2021.
  6. ^ “Medigen Collaborates with Dynavax to Develop Novel Adjuvanted COVID-19 Vaccine Candidate”http://www.medigenvac.com. Retrieved 7 August 2021.
  7. ^ “MVC Signed an License Agreement with NIH on COVID-19 Vaccine”. Medigen. 5 May 2020. Retrieved 27 July 2021.
  8. ^ “Medigen’s COVID-19 Vaccine Combined with Dynavax’s CpG 1018 Adjuvant Receives Taiwan Government Subsidy with First Participant Dosed in Early October”http://www.medigenvac.com. Retrieved 7 August 2021.
  9. ^ “A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult (COVID-19)”clinicaltrials.gov. United States National Library of Medicine. Retrieved 11 March 2021.
  10. ^ “A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19”clinicaltrials.gov. United States National Library of Medicine. Retrieved 11 March 2021.
  11. ^ “A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults”clinicaltrials.gov. United States National Library of Medicine. 28 March 2021. Retrieved 3 April 2021.
  12. ^ “MVC Released COVID-19 Vaccine Phase 2 Interim Analysis Result”http://www.medigenvac.com. Retrieved 7 August 2021.
  13. ^ “MVC Announces Paraguay Approval of IND Application for Phase 3 Clinical Trial”http://www.medigenvac.com. Retrieved 7 August 2021.
  14. ^ “A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents”clinicaltrials.gov. United States National Library of Medicine. 6 July 2021. Retrieved 6 July 2021.
  15. ^ “MVC COVID-19 Vaccine Obtains Taiwan EUA Approval”http://www.medigenvac.com. Retrieved 7 August 2021.
  16. ^ Taiwan begins contested rollout of new Medigen domestic vaccineNikkei Asia, Erin Hale, August 23, 2021
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Other namesMVC-COV1901
Routes of
administration
Intramuscular
Legal status
Legal statusFull and Emergency Authorizations: List of MVC COVID-19 vaccine authorizations
Identifiers
DrugBankDB15854
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////////Medigen vaccine, MVC COVID-19 vaccine, SARS-CoV-2, covid 19, corona virus, taiwan, approvals 2021, iss 1018, CpG 1018, MVC-COV1901

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Soberana 02, FINLAY-FR-2


IFV - Home

Soberana 02

FINLAY-FR-2

cas 2543416-58-4

A SARS-CoV-2 vaccine comprising a conjugate of the spike protein RBD domain with tetanus toxoid (Finlay Vaccine Institute of Cuba)
Soberana 02
, is a conjugate vaccine developed by Instituto Finlay de Vacunas.[517]

Cuba[518]

Iran[517]

517 Zimmer, Carl; Corum, Jonathan; Wee, Sui-Lee. “Coronavirus Vaccine Tracker”. The New York Times. Retrieved 30 June 2021.

518 Sesin, Carmen (14 May 2021). “Cuba begins mass Covid-19 vaccine inoculation before concluding trials”. NBC News. Retrieved 2 July 2021.

Soberana 02, technical name FINLAY-FR-2, is a COVID-19 vaccine produced by the Finlay Institute, a Cuban epidemiological research institute. It is a conjugate vaccine. This candidate followed a previous one called SOBERANA-01 (FINLAY-FR-1).[2] Professor Ihosvany Castellanos Santos said that the antigen is safe because it contains parts instead of the whole live virus, and therefore it does not require extra refrigeration, like other candidates in the world.[3] According to the WHO candidate landscape vaccine document, this vaccine requires two doses, the second one being administered 28 days after the first shot.[4]

The name of the vaccine, Soberana, is a Spanish word that means “sovereign”.[5]

An overview of current COVID-19 vaccine platforms - ScienceDirect

Efficacy

It has shown an efficacy of 62% after only two doses, according to BioCubaFarma, though a pre-print or details of the study have not been released.[6][7][8]

Pharmacology

FINLAY-FR-2 is a conjugate vaccine. It consists of the receptor binding domain of the SARS-CoV-2 spike protein conjugated chemically to tetanus toxoid.[2]

Manufacturing

The spike protein subunit is produced in Chinese hamster ovary cell culture.[2] In a pre-print article scientists from Cuba explain details of the vaccines technology and production.[9][non-primary source needed]

 
  Production  Deliveries  Planned Production  Potential Production

Deliveries (0)Effective production (implies deliveries) (1)

  1. Cuba[10][11]

Planned production

  1. Iran

Potential Production

  1. Ghana
  2. Argentina

In Cuba

The Cuban government says it is planning to produce 100 million doses of its vaccine to respond to its own demand and that of other countries.[12][13] Cuba has also suggested that, once it’s approved, it will offer the vaccine to tourists visiting the country.[14][15][16]

The production of the first batch of about 100,000 doses will start in April.[17] José Moya, representative of the World Health Organization and the Pan American Health Organization (PAHO) in Cuba, suggested that after the vaccine passes all clinical stages, it could be included as part of PAHO’s Revolving Fund.[18]

The roll-out began with an “Interventional Trial”[19] that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers.[20][21] On April 11, 2021, the Ministry of Public Health of Cuba announced that 75,000 health-care workers were inoculated with their first dose of either of the two Cuba’s Phase III vaccines (the other being Abdala).[22][23]

Outside Cuba

Vietnam, Iran, Venezuela, Argentina,[24][25][26] Pakistan, India, the African Union, Jamaica and Suriname[27] have expressed interest in purchasing the vaccine, although they are waiting on Phase 3 results.[28][29]

Iran has signed an agreement to manufacture the vaccine[30] and Argentina is negotiating one.[24][25][26] Additionally, the Cuban government offered a “transfer of technology” to Ghana and will also supply “active materials” needed to make the vaccine.[31][32][33]

While the price is currently unknown, the commercialization strategy of the vaccine will be a combination of the “impact on health” and the capability of Cuba’s system to financially support “the production of vaccines and drugs for the country”, per the director of the Finlay Institute, Vicente Vérez.[34]

Clinical trials

Phase I

FINLAY-FR-2, which started being developed in October 2020, had 40 volunteers for its Phase I, according to the Cuban Public Registry of Clinical Trials, with an open, sequential and adaptive study to assess safety, reactogenicity and explore immunogenicity of the vaccine.[35]

Phase II

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[36][37] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[38] The second phase has been supervised by Iranian officials from the Pasteur Institute.[5]

Phase III

Phase III commenced at the beginning of March as originally scheduled,[39][15] and “ready to publish” results are expected by June.[40][41][42] The trial volunteers are divided into three groups: some will receive two doses of the vaccine 28 days apart, another group will get two doses plus a third immune booster (Soberana Plus[43][44][45]), and the third a placebo.[39]

Although the trials involve thousands of adult volunteers recruited in Havana,[46] Cuba’s public health officials have said that they will also need to conduct phase III trials abroad because the island doesn’t have an outbreak of sufficient scale to produce meaningful statistics on vaccine protection.[5][14]

On March 13, 2021, the Cuban Biotechnology and Pharmaceutical Industries Business Group (BioCubaFarma) announced on social media that it had sent 100,000 doses of its Soberana 02 coronavirus vaccine candidate to the Pasteur Institute of Iran for clinical testing, “as part of the collaboration with other countries in the development of COVID-19 vaccines.” [47]

On April 26, 2021, it was reported that a Phase III conducted by the Pasteur Institute of Iran was approved to be started in Iran[48][49][50] It was previously reported that the Institute will host Phase 3 but the pre-requisites were “technology transfer and joint production”.[51][5]

Mexico plans to host a phase 3 trial.[52]

Interventional Study

The “Interventional Study” is set both in Havana,[53] Cuba’s capital and Santiago de Cuba, Cuba’s second most populous city [54][55] and in other provinces.[56] On May 6, 2021, the Finlay Institute of Vaccines announced on social media that the following adverse events have been observed: injection site pain (20%), inflammation at the injection site (5%), and general discomfort (5%).[57][58]

Authorizations

 
  Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § Soberana 02

References

  1. ^ “Cuba’s Soberana Plus against Covid-19 is showing good results”. Prensa Latina. Retrieved 10 May 2021.
  2. Jump up to:a b c Malik JA, Mulla AH, Farooqi T, Pottoo FH, Anwar S, Rengasamy KR (January 2021). “Targets and strategies for vaccine development against SARS-CoV-2”Biomedicine & Pharmacotherapy137: 111254. doi:10.1016/j.biopha.2021.111254PMC 7843096PMID 33550049.
  3. ^ Santos IC (January 2021). “Rapid response to: Covid 19: Hope is being eclipsed by deep frustration”BMJ372: n171. doi:10.1136/bmj.n171.
  4. ^ “Draft landscape and tracker of COVID-19 candidate vaccines”http://www.who.intWorld Health Organization. Retrieved 2021-02-04.
  5. Jump up to:a b c d Rasmussen SE, Eqbali A (12 January 2021). “Iran, Cuba, Under U.S. Sanctions, Team Up for Covid-19 Vaccine Trials”The Wall Street Journal.
  6. ^ “Cuba’s homegrown Covid vaccine shows promise”http://www.ft.com. Retrieved 2021-06-20.
  7. ^ “Cuba encouraged by early efficacy results of homegrown COVID-19 vaccine”http://www.zawya.com. Retrieved 2021-06-20.
  8. ^ Acosta, Nelson (2021-06-20). “Cuba encouraged by early results of homegrown COVID-19 vaccine amid worst outbreak”The Age. Retrieved 2021-06-20.
  9. ^ Valdes-Balbin, Yury; Santana-Mederos, Darielys; Quintero, Lauren; Fernández, Sonsire; Rodriguez, Laura; Ramirez, Belinda Sanchez; Perez, Rocmira; Acosta, Claudia; Méndez, Yanira; Ricardo, Manuel G.; Hernandez, Tays (2021-02-09). “SARS-CoV-2 RBD-Tetanus toxoid conjugate vaccine induces a strong neutralizing immunity in preclinical studies”doi:10.1101/2021.02.08.430146.
  10. ^ Melimopoulos, Elizabeth. “Is Cuba closing in on COVID vaccine sovereignty?”http://www.aljazeera.com. Retrieved 2021-05-07.
  11. ^ “Optimism as Cuba set to test its own Covid vaccine”BBC News. 2021-02-16. Retrieved 2021-05-07.
  12. ^ “Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02”Nodal (in Spanish). 21 January 2021.
  13. ^ “Vaccino, Cuba pronta a produrre 100 milioni di dosi di ‘Soberana 02′”Dire (in Italian). 21 January 2021.
  14. Jump up to:a b Ribeiro G (4 February 2021). “Cuba to offer coronavirus vaccines to tourists”Brazilian Report.
  15. Jump up to:a b “Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos”Deutsche Welle (in Spanish). 5 February 2021.
  16. ^ Meredith S (23 February 2021). “‘Sun, sea, sand and Soberana 02’: Cuba open to inoculating tourists with homegrown Covid vaccine”CNBC.
  17. ^ “Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos”Deutsche Welle (in Spanish). 5 February 2021. Las expectativas sobre Soberana 02 son tales que el titular del organismo estatal que desarrolló la vacuna, Vicente Vérez, confirmó que mientras se aguarden los resultados de la Fase 3 solo en La Habana, en abril se dará inicio a la producción del primer lote, de alrededor de 100 mil dosis.
  18. ^ “Cuba anuncia fase 3 de la vacuna Soberana 02”La Jornada(in Spanish). 7 February 2021. Una vez que superen las etapas clínicas, la OMS podría contar con el fármaco cubano, afirmó Moya, y “pasar a ser parte del grupo de vacunas que se oferten a través del Fondo Rotatorio”, un mecanismo que desde hace cuatro décadas permite gestionar antígenos e insumos a los países de las Américas.
  19. ^ “SOBERANA – INTERVENTION | Registro Público Cubano de Ensayos Clínicos”rpcec.sld.cu. Retrieved 2021-04-11.
  20. ^ “Cuba says it’s ‘betting it safe’ with its own Covid vaccine”NBC News. Retrieved 2021-04-11.
  21. ^ “Cuba begins testing 2nd COVID-19 vaccine on health care workers”medicalxpress.com. Retrieved 2021-04-11.
  22. ^ Ministry of Public Health of Cuba (11 April 2021). “[Translated] “The administration of the 1st dose of the Cuban vaccine candidates #Soberana02 and #Abdala to the 75 thousand health workers and Biocubafarma who are part of the intervention study taking place in #LaHabana has concluded.””Twitter. Retrieved 2021-04-11.
  23. ^ “Cuban scientists, health workers received first anti-Covid-19 dose”http://www.plenglish.com/index.php?o=rn&id=66247&SEO=cuban-scientists-health-workers-received-first-anti-covid-19-dose (in Spanish). Retrieved 2021-04-11.
  24. Jump up to:a b “ILARREGUI (EMBAJADOR EN CUBA): “DURANTE ESTE AÑO PODREMOS TENER VACUNAS CUBANAS EN ARGENTINA””RadioCut. Retrieved 2021-05-07.
  25. Jump up to:a b Argentina, Cadena 3. “Argentina comenzó a negociar con Cuba la vacuna Soberana”Cadena 3 Argentina (in Spanish). Retrieved 2021-05-07.
  26. Jump up to:a b de 2021, 6 de Mayo. “Sin definiciones sobre cuándo podrían llegar, el Gobierno avanza para conseguir las vacunas Soberana y Abdala de Cuba”infobae (in Spanish). Retrieved 2021-05-07.
  27. ^ admin (2021-04-09). “Cuba’s COVID-19 Vaccines Being Sought After by CARICOM Countries”Caribbean News. Retrieved 2021-05-07.
  28. ^ Guenot, Marianne (2021-02-15). “Cuba is working on a homegrown COVID-19 vaccine program. It has a history of fighting disease without help from the West”Business Insider France (in French). Retrieved 2021-05-07.
  29. ^ Página12 (2021-01-22). “Soberana 02: Cuba prepara cien millones de dosis de la vacuna contra el coronavirus | “No somos una multinacional. Nuestro fin es crear salud”, dijo el director del Instituto Finlay de Vacunas”PAGINA12. Retrieved 2021-05-07.
  30. ^ “Cuban coronavirus vaccine to start third clinical trial phase in Iran”Tehran Times. 2021-04-18. Retrieved 2021-05-07.
  31. ^ Banini | 0542440286, Awofisoye Richard. “CEO OF FDA DISCUSSES PRODUCTION OF COVID-19 VACCINE WITH CUBAN AMBASSADOR”http://www.fdaghana.gov.gh. Retrieved 2021-05-05.
  32. ^ “Cuba To Transfer COVID-19 Vaccine Technology To Ghana”http://www.gnbcc.net. Retrieved 2021-05-05.
  33. ^ “Cuban government offers to transfer COVID-19 Soberana 02 vaccine technology to Ghana”Rio Times Online. 16 February 2021.
  34. ^ “Coronavirus: Cuba will produce 100 million doses of its Soberana 02 vaccine”OnCubaNews English. 2021-01-21. Retrieved 2021-05-07.
  35. ^ “SOBERANA 02 | Registro Público Cubano de Ensayos Clínicos”Cuban Registry of Clinical Trials (in Spanish). Retrieved 24 January 2021.
  36. ^ Cuba inicia nova fase de testes com vacina que desenvolve contra covid-19 (in Portuguese), Universo Online, 19 January 2021, Wikidata Q105047566
  37. ^ “Cuba apuesta por crear primera vacuna de América Latina contra el covid-19”France 24 (in Spanish). 2021-01-21. Retrieved 24 January 2021.
  38. ^ “Cuba negotiates with other countries to develop phase 3 of Soberana 02 vaccine”OnCubaNews English. 2020-12-30. Retrieved 24 January 2021.
  39. Jump up to:a b “Cuban-developed vaccine enters Phase III trial”ABS CBN. 5 March 2021.
  40. ^ Mega, Emiliano Rodríguez (2021-04-29). “Can Cuba beat COVID with its homegrown vaccines?”Naturedoi:10.1038/d41586-021-01126-4PMID 33927405.
  41. ^ “Cuban Vaccine Ready in July. Interview with the Cuban Ambassador to the Czech Republic”Pressenza. 2021-03-23. Retrieved 2021-04-29.
  42. ^ Augustin, Ed (2021-05-12). “Cuba deploys unproven homegrown vaccines, hoping to slow an exploding virus outbreak”The New York TimesISSN 0362-4331. Retrieved 2021-05-14.
  43. ^ “L’esempio cubano sui vaccini”http://www.ilfoglio.it (in Italian). Retrieved 2021-05-07.
  44. ^ Avances de las vacunas cubanas contra la COVID-19, retrieved 2021-05-07
  45. ^ Mega, Emiliano Rodríguez (2021-04-29). “Can Cuba beat COVID with its homegrown vaccines?”Naturedoi:10.1038/d41586-021-01126-4PMID 33927405.
  46. ^ Yaffe, Helen. “Cuba’s five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa”LSE Latin America and Caribbean blog. Retrieved 2021-03-31.
  47. ^ “Cuba sends 100,000 doses of the Soberana 02 vaccine candidate to Iran” oncubanews.com. Retrieved 19 March 2021.
  48. ^ “Iran-Cuba vaccine enters phase three clinical trials”Tehran Times. 2021-04-26. Retrieved 2021-04-28.
  49. ^ “Cuban coronavirus vaccine to start third clinical trial phase in Iran”Tehran Times. 2021-04-18. Retrieved 2021-04-28.
  50. ^ “América Latina apura una vacuna propia. Cuba, adelante; México avanza. Pero no son los únicos”http://www.poresto.net (in Spanish). Retrieved 2021-04-28.
  51. ^ Marsh S (2021-01-09). “Cuba to collaborate with Iran on coronavirus vaccine”Reuters. Retrieved 2021-01-24.
  52. ^ “Mexico Hopes to Work With Cuba on Covid Vaccine Phase 3 Trial”Bloomberg.com. 2021-02-14. Retrieved 2021-05-07.
  53. ^ Marsh, Sarah (2021-03-24). “Nearly all Havana to receive experimental Cuban COVID-19 vaccines”Reuters. Retrieved 2021-04-28.
  54. ^ BioCubaFarma (April 6, 2021). “[Translated] Updating the vaccination process with vaccine candidates #Soberana02 and #Abdala during ongoing clinical trials.#VacunasCubanasCovid19”Twitter (in Spanish). Retrieved 2021-04-11.
  55. ^ “Intervention study with Covid-19 vaccine candidate Abdala begins”Radio Cadena Agramonte. Retrieved 2021-04-28.
  56. ^ “Cuba administers over 62,000 doses in intervention trials”http://www.plenglish.com/index.php?o=rn&id=66012&SEO=cuba-administers-over-62000-doses-in-intervention-trials (in Spanish). Retrieved 2021-04-28.
  57. ^ “[Trnslated] In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: 👉 Pain at the injection site (20%). 👉 Redness at the injection site (5%). 👉 Feeling of general malaise (5%)”Twitter. Retrieved 2021-05-07.
  58. ^ “[Translated]In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: 👉 Pain at the injection site (20%). 👉 Redness at the injection site (5%). 👉 Feeling of general malaise (5%)”Facebook. Retrieved 2021-05-07.

External links

Scholia has a profile for SOBERANA 02 (Q105047585).
Vaccine description
TargetSARS-CoV-2
Vaccine typeConjugate
Clinical data
Other namesFINLAY-FR-2, SOBERANA PLUS[1]
Routes of
administration
Intramuscular
Legal status
Legal statusFull and Emergency Authorizations: List of Soberana 02 authorizations
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)CasesDeaths
showTimeline
showLocations
showInternational response
showMedical response
showEconomic impact and recession
showImpacts
 COVID-19 portal

/////////////////SARS-CoV-2, covid 19, corona virus, vaccine, iran, cuba, Soberana 02, FINLAY-FR-2

 Nature (London, United Kingdom) (2021), 

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COVAX-19


Vaxine Pty Ltd company logo

Vaxine Pty Ltd company logo

Vaxine's promising new COVID-19 vaccine candidate

Vaxine’s promising new COVID-19 vaccine candidate

A new multivalent COVID-19 vaccine developed by Australian company Vaxine to tackle the new virus variants could be game-changer in the fight against COVID-19 

The world desperately needs a vaccine that blocks virus transmission and protects against all the variants. Covax-19 vaccine may soon change history”— Sharen Pringle, Vaxine Business Mananager

ADELAIDE, SA, AUSTRALIA, May 16, 2021 /EINPresswire.com/ — Professor Petrovsky, who is the Chairman and Research Director of Australian-based Vaxine Pty Ltd, explains that the two biggest challenges to tackling the COVID-19 pandemic are to develop a vaccine that completely prevents virus transmission something other COVID-19 have not been completely successful in achieving, and the second being to find a vaccine that protects equally against all the evolving immune-escape variants.

Professor Petrovsky has been researching coronavirus vaccines for the last 17 years, having previously published scientific papers on vaccines against both the SARS and MERS coronaviruses, which were highly protective in relevant animal models. He also recently published data from a collaboration with the US Army on development of a promising Ebola vaccine that protected mice against this most lethal disease after just a single vaccine dose. He has now successfully taken the same approach to design a protein-based vaccine against COVID-19.

Studies in a broad range of animal models including mice, hamsters, ferrets and monkeys, have recently revealed the high potential of this vaccine that is currently known as Covax-19(TM), but which likely will be soon rebranded as in its latest iteration it moves into late stage human trials in a number of countries.

Recent breakthrough data generated by Vaxine’s partner, Professor Kaissar Tabynov who leads the International Center for Vaccinology at the Kazakh National Agrarian University has shown that Vaxine’s unique spike protein antigen which is produced using insect cells in culture, was unique in that it not only totally protected hamsters from infection themselves but also prevented them from transmitting the virus to unvaccinated animals that were placed in the same cage two days after the vaccinated animals had been challenged with virus. Protection against transmission was not seen in hamsters given other vaccines making this finding unique to Vaxine’s spike protein antigen.

This hamster data reinforced findings in hamster, ferret and monkey challenge study performed by collaborating US Universities, who showed that two doses of Vaxine’s Covax-19 vaccine provided complete clearance of recoverable virus from the lungs and nose of animals when sampled just days after an infectious challenge.

“COVAX-19 vaccine has now been shown to be highly protective against the original Wuhan strain of the virus in hamster, ferret and monkey infection models performed by independent academic institutions in multiple countries, attesting to the strength of our protein-based vaccine approach”, says Prof. Petrovsky.

“A key element in the success of Covax-19 vaccine is the inclusion of Vaxine’s Advax adjuvant technology which acts as a turbocharger to drive an optimal immune response against the virus” explains Prof. Petrovsky who has been working on this promising vaccine adjuvant technology for the last 20 years with funding support from the US National Institutes of Health.

“We have now shown that our COVAX-19 vaccine can provide effective immunity including an ability to block nasal virus replication and this in turn successfully prevents transmission of the virus to vaccine-naïve animals,” he explains.

Follow on studies to confirm and expand upon these initial findings are currently underway at several US universities as well as Kazakh National Agrarian University, with a manuscript describing some of the initial animal data currently under review at a leading vaccine journal.

In another major breakthrough the team has now developed the vaccine into a multivariant format designed to protect against all the recently described variant strains of COVID-19, with work also underway on the most recently described Indian strains.

While the data is still preliminary says Prof. Petrovsky, the immune responses to the multivalent vaccine in mice are generating equally strong antibody binding activity against all the major virus variants. “This is extremely exciting as the world desperately needs vaccines able to protect against all the new strains of the virus including the UK, South African and Brazilian strains. By contrast , the currently available vaccines are clearly not as strong against some of these variants as they are against the original Wuhan strain” he explains.

Already there have been multiple confirmed cases of vaccine breakthrough where otherwise healthy individuals who have received mRNA, adenovirus or inactivated whole virus vaccines have become infected generally with either the South African or Brazilian variants.

This problem of immune-escape will only get worse over time as more complex variants emerge which is why Vaxine has been putting all its energy into finding a robust solution to this issue before proceeding with Phase 3 clinical trials of its Covax-19 vaccine.

Dr. Petrovsky went on to conclude “Now we have a multivalent formulation of Covax-19 vaccine that is showing high promise in animal studies, we plan to work as fast as we can to advance this new vaccine formulation in human trials, while expanding manufacturing capacity to ensure we are able to produce enough vaccine to meet the enormous global demand that will be attracted by such a successful vaccine.”

“To help us in this task Vaxine is looking to assemble a global network of partner organisations in countries around the world to assist Vaxine with vaccine development, clinical trials, manufacturing, distribution and sales. This is going to be a mammoth effort as we go to war against this insidious virus that continues to wreak havoc around the globe, with WHO recently predicting that the second year of the pandemic is likely to be much worse even than the first, an ominous warning for many countries that still remain poorly prepared and lacking in local vaccine manufacturing capability.

Vaxine wishes to help developing countries to establish their own local state-of-the-art vaccine manufacturing facilities, providing advice on appropriate facility design and undertaking technology transfer of its state of the art protein production technology to such facilities.

Countries in the developing world can no longer afford to sit and wait for outside organisations like COVAX to solve their vaccine supply problems, instead Vaxine proposes to help such countries find their own local solutions to the vaccine supply bottleneck for this.

Sharen Pringle
Vaxine Pty Ltd
437 033 400
email us here……..https://www.einnews.com/pr_news/541113168/covid-19-vaccine-breakthrough

Currently, the Australian influenza vaccine and adjuvant specialist and the Polish protein drug maker have just inked a memorandum of understanding, so the terms of a future contract remain to be defined. However, the technology behind is interesting.

The partners intent to utilize an insect cell-based recombinant spike protein of SARS-CoV–2 in combination with Vaxine’s proprietary Advax™ adjuvant and have already started Phase I testing in Australia with first result expected later this month. The company announced it will use artificial intelligence to evalutate clinical data in real time and announced the ambition to complete Phase II and III trials at the end of this year. “Supported by Microsoft technology, we aim to collect and analyse the COVAX-19™ trial data in real time, rather than waiting until the end of the trial before seeing if the vaccine is working, which is the traditional process,” said Vaxine’s Research Director Professor Nikolai Petrovsky from Flinders University in Adelaide.

Preclinically, Vaxine Pty Ltd’s syntetic spike protein with the company’s non-inflammatory Advax™ adjuvant, induced antibody and T-cell immune responses against the co-administered antigen. In various animal models, Covax-19 vaccination provided robust protection against an infection with the novel coronavirus.

The Phase I of Vaxine Pty Ltd in running since July in 40 healthy volunteers. If results are positive, the Australian vaccine maker is to expand studies and manufacturing to Europe. Under a future agreement Mabion SA would lead clinical development, manufacturing, regulatory negotiations and could exclusively market the vaccine in the EU and – optionally – in the US……..https://european-biotechnology.com/up-to-date/latest-news/news/mabion-to-licence-covid-19-jab-from-vaxine-pty-ltd.html

////////////////COVAX-19, corona virus, covid 19, Vaxine, australia, vaccine

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ARCT-021 (LUNAR-COV19)


ARCT-021 (LUNAR-COV19)

cas 2541451-24-3

A lipid-enabled and UnlockedNucleomonomer Agent modified RNA (LUNAR) of self-replicating RNA for vaccination against spike protein of SARS-CoV-2 (Arcturus)

Self-replicating RNA vaccine

Arcturus Therapeutics and Duke-NUS Medical School, Singapore
  • OriginatorArcturus Therapeutics
  • ClassCOVID-19 vaccines; RNA vaccines; Viral vaccines
  • Mechanism of ActionImmunostimulants
  • Orphan Drug StatusNo
  • New Molecular EntityNo
  • Available For LicensingYes – COVID 2019 infections
  • Phase IICOVID 2019 infections
  • 01 Mar 2021Arcturus Therapeutics has patent pending for STARR platform in USA
  • 01 Mar 2021Immunogenicity data from a preclinical studies in COVID-2019 infections released by Arcturus Therapeutics
  • 01 Mar 2021Arcturus Therapeutics completes a phase I/II trial in COVID-2019 infection in the Singapore

ref International Journal of Biological Sciences (2021), 17(6), 1446-1460. https://www.ijbs.com/v17p1446.htm

LUNAR-COV19T7m7GpppNmNYesVEEV-FL-SN1-methyl pseudouridineSilicon column 
protein[54]

ARCT-021: Currently undergoing phase 1/2 clinical trials, it combines two technologies, i.e., saRNA STARR™ and LUNAR® lipid-mediated delivery method. It was designed to enhance and extend antigen expression, enabling vaccination at lower doses [87]. In addition, LUNAR® lipids are pH-sensitive and biodegradable, causing minimal lipid accumulation in cells after multiple dosing [87]The Arcturus COVID-19 vaccine, commonly known as ARCT-021 and LUNAR-COV19, is a COVID-19 vaccine candidate developed by Arcturus Therapeutics.

LUNAR-
COV19
1Day 00.2 μg and 10 μg (Preclinical)IMArcturus TherapeuticsN/APhase 2NCT04668339 NCT04480957[54]

54. de Alwis R, Gan ES, Chen S, Leong YS, Tan HC, Zhang SL. et alA Single Dose of Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccine Produces Protective Adaptive Immunity In MicebioRxiv. 2020. 2020 09.03.280446
Development

Arcturus Therapeutics partnered with Singapore’s Duke–NUS Medical School to develop a COVID-19 vaccine.[1] The company also partnered with Catalent, a contract development and manufacturing organization, to manufacture multiple batches of Arcturus’ COVID-19 mRNA vaccine candidate.[2]

Clinical research

Phase I-II

LUNAR-COV19 clinical trials in humans began in July 2020.[3] On 4 January 2021, Arcturus Therapeutics started phase-2 clinical trials.[4]

Deployment

Arcturus has entered into development and supply agreements with the Economic Development Board of Singapore and supply agreements with the Israel Ministry of Health for LUNAR-COV19.[5][6]

Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States

https://www.businesswire.com/news/home/20210104005377/en/Arcturus-Therapeutics-Receives-FDA-Allowance-to-Proceed-with-Phase-2-Study-of-ARCT-021-LUNAR-COV19-Vaccine-Candidate-in-the-United-States

Phase 2 study to be conducted in the U.S. and Singapore, and will evaluate both single dose and two dose priming regimens of ARCT-021 in up to 600 participants

Anticipate interim Phase 2 data in early 2021; targeting global Phase 3 study start in Q2 2021 which could allow application for emergency use authorization/conditional approval in H2 2021January 04, 2021 07:01 AM Eastern Standard Time

SAN DIEGO–(BUSINESS WIRE)–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that the Company has received allowance of the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study.

Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States

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Arcturus previously announced that the ARCT-021 Phase 2 study had been approved to proceed by the Singapore Health Sciences Authority (HSA), who reviewed the same data as reviewed by the FDA. These Phase 1/2 study results demonstrated favorable tolerability and both humoral and cellular immunogenicity following administration of ARCT-021.

The Phase 2 study will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Both older and younger adult participants will be included. Early interim analyses of safety and immunogenicity will be performed to inform dose selection for a Phase 3 study, which is targeted to start in Q2 2021, if the Phase 2 study is successful.

“Allowance of the IND for our ARCT-021 Phase 2 clinical study represents an important milestone for the program and we look forward to starting to screen study participants at U.S. and Singapore clinical sites very soon,” said Steve Hughes, M.D., Chief Medical Officer of Arcturus. “We have advanced ARCT-021 to Phase 2 based on promising interim results from our Phase 1/2 study and extensive preclinical data. Our prior clinical results show that ARCT-021 administration results in humoral and cellular immunogenicity, and we are encouraged by an increasing body of evidence highlighting the potential importance of T cells in providing protection against SARS-CoV-2 infection and COVID-19. We believe that ARCT-021 holds promise to be a highly effective vaccine with a differentiated clinical profile, including the potential to only require a single dose for protection.”

About Arcturus Therapeutics

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, and Cardiovascular Disease along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (205 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS Medical School, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.

References

  1. ^ Teo J (15 April 2020). “Coronavirus: Clinical trials for Singapore’s vaccine project could start in August”The Straits Times. Retrieved 27 April 2020.
  2. ^ Stanton D (6 May 2020). “With Arcturus, Catalent bags another COVID project”Bioprocess Insider. Retrieved 8 May 2020.
  3. ^ Clinical trial number NCT04480957 for “Phase 1/2 Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects” at ClinicalTrials.gov
  4. ^ “Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the”. Bloomberg. 4 January 2021. Retrieved 17 January 2021.
  5. ^ Anwar N (26 November 2020). “Singapore’s co-developed vaccine candidate is in ‘good shape’ for delivery in 2021”. CNBC. Retrieved 18 March 2021.
  6. ^ Cheok M, Mookerjee I (5 August 2020). “Singapore Will Get First Claim to Any Successful Arcturus Vaccine”. Bloomberg. Retrieved 18 March 2021.

External links

Scholia has a profile for Lunar-COV19 (Q98713328).
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Other namesARCT-021, LUNAR-COV19
Routes of
administration
Intramuscular
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

/////////COVID-19, SARS-CoV-2, corona virus, singapore, ARCT 021, LUNAR-COV19

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IIBR-100


Coronavirus: Israel to start COVID-19 vaccine human trials on November 1 | Al Arabiya English

IIBR-100

Brilife

Recombinant vesicular stomatitis virus (rVSV) vaccine

Israel Institute for Biological Research

Hadassah Medical Center; Sheba Medical Center Hospital

The SARS-CoV-2 virus is responsible for the COVID-19 pandemic. The pandemic emerged from Wuhan Province in China in December 2019 and was declared by the WHO Director-General a Public Health Emergency of International Concern on 30 January 2020.

In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart.

Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) has begun, during which larger cohorts as well as elderly age subjects will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low, mid or high dose (prime-boost) or saline, 28 days apart. Additional top-dose (prime-boost) may be implemented when immunogenicity of any prime-boost arm is considered insufficient.

Based on immunogenicity preliminary data and DSMB recommendations, the two administrations of mid, high and top dose (prime-boost) or saline will continue.

The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.

https://clinicaltrials.gov/ct2/show/NCT04608305

IIBR-100 also known as Brilife is a COVID-19 vaccine candidate developed by The Israel Institute for Biological Research.[1][2]

References

  1. ^ Clinical trial number NCT04608305 for “Phase I/II Randomized, Multi-Center, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults” at ClinicalTrials.gov
  2. ^ Jeffay N (29 December 2020). “As Israel goes vaccine-wild, will the homegrown version lose its shot?”The Times of Israel. Retrieved 1 January 2021.

candidate developed by The Israel Institute for Biological Research.[1][2]

https://www.timesofisrael.com/israeli-institutes-vaccine-candidate-said-highly-effective-in-animal-trials/

Israeli institute’s COVID vaccine candidate said very effective in animal trials

Secretive Israeli research center’s shot shows near 100% efficacy in non-human trials, is on par with US company Moderna’s candidate, TV report says

Israeli researchers at a top secret research center have made progress on a coronavirus vaccine that shows a high level of effectiveness in animals, according to a Friday TV report.

However, there is no guarantee that the vaccine under development will be effective in humans, or will be available soon.

The Israel Institute for Biological Research (IIBR), a secretive unit that works under the Prime Minister’s Office, developed a vaccine that shows close to 100 percent protection against the virus in lab animals, the Channel 12 report said, citing “a security source.”

The vaccine under development is on par in effectiveness with a vaccine being developed by US biotechnology company Moderna, the report said.

Unlike vaccines developed abroad, the domestic vaccine will first be delivered to Israeli citizens, it added. If successful, it was expected to provide protection against the disease with a single dose.

The institute has not started human trials but was preparing to manufacture 10 to 15 million doses, report said.

Hebrew media have reported on potential breakthroughs at the shadowy institute several times before, starting in mid-March, with the Defense Ministry pushing back on some of the claims to tamper expectations.

Magen David Adom medical workers test Israelis for the coronavirus at a drive-through site in Lod, on July 10, 2020. (Yossi Aloni/Flash90)

IIBR said last month that it had completed successful coronavirus vaccine trials on rodents, paving the way for further testing on other animals and then possibly human trials.

In a paper published on the website of bioRxiv, an online repository for papers that haven’t yet been peer-reviewed, the institute, which is based in Ness Ziona, said it hopes to have a finished vaccine in a year, or possibly even earlier.

In the abstract of the report, the researchers say their vaccine, which they tested on hamsters, “results in rapid and potent induction of neutralizing antibodies against SARS-CoV-2,” the virus that causes COVID-19.

Earlier this month a vaccine adviser to the government cautioned that there was no guarantee that the shots being developed will prove widely effective.

In May, the institute confirmed that it had isolated an antibody it believed could be used to develop treatments against the virus. The development would not be useful in the creation of a vaccine, but would rather be a move toward a drug treatment for those who have already contracted the disease.

Tal Zaks, Moderna’s Israeli chief medical officer, described to Channel 12 on Friday the company’s push into Phase 3 testing of its vaccine candidate, which was developed with the National Institutes of Health, and began its first injections Monday.

The trial, the world’s largest vaccine study, plans to test the vaccine on 30,000 volunteers.

There’s still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Moderna Inc., will really offer protection.

“The first time we saw the first model, that the vaccine, even if it’s just in mice, successfully stimulated the immune system to identify the virus and neutralize it, I knew that we hadn’t missed anything, that we had the correct vaccine,” he said.

“And of course the second ‘ah-ha’ moment was when we saw the first clinical results, when it was clear that in humans we weren’t just getting to antibody levels we were seeing in sick people, which is what we aspired to, but we were getting to even higher levels,” Zaks said.

A Nurse gives a volunteer an injection, as the world’s biggest study of a possible COVID-19 vaccine, developed by the US National Institutes of Health and Moderna Inc., gets underway on July 27, 2020, in Binghamton, NY. (AP Photo/Hans Pennink)

Last month Israel signed a deal with Moderna for the potential purchase of its coronavirus vaccine if it ends up proving effective.

Moderna said the vaccination was administered in Savannah, Georgia, the first site to get underway among more than seven dozen trial sites scattered around the country.

Several other vaccines made by China and by Britain’s Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries.

The massive studies aren’t just to test if the shots work — they’re needed to check each potential vaccine’s safety. And following the same study rules will let scientists eventually compare all the shots.

It normally takes years to create a new vaccine from scratch, but scientists are setting speed records this time around, spurred by knowledge that vaccination is the world’s best hope against the pandemic.

If everything goes right with the final studies, it still will take months for the first data to trickle in from the Moderna test, followed by the Oxford one.

Governments around the world are trying to stockpile millions of doses of those leading candidates so if and when regulators approve one or more vaccines, immunizations can begin immediately. But the first available doses will be rationed, presumably reserved for people at highest risk from the virus.

Coronavirus cases in Israel rose by 1,791 in 24 hours on Friday and the national death toll hit 512, according to the latest Health Ministry figures.

The total case count stood at 70,970, with 320 patients in serious condition, including 98 on ventilators. The number of recovered patients reached 43,850.

Israel has the fifth-highest number of new coronavirus infections per capita in the world, overtaking the United States, according to data compiled by a scientific publication based at Oxford University.

And while Israel has seen the number of new coronavirus cases rocket to more than 2,000 a day in recent weeks, a new Hebrew University report published on Thursday asserted that Israel has managed to gain control of the second wave of the coronavirus, thanks to a recent stabilization in the number of seriously and moderately ill patients.

The curve for seriously and moderately ill patients began to spike in late June before stabilizing in recent days, the researchers reported. They credited the restrictions imposed by the government in recent weeks to limit crowding for helping to flatten the curve.

According to the report, the death toll will climb by roughly 200 in the coming three weeks as a result of the high infection rate over the past month.

Experts have blamed a too-speedy reopening and the lack of an effective contact-tracing program as main factors in the virus resurgence, which has come as new daily coronavirus cases around the world have also reached record highs.

Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Other namesBrilife
Routes of
administration
Intramuscular
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 virus (variants)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

//////IIBR-100, Brilife,  COVID-19,  vaccine,  israel, corona virus, covid 19, SARS-CoV-2

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ABDALA, CIGB-66


Cuban president praises progress of Abdala vaccine against Covid-19

ABDALA

CIGB-66, is a COVID-19 vaccine

Cuba says Abdala vaccine 92.28% effective against coronavirus

The announcement came just days after the government said another homegrown vaccine, Soberana 2, has proved to be 62% effective with just two of its three doses.

https://health.economictimes.indiatimes.com/news/industry/cuba-says-abdala-vaccine-92-28-effective-against-coronavirus/83735386

  • June 22, 2021, 10:03 IST

HavanaCuba said on Monday that its three-shot Abdala vaccine against the coronavirus has been proved 92.28% effective in last-stage clinical trials.

The announcement came just days after the government said another homegrown vaccine, Soberana 2, has proved to be 62% effective with just two of its three doses.

“Hit by the pandemic, our scientists at the Finlay Institute and Center for Genetic Engineering and Biotechnology have risen above all the obstacles and given us two very effective vaccines,” President Miguel Diaz-Canel tweeted.

The announcement came from state-run biopharmaceutical corporation BioCubaFarma, which oversees Finlay, the maker of Soberana 2, and the Center for Genetic Engineering and Biotechnology, the producer of Abdala.

Both vaccines are expected to be granted emergency authority by local regulators shortly.

Cuba, whose biotech sector has exported vaccines for decades, has five coronavirus vaccine candidates.

The Caribbean’s largest island is facing its worst Covid-19 outbreak since the start of the pandemic following the arrival of more contagious variants, setting new records for daily coronavirus cases.

The Communist-run country has opted not to import foreign vaccines but to rely on its own. Some experts said it was a risky bet but it appears to have paid off, putting Cuba in position to burnish its scientific reputation, generate much-needed hard currency through exports and strengthen the vaccination drive worldwide.

Several countries from Argentina and Jamaica to Mexico, Vietnam and Venezuela have expressed an interest in buying Cuba’s vaccines. Iran started producing Soberana 2 earlier this year as part of late-phase clinical trials.

Cuba’s authorities have already started administering the experimental vaccines en masse as part of “intervention studies” they hope will slow the spread of the virus.

About a million of the country’s 11.2 million residents have been fully vaccinated to date.

Daily cases have halved in the capital, Havana, since the start of the vaccination campaign a month ago, using Abdala, according to official data.

Cuba has reported a total of 169,365 Covid-19 cases and 1,170 deaths.

ABDALA, technical name CIGB-66, is a COVID-19 vaccine candidate developed by the Center for Genetic Engineering and Biotechnology in Cuba.[1][2] This vaccine candidate, named after a patriotic drama by Cuban independence hero José Martí, is a protein subunit vaccine containing COVID-derived proteins that trigger an immune response.[3] However, none of the clinical trial full results have been published. This candidate followed a previous one called CIGB-669 (MAMBISA).[4]

The vaccine is one of two Cuba-developed COVID-19 vaccines in Phase III trials.[5][6][7]

Clinical research

Phase I/II

In July 2020, CIGB-66 commenced phase I/II clinical trials.[8]

Phase III

The Phase III trial compares 3 doses of the vaccine administered at 0, 14 and 28 days against a placebo, with the primary outcome measuring the proportion of cases reported for each group 14 days after the third dose.

The trial was registered on 18 March 2021. The first dose was administered on 22 March and by April 4, the 48,000 participants had received their first dose,[9][10] and second doses started being administered from April 5.[11][12] Third doses have started being administered on 19 April[13][14][15] and on May 1, 97% of the original participants had received their 3 doses, the others 3% were lost in the process.

Intervention study

124,000 people aged 19 to 80 received 3 doses of the vaccine as part of an intervention study, with the primary outcome measuring the proportion of cases and deaths for the vaccinated compared to the unvaccinated population.[16]

A wider intervention study with the 1.7 million inhabitants of Havana is expected to start in May with the ABDALA and Soberana 2 vaccine.[17]

Efficacy

From May 3, the efficacy of the vaccine will start being evaluated.[18][19][20]

The “first evaluation of efficacy” can begin when there is 50 cases, then there is a second evaluation at 100 cases and a definitive efficacy can “finally be demonstrated” at 150 cases, Cuban Center for Genetic Engineering and Biotechnology director said.[21]

Production outside Cuba

Venezuela has claimed that it will manufacture the vaccine[22] but this claim has not yet materialised.[23] State-owned EspromedBIO will manufacture the vaccine but some “arrangements” are needed to start production.[24] In April, Nicolás Maduro said that a capacity of 2 Million doses per month is hoped to be reach by “August, September approximately”.[25

In June 2021, Vietnam’s Ministry of Health announced that negotiations were ongoing between Cuba and Vietnam for Abdala vaccine production. The Institute of Vaccines and Medical Biologicals (IVAC) was named as the focal point for receiving technology transfer.[26]

References

  1. ^ “ABDALA Clinical Study – Phase III”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
  2. ^ “ABDALA Clinical Study”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
  3. ^ Yaffe H (31 March 2021). “Cuba’s five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa”LSE Latin America and Caribbean blog. Retrieved 31 March 2021.
  4. ^ “MAMBISA Study”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
  5. ^ “Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III”http://www.bioworld.com. Retrieved 10 April 2021.
  6. ^ “Cuba’s Abdala COVID-19 vaccine enters phase 3 clinical trial – Xinhua | English.news.cn”http://www.xinhuanet.com. Retrieved 10 April 2021.
  7. ^ Zimmer C, Corum J, Wee SL. “Coronavirus Vaccine Tracker”The New York TimesISSN 0362-4331. Retrieved 10 April 2021.
  8. ^ “ABDALA Clinical Study”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 21 March 2021.
  9. ^ BioCubaFarma (4 April 2021). “[Translated] “The application of the 1st dose of #Abdala, in volunteer 48 thousand, of the Phase III Clinical Trial. Next Monday, April 5, the application of the 2nd dose of this vaccine candidate begins. #VcaunasCubanasCovid19 .””Twitter. Retrieved 10 April 2021.
  10. ^ “Covid Check-in: Cuba’s Homegrown Vaccines”AS/COA. Retrieved 10 April 2021.
  11. ^ BioCubaFarma (5 April 2021). “[Translated] “The application of the 2nd dose of the vaccine candidates begins today #Abdala and #Soberana02 , as part of the 3rd phase of the clinical trial. Workers of @Emcomed1 in Havana and eastern provinces, from very early hours they carry out their distribution until the vaccination centers””Twitter (in Spanish). Retrieved 10 April 2021.
  12. ^ “Two Cuban Vaccines Start Second Dose Phase III Trials”Kawsachun News. 5 April 2021. Retrieved 10 April 2021.
  13. ^ “Abdala: Comienza tercera dosis en el Oriente cubano”http://www.cuba.cu (in Spanish). Retrieved 21 April 2021.
  14. ^ BioCubaFarma. “[Translated] “Application of the 3rd dose of the vaccine candidate begins #Abdala in the provinces of Granma, Santiago de Cuba and Guantánamo. The application of the 2nd dose of #Soberana02 within the framework of the EC Phase III.#VacunasCubanasCovid19”Twitter. Retrieved 21 April 2021.
  15. ^ Noticias, Agencia Cubana de. “Convergen múltiples voluntades para éxito de estudio Abdala en Bayamo”ACN (in Spanish). Retrieved 21 April 2021.
  16. ^ “ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos”rpcec.sld.cu. Retrieved 10 April 2021.
  17. ^ Ministerio de Salud Pública en Cuba. “Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba”Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba (in Spanish). Retrieved 23 April 2021.
  18. ^ “Scientists announce Abdala’s administration of 3rd dose will finish”http://www.plenglish.com/index.php?o=rn&id=66941&SEO=scientists-announce-abdalas-administration-of-3rd-dose-will-finish (in Spanish). Retrieved 2 May 2021.
  19. ^ Noticias, Agencia Cubana de. “Concluye aplicación de vacuna Abdala en Oriente de Cuba”ACN (in Spanish). Retrieved 2 May2021.
  20. ^ “Cuba conclui ensaios clínicos de candidata a vacina contra covid-19”R7.com (in Portuguese). 2 May 2021. Retrieved 2 May2021.
  21. ^ “Abdala cerca de concluir la fase III de ensayos clínicos; Mambisa se alista para avanzar a nueva fase (+Video)”Granma.cu (in Spanish). Retrieved 3 May 2021.
  22. ^ “Cuba says it’s ‘betting it safe’ with its own Covid vaccine”NBC News. Retrieved 10 April 2021.
  23. ^ “Maduro struggles to make his grand vaccine promise”Eminetra.co.uk. 2 May 2021. Retrieved 3 May 2021.
  24. ^ “Venezuela producirá la vacuna cubana anticovid Abdala”http://www.efe.com (in Spanish). Retrieved 3 May 2021.
  25. ^ Apr 11, Reuters /; 2021; Ist, 16:27. “Indonesian President orders Java rescue efforts after quake kills 8 – Times of India”The Times of India. Retrieved 3 May 2021.
  26. ^ Ministry of Health Vietnam (16 June 2021). “Bộ trưởng Bộ Y tế đàm phán với Cuba về hợp tác sản xuất vaccine”giadinh.net.vn(in Vietnamese). Retrieved 17 June 2021.

External links

Scholia has a profile for Abdala (Q106390652).
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Other namesABDALA
Routes of
administration
Intramuscular
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 virus (variants)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

//ABDALA, CUBA, CIGB-66,  COVID-19,  vaccine, CORONA VIRUS, SARS-CoV-2

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Convidicea (Ad5-nCoV)


A vial of Convidecia vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesConvidecia
Routes of
administration
IntramuscularIntranasal
ATC codeNone
Legal status
Legal statusFull and Emergency authorizations
Identifiers
DrugBankDB15655

Convidicea (Ad5-nCoV)

Recombinant vaccine (adenovirus type 5 vector)

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

CanSino Biologics, china

see https://covid19.trackvaccines.org/vaccines/2/

AD5-nCOV, trade-named Convidecia, is a single-dose[1] viral vector vaccine for COVID-19 developed by CanSino Biologics. It conducted its Phase III trials in Argentina,[2] Chile,[3] Mexico,[4] Pakistan,[5] Russia,[6] and Saudi Arabia[7] with 40,000 participants.

In February 2021, global data from Phase III trials and 101 COVID cases showed that the vaccine had a 65.7% efficacy in preventing moderate symptoms of COVID-19, and 91% efficacy in preventing severe disease.[8] It has similar efficacy to Johnson & Johnson’s Ad26.COV2.S, another one-shot adenovirus vector vaccine with 66% efficacy in a global trial.[9][1] Convidecia is similar to other viral vector vaccines like AZD1222Gam-COVID-Vac, and Ad26.COV2.S.[10] Its single-dose regimen and normal refrigerator storage requirement (2°to 8 °C) could make it a favorable vaccine option for many countries.[9]

Convidecia is approved for use by some countries in Asia,[11][12][13] Europe,[14][15] and Latin America.[16][17][18] Production capacity for Ad5-NCov should reach 500 million doses in 2021. Manufacturing will take place in China,[19] Malaysia,[13] Mexico,[20] and Pakistan.[21]

Ad5-nCoV is a recombinant adenovirus type-5 vector (Ad5) vaccine currently being investigated for prophylaxis against SARS-CoV-2.1,2 It is being developed by CanSino Biologics Inc., in partnership with the Beijing Institute of Biotechnology, who in March 2020 announced the approval of a phase I clinical trial (ChiCTR2000030906)1 with an expected completion in December 2020. The study will evaluate antibody response in healthy patients between the ages of 18 and 60 who will receive one of three study doses, with follow-up taking place at weeks 2 and 4 and months 3 and 6 post-vaccination.2

  1. Chinese Clinical Trial Register: A phase I clinical trial for recombinant novel coronavirus (2019-COV) vaccine (adenoviral vector) [Link]
  2. Antibody Society: COVID-19 Archives [Link]

Technology

Convidecia is a viral vector vaccine similar to AstraZeneca‘s AZD1222 and Gamaleya‘s Gam-COVID-Vac.[10] Ad5-nCOV can be stored in less extreme cold conditions compared to mRNA vaccines.[22][9]

Efficacy

In February 2021, data released from an interim analysis of Phase III trials with 30,000 participants and 101 COVID cases showed that globally, the vaccine had an efficacy of 65.7% at preventing moderate cases of COVID-19 and 90.98% efficacy at preventing severe cases. In the Pakistan trial subset, the vaccine had an efficacy of 74.8% at preventing symptomatic cases 100% for preventing severe disease.[8]

While the efficacy rates were lower than the Pfizer–BioNTech and Moderna vaccines, its single-dose regimen and normal refrigerator storage requirement (2 to 8 °C) could make it a favorable option for many countries. It has similar efficacy to Johnson & Johnson’s Ad26.COV2.S, another one-shot adenovirus vaccine found to be 66% effective in a global trial.[9][1]

Clinical trials

Phase I-II

In early 2020, Chen Wei led a joint team of the Institute of Biotechnology, the Academy of Military Medical Sciences and CanSino Biologics to develop AD5-nCOV. According to the Chinese state media, the team registered an experimental COVID-19 vaccine for Phase I trial in China on 17 March 2020 to test its safety. The trial was conducted on 108 healthy adults aged 18 to 60 in two medical facilities in WuhanHubei province.[23]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials.[24] The Phase II trial results were published in the peer-reviewed journal The Lancet in August 2020, and noted neutralizing antibody and T cell responses based on statistical analyses of data involving 508 eligible participants.[25] In September, Zeng Guang, chief scientist of the Chinese Center for Disease Control and Prevention said the amount of COVID-19 antibodies in subjects from the Phase I trials remained high six months after the first shot. Zeng said the high levels of antibodies suggested the shots may provide immunity for an extended period of time, although Phase III results were still required.[26] On September 24, CanSino began Phase IIb trials on 481 participants to evaluate the safety and immunogenicity of Ad5-nCoV for children ages 6–17 and elderly individuals ages 56 and above.[27]

In August, China’s National Intellectual Property Administration issued the country’s first COVID-19 vaccine patent to CanSino.[28]

On 16 May 2020, Canadian Prime Minister Justin Trudeau announced Health Canada had approved Phase II trials to be conducted by the Canadian Center for Vaccinology (CCfV) on the COVID-19 vaccine produced by CanSino. Scott Halperin, director of the CCfV said the vaccine would not be the only one going into clinical trials in Canada, and any potential vaccine would not be publicly available until after Phase 3 is complete.[29][30] If the vaccine trials were successful, then the National Research Council would work with CanSino to produce and distribute the vaccine in Canada.[30] In August 2020, the National Research Council disclosed the vaccine had not been approved by Chinese customs to ship to Canada, after which the collaboration between CanSino and the Canadian Center for Vaccinology was abandoned.[31]

Nasal spray trials

In September, CanSino began a Phase I trial in China with 144 adults to determine the safety and immunogenicity of the vaccine to be administered as a nasal spray, in contrast with most COVID-19 vaccine candidates which require intramuscular injection.[32] On June 3, 2021, Chen Wei announced the expansion of clinical trials was approved by the NMPA, in the meantime, they are applying for Emergency Use Listing for the nasal spray.[33]

Phase III

In August, Saudi Arabia confirmed it would begin Phase III trials on 5,000 people for Ad5-nCoV in the cities of Riyadh, Dammam, and Mecca.[7]

In October, Mexico began Phase III trials on 15,000 volunteers.[34][4]

In September, Russia began Phase III trials on 500 volunteers,[35] which Petrovax later received approval from the government to expand to 8,000 more volunteers.[36][6]

In September, Pakistan began Phase III trials on 40,000 volunteers as part of a global multi-center study.[5] As of December, about 13,000 volunteers have participated in trials of Ad5-nCoV.[22]

In November, Chile began Phase III trials on 5,200 volunteers to be managed by University of La Frontera.[37][3]

In December, Argentina’s Fundación Huésped began Phase III trials in 11 health centers in the metropolitan area of Buenos Aires and Mar del Plata.[2]

Combination trials

In April 2021, a new trial was registered in Jiangsu involving one dose of Convidecia followed by a dose of ZF2001 28 or 56 days later using different technologies as a way to further boost efficacy.[38]

Manufacturing

In February, Chen Wei who lead the development of the vaccine, said annual production capacity for Ad5-NCov could reach 500 million doses in 2021.[19]

In February, Mexico received the first batch of active ingredients for Convidecia, which is being packaged in Querétaro by Drugmex.[20]

In Malaysia, final filling and packaging of the vaccine for distribution would be completed by Solution Biologics.[13]

In May, Pakistan began filling and finishing 3 million doses a month at the National Institute of Health, which would be branded as PakVac for domestic distribution.[39]

If the vaccine is approved in Russia, Petrovax said it would produce 10 million doses per month in 2021.[40]

Marketing and deployment

 
  Full authorization  Emergency authorization  Eligible COVAX recipient (ongoing assessment)[41]

See also: List of COVID-19 vaccine authorizations § Convidecia

Asia

On 25 June 2020, China approved the vaccine for limited use by the military.[42] In February 2021, China approved the vaccine for general use.[11]

In February, Malaysia‘s Solution Biologics agreed to supply 3.5 million doses to the government.[43] The doses would be delivered starting in April with 500,000 complete doses, with the rest in bulk to be finished by Solution Biologics.[13]

In October, Indonesia reached an agreement with CanSino to deliver 100,000 doses in November 2020, with the expectation that an additional 15 to 20 million doses would be delivered in 2021.[44]

In February, Pakistan approved the vaccine for emergency use.[45] The country purchased 20 million doses of the vaccine[12] of which the first 3 million doses are to arrive in May.[12]

Europe

In March, Hungary granted emergency use approval for the vaccine.[14]

In March, Moldova authorized use of the vaccine.[46]

North America

In December 2020, Mexico‘s Foreign Minister Marcelo Ebrard signed an agreement for 35 million doses.[47] In February, Mexico approved the vaccine for emergency use.[48] Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February.[16]

South America

In June, Argentina approved emergency use of the vaccine and ordered 5.4 million doses.[17]

In June, Brazil announced plans to purchase 60 million doses.[49] In May, Brazil began reviewing the vaccine for emergency use.[50]

In March, Chile signed a deal for 1.8 million doses for delivery between May and June,[51] for which emergency use approval was granted in April.[18]

In June, Ecuador approved emergency use and ordered 6 million doses for delivery between June and August 2021.[52]

References

  1. Jump up to:a b c “It’s not just Johnson & Johnson: China has a single-dose COVID-19 vaccine that has 65% efficacy”Fortune. Retrieved 2021-02-11.
  2. Jump up to:a b “Comenzará en la Argentina un nuevo estudio de vacuna recombinante contra el SARS-CoV-2”infobae (in Spanish). 14 December 2020. Retrieved 2020-12-15.
  3. Jump up to:a b “Gob.cl – Article: Science Minister: “We Work With Maximum Rigor So That Science And Technology Benefit People’S Health””Government of Chile. Retrieved 2020-11-21.
  4. Jump up to:a b “Chinese Covid vaccine trials to be expanded to five more states”Mexico News Daily. 2020-11-10. Retrieved 2020-11-11.
  5. Jump up to:a b “Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 2020-10-21.
  6. Jump up to:a b Reuters Staff (2020-12-07). “Russia approves clinical trials for Chinese COVID-19 vaccine Ad5-Ncov: Ifax”Reuters. Retrieved 2020-12-07.
  7. Jump up to:a b Eltahir N (9 August 2020). “CanSino to start Phase III trial of COVID-19 vaccine in Saudi”Reuters. Retrieved 9 August 2020.
  8. Jump up to:a b “CanSinoBIO’s COVID-19 vaccine 65.7% effective in global trials, Pakistan official says”Reuters. 8 February 2021. Retrieved 2021-02-08.
  9. Jump up to:a b c d “China’s CanSino Covid Vaccine Shows 65.7% Efficacy”Bloomberg.com. 2021-02-08. Retrieved 2021-02-10.
  10. Jump up to:a b Zimmer C, Corum J, Wee SL (2020-06-10). “Coronavirus Vaccine Tracker”The New York TimesISSN 0362-4331. Retrieved 2020-12-12.
  11. Jump up to:a b Liu R (2021-02-25). “China approves two more domestic COVID-19 vaccines for public use”Reuters. Retrieved 2021-02-26.
  12. Jump up to:a b c “Pakistan purchases over 30 million COVID doses from China: sources”ARY NEWS. 2021-04-25. Retrieved 2021-04-26.
  13. Jump up to:a b c d “Malaysia to receive CanSino vaccine this month | The Malaysian Insight”http://www.themalaysianinsight.com. Retrieved 2021-04-03.
  14. Jump up to:a b Ashok R (2021-03-22). “UPDATE 2-China’s CanSino Biologics COVID-19 vaccine receives emergency use approval in Hungary”Reuters. Retrieved 2021-03-22.
  15. ^ “Membrii NITAG au venit cu recomandări privind utilizarea vaccinurilor împotriva COVID-19 în Republica Moldova”Ministerul Sănătății, Muncii și Protecţiei Sociale. 2021-03-03. Retrieved 2021-05-21.
  16. Jump up to:a b “‘Our gratitude always’: From China’s CanSino, Mexico welcomes biggest vaccine shipment yet”Reuters. 2021-02-11. Retrieved 2021-02-11.
  17. Jump up to:a b “Argentina issues emergency approval to China’s single-dose Cansino COVID-19 vaccine”Reuters. 2021-06-11. Retrieved 2021-06-11.
  18. Jump up to:a b “ISP Approves Emergency Use And Importation Of Cansino Vaccine To Fight COVID-19”Institute of Public Health of Chile. Retrieved 2021-04-08.
  19. Jump up to:a b “China can hit 500-mln-dose annual capacity of CanSinoBIO COVID-19 vaccine this year”finance.yahoo.com. Retrieved 2021-02-28.
  20. Jump up to:a b Solomon DB (2021-02-28). “China’s CanSino says first vaccines packaged in Mexico will be ready in March”Reuters. Retrieved 2021-03-12.
  21. ^ “Pakistan develops homemade anti-Covid vaccine ‘PakVac'”The Express Tribune. 2021-05-24. Retrieved 2021-05-25.
  22. Jump up to:a b Constable P, Hussain S. “Defying fears and skepticism, thousands in Pakistan volunteer for Chinese vaccine trials”The Washington PostISSN 0190-8286. Retrieved 2021-01-01.
  23. ^ Cui J (23 March 2020). “Human vaccine trial gets underway”China Daily. Retrieved 18 April 2020.
  24. ^ Xie J (15 April 2020). “China Announces Phase 2 of Clinical Trials of COVID-19 Vaccine”Voice of America. Retrieved 18 April2020.
  25. ^ Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, et al. (August 2020). “Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial”Lancet396 (10249): 479–488. doi:10.1016/S0140-6736(20)31605-6PMC 7836858PMID 32702299.
  26. ^ O’Brien E (2020-09-25). “Covid Antibodies Endure Over Six Months in China Trial Subjects”http://www.bloomberg.com. Retrieved 2020-09-29.
  27. ^ “Phase IIb Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 2020-10-21.
  28. ^ Yu S (17 August 2020). “China grants country’s first COVID-19 vaccine patent to CanSino: state media”Reuters. Retrieved 17 August 2020.
  29. ^ Bogart N (16 May 2020). “Health Canada approves first clinical trial for potential COVID-19 vaccine”CTV News. Retrieved 7 September 2020.
  30. Jump up to:a b Ryan H (May 16, 2020). “Canada’s first COVID-19 vaccine trials approved for Halifax university”CBC News. Retrieved January 4, 2021.
  31. ^ Cooke A (26 August 2020). “Canadian COVID-19 clinical trial scrapped after China wouldn’t ship potential vaccine”CBC News. Retrieved 7 September 2020.
  32. ^ “A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 25 September 2020.
  33. ^ Cao X, Liu Y (2021-06-04). “陈薇院士:雾化吸入式新冠疫苗正在申请紧急使用”Sci Tech Daily. Chinanews.com. Retrieved 2021-06-04.
  34. ^ “México recibe el primer lote de la vacuna candidata de CanSino Biologics; alistan pruebas”EL CEO (in Spanish). 2020-11-03. Retrieved 2020-11-03.
  35. ^ “Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19 – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 2020-10-21.
  36. ^ Bloomberg News (2020-11-25). “Russia’s Richest Man Seeks Global Market for Local Covid-19 Drug – BNN Bloomberg”BNN. Retrieved 2020-11-28.
  37. ^ Yáñez PL (2020-11-15). “Así funcionan las cuatro vacunas que se probarán en Chile”La Tercera. Retrieved 2020-11-17.
  38. ^ “China trials mixing of CanSinoBIO’s and Zhifei Longcom’s COVID-19 vaccines -data”Reuters. 2021-04-19. Retrieved 2021-06-16.
  39. ^ “Covid vaccine: Pakistan starts production of CanSino, China’s single-dose jab”Khaleej Times. Retrieved 2021-05-28.
  40. ^ “Russian Recruits Show ‘No Side Effects’ in Chinese Coronavirus Vaccine Trials”The Moscow Times. 2020-09-21. Retrieved 2020-09-22.
  41. ^ “Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process”World Health Organization (WHO).
  42. ^ Reuters Staff (2020-06-29). “CanSino’s COVID-19 vaccine candidate approved for military use in China”Reuters. Retrieved 2020-12-13.
  43. ^ Reuters Staff (2021-02-04). “Malaysia’s Solution Group to supply 3.5 million doses of CanSino vaccine to government”Reuters. Retrieved 2021-02-04.
  44. ^ Taufiqurrahman M. “Indonesia can be manufacutring hub for COVID-19 vaccine, says Chinese foreign minister”. Jakarta Post. Retrieved 13 October 2020.
  45. ^ Shahzad A (2021-02-12). “Pakistan approves Chinese CanSinoBIO COVID vaccine for emergency use”Reuters. Retrieved 2021-02-12.
  46. ^ “Membrii NITAG au venit cu recomandări privind utilizarea vaccinurilor împotriva COVID-19 în Republica Moldova”Ministerul Sănătății, Muncii și Protecţiei Sociale. 2021-03-03. Retrieved 2021-05-21.
  47. ^ Reuters Staff (2020-12-10). “Mexico agrees to buy 35 million doses of CanSino COVID vaccine”Reuters. Retrieved 2020-12-10.
  48. ^ “Mexico approves China’s CanSino and Sinovac COVID-19 vaccines”Reuters. 10 February 2021.
  49. ^ “Brazil to buy single-shot Chinese COVID-19 vaccine”Reuters. 2021-06-15. Retrieved 2021-06-16.
  50. ^ “Brazil in vaccine talks with Moderna, reviewing CanSino shot”Reuters. 2021-05-19. Retrieved 2021-05-21.
  51. ^ Sherwood D (2021-03-30). “Chile inks deal for 1.8 million doses of CanSino COVID-19 vaccine as inoculation drive plows ahead”Reuters. Retrieved 2021-03-30.
  52. ^ Valencia A. “Ecuador authorizes use of China’s CanSino vaccine against COVID-19”Reuters. Retrieved 2021-06-16.

Further reading

External links

Scholia has a profile for Ad5-nCoV (Q96695265).

/////////Convidicea, Ad5-nCoV, Recombinant vaccine, adenovirus type 5 vector, CanSino Biologics, china, SARS-CoV-2, corona virus, vaccine, covid 19

Convidecia

 
  Full authorization  Emergency authorization  Eligible COVAX recipient (ongoing assessment)[2]

Convidecia is a viral vector vaccine[478] produced by the Chinese company CanSino Biologics and the Beijing Institute of Biotechnology of the Academy of Military Medical Sciences.Full (1)

  1. China[479]

Emergency (8)

  1. Argentina[480]
  2. Chile[481]
  3. Ecuador[482]
  4. Hungary[483][272]
  5. Malaysia[484]
  6. Mexico[436]
  7. Moldova[229]
  8. Pakistan[485]

wdt-17

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EpiVacCorona


Russia approves 2nd coronavirus vaccine "EpiVacCorona"

Origin of EpiVacCorona antigenes

  1. MKIEEGKLVIWINGDKGYNGLAEVGKKFEKDTGIKVTVEHPDKLEEKFPQVAATGDGPDIIFWAHDRFGGYAQSGLLAEITPDKAFQDKLYPFTWDAVRYNGKLIAYPIAVEALSLIYNKDLLPNPPKTWEEIPALDKELKAKGKSALMFNLQEPYFTWPLIAADGGYAFKYENGKYDIKDVGVDNAGAKAGLTFLVDLIKNKHMNADTDYSIAEAAFNKGETAMTINGPWAWSNIDTSKVNYGVTVLPTFKGQPSKPFVGVLSAGINAASPNKELAKEFLENYLLTDEGLEAVNKDKPLGAVALKSYEEELAKDPRIAATMENAQKGEIMPNIPQMSAFWYAVRTAVINAASGRQTVDEALKDAQTNSSSNNNNNNNNNNLGDNGPQNQRNAPRITFGGPSDSTGSNQNGERSGARSKQRRPQGLPNNTASWFTALTQHGKEDLKFPRGQGVPINTNSSPDDQIGYYRRATRRIRGGDGKMKDLSPRWYFYYLGTGPEAGLPYGANKDGIIWVATEGALNTPKDHIGTRNPANNAAIVLQLPQGTTLPKGFYAEGSRGGSQASSRSSSRSRNSSRNSTPGSSRGTSPARMAGNGGDAALALLLLDRLNQLESKMSGKGQQQQGQTVTKKSAAEASKKPRQKRTATKAYNVTQAFGRRGPEQTQGNFGDQELIRQGTDYKHWPQIAQFAPSASAFFGMSRIGMEVTPSGTWLTYTGAIKLDDKDPNFKDQVILLNKHIDAYKTFPPTEPKKDKKKKADETQALPQRQKKQQTVTLLPAADLDDLSKQLQQSMSSADSTQA. “Carrier protein sequence”.

EpiVacCorona

Federal Budgetary Research Institution State Research Center of Virology and Biotechnology

peptide, russia

PATENT https://www.fips.ru/registers-doc-view/fips_servlet?DB=RUPAT&DocNumber=2743594&TypeFile=htmlRU 2 743 594 RU 2 743 593RU 2 743 595 RU 2 738 081 Science (Washington, DC, United States) (2021), 372(6538), 116-117. 

EpiVacCorona (Russian: ЭпиВакКорона, tr. EpiVakKorona) is a peptide-based vaccine against COVID-19 developed by the VECTOR center of Virology.[1][2][3] It consists of three chemically synthesized peptides (short fragments of a viral spike protein) that are conjugated to a large carrier protein. This protein is a fusion product of a viral nucleocapsid protein and a bacterial MBP protein.The third phase of a clinical trial, which should show whether the vaccine is able to protect people from COVID-19 or not, was launched in November 2020 with more than three thousand participants.[2] It is assumed it will be completed in August 2021.[2] According to the vaccine developers, the peptides and the viral part of the chimeric protein should immunize people who received this vaccine against SARS-CoV-2 and trigger the production of protective antibodies. However, some experts in the field have expressed concerns about the selection of peptides for use as vaccine antigens.[3][4] In addition, there are also serious concerns about the vaccine immunogenicity data, which have fueled independent civic research efforts[5][6][7] and criticism by some experts.[3][8][4][9][10] Meanwhile, the EpiVacCorona has received vaccine emergency authorization in a form of government registration and is available for vaccination outside the clinical trials.[11] The vaccine delivered via intramuscular route and aluminum hydroxide serves as an immunological adjuvant.

Description[edit]

Origin of EpiVacCorona antigenes

Composition

The vaccine includes three chemically synthesized short fragments of the viral spike protein – peptides, which, according to the developers of EpiVacCorona represent the protein regions containing B-cell epitopes that should be recognized by the human immune system.

These peptides are represented by following amino acid sequences:

1) CRLFRKSNLKPFERDISTEIYQAGS, 2) CKEIDRLNEVAKNLNESLIDLQE, 3) CKNLNESLIDLQELGKYEQYIK.[1][12][13]

In the vaccine all peptides are conjugated to a carrier protein, which is an expression product of the chimeric gene. This chimeric gene was created by fusion of two genes originating from different organisms, namely a gene encoding a viral nucleocapsid protein and a gene encoding a bacterial maltose-binding protein (MBP). The fusion chimeric gene expressed in Escherichia coli. The sequence of the chimeric protein is available from the patent.[4] The genetic construct of the chimeric gene also includes a short genetic fragment encoding a polyhistidine-tag, which is used to purify the chimeric protein from E. coli lysate. After the purification, the protein is conjugated with three peptides in a way that only one variant of the peptide molecule is attached to each protein molecule. As a result, three types of conjugated molecules are created: chimeric protein with attached peptide number 1, the same protein with peptide number 2, and finally the same protein with peptide number 3. All three types of conjugated molecules are included in the vaccine.[citation needed]

EpiVacCorona: antigens origin and composition

Vaccine antigens and antibodies

According to the developers’ publications,[14][5][6] vaccine antigens are three peptides of the spike protein and a chimeric protein consisting of two parts (viral nucleocapsid protein and bacterial maltose-binding protein). In addition, the polyhistidine-tag – a short peptide that is introduced into a vaccine composition to purify a chimeric protein from a bacterial lysate – is also a vaccine antigen against which antibodies can form in those who have received the vaccine. A person vaccinated with EpiVacCorona can develop antibodies not only to the peptides of the spike protein, but also to other antigens present in the vaccine. According to Anna Popova who is a head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare, it takes 42 days for those vaccinated with EpiVacCorona to develop immunity.[15]

figure2

Development

Immunogenic peptide screening in rabbits for EpiVacCorona design

Preclinical studies

The primary screening of peptides for the search for the most immunogenic ones was carried out in animals. The level of antibodies that was triggered by each tested peptide after administration to rabbits was measured. In the test, hemocyanin protein was used as a carrier protein for the studied peptides. Further, on six species of animals (mice, rats, rabbits, African green monkeys, rhesus monkeys, guinea pigs), the vaccine was shown to be harmless in terms of such parameters as general toxicity, allergic properties, and mutagenic activity. In four species of animals (hamsters, ferrets, African green monkeys, rhesus monkeys), specific activity was shown: immunogenicity and protective properties against SARS-CoV-2. The main results of preclinical studies are published in the “Bulletin of the Russian Academy of Medical Sciences”.[12][13]

Clinical studies

The studies development timeline was reported in Russian media in January 2021.[16] There are currently two clinical trials of EpiVacCorona registered in the ClinicalTrials.gov database.[17][18][2]

Phase I-II

The trial “Study of the Safety, Reactogenicity and Immunogenicity of “EpiVacCorona” Vaccine for the Prevention of COVID-19 (EpiVacCorona)”[18] was registered in clinical trial database with ClinicalTrials.gov identifier: NCT04780035. Another trial with the same title was registered with ClinicalTrials.gov Identifier: NCT04527575. Results of the trial that included data on 86 participants were published in Russian Journal of Infection and Immunity, indicating preliminary evidence of safety and an immune response.[1] The publication reports preliminary results of the first two phases of clinical trials of the vaccine in volunteers, of which 14 people aged 18-30 years participated in the first phase, and 86 volunteers aged 18-60 years in the second phase. It is claimed that antibodies were formed in 100% of the volunteers, and the vaccine is also claimed to be safe.[1]

EpiVacCorona Vaccine Development Timeline

Phase III

The third phase of a clinical trial, which should show whether the vaccine is able to protect people from COVID-19 or not, was launched in November 2020 with more than three thousand participants planned. It is expected to be completed in September 2021.[2] In the clinical trials database the phase III trial etitled “Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19[2]” was registered only in March 2021 with ClinicalTrials.gov Identifier: NCT04780035. Phase 3-4 trial was registered in Russia at 18.11.2020 with 4991 participants planned.[19]

Intellectual property

The following patents of the Russian Federation for invention have been published, which protect the EpiVacCorona vaccine:

Peptide immunogens and vaccine composition against coronavirus infection COVID-19 using peptide immunogens” (No. 2738081). There are 7 peptides in patented vaccine compositions.

Peptide immunogens and vaccine composition against coronavirus infection COVID-19 using peptide immunogens” (No. 2743593). The patented vaccine composition contains 2 peptides.

Peptide immunogens used as a component of a vaccine composition against coronavirus infection COVID-19″ (No. 2743594). The patented vaccine composition contains 3 peptides.

Vaccine composition against coronavirus infection COVID-19″ (No. 2743595). The patented vaccine composition contains 3 peptides.

In all of these patents, the carrier protein is referred to as a chimeric fusion protein with an amino acid sequence derived from two parts, a bacterial maltose binding protein and a viral nucleocapsid protein.[20]

EpiVacCorona vaccine registration certificate

Authorization

 
  Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § EpiVacCorona

The VECTOR has received vaccine emergency authorization in a form of government registration in October 2020.[21]

In Russia phase III clinical study is called post-registration study. Therefore, government registration of the vaccine means permission to perform phase III clinical research and public vaccination outside of clinical trials as well.[21] Since December 2020, the vaccine has been released for public vaccination in Russia.[22]

As of March 2021, Turkmenistan is the only foreign state to register EpiVacCorona with full authorization.[23][24]

Russia’s Chief Health Officer Anna Popova said: “In December 2020 the EpiVacCorona documents were presented to the World Health Organization, and we are expecting a decision from WHO.”[25] However, Deutsche Welle reports “As of March 1, the WHO had yet to receive an Expression of Interest (EOI) from EpiVacCorona’s developers, “VECTOR,” to enable WHO experts to evaluate their vaccine.”[26]

Export

The Deputy Director-General of the World Health Organization (WHO) Dr. Soumya Swaminathan during news conference in Geneva that took place in October 2020, told: “We will only be able to have a position on a vaccine when we see results of the phase III clinical trials.”[27] According to the center’s director Rinat Maksyutov, many government and non-government organizations want to test or be involved in the production of the vaccine.[28] As of March 30, Venezuela obtained 1000 doses of the Russian EpiVacCorona vaccine for a trial.[29] Venezuela also has reached a deal to purchase doses of the vaccine, as well as manufacture it locally, Vice President Delcy Rodriguez provided this information on June 4, 2021.[30] Turkmenistan expects to receive EpiVacCorona, as the vaccine has already been approved for use in that country.[31]

Controversy

Independent study of clinical trial participants

Ministry of Health’s response to a request from trial participants to perform independent antibody screening tests

English translation of Ministry of Health’s response to a request from trial participants to perform independent antibody screening tests.

At the start of the Phase III, trial participants and those vaccinated outside the trial began to form a community through the Telegram messenger network. On January 18, 2021, the members of the community turned to the Ministry of Health of the Russian Federation with an open letter, in which they stated that the production of antibodies after vaccination among them is much lower than declared by vaccine developers. Study participants claimed that antibodies were not found in more than 50% of those who documented their participation in the study, although only 25% of the participants should have had a placebo according to the study design. The trial participants also claimed that negative results were obtained using the a special ELISA test developed and recommended by VECTOR for EpiVacCorona detection.[5][6][4] More questions about the quality and protectiveness of antibodies induced by EpiVacCorona appeared along with the first results of a special antibody VECTOR’s test, when, with a positive special test, negative results of all other commercially available tests were otained: LIAISON SARS-CoV-2 S1 / S2 IgG – DiaSorin, IgM / IgG – Mindray, SARS-CoV-2 IgG – Abbott Architect, Anti-SARS-CoV-2 ELISA (IgG) – Euroimmun, Access SARS-CoV-2 IgG (RBD) – Beckman Coulter, “SARS-CoV-2-IgG-ELISA -BEST “-” Vector-Best “,” Anti-RBD IgG “- Gamaleya Research Center.[5][6][4][8] Clinical trial participants conducted their own antibody mini-study that was performed in independent Russian laboratory. The study participants asked Dr. Alexander Chepurnov, the former head of the infectious diseases department at VECTOR, who now works at another medical institute, to check neutralizing antibodies presence in their serum samples.[3] They also sent to Dr. Chepurnov control serum samples from former COVID-19 patients or people vaccinated with another Russian vaccine, Sputnik V, which is known to trigger the production of neutralizing antibodies.[32] All serum samples were blinded before antibody tests. On 23 March 2021, the participants reported the results of their mini-study in an open letter to the Ministry of Health of the Russian Federation.[6][7] According to the letter, even with the help of the VECTOR antibody detection system, antibodies were detected only in 70-75% of those vaccinated with EpiVacCorona. However, the level of antibodies was very low. Moreover, according to the letter, virus-neutralizing antibodies were not detected in the independent research Dr. Alexander Chepurnov laboratory at all.[3][6][7] The trial participants asked Ministry of Health in their open letter to perform independent study for the verification of their findings.[3][6][7] In addition, the letter reports 18 cases of COVID-19 cases as of March 22, 2021 among those who received the vaccine and became ill (sometimes severe) three weeks or later after the second dose of EpiVacCorona.[33][6][7] April 20, 2021 the study participants got a reply, with refusal of performing any additional verification antibody tests or investigation of sever COVID-19 cases among vaccinated individuals. The reply include the following text: “Considering that the listed immunobiological preparations (vaccines) for the prevention of COVID-19 are registered in the prescribed manner, their effectiveness and safety have been confirmed.”

Vaccine criticism by independent experts

Some independent experts criticized the vaccine design[3][4] and clinical data presentation in the publication.[8][9][10] The experts are saying that peptide selection is “crucial” for the innovative peptide approach, which VECTOR uses for EpiVacCorona design. However, some researchers are not convinced that the viral spike protein peptides selected for the vaccine are actually “visible” by human immune system.[3][4][34] They stated that these peptides do not overlap[35] with peptides that have been shown in several publications to contain human linear B cell epitopes in spike protein of SARS-CoV-2.[36][37][38][39][40] Moreover, the study was criticized for the lack of positive control of convalescent plasma samples in reports related to neutralizing antibody titers in vaccinated individuals.[1][10] The same study was also criticized for presence of detectable antibodies in negative controls samples that were not discussed by authors.[1][10] In addition, vaccine developers have been criticized for aggressively advertising their vaccine efficacy prior to the completion of phase III clinical trial. The most substantial criticism came from Dr. Konstantin Chumakov, who currently serves as the Associate Director for Research at the FDA Office of Vaccines Research and Review. Dr. Chumakov said: “I would not be in a hurry to call this peptide formulation a vaccine yet, because its effectiveness has not yet been proven…For the introduction of such a vaccine, the level of evidence must be much higher, and therefore the developers of EpiVacCorona, before launching their vaccine on the market, had to conduct clinical trials and prove that their vaccine actually protects against the disease. However, such tests were not carried out, which is absolutely unacceptable.”[41]

The title page of the “EpiVacCorona” patent with Anna’s Popova name among inventors

Conflict of interest

The vaccine design was protected by several already issued patents (see section above). In each patent one of its co-authors is a namesake of Anna Popova who is a head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare. This patent authorship represents an issue as far as Anna Popova is a head of the Russian agency that is charged with overseeing vaccine safety and efficacy. As a co-author of these patents, she might have an interest in promoting the vaccine despite its shortcomings.

References

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External links

EpiVacCorona vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typePeptide subunit
Clinical data
Trade namesEpiVacCorona
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusRegistered in Russia on 14 October 2020 RU Registered.TU approved.Full list : List of EpiVacCorona COVID-19 vaccine authorizations
Identifiers
DrugBankDB16439
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

EpiVacCorona Vaccine, developed by the Vektor State Research Center of Virology and Biotechnology in Russia, is based on peptide-antigens that facilitate immunity to the SARS-CoV-2 virus1. It is currently being tested in Phase I/II clinical trials for safety and immunogenicity (NCT04527575)1,2.

  1. Precision Vaccinations: VACCINE INFO EpiVacCorona Vaccine [Link]
  2. The Pharma Letter: Russia’s EpiVacCorona vaccine post-registration trials started [Link]

//////EpiVacCorona, SARS-CoV-2, RUSSIA, CORONA VIRUS, COVID 19, VACCINE, PEPTIDE

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