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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 AFRICURE PHARMA as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 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, 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 32 PLUS year tenure till date Feb 2023, 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 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 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 38 lakh plus views on New Drug Approvals Blog in 227 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 He has total of 32 International and Indian awards

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Soberana 02, FINLAY-FR-2

July 4, 2021 9:25 am / Leave a comment


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 & Pharmacotherapy. 137: 111254. doi:10.1016/j.biopha.2021.111254. PMC 7843096. PMID 33550049.
  3. ^ Santos IC (January 2021). “Rapid response to: Covid 19: Hope is being eclipsed by deep frustration”. BMJ. 372: n171. doi:10.1136/bmj.n171.
  4. ^ “Draft landscape and tracker of COVID-19 candidate vaccines”. http://www.who.int. World 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?”. Nature. doi:10.1038/d41586-021-01126-4. PMID 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 Times. ISSN 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?”. Nature. doi:10.1038/d41586-021-01126-4. PMID 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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ABDALA, CIGB-66

June 22, 2021 5:41 am / Leave a comment


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

Havana: Cuba 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 Times. ISSN 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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Cuba may have found cure for cancer

April 8, 2014 1:07 am / 1 Comment on Cuba may have found cure for cancer


cuba's cancercure

Cuban doctors have filed Wednesday in Havana, the result of 14 years of research, a solution of antitumor peptides whose natural analogue is able to offer positive dynamics in cancer treatments

http://youthandeldersja.wordpress.com/2014/03/22/cuba-may-have-found-cure-for-cancer/

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