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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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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), 

wdt-3

NEW DRUG APPROVALS

one time

$10.00

COVIran Barakat


Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusEmergency use authorization: IRNFull and Emergency Authorizations: List of COVIran Barakat COVID-19 vaccine authorizations

COVIran Barakat

COVIran Barakat, is an inactivated virus vaccine developed by Shifa Pharmed Industrial Co in Iran.[501

https://en.trend.az/iran/society/3439812.html

BAKU, Azerbaijan, Jun. 14 2021

By Elnur Baghishov – Trend:

An emergency license was issued for the use of the Iranian-made “CovIran Barakat” vaccine against the coronavirus yesterday on June 13, the Iranian Minister of Health and Medical Education Saeed Namaki said, Trend reports citing IRNA.

He made the remark in an event dedicated to the launch of a number of health and medical facilities in Iran’s Markazi Province today on June 14.

Namaki said that moreover, a license for the using of the Iranian-made “Pastor” vaccine against the coronavirus will be issued next week.

“Also, the licenses for the using of Iranian-made “Razi” and “Fakhra” vaccines will be issued in the near future,” he added.

According to the minister, the Iranian population will be vaccinated fully by the end of autumn with the opportunities created in connection with the production of vaccines in Iran.

Reportedly, about 10 million people in Iran are planned to be vaccinated with the “CovIran Barakat’ vaccine next week. The production of “CovIran Barakat” vaccine in Iran is expected to reach 50 million doses per month by the end of the summer.

On June 14, 26 health and medical facilities were launched in Iran’s Markazi Province. A total of 1.45 trillion rials (about $34.5 million) has been spent on these facilities.

Iran continues to monitor the coronavirus situation in the country. According to recent reports from Iranian officials, over 3.03 million people have been infected, and 82,217 people have already died.

Meanwhile, over 2.66 million people have reportedly recovered from the disease.

The country continues to apply strict measures to contain further spread. Reportedly, the disease was brought to Iran by a businessman from Iran’s Qom city, who went on a business trip to China, despite official warnings. The man died later from the disease.

The Islamic Republic only announced its first infections and deaths from the coronavirus on Feb. 19.

The outbreak in the Chinese city of Wuhan – which is an international transport hub – began at a fish market in late December 2019.

The World Health Organization (WHO) on March 11 declared COVID-19 a pandemic. Some sources claim the coronavirus outbreak started as early as November 2019.

A total of 5.2 million people have been vaccinated in Iran so far. About 4.35 million people were vaccinated on the first stage, and 851,000 people were vaccinated on the second stage.

COVIran Barakat is a COVID-19 vaccine developed by Iranian state-owned Shifa Pharmed Industrial Group. It has successfully been tested on animals and has been approved by the Iran Food and Drug Administration for testing on humans.[1][2][3] Phase 2/3 (II/III) clinical trial began on 13 March 2021,[4] and the first participants were inoculated on March 29.[5] Finally, the vaccine consumption license was issued on June 13, 2021.[6] Around 650 people worked in 3 shifts around the clock to develop the vaccine.[7]

Dr. Minoo Mohraz has been selected as the lead of the “Corona vaccine project in Iran”.[8] Dr. Mohraz is an Iranian physician, scientist, and AIDS specialist. She is a Full Professor (Emeritus) of Infectious Diseases at Tehran University of Medical Sciences and head of the Iranian Centre for HIV/AIDS.[9] Dr. Mohraz has also served as within the World Health Organization as an expert on HIV/AIDS in Iran and the Eastern Mediterranean.[10]

This vaccine has been authorised for emergency use by the Iranian authorities. This makes it the first locally developed to be approved for emergency use in the Middle East.[11]

Technology

On 29 December 2020, human trials of Iran’s first domestic COVID-19 vaccine candidate were started. The mechanism of production of this vaccine is based on the inactivated vaccine. In other words, “it is made of a coronavirus that has been weakened or killed by chemicals, similar to how polio immunizations are made.”[12]

Development

Iran’s first domestic COVID-19 vaccine candidate was started

Tayyebeh Mokhber, the first volunteer who receives a shot of COVIran Barakat was the daughter of Mohammad Mokhber director of setad. Minister of Health Saeed Namaki and Vice President for Science and Technology Sorena Sattari participated at the ceremony of vaccine injection. According to reports, there are more than 65,000 Iranians volunteered to test the vaccine and 56 selected people took part in the first phase of human trials which last 45 to 60 days.[13] The initial phase of human-testing for this vaccine started with the injection of 56 volunteers who were at the age of 18-50.[14][15][16]

The second/third group of volunteers were also injected with the vaccine.[17][18] According to the head of the vaccine production team at the Setad, the results show that this vaccine also neutralizes the British mutated COVID-19 virus.[19][20][21]

In March 2021, the Executive Office of Imam Khomeini’s Order began a Phase II–III clinical trial of COVIran Barakat with 280 participants in cities including Tehran, Mashhad, Karaj, Esfahan, Shiraz. According to the allowance of medical equipment department, the second phase coincided with third phase.[22][23] The vaccine has reached its third phase of human-testing;[24] and the first injection(s) of the 3rd phase began 25 April 2021.[25]

As official in charge of manufacturing Iran Barakat vaccines, Mohammad Reza Salehi said, “some neighboring countries tend to enter the third phase of the clinical trial of the Iranian “COVIran Barakat””. They are reviewing recommendations to let them participate.[14]

Production

According to Setad (the Executive Headquarters of Imam’s Directive), under the direct control of the Supreme Leader of Iran, “production of the vaccine developed by one of its companies, Shifa Pharmed, could reach 12 million doses per month, six months after a successful trial ends”.[26] On 15 March 2021, he stated that EIKO has already a capacity of three million doses per month and that by end of June the capacity will be 15-20 million doses per month.[27][28]

On 29 March 2021, the Tehran Times reported that a capacity of three million doses per month was achieved;[citation needed] and the production line of 25 million doses per month of Iran Koo vaccine was discharged on 26 April 2021.[29]

On 10 May 2021, the first product of mass production of the Iranian corona vaccine called “COVIran Barakat” was unveiled in phase one of the vaccine production factory associated with Execution of Imam Khomeini’s Order (EIKO). Therefore, 2 industrial lines have been set up. The first production line is prepared and the second line is being prepared. By the end of September (taking into account the capacity of three million doses of the first line), 20 million doses of Iran Barakat vaccine will be available in the month.[30]

Authorizations

 
  Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § COVIran Barakat

References

  1. ^ “Iranians demand a COVID-19 vaccine, not politics, from their leaders”Los Angeles Times. 19 January 2021.
  2. ^ “Coronavirus Tzar Forced to Apologize to Clergy”iranwire.
  3. ^ Vahdat, Amir (29 December 2020). “Iran begins human trials for locally made coronavirus vaccine”Times of Israel. Retrieved 30 December 2020.
  4. ^ “IRCT | A double-blind, randomized, placebo-controlled Phase II/III Clinical trial to evaluate the safety and efficacy of COVID-19 inactivated vaccine (Shifa-Pharmed) in a population aged 18 to 75 years”en.irct.ir. Retrieved 2021-04-07.
  5. ^ 3080 (2021-03-30). “Some foreign states willing to cooperate in COVIran Barakat clinical test: Official”IRNA English. Retrieved 2021-04-07.
  6. ^ The vaccine consumption license was issued yjc.ir Retrieved 16 June 2021
  7. ^ دانش فنی واکسن برکت صد درصد ایرانی است/ تلاش ۶۵۰ نفر در ساخت واکسن ایرانی کرونا
  8. ^ “Iranian corona vaccine will arrive by ‘next July'”Persian Bibi (in Persian). 2020-12-06. Retrieved 2020-12-18.
  9. ^ “Good News About AIDS”Young Journalists Club. February 6, 2016. Retrieved 2020-02-26.
  10. ^ “Allameh Tabatabai | Professor Minoo Mehrz: Everything I have is from Tehran University of Medical Sciences”. Tehran University of Medical Sciences Alumni Communication Office. Retrieved March 29, 2017.
  11. ^ “Iran issues license on its coronavirus vaccine”Trend.Az. 2021-06-14. Retrieved 2021-06-14.
  12. ^ “Iran begins first human trial of locally made virus vaccine”health.economictimes.indiatimes. 29 December 2019.
  13. ^ “COVIran Barakat: Iran launches human trials of its COVID vaccine”aljazeera. 29 December 2019.
  14. Jump up to:a b “Some foreign states willing to cooperate in COVIran Barakat clinical test: Official”irna.
  15. ^ Human test of Iranian corona vaccine begins / Minister of Health: We are the first vaccinator in Asia with 100 years of experience tasnimnews.com Retrieved 29 December 2020
  16. ^ End of the injection of phase one (studies) of “Kovoo-Iran Barakat” vaccineyjc.ir Retrieved 16 February 2021
  17. ^ Start of injecting the Iranian corona vaccine to the second group of volunteersmehrnews.com
  18. ^ The injection of “Iranian corona vaccine” to the second group of volunteers began tasnimnews.com
  19. ^ Jalili: The Iranian vaccine neutralizes the British virus yjc.ir
  20. ^ Iranian vaccine succeeds in neutralizing “British mutated virus” isna.ir
  21. ^ “Iran Vaccine Boasts Total Protection Against U.K. Covid Strain”bloomberg.
  22. ^ “Clinical trials of COVIRAN vaccine enter phases 2, 3”isna. 15 March 2021.
  23. ^ “واکسن ایران برکت احتمالا تا پایان خرداد ۱۴۰۰ به دست هموطنان می‌رسد”IRNA. 24 March 2021.
  24. ^ The beginning of the third stage of the human test of COVIran Barakat IRINN, Retrieved 21 April 2021
  25. ^ The third phase of Iran Barakat vaccine was injected YJC, Retrieved 25 April 2021
  26. ^ “Iran starts human testing of first domestic COVID-19 vaccine”reuters. 29 December 2019.
  27. ^ “Iran starts mass-production of homegrown coronavirus vaccine”Tehran Times. 2021-03-15. Retrieved 2021-04-07.
  28. ^ “Iran to kick off production of 3mn doses of COVIRAN”Mehr News Agency. 2021-03-15. Retrieved 2021-04-07.
  29. ^ The production line of 25 million doses per month of Iran Koo vaccine was cleared, Retrieved 4 May 2021
  30. ^ “نخستین محصول تولید انبوه واکسن “کوو ایران برکت” فردا رونمایی می‌شود”irna. 10 May 2021.

External links

Scholia has a profile for COVIran Barakat (Q105217191).

/////////COVIran Barakat, iran, coronavirus,  COVID-19 vaccine, Shifa Pharmed, SARS-CoV-2

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