Covaxin

Last updated

Covaxin
COVAXIN Logo.svg
Bharat Biotech Covaxin Bangalore BESTpedia.jpg
A vial of Covaxin
Vaccine description
Target SARS-CoV-2
Vaccine type Inactivated
Clinical data
Trade names Covaxin
Routes of
administration 		Intramuscular
ATC code
Legal status
Legal status
Identifiers
DrugBank
UNII

Covaxin (development name, BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. [1]

Contents

On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use, as the first Indian-developed covid vaccine to be approved. [2] [3] By 31 January 2022, Covaxin had been granted emergency use approval in 13 countries. [4]

Medical uses

Effectiveness

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. [5] Effectiveness is generally expected to slowly decrease over time. [6]

Initial effectiveness by variant
Doses Severity of illness Delta
1 Symptomatic −1% (−51 to 33%) [upper-alpha 1] [7]
Hospitalization Not reported
2 Symptomatic 50% (33–62%) [7]
Hospitalization Not reported
  1. ↑ The confidence interval includes zero, so it is possible that vaccination had no effect.

Efficacy

A phase 3 clinical trial with 25,798 participants found that the vaccine is 64% (95% CI, 29–82%) effective against asymptomatic cases, 78% (65–86%) effective against symptomatic disease, 93% (57–100%) effective against severe disease, and 65% (33–83%) effective against the Delta variant. [8]

Manufacturing

As an inactivated vaccine, Covaxin uses a more traditional technology that is similar to the inactivated polio vaccine. Initially, a sample of SARS-CoV-2 was isolated by India's National Institute of Virology and used to grow large quantities of the virus using vero cells. From then on, the viruses are soaked in beta-propiolactone (BPL), which deactivates them by binding to their genes, while leaving other viral particles intact. The resulting inactivated viruses are then mixed with the aluminium-based adjuvant Alhydroxiquim-II. [1] [9] [10]

The vaccine is produced with Bharat Biotech's in-house vero cell manufacturing platform [11] that has the capacity to deliver about 300 million doses. [12] The company is in the process of setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin. The firm, in collaboration with the Government of Odisha, is establishing another facility at Odisha Biotech Park in Bhubaneswar to commence Covaxin production by June 2022. [13] [14]

In December 2020, Ocugen entered into a partnership with Bharat Biotech to co-develop and exclusively commercialise Covaxin in the US market; [15] [16] in June 2021, the partnership was extended to cover Canada. [17] In January 2021, Precisa Medicamentos entered into an agreement with Bharat Biotech to supply Covaxin to Brazil. [18] The contract was terminated in July 2021 after the Brazilian government suspended procurement to investigate allegations of irregularities in pricing. [19]

In May 2021, Haffkine Bio-Pharmaceutical Corporation Limited of Haffkine Institute entered into a memorandum of understanding (MoU) with Bharat Biotech and announced that the production of Covaxin by them will commence after obtaining support from the Maharashtra state government and approval from the Indian government [20] whereas Indian Immunologicals Limited (IIL) has signed a commercial agreement with Bharat Biotech for producing the drug substance, a critical component of the vaccine [21] Bharat Immunologicals and Biologicals Corporation (BIBCOL) will also manufacture the vaccine. [22]

On 1 April 2022, Bharat Biotech announced that it was cutting production due to reduction in demand. On 2 April the WHO said that a March 2022 inspection of facilities used to manufacture Covaxin had uncovered good manufacturing practice deficiencies. [23]

History

Clinical trials

Phase I and II trials

In May 2020, Indian Council of Medical Research's (ICMR's) National Institute of Virology approved and provided the virus strains for developing an Indian COVID-19 vaccine. [24] [25] In June 2020, the company received permission to conduct Phase I and Phase II human trials of a developmental COVID-19 vaccine codenamed BBV152, from the Drugs Controller General of India (DCGI), Government of India. [26] A total of 12 sites were selected by the Indian Council for Medical Research for Phase I and II randomised, double-blind and placebo-controlled clinical trials of vaccine candidate. [27] [28] [29]

In January 2021, the company published Phase I trial results in The Lancet . [30] On 8 March 2021, Phase II results were published in The Lancet. The study showed that Phase II trials had a higher immune response and induced T-cell response due to the difference in dosing regime from Phase I. The doses in Phase II were given at 4 weeks interval as opposed to 2 weeks in Phase I. Neutralization response of the vaccine were found significantly higher in Phase II. [31]

Phase III trials

In November 2020, Covaxin received the approval to conduct Phase III human trials [32] after completion of Phase I and II. [33] A randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above, it started on 25 November and involved around 26,000 volunteers from across 22 sites in India. [34] [35] [36] Refusal rate for Phase III trials was much higher than that for Phase I and Phase II. As a result, only 13,000 volunteers had been recruited by 22 December with the number increasing to 23,000 by 5 January. [37] [38]

Multiple ethical breaches have been reported at one of their trial sites in Bhopal, potentially hampering the quality of overall data. [39] [40] [41] [42]

US Immunobridging and booster Phase II/III trial

In March 2022, Ocugen registered a Phase 2/3 trial for 400 people in the US to compare the immune responses to those in people in the Indian phase 3 trial, as well as safety and tolerability. [43] The trial also aims to assess the vaccine as a booster after other Covid vaccines used in the US. Ocugen paused Covaxin's bridging trial in April 2022 citing WHO inspection results. [44]

Phase IV trials

In June 2021, Bharat Biotech announced the start of phase IV trials to evaluate the vaccine's real-world effectiveness. [45] A study of effectiveness and hesitancy study in Healthcare Workers of Max Group of Hospitals at New Delhi from Covaxin and Covishied is under trials. [46]

Trials on minors

In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years. [47] The trials are conducted at AIIMS Delhi and Patna. [48] As many as 54 children had registered at the AIIMS Patna. [49] In total 525 participants are enrolled in the study as per clinical trial data. [50]

Variants

In December 2020, the Alpha variant or lineage B.1.1.7, was identified in the UK. [51] An in vitro study on this variant was carried out and preliminary results show Covaxin to be effective in neutralising this strain. [52]

In April 2021, the Indian Council of Medical Research reported that the vaccine has shown promising results in neutralising lineage B.1.617. [53] [54]

In May 2021, a joint investigation by the scientists of the National Institute of Virology, found the vaccine effective in neutralising the Zeta variant or lineage P.2 (previously known as B.1.1.28). [55]

In June 2021, a group of researchers at the National Institute of Virology (NIV) India, collected sera from recovered patients and people who had received the Covaxin. They found the vaccine to be effective in neutralising the Delta (B.1.617.2) and Beta (B.1.351) variants. [56] [57] Later, the US National Institute of Health also approved the findings where the adjuvant used was developed jointly with funding from NIH. [58] [10]

Authorisations

  Full authorization
  Emergency authorization
  Allowed for travel
  Eligible COVAX recipient

India

A vial of Covaxin used at a private hospital in Bengaluru, India Bharat Biotech Covaxin Bangalore BESTpedia.jpg
A vial of Covaxin used at a private hospital in Bengaluru, India

On 6 December 2020, Bharat Biotech applied to the Drugs Controller General of India (DCGI), seeking emergency use authorisation. [59] It was the third firm after Serum Institute of India and Pfizer to apply under such provision. [60]

On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission, [61] which was granted the next day. [62] Covaxin was to be used in a "clinical trial mode" i.e. the public vaccination drive was to be an open-label, single-arm clinical trial in itself. [63] This emergency approval, granted without considering Phase III trial data concerning efficacy and safety, drew widespread criticism. [64] [65] [66] On 12 October 2021, Bharat Biotech's Covaxin got approved for usage on children between 2 and 18 years of age. [67]

Other nations

The vaccine was also approved for emergency use in Iran and Zimbabwe. [68] [69] Nepal granted EUA for Covaxin on 19 March 2021. [70] On 7 April, Mexico granted emergency authorisation for Covaxin. [71] On 19 April 2021, Philippines granted EUA to Covaxin. [72] Additionally, Covaxin was granted EUA in Guatemala, Nicaragua, Guyana, Venezuela and Botswana. [73]

On 31 March, the Brazilian health regulator Anvisa rejected Bharat Biotech's application for supplying Covaxin in the country due to non-compliance with manufacturing norms. Bharat Biotech stated that they would re-apply after meeting the requirements. [74] On 4 June, Anvisa approved exceptional imports of Covaxin, imposing conditions that restrict it mainly to healthy adults and limiting it to just 1% of the country's population to manage the risks through control and supervision of side effects. Anvisa cited as main concerns the incomplete phase III study, a short 45-day follow-up, which should be 60 days to meet the international consensus, and a novel imidazoquinoline adjuvant that may increase the chance of developing an autoimmune disease. [75] [76] [77] On 30 June, Brazilian regulators suspended the deal and an investigation was opened into it by federal prosecutors to probe accusations of irregularity. [78] Anvisa cancelled an ongoing clinical trial of the vaccine on 26 July [79] and suspended the temporary authorization and the import and distribution permit on 27 July. [80]

Mauritius received its first commercial supply of Covaxin on 18 March 2021. [81]

On 29 March 2021, Paraguay received 100,000 doses of Covaxin. [82]

In June 2021, Argentina agreed to buy 10 million doses of Covaxin and administer them to its citizens. [83]

On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use. [2] [3] A subsequent inspection of manufacturing facilities led WHO to suspend procurement of Covaxin through UN agencies in April 2022. [23]

See also

Related Research Articles

<span class="mw-page-title-main">Sinovac Biotech</span> Chinese biopharmaceutical company

Sinovac Biotech Ltd. is a Chinese biopharmaceutical company based in Haidian District, Beijing that focuses on the research, development, manufacture, and commercialization of vaccines that protect against human infectious diseases. The company was listed on the Nasdaq but the exchange halted Sinovac's trading in February 2019 due to a proxy fight. The company has faced bribery probes in China.

<span class="mw-page-title-main">Novavax</span> American biotechnology company

Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory syncytial virus (RSV), as well as Ebola and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for COVID-19.

<span class="mw-page-title-main">Bharat Biotech</span> Indian multinational biotechnology company and vaccine manufacturer

Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company headquartered in the city of Hyderabad, India engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products.

<span class="mw-page-title-main">Sputnik V COVID-19 vaccine</span> Russian vaccine against COVID-19

Sputnik V or Gam-COVID-Vac is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia. It is the world's first registered combination vector vaccine for the prevention of COVID-19, having been registered on 11 August 2020 by the Russian Ministry of Health.

<span class="mw-page-title-main">CoronaVac</span> Vaccine against COVID-19

CoronaVac, also known as the Sinovac COVID-19 vaccine, is a whole inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech. It was phase III clinically trialled in Brazil, Chile, Indonesia, the Philippines, and Turkey and relies on traditional technology similar to other inactivated-virus COVID-19 vaccines, such as the Sinopharm BIBP vaccine, another Chinese vaccine, and Covaxin, an Indian vaccine. CoronaVac does not need to be frozen, and both the final product and the raw material for formulating CoronaVac can be transported refrigerated at 2–8 °C (36–46 °F), the temperatures at which flu vaccines are kept.

<span class="mw-page-title-main">Sinopharm BIBP COVID-19 vaccine</span> Vaccine against COVID-19

The Sinopharm BIBP COVID-19 vaccine, also known as BBIBP-CorV, the Sinopharm COVID-19 vaccine, or BIBP vaccine, is one of two whole inactivated virus COVID-19 vaccines developed by Sinopharm's Beijing Institute of Biological Products. It completed Phase III trials in Argentina, Bahrain, Egypt, Morocco, Pakistan, Peru, and the United Arab Emirates (UAE) with over 60,000 participants. BBIBP-CorV shares similar technology with CoronaVac and Covaxin, other inactivated virus vaccines for COVID-19. Its product name is SARS-CoV-2 Vaccine, not to be confused with the similar product name of CoronaVac.

<span class="mw-page-title-main">Valneva COVID-19 vaccine</span> Vaccine candidate against COVID-19

Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.

<span class="mw-page-title-main">ZF2001</span> Vaccine against COVID-19

ZF2001, trade-named Zifivax or ZF-UZ-VAC-2001, is an adjuvanted protein subunit COVID-19 vaccine developed by Anhui Zhifei Longcom in collaboration with the Institute of Microbiology at the Chinese Academy of Sciences. The vaccine candidate is in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan, and Uzbekistan.

<span class="mw-page-title-main">Janssen COVID-19 vaccine</span> Vaccine against COVID-19

The Janssen COVID‑19 vaccine, sold under the brand name Jcovden, is a COVID‑19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, a subsidiary of American company Johnson & Johnson.

<span class="mw-page-title-main">COVID-19 vaccination in India</span> Immunisation programme against COVID-19 in India

India began administration of COVID-19 vaccines on 16 January 2021. As of 4 March 2023, India has administered over 2.2 billion doses overall, including first, second and precautionary (booster) doses of the currently approved vaccines. In India, 95% of the eligible population (12+) has received at least one shot, and 88% of the eligible population (12+) is fully vaccinated.

<span class="mw-page-title-main">ZyCoV-D</span> Vaccine candidate against COVID-19

ZyCoV-D is a DNA plasmid-based COVID-19 vaccine developed by Indian pharmaceutical company Cadila Healthcare, with support from the Biotechnology Industry Research Assistance Council. It is approved for emergency use in India.

<span class="mw-page-title-main">Vaccine Maitri</span> Vaccination initiative by the Indian government

Vaccine Maitri is a humanitarian initiative undertaken by the Indian government to provide COVID-19 vaccines to countries around the world. The government started providing vaccines from 20 January 2021. As of 21 February 2022, India had delivered around 16.29 crore doses of vaccines to 96 countries. Of these, 1.43 crore doses were gifted to 98 countries by the Government of India. The remaining 10.71 crore were supplied by the vaccine producers under its commercial and 4.15 crore were supplied by COVAX obligations. In late March 2021, the Government of India temporarily froze exports of the Covishield, citing India's own COVID crisis and the domestic need for these vaccines. The Health Minister of India, Mansukh Mandaviya announced in September that India will resume the export of vaccines from October to the rest of the world.

iNCOVACC Vaccine candidate against COVID-19

iNCOVACC is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech, American company Precision Virologics and the Washington University School of Medicine in St Louis, Missouri, United States.

<span class="mw-page-title-main">Sinopharm WIBP COVID-19 vaccine</span> Vaccine against COVID-19

The Sinopharm WIBP COVID-19 vaccine, also known as WIBP-CorV, is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. Peer-reviewed results show that the vaccine is 72.8% effective against symptomatic cases and 100% against severe cases. The other inactivated virus COVID-19 vaccine developed by Sinopharm is the BIBP vaccine (BBIBP-CorV) which is comparably more successful. 1 billion doses are expected to be produced per year.

<span class="mw-page-title-main">Walvax COVID-19 vaccine</span> Vaccine candidate against COVID-19

AWcorna, originally termed ARCoV and also known as the Walvax COVID-19 vaccine, is an mRNA COVID-19 vaccine developed by Walvax Biotechnology, Suzhou Abogen Biosciences, and the PLA Academy of Military Science. In contrast to other mRNA COVID vaccines, such as those by Pfizer-BioNtech and Moderna, this vaccine primarily targets the Sars-CoV-2 receptor-binding domain of the spike protein, rather than the entire spike protein. It is approved for Phase III trials in China, Mexico, Indonesia, and Nepal.

<span class="mw-page-title-main">Corbevax</span> Vaccine against COVID-19

Corbevax is a protein subunit COVID-19 vaccine developed by Texas Children's Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas and Dynavax technologies based in Emeryville, California. It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production.

Krishna Ella is an Indian scientist and entrepreneur. He is the founder and Executive Chairman of Bharat Biotech. Ella and his company were responsible for developing India's own COVID-19 vaccine, Covaxin, World's 1st clinically proven conjugated Typhoid Vaccine, TypbarTCV and ROTAVAC.

<span class="mw-page-title-main">Covaxgate</span> Vaccine controversy in Brazil

The Case Covaxin, also known as Covaxgate, refers to an investigation made by the Brazilian Federal Public Ministry (MPF), held on June 16, 2021, which found evidence of irregularities in the purchase of 20 million doses by the Ministry of Health of the Indian vaccine Covaxin, with the value of the vaccines 1000% higher than initially foreseen.

<span class="mw-page-title-main">COVID-19 vaccine clinical research</span> Clinical research to establish the characteristics of COVID-19 vaccines

COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. As of November 2022, 40 vaccines are authorized by at least one national regulatory authority for public use:

References

  1. 1 2 Hotez PJ, Bottazzi ME (January 2022). "Whole Inactivated Virus and Protein-Based COVID-19 Vaccines". Annual Review of Medicine. 73 (1): 55–64. doi: 10.1146/annurev-med-042420-113212 . PMID   34637324. S2CID   238747462.
  2. 1 2 Mitra AK, Singh S (3 November 2021). "India's first homegrown COVID-19 shot wins WHO emergency use listing". Reuters. Retrieved 8 November 2021.
  3. 1 2 "WHO issues emergency use listing for eighth COVID-19 vaccine". World Health Organization (WHO) (Press release). Retrieved 3 November 2021.
  4. ↑ "Covaxin granted emergency use approval in 13 countries, Govt informs Parliament". India Today . Retrieved 4 February 2022.
  5. ↑ Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R, Dean NE, et al. (12 September 2020). "COVID-19 vaccine trials should seek worthwhile efficacy". The Lancet. 396 (10253): 741–743. doi:10.1016/S0140-6736(20)31821-3. ISSN   0140-6736. PMC   7832749 . PMID   32861315. WHO recommends that successful vaccines should show an estimated risk reduction of at least one-half, with sufficient precision to conclude that the true vaccine efficacy is greater than 30%. This means that the 95% CI for the trial result should exclude efficacy less than 30%. Current US Food and Drug Administration guidance includes this lower limit of 30% as a criterion for vaccine licensure.
  6. ↑ Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, et al. (May 2021). "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine. 27 (7): 1205–1211. doi: 10.1038/s41591-021-01377-8 . ISSN   1546-170X. PMID   34002089. S2CID   234769053.
  7. 1 2 Desai D, Khan AR, Soneja M, Mittal A, Naik S, Kodan P, et al. (23 November 2021). "Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study". The Lancet Infectious Diseases. 22 (3). Table 2. doi:10.1016/S1473-3099(21)00674-5. ISSN   1473-3099. PMC   8610201 . PMID   34826383.
  8. ↑ Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, et al. (11 November 2021). "Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial". The Lancet. 398 (10317): 2173–2184. doi:10.1016/S0140-6736(21)02000-6. ISSN   0140-6736. PMC   8584828 . PMID   34774196.
  9. ↑ Corum J, Zimmer C (26 April 2021). "How Bharat Biotech's Vaccine Works". The New York Times. Retrieved 29 April 2021.
  10. 1 2 "Adjuvant developed with NIH funding enhances efficacy of India's COVID-19 vaccine". National Institutes of Health (NIH). 29 June 2021.
    PD-icon.svg This article incorporates public domain material from websites or documents of the National Institutes of Health.
  11. ↑ Hoeksema F, Karpilow J, Luitjens A, Lagerwerf F, Havenga M, Groothuizen M, et al. (April 2018). "Enhancing viral vaccine production using engineered knockout vero cell lines - A second look". Vaccine. 36 (16): 2093–2103. doi: 10.1016/j.vaccine.2018.03.010 . PMC   5890396 . PMID   29555218.
  12. ↑ "Coronavirus vaccine update: Bharat Biotech's Covaxin launch likely in Q2 of 2021, no word on pricing yet". www.businesstoday.in. India Today Group. Retrieved 13 December 2020.
  13. ↑ "Odisha sets June 2022 deadline to begin Covaxin production at Andharua". mint. 7 May 2021. Retrieved 19 May 2021.
  14. ↑ "Bhubaneswar: 'Expedite building of Biotech Park near city', says CS Suresh Chandra Mohapatra - Times of India". The Times of India. 7 May 2021. Retrieved 21 May 2021.
  15. ↑ "Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S." Reuters. 22 December 2020. Retrieved 5 January 2021.
  16. ↑ "Bharat Biotech, Ocugen to co-develop Covaxin for US market". The Economic Times. Retrieved 5 January 2021.
  17. ↑ Swati B (3 June 2021). "Covaxin vaccine: After US market, Bharat Biotech ties up with Ocugen for Covaxin sale in Canada". The Times of India. Retrieved 3 July 2021.
  18. ↑ "Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil". mint. 12 January 2021.
  19. ↑ Raghavan P (24 July 2021). "Bharat Biotech nixes Covaxin supply pact with Precisa in Brazil". Indian Express.
  20. ↑ "'Will have capacity for 22.8 crore vaccine doses a year', says managing director of Haffkine Institute". The Hindu Business Line. 29 April 2021.
  21. ↑ Bharadwaj S (29 April 2021). "Covid-19 chokes competition in Telangana: Vax makers BB, IIL join hands". The Times of India.
  22. ↑ "BIBCOL to manufacture 2 crore doses of Covaxin every month in UP". The Financial Express. 14 May 2021.
  23. 1 2 Pulla P (7 April 2022). "Exports of an Indian COVID-19 vaccine halted after WHO finds problems at manufacturing plant". Science . doi:10.1126/science.abq4311.
  24. ↑ "ICMR teams up with Bharat Biotech to develop Covid-19 vaccine". Livemint. 9 May 2020.
  25. ↑ Chakrabarti A (10 May 2020). "India to develop 'fully indigenous' Covid vaccine as ICMR partners with Bharat Biotech". ThePrint.
  26. ↑ "India's First COVID-19 Vaccine Candidate Approved for Human Trials". The New York Times. 29 June 2020.
  27. ↑ "Human clinical trials of potential Covid-19 vaccine 'Covaxin' started at AIIMS". DD News. Prasar Bharati, Ministry of I & B, Government of India. 25 July 2020.
  28. ↑ "Asia Today: Amid new surge, India tests potential vaccine". The Washington Post. 25 July 2020. Retrieved 17 December 2020.
  29. ↑ "Delhi: 30-year-old is first to get dose of trial drug Covaxin". The Indian Express. 25 July 2020.
  30. ↑ Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, et al. (May 2021). "Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial". The Lancet. Infectious Diseases. 21 (5): 637–646. doi:10.1016/S1473-3099(20)30942-7. PMC   7825810 . PMID   33485468.
  31. ↑ Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, et al. (March 2021). "Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial". The Lancet. Infectious Diseases. 21 (7): 950–961. doi: 10.1016/S1473-3099(21)00070-0 . PMC   8221739 . PMID   33705727.
  32. ↑ "Covaxin Phase III trial from November". The Hindu. 23 October 2020.
  33. ↑ Ganneru B, Jogdand H, Daram VK, Das D, Molugu NR, Prasad SD, et al. (April 2021). "Th1 skewed immune response of whole virion inactivated SARS CoV 2 vaccine and its safety evaluation". iScience. 24 (4): 102298. Bibcode:2021iSci...24j2298G. doi:10.1016/j.isci.2021.102298. PMC   7944858 . PMID   33723528.
  34. ↑ "Bharat Biotech begins Covaxin Phase III trials". The Indian Express. 18 November 2020.
  35. ↑ "An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers". clinicaltrials.gov (Registry). United States National Library of Medicine. NCT04641481. Retrieved 26 November 2020.
  36. ↑ Sen M (2 December 2020). "List of states that have started phase 3 trials of India's first Covid vaccine". mint.
  37. ↑ "70%-80% Drop in Participation For Phase 3 Trials Of Covaxin: Official". NDTV. 17 December 2020.
  38. ↑ "Bharat Biotech's Covaxin given conditional nod based on incomplete Phase 3 trial results data". The Print. 3 January 2021.
  39. ↑ Pulla P (9 February 2021). "Explained: Is the Data From Covaxin Trial's Bhopal Site Tainted?". TheQuint. Retrieved 18 May 2021.
  40. ↑ Bhuyan A (14 January 2021). "How Covaxin Trial Participants in Bhopal Were Misled". The Wire Science. Retrieved 18 May 2021.
  41. ↑ Esha Mitra and Julia Hollingsworth (26 February 2021). "More than a dozen slum residents in an Indian city say they didn't know they were part of a clinical vaccine trial". CNN. Retrieved 18 May 2021.
  42. ↑ Bmj IC (January 2021). "India: Doctors call for investigation into allegations of ethical abuse in covid-19 vaccine trial". BMJ. 372: n131. doi: 10.1136/bmj.n131 . PMID   33446480.
  43. ↑ Clinical trial number NCT05258669 for "Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults" at ClinicalTrials.gov
  44. ↑ "Ocugen, Inc. Provides Update on its Phase 2/3 Study of COVAXIN™ (BBV152)". Ocugen. 12 April 2022.
  45. ↑ "Bharat Biotech plans Covaxin Phase 4 trials, says will meet 'every scientific standard'". CNBC TV18. 10 June 2021. Retrieved 3 July 2021.
  46. ↑ "A prospective, longitudinal, observational, post licensure vaccine evaluation study to assess the effectiveness of COVID-19 vaccine among the Healthcare workers of Max group of hospitals". ctri.nic.in. Clinical Trials Registry India. 24 June 2021. CTRI/2021/01/030782. Retrieved 3 July 2021.
  47. ↑ Bhaduri A (18 May 2021). "Covaxin trials in children between 2 and 18 years to begin in 10-12 days, says Niti Aayog member". Hindustan Times.
  48. ↑ Jaswal M (6 June 2021). "Covaxin: AIIMS Delhi to start trials on children from tomorrow, says report". mint.
  49. ↑ Kumar R (1 June 2021). "Covaxin trials on children begin at AIIMS-Patna". Hindustan Times.
  50. ↑ "A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers Ages ≤18 to ≥ 2 Years". ClinicalTrials.gov. United States National Library of Medicine. 26 May 2021. NCT04918797. Retrieved 3 July 2021.
  51. ↑ "Inside the B.1.1.7 Coronavirus Variant". The New York Times. 18 January 2021. Retrieved 29 January 2021.
  52. ↑ Sapkal GN, Yadav PD, Ella R, Deshpande GR, Sahay RR, Gupta N, et al. (June 2021). "Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B.1.1.7 variant of SARS-CoV-2". Journal of Travel Medicine. 28 (4). doi: 10.1093/jtm/taab051 . PMC   8083765 . PMID   33772577.
  53. ↑ Mascarenhas A (21 April 2021). "Covaxin neutralises double mutant strain of SARS-CoV-2: ICMR study". The Indian Express.
  54. ↑ Yadav PD, Sapkal GN, Abraham P, Ella R, Deshpande G, Patil DY, et al. (May 2021). "Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees". Clinical Infectious Diseases. 74 (2): 366–368. doi:10.1093/cid/ciab411. PMID   33961693.
  55. ↑ Sapkal G, Yadav PD, Ella R, Abraham P, Patil DY, Gupta N, et al. (May 2021). "Neutralization of B.1.1.28 P2 variant with sera of natural SARS-CoV-2 infection and recipients of inactivated COVID-19 vaccine Covaxin". Journal of Travel Medicine. 28 (7). doi: 10.1093/jtm/taab077 . PMC   8194512 . PMID   34002240.
  56. ↑ Sarkar S (9 June 2021). "Covaxin effective in neutralising Delta, Beta variants of Covid-19: Study". Hindustan Times.
  57. ↑ Yadav PD, Sapkal GN, Ella R, Sahay RR, Nyayanit DA, Patil DY, et al. (7 June 2021). "Neutralization against B.1.351 and B.1.617.2 with sera of COVID-19 recovered cases and vaccinees of BBV152". bioRxiv   10.1101/2021.06.05.447177 .
  58. ↑ "India's Covaxin effectively neutralises Delta variant of Covid: US' National Institute of Health". The Indian Express. 30 June 2021.
  59. ↑ Ghosh N (7 December 2020). "Bharat Biotech seeks emergency use authorization for Covid-19 vaccine". Hindustan Times.
  60. ↑ "After SII, Bharat Biotech seeks DCGI approval for Covaxin". The Hindu. 7 December 2020.
  61. ↑ "Expert panel recommends granting approval for restricted emergency use of Bharat Biotech's Covaxin". The Indian Express. 2 January 2021.
  62. ↑ "Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca". BBC News. 3 January 2021. Retrieved 3 January 2021.
  63. ↑ Mukunth V (29 January 2021). "Covaxin Trial's Info Sheet Skips Mention of Two Rare but Known Risks". The Wire Science. Retrieved 18 May 2021.
  64. ↑ "Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out". The Wire. 12 January 2021.
  65. ↑ Thiagarajan K (April 2021). "What do we know about India's Covaxin vaccine?". BMJ. 373: n997. doi: 10.1136/bmj.n997 . PMID   33879478.
  66. ↑ Pulla P (5 January 2021). "Scientists criticize 'rushed' approval of Indian COVID-19 vaccine without efficacy data". Science | AAAS. Retrieved 18 May 2021.
  67. ↑ "COVID-19: Covaxin Vaccine Approved For Children Between 2 to 18". The Live Mirror. 12 October 2021. Retrieved 12 October 2021.
  68. ↑ Manral K (4 March 2021). "Zimbabwe approves Covaxin, first in Africa to okay India-made Covid-19 vaccine". Hindustan Times. Retrieved 6 March 2021.
  69. ↑ "Iran issues permit for emergency use for three other COVID-19 vaccines: Official". IRNA English. 17 February 2021.
  70. ↑ Sharma G (19 March 2021). "Nepal becomes third country to give emergency nod to Indian vaccine COVAXIN". Reuters. Retrieved 19 March 2021.
  71. ↑ "Mexico authorizes emergency use of Indian COVID-19 vaccine". Reuters. 7 April 2021. Retrieved 7 April 2021.
  72. ↑ "Covaxin, Janssen approved for emergency use in PH". CNN Philippines. 19 April 2021. Archived from the original on 20 April 2021. Retrieved 19 April 2021.
  73. ↑ Bharadwaj S (20 April 2021). "Covid-19: Bharat Biotech ramps up Covaxin capacity to 700 million doses per annum". Times of India.
  74. ↑ Som V (31 March 2021). "Brazil Says "No" To Covaxin, Bharat Biotech Explains". NDTV. Retrieved 18 April 2021.
  75. ↑ Mcgeever J, Paraguassu L (4 June 2021). "Brazil's Anvisa approves Russian Sputnik V vaccine, with conditions". Reuters. Retrieved 5 June 2021.
  76. ↑ "Anvisa aprova, com restrições, a importação excepcional de doses da Covaxin e Sputnik V" [Anvisa approves import of doses of Covaxin and Sputnik V, with restrictions]. G1 (in Portuguese). Globo. 4 June 2021. Retrieved 4 June 2021.
  77. ↑ Alegretti L, Barifouse R (4 June 2021). "Covaxin e Sputnik V: O que muda na vacinação do Brasil com decisão da Anvisa" [Covaxin and Sputnik V: What changes in vaccination in Brazil after Anvisa's decision]. BBC Brasil (in Portuguese). Retrieved 5 June 2021.
  78. ↑ "Brazil to suspend vaccine deal with India as graft allegations probed". The Hindu. Reuters. 30 June 2021. Retrieved 30 June 2021.
  79. ↑ "Brazil health regulator cancels clinical study for Bharat Biotech vaccine". Reuters. 26 July 2021. Retrieved 16 November 2021.
  80. ↑ "Brazil suspends import permit for Bharat Biotech's COVID-19 vaccine". Reuters. 27 July 2021. Retrieved 16 November 2021.
  81. ↑ The Editorial Board (19 March 2021). "Dr Jagutpal: Une cargaison de 200 000 vaccins Covaxin débarque demain" [Dr Jagutpal: Shipment of 200,000 Covaxin vaccines lands tomorrow]. Lexpress.mu (in French). L'Express.
  82. ↑ "India provides 100,000 doses of Covaxin to Paraguay". 30 March 2021.
  83. ↑ "Buenos Aires Province agrees to buy 10 million doses of Covaxin vaccine". BAT Times. 4 June 2021.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.