Medicine:Covaxin

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Short description: Vaccine against COVID-19

Covaxin
COVAXIN Logo.svg
Bharat Biotech Covaxin Bangalore BESTpedia.jpg
A vial of Covaxin
Vaccine description
Target diseaseSARS-CoV-2
TypeKilled/Inactivated
Clinical data
Trade namesCovaxin
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
  • Full list of Covaxin authorizations
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]

As of October 2021, 110.6 million people in India have received Covaxin.[2] On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use.[3][4] As of 31 January 2022, Covaxin has been granted emergency use approval in 13 countries [5]

Medical uses

Effectiveness

A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval.[6] Effectiveness is generally expected to slowly decrease over time.[7]

Initial effectiveness by variant
Doses Severity of illness Delta
1 Symptomatic Template:Estimate[upper-alpha 1][8]
Hospitalization Not reported
2 Symptomatic Template:Estimate[8]
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 Template:Estimate effective against asymptomatic cases, Template:Estimate effective against symptomatic disease, Template:Estimate effective against severe disease, and Template:Estimate effective against the Delta variant.[9]

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][10][11]

The vaccine candidate is produced with Bharat Biotech's in-house vero cell manufacturing platform[12] that has the capacity to deliver about 300 million doses.[13] 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 Government of Odisha is establishing another facility at Odisha Biotech Park in Bhubaneswar to commence Covaxin production by June 2022.[14][15]

In December 2020, Ocugen entered into a partnership with Bharat Biotech to co-develop and exclusively commercialise Covaxin in the US market;[16][17] in June 2021, the partnership was extended to cover Canada.[18] In January 2021, Precisa Medicamentos entered into an agreement with Bharat Biotech to supply Covaxin to Brazil.[19] The contract was terminated in July 2021 after the Brazil government suspended procurement to investigate allegations of irregularities in pricing.[20]

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[21] whereas Indian Immunologicals Limited (IIL) has signed a commercial agreement with Bharat Biotech for producing the drug substance, a critical component of the vaccine[22] Bharat Immunologicals and Biologicals Corporation (BIBCOL) will also manufacture the vaccine.[23]

On 1 April 2022, Bharat Biotech announced that it was cutting down 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.[24]

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 a fully indigenous COVID-19 vaccine.[25][26] 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.[27] 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.[28][29][30]

In January 2021, the company published Phase I trial results in The Lancet.[31] 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.[32]

Phase III trials

In November 2020, Covaxin received the approval to conduct Phase III human trials[33] after completion of Phase I and II.[34] 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.[35][36][37] 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.[38][39]

Multiple ethical breaches have been reported at one of their trial sites in Bhopal, potentially hampering the quality of overall data.[40][41][42][43]

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.[44] 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.[45]

Phase IV trials

In June 2021, Bharat Biotech announced the start of phase IV trials to evaluate the vaccine's real-world effectiveness.[46] 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.[47]

Trials on minors

In May 2021, Drugs Controller General of India (DCGI) approved clinical trials in the age group of 2 to 18 years.[48] The trials are conducted at AIIMS Delhi and Patna.[49] As many as 54 children had registered at the AIIMS Patna.[50] In total 525 participants are enrolled in the study as per clinical trial data.[51]

Variants

In December 2020, the Alpha variant or lineage B.1.1.7, was identified in the UK.[52] An in vitro study on this variant was carried out and preliminary results show Covaxin to be effective in neutralizing this strain.[53]

In April 2021, the Indian Council of Medical Research reported that the vaccine has shown promising results in neutralizing lineage B.1.617.[54][55]

In May 2021, a joint investigation by the scientists of National Institute of Virology (NIV) India, found the vaccine effective in neutralizing the Zeta variant or lineage P.2 (previously known as B.1.1.28).[56]

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 neutralizing the Delta (B.1.617.2) and Beta (B.1.351) variants.[57][58] Later, the US National Institute of Health also approved the findings where the adjuvant used was developed jointly with funding from NIH.[59][11]

Authorizations

India

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 authorization.[60] It was the third firm after Serum Institute of India and Pfizer to apply under such provision.[61]

On 2 January 2021, the Central Drugs Standard Control Organization (CDSCO) recommended permission,[62] which was granted the next day.[63] 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.[64] This emergency approval, granted without considering Phase III trial data concerning efficacy and safety, drew widespread criticism.[65][66][67] On 12 October 2021, Bharat Biotech's Covaxin got approved for usage on children between 2 and 18 years of age.[68]

Other nations

The vaccine was also approved for emergency use in Iran and Zimbabwe.[69][70] Nepal granted EUA for Covaxin on 19 March 2021.[71] On 7 April, Mexico gave emergency authorization for Covaxin.[72] On 19 April 2021, Philippines granted EUA to Covaxin.[73] Additionally, Covaxin was granted EUA in Guatemala, Nicaragua, Guyana, Venezuela and Botswana.[74]

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.[75] 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.[76][77][78] On 30 June, Brazilian regulators suspended the deal and an investigation was opened into it by federal prosecutors to probe accusations of irregularity.[79] Anvisa cancelled an ongoing clinical trial of the vaccine on 26 July[80] and suspended the temporary authorization and the import and distribution permit on 27 July.[81]

Mauritius received its first commercial supply of Covaxin on 18 March 2021.[82]

On 29 March 2021, Paraguay received 100,000 doses of Covaxin.[83]

In June 2021, Argentina agreed to buy 10 million doses of Covaxin and administer them to its citizens.[84]

On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use.[3][4] A subsequent inspection of manufacturing facilities led WHO to suspend procurement of Covaxin through UN agencies in April 2022.[24]

See also

  • BBV154
  • Case Covaxin (Brazil)
  • COVID-19 vaccination in India

References

  1. ↑ 1.0 1.1 "Whole Inactivated Virus and Protein-Based COVID-19 Vaccines". Annual Review of Medicine 73 (1): 55–64. January 2022. doi:10.1146/annurev-med-042420-113212. PMID 34637324. 
  2. ↑ "Cowin statistics". Ministry of health and family welfare India. 23 October 2021. https://dashboard.cowin.gov.in/. 
  3. ↑ 3.0 3.1 "India's first homegrown COVID-19 shot wins WHO emergency use listing" (in en). Reuters. 3 November 2021. https://www.reuters.com/world/india/whos-advisory-group-recommends-emergency-listing-indias-first-homegrown-covid-19-2021-11-03/. 
  4. ↑ 4.0 4.1 "WHO issues emergency use listing for eighth COVID-19 vaccine". World Health Organization (WHO) (Press release). Retrieved 3 November 2021.
  5. ↑ "Covaxin granted emergency use approval in 13 countries, Govt informs Parliament". https://www.indiatoday.in/coronavirus-outbreak/vaccine-updates/story/covaxin-granted-emergency-use-approval-in-13-countries-govt-informs-parliament-1908992-2022-02-04. 
  6. ↑ "COVID-19 vaccine trials should seek worthwhile efficacy". The Lancet 396 (10253): 741–743. 12 September 2020. doi:10.1016/S0140-6736(20)31821-3. ISSN 0140-6736. 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.". 
  7. ↑ "Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection". Nature Medicine 27 (7): 1205–1211. May 2021. doi:10.1038/s41591-021-01377-8. ISSN 1546-170X. PMID 34002089. 
  8. ↑ 8.0 8.1 "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. 23 November 2021. doi:10.1016/S1473-3099(21)00674-5. ISSN 1473-3099. PMID 34826383. 
  9. ↑ "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. 11 November 2021. doi:10.1016/S0140-6736(21)02000-6. ISSN 0140-6736. PMID 34774196. 
  10. ↑ "How Bharat Biotech's Vaccine Works". The New York Times. 26 April 2021. https://www.nytimes.com/interactive/2021/health/bharat-biotech-covid-19-vaccine.html. 
  11. ↑ 11.0 11.1 "Adjuvant developed with NIH funding enhances efficacy of India's COVID-19 vaccine" (in EN). National Institutes of Health (NIH). 29 June 2021. https://www.nih.gov/news-events/news-releases/adjuvant-developed-nih-funding-enhances-efficacy-indias-covid-19-vaccine. 
     This article incorporates public domain material from websites or documents of the National Institutes of Health.
  12. ↑ "Enhancing viral vaccine production using engineered knockout vero cell lines - A second look". Vaccine 36 (16): 2093–2103. April 2018. doi:10.1016/j.vaccine.2018.03.010. PMID 29555218. 
  13. ↑ "Coronavirus vaccine update: Bharat Biotech's Covaxin launch likely in Q2 of 2021, no word on pricing yet". www.businesstoday.in. India Today Group. https://www.businesstoday.in/sectors/pharma/coronavirus-vaccine-update-bharat-biotech-covaxin-launch-likely-in-q2-of-2021-no-word-on-pricing-yet/story/422659.html. 
  14. ↑ "Odisha sets June 2022 deadline to begin Covaxin production at Andharua" (in en). 7 May 2021. https://www.livemint.com/news/india/odisha-sets-june-2022-deadline-to-begin-covaxin-production-at-andharua-11620355118755.html. 
  15. ↑ "Bhubaneswar: 'Expedite building of Biotech Park near city', says CS Suresh Chandra Mohapatra - Times of India" (in en). https://timesofindia.indiatimes.com/city/bhubaneswar/bhubaneswar-expedite-building-of-biotech-park-near-city-says-cs-suresh-chandra-mohapatra/articleshow/82451910.cms. 
  16. ↑ Reuters Staff (22 December 2020). "Ocugen to co-develop Bharat Biotech's COVID-19 vaccine candidate for U.S.". Reuters. https://www.reuters.com/article/health-coronavirus-ocugen-bharat-idUSKBN28W1G4. 
  17. ↑ "Bharat Biotech, Ocugen to co-develop Covaxin for US market". The Economic Times. https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/bharat-biotech-ocugen-to-co-develop-covaxin-for-us-market/articleshow/79872249.cms?from=mdr. 
  18. ↑ "Covaxin vaccine: After US market, Bharat Biotech ties up with Ocugen for Covaxin sale in Canada" (in en). The Times of India. 3 June 2021. https://timesofindia.indiatimes.com/india/after-us-market-bharat-biotech-ties-up-with-ocugen-for-covaxin-sale-in-canada/articleshow/83206592.cms. 
  19. ↑ "Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil". mint. 12 January 2021. https://www.livemint.com/news/india/bharat-biotech-inks-pact-with-precisa-med-to-supply-covaxin-to-brazil-11610456928074.html. 
  20. ↑ "Bharat Biotech nixes Covaxin supply pact with Precisa in Brazil". Indian Express. 24 July 2021. https://indianexpress.com/article/business/bharat-biotech-nixes-covaxin-supply-pact-with-precisa-in-brazil-7419561/. 
  21. ↑ "'Will have capacity for 22.8 crore vaccine doses a year', says managing director of Haffkine Institute" (in en). The Hindu Business Line. 29 April 2021. https://www.thehindubusinessline.com/news/national/maharashtra-allows-haffkine-bio-pharma-to-manufacture-covid-vaccines/article34431710.ece. 
  22. ↑ "Covid-19 chokes competition in Telangana: Vax makers BB, IIL join hands" (in en). The Times of India. 29 April 2021. https://timesofindia.indiatimes.com/city/hyderabad/covid-19-chokes-competition-vax-makers-bb-iil-join-hands/articleshow/82300564.cms. 
  23. ↑ "BIBCOL to manufacture 2 crore doses of Covaxin every month in UP". The Financial Express. 14 May 2021. https://www.financialexpress.com/lifestyle/health/bibcol-to-manufacture-2-crore-doses-of-covaxin-every-month-in-up/2251627/. 
  24. ↑ 24.0 24.1 "Exports of an Indian COVID-19 vaccine halted after WHO finds problems at manufacturing plant". Science. 7 April 2022. doi:10.1126/science.abq4311. https://www.science.org/content/article/exports-indian-covid-19-vaccine-halted-after-who-finds-problems-manufacturing-plant. 
  25. ↑ "ICMR teams up with Bharat Biotech to develop Covid-19 vaccine". Livemint. 9 May 2020. https://www.livemint.com/news/india/icmr-teams-up-with-bharat-biotech-to-develop-covid-19-vaccine-11589038719666.html. 
  26. ↑ "India to develop 'fully indigenous' Covid vaccine as ICMR partners with Bharat Biotech". ThePrint. 10 May 2020. https://theprint.in/health/india-to-develop-fully-indigenous-covid-vaccine-as-icmr-partners-with-bharat-biotech/418180/. 
  27. ↑ "India's First COVID-19 Vaccine Candidate Approved for Human Trials". The New York Times. 29 June 2020. https://www.nytimes.com/reuters/2020/06/29/world/asia/29reuters-health-coronavirus-india-vaccine.html. 
  28. ↑ "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. http://ddnews.gov.in/health/human-clinical-trials-potential-covid-19-vaccine-%E2%80%98covaxin%E2%80%99-started-aiims. 
  29. ↑ "Asia Today: Amid new surge, India tests potential vaccine". The Washington Post. 25 July 2020. https://www.washingtonpost.com/business/asia-today-skorea-records-113-new-cases-most-from-overseas/2020/07/24/21f23ad0-ce17-11ea-99b0-8426e26d203b_story.html. 
  30. ↑ "Delhi: 30-year-old is first to get dose of trial drug Covaxin". The Indian Express. 25 July 2020. https://indianexpress.com/article/india/aiims-administers-first-dose-of-bharat-biotechs-potential-covid-vaccine-to-30-yr-old-man-6521778/. 
  31. ↑ "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. May 2021. doi:10.1016/S1473-3099(20)30942-7. PMID 33485468. 
  32. ↑ "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. March 2021. doi:10.1016/S1473-3099(21)00070-0. PMID 33705727. 
  33. ↑ "Covaxin Phase III trial from November". The Hindu. 23 October 2020. https://www.thehindu.com/business/covaxin-phase-iii-trial-from-november/article32928549.ece. 
  34. ↑ "Th1 skewed immune response of whole virion inactivated SARS CoV 2 vaccine and its safety evaluation". iScience 24 (4): 102298. April 2021. doi:10.1016/j.isci.2021.102298. PMID 33723528. Bibcode: 2021iSci...24j2298G. 
  35. ↑ "Bharat Biotech begins Covaxin Phase III trials". The Indian Express. 18 November 2020. https://indianexpress.com/article/india/bharat-biotech-begins-covaxin-phase-iii-trials-7055237/. 
  36. ↑ "An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers". United States National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT04641481. 
  37. ↑ "List of states that have started phase 3 trials of India's first Covid vaccine". mint. 2 December 2020. https://www.livemint.com/news/india/coronavirus-vaccine-in-india-these-states-have-started-phase-3-trials-of-bharat-biotech-covaxin-11606908773897.html. 
  38. ↑ "70%-80% Drop in Participation For Phase 3 Trials Of Covaxin: Official". NDTV. 17 December 2020. https://www.ndtv.com/india-news/coronavirus-news-70-80-drop-in-participation-for-phase-3-trials-of-covaxin-official-2340001. 
  39. ↑ "Bharat Biotech's Covaxin given conditional nod based on incomplete Phase 3 trial results data". The Print. 3 January 2021. https://theprint.in/health/bharat-biotechs-covaxin-given-conditional-nod-based-on-incomplete-phase-3-trial-results-data/578389/. 
  40. ↑ "Explained: Is the Data From Covaxin Trial's Bhopal Site Tainted?" (in en). 9 February 2021. https://www.thequint.com/coronavirus/explained-is-the-data-from-covaxin-trials-bhopal-site-tainted-bharat-biotech-icmr. 
  41. ↑ "How Covaxin Trial Participants in Bhopal Were Misled" (in en-GB). 14 January 2021. https://science.thewire.in/health/peoples-hospital-bhopal-covaxin-clinical-trials-exploitation-ethics-ground-report/. 
  42. ↑ 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". https://www.cnn.com/2021/02/25/asia/india-vaccine-trials-covid-ethics-intl-dst-hnk/index.html. 
  43. ↑ "India: Doctors call for investigation into allegations of ethical abuse in covid-19 vaccine trial". BMJ 372: n131. January 2021. doi:10.1136/bmj.n131. PMID 33446480. 
  44. ↑ Clinical trial number NCT05258669 for "Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults" at ClinicalTrials.gov
  45. ↑ "Ocugen, Inc. Provides Update on its Phase 2/3 Study of COVAXIN™ (BBV152)". Ocugen. 12 April 2022. https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-provides-update-its-phase-23-study-covaxintm-bbv152. 
  46. ↑ "Bharat Biotech plans Covaxin Phase 4 trials, says will meet 'every scientific standard'" (in en). CNBC TV18. 10 June 2021. https://www.cnbctv18.com/healthcare/bharat-biotech-plans-covaxin-phase-4-trials-says-will-meet-every-scientific-standard-9612031.htm. 
  47. ↑ "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". Clinical Trials Registry India. 24 June 2021. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52014. 
  48. ↑ "Covaxin trials in children between 2 and 18 years to begin in 10-12 days, says Niti Aayog member" (in en). Hindustan Times. 18 May 2021. https://www.hindustantimes.com/india-news/covaxin-trials-in-children-between-2-and-18-years-to-begin-in-10-12-days-says-niti-aayog-member-101621339718922.html. 
  49. ↑ "Covaxin: AIIMS Delhi to start trials on children from tomorrow, says report" (in en). mint. 6 June 2021. https://www.livemint.com/news/india/covaxin-aiims-delhi-to-start-trials-on-children-from-tomorrow-says-report-11622991708152.html. 
  50. ↑ "Covaxin trials on children begin at AIIMS-Patna" (in en). Hindustan Times. 1 June 2021. https://www.hindustantimes.com/cities/others/covaxin-trials-on-children-begin-at-aiimspatna-101622559658408.html. 
  51. ↑ 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.. United States National Library of Medicine. 26 May 2021. NCT04918797. https://clinicaltrials.gov/ct2/show/NCT04918797. Retrieved 3 July 2021. 
  52. ↑ "Inside the B.1.1.7 Coronavirus Variant". 18 January 2021. https://www.nytimes.com/interactive/2021/health/coronavirus-mutations-B117-variant.html. 
  53. ↑ "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). June 2021. doi:10.1093/jtm/taab051. PMID 33772577. 
  54. ↑ "Covaxin neutralises double mutant strain of SARS-CoV-2: ICMR study". The Indian Express. 21 April 2021. https://indianexpress.com/article/india/covaxin-neutralises-double-mutant-strain-icmr-study-7282835/. 
  55. ↑ "Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees". Clinical Infectious Diseases 74 (2): 366–368. May 2021. doi:10.1093/cid/ciab411. PMID 33961693. 
  56. ↑ "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). May 2021. doi:10.1093/jtm/taab077. PMID 34002240. 
  57. ↑ "Covaxin effective in neutralising Delta, Beta variants of Covid-19: Study" (in en). Hindustan Times. 9 June 2021. https://www.hindustantimes.com/india-news/covaxin-effective-in-neutralising-delta-beta-variants-of-covid-19-study-101623233592645.html. 
  58. ↑ 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.
  59. ↑ "India's Covaxin effectively neutralises Delta variant of Covid: US' National Institute of Health" (in en). The Indian Express. 30 June 2021. https://indianexpress.com/article/world/indias-covaxin-effectively-neutralises-delta-variant-of-covid-us-national-institute-of-health-7382053/. 
  60. ↑ "Bharat Biotech seeks emergency use authorization for Covid-19 vaccine". Hindustan Times. 7 December 2020. https://www.hindustantimes.com/india-news/bharat-biotech-seeks-emergency-use-authorization-for-covid-19-vaccine-govt-source/story-HmmD0JnniJeigdF6xmjxBO.html. 
  61. ↑ "After SII, Bharat Biotech seeks DCGI approval for Covaxin". The Hindu. 7 December 2020. https://www.thehindu.com/sci-tech/health/coronavirus-serum-institute-seeks-emergency-use-approval-for-covishield-in-india/article33265921.ece. 
  62. ↑ "Expert panel recommends granting approval for restricted emergency use of Bharat Biotech's Covaxin". The Indian Express. 2 January 2021. https://indianexpress.com/article/india/bharat-biotechs-covaxin-covid-vaccine-approval-cdsco-7130213/. 
  63. ↑ "Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca". BBC News. 3 January 2021. https://www.bbc.com/news/world-asia-india-55520658. 
  64. ↑ "Covaxin Trial's Info Sheet Skips Mention of Two Rare but Known Risks" (in en-GB). 29 January 2021. https://science.thewire.in/health/covaxin-phase-3-clinical-trials-information-sheet-ade-vaerd-informed-consent/. 
  65. ↑ "Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out". The Wire. 12 January 2021. https://science.thewire.in/health/covaxin-covishield-indian-government-rollout-peoples-hospital-phase-3-clinical-trials-centralisation-pm-cares/. 
  66. ↑ "What do we know about India's Covaxin vaccine?". BMJ 373: n997. April 2021. doi:10.1136/bmj.n997. PMID 33879478. 
  67. ↑ "Scientists criticize 'rushed' approval of Indian COVID-19 vaccine without efficacy data" (in en). 5 January 2021. https://www.science.org/content/article/scientists-criticize-rushed-approval-indian-covid-19-vaccine-without-efficacy-data. 
  68. ↑ "COVID-19: Covaxin Vaccine Approved For Children Between 2 to 18" (in en-US). 12 October 2021. https://www.thelivemirror.com/covaxin-approved-for-children-between-2-to-18/. 
  69. ↑ "Zimbabwe approves Covaxin, first in Africa to okay India-made Covid-19 vaccine". Hindustan Times. 4 March 2021. https://www.hindustantimes.com/world-news/zimbabwe-approves-covaxin-first-in-africa-to-okay-india-made-covid-19-vaccine-101614859597880.html. 
  70. ↑ "Iran issues permit for emergency use for three other COVID-19 vaccines: Official". IRNA English. 17 February 2021. https://en.irna.ir/news/84233593/Iran-issues-permit-for-emergency-use-for-three-other-COVID-19. 
  71. ↑ "Nepal becomes third country to give emergency nod to Indian vaccine COVAXIN". Reuters. 19 March 2021. https://www.reuters.com/article/health-coronavirus-nepal-india-idUSKBN2BB1KN. 
  72. ↑ "Mexico authorizes emergency use of Indian COVID-19 vaccine". Reuters. 7 April 2021. https://www.reuters.com/article/health-coronavirus-mexico-india-idUSKBN2BU04N. 
  73. ↑ "Covaxin, Janssen approved for emergency use in PH". CNN Philippines. 19 April 2021. https://cnnphilippines.com/news/2021/4/19/covaxin-janssen-emergency-use-authorization.html. 
  74. ↑ "Covid-19: Bharat Biotech ramps up Covaxin capacity to 700 million doses per annum". Times of India. 20 April 2021. https://timesofindia.indiatimes.com/india/covid-19-bharat-biotech-ramps-up-covaxin-capacity-to-700-million-doses-per-annum/articleshow/82162467.cms. 
  75. ↑ "Brazil Says "No" To Covaxin, Bharat Biotech Explains". NDTV. 31 March 2021. https://www.ndtv.com/india-news/brazil-says-no-to-covaxin-bharat-biotech-explains-2403218. 
  76. ↑ "Brazil's Anvisa approves Russian Sputnik V vaccine, with conditions". Reuters. 4 June 2021. https://www.reuters.com/world/americas/brazil-health-regulator-technical-staff-recommend-conditions-any-approval-2021-06-04/. 
  77. ↑ "Anvisa aprova, com restrições, a importação excepcional de doses da Covaxin e Sputnik V" (in Portuguese). G1. Globo. 4 June 2021. https://g1.globo.com/bemestar/vacina/noticia/2021/06/04/anvisa-covaxin-sputnik-v.ghtml. 
  78. ↑ "Covaxin e Sputnik V: O que muda na vacinação do Brasil com decisão da Anvisa" (in Portuguese). BBC Brasil. 4 June 2021. https://www.bbc.com/portuguese/brasil-57358261. 
  79. ↑ "Brazil to suspend vaccine deal with India as graft allegations probed". The Hindu. Reuters. 30 June 2021. https://www.thehindu.com/news/international/brazil-to-suspend-vaccine-deal-with-india-as-graft-allegations-probed/article35046662.ece. 
  80. ↑ "Brazil health regulator cancels clinical study for Bharat Biotech vaccine". Reuters. 26 July 2021. https://www.reuters.com/world/americas/brazil-health-regulator-cancels-clinical-study-bharat-biotech-vaccine-2021-07-26/. 
  81. ↑ "Brazil suspends import permit for Bharat Biotech's COVID-19 vaccine". Reuters. 27 July 2021. https://www.reuters.com/world/india/brazil-suspends-import-permit-bharat-biotechs-covid-19-vaccine-2021-07-27/. 
  82. ↑ The Editorial Board (19 March 2021). "Dr Jagutpal: Une cargaison de 200 000 vaccins Covaxin débarque demain" (in fr). Lexpress.mu (L'Express). https://www.lexpress.mu/article/390493/dr-jagutpal-une-cargaison-200-000-vaccins-covaxin-debarque-demain. 
  83. ↑ "India provides 100,000 doses of Covaxin to Paraguay". 30 March 2021. https://health.economictimes.indiatimes.com/news/industry/india-provides-100000-doses-of-covaxin-to-paraguay/81754661. 
  84. ↑ "Buenos Aires Province agrees to buy 10 million doses of Covaxin vaccine". BAT Times. 4 June 2021. https://www.batimes.com.ar/news/argentina/buenos-aires-province-agrees-to-buy-10-million-doses-of-covaxin-vaccine.phtml. 

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