Wikipedia

Covaxin

(Redirected fromBBV152)
This article is about Bharat Biotech's COVID-19 vaccine. ForNovavax's vaccine, seeCovovax.For the global vaccine alliance, seeCOVAX.

Covaxin(development name,BBV152) is awhole inactivated virus-basedCOVID-19 vaccinedeveloped byBharat Biotechin collaboration with theIndian Council of Medical Research-National Institute of Virology.[2]

Covaxin
A vial of Covaxin
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Trade namesCovaxin
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII

On 3 November 2021, theWorld Health Organization(WHO) validated the vaccine for emergency use, as the first Indian-developed covid vaccine to be approved.[3][4]By 31 January 2022, Covaxin had 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]

Initialeffectivenessbyvariant
Doses Severity of illness Delta
1 Symptomatic −1%(−51to33%)[A][8]
Hospitalization Not reported
2 Symptomatic 50%(33–62%)[8]
Hospitalization Not reported
  1. ^Theconfidence intervalincludes zero, so it is possible that vaccination had no effect.

Efficacy

A phase 3 clinical trial with 25,798 participants found that the vaccine is64%(95%CI,29–82%) effective against asymptomatic cases,78%(65–86%) effective against symptomatic disease,93%(57–100%) effective against severe disease, and65%(33–83%) effective against theDelta variant.[9]

Manufacturing

As aninactivated vaccine,Covaxin uses a more traditional technology that is similar to the inactivatedpolio vaccine.Initially, a sample ofSARS-CoV-2was isolated by India'sNational Institute of Virologyand used to grow large quantities of the virus usingvero cells.From then on, the viruses are soaked inbeta-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-basedadjuvantAlhydroxiquim-II.[2][10][11]

The vaccine is produced with Bharat Biotech's in-housevero cellmanufacturing 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 itsGenome Valleyfacility in Hyderabad to make Covaxin. The firm, in collaboration with theGovernment of Odisha,is establishing another facility atOdisha Biotech ParkinBhubaneswarto 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 Brazilian government suspended procurement to investigate allegations of irregularities in pricing.[20]

In May 2021, Haffkine Bio-Pharmaceutical Corporation Limited ofHaffkine Instituteentered into amemorandum 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]whereasIndian 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 production due to reduction in demand. On 2 April the WHO said that a March 2022 inspection of facilities used to manufacture Covaxin had uncoveredgood manufacturing practicedeficiencies.[24]

History

Clinical trials

Phase I and II trials

In May 2020, Indian Council of Medical Research's (ICMR's)National Institute of Virologyapproved and provided the virus strains for developing an IndianCOVID-19vaccine.[25][26]In June 2020, the company received permission to conduct Phase I and Phase II human trials of a developmentalCOVID-19vaccine codenamedBBV152,from the Drugs Controller General of India (DCGI),Government of India.[27]A total of 12 sites were selected by theIndian Council for Medical Researchfor 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 inThe Lancet.[31]On 8 March 2021, Phase II results were published inThe 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 inBhopal,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 ofMax Group of Hospitalsat 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 atAIIMS Delhiand Patna.[49]As many as 54 children had registered at theAIIMS Patna.[50]In total 525 participants are enrolled in the study as perclinical trialdata.[51]

Variants

In December 2020, theAlpha variantor lineage B.1.1.7, was identified in the UK.[52]Anin vitrostudy on this variant was carried out and preliminary results show Covaxin to be effective in neutralising this strain.[53]

In April 2021, theIndian Council of Medical Researchreported that the vaccine has shown promising results in neutralisinglineage B.1.617.[54][55]

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

In June 2021, a group of researchers at theNational Institute of Virology(NIV) India, collectedserafrom 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.[57][58]Later, the USNational Institute of Healthalso approved the findings where the adjuvant used was developed jointly with funding fromNIH.[59][11]

Authorisations

Full authorization
Emergency authorization
Allowed for travel
EligibleCOVAXrecipient
See also:List of COVID-19 vaccine authorizations § Covaxin,andCOVID-19 vaccine § Trial and authorization status

India

A vial of Covaxin used at a private hospital in Bengaluru, India

On 6 December 2020,Bharat Biotechapplied to theDrugs Controller General of India(DCGI), seeking emergency use authorisation.[60]It was the third firm afterSerum Institute of IndiaandPfizerto apply under such provision.[61]

On 2 January 2021, theCentral Drugs Standard Control Organisation(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 grantedEUAfor Covaxin on 19 March 2021.[71]On 7 April, Mexico granted emergency authorisation 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, theBrazilian health regulator Anvisarejected 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 novelimidazoquinolineadjuvantthat 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,Paraguayreceived 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, theWorld 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

References

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Scholiahas a profile forCovaxin / BBV152(Q98703813).
Retrieved from "https://en.wikipedia.org/w/index.php?title=Covaxin&oldid=1247427480"