covaxin covaxin 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. this article is about bharat biotech's covid-19 vaccine. for novavax's vaccine, see covovax. for the global vaccine alliance, see covax. covaxina vial of covaxinvaccine descriptiontargetsars-cov-2vaccine typeinactivatedclinical datatrade namescovaxinroutes ofadministrationintramuscularatc codej07bx03 (who) legal statuslegal status full list of covaxin authorizations identifiersdrugbankdb15847unii76jze5dsn6 part of a series on thecovid-19 pandemicscientifically accurate atomic model of the external structure of sars-cov-2. each "ball" is an atom. covid-19 (disease) sars-cov-2 (virus) cases deaths timeline 2019 2020 january responses february responses march responses april responses may responses june responses july responses august responses september responses october responses november responses december responses 2021 january responses february responses march responses april responses may responses june responses july responses august responses september responses october responses november responses december responses 2022 january responses february responses march responses april responses may responses june responses july responses august responses september responses october responses november december 2023 january february march april may locations by country and territory africa antarctica asia europe north america oceania south america by conveyance cruise ships naval ships international response endemic phase evacuations face masks international aid investigations into origin lockdowns by country misinformation by governments fake treatments social distancing software travel united nations world health organization wto ip waiver undercounting of deaths covid-19 apps zero-covid national responses africa china european union germany ghana india ireland netherlands new zealand nigeria philippines russia sweden uk government us federal government vietnam medical response disease testing breathalyzer development drug development drug repurposing public health mitigation vaccines history research vitt deployment authorizations operation warp speed misinformation and hesitancy us vaccine card vaccine passports current vaccines coronavac covaxin convidecia janssen medigen moderna novavax oxford–astrazeneca pfizer–biontech sinopharm bibp sputnik v variants variants of concern alpha beta gamma delta omicron other variants epsilon zeta eta theta iota kappa lambda mu cluster 5 lineage b.1.617 economic impact and recession arts and culture aviation cannabis cinema films disney fashion financial markets food industry food security journalism music performing arts retail shipping television us sportscasting programs tourism video games by country canada india ireland malaysia new zealand russia uk us by sport association football baseball basketball combat sports cricket disc golf gaelic games gridiron football ice hockey motorsport rugby league impacts animals black people crime death rates by country disability domestic violence emergency evacuations education female environment hospitals language lgbt community long-term care media coverage mental health symptoms migration military notable deaths other health issues politics diplomacy popular culture protests pregnancy prisons religion catholic church hajj science and technology social media strikes suicides telehealth xenophobia and racism society ireland malaysia new zealand russia uk us covid-19 portal as of october 2021, 110.6 million people in india have received covaxin. on 3 november 2021, the world health organization (who) validated the vaccine for emergency use. as of 31 january 2022, covaxin has been granted emergency use approval in 13 countries medical uses effectiveness a vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. effectiveness is generally expected to slowly decrease over time. initial effectiveness by variant doses severity of illness delta 1 symptomatic −1% (−51 to 33%) hospitalization not reported 2 symptomatic 50% (33–62%) hospitalization not reported 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. 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. the vaccine candidate is produced with bharat biotech's in-house vero cell manufacturing platform that has the capacity to deliver about 300 million doses. 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. in december 2020, ocugen entered into a partnership with bharat biotech to co-develop and exclusively commercialise covaxin in the us market; in june 2021, the partnership was extended to cover canada. in january 2021, precisa medicamentos entered into an agreement with bharat biotech to supply covaxin to brazil. the contract was terminated in july 2021 after the brazil government suspended procurement to investigate allegations of irregularities in pricing. 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 whereas indian immunologicals limited (iil) has signed a commercial agreement with bharat biotech for producing the drug substance, a critical component of the vaccine bharat immunologicals and biologicals corporation (bibcol) will also manufacture the vaccine. 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. history 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. 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. 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. in january 2021, the company published phase i trial results in the lancet. 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. phase iii trials in november 2020, covaxin received the approval to conduct phase iii human trials after completion of phase i and ii. 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. 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. multiple ethical breaches have been reported at one of their trial sites in bhopal, potentially hampering the quality of overall data. 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. 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. phase iv trials in june 2021, bharat biotech announced the start of phase iv trials to evaluate the vaccine's real-world effectiveness. 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. trials on minors in may 2021, drugs controller general of india (dcgi) approved clinical trials in the age group of 2 to 18 years. the trials are conducted at aiims delhi and patna. as many as 54 children had registered at the aiims patna. in total 525 participants are enrolled in the study as per clinical trial data. variants in december 2020, the alpha variant or lineage b.1.1.7, was identified in the uk. an in vitro study on this variant was carried out and preliminary results show covaxin to be effective in neutralizing this strain. in april 2021, the indian council of medical research reported that the vaccine has shown promising results in neutralizing lineage b.1.617. 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). 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. later, the us national institute of health also approved the findings where the adjuvant used was developed jointly with funding from nih. authorizations full authorization emergency authorization allowed for travel eligible covax recipient