The United States has decided not to give emergency use authorisation (EUA) to Covaxin, the inactivated whole virus vaccine developed by Bharat Biotech. The decision was communicated to the company’s American partner, Ocugen, even before it submitted an EUA application for the vaccine. Why did the US not want to give an EUA for Covaxin?
The US is no longer in a situation where it needs to fast-track approvals of Covid-19 vaccines for increased supplies to immunise its people. The country, through its Operation Warp Speed initiative, had invested $18 billion in the development of various vaccines for its population last year. It has already granted EUAs to the Pfizer-BioNTech and Moderna-NIAID mRNA vaccines, as well as Johnson & Johnson’s viral vector jabs. According to Bharat Biotech, the country has managed to vaccinate a “significant” percentage of its population and has also achieved “good” herd immunity.
In this scenario, the US Food and Drugs Administration (FDA) has decided on a new strategy to prioritise its review of EUA requests. The regulator had said in May that it “intends to decline to review and process” EUA requests in cases where it is “not feasible” for it to verify “any one” of the following — the conduct of the clinical trials, the integrity of the clinical trial data, and whether the manufacturing facilities for the vaccine meet “appropriate standards”. https://indianexpress.com/article/explained/covaxin-united-states-fda-emergency-use-authorisation-explained-7354206/
the conduct of the clinical trials, the integrity of the clinical trial data, and whether the manufacturing facilities for the vaccine meet “appropriate standards”.
Why did the US not want to give an EUA for Covaxin?
The US is no longer in a situation where it needs to fast-track approvals of Covid-19 vaccines for increased supplies to immunise its people. The country, through its Operation Warp Speed initiative, had invested $18 billion in the development of various vaccines for its population last year. It has already granted EUAs to the Pfizer-BioNTech and Moderna-NIAID mRNA vaccines, as well as Johnson & Johnson’s viral vector jabs. According to Bharat Biotech, the country has managed to vaccinate a “significant” percentage of its population and has also achieved “good” herd immunity.
In this scenario, the US Food and Drugs Administration (FDA) has decided on a new strategy to prioritise its review of EUA requests. The regulator had said in May that it “intends to decline to review and process” EUA requests in cases where it is “not feasible” for it to verify “any one” of the following — the conduct of the clinical trials, the integrity of the clinical trial data, and whether the manufacturing facilities for the vaccine meet “appropriate standards”.
https://indianexpress.com/article/explained/covaxin-united-states-fda-emergency-use-authorisation-explained-7354206/
We all know the real reasons.