The US drug regulator FDA has not approved the corona vaccine for emergency use. The Food and Drug Administration of America has refused to give its Emergency Use Authorization (EUA). Bharat Biotech’s US partner OcuGen had applied for Emergency Use Authorization (EUA) of the vaccine with the FDA. According to Bharat Biotech, the USFDA had earlier informed that no new Emergency Use Authorization (EUA) would be approved for new Covid-19 vaccines.
It may take some more time for Covaccine to get US approval. In a statement on Thursday, OcuGen said it would file a BLA for Covaccine in accordance with the FDA’s advice. BLA is the FDA’s “full approval” system, under which drugs and vaccines are approved.
According to Bharat Biotech, with good herd immunity and large population getting the vaccine, the epidemic in the US is decreasing. In addition, the USFDA previously informed that no new Emergency Use Authorization (EUA) will be approved for new Covid-19 vaccines.
Bharat Biotech says that our US partner, Ocugen has received a recommendation from FDA to pursue Biologics License Application (BLA) for Covaxin which is full approval. All applications must follow the BLA procedure, which is the standard procedure for vaccines. Therefore for BLA, data from additional clinical trials will be needed to support marketing application submission for Covxin. This process will extend our timeline.
At the same time, Bharat Biotech says that it has received Emergency Use Authorization (EUA) for Covaxin in 14 countries and the process is going on in more than 50 countries. Apart from this, no vaccine manufactured or developed in India has ever been fully licensed from EUA or USFDA. Thus, if it is approved, it will be a big leap for vaccine innovation and manufacturing from India.
Bharat Biotech’s Covaxin was trialled in India and on January 3, it got emergency use authorization in India, after which it is being used in corona vaccination in India.
No vaccine made or developed in India has ever received EUA or full license from the USFDA. Meanwhile, Bharat Biotech said that once approved, it will be a major step towards innovation and manufacturing of vaccines in India.
OcuGen recently announced that it has received exclusive rights to commercialize Covaccine in Canada and is in discussion with Health Canada for regulatory approval.