Bharat Biotech’s US partner OcuGen had applied for Emergency Use Authorization (EUA) of the vaccine with the FDA. However, the US refused to grant Emergency Use Approval (EUA) to this vaccine.
New Delhi. The company has taken a big decision after Bharat Biotech’s covaccine was not approved by the US drug regulator FDA for emergency use. On Saturday, the company said it would conduct clinical trials in the US to support the marketing application of COVAXIN.
In fact, Bharat Biotech’s US partner Ocugen had applied for the Emergency Use Authorization (EUA) of the vaccine with the FDA. However, the US refused to grant Emergency Use Approval (EUA) to this vaccine. It is being said that this decision has been taken due to lack of complete data.
The USFDA had advised Ocugen Inc. to request the Biological License Application (BLA) route with additional data to obtain approval for use of the Indian vaccine. OcuGen said in a statement that it would file a BLA for Covaccine as advised by the FDA.
Bharat Biotech’s vaccine is lacking?
For information, let us tell you that non-approval of emergency use in America does not mean that there is any shortage in the vaccine. However, the FDA says that it wants to see some more results of the Covaccine trial. Let us tell you that the vaccine has not been approved by the WHO as of now.