Dr Krishna Ella, led Hyderabad-based vaccine maker Bharat Biotech said yesterday (11 June) that it will be carrying out a clinical trial of India's maiden indigenously developed COVID-19 vaccine Covaxin in the US, reports The Economic Times.
Bharat Biotech's announcement comes after its US-based partner for Covaxin, Ocugen, announced on Thursday (10 June) that it will no longer be pursuing an Emergency Use Authorisation (EUA) in the US and will instead be pursuing the submission of a Biologics License Application (BLA).
It should be noted that submission of a BLA represents the pursuit of full approval for the vaccine rather than a provisional approval under a EUA. Thus, the approval for the launch of Covaxin in the US could take longer.
As per a statement issued by Bharat Biotech, the USFDA had earlier said that no new EUAs would be approved for any COVID-19 vaccines. All applicants will have to follow now the BLA process, which is the standard process for all kinds of vaccines in the US. To date, no vaccine manufactured or developed in India has ever received a EUA or a full license from the USFDA.
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