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Coronavirus latest news, the U.S. Food and Drug Administration (USFDA) has asked Ocugen, a partner of Bharat Biotech in the United States, to apply for a full license for the Covid-19 vaccine, Covaxin, rather than seeking an emergency use authorization (USA). The US regulator also sought additional data and information about Covaxin.
The US Food and Drug Administration (USFDA) recommendation came in response to the EUA requested by Hyderabad-based Bhart Biotech's US partner for Covaxin, Ocugen Inc.
According to Ocugen, it will now work to gain full approval for Covaxin in the United States under USFDA regulations. It is expected that additional clinical trial data will be required to support the submission of a marketing application for Covaxin, according to the regulatory filing.
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Bharat Biotech has already announced that full data on Phase 3 trials will be available in July and Phase 4 trials will also be conducted.
“While this will extend our schedules, we are committed to bringing Covaxin to the United States,” said Dr. Shankar Musunori, CEO of Ocugen.
When called, Bharat Biotech said the USFDA had previously notified that no new US Covid vaccines would be approved. With good herd immunity and a large proportion of the population vaccinated, he said, the epidemic is easing in the United States.
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Also read about Bharat Biotech to give 55 Lakh Covaxin portions at Rs 295 for Each Dose.
“All applications must follow the biological authorization application process, which is the standard process for vaccines. Data from an additional clinical trial will be required to support the submission of a marketing application for Covaxin,” he added.
Covaxin has received USA from 15 countries with more than 50 countries in operation.
We all are together in this fight with covid-19, get yourself vaccinated and tested in case you are experiencing any sysmptoms of Corona virus.
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