Covaxine rejected by US FDA
- The US Food and Drug Administration (FDA) has rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of its covid vaccine.
- The FDA sought more data on the clinical trials for the vaccine, the complete extent of which is still lacking.
Why rejected for emergency use:
- The US is no longer in a situation where it needs to fast-track approvals of Covid-19 vaccines for increased supplies to immunize its people.
- It has already granted EUAs to the Pfizer-BioNTech and Moderna-NIAID mRNA vaccines, as well as Johnson & Johnson’s viral vector jabs.
- The country has managed to vaccinate a “significant” percentage of its population and has also achieved “good” herd immunity.
- Data from the phase 3 clinical trials of the vaccine, which were conducted on over 25,000 participants, is still awaited.
Is anything wrong with Covaxin?
- No, Bharat Biotech claims that the vaccine’s efficacy is around 78%.
- The US FDA has instead recommended that Ocugen (Bharat Biotech’s American partner,) now apply for full authorization for the vaccine instead of an emergency approval.
The issue with non-approval vaccine:
- If anybody vaccinated with covaxin, and travel abroad, then he will be needed a negative RT-PCR test or will be quarantined for a certain period.
- Will not get vaccine passport, if vaccinated with Covaxin.