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Covaxine rejected by US FDA

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.