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Current Affairs

US denies approval for Covaxin

Date: 14 June 2021 Tags: Miscellaneous

Issue

Covaxin drug developed by Bharat Biotech has been denied the Emergency Use Authorisation by the US government.

 

Details

  • The US government is in no hurry to give fast approval for vaccines as it already has immunised large sections of its population.

  • The Emergency Use Approval was earlier given to Pfizer-BioNTech, Moderna mRNA and Johnson & Johnson vaccines.

  • The USFDA has decided not to entertain requests by drug companies where there is a need to check the validity of the clinical trial data, manufacturing facilities and clinical trials.

 

What does that mean for Covaxin?

The FDA has asked the American partner of the company to apply for full authorisation instead of an Emergency Use Approval.

 

Effects on Indian students

  • Indian students aiming to join American universities will have to get inoculated with both doses. It could also be Covaxin.

  • They should be able to produce negative RT-PCR report before boarding the flight to US. There would not be any restrictions on students taking Covaxin jabs.

 

Situation in other countries

  • Brazil had declined Bharat Biotech certificate of Good Manufacturing Practices after officials visited its facilities in Hyderabad.

  • This move would not affect its approval in Brazil but it could delay the supply of vaccine to the country.