World America 12 Jun 2021 FDA says 'no� ...

FDA says 'no' to use of Covaxin in US

DECCAN CHRONICLE.
Published Jun 12, 2021, 9:27 am IST
Updated Jun 12, 2021, 9:54 am IST
The FDA recommended Bharat Biotech's US partner, Ocugen, to submit a biologics licence application (BLA) or take the full approval route
Covaxin has been administered to millions of people in India and it was given approval for emergency use in 14 countries. — Representational image/DC
 Covaxin has been administered to millions of people in India and it was given approval for emergency use in 14 countries. — Representational image/DC

Hyderabad: In what is seen as an instance of the West denying "due recognition" to Indian technological prowess, the US Food and Drug Administration (FDA) has refused to allow Indian vaccine-maker Bharat Biotech to sell its Covid-19 vaccine there.

The grant of an “emergency approval use" (EAU) would have allowed the Hyderabad-based firm to sell Covaxin in the US with immediate effect.

 

The FDA, however, recommended Bharat Biotech's American partner, Ocugen, to submit a  biologics licence application (BLA) or take the full approval route with additional data. Ocugen said in an official release on Friday that this may delay the launch of Covaxin in the US.

Explaining the process of granting an EUA on its website, FDA said that it “may allow use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”

 

Under this process, the FDA has granted emergency authorization to vaccines of Pfizer-BioNTech, Moderna and Janssen. However, none of these has proven its efficacy for the highly transmissible Delta variant that was initially found in India and spread to many other countries.

Though the FDA cites the unavailability of alternatives as a criteria for granting emergency approval, it turned a blind eye to the fact that Covaxin has been proven to be effective against the Delta variant. 

The FDA’s move shows the distrust that the US harbours for Indian products, especially those in the field of cutting-edge technology. 

 

Covaxin has been administered to millions of people in India and it was given approval for emergency use in 14 countries.

"No vaccine manufactured or developed from India has ever received EAU or full licensure from USFDA. When approved, it will be a great leap forward for vaccine innovation and manufacturing from India," Bharat Biotech said in its statement.

Covaxin is also facing prejudice at the top global health entity dominated by the West:  The World Health Organisation (WHO). The global health body has not yet included Covaxin in the list of the vaccines that are approved for international travel.

 

...




ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT
-->