US vaccine stuck over quality issues; FDA yet to give its nod

The US Food and Drug Administration has not yet approved the 20 million AstraZeneca vaccines to India following concerns over the quality of the product manufactured at a plant in Baltimore.

Newly appointed US charge d’affaires to India Daniel B Smith said on Tuesday that the entire production from the plant has not been approved by FDA for any use. “There was a problem with the plant in Baltimore that produced AstraZeneca vaccines. The FDA is yet to approve vaccines. We will not export unless it is safe,” Smith said on the visibility of export of 20 million AstraZeneca vaccines to India.

The US had earlier consented to dispatch 20 million Covishield doses to India, the biggest share of AstraZeneca vaccines from abroad. The US Health and Human Services Department stopped the Baltimore manufacturer from making Covid-19 vaccine days after the facility ruined 15 million doses of shots developed by Johnson & Johnson, the New York Times had reported a few weeks back.


Smith said the US has received a list for procuring raw material for vaccines and India and the US were going through the list on what can be made available to boost production for India and global requirements.

“We have to work together as a global community for procuring raw material… We are watching carefully the situation and in touch with SII,” Smith said in response to a query on Quad’s plans for vaccine manufacturing and current situation that India finds itself in.