Pfizer must do local study to be approved by India: NITI Aayog

New Delhi, Jan 14: Any vaccine maker, including Pfizer that has sought emergency-use authorisation for its COVID-19 shot in India, must conduct a local study to be considered for the immunisation programme, NITI Aayog member Dr V K Paul said.

Pfizer was the first company to seek emergency-use approval in India, but didn't attend meetings called by the Central Drugs Standard Control Organisation, Reuters reported.
Serum Institute of India, the local manufacturer of the vaccine developed by AstraZeneca Plc and Oxford University, did months-long local study on more than 1,500 people before seeking and receiving emergency approval on January 3.

India has also approved a homegrown vaccine made by Bharat Biotech ahead of its inoculation campaign which starts on Saturday.

Pfizer had sought to import and distribute its vaccine in India without doing local trials, according to reports.

"As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial," Vinod K Paul, who heads a government panel on vaccine strategy, said in an interview in his office near the parliament building.

The government has already distributed 16.5 million doses of the two approved vaccines to states, with a plan to deliver 600 million jabs to the most vulnerable people in the next six to eight months. Serum Institute has stockpiled 50 million doses of the AstraZeneca vaccine and says it will raise its monthly output to much more than that now the approval has come.