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Pfizer must carry out a domestic study to be approved by India: NITI Aayog

India

Uwe Pretty Roy Barman

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New Delhi, January 14: Dr VK Paul, a member of NITI Aayog, said any vaccine maker, including Pfizer that has sought permission for emergency use of a COVID-19 dose in India, should conduct a local study to consider the immunization program.

Pfizer must carry out a domestic study to be approved by India: NITI Aayog

Reuters reported that Pfizer was the first company to seek approval for emergency use in India, but did not attend meetings called by the central drug standards monitoring organization.

The Serum Institute of India, the local vaccine manufacturer developed by AstraZeneca Plc and the University of Oxford, conducted a month-long home study of more than 1,500 people before seeking and obtaining emergency approval on January 3.

India has also approved a homemade Bharat Biotech vaccine ahead of the vaccination campaign that starts on Saturday.

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

Vinod K. Paul, who chairs a government committee on vaccine strategy, said in an interview in his office near the center: “As of now, the precondition for any vaccine that is being implemented in India is that you have to have a transitional trial.” parliament building.

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

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