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NEW DELHI: Any vaccine maker, together with Pfizer, which has sought emergency-use authorisation for its Covid-19 shot in India, should conduct a neighborhood “bridging” security and immunogenicity examine to be thought of for the nation’s immunisation programme, a senior authorities official instructed Reuters.

Serum Institute of India, the native producer of the vaccine developed by AstraZeneca and Oxford University, has accomplished the same examine on greater than 1,500 folks over months earlier than in search of and receiving emergency approval within the nation.

According to reviews, Pfizer had sought an exception when final month it turned the primary firm to hunt emergency-use approval in India for its vaccine already in use abroad. The firm has not attended subsequent conferences known as by India’s medication regulator.

“As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial,” Vinod Ok Paul, who heads a authorities panel on vaccine technique, stated in an interview in his workplace close to the parliament constructing.

A Pfizer spokeswomen didn’t instantly reply to a request in search of remark.

Paul additionally stated Russia’s Sputnik V, a shot present process last-stage trials in India, will quickly apply for emergency-use approval within the nation.

No vaccine maker can be given indemnity by the federal government ought to one thing go fallacious, Paul stated. Serum Institute had written to the federal government in search of indemnity. AstraZeneca has stated it has obtained such indemnity in lots of different international locations.

India has additionally authorised for emergency use a vaccine developed regionally by Bharat Biotech.




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