July 5, 2022

India urges Pfizer for conducting local study to get approval

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Pfizer Inc or any vaccine maker, which has applied for emergency use authorization in India has to conduct a safety and immunogenicity study for being given a consideration and approval to be a part of the vaccination drive to be organized inn the country, according to the senior official who revealed it to Reuters.

The vaccine-manufacturing company Serum Institute of India (SII), who is manufacturing the vaccine developed by AstraZeneca and Oxford University has conducted a similar study on over 1,500 people in the months prior to filing for emergency use approval.

The media had published about Pfizer being an exception as in the month of December, it was declared as the first company to receive an approval after it being approved for use in various countries. However, Pfizer has not been able to be a part of the meetings called by India’s drug regulator.

Vinod K Paul, leading the government panel on vaccine strategy said, “As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial.”

When asked about it, Pfizer spokesperson did not give any immediate comment. Paul further revealed about Russia’s Sputnik V, to be the next for emergency approval in India as is on the last-stage trials.

Paul further iterated that no vaccine will be granted indemnity by the government in case anything goes wrong. SII had appealed to the government for indemnity and AstraZeneca had stated about already getting it from many other countries. Meanwhile, India has given approval for emergency use to the indigenously developed vaccine – Covaxin developed by Hyderabad based company Bharat Biotech.

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