Pfizer withdraws application for authorization of COVID-19 vaccine in India

The decision followed the Indian drug regulator’s request for ‘bridging trials’
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NEW DELHI —Pfizer said on February 5 that it withdrew an application for the emergency use of its COVID-19 vaccine in India. This decision followed India’s drug regulator’s request for a local safety and immunogenicity study, Reuters reported.

“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” the pharmaceutical corporation said in a statement, according to Reuters.

“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”

Indian health officials said they ask for such “bridging trials” to see if a vaccine is safe and generates an immune response in citizens. According to Reuters, special conditions do allow a waiver of such trials.

Pfizer had sought exemption from such trials on the ground that it received approvals elsewhere based on trials conducted in the US and Germany.

According to Reuters, the drug regulator said that its experts did not recommend the Pfizer vaccine due to the side effects reported overseas, which are still undergoing investigation. The regulator also noted that the company did not propose any plan to produce safety and immunogenicity data in India. 

Pfizer’s COVID-19 vaccine will not be available for sale in India, which will be immunizing citizens with other products, including the shots from Oxford University/AstraZeneca and another developed domestically by Bharat Biotech with the Indian Council of Medical Research.

Readers, please note that most current COVID-19 vaccines are authorized for emergency use only in most countries, including the US.

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