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Pfizer withdraws vaccine application in India

February 5, 2021

The company has said it would submit another authorization request with further information, as India said it had not seen enough evidence the shot was safe.

A hand wearing gloves uses a syringe to pull liquid out of a drug bottle.
Pfizer was the first company to seek emergency use authorization of a coronavirus vaccine in India Image: Patrick Pleul/dpa/picture alliance

Pfizer Inc. said on Friday that it has pulled out an application for emergency use authorization of the BioNTech-Pfizer coronavirus vaccine in India.  

The decision came after Pfizer representatives met with India’s health regulator on Wednesday, who refused to grant the pharmaceutical's vaccine the authorization, citing a lack of immunogenicity trials.

"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," Pfizer said in a statement. 

The company said that it would shortly submit another authorization request with further information when available. 

What are the challenges Pfizer faces in India? 

India's drug regulator wanted Pfizer to conduct local trials to ensure the safety of the vaccine for official authorization 

But the company failed to present evidence that its vaccine was safe for the Indian population, according to a Central Drugs Standard Control Organization (CDSCO) statement.  

"After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage," the CDSCO said after a meeting with Pfizer on Wednesday.  

India’s vaccination drive

Vinod K. Paul, head of a government panel on vaccine strategy, had earlier said in an interview with Reuters that any vaccine would have to go through a "bridging trial" for India to approve its use. 

Bridging trials typically determine the immune repose of different genetic makeup. 

The pharmaceutical company had earlier said that the BioNTech-Pfizer shot had a 95% efficacy rate as the final results of its trials

Indian Health Ministry officials also said that the BioNTech-Pfizer vaccine was not the best suited to the country, given how it requires storage in high-cost freezers that aren't easily available in India, according to the Associated Press.  

The BioNTech-Pfizer vaccine must be stored at as low of a temperature as minus 70 degrees Celsius (minus 94 Fahrenheit).
India began its coronavirus vaccine rollout in January, with the Oxford University/AstraZeneca's Covishield vaccine and the Indian company Bharat Biotech's Covaxin. 

fb/rt (AP, Reuters)