Pharma major Pfizer on Friday said it has decided to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India. Pfizer Inc has withdrawn an application for emergency-use authorization of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech, the company told Reuters on Friday.

The U.S. company, which was the first drugmaker to apply for emergency use authorization of its COVID-19 vaccine in the country, had a meeting with India’s drugs regulator on Wednesday and the decision was made after that, the company said.

“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,” it said in a statement to Reuters, adding it will in the future look to resubmit its application with the additional information that the regulator requires.

 

 

Pfizer was the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) for the emergency use authorization for its Covid-19 vaccine in the country. Meanwhile, India started its mass vaccination against the virus on 16 January after approving two Covid-19 vaccines from emergency use in the country – Serum Institute of India’s locally produced Oxford Covid-19 vaccine Covishield and Bharat Biotech’s indigenously manufactured Covaxin.

 

Pfizer’s Covid-19 vaccine needs to be stored at an extremely low temperature of minus 70 degrees Celsius since the vaccine uses synthetic messenger RNA (mRNA) to prompt an immune response against the virus.

Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on the Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources had told PTI.

 

LEAVE A REPLY

Please enter your comment!
Please enter your name here