Pfizer's Lack Of 'Safety Data' Results In Withdrawal Of Emergency Use Of Its Covid Vaccine In India

Pfizer was also the first one to seek emergency use authorisation for their COVID-19 vaccine from the Drugs Controller General of India (DCGI), ahead of Bharat Biotech and Serum Institute of India's AstraZeneca-Oxford vaccine.

A dose of the Pfizer-BioNtech Covid-19 Vaccine | AFP

Pfizer on Friday decided to withdraw its emergency use authorisation (EUA) for its coronavirus vaccine in India. This may come as a surprise to the onlookers as Pfizer was one of the first pharmaceutical firms to get EUA nod for its vaccine in UK, Canada, Mexico, US and Baharain.

Pfizer was also the first one to seek emergency use authorisation for their COVID-19 vaccine from the Drugs Controller General of India (DCGI), ahead of Bharat Biotech and Serum Institute of India's AstraZeneca-Oxford vaccine.

It is to be noted that Pfizer and BioNTech’s vaccine BNT162b2's two-dose regimen had conferred 95% protection against COVID-19, efficacy better than Covishield and Covaxin.

Emergency Use Of Pfizer's Coronavirus Vaccine In India Rejected

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on February 3 met and deliberated on Pfizer's application. As per SEC, it recommended against granting approval to Pfizer's Covid Vaccine at this stage due to lack of safety plan for the Indian population.

"The firm has not proposed any plan to generate safety and immunogenicity data in the Indian population," recommendations of SEC stated as reported by news agency PTI.

"SEC noted that incidents of palsy, anaphylaxis and other SAE's have been reported during post-marketing and the causality of the events with the vaccine is being investigated," the recommendations mentioned.

Pfizer's Withdrawal

Pfizer on Friday announced that they are withdrawing their application for Emergency Use Authorisation in India. An official statement 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."

The company further stated that it will continue to engage with the Indian authority and resubmit its approval request. 

"Pfizer remains committed to making its vaccine available for use by the government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," the official statement from Pfizer mentioned.

Meanwhile, two coronavirus vaccine - Covishield and Covaxin -  have been approved by the authorities for restricted emergency use. India is in the first phase of inoculation which kickstarted on January 16, 2021. In the first phase, 300 million people are targetted to be jabbed which include doctors, health workers and front line workers mainly.