Pfizer withdraws application for emergency use of COVID-19 vaccine in India

New Delhi: US pharmaceutical giant Pfizer has decided to withdraw its application to seek an emergency nod for its Covid-19 vaccine in India, the company said Friday.

Pfizer, which became the first pharmaceutical firm to apply for emergency use for its Covid-19 vaccine from the Drugs Controller General of India (DCGI), was missing from every “crucial” Subject Expert Committee’s (SEC) meeting held from 30 November to 2 January.

“In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3,” the company’s spokesperson said in a press statement.

“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 statement said.

It added that the company will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future.

“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.”

On 3 January, the Modi government had granted emergency-use authorisation to two other vaccines — Covishield, manufactured by Oxford University and AstraZeneca, and Covaxin, produced by Bharat Biotech and Indian Council of Medical Research (ICMR). Both of them had applied for the approval after Pfizer.

Experimental vaccine shots developed by Pfizer, along with German biotechnology firm BioNTech SE, have shown more than 90 per cent efficacy in stopping SARS-CoV-2 infections.

In December last year, the drugmaker had told Reuters that “Pfizer will pursue its request for India to approve its COVID-19 vaccine if the government commits to buying shots.”

Pfizer missing from SEC meetings

Pfizer had earlier said it was unable to attend expert panel meetings due to “extremely short” notice period of “a few hours or less”. It also cited “time-zone limitations” as its team is based out of the US.

“The company representatives have been unable to participate in previous meetings due to extremely short notices of a few hours or less, and time-zone limitations given that the participating team is primarily based out of the United States,” it said earlier.

It further added that it is keen on bringing Pfizer-BioNTech vaccine to India and is working on “compiling responses” for upcoming presentations.

“Pfizer remains committed to working with the Government of India and providing equitable access to our Covid-19 vaccine,” the spokesperson said earlier, adding that “in the meantime, we are in the process of compiling responses to queries raised by the regulator on the data provided”.