Pfizer Inc has withdrawn an application for emergency-use authorization of its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 US company, which was the first drugmaker to apply for emergency use authorization of its Covid-19 vaccine in India, had a meeting with the country’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.
“Pfizer 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,” a company statement said.
The Pfizer-BioNTech m-RNA vacccine employs a novel technology—in the form of small piece of genetic material from the coronavirus called a messenger ribonucleic acid—to make a vaccine for the coronavirus. Interim Phase-3 efficacy trials in Americans showed that those inoculated were 95% more likely to be protected than those who didn’t take the vaccine.
After being approved in the United States, the United Kingdom and the European Union, Pfizer also applied for the vaccine to be made available in India under ‘emergency use listing’ conditions. This is the clause under which Covishield and Covaxin have been approved in India. While the latter has been administered to over 4.5 million Indians, Pfizer India had been given an opportunity at least thrice, since late December, to appear before the Subject Expert Committee (SEC) of the DCGI to furnish evidence enough for an approval.
In a statement, the CDSCO’s expert committee said, “Pfizer did not propose any plan to generate safety and immunogenicity data in Indian population.”
The committee also said that it noted side effects reported abroad, causality of events being investigated.
Pfizer’s Covid-19 vaccine needs to be stored in 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 aims to make two billion doses of the Covid-19 vaccine in 2021.
