Drug regulator urges Pfizer to apply for emergency use of Covid-19 vaccine

New Delhi, July 06: The Drugs Controller General of India (DCGI) has urged Pfizer twice in writing to apply for emergency use authorization for its COVID vaccine so that application is processed well in time but Pfizer has not applied for the license yet.

Earlier, an expert committee of the DCGI declined to approve the vaccine on the grounds that there were reports of "palsy, anaphylaxis and other Severe Adverse Events" after the vaccine's approvals in some other countries and that it still wasn't clear if this was connected to vaccination.

Moreover, Pfizer India hadn't spelt out a plan to generate safety and immunogenicity data in the Indian population, the committee noted.

It must be noted that last week Pfizer's chief executive Albert Bourla said that the company was in the final stages to get approval for the coronavirus vaccine in India. " I hope very soon we will finalise an agreement with the govt," Bourla had said.

The Pfizer-BioNTech shot has been approved by the US Food and Drug Administration (US FDA), and other western regulators for emergency use. The vaccine is also authorised for use in teens in the US.

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.