DCGI urges Pfizer to apply for emergency use of COVID-19 vaccine
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.
FollowNew Delhi: 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.
“In the light of the pandemic situation, the drug regulatory authority took it up with the company pleading to apply for licensure so that the application is processed well in time,” an official was quoted by Economic Times. “It is paradoxical on part of company to not start the process despite persuasion.” The regulator has written to the drug maker twice, the person said.
Pfizer said it is committed to continued engagement with the government to support its fight against the pandemic and to make the Pfizer-BioNTech Covid-19 vaccine available for use in India. “This is an ongoing discussion with the government; therefore, we are unable to confirm more,” a company spokesperson said.
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.
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.
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