Pfizer showed no plans to generate safety data in Indian population for COVID-19 vaccine, says DCGI panel
Feb 05, 2021
By Priyanka Sharma
New Delhi [India] February 5 : The subject expert panel of Drugs Controller General of India did not recommend granting emergency use authorisation to Pfizer's COVID-19 vaccine noting that the firm has not proposed plans to generate safety and immunogenicity data concerning Indian population.
The panel also noted that incidents of palsy, anaphylaxis and other Serious Adverse Event (SAE's) have been reported in the post-marketing period and "causality of the events with the vaccine is being investigated".
The US pharma company on Wednesday withdrew its application for emergency-use authorisation of its COVID-19 vaccine in India.
Subject Expert Committee (SEC) held a meeting on Wednesday to examine Pfizer's application.
"The firm presented its proposal for the emergency use authorization of COVID19 mRNA vaccine BNT162b before the committee. The committee noted that incidents of palsy, anaphylaxis and other Serious Adverse Event (SAE's) have been reported during the post-marketing and the causality of the events with the vaccine is being investigated. Further, the firm has not proposed any plans to generate safety and immunogenicity data in the Indian population," SEC said.
The mRNA or Messenger Ribonucleic Acid vaccines are those vaccines that protect against infectious diseases.
The SEC said it had has not recommended the grant of permission for emergency use in the country at this stage after a detailed deliberation.
Pfizer spokesperson had said in a statement later that it will continue to engage with the Drug Regulatory Authority of India and resubmit its approval request with additional information as it becomes available in the near future.
Pfizer had applied for the emergency use authorisation to DCGI on December 6.
The United Kingdom became the first country in the world to administer the new coronavirus vaccine developed jointly by Pfizer and BioNTech. Canada, Mexico, the US are among the countries that later approved the Pfizer-BioNTech Covid-19 vaccine for their citizens.
