Pfizer seeks approval for emergency use of its COVID-19 vaccine in India: Details

In a new development on the vaccine front, Pfizer India has approached the Drugs Controller General of India (DCGI) seeking an emergency use authorisation for its coronavirus vaccine in the country.

The Covid-19 vaccine candidate, developed jointly by Pfizer and German biotechnology partner BioNTech, has reported an efficiency of 95 percent in the third stage of trials. Pfizer got its first emergency-use clearance in the United Kingdom on December 2, followed by Bahrain. In an application submitted to the DCGI on Friday, Pfizer India sought permission to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019,” sources were quoted as saying by a news agency.

So far, Pfizer and BioNTech, Moderna, and Russia’s Sputnik V are the only vaccines that have reported over 90 percent efficiency of their candidates. “Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its Covid-19 vaccine. The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech’s Covid-19 mRNA vaccine BNT162b2 in the country,” the source reportedly added. 

“The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult,” senior government officials reportedly noted.

Data from Pfizer’s Phase 3 study of nearly 44,000 people had demonstrated that the vaccine candidate was 95 percent effective in helping to prevent COVID-19. Efficacy was reportedly consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%, according to a statement by the parent company.