Pfizer CEO Says In Final Stages To Get Approval For COVID-19 Vaccine In India: Report

Pfizer's Chief Executive Officer Albert Bourla has said it is in the final stages to get an approval for the use of its Covid-19 vaccine in India.

Pfizer CEO Says In Final Stages To Get Approval For COVID-19 Vaccine In India: Report

Earlier this month, the drug controller did away with the requirement of India-specific trials. File

Highlights

  • 'In final stages to get approval in India': Pfizer's CEO Albert Bourla
  • Pfizer vaccine uses mRNA and is double-dose, like vaccines in India
  • Pfizer vaccine approval will make it the second foreign vaccine in India

US pharmaceutical company Pfizer is in the final stages of an agreement with India to supply Covid vaccines, Chief Executive Officer Albert Bourla said today.

"My hope is that very soon we will finalise the approval of the product in India by the Indian health care authorities and the agreement with the government so that we can also start sending vaccines, on our side," Dr Bourla said, according to a PTI report. He was addressing the 15th edition of the India-US Bio Pharma & Healthcare Summit organised by the US-India Chamber of Commerce.

He added that Pfizer has planned that mid and low-income countries, which include India, will receive at least two billion such doses.

The Pfizer CEO said that a significant local manufacturing of vaccines that is happening at the Serum Institute of India will provide the "backbone of vaccinating" the Indian people.

"But getting the additional mRNA vaccines from us and also from Moderna will contribute significantly," he said.

This comes weeks after the Drug Controller General of India (DCGI) paved the way for foreign vaccines like Pfizer and Moderna to be used in India by doing away with the requirement of India-specific trials. The move had come amid a shortage of vaccine doses across the country and was aimed at speeding up their import.

Earlier, manufacturers of vaccines were required to carry out "bridging trials" or limited clinical trials on the Indian population to know how the drug works on people here.

But earlier this month, DCGI chief V G Somani said in a letter that it has waived the requirement "in the light of the huge vaccination requirements in India in the wake of the recent surge of COVID-19 cases and the need for increased availability of imported vaccines".

The letter said the foreign vaccines would only require approval from specific countries or health bodies.

The move came following a recommendation by the National Expert Group on Vaccine Administration for COVID-19.

"It has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL) and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin," Dr Somani had said in the letter.

The Pfizer vaccine is developed using the mRNA technology and is a double-dose vaccine, like the other vaccines currently available in India.

A go-ahead to the Pfizer vaccine will make it the second foreign vaccine to be cleared for use in India, after Sputnik V. The nod is expected to further boost the immunisation exercise in the country.

India yesterday administered a record 86.16 lakh doses of Covid vaccines, as per data on the CoWIN portal. The jump in jabs administered came on Day One of the new vaccine policy.

Reversing a policy enforced a month ago, Prime Minister Narendra Modi announced on June 7 that the Centre would provide vaccines for free all above 18, starting June 21, and take back control of vaccination from states.