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

Pfizer’s Chief Executive Officer (CEO) Albert Bourla has said that the pharmaceutical company is in the final stages to get an approval for the use of its Covid-19 vaccine in India.

“I hope very soon we will finalise an agreement with the government,” he was quoted as saying by news agency ANI.

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, manufactures 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 to have approvals 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.

Source link