Pfizer Inc has applied for emergency use authorisation of its coronavirus vaccine in India, reports said on Sunday. With this, Pfizer India has become the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its vaccine in the country, after its parent company secured such clearance in the UK and Bahrain.
According to PTI, Pfizer India submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine in India. 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. Indian officials have said they are pinning their hopes mainly on locally tested vaccines instead of those developed by Pfizer and Moderna Inc. The Pfizer shot needs to be stored at minus 70 degrees Celsius (-94 F) or below, temperatures that most Indian cold storages cannot reach.
Prime Minister Narendra Modi on Friday said “three indigenous vaccines are already in the final stages of the trial. “Vaccines for COVID are likely to be ready within a few weeks. Indian health agencies and manufacturers are working in tandem with global agencies. We are fully prepared for the rollout,” he said after an all-party meeting. The UK is preparing to become the first country to roll out the Pfizer/BioNTech Covid-19 vaccine this week. As per the government, the shots will be initially available at hospitals before distributing stocks to doctors’ clinics. Britain gave emergency use approval for the vaccine developed by Pfizer and BioNTech last week. “This coming week will be a historic moment as we begin vaccination against Covid-19,” Matt Hancock, the U.K.’s health secretary, said in a statement. “We are doing everything we can to make sure we can overcome significant challenges to vaccinate care home residents.”