Pfizer seeks approval for emergency use in India after nod in UK, Bahrain

Pfizer has become the first company to seek emergency use approval of its vaccine candidate in India after getting clearance in the UK and Bahrain. Pfizer Inc and BioNTech SE vaccine candidate, BNT162b2, has shown 95 per cent efficacy against coronavirus during a preliminary clinical trial data analysis. It has sought approval from the Drugs Controller General of India for emergency use authorisation. The development is significant since Prime Minister Narendra Modi, during an all-party meet on Friday, cited experts to say that India could have the first coronavirus vaccine in weeks and that eight vaccines will be manufactured in India.

Pfizer, in its application submitted on December 4, has sought permission to import the vaccine for sale and distribution in India. It also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to get instant approval for emergency use, a PTI report said.

"Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine in India," an official source told the news agency.

AIIMS Delhi Director Dr Randeep Guleria had earlier said that India was in talks with Pfizer-BioNTech regarding its COVID-19 vaccine candidate. He said no such communication had been initiated with Moderna for its experimental COVID-19 vaccine.

The UK became the first country in the world to approve Pfizer and BioNTech coronavirus candidate on December 2 after the Medicines and Healthcare Products Regulatory Agency (MHRA) found the jab safe. The country has already ordered 40 million doses of the Pfizer vaccine to vaccinate its 20 million population. After the UK, Bahrain has also approved the vaccine for 'emergency use'. Bahrain's drug regulatory body said the approval was granted after a thorough analysis and review of all available data.

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The approval for Pfizer's vaccine candidate came in only 10 months since it started developing it, which is the fastest in the history of vaccines. Other countries like the US and the European Union are also vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc.

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Notably, Pfizer, BioNTech, Moderna, and Russia's Sputnik V are the only vaccines that have claimed over 90 per cent efficacy of their respective candidates so far. While Russia had already rolled out Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, Pfizer, and BioNTech's vaccines have also raised high hopes. Besides, Swedish drugmaker AstraZeneca and the University of Oxford's vaccine candidate, being developed along with India's Serum Institute, has also achieved 70 per cent efficacy during the preliminary analysis of its Covid-19 trial participants.

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