Pfizer seeks clinical trial waiver for emergency marketing approval in India
09 Dec 2020
US pharmaceuticals major Pfizer is looking to India, the biggest consumer and also the biggest contract manufacturer of vaccines in the world, for early marketing of its Covid-19 vaccine has contracted to buy 1.6 billion doses of Covid-19 vaccine as vaccine makers from around the world are eager to sell their products to India.
India has already contracted 500 million doses of the Oxford University-AstraZeneca vaccine, 1 billion from the US company Novavax and 100 million doses of the 'Sputnik V' from Russia's Gamaleya Research Institute.
Serum Institute of India (SII), which manufactures Oxford-AstraZeneca and Novavax vaccines for Covid-19 is reported to be ready with 400 million doses of the vaccine and has sought government approval for emergency use of the vaccine.
While SII would be the first choice for the government, there is still an unmet demand for 100s of millions of doses of the Covid-19 vaccine. Pfizer and other vaccine makers are looking at this market.
Pfizer India is the first pharmaceutical firm to seek emergency use authorisation from the Drugs Controller General of India (DCGI) for its Covid-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain.
The US firm, however, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials in India, in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources have said.
Pfizer India is moving on the strength of the emergency approval granted by the UK and may cite this as an excuse for seeking waiver of clinical trials in India.
Pfizer has submitted the EUA application for grant of permission to import and market Pfizer-BioNTech's Covid-19 mRNA vaccine BNT162b2 in the country.
Meanwhile, five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trials of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.
Drug firm Zydus Cadila has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine.
It is not known whether Pfizer will get approval for its vaccine without undertaking clinical trials in India.