Pfizer Must Conduct Local Study for Vaccine Approval: Dr VK Paul
Several countries including the US and the UK have already approved the Pfizer-BioNTech Covid-19 vaccine.
In an interview with Reuters, Dr VK Paul, Member (Health), NITI Aayog, said that all vaccine makers, including Pfizer, must conduct supplementary local trials for their COVID-19 vaccines to receive emergency use authorisation in India.
Administration of the COVID-19 vaccine in the country is slated to begin on 16 January.
Two vaccine candidates – SII’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ – were earlier given emergency use approval by the drug regulator.
The UK Oxford-AstraZeneca vaccine is being produced under the name ‘Covishield’ here by Serum Institute. Importantly, SII had conducted a month-long local trial on over 1,500 people before it sought and received approval from India’s drug regulator.
Pfizer-BioNTech became the first to seek emergency use approval in India from the Drugs Controller General of India (DCGI) on 4 December for the mRNA vaccine candidate. The US’s FDA has given emergency approval to the vaccine as well.
The firm had reportedly sought permission to import the vaccine for sale and distribution in the country, and had asked for a waiver for clinical trials on Indian population.
“As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial.”Dr VK Paul to Reuters
It must be noted here that provisions for emergency approvals without bridging studies to exist under India's New Drugs and Clinical Trial Rules. However, Indian officials normally do ask for these trials to ascertain safety and efficacy in the country’s population.
The World Health Organization (WHO) granted emergency use validation for the Pfizer-BioNTech Covid-19 vaccine on 31 December. Several countries including the US and the UK had already approved the candidate vaccine.
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