India fast-tracks approvals for foreign vaccines amid soaring Covid cases
Move comes after several states say they are facing vaccination shortage
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Your support makes all the difference.India has fast-tracked its emergency authorisation process for coronavirus vaccines that have received approval by overeas regulators, as the country grapples with its raging second wave of pandemic.
Vaccines that have been cleared for use in countries including the US and the UK will not have to await the completion of local bridging studies before manufactuers apply for emergency-use authorisation in India. Instead, they will be allowed to carry out the post-approval bridging study.
The Indian government said the first 100 recipients of each approved foreign vaccine would be assessed for seven days for safety outcomes before it is rolled out further.
The rule will apply for the vaccine candidates that have received emergency approval for restricted use by the United States Food and Drug Administration, the European Medicines Agency, the UK’s Medicines and Healthcare products Regulatory Agency, and Japan’s Pharmaceuticals Medical Devices Agency, as well as those which are listed in WHO’s emergency use lisitng
It comes amid a vaccine shortage in several states in India. So far, 10 states including Odisha, Maharashtra, Punjab, Delhi and Kerala have reported unsufficient supply.
India has been consistently posting over 100,000 new coronavirus cases from the last few weeks. On Tuesday, 161,736 new coronavirus infections were reported in the country, the world’s highest daily increase in cases.
India also overtook Brazil to be the second-worst affected country in the world with its second wave becoming deadlier than the first last year.
Nearly all states in India have been showing a surge in coronavirus cases, with the situation particularly sevre in Maharashtra.
“Vaccination is one of the critical pillars of Covid control,” the government said in a statement. It added that India was following a comprehensive approach to controlling the pandemic in “a proactive and pre-emptive manner”.
Seeing the desperate need for the vaccine, India recently also gave restricted emergency use approval for Russia’s Sputnik V, which is being developed in India in partnership with Dr Reddy’s Laboratories in Hyderabad and is the third vaccine to get approved in the country after Serum Institute of India produced Oxford-AstraZeneca vaccine labelled Covishield and Bharat Biotech’s Covaxin.
Several other vaccine candidates including Johnson & Johnson and SII-produced Novavax are awaiting approval from the government. The fast-tracked process will also make it easier for vaccines from Pfizer and Moderna to apply for authorisation in India.
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