India fast tracks emergency approvals of foreign-made Covid vaccines

Last Updated: Tuesday, 13 April 2021 (16:16 IST)
India announced on Tuesday it would fast-track emergency approvals for vaccines that have been granted emergency authorization in other countries.

Vaccines authorized by the World Health Organization or authorities in the United States, the European Union, the United Kingdom and Japan “may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial,” the health ministry said in a statement.
“The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country,” it added.
The measure forgoes the need for companies to conduct local safety trials for their vaccines before seeking emergency approval.
India battles fatal COVID wave
The decision came amid a surge in infections. Tuesday’s milestone of 161,736 COVID cases fell just shy of a national record the previous day. Total deaths jumped by 879 to 171,058.
Since April 2, India has reported the world’s highest daily tallies of infections. The latest surge of infections threatens to overwhelm hospitals in hard-hit cities including Mumbai.
The announcement came after India’s drug regulator confirmed approval of Russia’s Sputnik V vaccine as the South Asian country battles the deadly wave of the pandemic.
The decision to fast-track emergency approvals for foreign-produced COVID-19 vaccines also paves the way for possible imports of Pfizer, Johnson & Johnson, and shots.
India is currently using the AstraZeneca vaccine and a local vaccine developed by Bharat Biotech.
India has so far administered more than 106 million doses of COVID-19 shots, but many states are now running short of supplies as infections spike.
India is the world’s biggest maker of vaccines. Its domestic needs have delayed the delivery of shots to the United Nations-backed COVAX initiative, which aims to distributing vaccines more equitably.