Deutsche Welle (English edition)
Coronavirus: India fast-tracks COVID vaccines with emergency approval in EU, UK, US, Japan
India has given the green light to fast-track emergency approvals for foreign-approved COVID-19 vaccines as infections surge. It could pave the way for imports of Pfizer, Johnson & Johnson, Novavax and Moderna shots.
India announced on Tuesday that it would fast-track emergency approvals for COVID-19 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 announced 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 safety trials for their vaccines before seeking emergency approval in India.
India battles fatal COVID wave
The decision came during a surge in infections. Tuesday's milestone of 161,736 COVID cases fell just shy of the national record set Monday. 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 coronavirus 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, Novavax and Moderna 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.
mvb (AP, Reuters)