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India fast-tracks approval for foreign COVID-19 vaccines

NEW DELHI: India is to fast-track emergency approvals for COVID-19 vaccines that have been authorised by Western countries and Japan, paving the way for possible imports of Pfizer, Johnson & Johnson, and Moderna shots.

The move, which will drop the need for companies to do small, local safety trials for their vaccines before seeking emergency approval, came following the world’s biggest surge in cases in the country this month.

Vaccines authorised by the World Health Organization or authorities in the United States, Europe, 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 they are rolled out,” it said.

India, the world’s biggest maker of vaccines, has so far administered more than 106 million doses of COVID-19 shots, but many states are now running short of supplies as inoculations expand due to surging cases.

India has sold more than 54.6 million vaccine doses abroad and gifted more than 10 million doses to partner countries.

It is currently using the AstraZeneca shot and a homegrown vaccine developed by Bharat Biotech for its own immunisation drive. The country this week approved Russia’s Sputnik V shot for emergency use.

Since April 2, India has reported the world’s highest daily tallies of infections, reaching more than 100,000 a day in the last week, compared with fewer than 10,000 daily cases earlier in the year.

India reported 161,736 cases on Tuesday, taking its total to 13.7 million. Deaths rose by 879 to 171,058.

The world’s second-most populous country has also stopped exports of anti-viral drug Remdesivir, developed by Gilead Sciences, due to a local shortage. Indian drug maker Cipla Ltd said it had doubled production of the drug to meet “unprecedented demand”.

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