India scraps local trials to fast-track foreign vaccines

NEW DELHI • India yesterday scrapped local trials for “well-established” foreign coronavirus vaccines to fast-track imports as it battles a devastating second wave of the pandemic that has killed tens of thousands of people.

India recorded its highest Covid-19 monthly death toll in May since the pandemic began last year, with this month’s fatalities accounting for just over a third of the overall total. The country recorded 3,847 fatalities yesterday.

India has been inoculating its people with the AstraZeneca vaccine produced locally at the Serum Institute of India and Covaxin made by local firm Bharat Biotech, and has begun rolling out Russia’s Sputnik V.

But supplies are far short of the millions of doses the world’s second-most populous country needs.

The government said it was in talks with Pfizer for “earliest possible” imports of its shots and that it had also had discussions with Johnson & Johnson and Moderna.

Last month, India pledged to fast-track approvals for foreign vaccines but its insistence on local trials was a key reason for stalled discussions with Pfizer.

“The provision has now been further amended to waive the trial requirement altogether for the well-established vaccines manufactured in other countries,” the government said in a statement yesterday.

None of the drugmakers has sent in applications for approval with India’s drugs regulator, it said.

“We reiterate our request to all international vaccine makers to come and make in India – for India and for the world.”

Just about 3 per cent of the country’s 1.3 billion people have been fully vaccinated, the lowest rate among the 10 countries with the most Covid-19 cases.

Union Minister of State for Home Affairs G. Kishan Reddy said yesterday India is ramping up vaccine production and will produce 2.59 billion doses of various Covid-19 vaccines by the year end.

The country reported 211,298 new infections yesterday, still the world’s highest daily rise, but nearly half the daily infections it recorded earlier this month. The overall case load is now at 27.37 million, while deaths stand at 315,235, according to Health Ministry data.

But experts believe that figure grossly underestimates the actual toll as only people who have tested positive are counted, whereas many victims were never tested.

Desperate Indian states are launching global tenders or seeking expressions of interest from firms including Pfizer and Moderna, but vaccine makers said they would talk with only the federal government.

The government said supplies were tight.

“The fact that global tenders have not given any results only reaffirms what we have been telling the states from day one – that vaccines are in short supply in the world and it is not easy to procure them at short notice,” it said.

Tamil Nadu in southern India yesterday recorded the highest new cases with 33,764 people testing positive for the virus, while neighbouring Kerala state added 28,798 cases. Maharashtra, India’s second-most populous state, saw the most fatalities at 1,013.



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