India approves AstraZeneca and local COVID-19 vaccines

January 03, 2021
AstraZeneca and Oxford University's Covishield and Bharat Biotech's Covaxin.
AstraZeneca and Oxford University's Covishield and Bharat Biotech's Covaxin.

NEW DELHI — India's drugs regulator on Sunday gave final approval for the emergency-use of two coronavirus vaccines, one developed by AstraZeneca and Oxford University and the other by local company Bharat Biotech and a state-run institute, Reuters reported.

The decisions mark the first vaccine approvals for the world's second-most populous country, which after the United States, has recorded the most infections of the coronavirus disease.

It is now expected to start a massive immunization program within about a week, a government official said, and hopes to inoculate 300 million of its 1.35 billion people free of charge in the first six to eight months of this year.

The drugs regulatory authority gave the green light to the jabs developed by AstraZeneca with Oxford University and by local firm Bharat Biotech. Prime Minister Narendra Modi called it "a decisive turning point".

On Saturday, India held nationwide drills to prepare more than 90,000 health care workers to administer vaccines across the country, which has a population of 1.3 billion people.

The Drugs Controller General of India said both manufacturers had submitted data showing their vaccines were safe to use.

The Oxford/AstraZeneca vaccine is being manufactured locally by the Serum Institute of India, the world's largest vaccine manufacturer. It says it is producing more than 50 million doses a month.

Adar Poonawalla, the company's CEO, told the BBC in November that he aimed to ramp up production to 100 million doses a month after receiving regulatory approval.

The jab, which is known as Covishield in India, is administered in two doses given between four and 12 weeks apart.

It can be safely stored at temperatures of 2C to 8C, about the same as a domestic fridge, and can be delivered in existing health care settings such as doctors' surgeries.

This makes it easier to distribute than some of the other vaccines. The jab developed by Pfizer/BioNTech - which is currently being administered in several countries — must be stored at -70C and can only be moved a limited number of times — a particular challenge in India, where summer temperatures can reach 50C.

The local vaccine, however, was approved despite the absence of data on how efficient it can be. It has yet to go through large-scale trials.

The Drugs Controller General, V.G. Somani, said Bharat Biotech's Covaxin was "safe and provides a robust immune response".

Somani said it had been approved "in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains".

Pfizer, whose vaccine has already been approved for use in jurisdictions including the UK, the US and the EU, is also seeking emergency authorization in India. In all, some 30 vaccine candidates are being developed in India.. — Agencies

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