India approves Oxford-AstraZeneca and local COVID-19 vaccine

World
By Editor_1
A Serum Institute facility in Pune, India. The company has had a difficult time meeting a pledge to produce vaccines on a huge scale but says it is overcoming obstacles -Francis Mascarenhas/Reuters
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By Emily Schmall and Sameer Yasir

NEW DELHI — India on Sunday (3) approved two coronavirus vaccines, one made by AstraZeneca and Oxford University and the other developed in India, for emergency use, a major step toward halting the spread of the coronavirus in one of the world’s hardest-hit countries.

The approvals were announced at a news conference in New Delhi. Dr. V.G. Somani, the drugs controller general of India, said the decision to approve the Oxford-AstraZeneca vaccine and a local vaccine developed by Bharat Biotech came after “careful examination” of both by the Central Drugs Standard Control Organization, India’s pharmaceutical regulator.

Indian regulators are still considering approvals for other vaccines. One, made by Pfizer and BioNTech, has been approved in the United States and Europe. Another, Russia’s Sputnik V, appears to be less far along.

On Wednesday (Dec 30), Britain became the first country to grant emergency approval for the Oxford-AstraZeneca vaccine. Argentina soon followed suit.

India will face some steep challenges. Doses for more than 1.3 billion people must be paid for and distributed across a vast country. Government officials could also face doubts among the public about the safety and efficacy of the vaccine, fuelled in part by the government’s lack of transparency about clinical trial protocols.

All India Drug Action Network, a public health watchdog, issued a statement requesting more information about the scope of clinical trials and dosing regimens for both vaccines.

On the Bharat Biotech vaccine, called Covaxin, the group said it was “baffled to understand what scientific logic has motivated the top experts” to authorize a vaccine still in clinical trials.

Somani, the regulator, said the vaccine had so far been administered to 22,500 trial participants and had “been found to be safe”.

Both the AstraZeneca vaccine and the Bharat Biotech vaccine require two doses, Somani said. He did not specify whether the participants in Bharat Biotech’s continuing clinical trials had received both doses.

Already the effort has faced setbacks. The Serum Institute, an Indian drug-maker that struck a deal to produce the Oxford vaccine even before its effectiveness had been proved, has managed to make only about one-tenth of the 400 million doses it has committed to manufacturing before the end of the year.

The government says it is ready. To get the vaccine across a country famous for its size and its sometimes unreliable roads, officials will tap into knowledge from nationwide polio vaccination and newborn immunization campaigns, and the skill and flexibility employed in India’s mammoth general elections, where ballot boxes are delivered to the furthest reaches of the country.

The Serum Institute says it is on track to increase production of the vaccine, which is known as Covishield in India. With $270 million of its own funds and $300 million from the Bill and Melinda Gates Foundation, Serum plans to ramp up manufacturing capacity to 100 million doses per month by February, said Mayank Sen, a company spokesman.

Initially, the Serum Institute signed a pact with AstraZeneca to make one billion doses of the vaccine for low-and-middle-income countries. The vaccine holds appeal to developing countries because it is cheaper to make and easier to transport than those that require lower temperatures during storage and transportation.

The Serum Institute hit production delays as it built facilities to make the vaccine. It says it has already produced between 40 million and 50 million doses for the world. The company’s chief executive, Adar Poonawalla, told reporters Monday (Dec 28) that a majority of the doses would be given to India.

Indian officials have been vague on how many doses they expect to receive and when. Sen said the Serum Institute did not have a firm agreement with the Indian government but had pledged to reserve most of its existing stockpile for India.

-New York Times

 

 

 

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