India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other

NEW DELHI — India on Sunday 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 on Sunday. 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 already been approved in the United States and Europe. Another, Russia’s Sputnik V, appears to be less far along.

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

Officials in India moved quickly for a number of reasons. The country is No. 2 in confirmed infections behind the United States, and the outbreak is widely believed to be worse than the official figures suggest. The pandemic has devastated the economy, and the unemployment rate is at a 45-year high. Education has been disrupted, leading to worries about the long-term impact on the country’s youth.

India will now 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, fueled in part by the government’s lack of transparency about clinical trial protocols.

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 proven, has managed to make only about one-tenth of the 400 million doses it had committed to manufacturing before the end of the year.

The Bharat Biotech vaccine, called Covaxin, is still in Phase 3 clinical trials in India and has not published efficacy data. Dr. Somani, the regulator, said the vaccine has so far been administered to 22,500 trial participants, “and the vaccine has been found to be safe.”

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

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 colder temperatures during storage and transportation.

The Serum Institute hit production delays as it built new 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 on Monday 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. Mr. 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.

“Government has yet to sign the papers and the final dotted line, but this is based on initial discussions we have had because we’ve always said that India was going to be the priority,” Mr. Sen said.

Pending approval of the vaccine by the World Health Organization, Serum will begin supplying other developing nations with doses at manufacturing cost, Mr. Sen said.

India’s approval process has also been delayed. The Serum Institute applied for emergency use approval early last month, but regulators asked for additional details from clinical trials, including whether a person involved in the trials had experienced medical complications.

The details of that claim are not clear. After receiving the Covishield vaccine on Oct. 1, a 40-year-old volunteer from Chennai, India, publicly reported neurological symptoms in a legal notice to the Serum Institute. The…