India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other
The move, coming days after Britain became the first country to approve the AstraZeneca shots for emergency use, begins a vast campaign to inoculate the hard-hit nation’s 1.3 billion people.
A market in Mumbai on Wednesday. India has been hit hard by the coronavirus pandemic, but it has long experience with inoculating its vast population.
A market in Mumbai on Wednesday. India has been hit hard by the coronavirus pandemic, but it has long experience with inoculating its vast population. Credit…Rafiq Maqbool/Associated Press
By Emily Schmall and Sameer Yasir
Jan. 3, 2021, 1:01 a.m. ET
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.
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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.
ImageA 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.
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.Credit…Francis Mascarenhas/Reuters
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.
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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.
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Coronavirus testing in the city of Jammu last month. Experts believe that India’s real infection numbers surpass official figures.
Coronavirus testing in the city of Jammu last month. Experts believe that India’s real infection numbers surpass official figures. Credit…Channi Anand/Associated Press
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 company responded by threatening a defamation suit and demanding the trial volunteer pay about $13.7 million. While negative health effects from vaccine trials are rare, health experts said the Serum Institute risked fostering misinformation by appearing to punish somebody for speaking out.
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A temperature-controlled storage room at Indira Gandhi International Airport in New Delhi.
A temperature-controlled storage room at Indira Gandhi International Airport in New Delhi. Credit…Anushree Fadnavis/Reuters
Mr. Poonawalla said on Monday that the Serum Institute had submitted the additional information regulators had requested. It has denied that the problems reported by the trial participant in Chennai had anything to do with Covishield, but has declined to comment on accusations of trying to intimidate that person.
Indian officials have laid out an ambitious plan to inoculate the country’s huge population, which they have said would be the largest such effort in the country’s history.
India plans to begin a vaccination campaign in the first three months of the year that will cover about one-quarter of the population by August. The first 30 million people inoculated will be health care providers, then police and other frontline workers. For the remaining 270 million people, the authorities will focus on those over 50 or who have conditions that might make them more vulnerable.
The rest of the population will be immunized based on vaccine availability and the latest science.
India has long experience with inoculating its people. India’s first mass vaccination took place in 1802, to fight smallpox. Subsequent efforts suffered from misinformation and slow acceptance.
The New York Times