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, an important step in spreading the coronavirus in one of the world’s hardest hit countries to stop.
The approvals were announced at a news conference in New Delhi on Sunday. Dr VG Somani, the General Practitioner General of India, said that the decision to approve the Oxford-AstraZeneca vaccine and a local vaccine developed by Bharat Biotech, after a thorough investigation of both by the Central Drugs Standard Control Organization, the pharmaceutical regulator of India.
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, Russian Sputnik V, appears to be less distant.
On Wednesday, Britain became the first country to grant emergency authorization for the Oxford-AstraZeneca vaccine. Argentina soon followed.
Officials in India moved quickly for several reasons. The country is number 2 in confirmed infections behind the United States, and the outbreak is generally considered worse than the official figures suggest. The pandemic has devastated the economy, and the unemployment rate is 45 years high. Education has been disrupted, leading to concerns about the long-term impact on the country’s youth.
India is now going to face some steep challenges. Doses for more than 1.3 billion people must be paid for and distributed across a vast country. Government officials may also have doubts among the public about the safety and efficacy of the vaccine, which is fueled in part by the government’s lack of transparency over clinical trial protocols.
Criticism about the lack of clarity about the data the regulator examined came quickly after the two vaccines were approved for emergency use.
All India Drug Action Network, a public health watchdog, immediately issued a statement requesting more information on the scope of clinical trials and dosage regimens for both vaccines.
Regarding the Bharat Biotech vaccine, called Covaxin, the group said they were ‘surprised to understand what scientific logic motivated the best experts’ to authorize a vaccine that is still in clinical trials.
Dr. Somani, the regulator, said the vaccine had so far been administered to 22,500 participants in the trial, and that it had been ‘found safe’.
Both the AstraZeneca vaccine and the Bharat Biotech vaccine require two doses, said Dr. Somani said. He did not specify whether the participants in the ongoing clinical trials of Bharat Biotech received both doses.
The effort has already suffered setbacks. The Serum Institute, an Indian drug manufacturer that entered into an agreement to produce the Oxford vaccine even before its efficacy was proven, managed to make about one-tenth of the 400 million doses it received before the end of the years dedicated to manufacturing. .
The government says he is ready. To glorify the vaccine in a country known for its size and sometimes unreliable roads, officials will be aware of nationwide polio vaccination and newborn vaccination campaigns, and the skill and flexibility used in India’s giant general elections, where ballot boxes at the farthest corners of the country.
According to the Serum Institute, it is on course to increase the production of the vaccine, known in India as Covishield. With $ 270 million from its own funds and $ 300 million from the Bill and Melinda Gates Foundation, Serum plans to increase production capacity to 100 million doses per month by February, company spokeswoman Mayank Sen said.
Initially, the Serum Institute signed an agreement with AstraZeneca to make one billion doses of the vaccine for low- and middle-income countries. The vaccine appeals to developing countries because it is cheaper to transport and easier to transport than those that require colder temperatures during storage and transport.
The Serum Institute suffered production delays as it built new facilities to make the vaccine. It says it has already produced between 40 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 were vague about how many doses they were expecting and when. Mr. Sen said the Serum Institute did not have a firm agreement with the Indian government but promised to discuss most of its existing stock for India.
“The government has yet to sign the papers and the final dotted line, but it is based on initial discussions we had because we have always said that India is going to be the priority,” he said. Sen said.
Pending the approval of the vaccine by the World Health Organization, Serum will start supplying doses at manufacturing costs to other developing countries, said Mr. Sen said.
India’s approval process has also been delayed. The Serum Institute applied for emergency approval early last month, but regulators have asked for additional details from clinical trials, including whether a person involved in the trials experienced medical complications.
The details of the claim are not clear. Upon receiving the vaccination against Covishield on October 1, a 40-year-old volunteer from Chennai, India, reported neurological symptoms in a legal notice to the Serum Institute in public. The company responded by filing a defamation suit and demanding that the trial volunteer pay about $ 13.7 million. While negative health consequences of vaccination trials are rare, health experts say the Serum Institute is at risk of promoting misinformation by punishing someone for talking.
Mr. Poonawalla said on Monday that the Serum Institute had submitted the additional information requested by regulators. It denied that the problems the contestant reported to Chennai had anything to do with Covishield, but declined to comment on the allegations that he was trying to intimidate that person.
Indian officials have drawn up an ambitious plan to vaccinate the country’s large population, which they say is the biggest effort in the country’s history.
India plans to launch a vaccination campaign in the first three months of the year, which will cover about a quarter of the population by August. The first 30 million people to be vaccinated are healthcare providers, then police and other front-line workers. For the remaining 270 million people, the authorities will concentrate on those over 50 or with conditions that could make them more vulnerable.
The rest of the population will be vaccinated based on the availability of vaccines and the latest science.
India has a long experience with vaccinating its people. India’s first mass vaccination took place in 1802 to combat smallpox. Subsequent attempts suffered from misinformation and slow acceptance.
The country has made progress in recent years. In the fight against polio, government officials have targeted information campaigns on religious leaders to virtually eradicate the disease. According to one study, a mass vaccination campaign by 2010 and 2013 saved the lives of tens of thousands of children.
For the coronavirus campaign, the national government has asked countries to prepare vaccination strategies. Some formed task forces at the state, district, and bloc levels. More than 20,000 health workers in about 260 districts have so far been trained to administer the vaccine, the Indian Ministry of Health said.
The government plans to use the framework of its universal vaccination program for pregnant women and newborns – one of the largest and cheapest public health interventions in the world.
Indian Civil Aviation Minister Hardeep Singh Puri said on Tuesday that airlines, airports and land handlers were asked to draw up plans for transporting scales with vaccinations at cold temperatures.
This week, health workers in four Indian states conducted an exercise to smooth out wrinkles. Health officials handed out 100 doses of placebo vaccine to trainers at various locations. They followed the temperature of the doses by the journey from the train depot to the vaccination site, as well as the time and whether they reached the intended patients.
India will continue to need to improve its ability to store and relocate vaccines in temperature-controlled conditions – known as a cold chain network, as well as improve distribution methods and train new workers.
India may have to double the number of health workers from the current 2.5 million, said Thekkekara Jacob John, a senior virologist in the southern state of Tamil Nadu.
“This is a big task,” he said. John said about the vaccination. “And the challenge does not go to densely populated cities, but to the rural areas – the home of real India.”
Government officials will also have to stop rumors, he said. Chat groups on WhatsApp, the messaging service commonly used by Facebook in India, have already become the home of misinformation about side effects.
A month ago, Prime Minister Narendra Modi urged citizens to stop those trying to spread rumors about the vaccine, which he called “anti-national and anti-human”, and urged politicians to help raise awareness .
Mr. Modi on Thursday renewed the call and voiced the ongoing battle against the virus as an unknown enemy.
“Be wary of rumors,” he said, “and as responsible citizens, you should refrain from posting on social media without checking it.”