NEW DELHI – India on Sunday approved two vaccines against the coronavirus, one made by AstraZeneca and Oxford University and another developed in India, for emergency use, a big step to contain the spread of the coronavirus in one of the most affected countries in the world.
The approvals were announced at a news conference in New Delhi on Sunday. Dr. VG Somani, India’s general drug controller, said the decision to approve the Oxford-AstraZeneca vaccine and a local vaccine developed by Bharat Biotech came after a “careful examination” of both by the Central Drugs Standard Control Organization, the regulator pharmacist from 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, Russia’s Sputnik V, appears to be less advanced.
On Wednesday, Britain became the first country to grant emergency approval for the Oxford-AstraZeneca vaccine. Argentina soon followed suit.
The authorities in India acted quickly for a number of reasons. The country ranks second in confirmed infections, behind the United States, and the outbreak is believed to be worse than official figures suggest. The pandemic devastated the economy and the unemployment rate peaked at 45 years. Education has been disrupted, leading to concerns about the long-term impact on the country’s youth.
India will now face some enormous challenges. Doses for more than 1.3 billion people must be paid for and distributed across a vast country. Government officials may also face public doubts about the safety and efficacy of the vaccine, fueled in part by the government’s lack of transparency about clinical trial protocols.
The effort has already faced setbacks. The Serum Institute, an Indian drug manufacturer that struck a deal to produce the Oxford vaccine even before its effectiveness was proven, managed to produce only about a tenth of the 400 million doses it committed to manufacture 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, said Dr. Somani. He did not specify whether participants in Bharat Biotech’s ongoing clinical trials received both doses.
The government says it is ready. To take the vaccine to a country famous for its size and its sometimes unreliable roads, employees will explore the knowledge of polio vaccination and newborn immunization campaigns across the country, and the skill and flexibility employed in India’s massive general elections, where the ballot boxes are delivered to the ends of the country.
The Serum Institute says it is on track to increase production of the vaccine, known as Covishield in India. With $ 270 million from its own funds and $ 300 million from the Bill and Melinda Gates Foundation, Serum plans to increase manufacturing capacity to 100 million doses per month by February, said Mayank Sen, a spokesman for the company.
Initially, the Serum Institute signed a pact with AstraZeneca to manufacture one billion doses of the vaccine for low- and middle-income countries. The vaccine has appeal to developing countries because it is cheaper to make and easier to transport than those that require cooler temperatures during storage and transport.
The Serum Institute suffered production delays when building new facilities to make the vaccine. He says he 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 most doses would be given to India.
Indian authorities were vague about how many doses they expect to receive and when. Sen said the Serum Institute does not have a firm agreement with the Indian government, but has pledged to reserve most of its existing stock to India.
“The government has not yet signed the papers and the final dotted line, but this is based on the initial discussions we had because we always said that India would be the priority,” said Sen.
Pending the approval of the vaccine by the World Health Organization, Serum will begin supplying other developing countries with doses at manufacturing cost, said Sen.
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 of the clinical tests, including whether a person involved in the tests had medical complications.
The details of this statement are not clear. After receiving the Covishield vaccine on October 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 that the test volunteer pay about $ 13.7 million. While the negative health effects of vaccine testing are rare, health experts say the Serum Institute is at risk of fostering misinformation by appearing to punish someone for speaking out.
Poonawalla said on Monday that the Serum Institute presented the additional information that regulators requested. She denied that the problems reported by the trial participant in Chennai had anything to do with Covishield, but declined to comment on the charges of attempting to intimidate that person.
Indian authorities have drawn up an ambitious plan to inoculate the country’s huge population, which they said would be the biggest such effort in the country’s history.
India plans to start a vaccination campaign in the first three months of the year that will cover about a quarter of the population by August. The first 30 million people vaccinated will be health professionals, then police and other frontline workers. For the remaining 270 million people, the authorities will focus on people over 50 or who have conditions that could make them more vulnerable.
The rest of the population will be immunized based on the availability of the vaccine and the latest scientific advances.
India has a long experience in inoculating its people. India’s first mass vaccination took place in 1802 to combat smallpox. Subsequent efforts suffered from disinformation and slow acceptance.
The country has made great strides in recent years. In the fight against polio, government officials directed information campaigns to religious leaders, helping to almost eradicate the disease. According to one study, a mass measles vaccination campaign saved the lives of tens of thousands of children between 2010 and 2013.
For the coronavirus campaign, the national government asked states to prepare vaccination strategies. Some formed task forces at the state, district and block levels. More than 20,000 health workers in some 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 immunization program for pregnant women and newborns – one of the largest and cheapest public health interventions in the world.
India’s civil aviation minister, Hardeep Singh Puri, said on Tuesday that airlines, airports and ground operators were asked to draw up plans for transporting vaccine bottles at low temperatures.
This week, health professionals in four Indian states carried out an exercise to eliminate any wrinkles. Health officials in different places distributed more than 100 doses of placebo vaccine to coaches. They then tracked the dose temperatures during the journey from the train depot to the vaccination site, as well as the time and whether they reached the intended patients.
India will still need to improve its capacity to store and transport vaccines in controlled temperature 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 Herculean task,” said John of the vaccine effort. “And the challenge is not in densely populated cities, but in rural areas – home to true India.”
Government officials will also have to stop the spread of rumors, he said. Chat groups on WhatsApp, the Facebook messaging service widely used in India, have already become the home of misinformation about side effects.
A month ago, Prime Minister Narendra Modi asked citizens to be alert to those trying to spread rumors about the vaccine, which he called “anti-national and anti-human”, and asked politicians to help raise awareness.
Modi renewed the appeal on Thursday, classifying the ongoing fight against the virus as a fight against an unknown enemy.
“Be careful of rumors,” he said, “and as responsible citizens, avoid forwarding messages on social media without checking.”