India officially approved two Covid vaccines after giving the green light to the Oxford Astra Zeneca bump and another from Indian company Bharat Biotech.
The move paves the way the way for a huge vaccination program to contain the coronavirus pandemic in the world's second largest country.
The country's medicines agency issued emergency approval for the vaccine developed by Oxford University and UK drug maker AstraZeneca and another vaccine developed by Indian company Bharat Biotech.
Health officials participate in a dry run or mock exercise dispensing Covid-19 coronavirus vaccines at a primary health center in Chennai on Jan. 2
Dr. Venugopal G. Somani, General Controller of Medicines, said both vaccines would be given in two doses. He said the decision to approve the vaccines was made after "careful review" by the Central Drugs Standard Control Organization, India's medicines agency.
Prime Minister Narendra Modi described the vaccine approval as "a crucial turning point in strengthening a spirited struggle".
"It would make every Indian proud that the two vaccines approved for emergency use are made in India!" Modi tweeted.
AstraZeneca has contracted the Serum Institute of India, the world's largest vaccine manufacturer, to manufacture 1 billion doses of its vaccine for developing countries, including India. On Wednesday, Britain became the first country to approve the shot.
A health officer prepares a vaccine kit while participating in a dry run or mock exercise for delivering Covid-19 coronavirus vaccines at a primary health center in Chennai
However, India will not allow the export of the Oxford-AstraZeneca University vaccine for several months, Adar Poonawalla, CEO of the Serum Institute, said on Sunday. The export ban means poorer nations will likely have to wait a few months before receiving their first shots.
The move was taken to ensure India's vulnerable populations are protected and to prevent hoarding, Poonawalla said in an interview with The Associated Press.
However, health experts have asked questions about the vaccine developed by Bharat Biotech. They point out that clinical trials have only recently begun, which has made it nearly impossible for the company to analyze and submit data showing its recordings are effective in preventing coronavirus disease.
India has confirmed more than 10.3 million cases of the virus, second only to the US in the world, although its infection rate has dropped significantly since mid-September. Over 149,000 deaths have also been reported.
The country's initial vaccination plan is to vaccinate 300 million people by August 2021 – health professionals, frontline workers including the police, and those considered at risk because of their age or other illnesses. For effective distribution, over 20,000 healthcare workers have been trained widely to administer the vaccine, the Department of Health said.
However, the plan is a major challenge. India has one of the largest immunization programs in the world, but it is not targeted at adults and vaccine coverage remains patchy. Still, none of the approved vaccines require the ultra-cold storage facilities that some others offer. Instead, they can be kept in refrigerators, which makes them more practical for the country.
Health officials participate in a dry run or mock exercise to deliver Covid-19 coronavirus vaccines at a primary health center in Chennai
Although the Serum Institute of India does not have a written agreement with the Indian government, its executive director, Adar Poonawalla, said India would be "prioritized" and would receive most of its inventory of around 50 million cans.
Partial results from studies for Oxford-AstraZeneca uptake in nearly 24,000 people in the UK, Brazil and South Africa suggest that the vaccine is safe and about 70% effective. That's not as good as some of the other vaccine candidates, and there are also concerns about how well the vaccine will protect the elderly.
The other vaccine, known as COVAXIN, was developed by Bharat Biotech in collaboration with government agencies and is based on an inactivated form of the coronavirus.
Early clinical studies showed the vaccine had no serious side effects and produced antibodies to COVID-19. However, the late clinical trials began in mid-November. The second shot should be given 28 days after the first, and an immune response was triggered two weeks later.
That timeframe means the company will not be able to submit data showing that the shots are effective in preventing infection by the virus, said Dr. Gagandeep Kang, an infectious disease expert at Christian Medical College in Vellore.
All India Drug Action Network, a public health watchdog, issued a statement calling for more transparency.
Somani, the regulator, said "the vaccine was found to be safe" but refused to say whether efficacy data had been disclosed.
The Ministry of Health said in a statement that permission for the Bharat Biotech shot was given for restricted use in the "public interest as an ample precaution in clinical trial mode, particularly in relation to infections by mutant strains".
But Kang said the claim that the vaccine could help against a mutated variant of the virus was "hypothetical" and without evidence.
Indian regulators are still considering approvals for other vaccines, including one from Pfizer.