NEW DELHI (AP) – India authorized two COVID-19 vaccines on Sunday, paving the way for a huge inoculation program to stop the coronavirus pandemic in the second most populous country in the world.
The country’s drug regulator has granted emergency permits for the vaccine developed by Oxford University and the British doctor AstraZeneca and another developed by the Indian company Bharat Biotech.
Comptroller General Dr. Venugopal G. Somani said both vaccines will be given in two doses. He said the decision to approve the vaccines was made after “careful examination” by the Central Organization for the Control of Drug Standards, India’s pharmaceutical regulator.
Prime Minister Narendra Modi called the approval of the vaccine a “decisive moment in strengthening a spiritual struggle.”
“It would make every Indian proud that the two vaccines that have been given emergency approval for use are made in India!” Modi posted on Twitter.
AstraZeneca has contracted the Serum Institute of India, the world’s largest vaccine maker, to produce 1 billion doses of vaccine for developing countries, including India. On Wednesday, Britain became the first country to approve the shooting.
But questions have been raised by health experts about the vaccine developed by Bharat Biotech. They point out that clinical trials have only recently begun, making it almost impossible for the company to analyze and present data showing that its photographs are effective in preventing coronavirus disease.
India has confirmed more than 10.3 million cases of the virus, the second in the world behind the US, although its infection rate has dropped significantly since its peak in mid-September. It also reported more than 149,000 deaths.
The country’s initial immunization plan aims to vaccinate 300 million people – health workers, front-line staff, including police and those considered vulnerable due to age or other diseases – by August 2021. For efficient distribution, more than 20,000 health workers have been trained so far from administering the vaccine, the health ministry said.
But the plan is a major challenge. India has one of the largest immunization programs in the world, but it is not aimed at adults, and vaccine coverage remains uneven. However, none of the approved vaccines require ultra-cold storage facilities that others do. Instead, they can be stored in refrigerators, making them more feasible for the country.
Although India’s Serum Institute does not have a written agreement with the Indian government, its chief executive, Adar Poonawalla, said India would receive “priority” and receive most of its stock of about 50 million doses.
Partial results from studies conducted for Oxford-AstraZeneca shot in nearly 24,000 people in the UK, Brazil and South Africa suggest that the vaccine is safe and about 70% effective. This is not as good as other vaccine candidates and there are also concerns about how well the vaccine will protect the elderly.
The other vaccine, known as COVAXIN, is being developed by Bharat Biotech in collaboration with government agencies and is based on an inactivated form of coronavirus. Early clinical trials have shown that the vaccine has no serious side effects and produces antibodies to COVID-19. But late clinical trials began in mid-November. The second stroke was to be administered 28 days after the first, and an immune response was determined two weeks later.
This time means that it is not possible for the company to send data showing that the shots are effective in preventing the virus infection, said Dr. Gagandeep Kang, an infectious disease expert at Christian Medical College in Vellore.
The All India Drug Action Network, a public health surveillance dog, issued a statement calling for greater transparency.
Somani, the regulator, said that “the vaccine was found to be safe”, but declined to say whether efficacy data were shared.
The Ministry of Health said in a statement that permission had been granted to shoot Bharat Biotech for restricted use in “public interest as a precautionary measure in the clinical trial mode, especially in the context of infection with mutant strains.”
But Kang said the claim that the vaccine could help against a mutant variant of the virus is “hypothetical” and without any evidence.
Indian regulators are still considering approving other vaccines, including those made by Pfizer.
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