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NEW DELHI (AP) – India authorized two COVID-19 vaccines on Sunday, paving the way for a massive vaccination program to stem the coronavirus pandemic in the world’s second most populous country.
The country’s drug regulator has given emergency clearance for the vaccine developed by the University of Oxford and British manufacturer AstraZeneca, and another developed by Indian company Bharat Biotech.
Dr Venugopal G. Somani, Comptroller General of Medicines, said the two vaccines would be given in two dosages. He said the decision to approve the vaccines was taken after “careful scrutiny” by the Central Drugs Standard Control Organization, India’s pharmaceutical regulator.
Prime Minister Narendra Modi called the approval of the vaccine “a turning point to strengthen a heated struggle”.
“It would make all Indians proud if the two vaccines that received emergency use authorization were made in India!” Modi tweeted.
AstraZeneca has hired the Serum Institute of India, the world’s largest vaccine manufacturer, to manufacture 1 billion doses of its vaccine for developing countries, including India. Britain on Wednesday became the first country to approve the shooting.
India, however, will not allow the export of the University of Oxford-AstraZeneca vaccine for several months, Adar Poonawalla, CEO of the Serum Institute, said on Sunday. The export ban means poorer countries will likely have to wait a few months before receiving their first vaccines.
The move was taken to ensure the protection of vulnerable populations in India and to prevent hoarding, Poonawalla said in an interview with The Associated Press..
But questions have been raised by health experts about the vaccine developed by Bharat Biotech. They point out that clinical trials only started recently, making it nearly impossible for the company to have analyzed and submitted data showing that its injections are effective in preventing disease from the coronavirus.
India has confirmed more than 10.3 million cases of the virus, second in the world behind the United States, although its infection rate has declined significantly from its peak in mid-September. It also reported more than 149,000 deaths.
The country’s initial immunization plan aims to immunize 300 million people – health workers, frontline staff, including the police, and those considered vulnerable due to their age or other illnesses – by August 2021. For efficient distribution, more than 20,000 health workers have been trained. away from administering the vaccine, the health ministry said.
But the plan poses a major challenge. India has one of the largest immunization programs in the world, but it is not focused on adults and vaccine coverage remains uneven. Yet none of the approved vaccines require the ultra-cold storage facilities that some others do. Instead, they can be stored in refrigerators, making them more feasible for the country.
Although the Serum Institute of India did not have a written agreement with the Indian government, its managing director, Adar Poonawalla, said India would be “priority” and would receive most of its stock from around. 50 million doses.
Partial results from studies for the Oxford-AstraZeneca vaccine in nearly 24,000 people in Britain, Brazil and South Africa suggest the vaccine is around 70% safe and effective. It’s not as good as some of the other vaccine candidates, and there are also concerns about the vaccine’s ability to protect older people.
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 the coronavirus. The first clinical studies showed that the vaccine did not have serious side effects and produced antibodies against COVID-19. But the late clinical trials began in mid-November. The second vaccine was to be given 28 days after the first, and an immune response was triggered two weeks later.
This time frame means that it is not possible that the company has submitted data showing that the vaccines are effective in preventing infection with the virus, said Dr Gagandeep Kang, an infectious disease expert at Christian Medical College. by Vellore.
All India Drug Action Network, a public health watchdog, issued a statement demanding greater transparency.
Somani, the regulator, said “the vaccine has been shown to be safe,” but declined to say whether efficacy data was shared.
The health ministry said in a statement that authorization had been granted for the shooting of Bharat Biotech for restricted use in “the public interest as a plentiful precaution in clinical trial mode, particularly in the context of an infection. by mutant strains ”.
But Kang said the claim that the vaccine could help against a mutant variant of the virus was “hypothetical” and without any evidence.
Indian regulators are still considering approving other vaccines, including one made by Pfizer.
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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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