NEW DELHI (AP) – India authorized two COVID-19 vaccines on Sunday, paving the way for a major inoculation program to contain the coronavirus pandemic in the world’s second most populous country.
The country’s drug regulator gave emergency authorization for the vaccine developed by the University of Oxford and the UK-based pharmaceutical company AstraZeneca, and another developed by the Indian company Bharat Biotech.
The General Controller of Drugs, Dr. Venugopal G. Somani, said that both vaccines would be administered in two doses. He said the decision to approve the vaccines was made after “careful examination” by the Central Drugs Standard Control Organization, India’s pharmaceutical regulator.
Prime Minister Narendra Modi called the vaccine’s approval a “decisive turning point to strengthen a vigorous fight”
“All Indians would be proud that the two vaccines that have been 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 make 1 billion doses of its vaccine for developing nations, including India. On Wednesday, Britain was the first country to approve the shot.
But questions were 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 have analyzed and presented data that shows that its vaccines 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 United States, although its infection rate has dropped significantly since its peak in mid-September. He also reported more than 149,000 deaths.
The country’s initial immunization plan aims to vaccinate 300 million people – health professionals, frontline officials, including police, and those considered vulnerable due to their age or other illnesses – by August 2021. For effective distribution , more than 20,000 health professionals have been trained. far from administering the vaccine, informed the Ministry of Health.
But the plan represents a major challenge. India has one of the largest immunization programs in the world, but it is not aimed at adults, and vaccination coverage remains uneven. Still, none of the approved vaccines requires the ultra-cool storage facilities that some others require. Instead, they can be stored in refrigerators, which makes them more viable for the country.
Although the Serum Institute of India does not have a written agreement with the Indian government, its chief executive, Adar Poonawalla, said that India would have “priority” and would receive most of its stock of around 50 million doses.
Partial results from studies for the injection of Oxford-AstraZeneca in nearly 24,000 people in Britain, Brazil and South Africa suggest that the vaccine is safe and about 70% effective. This is not as good as some other vaccine candidates, and there are also concerns about how well the vaccine will protect the elderly.
The other vaccine, known as COVAXIN, is 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 has no serious side effects and produces antibodies to COVID-19. But the latest clinical trials began in mid-November. The second injection was to be given 28 days after the first, and an immune response was started two weeks later.
That time interval means that the company cannot have submitted data showing that vaccines are effective in preventing virus infection, said Dr. Gagandeep Kang, an infectious disease specialist at Christian Medical College in Vellore.
The All India Drug Action Network, a public health watchdog, issued a statement demanding greater transparency.
Somani, the regulator, said that “the vaccine was considered safe”, but declined to say whether any data on effectiveness was shared.
The Ministry of Health said in a statement that permission was granted for the injection of Bharat Biotech for restricted use in “public interest as an abundant precaution in clinical trial mode, especially in the context of 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 approval for other vaccines, including one made by Pfizer.
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