NEW DELHI (AP) – India authorized two COVID-19 vaccines on Sunday, paving the way for a huge inoculation program to curb the coronavirus pandemic in the world’s second most populous country.
The country’s drug regulator gave emergency authorization for the vaccine developed by Oxford University and UK-based drug maker AstraZeneca, and by another developed by Indian company Bharat Biotech.
Dr. Venugopal G. Somani, a drug controller, said the two vaccines would be given in two doses. He said the decision to approve the vaccines was made after a “careful examination” by the Central Drug Standards Control Organization, India’s pharmaceutical regulator.
Prime Minister Narendra Modi described the approval of the vaccine as a “decisive turning point to strengthen a lively struggle”.
“It would make all Indians proud that the two vaccines that have received emergency approval be 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. On Wednesday, Britain became the first country to approve the shooting.
But health experts have raised questions about the vaccine developed by Bharat Biotech. They point out that clinical trials began recently, making it nearly impossible for the company to analyze and present data that shows its features are effective in preventing coronavirus disease.
India has confirmed more than 10.3 million cases of the virus, the second largest in the world behind the United States, although its infection rate has dropped significantly from a peak in mid-September. It has also reported more than 149,000 deaths.
The country’s initial vaccination plan aims to vaccinate 300 million people (health workers, front-line staff, including police and those who are considered vulnerable due to their age or other illnesses) by August 2021. For effective distribution, more than 20,000 health workers have been trained to administer the vaccine, the Ministry of Health said.
But the plan poses a major challenge. India has one of the largest vaccination programs in the world, but it is not aimed at adults and vaccine coverage remains uneven. However, 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 India’s Serum Institute does not have a written agreement with the Indian government, its chief executive, Adar Poonawalla, said India would “give priority” and receive most of its stock of some. 50 million doses.
Partial results from studies on the Oxford-AstraZeneca shot in nearly 24,000 people in Britain, Brazil and South Africa suggest that the vaccine is safe and around 70% effective. This is not as good as some other vaccine candidates, and there are also concerns about vaccine protection for 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. Early clinical studies showed that the vaccine has no serious side effects and produces antibodies against COVID-19. But final clinical trials began in mid-November. The second shot was to be given 28 days after the first and an immune response occurred two weeks later.
That deadline means the company may not have submitted data proving the traits are effective in preventing the virus infection, said Dr. Gagandeep Kang, an infectious disease expert at Christian Medical College in Vellore.
All India Drug Action Network, a public health monitoring body, issued a statement demanding greater transparency.
Somani, the regulator, said “the vaccine has been found to be safe,” but declined to say whether efficacy data were shared.
The Ministry of Health said in a statement that permission was granted for the taking of Bharat Biotech for restricted use in “public interest as a precaution in the clinical trial mode, especially in the context of strain infection. mutants “.
But Kang said the claim that the vaccine could help against a mutant variant of the virus was “hypothetical” and without any evidence.
Regulators in India are still considering approving other vaccines, including one from Pfizer.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.