NEW DELHI (AP) – India approved two COVID-19 vaccines on Sunday, paving the way for a massive vaccination program to stop the coronavirus pandemic in the world’s second-most populous country.
The Indian medicines regulator issued an emergency permit for the vaccines developed by the University of Oxford and UK-based drug manufacturer AstraZeneca and another developed by the Indian company Bharat Biotech.
Drug Controller General Dr. Venugopal G Somani said both vaccines will be given in two doses.
Somani said the decision to approve the vaccines was made after “careful scrutiny” 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 reinforce a tough battle”.
“Congratulations India,” Modi tweeted.
The country’s original immunization plan aims to vaccinate 300 million people – health workers, frontline workers including police, and those considered vulnerable because of their age or other illnesses by August 2021. For effective distribution, more than 20,000 health workers have been trained to administer the vaccine far, the health ministry said.
But this will be a challenge for India. Despite having one of the largest immunization programs, it is not aimed at adults and vaccination coverage remains patchy. Neither vaccine requires the ultra-cold storage facilities that some others have. Instead, they can be kept in refrigerators, making them more viable for the country.
While the world’s largest vaccine producer has no written agreement with the Indian government, Chief Executive Adar Poonawalla said during a virtual briefing on Monday that India would be “given priority” and receive the bulk of its stock of about 50 million. doses.
The Serum Institute of India has been contracted by AstraZeneca to produce a billion doses for developing countries, including India. On Wednesday, Great Britain was the first to approve the shot.
Partial results of studies for the Oxford AstraZeneca injection in nearly 24,000 people in Great Britain, Brazil and South Africa suggest 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 older people.
Researchers had also claimed that the vaccine protected against the virus in 62% of people who received two doses and 90% of those who received half a dose due to a manufacturing defect. But the latter group included only 2,741 people, which is too small to be definitive.
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. The company has only gone through two of the three pilot phases. The third, testing for efficacy, began in mid-November.
Early clinical studies showed that the vaccine has no serious side effects and produces antibodies to COVID-19. With the second injection due to be given 28 days after the first and an immune response being evoked two weeks later, it is not clear whether the company has provided data on the effectiveness of the vaccine.
Somani said, “The vaccine has been found to be safe.”
The Ministry of Health said in a statement that the Bharat Biotech shot was authorized for limited use in “public interest as an abundant precaution in clinical trial mode, especially in the context of infection by mutant strains.”
Dr. Gagandeep Kang of Christian Medical College in Vellore said the idea that the vaccine could help against a mutant variant of the virus was “hypothetical.”
India is the second most affected by the coronavirus with nearly 1.4 billion people after the US, with more than 10.3 million confirmed cases and 149,435 deaths, although the infection rate has fallen significantly from a peak in mid-September .
Indian regulators are still considering approvals for other vaccines, including one made by Pfizer.
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The Associated Press Health and Science Department is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.