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 country’s drug regulator issued emergency authorization for the vaccine developed by the University of Oxford and the UK-based drug manufacturer AstraZeneca, and another developed by the Indian company Bharat Biotech.
Drug Controller General Dr. Venugopal G. Somani said both vaccines would be given in two doses. He 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”.
“It would make any Indian proud that the two emergency approved vaccines 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 countries, including India. On Wednesday, Britain became the first country to approve the shot.
But health experts have raised questions about the vaccine being developed by Bharat Biotech. They point out that clinical trials have only recently begun, making it nearly impossible for the company to have analyzed and submitted data showing that the admissions are effective in preventing coronavirus disease.
India has confirmed more than 10.3 million cases of the virus, the second in the world after the US, although the infection rate has dropped significantly from a peak in mid-September. It has also reported more than 149,000 deaths.
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. More than 20,000 health workers have been trained for effective distribution. far to administer the vaccine, the Health Ministry said.
But the plan is a major challenge. India has one of the world’s largest immunization programs, but it does not target adults and vaccination coverage remains patchy. Still, none of the approved vaccines requires the ultra-cold storage facilities that some others have. Instead, they can be kept in refrigerators, making them more viable for the country.
Although Serum Institute of India does not have a written agreement with the Indian government, its managing director, Adar Poonawalla, said India would be “given priority” and receive most of its supply of about 50 million doses.
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. That’s not as good as some other vaccine candidates, and there are also concerns about how well the vaccine will protect older people.
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. Early clinical studies showed that the vaccine has no serious side effects and produces antibodies to COVID-19. But the late clinical trials began in mid-November. The second injection would be given 28 days after the first and an immune response was triggered two weeks later.
That time frame means it’s not possible that the company has submitted data showing that the shots are effective at preventing infection from the virus, said Dr. Gagandeep Kang, an infectious disease expert at Christian Medical College in Vellore.
All India Drug Action Network, a public health watchdog, has released a statement calling for greater transparency.
Somani, the regulator, said that “the vaccine has been found to be safe,” but declined to say whether data on its effectiveness was shared.
The Ministry of Health said in a statement that the Bharat Biotech shot was authorized for limited use in the “public interest as an abundant precaution in clinical trial, 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 approvals for other vaccines, including one made by Pfizer.
___
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.