NEW DELHI (AP) – India on Sunday approved two COVID-19 vaccines, paving the way for a major vaccination program to stem the coronavirus pandemic in the world’s most populous country.
The country’s drug regulator has granted emergency approval for the vaccine developed by Oxford University and drugmaker AstraZeneca in the UK, and another developed by Indian company Bharat Biotech.
Venugopal G. Somani, general practitioner general, said both vaccines would be administered in two doses. He said the decision to approve the vaccines was taken after a thorough investigation by the Central Drugs Standard Control Organization, the pharmaceutical regulator of India.
Prime Minister Narendra Modi calls the vaccine’s approval a “decisive turning point to intensify an enthusiastic fight.”
“It will make every Indian proud that the two vaccines approved in emergencies are made in India!” Modi tweeted.
AstraZeneca has contracted Serum Institute of India, the largest vaccine manufacturer in the world, 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 asked questions about the vaccine developed by Bharat Biotech. They point out that clinical trials have only recently begun, making it nearly impossible for the company to analyze and submit data showing that its shots are effective in preventing coronavirus diseases.
India has confirmed more than 10.3 million cases of the virus, ranking second in the world behind the US, although the infection rate has dropped significantly from a peak in September. More than 149,000 deaths were also reported.
The country’s initial vaccination plan aims to vaccinate 300 million people by August 2021 – health workers, frontline staff, including the police, and those considered vulnerable due to their age or other illnesses. far to administer the vaccine, the Ministry of Health said.
But the plan presents a major challenge. India has one of the world’s largest vaccination programs, but it is not aimed at adults, and vaccine coverage remains volatile. None of the approved vaccines require the ultra-cold storage facilities that some do. Instead, it can be stored in refrigerators, making it more feasible for the country.
Although Serum Institute of India does not have a written agreement with the Indian government, its chief executive Adar Poonawalla said India would “enjoy priority” and receive the bulk of its stock of about 50 million doses.
Partial results from studies for the Oxford-AstraZeneca that shot nearly 24,000 people in Britain, Brazil and South Africa indicate that the vaccine is safe and about 70% effective. It is not as good as 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 have shown that the vaccine has no serious side effects and produces antibodies to COVID-19. But late clinical trials began in mid-November. The second shot had to be given 28 days after the first shot, and two weeks later an immune response developed.
The time frame means that it is not possible for the company to submit data showing that the shots are effective in preventing infection by the virus, Dr. Gagandeep Kang, an expert in infectious diseases at Christian Medical College in Vellore, said.
All India Drug Action Network, a public health watchdog, has issued a statement demanding greater transparency.
Somani, the regulator, said that ‘the safety of the vaccine is safe’, but declined to say whether any efficacy data would be shared.
The Ministry of Health said in a statement that permission had been granted for the inclusion of Bharat Biotech for limited use in the “public interest as an abundant precaution in the clinical trial mode, especially in the context of mutant strain infection.”
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.
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