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 drug regulator of India has granted an emergency permit for the vaccines developed by the University of Oxford and the drug manufacturer AstraZeneca in the UK and another developed by the Indian company Bharat Biotech.
Venugopal G Somani, drug control general, said both vaccines are administered in two doses.
According to Somani, 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.”
“Congratulations India,” Modi tweeted.
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 it will be a challenge for India. Despite being one of the largest vaccination programs, it is not aimed at adults, and vaccine coverage remains volatile. No vaccine needs the ultra-cold storage facilities that some do. Instead, it can be stored in refrigerators, making it more feasible for the country.
Although the world’s largest vaccine manufacturing company does not have a written agreement with the Indian government, its chief executive, Adar Poonawalla, said at a virtual briefing on Monday that India would ‘take precedence’ and make up the bulk of its stock of around 50 million will receive. doses.
The Serum Institute of India has been contracted by AstraZeneca to make one billion doses for developing countries, including India. On Wednesday, Britain became the first to approve the shot.
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.
Researchers also claimed that the vaccine was protected against the virus in 62% of people who received two doses and 90% in 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 conclusive.
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 completed only two of three trial phases. The third, which tests for effectiveness, began in mid-November.
Early clinical studies have shown that the vaccine has no serious side effects and produces antibodies to COVID-19. With the second shot to be given 28 days after the first shot, and an immune response claimed two weeks later, it is not clear whether the company provided data on the efficacy of the vaccine.
Somani said that ‘the vaccine is safe’.
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 a major precaution in the clinical trial mode, especially in the context of mutant strain infection. ‘
Dr. Gagandeep Kang at Christian Medical College in Vellore said the idea that the vaccine could help against a mutant variant of the virus was ‘hypothetical’.
India, with nearly 1.4 billion people, is the second worst affected by the coronavirus after the US, with more than 10.3 million confirmed cases and 149,435 deaths, although the infection rate has dropped significantly from a peak in 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 Division receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.