NEW DELHI (AP) – India authorized two COVID-19 vaccines on Sunday, paving the way for a major inoculation program to contain the coronavirus pandemic in the world’s second most populous country.
The Indian drug regulator has issued an emergency authorization for vaccines developed by the University of Oxford and the UK-based pharmaceutical company AstraZeneca and another developed by Indian company Bharat Biotech.
The General Controller of Drugs, Dr. Venugopal G Somani, said that both vaccines will be administered in two doses.
Somani said the decision to approve the vaccines was made after “careful examination” by the Central Drugs Standard Control Organization, the Indian pharmaceutical regulator.
Prime Minister Narendra Modi called the vaccine’s approval a “decisive turning point to strengthen a vigorous fight”
“Congratulations, India,” tweeted Modi.
The country’s initial immunization plan aims to vaccinate 300 million people – health professionals, frontline workers, including police and those deemed vulnerable due to their age or other illnesses – by August 2021. For effective distribution, more than 20,000 health professionals have been trained. far from administering the vaccine, informed the Ministry of Health.
But that will be a challenge for India. Despite having one of the largest immunization programs, it is not aimed at adults and vaccination coverage remains uneven. None of the vaccines require the ultra-cold storage facilities that some others require. Instead, they can be stored in refrigerators, which makes them more viable 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 meeting on Monday that India would be “priority” and would receive most of its stock of about 50 million. doses.
The Serum Institute of India was contracted by AstraZeneca to make one billion doses for developing nations, including India. On Wednesday, Britain was the first to approve the shot.
Partial results from studies for the injection of Oxford-AstraZeneca in nearly 24,000 people in Britain, Brazil and South Africa suggest that 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 the elderly.
The researchers also said 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 error. But the latter group included only 2,741 people, which is too small to be conclusive.
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. The company completed only two of the three test phases. The third, which tests effectiveness, started in mid-November.
The first clinical studies showed that the vaccine has no serious side effects and produces antibodies to COVID-19. With the second injection being given 28 days after the first, and an immune response starting two weeks later, it is unclear whether the company provided data on the vaccine’s effectiveness.
Somani said that “the vaccine was considered safe”.
The Ministry of Health said in a statement that permission was granted for the injection of Bharat Biotech for restricted use in “public interest as an abundant precaution in clinical trial mode, especially in the context of infection by mutant strains”.
Dr. Gagandeep Kang, from Christian Medical College in Vellore, said the idea that the vaccine could help against a mutant variant of the virus was “hypothetical”.
India, with almost 1.4 billion people, is the second country most affected by the coronavirus after the United States, with more than 10.3 million confirmed cases and 149,435 deaths, although its infection rate has dropped significantly since the peak mid September.
Indian regulators are still considering approval for other vaccines, including one made by Pfizer.
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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.