NEW DELHI (AP) – India authorized two COVID-19 vaccines on Sunday, paving the way for a huge inoculation program to stop the coronavirus pandemic in the second most populous country in the world.
The Indian Drug Regulatory Authority has granted an emergency permit for vaccines developed by Oxford University and the British doctor AstraZeneca and another developed by the Indian company Bharat Biotech.
Comptroller General of Medicines 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 examination” by the Central Organization for the Control of Drug Standards, India’s pharmaceutical regulator.
Prime Minister Narendra Modi called the approval of the vaccine a “decisive moment in strengthening a spiritual struggle.”
“Congratulations India,” Modi wrote on Twitter.
The country’s initial immunization plan aims to vaccinate 300 million people – health workers, front-line staff, including police officers and those considered vulnerable due to their age or other illnesses – by August 2021. For efficient distribution, more than 20,000 health workers have been trained so far from administering the vaccine, the health ministry said.
But this will be a challenge for India. Despite having one of the largest immunization programs, it is not adult-oriented and vaccine coverage remains uneven. None of the vaccines require ultra-cold storage facilities, which others do. Instead, they can be stored in refrigerators, making them more feasible for the country.
Although the world’s largest vaccine company has no written agreement with the Indian government, its chief executive, Adar Poonawalla, said in a virtual briefing on Monday that India would receive “priority” and receive most of it. its stock of about 50 million doses.
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 shooting.
Partial results from studies conducted for Oxford-AstraZeneca shot in nearly 24,000 people in the UK, Brazil and South Africa suggest that the vaccine is safe and about 70% effective. This is not as good as other vaccine candidates and there are also concerns about how well the vaccine will protect the elderly.
The researchers also claimed that the vaccine protects against the virus in 62% of people who received two doses and in 90% of those who received half a dose due to a manufacturing error. But the last group included only 2,741 people, which is too small to be conclusive.
The other vaccine known as COVAXIN is being developed by Bharat Biotech in collaboration with government agencies and is based on an inactivated form of coronavirus. The company completed only two of the three test stages. The third, which tests effectiveness, began in mid-November.
Early clinical trials 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, and with an immune response two weeks later, it is unclear whether the company provided data on the vaccine’s effectiveness.
Somani said that “the vaccine has been found to be safe.”
The Ministry of Health said in a statement that permission had been granted for the Bharat Biotech shot for restricted use in “public interest as a precautionary measure in the clinical trial mode, especially in the context of infection with 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 is “hypothetical.”
India, with nearly 1.4 billion people, is the second most affected by coronavirus after the US, with over 10.3 million confirmed cases and 149,435 deaths, although its infection rate has dropped significantly from the top to the middle. September.
Indian regulators are still considering approving other vaccines, including those made by Pfizer.
___
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.