The drug regulator authorizes vaccines developed by the University of Oxford and AstraZeneca, based in the United Kingdom, and another developed by Bharat Biotech of India.
India has authorized the emergency use of two coronavirus vaccines developed by AstraZeneca and the University of Oxford, and by local pharmaceutical firm Bharat Biotech, according to the country’s drug regulator.
At a press conference on Sunday, the Comptroller General of Drugs, Dr. Venugopal G Somani, said that both vaccines will be administered in two doses.
“The … vaccines of the Serum Institute [AstraZeneca-Oxford vaccine] and Bharat Biotech are being approved for restricted use in emergency situations, ”Somani said, referring to the Indian company that made the earlier vaccine.
Prime Minister Narendra Modi tweeted that the expedited approvals were “a decisive turning point in strengthening an energetic fight” that “accelerates the path to a healthier and COVID-free nation.”
“All Indians would be proud that the two vaccines that have received emergency use approval are made in India!” he said on Twitter, calling it a sign of a “self-sufficient” country.
All Indians would be proud that the two vaccines that have received emergency use approval are made in India! This shows the enthusiasm of our scientific community to fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.
– Narendra Modi (@narendramodi) January 3, 2021
The approval is expected to kick off one of the world’s largest vaccination campaigns in the coming days in the country of more than 1.3 billion people.
The initial immunization plan aims to vaccinate 300 million people (healthcare workers, front-line personnel, including the police, and those deemed vulnerable due to age or other diseases) by August 2021
AstraZeneca contracted with the Serum Institute of India, the world’s largest vaccine manufacturing company, to produce 1 billion doses for developing countries, including India. On Friday, the UK became the first country to approve the vaccine.
Serum Institute Executive Director Adar Poonawalla tweeted after approvals that the vaccine would be “ready to roll out in the next few weeks.”
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 has completed only two of the three testing phases. The third, which tests the effectiveness, started in mid-November.
Early clinical studies showed that Covaxin has no serious side effects and produces antibodies to COVID-19.
Somani told reporters after the briefing that the drug regulator “would never approve anything if there is the slightest concern for safety.”
“The vaccines are 100 percent safe,” he said, adding that side effects such as “mild fever, pain and allergies are common to all vaccines.”
An application for a vaccine made by Pfizer Inc. is still under review.
India is the second most affected country 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 from a peak in mid-September.
On Saturday, the country held drills across the country to kick off one of the largest coronavirus vaccination programs in the world. 25 healthcare workers were seen receiving mock vaccines at each of the centers to be used across the country in a pre-launch test.
Health Minister Harsh Vardhan called for a campaign to counter “misleading rumors” that can scare people from getting vaccinated.
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