Country’s drugs regulator gives final emergency-use approval for two coronavirus vaccines, both ‘made in India’.
India has authorised the emergency use of two coronavirus vaccines developed by AstraZeneca and Oxford University, and by local pharmaceutical firm Bharat Biotech, according to the country’s drug regulator.
Drugs Controller General Dr Venugopal, G Somani, said both vaccines would be administered in two doses at a news briefing on Sunday.
“The … vaccines of Serum Institute [AstraZeneca-Oxford vaccine] and Bharat Biotech are being approved for restricted use in emergency situations,” Somani said, referring to the Indian firm that manufactured the former vaccine.
Prime Minister Narendra Modi tweeted that the fast-track approvals were “a decisive turning point to strengthen a spirited fight” that “accelerates the road to a healthier and COVID-free nation”.
“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India!” he said on Twitter, calling it a sign of a “self-reliant” country.
It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil 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 biggest vaccination drives in coming days in the country of more than 1.3 billion people.
The initial immunisation plan aims to vaccinate 300 million people – healthcare workers, front-line staff including police and those considered vulnerable due to their age or other diseases – by August 2021
The Serum Institute of India, the world’s largest vaccine manufacturing company, has been contracted by AstraZeneca to make a billion doses for developing nations, including India. On Friday, the United Kingdom became the first country to approve the shot.
Serum Institute’s chief executive Adar Poonawalla tweeted after the approvals that the vaccine would be “ready to roll-out in the coming 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 three trial phases. The third, which tests for efficacy, began in mid-November.
Early clinical studies showed Covaxin does not have any serious side effects and produces antibodies for COVID-19.
Somani told reporters after the briefing that the drug regulator would “never approve anything if there is the slightest safety concern”.
“The vaccines are 100 percent safe,” he said, adding that side effects such as “mild fever, pain and allergy are common for every vaccine”.
An application for a vaccine made by Pfizer Inc is still being reviewed.
India is the second-worst affected country by the coronavirus after the United States, with more than 10.3 million confirmed cases and 149,435 deaths, though its rate of infection has come down significantly from a mid-September peak.
On Saturday, the country staged nationwide drills to start one of the world’s biggest coronavirus vaccination programmes. It saw 25 health workers receive dummy vaccines at each of the centres to be used across the country in a test run before the launch.
Health Minister Harsh Vardhan called for a campaign to counter “misleading rumours” that may scare people off getting the vaccine.