India gets two vaccines approved for emergency use, soon to the masses


Two vaccines for coronavirus, Pune-based Serum Institute’s Covishield and Bharat Biotech’s Covaxin, received emergency approval from the country’s drug regulator today.

The Drug Controller General of India VG Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use”.

We’ll never approve anything if there is the slightest of safety concern. The vaccines are 100 percent safe,” Somani said.

Hailing the scientific community, Prime Minister Narendra Modi tweeted, “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India!”

Serum Institute, the Drug Controller General said, has submitted data of over 73,000 participants and found 70.42 percent efficacy. The firm is conducting Phase 2 and Phase 3 trials on 1,600 participants in India. The recommendation was made for restricted use and the trials will continue, he added.

The vaccine, developed by the Oxford University and pharma giant AstraZeneca is already in use abroad.

Bharat Biotech’s Covaxin is conducting trials in collaboration with the Indian Council of Medical Research.

The Drug Controller said that its Phase I and Phase II trials were conducted in around 800 people and the results showed that it is “safe and provides a robust immune response”.  The Phase III trial in on and  22,500 of the 25,800 participants have been vaccinated.

The health ministry said the government’s expert committee has reviewed Bharat Biotech’s data on “safety and immunogenicity” and gave permission for “restricted use in an emergency situation in public interest”. The idea was to have “more options for vaccinations, especially in case of infection by mutant strains,” the ministry said, adding that the clinical trials will continue.

The approval is expected to kick off one of the world’s biggest vaccination drives 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 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”.

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 programs. It saw 25 health workers receive dummy vaccines at each of the centers to be used across the country in a test run before the launch.

Health Minister Harsh Vardhan called for a campaign to counter “misleading rumors” that may scare people off getting the vaccine.