India authorised the emergency use of a Covid-19 vaccine produced by local pharmaceutical company Bharat Biotech on Sunday, the country’s drug regulator said.
The country has also approved the AstraZeneca vaccine.
“The vaccines of Serum Institute (AstraZeneca/Oxford vaccine) and Bharat Biotech are being approved for restricted use in emergency situations,” said India’s drugs controller general, Dr VG Somani.
India has the world’s second-highest caseload, with more than 10.3 million infections including about 150,000 deaths. But its rate of infection has come down significantly from a mid-September peak of more than 90,000 cases daily.
The government has held nationwide drills before the mass vaccination drive of the nation’s 1.3 billion people begins. About 96,000 health workers have been trained to administer the shots.
“The use of vaccine[s] in prioritised populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of Covid-19,” WHO regional director Dr Poonam Khetrapal Singh said.
Both vaccines are to be administered in two doses and can be transported and stored at normal refrigeration temperatures.
The Serum Institute of India, the world’s biggest manufacturer of vaccines, said it is making between 50 and 60 million doses a month of the AstraZeneca/Oxford vaccine.
Serum Institutes chief executive Adar Poonawalla tweeted following the approvals that the vaccine would be “ready to roll out in the coming weeks”.
Bharat Biotech has yet to complete Phase-3 trials, but Dr Somani said the company’s jabs were approved for restricted use in the “public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains”.
He said after the briefing that the drug regulator would “never approve anything if there is the slightest safety concern”.
“The vaccines are 100 per cent safe,” he told reporters. Side effects such as mild fever and pain are common for every vaccine, he said.
Dr Somani said the overall efficacy of the AstraZeneca/Oxford vaccine was 70.42 per cent, while Bharat Biotech’s Covaxin was safe and stimulates a robust immune response.
The British-developed AstraZeneca/Oxford shot is being made locally by the Serum Institute of India and will be branded Covishield, while Bharat Biotech has teamed up with the government-run Indian Council of Medical Research.
A politician from Prime Minister Narendra Modi’s nationalist party had earlier complained about the apparent preference for the foreign-made vaccine over the local one, the approval of which was criticised for a lack of transparency.
“Vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations,” Dr Somani said.
Each vaccine will be administered in two doses and stored at between 2 and 8° degrees Celsius, he said.
Sources said on Saturday the doses would have to be given four weeks apart.
Prime Minister Narendra Modi welcomed the approvals.
“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.
Bharat Biotech earlier said they could produce up to 300 million doses a year.
“While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most,” the company’s chairman, Krishna Ella, said. “Covaxin has generated excellent safety data with robust immune responses.”
An opposition lawmaker and former minister, however, questioned the approval process for Covaxin.
“Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally accepted protocols relating to Phase-3 trials are being modified for Covaxin,” Jairam Ramesh wrote on Twitter.
India’s regulator has also received an emergency-use application for the Covid-19 vaccine made by Pfizer and Germany’s BioNTech, the first shot to secure regulatory approval in the West.
India has reported more than 10.3 million cases including about 150,000 deaths, though its infection rate has fallen significantly from its mid-September peak.
SII plans to sell the AstraZeneca/Oxford vaccine to the Indian government at about 250 rupees ($3.42) per dose and 1,000 rupees on the private market.
The regulator on Sunday also gave permission to Cadila Healthcare Ltd to conduct Phase-3 clinical trials on 26,000 Indian participants for its DNA-platform vaccine candidate, saying the interim trial data had shown it was safe and prompted an immune response under a three-dose regimen.