New Delhi:
India is to fast-track emergency approvals for COVID-19 vaccines that have been authorised by Western countries and Japan, paving the way for possible imports of Pfizer, Johnson & Johnson, and Moderna shots.
The move, which will drop the need for companies to do small, local safety trials for their vaccines before seeking emergency approval, came following the world’s biggest surge in cases in the country this month.
Vaccines authorised by the World Health Organization or authorities in the United States, Europe, the United Kingdom and Japan “may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial”, the health ministry said in a statement.
“The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before they are rolled out,” it said.
India, the world’s biggest maker of vaccines, has so far administered more than 106 million doses of COVID-19 shots, but many states are now running short of supplies as inoculations expand due to surging cases.
India is currently using the AstraZeneca shot and a homegrown vaccine developed by Bharat Biotech.
Pharma major Dr Reddy's on Tuesday said it has received regulatory approval for emergency use of Sputnik V, which will be imported from Russia, paving the way for the third COVID vaccine in India.
The Russian Direct Investment Fund said more than 850 million doses of Sputnik V are going to be produced annually in India — the 60th country to approve the vaccine.
The company has received permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted use in emergency situations, Dr Reddy's said in a regulatory filing.
''We are very pleased to obtain the emergency use authorisation for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against COVID-19. This will enable us to contribute to our nation's effort of vaccinating a significant proportion of our population,'' said Dr Reddy's Laboratories Co-chairman and MD GV Prasad.
Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators, Dr Reddy's said.
Pfizer Inc said on Tuesday it would work towards bringing the COVID-19 vaccine it developed with Germany’s BioNTech to India after the government eased import rules, after withdrawing its application in February.
“We have noted the recent announcement with regard to the regulatory pathway for global vaccines,” a Pfizer spokesperson told Reuters in an email.
“We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunisation program.”
Cipla Ltd has doubled production of COVID-19 medication remdesivir to help meet “unprecedented demand” as the country battles a massive second wave of infections, the drugmaker said on Tuesday.
Since April 2, India has reported the world’s highest daily tallies of infections, reaching more than 100,000 a day in the last week, compared with fewer than 10,000 a day earlier in the year.
India reported 161,736 cases on Tuesday, taking its total to 13.7 million. Deaths rose by 879 to 171,058.
Hundreds of thousands of devout Hindus are set to bathe in the Ganges river on Wednesday, the third key day of a festival, even as peaks in daily coronavirus infections have prompted government critics to demand the cancellation of huge events.
The widely read Hindustan Times newspaper called for an immediate halt to mass gatherings.
“Governments have happily allowed mega religious festivals, (and) political leaders are still, even in the middle of this nightmarish pandemic, addressing hundreds of thousands,” it said in an editorial.