India has formally approved the emergency use of two coronavirus vaccines as it prepares for one of the world’s biggest inoculation drives.
The drugs regulatory authority gave the approval to the vaccines developed by AstraZeneca with Oxford University and by local firm Bharat Biotech.
Prime Minister Narendra Modi called it “a decisive turning point”.
At a news briefing on Sunday, Drugs Controller General, Dr Venugopal G Somani said both manufacturers had submitted data showing their vaccines were safe to use and vaccines would be administered in two doses.
“The… vaccines of Serum Institute (AstraZeneca-Oxford vaccine) and Bharat Biotech are being approved for restricted use in emergency situations,” Somani said.
The Oxford/AstraZeneca vaccine is being manufactured locally by the Serum Institute of India, the world’s largest vaccine manufacturer. It says it is producing more than 50 million doses a month.
The vaccine, which is known as Covishield in India, is administered in two doses given between four and 12 weeks apart. It can be safely stored at temperatures of 2C to 8C, about the same as a domestic fridge, and can be delivered in existing health care settings such as doctors’ surgeries.
This makes it easier to distribute than some of the other vaccines. The vaccine developed by Pfizer/BioNTech – which is currently being administered in several countries – must be stored at -70C and can only be moved a limited number of times – a particular challenge in India, where summer temperatures can reach 50C.
The local vaccine, however, was approved despite the absence of data on how efficient it can be. It has yet to go through large-scale trials.
India, which makes about 60% of vaccines globally, plans to immunise about 300 million people by July 2021. It will prioritise health care workers, the emergency services, and those who are clinically vulnerable because of age or pre-existing conditions.
India’s existing vaccination programme already reaches about 55 million people a year, administering 390 million free vaccines against a dozen diseases. It stocks and tracks the vaccines through a well-oiled electronic system.
Pfizer, whose vaccine has already been approved for use in jurisdictions including the UK, the US and the EU, is also seeking emergency authorisation in India.
In all, some 30 vaccine candidates are being developed in India.