Virendra Pandit
New Delhi: With the United Kingdom granting approval to the coronavirus vaccine, developed by Oxford University, and pharmaceutical major AstraZeneca, India is also expected to approve the much-awaited shots at the earliest.
London’s approval came within days of detection of a new, highly-infectious strand in the coronavirus in the UK from where it is spreading to other countries. In 2020, coronavirus has mutated at least 17 times.
Media reports said on Wednesday that the Indian drug regulator, Central Drugs Standards Control Organization (CDSCO), is looking into the issue on a top priority basis after the Government of India was informed of the British approval. The CDSCO, part of the Union Health Ministry, will thoroughly review the safety and immunogenicity data from the clinical evaluations conducted in India, and overseas, before granting any emergency authorization for the vaccine here.
A subject expert committee (SEC) will take a decision on emergency use authorization (EUA) of the vaccine, known as Covishield. It will also consider the application of the Serum Institute of India, which has a manufacturing tie-up for the vaccine, seeking EUA.
The Indian regulator was waiting for the UK’s approval to the Oxford COVID-19 vaccine, before deciding on giving emergency use authorization to the Serum Institute that is manufacturing the shots here.
In India, the vaccination drive is likely to begin in January 2021. Mock drills have already been held in four states this week.
“The government today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorize Oxford University/AstraZeneca’s COVID-19 vaccine for use,” the British health ministry said in a statement.
The vaccine, viewed by British scientists as a “game-changer”, was being evaluated by the MHRA after getting the final data on Monday. The vaccine could see the UK achieve herd immunity by the summer of next year.
Britain has ordered 100 million doses of the vaccine, of which 40 million are expected to be made available by March-end.
AstraZeneca CEO Pascal Soriot has expressed the hope that the vaccine should be effective against a new variant of the coronavirus that is now causing havoc in most parts of the UK, and also other countries.
Reacting after granting approval to the vaccine, British Prime Minister Boris Johnson said it was “truly fantastic news”. “We will now vaccinate as many people as quickly as possible,” he tweeted.
Soriot said: “Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer, and is supplied by AstraZeneca at no profit. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government, and the tens of thousands of clinical trial participants.”
Matt Hancock, UK Secretary of State for Health and Social Care, said: “Not only have we discovered the first treatment to reduce mortality for COVID-19, but this vaccine will also be provided to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease.”
