UK approves Oxford Covid vaccine, Indian regulators ask for extra knowledge

Aditi Tandon
Tribune News Service
New Delhi, December 30

The UK regulator on Wednesday approved the Oxford University Astra Zeneca COVID-19 vaccine for emergency use in its population a day after the country reported a whopping 40,000 new cases as it reeled under the impact of a new more infectious mutant strain.

India has yet to give its approval to the vaccine.  The Drug Controller of India, which held a meeting on a pending application from Serum Institute of India for emergency use approval of the vaccine, asked for more data from the SII as well as Bharat Biotech.

Also read: Britain first to approve AstraZeneca/Oxford COVID-19 vaccine

Serum Institute is the production collaborator for the Oxford vaccine and has readied millions of doses for rollout the moment emergency use approval comes.

Meanwhile, The University of Oxford welcomed the news that the UK government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise the emergency use of the ChAdOx1 nCoV-19 coronavirus vaccine in the UK.

The university said the Joint Committee on Vaccination and Immunisation (JCVI) would also publish its latest advice for the priority groups to receive the vaccine.

With this announcement indicating that the JCVI has advised that priority should be to give as many people in the ‘at-risk groups’ their first dose, rather than providing the required two doses in as short a time as possible.

Oxford vaccine is a two-dose vaccine

The second dose completes the course and is important for longer-term protection, and everyone will still receive their second dose within 12 weeks of their first, an approach the JCVI believes will maximise the benefits of this vaccine, ensuring at-risk people are able to get meaningful protection and ease the pressure on the UK National Health Service.

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants.”

“Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible,” he added.

Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford, said: “This is a day for the team developing the vaccine to celebrate, after a year of extremely hard work under difficult circumstances. Now that the first authorisation or use of the vaccine outside of clinical trials has been granted, we still have more to do and will continue to provide more data to multiple regulatory authorities, until we are able to see the vaccine being used to save lives around the world.”

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