Pfizer-BioNTech Covid vaccine first to get Emergency Use Authorisation from UK

In a cross-country moment that signals hope in the fight against the pandemic, the UK has given its green-signal to roll out a Covid-19 vaccine developed by American giant Pfizer and its German collaborator BioNTech.

Coming days before a similar regulatory action is expected from the US, the Pfizer-BioNTech combine said the UK’s Medicines and Healthcare Products Regulatory Agency had granted a temporary authorisation for emergency use of their mRNA vaccine.

Global first

This is the first Emergency Use Authorisation (EUA) following a worldwide Phase-III trial of a vaccine to help fight the pandemic.

And the first doses are expected to arrive in the UK in the coming days, with complete delivery expected in 2021.

“Pfizer is dedicated to ensure the availability of this vaccine for use by governments across the world. We remain committed to engaging with the Government of India to advance our dialogue and explore opportunities to make this vaccine available for use in the country,” a Pfizer spokesperson told BusinessLine .

Incidentally, Pfizer and fellow-American company Moderna have also approached the US Food and Drug Administration for an EUA.

Others lining up for approvals or deploying in their home-countries include Britain’s AstraZeneca-Oxford University vaccine, Russia’s Sputnik V from the Gamaleya Institute, and China’s vaccines from Sinovac and CanSino.

But Pfizer’s vaccine may be out of bounds for India, given its storage and distribution challenges of needing temperatures of -70°C. Pfizer had told BusinessLine that its vaccine had the potential to be part of India’s arsenal against the coronavirus. Pfizer has an India presence, but no local alliance to bring in its vaccine, like AstraZeneca, for instance, which has an India base and an alliance with Serum Institute of India to bring the AZ-Oxford University vaccine to the country.

Calling it a “historic moment”, Albert Bourla, Pfizer Chairman and Chief Executive Officer, said: “As we anticipate further authorisations and approvals, we are focussed on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”

Hope for India

Swapneil Parikh, co-author of The Coronavirus: What you need to know about the Global Pandemic, said the development was “excellent” for the UK and may not necessarily have limited implications for India. The company may innovate to stabilise and adapt it to suit conditions in other countries, he observed.

Addressing safety-concerns involving the mRNA vaccine, he said, though this is the first to be licensed, many on trial are seen to be safe. Despite its price, he suggested, it should be brought India and given in limited settings to help mitigate the health crisis.

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