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MHRA reviewing first Covid vaccine after receiving final trial results


MHRA to review Pfizer Covid vaccine


The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a review into licensing the first vaccine against Covid-19, after receiving final trial data from Pfizer.

The update, from the Department of Health and Social Care, comes as the US pharma giant last week reported that its vaccine was 94% effective for over-65s and 95% effective across all over-18s in phase 3 trials.

Legal amendments to the Human Medicine Regulations 2012, brought in by the Government in October, allow the MHRA approve temporary licencing of medicines and vaccines, on an exceptional basis, pending the grant of a full licence.

The MHRA will now review data from Pfizer/BioNTech to determine whether their vaccine meets ‘robust standards of quality, safety, and effectiveness’, the DHSC said.

The MHRA must also be satisfied that the vaccine ‘can be consistently manufactured’, the announcement added.

Health secretary Matt Hancock said: ‘The whole country will be cheered by the news that Pfizer/BioNTech have formally reported the data from their clinical trials for their vaccine to the regulator. This is another important step on the road to recovery. We must now allow the MHRA’s renowned teams of scientists and clinicians to make an independent assessment of whether it meets their robust standards of quality, safety, and effectiveness.’

Referring to advanced plans for the NHS to roll out a Covid-19 mass vaccination campaign, Mr Hancock added that ‘f approval is granted, the NHS will be ready to deliver’.

He said: ‘The NHS has vast experience in delivering widespread vaccination programmes and an enormous amount of work has taken place to ensure we have the logistical expertise, transport and workforce to roll out a vaccine according to clinical priority, at the speed at which it can be manufactured.’

It comes as the Oxford/AstraZeneca vaccine trial reported its first phase 3 findings today, although the MHRA is still awaiting its full findings.

The UK-developed vaccine – of which the Government has ordered 100 million doses – has been found to be 90% effective when given as a half dose followed by a full dose.

The vaccine is expected to cause fewer logistical hurdles as it can be stored at fridge temperature, unlike the Pfizer vaccine which has to be deep-frozen.

A Government spokesperson said earlier today: ‘The independent [MHRA] will carry out their crucial work to assess whether the vaccine meets robust standards of safety, effectiveness and quality once it receives the full data from Oxford/AstraZeneca.

‘If authorised, the NHS will begin to roll out more widely, starting with those most at risk, in line with Joint Committee on Vaccination and Immunisation advice, and taking into account logistics and practicality.’