UK Government welcomes the MHRA review into Pfizer and BioNTech vaccine

The government today (Monday 23 November) welcomes the Medicines and Healthcare products Regulatory Agency’s (MHRA) review of data from Pfizer/BioNTech to determine whether its vaccine meets robust standards of quality, safety, and effectiveness.

The companies have reported data that indicates their vaccine is 94% effective in protecting people over 65 years old from COVID-19, with trials suggesting it works equally well in people of all ages, races and ethnicities.

As the first country to pre-order the vaccine from Pfizer/BioNTech, the UK is expected to receive a total of 40 million doses by the end of 2021, enough to vaccinate up to a third of the population, with the majority of doses anticipated in the first half of next year.

The COVID-19 vaccine will only be authorised for supply by the UK’s independent regulator the MHRA if it meets strict standards of quality, safety, and effectiveness, and if they are satisfied the vaccine can be consistently manufactured.

Today marks the next step forward for the vaccine following the MHRA’s confirmation that it has received the necessary data to progress their review into whether the vaccine meets the required standards.

Despite encouraging data about this vaccine, people must continue to follow public health advice to keep themselves and their loved ones safe; regularly washing their hands, wearing a face mask and making space.

Health and Social Care 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.

If approval is granted, the NHS will be ready to deliver. 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.

Business Secretary Alok Sharma said:

Today, we have renewed hope that we are on the brink of one of the most significant scientific discoveries of our time, as we reach the crucial last stage to finding a COVID-19 vaccine.

While this news is a cause for celebration, we must make sure that this vaccine, like all new medicines, meets standards of quality, safety, and effectiveness. I urge the public to be patient while we wait for regulators to do a thorough assessment.

Finding a vaccine is not going to end the pandemic overnight, but we are hopeful of being one step closer to defeating this terrible virus.

Final deployment plans will depend on decisions by regulators but preparations have been underway for months and are in place to ensure that:

the NHS will be ready to begin vaccinating as soon as the first vaccine is approved and delivered to the UK
GPs have already been signed up to take part in the programme when an appropriate vaccine is ready
dozens of hospitals across the country will lead co-ordination on behalf of neighbouring hospitals, community trusts and local health groups in vaccinating staff and other priority groups
there will also be vaccinations sites across the country
The government has purchased 7 different types of vaccine in advance and procured 355 million doses. This includes 100 million doses of the vaccine being developed by AstraZeneca and the University of Oxford.

The UK government is working closely with the devolved administrations to ensure an aligned approach to COVID-19 vaccine deployment across the UK.

Chair of Vaccines Taskforce, Kate Bingham, said:

We are moving ever closer to having the means with which to help end this pandemic but we must wait for the outcome of the MHRA assessment before we will truly know if we have our first approved vaccine.

Irrespective of the outcome, which we all hope will be positive, this is a tremendous day for science. It is testament to the Herculean efforts of the scientific and biopharmaceutical community and it makes me immensely proud.

 

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