UK’s independent regulator to evaluate latest data from Pfizer and BioNTech to ensure the quality, safety and effectiveness of the COVID-19 vaccine meets standards
The Government this week welcome the announcement of a review by the Medicines and Healthcare products Regulatory Agency (MHRA) of data from Pfizer/BioNTech to determine whether its COVID-19 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, and with the majority of doses anticipated in the first half of next year.
The 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 the board is satisfied the vaccine can be consistently manufactured.
This marks the next step forward for the vaccine following the MHRA’s confirmation that it has received the necessary data to progress its review into whether the vaccine meets the required standards.
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.
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
“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 rollout a vaccine according to clinical priority, at the speed at which it can be manufactured.
Business Secretary. Alok Sharma. added: “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 and 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.”
We must 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
GPs have already been signed up to take part in the programme when an appropriate vaccine is ready
And dozens of hospitals will lead co-ordination on behalf of neighbouring hospitals, community trusts and local health groups in vaccinating staff and other priority groups, with vaccination sites set up across the country.
The Government has purchased seven 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.
And Whitehall chiefs are working closely with the devolved administrations to ensure an aligned approach to COVID-19 vaccine deployment across the UK.