News that the Medicines and Healthcare products Regulatory Agency (MHRA) will review the data from trials of one of the most promising Covid-19 vaccine candidates, to see whether it meets the agency’s robust standards of quality, safety and effectiveness, has been welcomed by the UK Government.
Initial data had shown the Pfizer/BioNTech vaccine is 94% effective in protecting people over 65 years of age from coronavirus, with no serious safety concerns having been raised during the clinical trials.
Already the UK Government has pre-ordered 40 million vaccine doses – enough to provide vaccinations for up to a third of the population – and is expected to receive the total amount by the end of 2021.
The majority of doses are anticipated to be received in the first half of next year.
As well as successfully protecting those over the age of 65, trial data also showed that the vaccine candidate also performed equally well in people of all ages, races and ethnicities.
Approval from the MHRA, as the UK’s independent regulator, is required for the Covid-19 vaccine to be authorised for consistent manufacture and supply. To achieve this approval, it must demonstrate that it meets strict quality, safety and effectiveness standards set by the MHRA.
Confirmation from the MHRA that they had received the necessary data to progress their review into the vaccine candidate means it can now progress to the next stage of the process.
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 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. 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.”