The British government has on December 2 accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.
The decision was made following a regulatory process known as a rolling review. A rolling review can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis, as opposed to waiting until the end of the program.
The U.K. has worked very closely with the companies involved from the outset. The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.
The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.
The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
Approximately 800,000 doses of the vaccine will be made available across the U.K. from next week. Altogether, the U.K. has ordered 40 million doses of this particular vaccine.
The National Health Service (NHS) will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination. Because of the need to store the vaccine at very low temperatures, it is possible that the vaccines will only be given in hospitals in the early stages, until necessary infrastructure is in place elsewhere.
Vaccination volunteers have and continue to be recruited, some of these will be trained how to administer the vaccine. Alongside hospitals, doctors’ surgeries, and pharmacies, the U.K. is also establishing vaccination centers in venues such as conference centers or sports stadiums.
To aid the success of the vaccination program, the government reminds everyone to play their part and abide by the necessary restrictions.
At this time, it is expected that the vaccine will only be available via the NHS, free of charge, meaning those not in the most vulnerable groups will not be able to get an early jump by paying for it. The government assures however, that there will be plenty for everyone over the coming months. The annual flu vaccine in the U.K. has historically been available free of charge for the elderly and clinically vulnerable, with the option for other citizens to pay around $15-20 for it at private pharmacies. However, due to increased demand this year, restrictions were placed on who could be the first to receive it.