The Medicines and Healthcare products Regulatory Agency (MHRA) in Britain concluded that the vaccine had “met its strict standards of safety, quality and effectiveness” following months of rigorous clinical trials and analysis of data by the agency. The U.K Department of Health said the government had accepted the recommendation from the independent MHRA that the vaccine should be approved for use.
“Help is on its way,” Health Secretary Matt Hancock tweeted on Wednesday. “The MHRA has formally authorized the Pfizer/BioNTech vaccine for COVID-19. The U.K. is the first country in the world to have a clinically approved vaccine for supply.”
When will the first doses of the vaccine be administered?
National Health Service (NHS) staff were earlier told to prepare to administer doses of the 95 percent effective vaccine for those most at risk from the virus by December 1.
The government said that deployment plans “have been underway for months” and the NHS “will be ready to begin vaccinating as soon as the first vaccine is approved and delivered” with health officials saying it will be made available “from next week”.
The U.K. has ordered 40 million vaccine doses from Pfizer/BioNTech, which it expects to start receiving soon but will not receive in full until the end of 2021. This will be enough to vaccinate up to a third of the population by then.
Hancock said “an enormous amount of work has taken place” to ensure the NHS has the logistics, transport, and workforce to administer the vaccine in the U.K.
Why won’t people in the United States get it first?
Independent advisers to the Food and Drug Administration (FDA) are not scheduled to meet until December 10 to discuss the jab.
They will make recommendations about the vaccine as part of an exhaustive review to vet the safety, effectiveness and manufacturing. The FDA is expected to make a decision shortly after its advisers meet.
A week after the Pfizer/BioNTech meeting, FDA advisers will discuss a second vaccine being developed by Moderna. Moderna’s vaccine was 94 percent effective at preventing illness in a 30,000-person clinical trial.
The U.S. government, through Operation Warp Speed, has preordered 100 million doses from both Moderna and Pfizer.
Who will get the vaccine first in the U.K.?
The Joint Committee on Vaccination and Immunisation (JCVI) is made up of independent experts who advise the government on which vaccines the U.K. should use and provide advice on who should be offered the vaccination first.
The committee’s interim advice is that a COVID-19 vaccine should first be given to care home residents and staff, followed by people over 80 and health and social workers, then to the rest of the population in order of age and risk.
There are currently no plans for a vaccine to be compulsory. Vaccination will be managed by the health services in each nation: NHS England and NHS Improvement, NHS Wales, NHS Scotland, and Health and Social Care Northern Ireland.
The JCVI’s provisional prioritization for COVID-19 vaccines is subject to change should more information about vaccine effectiveness in different age groups become available. A simple age-based priority list will “likely result in faster delivery and better uptake in those at the highest risk” the committee said.
- Older adults’ resident in a care home and care home workers
- All those 80 years of age and over and health and social care workers
- All those 75 years of age and over
- All those 70 years of age and over
- All those 65 years of age and over
- High-risk adults under 65 years of age
- Moderate-risk adults under 65 years of age
- All those 60 years of age and over
- All those 55 years of age and over
- All those 50 years of age and over
- Rest of the population (priority to be determined)
What other vaccines are available?
Through the U.K. government’s Vaccines Taskforce, Britain has secured early access to over 355 million doses of seven of the most promising vaccine candidates, including:
- BioNTech/Pfizer for 40 million doses
- Oxford/AstraZeneca for 100 million doses
- Moderna for 5 million doses
- GlaxoSmithKline and Sanofi Pasteur for 60 million doses
- Novavax for 60 million doses
- Janssen for 30 million doses
- Valneva for 60 million doses
Currently, the BioNTech/Pfizer vaccine is the only one to have been approved by the MHRA.
Is the Pfizer/BioNTech vaccine easily produced and stored?
Pfizer has said that based on current projections it expects to produce globally up to 50 million vaccine doses in 2020. The U.K. is currently in discussion with Pfizer/BioNTech on how many doses could be provided to Britain by the end of the year.
The vaccine will be manufactured in BioNTech’s German sites, as well as Pfizer’s manufacturing site in Belgium.
The U.K. government said it is working on “robust measures” for the end of the Brexit transition period to ensure that a COVID vaccine can be delivered across the country wherever it is needed, including ensuring that freight transport of vaccines from the EU will not be impeded by Brexit.
The government is confident that the cold supply chain needed to distribute the Pfizer/BioNTech vaccine will not cause any problems and will make no difference to the speed at which the U.K. will receive its doses, a Department for Health spokesman said.
Pfizer’s vaccine needs to be stored at a temperature of -70°C. Temperature controlled thermal shippers that use dry ice to maintain the recommended temperature conditions can be used as temporary storage units for 15 days by refilling with dry ice.
When the vaccine is stored in a fridge, it has an effective life of up to five days at temperatures of 2-8°C, which allows it to be easily stored at distribution centers across the country, the government said.
A Department of Health and Social Care spokesperson said: “The Government has today 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 Joint Committee on Vaccination and Immunisation (JCVI) will shortly also publish its latest advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
“The vaccine will be made available across the U.K. from next week. The NHS has decades of experience in delivering large scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.
“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed.”