- UK medicines regulator authorises first COVID-19 vaccine
- Pfizer/BioNTech vaccine meets regulator’s strict standards of safety, efficacy and quality
- Vaccine to be made available across the UK to priority groups from next week
Tens of thousands of people will receive an effective and high-quality COVID-19 vaccine from next week, as the UK becomes the first country in the western world to authorise a vaccine.
Following rigorous clinical trials involving thousands of people and extensive analysis of the vaccine’s safety, quality and effectiveness by experts from the Medicines and Healthcare products Regulatory Agency (MHRA), Pfizer/BioNTech’s vaccine has been authorised for use in the UK.
Now authorisation has been granted, Pfizer will deliver the vaccine to the UK. In making the recommendation to authorise supply, the MHRA will decide what additional quality assurance checks may be required before a vaccine can be made available. Pfizer will then deliver the vaccines to the UK as soon as possible.
The NHS has decades of experience in rolling out successful widespread vaccination programmes and has put in place extensive deployment plans.
In line with the recommendations of the independent Joint Committee for Vaccination and Immunisation (JCVI), the vaccine will be rolled out to the priority groups including care home residents and staff, people over 80 and health and care workers, then to the rest of the population in order of age and risk, including those who are clinically extremely vulnerable.
The vaccine is given in 2 doses – 3 weeks apart – and data from clinical trials showed the vaccine is 94% effective in protecting people over the age of 65 from coronavirus, with trials suggesting it works equally well in people of all ages, races and ethnicities. There were also no serious safety concerns reported in the trials.
The UK was the first country to pre-order supplies of the vaccine from Pfizer/BioNTech, with 800,000 doses being made available next week and 40 million doses ordered overall – enough to vaccinate up to a third of the population, and the majority of doses anticipated in the first half of next year.
NHS England will outline further details on deployment shortly, but the plans will include:
- hospital hubs for NHS and care staff and older patients to get vaccinated
- local community services with local teams and GPs already signing up to take part in the programme
- vaccination centres across the country, ensuring people can access a vaccine regardless of where they live
The global deployment of the Pfizer/BioNTech vaccine will require a huge logistical exercise over land, air and sea.
Pfizer has years of proven experience in cold supply chain management and delivering temperature-controlled vaccines to locations across the world. It has developed packaging and storage innovations for the vaccine, including specifically designed, temperature-controlled thermal shippers to maintain conditions of ultra-low temperatures.
As the JCVI has made clear, there will need to be flexibility in terms of operational challenges around delivery of the vaccine to those in care homes. In line with the advice, every effort will be made to supply vaccine and offer vaccinations to care home residents and we will deliver the vaccine according to clinical prioritisation and operational necessity.
Through the Vaccine Taskforce, the UK has secured early access to 357 million doses of 7 of the most promising vaccine candidates so far. To date, the government has invested over £230 million into manufacturing a successful vaccine. In the Chancellor’s Spending Review, published on 25 November, it was announced that the government has made more than £6 billion available to develop and procure successful vaccines.
Background information
The full prioritisation list is on GOV.UK and is as follows (in order of priority):
- Residents in a care home for older adults and their carers
- All those 80 years of age and over and frontline health and social care workers
- All those 75 years of age and over
- All those 70 years of age and over and clinically extremely vulnerable individuals
- All those 65 years of age and over.
- All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
- All those 60 years of age and over
- All those 55 years of age and over
- All those 50 years of age and over
Deployment plans
Despite the huge complexities, staff have been working to ensure that when it is approved and ready for use, the NHS is able to vaccinate from day one. The time between approval and deployment of a vaccine like this might typically be expected to take around a week, due to travel and extensive safety and quality control checks.
The steps include:
- Pfizer dispatches the vaccine from Belgium and it will arrive in the UK. This is followed by a post-delivery quality assurance process to ensure the vaccine’s quality and integrity has been maintained.
- Once all checks are complete the vaccine will be made available to order by authorised sites in the NHS.
- Orders will be packed and shipped as appropriate for the required storage temperature of each vaccine. Generally vaccines will be delivered on a next day delivery schedule except for more remote parts of the UK where delivery may take 48 hours.
- Delivering the Pfizer/BioNTech COVID-19 vaccine is complex as it needs to be stored at very cold temperatures and moved carefully, so at first we will only be able to deliver it from ‘hospital hubs’. Defrosting the vaccine takes a few hours and then additional time is required to prepare the vaccine for administering.
- Stage one of the phased roll-out of the vaccine will begin when it has been distributed.
Further information
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.
Until the end of December, and as part of the transition period, vaccines must be authorised via the European Medicines Agency and that authorisation will automatically be valid in the UK.
However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation which we have implemented – Regulation 174 – allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.
Through the government’s Vaccine Taskforce, the UK has secured early access to 357 million doses of 7 of the most promising vaccine candidates, including:
- BioNTech/Pfizer for 40 million doses
- Oxford/AstraZeneca for 100 million doses
- Moderna for 7 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
