Pfizer/BioNTech vaccine doses, manufacturing and storage
Pfizer has said that based on current projections it expects to produce globally up to 50 million vaccine doses in 2020. The UK is currently in discussion with Pfizer/BioNTech on how many doses could be provided to the UK by the end of the year.
Nov 24, London: The vaccine will be manufactured in BioNTech’s German sites, as well as Pfizer’s manufacturing site in Belgium. The government is working closely with partners across the health system to put in place robust measures for the end of the transition period to ensure that a COVID-19 vaccine can be delivered across the country wherever it is needed. This includes putting in place robust contingency measures to ensure that vaccine freight will continue unimpeded.
All vaccine candidates for supply and onward deployment have clear supply chain plans, including materials, manufacturing, transport, storage and distribution.
Also, read- UK Government welcomes the MHRA review into Pfizer and BioNTech vaccine
The government, through its Vaccines Taskforce, has conducted a supply chain risk assessment and is working with the vaccine suppliers to understand the optimal logistics and timings to deliver vaccines. Capacity has already been reserved by the suppliers where their programmes are mature and detailed plans are in place for all early candidates.
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 UK will receive its doses.
Pfizer has years of proven experience in cold supply chain management and delivering temperature-controlled vaccines to locations across the world. Pfizer has developed packaging and storage innovations for the vaccine and has specifically designed, temperature-controlled thermal shippers that use dry ice to maintain recommended temperature conditions (-70°C ±10°C). They can be used as temporary storage units for 15 days by refilling with dry ice. The thermal shippers also have GPS-enabled thermal sensors in every thermal shipper that will enable their location and temperature to be tracked across their pre-set routes.
Also, read- UK Government welcomes the MHRA review into Pfizer and BioNTech vaccine
When the vaccine is stored in a fridge, it has an effective life of up to 5 days at temperatures of 2 to 8 degrees, which allows it to be easily stored at distribution centres across the country.
MHRA
The MHRA is the UK’s independent regulator, globally recognised for requiring the highest standards for quality, safety and effectiveness.
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 become available before the end of the transition period, EU legislation which we have implemented via Regulation 174 of the Human Medicines Regulations allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.
Also, read- UK Government welcomes the MHRA review into Pfizer and BioNTech vaccine
After the transition period ends in January 2021, the MHRA will have new powers to approve medicines, including vaccines, and will have greater flexibility to do this in a shorter time, while maintaining the highest standards of safety, quality and effectiveness.
Vaccine prioritisation and deployment
The Joint Committee on Vaccination and Immunisation (JCVI) are the independent experts who advise the government on which vaccines the UK 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 the order of age and risk.
There are currently no plans for a COVID-19 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.
Also, read- UK Government welcomes the MHRA review into Pfizer and BioNTech vaccine
UK vaccine procurement
Through the government’s Vaccines Taskforce, the UK has secured early access to over 355 million doses of 7 of the most promising vaccine candidates, including:
1. BioNTech/Pfizer for 40 million doses
2. Oxford/AstraZeneca for 100 million doses
3. Moderna for 5 million doses
4. GlaxoSmithKline and Sanofi Pasteur for 60 million doses
5. Novavax for 60 million doses
6. Janssen for 30 million doses
7. Valneva for 60 million doses
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