The mRNA-based vaccine BNT162b2 is under a rolling review with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). If it gets the green light this week, the first injections of the two-dose vaccine could take place from December 7, according to the Financial Times.
A statement from the MHRA confirmed last week (Monday 23 November) that data and evidence for the vaccine’s safety, quality and effectiveness had been received and was being assessed. It pledged to make “a decision in the shortest time possible, without compromising the thoroughness of our review” but did not set out a timeline. Advice is also being drawn in from the government’s independent advisory body, the Commission on Human Medicines.
The UK has 40 million doses of the Pfizer/BioNTech vaccine on order, which would be delivered by the end of 2021 (the majority of doses are anticipated in the first half of 2021) and is enough to vaccinate up to a third of the population.
The vaccine reported 95% efficacy in its Phase 3 trial; with similar efficacy in older people.
Manufacturing and distribution plans in place
Vaccine doses destined for the UK will be manufactured at BioNTech’s German sites and Pfizer’s manufacturing site in Belgium.
While the vaccine requires ultra-cold storage and distribution conditions (at around -70°C), the UK government says it 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 developed packaging and storage innovations for the vaccine and has specifically designed, temperature controlled thermal shippers that use dry ice to maintain the required conditions. Thermal sensors will be present in every shipper to track conditions. The shippers can also 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 to 8 degrees, which allows it to be easily stored at distribution centres across the country,” notes the UK Government.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has been advising the government on vaccine schedules: suggesting the vaccine should first be given to care home residents and staff; followed by people over 80 and health and social workers; and then to the rest of the population in order of age and risk. There are 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.
On Saturday the government appointed Nadhim Zahawi as vaccines minister.
Moderna and other vaccine supply deals
BNT162b2 is also under a rolling review with the European Medicines Agency (EMA), which was initiated at the start of October.
Until the end of December, and as part of the Brexit transition period, COVID-19 vaccine candidates can be authorized in the UK via the European Medicines Agency (EMA). However, EU legislation also allows for the UK to authorize supply based on public health need.
After January 2021, all COVID-19 vaccines for the UK will be directly assessed by the MHRA.
The Pfizer vaccine is one of seven agreements formed by the UK with vaccine developers, which now has access to around 357 million vaccine doses. Its other agreements are with AstraZeneca and the University of Oxford; Moderna’s mRNA vaccine (a further 2 million doses were added to an existing agreement for 5 million doses this weekend); Novavax, Valneva, Sanofi/GSK and Janssen.
Number of doses
Phase 3 trials; rolling review with MHRA
Phase 3 trial concluded; rolling review with MHRA
Phase 3 trial; rolling review with MHRA
Phase 3 clinical trial
Phase 1/2 clinical trials
Phase 3 clinical trials