UK Faces Distribution Challenges With Pfizer/BioNTech Vaccine
Regulator Issues Guidance As First Consignment Arrives From Belgium
Executive Summary
New guidance from the UK regulator covers distribution and deployment of Pfizer/BioNTech's COVID-19 vaccine, which will be complex because of the temperature storage requirements and the large packs in which the vaccine doses will be delivered.
The UK Medicines and Healthcare products Regulatory Agency has published guidance on the distribution, deployment and safety monitoring of Pfizer/BioNTech’s newly approved COVID-19 vaccine.
The vaccine received its first emergency use authorization from the UK regulator on 2 December. (Also see "UK First To Authorize Pfizer/BioNTech COVID-19 Vaccine" - Pink Sheet, 2 Dec, 2020.)
On the distribution front, the MHRA notes that the vaccine has to be transported at ultra-low temperature (ULT) conditions (-70 +/-10 degrees Celsius), although it can then be stored at 2-8 degrees Celsius for up to 120 hours to allow “further packing down of lots to aid deployment.”
There are likely to be logistical difficulties in distributing the vaccine, not only because of the temperature requirements, but also because it comes in packs of 975 doses.
In order to distribute the vaccine doses to places without suitable storage facilities, such as the thousands of care homes that are at the top of the vaccination priority agenda drawn up by the Joint Committee on Vaccination and Immunisation, the packs would need to be split up.
According to the MHRA guidance, the vaccine will initially be delivered to designated National Health Service bodies or contractors with the capacity to hold the vaccines at ULT. “Thereafter, the NHS arrangements for the onward and (if different) final distribution of the products, and their final deployment, are still being developed,” it says.
Health secretary Matt Hancock said that about 50 hospitals are ready to take deliveries of the bulk vaccine, and that large centers where people could go for their vaccination were also being set up.
The UK initially expected a total of 800,000 vaccine doses to be delivered from the manufacturing plant in Belgium by next week, but while the first consignment arrived in Thursday, there is some debate over when the remainder will arrive. The government has ordered total of 40 million doses of the vaccine, enough for 20 million people. The first vaccinations are expected to be given on 8 December.
Safety Monitoring
As for safety monitoring of the vaccine, the MHRA says Pfizer and BioNTech must “operate a comprehensive pharmacovigilance system for this product in accordance with UK legislation for licensed products, as if they were marketing authorization holders.”
They must allow the MHRA to conduct inspections to assess compliance with the pharmacovigilance obligations attached to the authorization, which was granted under Regulation 174 of the Human Medicines Regulations 2012. (Also see "COVID-19 Vaccine 'Brexit Bonus' A Myth" - Pink Sheet, 3 Dec, 2020.) They also have to ensure compliance with the risk management plan developed for the vaccine.
One-Off Payment For Vaccine Damage
Meanwhile, the Department Of Health And Social Care has added COVID-19 vaccines to the list of vaccines covered by the Vaccine Damage Payments Scheme. This offers a one-off, tax-free lump sum of £120,000 ($161,700) to anyone who suffers a severe disability as a result of taking a vaccine.
Stressing that “no safety concerns have been reported in clinical trials for COVID-19 vaccines authorized for use,” the DHSC says that adding diseases to the scheme is not new, and that numerous disease have been added as more immunization programs have been rolled out, including HPV and meningitis B.
Generally speaking, only childhood vaccinations are covered by the scheme, but “because COVID-19 vaccines will be rolled out to a large proportion of the adult population, the government will amend the eligibility requirements” to include adults who are given a COVID-19 vaccine.
The money will only be paid out under the scheme if it is “accepted, on the balance of probability, that there is a causal link between the vaccine and the claimed disability and that the resulting disability amounts to severe (ie, at least 60%) disablement,” the DHSC notes.