Vaccination: legislation moving as fast as Pfizer

The virus is beatable, and the vaccine works…and now the Pfizer /BioNTech vaccine has been authorised by the MHRA for use in the UK population.  This comes as the legal framework is being changed to allow for the safe production and distribution of the vaccine.

In an article in the Lancet, Kate Bingham, current head of the Vaccine Taskforce, said this about the front runners at the end of October:-

“…. The most advanced vaccines, such as those developed by AstraZeneca and the University of Oxford, BioNTech and Pfizer, and Janssen, are based on novel formats for which we have little experience of their use as vaccines, although the initial immunogenicity and safety data are encouraging.”[1]

What are the legal steps that have been taken to get to a position where a novel format of vaccine can be offered for mass immunisation? What do they mean for healthcare professionals?

The changes are largely to the Human Medicines Regulations 2012 (HMR) in relation to licencing medicines  and the way the vaccines can be delivered.[2] There is a new enhanced service for GPs to deliver a Covid-19 vaccination programme. Also, the recent amendments to the pharmaceutical services regulations provide detail for pharmacists’ involvement.

Changes to licencing

In relation to authorisation, there are tweaks to the all-important regulation 174 of the HMR – which gives the MHRA scope to grant a temporary authorisation for the supply of an unlicensed medicinal product for use during pandemics. Sufficient evidence to show safety, quality and efficacy of the medicinal product is still required. The provision can  be used to authorise nationwide distribution and supply of an unlicensed COVID-19 vaccine. What it doesn’t do at the moment is expressly allow the imposition of conditions on the use of the vaccine. The new amendments allow this. Dr June Raine of the MHRA described the conditions that apply to the Pfizer vaccine as strict about quality, vigilant about safety and put in place to ensure good laboratory, clinical and manufacturing practises.

Additionally, immunity from civil liability is extended. There was already provision for immunity from civil liability for certain products whose unlicensed use is recommended by the state but this will  be extended. It will include companies placing an unlicensed medicine such as a vaccine on the market and the “additional vaccinators” for COVID-19 and flu who are not registered health care professionals.  Immunity already applied to healthcare professionals which included GPs, pharmacists and nurses among others. It is worth noting that if conditions are imposed and they are breached the immunity does not apply in some circumstances, although, if a breach was by a manufacturing company making the medicinal product, the healthcare professional administering it should not be liable.

Guidance from the MHRA (the Green Book) and PHE on the Covid-19 vaccination programme has been published which, as the MHRA makes clear, is provisional and clearly cannot be finalised until the Summary of Product Characteristics of the vaccines are confirmed.

Changes to the logistics

The vaccination programme will be more ambitious than any undertaken before and the two-dose regimen plus cold-chain restrictions for some vaccines adds to the manpower, transport and location difficulties. It is reported that the UK should get 10 million doses of the Pfizer vaccine by the end of the year, with a further 30 million doses already ordered. To put it in perspective, in 2019 approximately 15 million annual flu jabs were given in England. Keith Ridge and “We are primary care”  have tweeted congratulating GPs and community pharmacists on giving 9.5 million people the flu vaccine so far this year.

So how do the HMR changes help?

Firstly, in changes to Patient Group Directives (PGDs). A change has now been made to the HMR which specifically allows healthcare professionals to supply vaccinations that have been temporarily authorised under regulation 174 of the HMR under a PGD. Interestingly, it is reported that  the Covid vaccine is  “currently not to be coadministered with the influenza vaccination (although clinical trials are exploring coadministration of influenza and COVID-19 vaccines).”[3]

Secondly, scope for national protocols has been introduced. The protocol will allow registered healthcare professionals who do not normally administer vaccines and people who are not registered healthcare professionals (working under supervision) to administer a licensed or temporarily authorised COVID-19 vaccine. It appears that GPs will take the lead but there will be provision from other healthcare professionals. For example, for pharmacists, the protocol is  implemented as the Pandemic Treatment Protocol, introduced into the pharmaceutical services regulations and the pharmacists’ Terms of Service and containing details about service provision such as labelling and the obligation to supply with reasonable promptness.  The HMR indicates that such protocols will be reviewed after a year.

Thirdly, there will be changes to the requirement for a wholesale dealer’s licence in some circumstances. This is required because at the moment excess vaccines in one organisation would have to be returned  to the wholesale supplier who would then dispatch them to the organisation with too few vaccines.  Clearly this is a time-consuming arrangement. The change is to permit authorised entities at the end of the supply chain to distribute the vaccine without a wholesale dealers’ licence. This aims to prevent backlogs and would open the way to bring in the army. The measure is  time limited to April 2022.

Finally, healthcare professionals may be advertising a temporarily authorised POM to the general public in the near future. There are already exceptions for approved vaccination campaigns, but the amendments offer new relaxations in advertising medicines.

Given the logistical challenges and the huge experience and expertise of healthcare professionals, support from all areas will be crucial.  And assistance is needed – the impact assessment looking at the effect of the HMR changes gave an estimate of 36 weeks to deliver Covid and flu injections to the at-risk population without legislative changes but only 21 weeks for the “optimistic” assessment involving the deployment of the HMR changes.[4]

This is a general overview and any views or reflections are the author’s own.

Susan Hunneyball – Solicitor, Gordons Partnership

Susan@gordonsols.co.uk

@susanhunneyball


[1]https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32175-9/fulltext
[2] https://www.legislation.gov.uk/uksi/2020/1125/made
[3]https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32175-9/fulltext
[4] https://www.legislation.gov.uk/ukia/2020/67/pdfs/ukia_20200067_en.pdf