Covid-19 coronavirus – the UK’s preparation for a vaccine

The UK Government has agreed supply deals for at least 340 million doses of six different vaccines, with most likely to require two doses:

• AstraZeneca and the University of Oxford (adenoviral vector vaccine, 100m doses);
• Johnson & Johnson (adenoviral vector vaccine, 30m doses, with an option to acquire an addition 22m doses);
• Sanofi and GlaxoSmithKline (adjuvanted protein-based vaccine, 60m doses);
• Novavax (adjuvanted protein-based vaccine, 60m doses);
• BioNTech and Pfizer (mRNA-based vaccine, 30m doses); and
• Valneva (inactivated whole virus vaccine, 60m doses, with options over further doses).

The vaccines are based on a range of vaccine technologies and are in various stages of clinical development. For further details, please see the attached PDF here.

Other countries are also working to build diverse vaccine portfolios. For example, the European Commission has secured access to three vaccines – AstraZeneca/Oxford (300m doses), Sanofi/GSK (option for 300m doses) and Johnson & Johnson (200m doses). All EU Member States will have access to Covid-19 vaccines at the same time and doses will be distributed between Member States on the basis of their respective population sizes.

The challenges of delivering a successful vaccine

Even after successful clinical trials, the potential vaccines face many further challenges such as regulatory approval and large-scale manufacture and distribution. Steps are already being taken to help speed up the overall timeline; for example, many pharmaceutical companies are already manufacturing in parallel. The huge manufacturing investments made suggest that the Medicines and Healthcare products Regulatory Agency is reviewing evidence as it becomes available, which should speed up the regulatory approval process later.

Once a vaccine is approved, the Government has to determine how best to deliver a mass vaccination programme. Kate Bingham, chair of the UK’s vaccine task force, told the Financial Times that everyone in the UK does not need to be vaccinated – the focus will be on those at risk, with the Government aiming to vaccinate approximately 30 million people. The Joint Committee on Vaccination and Immunisation have already published advice on delivery of a Covid-19 vaccine – the committee agreed that a simple age-based programme is likely to result in quicker delivery and higher uptake.

In the EU, the European Commission has asked Member States to take preparatory steps to enable as efficient and targeted rollout as possible – this includes ensuring vaccination services have sufficient resources and are easily accessible for target populations. The European Commission has also set out priority groups to be considered for vaccination, including health care workers, people above 60 years of age and vulnerable people.

Supporting regulatory changes

In the UK, a wide range of regulatory changes have also been introduced to support the delivery of a successful Covid-19 vaccine – changes to the Human Medicines Regulations 2012 (HMRs) entered into force on 16 October after a public consultation and the Government’s response:

1. Strengthening existing regulations for temporary licensing

Regulation 174 of the HMRs allows for the temporary authorisation of the supply of an unlicensed medicine in the event of a public health emergency. In its previous form, this regulation could be used to authorise UK supply of an unlicensed COVID-19 vaccine. This is based on Directive 2001/83/EC, so the position should be the same in all EU member states.

The amendments to the HMRs add an express statement that any such temporary authorisation may be subject to certain conditions. The Government stated that conditions imposed on any such authorisation for a Covid-19 vaccine are likely to be equivalent those for marketing authorisations (e.g. eligibility criteria, appropriate storage), but that some flexibilities may be required.

The consultation response highlighted that a decision to grant such temporary authorisation will be rare and only in exceptional circumstances at the request of the Secretary of State for Health and Social Care, and only where there is robust evidence demonstrating safety, quality and efficacy. Based on consultation feedback, a public review will be carried out within a year of the first use of regulation 174.

2. Extending civil immunity

Under regulation 345 of the HMRs, where the relevant licensing agency recommends an unlicensed product or new use of a licensed product for certain health threats, key actors in the pharmaceutical supply chain are generally protected from civil liability for the consequences resulting from supply.

As previously drafted, immunity covered: (a) the authorisation holder; (b) the manufacturer; (c) any officer or employee of the authorisation holder or the manufacturer; and (d) any healthcare professional. Regulation 345 was silent on the position relating to pharmaceutical companies who are authorised to place an unlicensed product on the market. The HMRs now treat any such pharmaceutical company in the same way as the relevant manufacturer, with the Government noting that this gives some assurance to such companies that they will not be exposed inappropriately to civil liability.

It is important to note that, in line with Directive 2001/83/EC, Regulation 345 does not provide total immunity – liability for defective products still applies. Furthermore, immunity does not apply where supply is materially inconsistent with the terms of approval – sufficiently serious breaches will lead to a loss of immunity. The amendments clarify that only persons or entities who are ‘wholly or partly responsible’ for a breach of the conditions lose immunity and that the legal consequences of a breach will be the same as standard penalties for breach of marketing authorisation conditions.

3. Allowing more personnel to administer vaccines

Under regulation 214 of the HMRs, only doctors and other qualified prescribers could previously administer vaccines. Various amendments have been made to increase the number of persons to be able to safely administer a licensed or temporarily authorised Covid-19 or flu vaccine.

4. Allowing vaccine promotion

There is a general prohibition on promoting unlicensed medicines under Chapter 2 of the HMRs, both to healthcare professionals and the public. This has been disapplied to allow advertising of products that are used in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical or agents or nuclear radiation as part of advertising campaigns approved by ministers.

5. Providing exemptions from wholesale dealer’s licences

For NHS organisations, NHS contracted service providers and the medical services of the armed forces that are end-point users, there is now an exemption from the need for a wholesale dealer’s licence under regulation 18 of the HMRs to allow the transfer of Covid-19 and flu vaccines directly between them in response to patient need. This exemption will cease on 1 April 2022.

Vaccine development usually takes around ten years, so it is clear that delivering a successful Covid-19 vaccine quickly is a huge challenge. However, there are many reasons to be hopeful. The diversity of the UK’s vaccine portfolio makes it more likely that it will result in at least one successful vaccine, particularly as it includes vaccines based on more traditional approaches (e.g. vector vaccines) together with vaccines based on newer technologies (e.g. mRNA-based vaccines). Behind the scenes, supported by the amended HMRs, both vaccine developers and governmental/regulatory authorities are investing significantly in preparation for a vaccine. Once a vaccine can demonstrate its safety, quality and efficacy, this preparation should enable a successful mass vaccination programme in the UK.