Irrespective of your political leanings, and without partisan disclosures, this has been an excellent news week for the world. On Tuesday 10 November, Pfizer/BioNTech announced that their COVID-19 vaccine candidate is 90% effective in protecting people from transmission of the virus in global trials.

COVID-19 vaccination

The vaccine has surpassed experts’ hopes in terms of efficacy. As much of the world faces Lockdown II, or similar restrictions, the announcement could signal that by the end of 2020 we will be much better positioned to deal with a pandemic that has killed more than a million people.

The data published by Pfizer is based on early results with trials of the vaccine continuing. However, it is very likely that global healthcare regulators will look to facilitate emergency license application at unprecedented speed.

Reports indicate that there are so far no safety concerns with the Pfizer vaccine, with no adverse effects reported by either Pfizer or partner BioTech.

Caution

However, some scientists have urged caution in assessing the efficacy and safety of the vaccine until the trials are more fully completed.

Within a regulatory and patient safety context, concerns have also been raised concerning the ‘short-cutting’ of conventional phases of vaccine development.

Those fears may be exacerbated by targeted disinformation campaigns; confusion about reports of less well-studied vaccines being launched already, for example, in Russia and China; and memories of other rapid vaccine rollouts, such as the 19702 US swine flu vaccination (H1N1) which was linked with reports of vaccine induced Guillain-Barre syndrome.

Success

Any widespread concerns regarding the safety of the vaccine may impact upon the willingness of individuals, particularly those in the first wave of rollout, to consent to vaccination. Any vaccination will have little impact in fighting the pandemic, regardless of its purported 90% efficacy, unless widespread societal confidence in the safety of the vaccine can be fostered – such that we can reach what public health officials term ‘herd immunity’. 

A briefing paper published by a multi-disciplinary group of academics at the British Institute of International and Comparative Law (BIICL) this week, looks at the vital role that the law can play in supporting the acceptability of an emergency COVID-19 vaccine, particularly for those individuals, including the most COVID vulnerable, and our frontline-workers, who are likely to be in the first wave of vaccination.

The paper notes in particular:

  • That providing recipients of new COVID-19 vaccines with recourse to compensation covering healthcare costs, any loss of livelihood and long term complications, can form an ‘important foundation on which to build an maintain public vaccine acceptance’.
  • That under existing UK product liability laws, claimants injured by medicines and medical devices face significant hurdles in seeking compensation from manufacturers, within the scope of the Product Liability Directive (85/374) or the Consumer Protection Act 1987.
  • That whilst under UK law, claimants do have the benefit of the Vaccine Damage Payments Act 1979, which is a no-fault scheme enabling those injured by vaccinations, to seek payments without having to establish negligence, such payments are capped at a maximum of £120,000, which may do little to compensate for those suffering maximum harms.
  • That in this context, urgent consideration should be given to the setting up of ‘a bespoke COVID-19 vaccine compensation scheme’.

A COVID-19 vaccine compensation scheme

The paper recommends that the scheme should be based on a no-fault model, enabling swift and simple claimant access, and that the compensation available should be at a level which will incentivise individuals to use the scheme rather than more expensive and protracted litigation.

The BIICL briefing paper concludes that ‘being proactive in establishing such a fund will improve the chances of any immunization programme being effective and at the same time reduce the overall costs to society’.

What the BIICL paper does not address is how the scheme should be funded. In other jurisdictions no-fault schemes have been funded by a levy on manufacturers of medicines and vaccinations.

In the context of both an unprecedented global pandemic and global economic depression, any role that UK regulators and lawyers can play in encouraging take-up of a vaccine – whilst also reducing the overall societal costs, to the individual, our NHS, and the government, deserves serious and urgent consideration.