Amid the growing excitement that a vaccine to prevent COVID-19 will be found, two questions occur from a legal pedant’s point of view. What are the regulatory steps to get there? What needs to be done for the vaccine to be administered legally?
A vaccine seems to be much closer now. On April 17, the government launched a taskforce designed to “rapidly develop a coronavirus vaccine”, as well as to scale up manufacturing so it can be quickly produced and delivered in mass quantities.
On April 30, a collaboration between Oxford University and AstraZeneca was announced to enable the further development, large-scale manufacture and potential distribution of the COVID-19 vaccine candidate being trialled by the university.
What are the regulatory steps?
The Medicines and Healthcare products Regulatory Agency (MHRA) approved human trials for the vaccine in a rapid seven-day turnaround. The regulator has issued a statement saying that it will “be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time…The first priority should be the safety of trial participants and this will remain our focus”.
On April 22, Oxford University and Imperial College London started human trials and have recruited around 1,110 participants for phase I trials. The usual process is:
Laboratory testing and development. The vaccine will have had to pass safety tests at this stage and demonstrate that it works in animals.
- Phase I – an initial trial. This appears to be where we are now with the Oxford COVID-19 vaccine. The trial is carried out to make sure that the vaccine does not have major safety concerns in humans, and also to work out the most effective dose.
- Phase II – a trial in a larger group of participants. Phase II trials check that the vaccine works consistently and look at whether it generates an immune response. Researchers also start looking for potential side effects.
- Phase III – a trial in a much larger group of people (usually several thousand). These gather statistically significant data on the vaccine's safety and efficacy.
- Licensing – the licensing requirements are set out in European law. The MHRA will check that the trials show that the product meets the necessary efficacy and safety levels. They also make sure that, for most people, the product’s advantages far outweigh the disadvantages.
- Phase IV – post-marketing surveillance.
The studies are also governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 and will be subject to scrutiny in relation to ethics. There have been discussions about the ethics of using placebo controls.
At the more extreme end, it has been suggested that a quicker way to test the efficacy of the vaccine would be to expose vaccinated individuals to the virus rather than to wait for them to encounter it naturally. There would be a clear ethical issue here, as even if volunteers were young, fit and healthy, there would be a risk of death.
The chief executive of AstraZeneca has indicated that he expects that by June or July there will be a preliminary idea of the efficacy and safety of the Oxford vaccine.
The significant hurdle for vaccine development is manufacture and distribution at scale, but AstraZeneca has said that they are already manufacturing for the clinical trials and are going to be scaling up so that if the vaccine is approved, they can supply by October.
This suggests the timeframe to supply may be much shorter than most had thought. It raises the question of whether the next step – vaccine delivery – has been planned for.
Who administers the vaccine?
Given the eager anticipation of a vaccine, it seems strange that there appears to be a lack of information about who will give it. There could be a role for pharmacists, but there is nothing in the government’s COVID-19 action plan or on publicly available documents about vaccine delivery.
Other candidates for giving patients the vaccine are GPs and nurses.
How could pharmacists take the lead?
If pharmacists do administer the vaccine, there will be much preparation to do. There is a precedent in the seasonal influenza advance service. However, the regulatory framework to provide this has a number of aspects worth considering:
- The service is put in place through patient group directions (PGDs) that are a form of delegated legislation. The directions for influenza for the 2019/20 season expired on March 31 and arrangements should be in train for their renewal. These directions entitle the pharmacist to be paid for providing the service.
- The vaccine – a prescription-only medicine (POM) can legally be supplied by pharmacists only because it is covered by a national PGD.
- This legal framework is supported by a detailed 20-page service specification. Pharmacists also have to be trained to gain accreditation, although there are COVID-19 relaxations on the renewal of pharmacists’ repeat face-to-face training for both injection technique and basic life support.
All these documents will take time to prepare. Although the Coronavirus Act 2020 was put in place in a very short timeframe, the future vaccine is one of the few aspects of COVID-19 where there is enough time to plan. Surely there should be some steps put in place to move forward on this.
Susan Hunneyball is consultant solicitor at Gordons Partnership law firm