More than 1,000 volunteers have taken part in the Oxford vaccine study and have received either ChAdOx1 nCoV-19, as the vaccine is called, or a control vaccine which protects against meningitis. In order to determine if the vaccine works, it is vital that those given the jab come across the virus in their daily lives. The trial has now moved to the next phase and Oxford is looking to recruit a further 10,000 volunteers.
Recently, there has been a report that some UK scientists want to infect volunteers with COVID-19 in the race to find a vaccine.
This is because scientists have warned that there could be major delays in producing a COVID-19 vaccine if current UK infection rates remain low and lengthy waiting times are needed to show if potential vaccine products are effective. It is felt that trials could be speeded up by using the risky strategy of injecting the virus into volunteers. But this poses ethical and consent issues.
Informed consent is a core prerequisite for enrolling any person in a clinical, drug or vaccine trial. It is a fundamental principle of medical ethics, enshrined in numerous international conventions and documents starting with the Nuremberg trials that people cannot be used as human guinea pigs. In addition any trial should avoid unnecessary harm to the volunteer. Given that there is no treatment for COVID-19 should the act of deliberately causing harm (and possible death) by injecting a virus be disallowed as a matter of principle?
In giving informed consent, there has to be a full disclosure of risk. This is a process and cannot simply be satisfied by providing information in a form to be signed. There needs to be a "facilitation" for understanding any risk by full discussion with relevant documentation between the volunteer and doctors as to all possible risks as well as information as to the proposed supervision, management and follow-up once the trial begins. In addition there needs to be information as to whether there are any medical treatments available if injury occurs and, if so, what they consist of, or where further information may be obtained.
The case of Montgomery v Lanarkshire Health Board 2015 established that a patient/volunteer must be able to weigh up the risks in order to reach a decision that reflects their own values and priorities.
The oxford vaccine trial is said to be relatively safe. The vaccine is an adenovirus and was developed at Oxford's Jenner Institute. It was chosen as the most suitable vaccine technology as it can generate a strong immune response from one dose and it is not a replicating virus so it cannot cause an ongoing infection in the vaccinated volunteer.
The risks are broadly described in their consent form as follows:
- blood samples: drawing blood may cause slight pain and occasionally bruising
- vaccinations: common side effects are some mild redness and swelling at the injection site. You may feel like you have flu-like symptoms within 24 hours of the vaccinations. These usually resolve within 48 hours
The proposal to Inject the COVID-19 virus into a volunteer is a very different proposition as it carries significant risk of serious harm for which there is no cure at present and much is still unknown about the virus and effective treatments for it. Full disclosure of risk cannot be given and therefore it is difficult to see how a volunteer could give their fully informed consent to such procedure as well as any ethical basis for a procedure which will deliberately cause them harm.
Whilst the world eagerly awaits a coronavirus vaccine, it may become increasingly difficult to make ethical decisions as pressure builds on laboratories to develop a vaccine as quickly as possible.