Covid-19 Vaccine Deployment and the importance of Consent

With several potential vaccines for COVID-19 in development, the positive news concerning those in development has been welcome following the second national lockdown.

The NHS deployment of a COVID-19 vaccine builds on the tried-and-tested rollout plans for influenza vaccine, which is deployed every autumn. With NHS trusts kick-starting the vaccination programme, the roll out will progress through to primary care. For general practice, the COVID-19 vaccination service is commissioned in line with agreed national terms and conditions as an enhanced service (ES).

Practices participating in this enhanced service will need to work collaboratively with other practices to deliver vaccinations in PCN groupings and it is anticipated that initially there will be one vaccination site per PCN. Practices who are not members of a PCN will be expected to collaborate with neighbouring practices and established PCNs in a ‘PCN grouping’ to deliver all aspects of the service. The COVID-19 ES Vaccination Collaboration Agreement sets out the collective responsibilities of the practices in the grouping as part of the COVID-19 vaccination programme.

As supply generally increases over time, it is anticipated that the number of vaccination sites will expand. Designated sites will be expected to deliver a vaccination service seven days a week, including bank holidays, between 8am and 8pm if vaccine supply allows.

Informed Consent

Aside from the logistics, primary care teams, including GP and community pharmacies, will have an important role in explaining the importance of the vaccine to the general population. With varied and conflicting advice circulating online, patients will be relying on clinicians to clearly set out the information concerning the vaccine and to candidly answer their questions.

In delivering the vaccination programme, the necessity to obtain informed consent from the individual patient remains crucial. For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The law regarding consent was updated following 2015 Supreme Court judgment of Montgomery v Lanarkshire Health Board. In that case, the Claimant succeeded on the basis that had she been fully advised of the risks to her child, as a Type 1 diabetic, she would have elected to undergo a caesarean section rather than a vaginal delivery, and that would have avoided the catastrophic brain injury her child suffered during labour.

As part of their role in seeking informed consent, clinicians will have to fully explain what the vaccination procedure involves and the risks and benefits, with the most up-to-date information. They should be transparent as to what is known and not known about the vaccine. For example, more evidence is needed before the vaccine will be provided to those pregnant or breastfeeding. Patients should also be made aware of any risks that are material to them (as distinct from being material to the clinician).

At the time of writing, the only approved vaccine is that produced by Pfizer.  However, patients should be informed of alternative treatments and that they have a choice whether to have the vaccine or not. The decision to consent or not must be voluntary and must not be influenced by pressure from medical staff, friends or family.

The news of the vaccine has certainly boosted the national morale, but clinicians should ensure that the specific needs and wishes of the individual patient in their care have been considered before deciding whether to proceed. The individual must have capacity the person must understand the information given to them and use it to make an informed decision. They must be capable of giving consent.