On 2nd December 2020, the first COVID-19 vaccine was approved for use in the UK; and six days later was administered to 90-year-old Margaret Keenan. Since then the roll-out of the COVID-19 vaccination programme across the four nations of the United Kingdom has provided a much-needed source of hope as we all continue to struggle with the challenges of the pandemic.

This is the largest inoculation programme ever undertaken across the United Kingdom and is being overseen by the NHS. A range of healthcare professionals (HCP’s) are involved in the roll-out and administration of the vaccination programme, with people being vaccinated at either general practices and community pharmacies; hospital hubs; or major vaccination sites. At the time of writing, three vaccines – the Pfizer-BioNTech, the Moderna and the Oxford University-AstraZeneca vaccines – have been approved for use throughout the UK.

There are a number of aspects of the role of HCPs in the COVID-19 vaccination programme that have noteworthy medicolegal implications.

A COVID-19 vaccine will only be approved for use on the general population once it has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) – the UK’s medicine regulator. Generally, a vaccine would have to have been granted UK marketing authorisation or license prior to administration. Given the extreme circumstances represented by the pandemic, COVID-19 vaccines have been provided with temporary authorisation by the MHRA for emergency supply and administration in the UK under Regulation 174 of the Human Medicine Regulations 2012.

HCPs are required by law to record certain information in a patient’s medical records pertaining to the vaccine – including the date of administration; vaccine manufacturer; and vaccine lot number. The name and title of the HCP should also be recorded along with location of where the vaccine was administered. The importance of good documentation should not be under-estimated – it is an essential professional and legal requirement of any HCP.

Securing consent is an integral part of any clinical intervention. Obtaining valid consent is an ethical, clinical and legal requirement for HCPs administrating the COVID-19 vaccines.

HCPs should be able to discuss the anticipated benefits, any concerns about side effects or allergic reactions, and implications of not being vaccinated with the individual patient – or their representative – to obtain informed consent. It is Securing consent also requires that HSCPs talk to the patient to ascertain their medical history, known allergies or any contraindications to the vaccine that they are due to be given. While there is no legal requirement for consent to be in writing, once consent has been given it should be recorded within the patient’s clinical notes.

Where an individual patient has reduced or lack capacity to make an informed decision, HCPs should take steps to establish whether there is someone else who has he legal authority to offer consent for vaccination on the patient’s behalf. HCPs need to ensure that such patients remain at the centre of decision making and are fully safeguarded in compliance with relevant legislation for the UK nation that they are practicing within.

The MHRA has stated that the COVID-19 vaccines currently being administered in the UK are extremely safe; and that most side effects of are mild. It is important to remember that the COVID-19 vaccines are new, and so that it is especially important that they are closely monitored; and that any suspected incidents are reported quickly. It is worth noting that the UK is one of a number of countries that has in place a vaccine-injury compensation programme. These programmes work on the premise that it is reasonable that a community that is protected by a vaccination programme accepts responsibility for and provides compensation to those who it can be proven have been injured by it; and that the adverse outcome is not attributable to a specific individual but due to an unavoidable risk associated with the vaccine that was administered.

In the event of a vaccine error, HCPs need to decide whether the patient ought to be informed under the duty of candour. If it is concluded that a vaccine incident may have resulted in reduced vaccine potency, the HCP has a professional duty of candour to inform the patient that they may not be protected by the vaccine they have been given. In such instances, HCPs should inform the patient – or their representative – about what has happened; apologise; offer an action to put matters right where appropriate (e.g. re-vaccination); and fully explain the potential short and long-term effects of what has happened.

Comprehensive vaccination for COVID-19 is a critical element of tackling the pandemic; and its delivery is dependent upon a range and large number of HCPs continuing to play their part in what is an unprecedented undertaking. Nonetheless, all HCPs involved in the administration of COVID-19 vaccines need to be aware of their legal responsibilities; and be able to demonstrate that they have and are acting in compliance with the requirements of their professional registration bodies.

Anne Scott, RGN, BSc (hons); PGD (Law) is a Senior General Practice Nurse in Glasgow with current experience in all areas of General Practice Nursing. Specific interests include vaccination, prescribing, women’s health, and contraception (including implant fitting and removal). Anne has been assessing clinical negligence cases since 2016. She has also been administering COVID-19 vaccines as part of national programme.

You can contact Anne for all medico legal enquiries at annescott@inneg.co.uk