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.