Informed Consent for Vaccination for COVID-19

Written by
John Ringrose on
02 June 2021

The Health Service Executive (HSE) currently offers several vaccines against Covid 19 such as the Pfizer/BioNTech, Oxford AstraZeneca and Moderna vaccines. 

The HSE stresses that they only use vaccines which meet the required standards of safety and effectiveness having been tested on thousands of people as part of clinical trials and have been approved and licenced by the relevant regulatory authority. For Ireland, the regulator is the European Medicines Agency (EMA). 

However, like all medicines, vaccines can occasionally cause side effects in some people. Accordingly, it is recognised that there exists some level of risk to the recipient in taking the vaccine. These risks can vary in severity and frequency. 

Many people (more than 1 in 10) may experience soreness where the injection is given or experience muscle pain, headache, and fever. These are usually temporary and mild symptoms. 

A few people (more than 1 in 100) may have redness or swelling where they had the injection. 

Rarely (more than 1 in 1,000) people may experience swollen lymph glands and (more than 1 in 10,000) people can experience Bell’s Palsy, which is temporary, one-sided facial drooping. 

Very rarely (up to 1 in 100,000) there is a serious allegoric reaction (anaphylaxis) to the vaccine. 

Thankfully, many of these side effects are temporary in nature and people go on to make a full recovery within a period of a few days, weeks, or months. 

Occasionally however the side effects may be potentially more severe and/or longer lasting. 

Recently the National Immunisation Advisory Committee (NIAC) has recommended that the Oxford-AstraZeneca Covid-19 vaccine should be limited to people above the age of 50. This arises from a ruling by the EMA that that there is a plausible but ‘very rare’ connection between the AstraZeneca jab and unusual blood clotting which in some cases resulted in death. Other findings have concluded that these rare blood clotting incidences typically occur in younger people. 

Informed Consent 

It is long established in Irish law that consent must first be obtained from a patient before they undergo any medical examination, treatment, service, or investigation. A patient (in this case a recipient of a vaccine) is legally and ethically entitled to an explanation of the facts concerning the nature of a procedure and the potential risks, as well as any alternative options.  

Consent is the giving of permission or agreement for an intervention such as a vaccination following a process of communication about the proposed intervention.  

Informed consent involves a process of communication between a healthcare worker and a person that enables that person to have a clear understanding of the nature of the intervention, and likely risks and benefits of receiving it, thus enabling the person to make an informed choice about whether to proceed. 

For informed consent to be valid, the person must: - 

  • Have received sufficient information in a comprehensible manner about: - 
    • The nature, potential risks, and benefits of the proposed intervention  
    • Any other alternative intervention options; and  
    • The implications of not receiving the intervention. 
  • Not be acting under duress; and 
  • Have the decision-making capacity to make the decision (even if requiring support to do so).  

To give valid, informed consent, to receive a Covid-19 vaccination a person should be provided with written information in advance.  

Information should be provided in a format accessible for that person and translation/interpretation support should be made available as required. In the context of vaccination for Sars-CoV-2, the HSE Vaccination Leaflet should specify the vaccine being given.  

As a general principle, all material risks and benefits of the vaccine must be disclosed. Additionally, in relation to Covid-19 vaccination such information should include individual as well societal benefits that may be conferred by ‘herd immunity’. 

If you have experienced a serious side effect, because of receiving a Covid-19 vaccination, arising from a known risk that that you believe you were not adequately informed of before you received the vaccination, you may be entitled to bring a claim for medical negligence. 

These can be complex and difficult cases and you will need to prove amongst other things that you were not properly advised about the risks involved and that if you had been properly advised, you would not have consented and gone ahead with the vaccination at that time. 

At HOMS Assist, we make the process of investigating your case straightforward. With your authority, we will take up a copy of your medical records and engage with our panel of medical expert witnesses to review your medical records. If the expert is of the opinion that there was a lack of informed consent and negligence has occurred, we will proceed with an action on your behalf.