COVID-19 vaccines – understanding the data and background information on the evaluation of suspected side effect reports

Understanding the data

The HPRA COVID-19 safety updates/suspected side effects summary information include reports of suspected side effects notified to the HPRA safety monitoring system, and are provided as an enhanced transparency measure for members of the public and healthcare professionals. All vaccines have some side effects, the vast majority of which are mild to moderate in nature. These side effects need to be continuously balanced against the expected benefits in preventing COVID-19 illness.

Reports included are those notified to the HPRA on a voluntary basis by healthcare professionals and members of the public, with reporting of suspected side effects to COVID-19 vaccines encouraged. The relevant forms are available on our report an issue page. Any reports of Irish cases received by the HPRA from the company (i.e. the licence holder, to date, BioNTech, Moderna, AstraZeneca, Janssen, Novavax, Valneva, Sanofi) responsible for the vaccine are also included.

However, it is important to understand that conclusions on the safety of a vaccine cannot be drawn based on the information provided, given well-established and known limitations in interpreting such data in isolation, examples of which are described below.

Causation

• The HPRA receives reports based on suspicion that an adverse experience may be associated with vaccination. This does not mean the vaccine caused the adverse experience. As such, these are referred to as ‘suspected’ side effects.
• Reports may describe coincidental events, which have occurred post-vaccination, but would have occurred even if vaccination had not taken place (e.g. they may be due to an underlying medical condition, or be signs and symptoms of another illness).
• Each individual report is carefully reviewed, however, the totality of data from all sources (e.g. clinical and epidemiological studies and literature) must be considered as part of ongoing safety monitoring to ensure evidenced-based conclusions are drawn.

Number/volume

• As the HPRA system is based on voluntary reporting, not all suspected side effects will be reported. As such, the number and types of reports notified can vary for a variety of reasons.
• An increased number of reports is expected for COVID-19 vaccines, given public interest as well as HPRA calls encouraging reporting. This is known as stimulated reporting.
• A single report may describe more than one suspected side effect in an individual (e.g. headache and nausea reported together), therefore, the number of side effects may exceed the total number of reports received.

Comparisons

• The type and number of reports received for different COVID-19 vaccines are not directly comparable as, for example, the vaccines have not been used in the vaccination programme for the same length of time, and will have been administered to different numbers of people, with different underlying medical conditions and across different settings.
• Each vaccine is authorised on the basis that its benefits-risk profile has and continues to be favourable.

Changes to data over time

• The description of suspected side effects reflects available information known at the time by the HPRA. These data may undergo changes as more information about individual reports becomes available through follow-up, and as more data are reported and evaluated.
• For these reasons, the information in this report is not sufficient in isolation to draw conclusions on the safety profile of a vaccine. Like all vaccines, some side effects are to be expected, with the vast majority mild or moderate in intensity and resolving within a few days. Vaccines are approved for use on the basis of robust scientific evidence that demonstrates their benefits outweigh any risks.

Product information

Always refer to the product information for COVID-19 vaccines for information on the established safety profile, including known side effects of a COVID-19 vaccine.

This includes the Package Leaflet (for members of the public) and Summary of Product Characteristics (for healthcare professionals.

Background information on the evaluation of suspected side effect reports

As for all medicines and vaccines, suspected side effect reports in association with COVID-19 vaccines submitted to the HPRA are recorded and stored on the HPRA’s national adverse reactions database. They are subsequently submitted (with any personal identifiers and contact details removed) to the EudraVigilance database operated and managed by the European Medicines Agency (EMA). EudraVigilance provides for the transfer of reports from national regulatory agencies such as the HPRA and marketing authorisation holders to the EMA. This supports early detection and monitoring of possible safety signals in relation to reported side effects.

The EMA also makes available anonymised information on all reports, based on global safety experience. This information is publically available on the EudraVigilance database of suspected adverse drug reaction reports. The EMA also publishes regular safety updates for COVID-19 vaccines, as well as highlights from meetings of the EMA’s safety committee (Pharmacovigilance Risk Assessment Committee), which describe safety issues under review, as well as recommendations to revise product information. 

Information from side effect reports, together with additional safety data (e.g. from the scientific literature, cumulative safety data analysis, epidemiological studies etc.) are assessed on an on-going basis, in conjunction with our EU counterparts to consider their impact on the known safety profile of the COVID-19 vaccines and any need for regulatory changes to support safe and appropriate use.

Partially anonymised details of reports are also shared with other bodies also involved in safety monitoring of medicines, in accordance with the legislative provisions, including GDPR (please see the HPRA privacy statement). These bodies include the World Health Organisation (WHO) and as appropriate, the company(ies) that hold the licence(s) for the medicine(s) concerned (i.e. marketing authorisation holders or ‘MAHs’). Sharing of this information ensures that the information is available to all parties responsible for the ongoing safety monitoring of medicines.