Product Information for COVID-19 Vaccines
The European Medicines Agency (EMA) publishes product information for authorised COVID-19 vaccines. The product information includes the package leaflet, which provides information for members of the public, and the Summary of Product Characteristics (SPC), which contains information for healthcare professionals. These documents are updated regularly with the latest information on use and safety of each of the COVID-19 vaccines including details of possible side effects.
The SPC and the package leaflet for authorised vaccines are available to download from the EMA website using the links included in the table below.
* This information is contained in a PDF document titled 'EPAR - Product Information' on the linked EMA page.
The SPC is available in Annex I, beginning on page 1.
The package leaflet is available in Annex IIIB. This begins on page 25 in the documents for Comirnaty, COVID-19 Vaccine Janssen and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). The package leaflet begins on page 21 in the document for Spikevax (previously COVID-19 Vaccine Moderna).
The EMA publishes information for each vaccine, including a European Public Assessment Report (EPAR) and Risk Management Plan (RMP). An EPAR provides the public with information on a medicine and how it was assessed by EMA, including information on the decision to approve (or not approve) an application for a licence for the medicine or vaccine in question. An RMP is a document containing information on the safety profile of a medicine or vaccine and explains how the company which holds the licence for a medicine/vaccine must monitor and report on the safety of the medicine/vaccine once authorised. RMPs are updated as new information becomes available.
The HSE’s immunisation guidelines for COVID-19 vaccines provide further specific information on use of COVID-19 vaccines as part of Ireland’s immunisation programme.