Product Information for COVID-19 Vaccines 

As each COVID-19 vaccine is authorised for use, the European Medicines Agency (EMA) will publish information about that specific brand of vaccine.  This will include recommendations for use, including, how and when the vaccine should be administered, any special warnings and conditions of use, as well as the known undesirable effects. These recommendations will be published in the Summary of Product Characteristics (SmPC) (for healthcare professionals) and Package Leaflet (PL) (for the public). These documents are continuously reviewed and will be updated if needed, as new information is submitted to, and considered by, the EMA.

The HPRA will provide links to COVID-19 vaccine product information published by the EMA, as vaccines are approved. Information for the currently approved vaccines is available through the table below:

COVID-19 vaccine brandname

Marketing authorisation holder

Product information: package leaflet and SmPC

Comirnaty

BioNTech

See here 

COVID-19 Vaccine Moderna

Moderna Biotech Spain, S.L.
See here
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

AstraZeneca 
See here
COVID-19 Vaccine Janssen

Janssen-Cilag International NV
See here
 

The EMA also publishes additional 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 provides further specific information on use of COVID-19 vaccines as part of Ireland’s immunisation programme.