At this point in time, no causal relationship with myocarditis or pericarditis could be established with two other COVID-19 vaccines authorised in the EEA, COVID-19 Vaccine Janssen and Vaxzevria.
Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies.
The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations.