EFPIA statement on COVID-19 vaccine
Vaccine developers' top priority is always safety and that is no different for COVID-19 vaccines. Rigorous clinical studies are now underway to determine the safety and efficacy of COVID-19 vaccines and as with all clinical studies, manufacturers’ first priority is to ensure safety. Responding to the global need to shorten timelines, work that would normally happen sequentially over time is now being run in parallel but never at the expense of safety or quality. COVID-19 vaccines will be approved for use only when their safety and efficacy are demonstrated to regulatory authorities in Europe. All COVID-19 vaccines will have on-going safety monitoring after approval.
Having gone through this process, deploying billions of doses of vaccines around the world means it is possible that some people receiving a COVID-19 vaccine will experience medical events following immunisation. This is not unique to COVID-19 vaccines, as all medicines and vaccines can give rise to side-effects in some individuals. Our aim is to work with governments to develop a system of compensation that works for any individuals affected, for healthcare systems and for all those working to end the coronavirus pandemic. Any system should aim to get the right level of compensation to the right patient when they need it, avoiding endless delays through prohibitively expensive litigation with uncertain outcomes.
EFPIA and Vaccines Europe members are currently engaged in discussions with authorities and relevant stakeholders to define how such a system could work based on best practice examples that already exist in a number of countries across Europe.