The responsibility for inoculating with more doses of Covid-19 vaccine than those recommended by the European Medicines Agency (EMA) remains with the Member States. However, in doing so, they risk increased legal liability in the event of unexpected adverse effects. Because the liability of companies “will be reduced”, the European Commission told EUROPE on Thursday 26 August, confirming a Reuters report.
The use of an additional dose (a third dose for two-dose vaccines) or a booster dose (a second dose for one-dose vaccines) “has not yet been subject to a scientific assessment by EMA in the absence of sufficient data”, the Commission stresses.
This option is therefore not included in the market authorisation granted by the Commission to the manufacturers of the four main vaccines used in the EU - AstraZeneca, Johnson&Johnson, Pfizer/BioNtech and Moderna.
“To the extent that booster doses are not part of the marketing authorisation, companies’ liability will be reduced. Their liability will in any case depend on the actual case and the actual reason for the harm experienced by the vaccinee”, says the European Commission.
Companies, it explains, will, for example, continue to be liable for problems in the manufacture of vaccines.
Seven EU countries concerned at this stage
According to the latest available information, seven EU countries - Austria, Belgium, France, Hungary, Lithuania, Luxembourg and Slovenia - currently recommend the use of an additional dose of vaccine or a booster dose, the European Centre for Disease Prevention and Control (ECDC) told EUROPE on Thursday.
In Belgium, the recommendation applies to immunocompromised people and in Luxembourg to highly vulnerable people. The French Health Authority recommends a recall for people aged 65 and over and those at risk of severe forms of Covid-19.
And the list of states concerned is expected to grow. Germany is planning to implement this measure in the autumn, the ECDC says, pointing out that the subject is “currently under discussion in thirteen EU and European Economic Area countries”.
“Decisions on how vaccinations should be given remain the prerogative of the expert bodies guiding the vaccination campaign in each Member State, considering factors such as the local conditions, the spread of the virus (including any variants of concern), the availability of vaccines, and the capacity of the national health system”, the EMA comments.
The Agency also states that it is currently reviewing the emerging data “in order to make recommendations that could support Member States”. However, it is not able to give any estimated timeline for publication of its opinion on the matter. (Original version in French by Agathe Cherki)