Coronavirus: EU warning on vaccine booster campaigns – archyde

by Francesco Guarascio

BRUSSELS (Reuters) – European Union (EU) member countries that have decided to launch COVID-19 vaccine booster campaigns could face increased legal risks, as the administration of a recall has not yet been recommended by the European Medicines Agency (EMA), recalled Thursday the European Commission.

The EMA, the European medicines regulator, has stated on numerous occasions that it does not have sufficient data to be able to decide on the possible need for a vaccine booster against COVID-19 and its administration schedule. .

“The booster doses are not currently included in the marketing authorizations for COVID-19 vaccines and have not yet been scientifically evaluated by the AEM due to lack of data sufficient, “noted the European Commission in a statement to Reuters on Thursday.

“The responsibility for including the boosters in national vaccination campaigns therefore rests with the Member States,” the Commission said in its message.

This could mean that in the event of unexpected adverse reactions that could be attributed specifically to the recalls, the states concerned could be the first to bear the brunt of possible lawsuits or compensation claims. However, the laboratories would not be entirely exempt from responsibilities, for example in the event of a post-recall adverse reaction linked to a production problem.

Even if the indication of the booster dose does not appear for the moment in the marketing authorizations granted in Europe, eight European countries – including France – have already decided to recommend an anti-COVID-19 vaccine booster and nearly fifteen more are said to be on the verge of doing the same.

French Prime Minister Jean Castex announced Thursday morning on RTL that the COVID-19 vaccine booster campaign would be launched in September.

WHO IS AGAINST RECALL CAMPAIGNS FOR THE MOMENT

The High Authority for Health (HAS), which recommended Tuesday to target the 65 years and over for this vaccination booster campaign, specified that its opinion was “conditioned on the validation of this recall by the European Medicines Agency”.

According to the European Center for Disease Control and Prevention (ECDC), in addition to France, Austria, Belgium, Hungary, Liechtenstein, Lithuania, Luxembourg and Slovenia already recommend these reminders. Germany plans to do the same in the fall, and 13 other countries, including Italy, are considering it.

Outside the EU, the United States plans to scale up its booster vaccination campaign from September 20, and Israel – which has reached a deal with Pfizer to provide data – has gradually extended its booster campaign since late July.

The countries that have implemented recall campaigns justify them by citing the decrease over time of the immune response in vaccinated people, as well as the need to contain the recent epidemic outbreaks associated with the Delta variant of the SARS-CoV-coronavirus. 2, originally discovered in India and highly contagious.

The World Health Organization (WHO) has repeatedly advised against such recall campaigns in recent months, considering it a priority to improve immunization coverage in developing countries.

European rules on liability and compensation apply in the event of unexpected adverse effects linked to the general characteristics of the product or its manufacture. Each supplier of anti-COVID-19 vaccines has negotiated specific clauses in this area with the European authorities, which remain largely confidential.

Any compensation for adverse effects related to COVID-19 vaccines is managed nationally. In France, they come under the National Office for Compensation for Medical Accidents, Iatrogenic Affections and Nosocomial Infections (Oniam).

(Report Francesco Guarascio, with the contribution of Stine Jacobsen in Copenhagen, Gwladys Fouche in Oslo, Michael Shields in Zurich, Caroline Copley in Berlin; French version Myriam Rivet, edited by Marc Angrand)