Coronavirus: EU warning on campaigns to boost vaccines

Par Francesco Guaraccio

BRUSSELS (Reuters) – The European Medicines Agency (EMA) has indicated that European Union member states that have decided to launch campaigns to promote a COVID-19 vaccine may face increased legal risks, as the European Medicines Agency (EMA) has not recommended a withdrawal. Thursday European Commission.

EMA, the European medicines regulator, has said on several occasions that it does not have enough data to be able to comment on the potential need for a COVID-19 booster vaccine and its administration schedule.

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

In its letter, the Commission said: “The responsibility for including boosters in national vaccination campaigns lies with Member States.”

This could mean that in the event of unexpected adverse reactions that can be specifically attributed to refunds, the countries involved could be the first to bear the brunt of potential lawsuits or compensation claims. However, laboratories will not be completely relieved of responsibilities, for example in the event of an adverse reaction after a recall associated with a production problem.

Even if the booster-dose indication does not currently appear in marketing licenses granted in Europe, eight European countries – including France – have already decided to recommend a COVID-19 booster vaccine and nearly fifteen more are said to be. About to do the same.

French Prime Minister Jean Castix announced Thursday morning on RTL that the booster COVID-19 vaccine campaign will kick off in September.

Who is against calling campaigns at the moment

The High Authority for Health (HAS), which on Tuesday recommended targeting 65 and over in this booster vaccine campaign, said its opinion was “conditional on confirmation of this recall by the European Medicines Agency”.

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

Outside the European Union, the United States plans to expand its booster vaccination campaign from September 20, and Israel – which has reached an agreement with Pfizer to provide the data – has gradually expanded its booster campaign since the end of July.

Countries that have set up recall campaigns justify them by citing the decrease over time in the immune response in vaccinated people, as well as the need to contain the recent epidemic outbreak associated with the delta type of SARS-CoV-Coronavirus. It was originally discovered in India and is highly contagious.

The World Health Organization (WHO) has repeatedly warned against such recall campaigns in recent months, arguing that improving immunization coverage in developing countries is a priority.

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

Any compensation for adverse effects related to COVID-19 vaccines is administered at the national level. In France, they are subject to the National Office of Compensation for Medical Accidents, Iatrogenic Effects and Hospital Infections (ONIAM).

(Reporting by Francesco Guaracchio, contributing by Stein Jacobsen in Copenhagen, Goladis Foch in Oslo, Michael Shields in Zurich, and Caroline Copley in Berlin; French version by Miriam Rivette, Editing by Marc Angrand)