3ª dose de Vacina Covid: A Comissão assumirá a responsabilidade se algo der errado?

The Brussels-based executive recalled that the European Medicines Agency had not yet validated the principle of a third dose, although eight countries have decided to do so. The Commission will not take responsibility for any problems.

Do we really need Covid-19 Vaccine Booster?

European Union (EU) member countries that have decided to launch Covid-19 vaccine booster campaigns may be exposing themselves to increased legal risks, as the administration of a booster has not yet been recommended by the European Medicines Agency (EMA), the European Commission reminded on Thursday, August 26, 2021.

The EMEA, the European medicines regulator, has repeatedly stated that it does not have sufficient data to make a judgement on the possible need for a Covid-19 vaccine booster and its timing.

Booster doses are not currently included in marketing authorizations for Covid-19 vaccines and have not yet been scientifically assessed by the EMEA due to insufficient data, the European Commission noted in a statement to Reuters on Thursday. The responsibility for including the recalls in national vaccination campaigns therefore lies with member states, the Commission said in its message.

Eight European countries to launch Vaccine Booster

This could mean that in the event of unexpected adverse events that could be specifically attributed to the recalls, the states involved could bear the brunt of any lawsuits or compensation claims. However, laboratories would not be entirely exempt from liability, for example in the case of a post-recall adverse event related to a production problem.

Although the booster dose is not currently included in European marketing authorizations, eight European countries – including France – have already decided to recommend a Covid-19 booster dose, and nearly 15 others are reportedly in the process of doing so.

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

The French National Authority for Health (HAS), which recommended on Tuesday to target the 65 years old and more for this vaccination campaign, specified that its opinion was conditioned to the validation of this recall by the European Agency for Medicines.

According to the European Centre for Disease Control and Prevention (ECDC), in addition to France, Austria, Belgium, Hungary, Liechtenstein, Lithuania, Luxembourg and Slovenia already recommend these recalls. 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 expand its booster campaign starting September 20, and Israel – which has an agreement with Pfizer to provide data – has been gradually expanding its campaign since late July.

What about the unexpected Adverse Events?

Countries that have implemented booster campaigns cite the decline in immune response over time in vaccinated individuals, as well as the need to stem recent outbreaks associated with the highly contagious Delta variant of the SARS-CoV-2 coronavirus, first discovered in India.

The World Health Organization (WHO) has repeatedly advised against such booster campaigns in recent months, citing improved vaccine coverage in developing countries as a priority.

European liability and compensation rules apply in case of unexpected adverse events related to the general characteristics of the product or its manufacture. Each supplier of Covid-19 vaccines has negotiated with the European authorities specific clauses in this regard, which remain largely confidential.

Potential compensation for adverse events related to COVID-19 vaccines is managed at the national level. In France, they are managed by the National Office for Compensation of Medical Accidents, Iatrogenic Affections and Nosocomial Infections (Oniam).