The European Union is not clear about whether to run with the third dose of the coronavirus vaccine. While the European Medicines Agency continues to claim that enough data is lacking to draw conclusions, the European Center for Disease Prevention and Control (ECDC) has published a report this Wednesday in which it also calls for calm , except for severe cases of people with weakened immune systems in which the full regimen is not proving sufficient.
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“Based on the available data,” says the report Interim Public Health Considerations for Providing Additional Doses of the COVID-19 Vaccine, “there is no urgent need to administer a booster dose in people on the regimen. The document, however, states that “additional doses should already be considered for people with severely weakened immune systems as part of their vaccination schedule if they have not achieved an adequate level of protection with the schedule of standard vaccination “.
The European Health Commissioner herself, Stella Kyriakides, has reaffirmed the priority of vaccinating those who miss more than a third dose.
The ECDC considers that “the effectiveness and duration of protection of vaccines authorized in the EU provide great protection against COVID-19 related hospitalization, serious illness and death, although one in three adults in the EU still he is not fully vaccinated. ”
Given this situation, the community institution considers that the “priority should be to vaccinate all people who are not yet vaccinated. To complete vaccination efforts, it is also crucial to continue applying measures such as social distance, hand and respiratory hygiene and the use of masks when necessary, in particular in places of risk such as residences and health personnel who deal with patients with COVID-19 “.
According to the ECDC “it is important to distinguish between booster doses for people with normal immune systems and additional doses for those with weakened immune systems.” The agency maintains that “some studies report that an additional dose of vaccine can improve the immune response in immunosuppressed individuals, such as organ transplant recipients whose initial responses to vaccination have been low. In such cases, the option should already be considered. to administer an additional dose of vaccine. An additional dose could also be considered, as a precautionary measure, to the elderly and frail, particularly those living in closed environments, such as residents of nursing homes. ” .
In any case, the community institution affirms that “advice on how vaccines should be administered remains the prerogative of national immunization technicians, who guide vaccination campaigns in each EU Member State. These bodies are in the best position to take into account local conditions, including the spread of the virus (especially any variant of concern), the availability of vaccines and the capacities of national health systems. ”
Likewise, the institution announces that it will update its report as the ECDC and the European Medicines Agency (EMA) continue to work together to collect and evaluate the available data on boosters and additional doses. “Data on vaccine efficacy and infections should continue to be closely monitored, particularly among vulnerable groups at risk of severely contracting coronavirus, and among those living in closed environments,” ECDC states: “In the meantime, Member States should prepare for possible adaptations of their vaccination programs in the event that a substantial decrease in the efficacy of the vaccine is observed in one or more population groups.”
Legal “responsibility” in the States
European Union countries that decide to use a third booster dose against COVID-19 may be subject to greater risks, also legal, because this additional dose has not yet been recommended by the EU drug regulator, as recalled by the last week the European Commission.
The European Medicines Agency (EMA) has said on several occasions that more data is needed before making a decision, but, at the moment, there are already eight European countries that have decided to recommend the additional dose, and more than a dozen are ready to do so. do similar movements shortly.
“The booster doses are not part of the marketing authorization for vaccines against COVID-19, and have not yet been subjected to a scientific evaluation by the EMA due to the lack of sufficient data,” said the Community Executive : “The responsibility to decide to include boosters in their vaccination campaign remains with the Member States. As long as the booster doses are not part of the marketing authorization, the responsibility of the companies changes.”
And this means? Well, in the event of unexpected side effects that may be linked to the third dose, the Member States could be the most affected by legal consequences and compensation claims.
However, the Commission has said that the responsibility of companies would not completely disappear if the third dose is administered without EMA approval: for example, if a side effect after a third dose is caused by manufacturing problems, the The manufacturer of the vaccine will remain responsible.
EU liability and compensation rules apply in cases of unexpected adverse effects related to the general characteristics of the product or its manufacture. Each company supplying COVID-19 vaccines to the EU has negotiated different clauses, which remain largely confidential.
The European Center for Disease Prevention and Control (ECDC) has reported that Austria, Belgium, France, Hungary, Liechtenstein, Lithuania, Luxembourg and Slovenia are already recommending the use of the third dose.
Germany plans to do the same in the fall, while 13 other European states are debating the matter.