According to a relevant technical report issued today by the European Center for Disease Prevention and Control (ECDC) and based on current data, there is no urgent need to administer booster vaccines to the general population and to fully vaccinated people. As reported in the report, overdose should be considered in people with severely weakened immune systems as part of their initial vaccination.
Evidence of vaccine efficacy and duration of protection show that all vaccines currently approved in the EU / EEA offer high protection against hospitalization, serious illness and death associated with COVID-19, while approximately one in three adults in the EU / EEA over 18 years of age is not yet fully vaccinated. With this in mind, the priority now should be to vaccinate all individuals who have not yet completed their recommended vaccination regimen. At the same time, in order to strengthen the efforts of the vaccination program, it is important to continue the application of protective measures such as physical distancing, hand hygiene and the use of a face mask where required, especially in high-risk areas, such as closed structures.
It is important to distinguish between booster doses in people with a normal immune system and additional doses in people with a weakened immune system. Some studies suggest that an extra dose of vaccine may improve the immune response in immunocompromised individuals, such as organ transplant recipients, whose initial response to vaccination was low. In these cases, the option of an additional dose should already be considered. In addition, the provision of an additional dose, as a precautionary measure, to elderly sick people, especially those living in closed structures, could also be considered.
The European Medicines Agency (Coreper) is currently evaluating data on additional doses and will also consider whether updating product information is appropriate. The EMA will also evaluate booster data.
While the EMA evaluates all relevant data, Member States may schedule additional and additional doses.
National Immunization technical advisory groups (NITAGs) are responsible for guiding vaccination campaigns in each EU Member State. These groups are best placed to know and take into account domestic conditions, including prevalence. virus (especially any variants of concern), the availability of vaccines and the specificities of national Health Systems.
The ECDC will update the technical report as the ECDC and EMA will continue to collect and evaluate data as they become available for booster and additional doses. Close monitoring of data on the efficacy of vaccines and post-vaccination infections should be continued, especially among vulnerable groups at risk of severe COVID-19 disease and those living in closed structures. In the meantime, Member States should be prepared for possible adjustments to their vaccination plans in the event of a significant reduction in the effectiveness of vaccines in one or more groups of the population.
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