ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines

Evidence for vaccine efficacy and duration of protection shows that all vaccines authorized in the EU/EEA currently offer high protection against COVID-19-related hospitalization, severe illness and death, while about one in three adults in the EU/EEA Above 18 is currently not fully immunized. In this case, the priority should now be to vaccinate all eligible individuals who have not yet completed the recommended course of vaccination. To complement vaccination efforts, it is also essential to continue to apply measures such as physical distancing, hand and respiratory hygiene, and use of face masks when needed, particularly in high-risk settings such as long-term care facilities or hospital wards with patients at risk of contracting the COVID-19 virus. severe.

It is important to distinguish between booster doses for people with a normal immune system and extra doses for people with compromised immune systems. Some studies suggest that an additional vaccine dose can improve the immune response in immunocompromised individuals, such as organ transplant recipients whose initial responses to vaccination were low. In such cases, the option of administering an additional dose should already be considered. An additional dose may also be considered, as a precaution, for older frail individuals, particularly those living in enclosed settings such as those residing in long-term care facilities.

The European Medicines Agency (EMA) is currently evaluating data on additional doses and will consider whether updates to product information are appropriate. The EMA will also evaluate data on stimulant doses.

While the EMA is evaluating relevant data, Member States may consider preparatory plans to administer boosters and additional doses.

Advice on how to administer vaccines remains the prerogative of the National Immunization Technical Advisory Groups (NITAGs) that guide vaccination campaigns in each EU Member State. These bodies are best suited to take into account local conditions, including the spread of the virus (particularly any variables of concern), the availability of vaccines and the capabilities of national health systems.

ECDC will update its technical report as ECDC and EMA continue to work together to collect and evaluate data that has become available on reinforcements and additional doses. Careful monitoring of vaccine efficacy data and breakthrough infections must continue, particularly among vulnerable groups at high risk of severe COVID-19 infection and among those living indoors. In the meantime, Member States need to prepare for potential adaptations to their vaccination programs should a significant decrease in vaccine efficacy be observed in one or more populations.



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