ECDC and EMA: No Need for the Second Booster

The European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF) have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines (Pfizer’s Comirnaty and Moderna’s Spikevax) in the general population.

Evidence on the effects of a fourth dose comes largely from Israel, where data indicate that a second booster given at least 4 months after first booster restores antibody levels without raising any new safety concerns. Data also suggest that a second booster provides additional protection against severe disease, although the duration of the benefits is not yet known and the evidence is still limited, ECDC and EMA explained.

However, both agencies agreed that a fourth dose (or second booster) can be given to adults 80 years of age and above after reviewing data on the higher risk of severe COVID-19 in this age group and the protection provided by a fourth dose, ECDC and EMA said in the joint statement.

ECDC and EMA also noted that there is currently no clear evidence in the EU that vaccine protection against severe disease is waning substantially in adults with normal immune systems aged 60 to 79 years and thus no clear evidence to support the immediate use of a fourth dose.

Authorities will continue to monitor data to determine if there is an increasing risk of severe illness among those who are vaccinated, ECDC and EMA said. If the current epidemiological situation changes and new signals emerge, it may become necessary to consider a fourth dose in this age group. In the meantime, national authorities will also consider local data in deciding whether to use a fourth dose in those people at higher risk.

For adults below 60 years of age with normal immune systems, there is currently no conclusive evidence that vaccine protection against severe disease is waning or that there is an added value of a fourth dose, ECDC and EMA noted.

Also, as re-vaccination campaigns could start in the autumn, authorities will consider the best timing for additional doses, possibly taking advantage of updated vaccines. So far, no safety concerns have emerged from the studies on additional boosters,