Europe Holds Second COVID-19 Booster Dose For People Aged Under 80 Years

European Medicines Agency concluded that it is too early to consider using the fourth dose of either Pfizer Inc (NYSE: PFE) / BioNTech SE (NASDAQ: BNTX) or Moderna Inc's (NASDAQ: MRNA) mRNA COVID-19 vaccine in the general population.

However, the EU agencies agreed that a fourth dose could be given to adults 80 years of age and above after reviewing data on the higher risk of severe Covid in this age group and the protection provided by a fourth dose.

The 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. Thus, there is no clear evidence to support the immediate use of a fourth dose."

Related: Pfizer/BioNTech's Second COVID-19 Vaccine Booster Provides Short-Lived Protection In Elderly, Israel Study Shows.

But for those under the age of 60, the EU agencies said that for those 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."

As re-vaccination campaigns could start in the autumn, authorities will consider the best timing for additional doses, possibly taking advantage of updated vaccines.

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

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