Europe Delays 4th mRNA Vaccinations

The European Centre for Disease Prevention and Control (ECDC) and European Medicine Agency (EMA) COVID-19 task force today announced they have concluded that it is too early to consider using the fourth dose of mRNA COVID-19 vaccines in the general population.

However, both agencies agreed that a 4th dose (or second booster) of Comirnaty and Spikevax can be given to adults 80 years of age and above.

ECDC and EMA also noted on April 6, 2022, that there is currently no clear evidence in the European Union (EU) that vaccine protection against severe disease is waning substantially in adults with typical immune systems aged 60 to 79 years, and thus no clear evidence to support the immediate use of a 4th dose.

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, says these agencies.

And if the current epidemiological situation changes and new signals emerge, it may become necessary to consider the 4th dose in this age group. 

In the meantime, national authorities will also consider local data to decide whether to use the fourth dose in those at higher risk.

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.

The ECDC and EMA continue urging EU citizens to complete their schedules for both initial and booster vaccinations in line with national recommendations. 

As of the end of March 2022, 83% of adults had received full initial vaccinations, and only 64% had received a booster (3rd) dose.

‘Vaccination against COVID-19 remains the most effective way to prevent severe illness during the current pandemic, including severe illness caused by the Omicron variant,’ says the ECDC and EMA.

Today’s advice differs from the recent U.S. Food and Drug Administration announcement.

On March 29, 2022, the FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people (50 yrs.+) and certain immunocompromised individuals.

The FDA previously authorized a single booster (4th) dose for certain immunocompromised individuals following the completion of a three-dose primary vaccination series. 

“Current evidence suggests some waning of protection overtime against serious outcomes from COVID-19 in older and immunocompromised individuals.”

“Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” stated Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a related press release.

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