EU regulator backs booster mRNA vaccine for people with weak immunity

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The European Union’s drug regulator said Monday that people with weakened immune systems should receive a third dose of a COVID-19 vaccine from Pfizer-BioNTech or Moderna, but left it up to member states to decide whether the general population should receive. a booster.

The long-awaited guidance comes after several EU member states got ahead of the opinion of the European Medicines Agency (EMA) and launched their own booster campaigns, though they vary widely on who is eligible.

The EU joins the United States, Britain and Israel, where regulators have approved the use of enhancers from Pfizer, although there is no consensus among scientists on the extent to which they should be implemented. Israel is the outlier, using them across the entire population.

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Governments are under pressure to revive their ailing economies, fight the most infectious variant of the Delta coronavirus, and avoid further lockdowns in the winter.

The EMA ruling comes after the EU center for infectious diseases warned last week that vaccine coverage in the region was still too low and there was a risk of a significant increase in cases, hospitalizations and deaths during the next six weeks.

The EMA said that people with severely weakened immune systems should receive a third dose of the Pfizer-BioNTech and Moderna vaccines, both based on mRNA technology, at least 28 days after the second.

He also said that a booster shot of the Pfizer / BioNTech vaccine could be considered for adults with normal immune systems around six months after the second dose, but added that that depends on each country.

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“At the national level, public health agencies can issue official recommendations on the use of booster doses, taking into account emerging efficacy data and limited safety data,” he said.

The World Health Organization has criticized rich nations for stockpiling COVID-19 vaccines for booster campaigns for larger population groups, while poorer countries are struggling to implement even the first doses.

Allowing EU countries to decide on a broader use of a booster is consistent with previous EMA decisions in the pandemic; for example, it largely left to member states the decision to restrict vaccines due to possible side effects. (Reporting by Ludwig Burger in Frankfurt and Yadarisa Shabong in Bengaluru Edited by Maju Samuel and Mark Potter)