More 'complex EU’ leads Europe to diverge from US on coronavirus vaccine booster recomendations

‘Complex EU’ leads Europe to diverge from US on coronavirus vaccine booster Europe’s vaccine rollout is slightly different from the US program, and this played into the broader opinion by the EMA. POLITICO

The world's two leading medicines regulators have reached different decisions on a third dose of the BioNTech/Pfizer COVID-19 vaccine — and it’s partly because of the complexity of the EU, according to the European Medicines Agency.

On September 22, the U.S. Food and Drug Administration authorized the use of the vaccine as a third, or booster, dose for all over 65s, and only those over 18 who are at greater risk from infection, such as those with underlying illnesses or frequently exposed to the virus, like health workers.

By contrast, the European Medicines Agency said on Monday that the third dose can be given to all healthy people over 18 at least six months after their second dose.

Both agencies were tasked with reviewing whether the benefits of having the third shot are outweighed by the risks of any side effects. And both agencies assessed the same supporting data, the EMA confirmed to journalists Tuesday.

However, Europe’s vaccine rollout is slightly different from the U.S. program, and this played into the broader opinion by the EMA, said Marco Cavaleri, head of vaccines at the EU agency.

“The conclusions on the data are pretty similar,” he said, “but the implementation in terms of regulatory decision are slightly different because we are working in a much more complex environment in Europe.”

Cavaleri said epidemiological data might be different across different countries and there is different use of vaccines across the EU. ...