‘Complex EU’ leads Europe to diverge from U.S. on coronavirus vaccine booster

The world’s two leading drug regulators have made different decisions about a third dose of the BioNTech / Pfizer COVID-19 vaccine – and this is in part due to the complexity of the EU, according to the European Medicines Agency.

On September 22nd, the US Food and Drug Administration authorized the use of the vaccine as a third or booster dose for everyone over 65 and only for those over 18 who are at a higher risk of infection, such as:

In contrast, the European Medicines Agency announced on Monday that the third dose could be given to all healthy people over the age of 18 at least six months after the second dose.

Both agencies were tasked with examining whether the benefits of the third injection were outweighed by the risks of side effects. And both agencies assessed the same supportive data, the EMA confirmed to journalists on Tuesday.

The launch of vaccines in Europe is slightly different from the US program, however, and this played into the wider EMA’s mind, 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 decisions is a little different as we work in a much more complex environment in Europe.”

Cavaleri said epidemiological data might be different in different countries and that vaccines are used differently across the EU.

The US has relied heavily on the use of BioNTech / Pfizer and Moderna mRNA vaccines, and later the Johnson & Johnson vaccine. Europe has also approved the Oxford / AstraZeneca vaccine, while a handful have also administered vaccines from Russia and China that are not centrally approved in the EU.

Meanwhile, data on epidemiology in Europe and vaccine efficacy is moving “very rapidly,” Cavaleri said.

“So we prefer to keep a slightly broader approach … looking at the overall impact of the booster rather than looking at what type of population is most needed at this point,” he said.

The data showed that antibody levels to the virus tripled after the booster dose, and it was “overall safe … clearly shows that the benefit-risk of the booster dose is positive”.

However, he noted that the EMA awaits further efficacy studies on booster doses. In its decision on Monday, the EMA pointed out that there was no direct link between antibody levels and effectiveness.

Cavaleri stressed that the EMA’s decision was provisional and would allow EU countries to administer boosters if that was their national decision. At least 10 EU countries have started using booster doses.

The vaccine information also states that this is a “prudent recommendation,” he said.

The European Commission has yet to sign the EMA’s opinion, but this is expected in a few days.


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