EU regulator backs Pfizer vaccine booster for all adults after 6 months – POLITICO Europe

Europe’s drugs regulator on Monday advised that healthy adults can receive a third, booster dose of the BioNTech/Pfizer COVID-19 vaccine six months after the second dose.

The European Medicines Agency’s medicines committee said the recommendation was based on data from a study of 18 to 55-year-olds, showing an increase in antibodies after a third shot. Data has shown that immunity wanes with the vaccines currently in use, and appears to wane more quickly with the BioNTech/Pfizer jab.

The EMA also said that people with severely weakened immune systems may be given a booster dose of either the BioNTech/Pfizer or Moderna jabs just 28 days after their second dose.

While there is no direct evidence linking antibody levels to stronger protection in those with weakened immune systems, “it is expected that the extra dose would increase protection at least in some patients,” the EMA said.

Many EU countries have already begun administering booster doses to people with weakened immune systems — due to medication they are taking or disease — jumping the gun on the EMA’s decision. But fewer countries, among them Hungary, have been administering boosters to all adults.

In the U.S., the Food and Drug Administration has recommended boosters only for those aged 65 and over; people at high risk of severe COVID-19; and people whose jobs put them at higher risk of complications from the virus — holding off from backing a third shot for all adults.

In its announcement Monday, the EU regulator warned that the risk of inflammatory heart conditions — observed after the BioNTech/Pfizer jab — or other very rare side effects after a booster was not yet known and “is being carefully monitored.”

Widest indication

For EU politicians faced with calls from citizens for boosters ahead of the coming winter, it will come as some relief to have the full backing of Europe’s drugs regulator, known for the high caliber of its scientific reviews.

Many countries, including France and Germany, have so far restricted third doses to vulnerable people and those with weakened immune systems. The EMA’s support for the widest possible booster indication with the Pfizer jab — for all over-18s after at least six months — provides countries with the flexibility to expand their programs in the knowledge that doing so is supported by the science.

For German MEP Peter Liese, EPP’s health spokesperson, however, delivering boosters to healthy people falls behind the dire need first vaccinate all eligible citizens. “… We must not forget that still a third of the population, including many over 16, for whom the vaccination has been approved and recommended since the end of last year, is not vaccinated,” he said in a statement.

“We must therefore continue to do everything together to convince people of the benefits of vaccination and to make low-threshold offers,” he said. Liese, meanwhile, noted that immunocompromised people should “promptly” receive a booster dose, to “greatly minimize” the risk of dying.  

EU backing could also be linked to the widening of health passes for three doses for travel in the future, pointed out Simon Clarke, associate professor in cellular microbiology at the University of Reading.

“While vaccine passports in various forms are being hotly debated in the U.K., we risk ignoring the need for booster jabs,” he said. The U.K. has initiated a booster program for the over-50s, vulnerable people and people who work in front-line health and social care settings. 

“If they become commonplace in the European Union, they may end up being required for travel and will become necessary almost by default,” he added.

The green light for third shots in the EU is unlikely to be met with support from the World Health Organization. Its chief, Tedros Adhanom Ghebreyesus, has called for a moratorium on boosters for healthy people until 40 percent of every country’s population is vaccinated, a target the WHO hopes to hit by the end of this year. It aims to vaccinate 70 people of all populations by the middle of next year.

During a journalists’ briefing last month, Tedros said that globally, “5.5 billion vaccine doses have now been administered, but 80 percent have been administered in high- and upper-middle-income countries.”

Meanwhile, doses promised to COVAX, the global vaccines distribution scheme, have failed to deliver. Of the 1 billion doses promised, fewer than 15 percent have materialized, he said last month.

Until the WHO’s targets are met, “we do not want to see widespread use of boosters for healthy people who are fully vaccinated,” Tedros said.

Currently, the EMA has made a decision only on the BioNTech/Pfizer vaccine booster for healthy people. But a similar decision on Moderna’s jab should not be far off; the company filed its application towards the end of last month.

This article has been updated.

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