Germany expects EU to OK AstraZeneca vaccine with age caveat

by Jeremy


Jens Spahn said it wasn’t clear whether the decision by the European Medicines Agency would explicitly recommend against using the vaccine in people 65 and over, or whether it would merely note the lack of data for older people, meaning “no restrictions but caution in certain areas.” Germany will adjust its own guidance once it sees the EMA’s decision.

“We don’t expect an unrestricted approval,” Spahn told reporters in Berlin. “The data available for older people, and that’s been the debate in recent days, isn’t sufficient for that.”

While the AstraZeneca vaccine has been authorized for all adults in other countries, only 12% of the participants in its research were over 55 and they were enrolled later, so there hasn’t been enough time to get results.

A large trial published last month showed the vaccine was about 70% effective in preventing people from getting sick from the coronavirus, although it is unknown whether the shot stops disease transmission.

A recommendation that only people under 65 get the vaccine could complicate the rollout in many European countries that have focused on giving shots to older people first at a time when they have been criticized for not vaccinating people as quickly as Britain, Israel and the U.S. The rollout difficulties are particularly worrying as countries face surging cases in a pandemic that has taken the lives of more than 400,000 people in the 27-nation bloc.

On Thursday, a draft recommendation from Germany’s vaccination advisory committee said the AstraZeneca vaccine should only be given to people aged 18-64 for now. Britain’s medicines regulatory agency also acknowledged the limited data in older people but still cleared the shot last month for all adults, with some caution for pregnant women.

A separate study testing the AstraZeneca vaccine in the U.S. is still underway.

Julian Tang, a virologist at the University of Leicester, said he thought any recommendation to limit the vaccine’s use to people under 65 was understandable, but “overly cautious.”

He said that although data on the vaccine’s effectiveness in older populations was limited, it was reasonable to extrapolate that it would help protect older people against COVID-19, even though there are not yet enough numbers of older people enrolled in trials to know for certain.

“The vaccine clearly offers some protection and since the older 65’s are your most vulnerable population, I’d think you want to get some vaccine into them sooner rather than later,” he said. “If Europe and the Germans want to be nitpicky, they can restrict its use, but I think giving older people this vaccine is better than nothing.”

The AstraZeneca shot would be the third COVID-19 vaccine given the greenlight by the EMA, after ones made by Pfizer and Moderna. Those were authorized for all adults and trials showed they provided more protection, with roughly 95% efficacy rates. Two more vaccine makers also recently announced results, with Novavax saying this week that its shot appears 89% effective based on early findings and Johnson & Johnson saying its long-awaited single-shot vaccine was 66% effective at preventing moderate to severe illness. If those vaccines are eventually licensed for use, that could help alleviate the pressure on the world’s huge demand for the limited shots currently available.

The expected authorization of the AstraZeneca vaccine comes amid a bitter dispute between the drugmaker and the bloc over expected supply delays.

Earlier this week, the EU lashed out at the British-Swedish drugmaker after it said it would sharply reduce initial deliveries from 80 million doses to 31 million, blaming manufacturing problems. Amid fears doses from AstraZeneca could be diverted outside the bloc, EU officials are expected to propose measures Friday that could be used to block vaccine shipments to non-EU countries and ensure that any exporting company based in the EU will first have to submit their plans to national authorities.

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Cheng reported from Toronto. Associated Press writers Samuel Petrequin in Brussels, Nicole Winfield in Rome and Jan M. Olsen in Copenhagen, Denmark, contributed to this report.

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Follow AP’s pandemic coverage at: https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.



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