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German experts said Thursday that people aged 65 or older should not be given the AstraZeneca coronavirus jab, dealing another blow to European vaccination efforts.
The draft recommendation from a committee that advises the country’s public health institute stated more data is needed to determine the effectiveness of the vaccine in this age group.
The committee chose to publish its view a day before the European Medicines Agency (EMA) is expected to decide on the EU-wide authorization of the vaccine, which was developed with Oxford University.
Germany’s Health Minister Jens Spahn cautioned that the final recommendation from the expert committee would come only after the EMA has made its decision. But the experts’ highly public move makes it very difficult for German authorities to advocate giving the jab to those 65 and over, at least for now, even the EMA deems it safe to do so.
That means Europe’s most populous country would not be able to administer the jab to people considered the highest priority for vaccination. And it means other national authorities will be under pressure to follow the same line.
The news comes hard on the heels of AstraZeneca telling the EU that it will deliver far fewer doses of the vaccine than expected in the first quarter of this year, prompting a furious reaction from Brussels and plans to impose export controls on vaccines.
Crisis talks held late Wednesday failed to address a “massive” shortfall in production of the vaccine that will leave the EU at least some 75 million doses short of expectations in the first three months of 2021.
The German recommendation also raises questions for Britain, which has been using the AstraZeneca vaccine since January 4 in people of all ages.
Both British Prime Minister Boris Johnson and AstraZeneca swiftly took issue with the German experts’ conclusions, issued by the Standing Committee on Vaccination of the Robert Koch Institute.
Johnson said the U.K.’s own regulator has “made it very clear that they think the Oxford/AstraZeneca vaccine is very good and efficacious … the evidence that they’ve supplied is that they think it is effective across all age groups.”
The draft recommendation is bad news for the European Commission, which is facing strong criticism — particularly in Germany — for not having bought more of the BioNTech/Pfizer and Moderna vaccines authorized earlier in December and January, and instead having focused initial attention on vaccines such the AstraZeneca jab.
The Commission has consistently rejected that criticism by saying it agreed to buy a broad portfolio of over 2 billion doses from different drugmakers, and has raised hopes that the approval of the AstraZeneca vaccine — of which the EU bought 300 million doses, plus an optional 100 million — will alleviate vaccine shortages in the bloc. EU countries are largely lagging behind the U.K., U.S. and Israel when it comes to inoculations per capita.
If the EMA or national authorities follow the German recommendations, this would mean that the Commission’s goal of vaccinating 80 percent of health care professionals and people over 80 by March — which is already at risk due to AstraZeneca’s supply shortages — will be very difficult to reach.
“Obviously these are ambitious objectives,” Commission chief spokesperson Eric Mamer said Thursday in defense of the EU’s joint vaccine procurement strategy, speaking before the German recommendations were made public.
“We knew there were going to be difficulties. We knew it wasn’t going to be an easy path,” he told a news briefing. Mamer stressed that “we’re not changing the target, but what we are going to do is trying to find the means to stick to our target,” without specifying how this could be done.
If the experts’ recommendation is adopted, Germany will likely prioritize BioNTech/Pfizer and Moderna vaccines — which use new mRNA technology — for older people and give younger people the AstraZeneca jab. Both the BioNTech/Pfizer and Moderna vaccines have shown high efficacy in over 65s.
“Now we should use [the AstraZeneca vaccine] for younger people,” said Karl Lauterbach, a health policy expert from Germany’s Social Democratic Party.
Lauterbach slammed AstraZeneca’s vaccine efficiency studies, which included only a small number of people over 65, as “simply poorly done.” Yet he also criticized the experts’ recommendation: “Not allowing vaccines for elderly who carry such a risk is something I would not have done myself. I therefore find the decision wrong.”
AstraZeneca rejected the experts’ view, stating that the latest analysis of the clinical trial data in fact supports efficacy in those over 65 and that this information is expected to be published by the EMA in the coming days. A spokesperson added that reports of efficacy being low in adults over 65 is “not an accurate reflection of the totality of the data.”
Jim Naismith, a professor of structural biology at the University of Oxford, said that scientists often disagree on how much evidence is needed to make a decision. Instead of trying to “impugn the quality or character” of the scientists involved, there should rather be “good faith discussions about what evidence is needed for vaccine effectiveness,” he said.
Merlin Sugue and Charlie Cooper contributed reporting.
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.
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