Germany set to limit AstraZeneca vaccine to under-65s

‘Insufficient data’ from trials to determine efficacy of Covid-19 drug on elderly

AstraZeneca’s trial data is being challenged in the US, where a pension fund has launched a lawsuit on behalf of investors faulting the company for including too few older people and for a mix-up in the trial. Photograph: Ian Forsyth

AstraZeneca’s trial data is being challenged in the US, where a pension fund has launched a lawsuit on behalf of investors faulting the company for including too few older people and for a mix-up in the trial. Photograph: Ian Forsyth

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German health authorities have recommended that AstraZeneca’s Covid-19 vaccine should be not be given to those aged over 65 due to a lack of data, in a potential fresh blow to vaccination efforts in the European Union.

It comes on the eve of an expected approval of the vaccine by the European Medicines Agency (EMA) and amid a fierce row over a drastic cut in expected deliveries by the British-Swedish pharmaceutical company, which has spurred the EU to move to control exports of vaccines from the bloc.

There is “insufficient data currently available to ascertain how effective the vaccination is above 65 years”, the vaccine committee of Germany’s main public health agency the Robert Koch Institute said in a statement. “The AstraZeneca vaccine, unlike the mRNA vaccines, should only be offered to people aged 18-64 years at each stage.”

UK rollout

Only 341 people aged over 65 in AstraZeneca’s trial received the vaccine, and 319 were given a placebo, meaning that too little data is available to show the vaccine’s effectiveness in that age group with certainty, the committee said.

The UK has already rolled out the vaccine and thousands of people have received it in Northern Ireland. Public Health England has said that while there were too few cases in older people in AstraZeneca’s trials to measure protection with certainty, data on immune responses were “very reassuring”.

AstraZeneca’s trial data is also being challenged in the United States, where a pension fund has launched a lawsuit on behalf of investors faulting the company for including too few older people, and for a mix-up in the trial in which some participants were accidentally only given a half-dose as one of their shots.

National strategies

The EMA is expected to make a decision on authorising the vaccine on Friday, and so far has not indicated whether doses could be approved only for younger age groups.

AstraZeneca would be the third Covid-19 vaccine available in the EU if approved, following BioNTech-Pfizer and Moderna, and is key to national vaccination strategies because it is easier to roll out as it does not need to be deeply frozen.

In Dublin, the Government is developing contingency plans if it is not able to administer AstraZeneca to the over-65s. However, Government sources said there is confidence there would be sufficient Pfizer supplies from mid-February onwards to allow for the vaccination of older people, but conceded that logistical issues would be more challenging if this was required.

Sources said the third cohort in the vaccine list – the over 70s – could still be done by the end of spring, rather than March, if AstraZeneca were not available.

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