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HSE aware of German decision on Astrazeneca vaccine but will follow EMA advice on over 65s

The EMA is expected to make a decision on approval tomorrow and will issue guidance on use of the vaccine.

A healthcare worker prepares a dose of the Oxford-AstraZeneca vaccine in Rio, Brazil.
A healthcare worker prepares a dose of the Oxford-AstraZeneca vaccine in Rio, Brazil.
Image: Silvia Izquierdo

Updated Jan 28th 2021, 4:41 PM

THE HSE HAS said it is aware of the decision by German authorities not to use the Astrazeneca vaccine for people over the age of 65, but said it will follow the recommendation of the European Medicines Agency (EMA) – which may differ from the German approach – when it is revealed tomorrow.

Germany’s vaccine commission STIKO has said it is recommending the use of AstraZeneca’s coronavirus vaccine only for under-65-year-olds, due to insufficient data on its effectiveness on older people.

The panel of scientific experts said the vaccine, jointly developed with the University of Oxford, should only be used for “persons aged 18 to 65 years old based on available data”.

“Other than this limitation, this vaccine is considered appropriate” for usage, according to the recommendation by STIKO.

AstraZeneca’s vaccine has not been granted approval yet for general use in the European Union, but the bloc’s medicines regulator EMA is poised to authorise it tomorrow.

Speaking at the HSE’s weekly media briefing today, CEO Paul Reid said any decision on this will be based on the EMA recommendations, and there are contingency plans if it turns out that the Astrazeneca vaccine is not advised for those over 65 in Europe.

“Everything about the delivery of these vaccines, we’ve had to look at it from a contingency basis, whether it’s the volume delivered as committed and particularly as we look ahead with different projections from different suppliers of different vaccines,” he said.

“We’re continuously, at the high level task force, looking at various modellings or scenarios that may emerge and certainly in terms of that one and what way it emerges, we’ll be looking at if it is approved, what settings it’s approved in and how we mobilise to deliver that as well.”

He said when the vaccine is given the green light at European level, the HSE and the National Immunisation Advisory Committee (NIAC) will look at the different scenarios and cohorts that may have to be moved to different phases.

He said flexibility is going to be a feature of the programme for most of the year, depending on deliveries, approval of different vaccines and the settings they can be used in, as well as the cohorts they are best suited to.

HSE Chief Clinical Officer Dr Colm Henry said that while officials were aware of the reports from Germany “it’s the EMA who we’ll listen to tomorrow”.

He said the vaccine has already been deployed at scale in the UK and while clinical trials provide a good basis for efficacy, the results “aren’t always reproduced in real life”. He said it remains to be seen how effective – and for how long – each of the vaccines will be when they are rolled out across populations.

“It underlines the volatility, of not just the pandemic, but that we’re rolling out vaccines against constantly evolving information, against a constantly changing landscape,” he said.

‘False claim’

STIKO did not detail the data from clinical trials on the vaccine on older people, but two prominent German media outlets had reported that the efficacy on over-65s was below 10%.

The Handelsblatt economic daily had reported Monday that Berlin had estimated the efficacy of the jab among over-65s was just eight percent, citing unnamed sources.

Separately the Bild daily, quoting anonymous sources, said the efficacy rate was at “less than 10%”.

The reports had been rejected firmly by AstraZeneca as well as by the German health ministry, the latter of which said that 8% of the trials volunteers were people aged over 65, and on first glance, the report seemed to confuse two figures.

“A false claim does not become true just because it is repeated,” a German health ministry spokesman said yesterday, dismissing the reports.

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He noted that it is a known fact that the AstraZeneca trials involved fewer older people than other manufacturers’.

But “that the efficacy is only 8% is incomprehensible and in our view, wrong,” he added.

Beyond questions over the efficacy of the vaccine on older people, AstraZeneca is currently embroiled in a row with the European Union after it said it could only supply a quarter of the doses it had promised for the first quarter of 2021.

The pharmaceutical giant’s chief executive Pascal Soriot said in an interview on Tuesday that his company was prioritising supplies to Britain, which signed its contract three months before the EU did.

He argued that the firm was only required to make a “best effort” to supply the bloc.

The European Commission erupted in fury, demanding yesterday that the British-Swedish company make up for the delays by supplying doses from its UK factories.

© – AFP 2021 with reporting by Michelle Hennessy

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