Last checked at 
* Expert panel cites insufficient data in older age group
* EU regulators due to decide on AstraZeneca vaccine on
Friday
* Health minister says recommendation not final
* EMA set to leave decision on including elderly to member
states
(Adds rate of elderly in study, details in EMA, Astra comment)
By Caroline Copley and Ludwig Burger
BERLIN, Jan 28 (Reuters) - AstraZeneca's COVID-19 vaccine
should only be given to people aged between 18 and 64, Germany's
vaccine committee recommended on Thursday, a day ahead of a
decision by European regulators on whether to approve the
drugmaker's shot.
The recommendation for Germany comes as the European Union,
which is scrambling for vaccine supplies, warned AstraZeneca to
deliver shots as promised despite a shortfall in its
first-quarter vaccine output caused by a glitch in its European
supply chain.
"There are currently insufficient data available to assess
the vaccine efficacy from 65 years of age," the German
committee, also known as STIKO, said in a draft recommendation
made available by the German health ministry on Thursday.
The European Union approved a vaccine developed by Pfizer
and its German partner BioNTech in late
December and gave the green light to a shot made by Moderna
in early January, both based on so-called mRNA
technology.
The bloc's drugs regulator, the European Medicines Agency
(EMA), is due to issue a recommendation on AstraZeneca's
vaccine, co-developed by Oxford University, on Friday.
STIKO said that, apart from the age caveat for the
AstraZeneca product, all three were equally suited for use.
Its assessment was based on the same trial data published by
medical journal The Lancet on Dec 8.
On Monday, the drugmaker denied that its COVID-19 vaccine is
not very effective for people over 65, after German media
reports said officials fear the vaccine may not be approved in
the European Union for use in the elderly.
A person with knowledge of EMA's regulatory procedures said
that the watchdog - while set to state a positive risk-benefit
ratio overall - will likely point to a lack of data on the
elderly and leave it up to member states to decide whether to
omit or include that demographic in their immunisation campaigns
for now.
"I don't think there will be restrictions by age group," the
source said.
Only 5.7% of the 11,636 trial participants included in the
analysis were 65 years or older, data released by STIKO showed.
Within the older cohort, one of 341 vaccinated people and
one in a control group of 319 people without the vaccine became
infected with the coronavirus, making a statistically reliable
conclusion impossible.
AstraZeneca Chief Executive Pascal Soriot said the company
had less data than other drugmakers on the elderly because it
started vaccinating older people later.
"But we have strong data showing very strong antibody
production against the virus in the elderly, similar to what we
see in younger people," he told Die Welt newspaper in an
interview earlier this week, referring to blood analysis.
AstraZeneca on Thursday said the latest analyses of clinical
trial data support efficacy in those over 65. "We await a
regulatory decision on the vaccine by the EMA in the coming
days," it added.
Pfizer and partner BioNTech have also announced delays to EU
deliveries in recent weeks, and German Health Minister Jens
Spahn warned shortages would last well into April.
Spahn said there were younger age groups with existing
conditions who were waiting to be vaccinated, adding the final
recommendation on the use of the AstraZeneca shot would only
come following EU approval.
As well as those aged over 80 and people living in senior
citizens' homes, Germany is prioritising front-line medical and
care staff.
In late December, Britain became the first country to
approve the AstraZeneca vaccine.
The government said at the time it would not recommend one
vaccine over another for different cohorts of the population,
even though data on the AstraZeneca shot's efficacy in older
people is currently limited.
Britain's main public health body on Thursday said it still
supported that decision. Even though there were too few
infection cases observed in late stage trials, prior blood
analysis on immune responses were "very reassuring".
It began rolling out the vaccine in January in a campaign
that has targeted older people and seen more than 7 million
given their first dose. Britain has also been using the vaccine
developed by Pfizer and BioNTech.
(Reporting by Caroline Copley in Berlin, Ludwig Burger in
Frankfurt and Emilio Parodi in Milan
Additional reporting by Emma Thomasson; Editing by Maria Sheahan
and Alexandra Hudson)
