(Adds comments from news conference, reaction)
By Ludwig Burger and Pushkala Aripaka
Jan 29 (Reuters) - Europe's medicines regulator on Friday
approved AstraZeneca and Oxford University's COVID-19
vaccine for people over the age of 18, the third vaccine to be
cleared for use in the European Union.
The AstraZeneca vaccine demonstrated an efficacy of around
60% in the trials on which the decision was based, the European
Medicines Agency (EMA) said in a statement https://bit.ly/3pwGYlx.
That is well below the level of protection shown by
authorised vaccines from Pfizer and its German partner
BioNTech and rival Moderna, which were
around 95% effective in preventing symptomatic illness in
pivotal trials.
“With this third positive opinion, we have further expanded
the arsenal of vaccines available to EU and EEA member states to
combat the pandemic and protect their citizens,” said Emer
Cooke, Executive Director of EMA.
The European Union last year agreed to buy up to 400 million
doses of the vaccine and has been at the centre of a dispute
with AstraZeneca this week over the speed of supplies.
Europe urgently needs more shots to speed up its inoculation
programme with Pfizer and Moderna also facing difficulties in
delivering the quantities promised for the early months of the
year.
The AstraZeneca vaccine is cheaper and easier to store than
the two already approved from Pfizer and Moderna.
AstraZeneca CEO Pascal Soriot welcomed the decision.
"Today’s recommendation underscores the value of
AstraZeneca’s COVID-19 vaccine which is not only effective and
well-tolerated, but also easy to administer and, importantly,
protects fully against severe disease and hospitalisations," he
said in a statement.
The AstraZeneca vaccine is administered via two injections
into the arm, the second between 4 and 12 weeks after the first.
There were not yet enough results for people over the age of
55 to determine how well the vaccine would work for this group,
EMA said. However, it said that the vaccine can be given to
older people.
"At least some protection is expected in this subgroup,
although the exact level of protection cannot be estimated for
the time being," Bruno Sepodes, vice chair of EMA's human
medicines committee, told a briefing.
Concerns over its value for the elderly were raised on
Thursday when Germany's vaccine committee said it should be
given only to people aged between 18 and 64, due to a lack of
data about how effective it is in older people.
Antonella Viola, professor of immunology at Italy's
University of Padua, was sceptical about the vaccine.
"60% efficacy with a double dose and with doubts for the age
group over 55 years.... Herd immunity will never be achieved
with this vaccine, it's mathematical," she said.
"I would only use it for younger people at most".
(Additional reporting by Emilio Parodi in Milan
Writing by Douglas Busvine and Keith Weir
Editing by Elaine Hardcastle and Kirsten Donovan)