Italy, Britain suggest age limits for AstraZeneca vaccine but still recommend it
By Kate Kelland, Gavin Jones and Francesco Guarascio
LONDON (Reuters) - Italy on Wednesday recommended using AstraZeneca's COVID-19 shot only on people over 60 and in the UK where people under 30 should be given an alternative due to possible links between the vaccine and very rare cases of blood clots .
More than a dozen countries have suddenly stopped using the vaccine, which has been administered to tens of millions of people in Europe. Most have been re-admitted, however, with some including France, the Netherlands and Germany recommending a minimum age.
European Union health ministers have not agreed on common guidelines for the use of the shot, despite calling for coordination between Member States to address public reluctance to introduce a vaccine that is said to be a key part of many vaccination programs.
The Italian health authority recommended that the shot only be used on people over 60, but said people under 60 who took a first AstraZeneca shot can take a second.
An official in the UK said the new advice from a government advisory group that other vaccines should be selected for people under the age of 30 when possible was "really out of extreme caution, not because we have serious safety concerns".
European regulators reiterated that they had identified possible links between the vaccine and very rare cases of blood clots, but reiterated its importance in protecting people from COVID-19.
Increasing infections from more infectious variants threaten to overwhelm hospitals in many EU countries - where the vaccination rate lags far behind the United Kingdom and the United States - and force France and others to re-locks.
According to Sabine Straus, Chair of the EMA's Safety Committee, the European Medicines Agency (EMA) had received reports of 169 cases of the rare cerebral blood clot by early April after 34 million doses had been administered in the European Economic Area (EEA). The EEA includes the 27 EU countries as well as Iceland, Norway and Liechtenstein.
This compares with four out of 10,000 women who would get a blood clot using oral contraception.
In its statement, the EMA said it reminded health professionals and beneficiaries to be aware of the "possibility of very rare cases of blood clots combined with low platelet levels within two weeks of vaccination".
NO NEW GUIDELINES
"So far, most cases in women under 60 have occurred within two weeks of being vaccinated," he added.
No new guidelines have been issued that European countries should make their own decisions about how to deal with the risk.
AstraZeneca's shot sells at cost for a few dollars a dose. It's by far the cheapest, highest-volume product launched to date, and it doesn't have any of the extreme cooling requirements of some other COVID-19 vaccines, making it likely the mainstay of many vaccination programs in developing countries.
In Germany, which recommended last week that people under the age of 60 who received an AstraZeneca shot should receive a second dose of a different vaccine, an official said cases of the rare clotting disease occurred in those who received the shot have were 20 times higher.
However, experts say the risk of developing a serious clot, even if a causal link is established, is negligible compared to the risks of possible COVID-19 infection, which can cause similar clots along with other serious symptoms.
"The risk of mortality from COVID is much greater than the risk of mortality from these rare side effects," said Emer Cooke, EMA Executive Director.
ADVANTAGES MONITOR RISKS
Even so, AstraZeneca's shares fell 1.2% to a two-week low.
The shot has had questions since late last year when the drug manufacturer and Oxford University released study data with two different efficacy values due to a dosage error.
UK Medicines Agency head June Raine said the benefits outweighed the risks for the vast majority, but were more balanced for younger people - for whom the risks of coronavirus infection are lower on average.
Wei Shen Lim, COVID-19 chairman of the UK Vaccines and Immunization Advisory Committee, said it was preferable to offer another vaccine to adults under 30 with no underlying health conditions.
AstraZeneca said it was working with UK and European regulators to list possible blood clots in the brain as an "extremely rare potential side effect".
One of the possible causes of the rare coagulation nerve clots examined is that the vaccine, in rare cases, raises an unusual antibody or a possible association with birth control pills. However, there is no definitive evidence.
Andreas Greinacher, scientist at the University of Greifswald, said his work shows that neither birth control nor a mutation of the coagulation factor play a role.
Many experts say it's not clear if or why AstraZeneca's vaccine would cause a problem that other vaccines that target a similar part of the virus don't share.
(Reporting by Francesco Guarascio, Kate Kelland, Alistair Smout, John Miller, Toby Sterling, Bart Meijer, Anthony Deutsch, Pushkala Aripaka, Stephane Nebehay and Josephine Mason; writing by Nick Macfie and Philippa Fletcher; editing by Kevin Liffey and Peter Cooney)
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