Germany’s vaccine committee (Stiko) has advised giving the Oxford-AstraZeneca Covid-19 vaccine only to people aged 60 + because of a risk of rare blood clots.
The German drugs regulator found 31 cases of a type of rare blood clot among the nearly 2.7 million people who had received the vaccine in Germany.
Canada earlier suspended use of the AstraZeneca jab in people under 55.
AstraZeneca said international regulators had found the benefits of its vaccine outweighed risks significantly.
The company said it was continuing to analyze its database to understand “whether these very rare cases of blood clots associated with thrombocytopenia occur any more commonly than would be expected naturally in a population of millions of people”.
“We will continue to work with German authorities to address any questions they may have,” AstraZeneca added.
The EU and UK medicine regulators both backed the vaccine after previous cautionary suspensions in Europe this month.
The European Medicines Agency (EMA) and the UK Medicines & Healthcare products Regulatory Agency stressed that the benefits of the AstraZeneca vaccine continued to outweigh the risk of side effects.
AstraZeneca’s vaccine is one of the most widely used coronavirus vaccines in the West, and is meant to be supplied on a not-for-profit basis to the developing world.
The EU’s rollout of its vaccination program has been dogged by delays because of delivery and production problems, and Germany is among several states now fearing a third wave of infections.
On March 30, Italy’s PM Mario Draghi and his wife, who are both 73, received their first doses of AstraZeneca in a display of confidence in the vaccine.
Ahead of the Stiko announcement, the German cities of Berlin and Munich, and the region of Brandenburg, halted use of the vaccine in people below the age of 60.
“After several consultations, Stiko, with the help of external experts, decided by a majority to recommend the AstraZeneca Covid-19 vaccine only for persons aged 60 years and older on the basis of available data on the occurrence of rare but very severe thromboembolic side effects,” the committee said, as quoted by Reuters.
“Regarding the question of administering the second vaccine dose to younger persons who have already received a first dose of the AstraZeneca Covid-19 vaccine, Stiko will issue a supplementary recommendation by the end of April.”
Germany was one of the European states which briefly suspended use of the AstraZeneca vaccine earlier this month pending an EMA review into the possible link to blood clots.
When the EMA declared the vaccine “safe and effective”, Germany and others resumed its use but investigations continued.
The German medicines regulator, the Paul Ehrlich Institute, has found 31 cases of cerebral sinus vein thrombosis (CSVT) among people who received AstraZeneca in Germany.
Almost all the cases are reportedly in younger and middle-aged women.
France already limits use of AstraZeneca to those aged over 55.