Germany’s vaccine committee, STIKO, has recommended AstraZeneca’s Covid-19 vaccine only be used in people aged 60 and over.
The recommendation comes after reports of “rare but very severe thromboembolic side effects,” in 31 people following the first dose. The symptoms occurred four to 16 days after the shot, mainly in people younger than 60, according to Germany’s Paul Ehrlich Institute – the country's medical regulatory body.
German Chancellor Angela Merkel and Health Minister Jens Spahn are expected to hold a news conference Tuesday evening in Berlin to address the recommendation.
STIKO will issue further guidance on whether to administer a second dose to people under 60 who have already had their first shot.
The AstraZeneca vaccine started being administered in Germany in February.
CNN reached out AstraZeneca which gave the following statement:
"We respect the decision taken by STIKO in their advisory capacity for use of vaccines in Germany.
Patient safety remains the Company’s highest priority. Investigations by both the UK Medicines & Products regulatory agency (MRHA) and the European Medicines Agency (EMA) were not able to establish a causal relationship between the vaccine and clotting events, however, the EMA concluded that for very rare cases of serious cerebral thromboembolic events with thrombocytopenia a causal link with the vaccine is not proven but
deserves further analysis.
Regulatory authorities in the UK, European Union, the World Health Organization have concluded that the benefits of using our vaccine to protect people from this deadly virus significantly outweigh the risks across all adult age groups. The benefit risk profile of the vaccine was reaffirmed in the EMA’s monthly safety update published earlier today
Tens of millions of people have now received our vaccine across the globe. The extensive body of data from two large clinical datasets and real-world evidence demonstrate its effectiveness, reaffirming the role the vaccine can play during this public health crisis.
AstraZeneca continues to analyse its database on tens of millions of records for COVID-19 Vaccine AstraZeneca 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."