COVID-19 Vaccine AstraZeneca: Investigations of blood clots with low numbers of platelets and bleeding continue in Denmark and in the EU
The EMA is convening an expert group on 29 March to provide input to the continued investigation of blood clot cases, including the very rare cases of blood clots accompanied by low numbers of platelets in people vaccinated with COVID-19 Vaccine AstraZeneca.
Last week, the EMA concluded a preliminary review of the very rare and unusual cases of blood clots accompanied by low numbers of platelets in people vaccinated with AstraZeneca COVID-19 Vaccine, including two cases in Denmark one of which had a fatal outcome.
The review concluded that the vaccine is still a safe and effective vaccine against COVID-19, but also that a connection between the vaccine and the symptoms in questions cannot be ruled out. Conversely, an association has not been established either.
EMA forms expert group
The EMA continues its investigations. Yesterday, the EMA announced the establishment of an expert committee that will meet on 29 March to contribute further to these investigations. The group will consist of experts in blood diseases, heart diseases, infectious diseases, virology, neurology, immunology and epidemiology.
These experts are to provide their knowledge on aspects such as any plausible mechanism of action, possible underlying risk factors and any additional data needed to gain a deeper understanding of the reported events and the potential risk.
The input from the experts will be included in the EMA’s ongoing evaluation. The expected outcome is an updated recommendation from the EMA after a meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on 9 April.
Status on the Danish investigation of cases of blood clots, low numbers of platelets and bleeding
More than 140,000 Danes have so far been vaccinated with the COVID-19 Vaccine AstraZeneca. The Danish Medicines Agency in Denmark is currently investigating two Danish reports of the very rare cases of the above-mentioned unusual symptoms after vaccination with the AstraZeneca vaccine.
The two Danish cases and the similar cases reported in other countries occurred within 7-14 days of the vaccinations. One case in Denmark had a fatal outcome.
In addition, the Danish Medicines Agency is in the process of reviewing one more report of a death after vaccination with the AstraZeneca vaccine. It is still unknown if this is also a case of the unusual symptoms.
At present, there is no evidence to conclude that these incidents are linked to the vaccine as the review of these cases has not yet finished.
The Danish Medicines Agency collaborates with the EMA and the other national medicines agencies in the EU on the investigation and evaluation of cases of blood clots, low level of platelets and bleeding.
EMA’s press release: COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases.
25 March: News on the website of the Danish Medicines Agency: Status on reviewed reports of suspected side effects of the COVID-19 Vaccine AstraZeneca after vaccination of more than 140,000 Danes
Safety information on the AstraZeneca vaccine (DHPC) sent to doctors in Denmark (in Danish only).
AstraZeneca’s product information.
Danish Medicines Agency’s theme on the investigations of the AstraZeneca vaccine.