MHRA provides updated information on cases of blood clots with concurrent thrombocytopenia following vaccination with Covid-19 Vaccine AstraZeneca
Up to 5 April 2021, the MHRA had received Yellow Card reports of 100 cases of major thromboembolic events (including 50 cerebral venous sinus thrombosis) with concurrent thrombocytopenia in the UK following vaccination with COVID-19 Vaccine AstraZeneca (22% case fatality).
Source:
Medicines and Healthcare products Regulatory Agency
SPS commentary:
Of these reports, 99 were associated with the first dose of the vaccine and a single report followed a second dose, although this individual had medical conditions that could have caused the events. The estimated number of first doses of COVID-19 Vaccine AstraZeneca administered in the UK by 5 April was 20.6 million, giving an overall case incidence of 4.9 per million doses. The data suggest there is a higher incidence reported in the younger adult age groups and the MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine.
These reports have been analysed by the Commission on Human Medicines and its COVID-19 Vaccines Benefit Risk Expert Working Group. On the basis of this review, the advice remains that the benefits of the vaccine outweigh the risks in the majority of people.
The Information for Healthcare Professionals and Information for UK Recipients on COVID-19 Vaccine AstraZeneca have been updated with new information about extremely rare serious thromboembolic events with concurrent thrombocytopenia.