Vaxzevria COVID-19 Vaccine Review Continues Regarding Unusual Blood Clots

The European Medicines Agency (EMA) safety committee met on March 31, 2021, in the context of its ongoing review of very rare cases of unusual blood clots associated with low numbers of platelets in people vaccinated with AstraZeneca’s COVID-19 vaccine (now called Vaxzevria).

The EMA stated 'At present, the review has not identified any specific risk factors, such as age, gender, or a previous medical history of clotting disorders, for these very rare events. A causal link with the vaccine is not proven but is possible, and further analysis is continuing.'

Furthermore, as communicated on March 18th, the 'EMA is of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.'

However, vaccinated people should be aware of the remote possibility of these very rare types of blood clots occurring. If they have symptoms suggestive of clotting problems as described in the product information, they should seek immediate medical attention and inform healthcare professionals of their recent vaccination, says the EMA.

'EMA continues to work with the national authorities in the EU Member States to ensure that suspected cases of unusual blood clots are reported; these cases are being analyzed in ongoing assessments. Based on all the currently available data, the committee is expected to issue an updated recommendation during its April plenary meeting (6–9 April).

More information and advice for healthcare professionals and the public is available in the vaccine’s product information and direct healthcare professional communication.

Based in The Netherlands, the mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union.