EU adds rare disease as a side effect

On Friday, the European Medicines Agency identified another rare blood disease as a possible side effect of AstraZeneca’s Covid-19 vaccine. The European Medicines Agency (EMA) Safety Committee has said that capillary leak syndrome should be included as a new side effect in the labeling of AstraZeneca’s Vaxzevria vaccine. The regulator said it was investigating cases of heart inflammation after vaccination with all coronavirus vaccines.

The EMA said people who previously had the disease, when fluid leaked from smaller blood vessels, causing swelling and low blood pressure, should not receive the vaccine. Review of these cases began in April last year. This rare new disease is associated with AstraZeneca in addition to the very rare and potentially fatal cases of low platelet count blood clotting.

Review of six validated cases of capillary leak syndrome

For people with this bleeding disorder known as thrombosis with thrombocytopenia syndrome (TTS), the EMA last month advised against using the second injection of AstraZeneca for those who have already taken the first. The committee reviewed six validated cases of capillary leak syndrome in people, mainly women, who had received Vaxzevria, including one fatality. Three had a history of the disease.

To date, over 78 million doses of Vaxzevria have been administered in the European Union, Liechtenstein, Iceland, Norway and the UK. The UK regulator MHRA said Thursday that it had received 8 reports of capillary leak syndrome in more than 40 million doses of the AstraZeneca vaccine given and that it currently sees no causal link. US health officials also announced Thursday that they had higher-than-expected incidences of heart infections in young men who received a second dose of mRNA injections, although a cause-and-effect relationship had not been established.

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