EMA confirms AstraZeneca coronavirus (COVID-19) vaccine benefits outweigh risks

EMA confirms AstraZeneca coronavirus (COVID-19) vaccine benefits outweigh risks

The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevriathe—the coronavirus (COVID-19) vaccine produced by AstraZeneca. The EMA has confirmed that the overall benefit to risk analysis remains positive and that the vaccine is effective at preventing the virus and reducing hospitalisations and deaths. The EMA has stressed that it will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information, as it does for all vaccines.

Most of the cases of very rare cases of blood clots combined with low levels of blood platelets reported have occurred in women under 60 years of age within two weeks of vaccination. The EMA has not yet confirmed specific risk factors, and urges people who have received the vaccine to immediately seek medical assistance if they develop the following symptoms within two weeks of vaccination:

• shortness of breath

• chest pain

• leg swelling

• persistent abdominal pain

• neurological symptoms, such as severe and persistent headaches or blurred vision

• tiny blood spots under the skin beyond the site of the injection

The PRAC reviewed 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database as of 22 March 2021, including 18 fatal cases. The EMA believes the combination of blood clots and low blood platelets may be due to an immune response, leading to an atypical heparin-induced-thrombocytopenia like disorder. The PRAC will continue to study the matter to provide more information.

The EMA reminds stakeholders that national authorities may provide additional guidance on the vaccine roll out.

Source: AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

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