EMA finds possible link of AZ’s vaccine to very rare cases of unusual blood clots

The EU drugs regulator proposes the symptoms to be listed as ‘very rare’ side effects of Vaxzevria

Photo: EU EMA's headquarters in Amsterdam.

EMA’s safety committee (PRAC) announced on Wednesday its conclusion that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria, formerly COVID-19 Vaccine AstraZeneca. But Emer Cooke, EMA Executive Director, reiterated at a news conference that overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.

The committee took into consideration all currently available evidence, including the advice from an ad hoc expert group. The agency is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination.

According to the assessment, so far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.

People who have received the vaccine should seek medical assistance immediately if they develop symptoms such as shortness of breath, chest pain, swelling in leg, persistent belly pain,    neurological symptoms, including severe and persistent headaches or blurred vision, tiny blood spots under the skin beyond the site of injection.

By recognising the signs of bloods clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications, EMA’s scientists said.

The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

The committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal. The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine.

The PRAC, informs that as of 4 April 2021, a total of 169 cases of CVST and 53 cases of splanchnic vein thrombosis were reported to EudraVigilance. Around 34 million people had been vaccinated in the EEA and UK by this date. The more recent data do not change the PRAC’s recommendations.

COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects, EMA concluded.

As for all vaccines, EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.

 

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