European Medicines Agency (EMA) announces that it has provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
EMA’s human medicines committee (Committee for Medicinal Products for Human Use, CHMP) is recommending that healthcare professionals:
- must not give Vaxzevria to anyone who has had blood clots with low blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after receiving the vaccine.
- should check for signs of blood clots in any person who has low blood platelets within 3 weeks of vaccination.
- should check for signs of low blood platelets in any person who has blood clots within 3 weeks of vaccination.
- should ensure that patients who have blood clots with low blood platelets after vaccination receive specialist care.
While blood clots with low blood platelets following vaccination are very rare, EMA continues to advise people to be aware of symptoms, so they can receive prompt specialised medical treatment if needed.
The updated EMA recommendations for healthcare professionals are available in the vaccine’s product information. As for all vaccines, EMA and national authorities continuously monitor the safety of Vaxzevria and will update recommendations when necessary to protect public health.
Information for the public:
- Cases of unusual blood clots with low platelets have occurred in people who received Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
- You must not have Vaxzevria if you have had blood clots with low platelets after receiving the vaccine.
- Your doctor will carry out tests if you have any type of blood clot or low blood platelets following vaccination.
- You must seek urgent medical attention immediately if you have any of the following symptoms within 3 weeks of your injection: shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal (belly) pain, neurological symptoms, such as severe and persistent headaches, blurred vision, confusion or seizures (fits), unusual skin bruising or pinpoint round spots beyond the site of the injection.
Information for healthcare professionals:
- EMA is introducing a contraindication for Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) in people who have had thrombosis with thrombocytopenia syndrome (TTS) after previously receiving this vaccine.
- As TTS requires specialist treatment, healthcare professionals should consult applicable guidance and/or specialists (e.g. a haematologist and coagulation specialist) to diagnose and treat the condition.
- Healthcare professionals should check for signs of thrombosis in any person who has thrombocytopenia within 3 weeks of vaccination with Vaxzevria. Similarly, they should check for signs of thrombocytopenia in any person who has thrombosis within 3 weeks of vaccination.
- Healthcare professionals should continue to advise people to seek urgent medical attention if they have any symptoms suggestive of thrombosis or thrombocytopenia.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/vaxzevria-further-advice-blood-clots-low-blood-platelets
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 11 Mar 2021, with the latest update posted on 24 Apr 2021.
Ends/Saturday, May 22, 2021
Issued at HKT 12:00
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