News Category: Regulatory news
The European Medicines Agency (EMA) earlier this afternoon published the outcome of a preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca including information for patients and healthcare professionals.
Through its membership of the EMA’s safety committee (PRAC), the HPRA has participated fully in this scientific and evidence based review, which has involved regulatory experts from across the EU, as well as experts in the field of thrombosis (blood clotting disorders).
The conclusion of the preliminary review is that the benefits of the vaccine in protecting against the significant threat of COVID-19 as a disease, and in preventing hospitalisation and death, continue to outweigh the risk of possible side effects.
The initial findings of the review include that the vaccine does not cause an increase in the overall risk of blood clots (thromboembolic events) of a more typical nature in those who receive it. However, at this point, it cannot be excluded that the use of the vaccine may be associated with very rare cases of blood clots accompanied by low levels of blood platelets (thrombocytopenia), which are elements in the blood that help it to clot. These rare cases also include a condition known as CVST (cerebral venous sinus thrombosis).
Based on the review, the HPRA emphasises that these are very rare cases. A causal link with the vaccine is not proven but is possible and deserves further analysis. Close safety monitoring of reports of blood clotting disorders will continue, and further studies are underway to provide more laboratory data as well as analysis of further real-world evidence. The HPRA will continue to participate in this review with the EMA and other national medicines regulators. Further updates will be communicated as appropriate.
To date, no national cases of these very rare blood clots associated with low levels of platelets have been reported to the HPRA. In the region of 2,000 reports associated with COVID-19 Vaccine AstraZeneca have been notified, of which seven describe individuals who have been diagnosed or are being investigated for a blood clotting event after vaccination. These events describe a typical profile of clotting seen at any time in the general population, such as clots in the lung or legs. Such events are not unusual and there is no evidence that these are occurring at a level greater than would be expected in the absence of vaccination.
The HPRA will discuss the outcome of the EMA review with national health partners, including the National Immunisation Advisory Committee (NIAC).
Information for patients and health care professionals released today by the EMA is provided below.
Information for patients
COVID-19 Vaccine AstraZeneca is not associated with an increased overall risk of blood clotting disorders.
There have been very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination. The reported cases were almost all in women under 55.
Because COVID-19 can be so serious and is so widespread, the benefits of the vaccine in preventing it outweigh the risks of side effects.
However, if you get any of the following after receiving the COVID-19 Vaccine AstraZeneca, you should seek prompt medical assistance and mention your recent vaccination: Shortness of breath, chest pain, leg swelling, or persistent abdominal pain following vaccination. Also, seek immediate medical attention if you experience after a few days severe or persistent headaches or blurred vision after vaccination, or experience skin bruising or pinpoint round spots beyond the site of vaccination which appears after a few days.
Information for healthcare professionals
Cases of thrombosis and thrombocytopenia, some presenting as mesenteric vein or cerebral vein/cerebral venous sinus thrombosis, have been reported in persons who had recently received COVID-19 Vaccine AstraZeneca, mostly occurring within 14 days after vaccination. The majority of reports involved women under 55, although some of this may reflect greater exposure of such individuals due to targeting of particular populations for vaccine campaigns in different Member States.
The number of reported events exceeds those expected, and causality although not confirmed, cannot therefore be excluded. However, given the rarity of the events, and the difficulty of establishing baseline incidence since COVID-19 itself is resulting in hospitalisations with thromboembolic complications, the strength of any association is uncertain.
EMA considers that the benefit-risk balance of the medicine remains positive, and there is no association with thromboembolic disorders overall. However, steps will be taken to update the SmPC and package leaflet with information on cases of DIC and CVST that have occurred.
Healthcare professionals are urged to be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia occurring in vaccinated individuals.
Recipients should be warned to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.
A direct healthcare professional communication (DHPC) will be sent to healthcare professionals prescribing, dispensing or administering the medicine. The DHPC will also be published on a dedicated page on the EMA website.
Barry Dunning 083 167 4871
Siobhan Molloy 086 817 5066