The AstraZeneca vaccine benefits "outweigh the risks" of side effects such as blood clots the Health Products Regulatory Authority has said today.
The Irish authority released a statement today after the European Medicines Agency today concluded its investigation into the rare events.
There have been 204,270 doses of the vaccine administered in Ireland so far with around 2,800 reports of adverse side effects caused by the jab.
Of those side effects 18 reports describe blood clots or events possibly associated with blood clots.
None are of the nature of the very rare blood clots of concern (e.g. cerebral venous sinus thrombosis or splanchnic vein thrombosis or blood clots in combination with low platelets).
An additional small number of cases describing low platelet counts have been received and follow up is ongoing to rule out the presence of blood clots.
The HPRA said: "As for all vaccines, it is possible to experience side effects, the majority of which are known to be mild to moderate. COVID-19 is a disease itself associated with blood clotting, as well as risk of hospitalisation and death. The overall benefit of vaccination in preventing COVID-19 disease outweighs the risks of known side effects."
The HPRA highlights the following key aspects of the EMA conclusion:
- 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.
- Based on a careful review of the available evidence, a causal relationship is considered plausible between vaccination with Vaxzevria® and cases of blood clots in combination with a low blood platelets. Although such adverse reactions are very rare, they exceeded what would be expected in the general population.
- No specific risk factors have been identified at this stage, as based on the available evidence, it was not possible to conclude on factors that may predispose a person to develop this side effect. While cases mostly occurred in women under the age of 60 years, this may be explained by other factors, such as the profile of groups vaccinated in the EEA.
- Vaxcevria® product information was recently updated to include advice to healthcare professionals and those vaccinated. This includes recommendation to seek immediate medical attention if any of the following signs and symptoms are experienced following vaccination; shortness of breath, chest pain, leg swelling, or persistent abdominal pain. Medical attention should also be immediately sought if severe or persistent headaches or blurred vision after vaccination occurs, or if there is an experience of skin bruising or pinpoint spots beyond the site of vaccination appearing after a few days.
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