News Category: Regulatory news
The European Medicines Agency (EMA) today concluded its initial review of very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine and has concluded these events are possible very rare side effects.
The Health Products Regulatory Authority (HPRA) participated in the scientific review of this important safety issue, through participation in the EMA's Pharmacovigilance and Risk Assessment Committee (PRAC).
The HPRA in particular highlight that following this review, the product information for COVID-19 Vaccine Janssen will be revised to include information about this possible, but very rare side effect. The details provided will ensure that whilst the risk is very low, healthcare professionals and those vaccinated will have the necessary advice and will be alert to the signs and symptoms.
In reaching its conclusion, the EMA took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States. The vaccine has not been used to date in Ireland.
The HPRA is engaging with NIAC and the Department of Health on this matter and will continue to participate in the EMA’s coordinated safety monitoring of Covid-19 vaccines.
Additionally, the HPRA highlights the following EMA findings and recommendations:
A combination of blood clots and low levels of ‘platelets’ (cells that help blood to clot) in the blood has been observed very rarely following vaccination with COVID-19 Vaccine Janssen. The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.
These cases occurred within the first three weeks following vaccination and occurred mostly in women below 60 years of age. No specific risk factors have been identified at this stage.
Healthcare professionals and those vaccinated are advised to be alert for signs and symptoms and to seek immediate medical attention if the following is experienced; a severe or persistent headache or blurred vision, unexplained skin bruising beyond the site of vaccination which appear a few days after vaccination, develop shortness of breath, chest pain, leg swelling, or persistent abdominal pain.
These cases require specialised clinical management. Healthcare professionals may consult applicable guidance and/or specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.
COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare. The overall benefits of COVID-19 Vaccine Janssen outweigh the risks of side effects.
The safety of those receiving vaccines will always be of utmost importance. It is therefore essential that any reports of potential safety concerns, even if very rare, are rigorously and swiftly investigated so that the public can be reassured and, where required, appropriate action can be taken.
It is possible to experience side effects following vaccination, the vast 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.
Revised product information will be published by the EMA in the coming days and will be available on www.ema.europa.eu and through www.hpra.ie. A direct healthcare professional communication will also be distributed by the marketing authorisation holder.
EMA Statement – 20 April 2021
Barry Dunning - 083 167 4871
Siobhan Molloy - 086 817 5066