News Category: Regulatory news
The National Immunisation Advisory Committee (NIAC) has today (Sunday, 14 March) recommended that the administration of COVID-19 Vaccine AstraZeneca be deferred on a temporary and precautionary basis, pending the outcome of the ongoing investigation underway at EU level into a small number of reports of thromboembolic (blood clotting) events. These events occurred in patients who had recently received the AstraZeneca COVID-19 vaccine.
The HPRA is in continuous dialogue with the European Medicines Agency (EMA) and national medicines regulators across Europe in respect of the ongoing European review. The EMA, through its safety committee, PRAC, initiated an urgent review of all blood clotting events occurring with the AstraZeneca COVID-19 vaccine (11 March) to determine if there is a possible safety risk. As a member of PRAC, the HPRA is involved in the review of all cases of thromboembolic events, and other conditions related to blood clots, reported post-vaccination with the AstraZeneca COVID-19 vaccine.
The NIAC made its recommendation following notification from the HPRA on Saturday, 13 March, of a new safety alert regarding the vaccine. This alert originated from the Norwegian Medicines Agency, following four new reports of serious, rare blood clotting events, including some complicated by very low levels of platelets in the blood in younger adults after vaccination.
To date, the HPRA has received a small number of reports associated with blood clots following vaccination with the AstraZeneca vaccine. However, it has not received any reports of the nature of those described by the Norwegian Medicines Agency. We will continue to monitor national reports very closely and continue to encourage the reporting of any suspected side effect following vaccination with a COVID-19 vaccine.
There is currently no indication that vaccination was the cause of these events, and there may be alternative explanations for their occurrence that are unrelated to the vaccine. However, the safety of the public is of the utmost importance, and it is essential that reports of potential safety concerns, even if very rare, are rigorously and swiftly investigated so that the public can be reassured and if required, appropriate action can be taken.
The preliminary assessment of similar events published by the EMA on 11 March found the number of blood clotting events in vaccinated people was no higher than the number seen in the general population. As of 10 March, 30 cases of blood clotting events were reported in the EMA’s database of side effects following vaccination of close to 5 million people in the European Economic Area. A thorough analysis of all relevant reports will be performed, including those newly notified from Norway.
As for all vaccines, it is possible to experience side effects and the majority of these are known to be mild to moderate. Anyone who may have a concern regarding their health following vaccination should consult their doctor or out-of-hours medical service.
The HPRA will continue to participate in the EMA review and engage with NIAC and the Department of Health on this matter.
Barry Dunning 083 167 4871
Siobhan Molloy 086 817 5066