PRAC meeting highlights

In a recent publication, the EMA reported highlights from a meeting of the Pharmacovigilance Risk Assessment Committee.

The first reference noted that their first evaluation of the monthly summary safety report for COVID-19 vaccines submitted by marketing authorisation holders will involve tozinameran [Comirnaty]. The monthly report will include information about suspected adverse reactions, including adverse events of special interest (AESIs), and will complement submitted periodic safety update reports (PSURs). The outcome of the evaluation will subsequently be reported on the EMA's website.

The second reference concerned the committee's evaluation of acute renal insufficiency (ARI) in children receiving an oral hydrocortisone formulation of capsules containing granules [Alkindi]. In children receiving conventional oral hydrocortisone formulations, switching to Alkindi may trigger ARI, potentially due to inaccurate dosing. The PRAC recommended actions including a direct healthcare professional communication letter, where carers should carefully observe children for ARI symptoms during the first week after switching, and if observed, they should increase the Alkindi dose and seek medical attention immediately. The recommendations will be assessed by the human medicines committee for a final opinion.

The third reference summarised the committee's statistics, which included the following:

• 16 assessments of safety signals for medicines;

• 126 single assessments of periodic safety update reports;

• 45 risk management plans for centrally authorised medicines; and

• 22 post-authorisation safety studies.