Update on review of cases of heavy menstrual bleeding with mRNA COVID-19 vaccines
The PRAC is continuing its assessment of cases of heavy menstrual bleeding (heavy periods) with the COVID-19 mRNA vaccines Comirnaty and Spikevax.
Heavy periods may be defined as bleeding characterised by an increased volume and/or duration which interferes with the person’s physical, social, emotional and material quality of life. Menstrual disorders are very common and can occur with a wide range of underlying medical conditions as well as from stress and tiredness.
The PRAC has reviewed all the available data, including cases reported during the clinical trials, cases spontaneously reported in Eudravigilance and data from the literature.
The committee agreed to continue the assessment of this safety signal and to request from the marketing authorisation holders an updated cumulative review of the cases of heavy periods.
EMA will communicate further as soon as more information is available.

PRAC finds no link between mRNA COVID-19 vaccines and absence of menstruation
The PRAC concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of absence of menstruation (amenorrhoea).
Absence of menstruation may be defined as no bleeding for a period of 90 days or more.
The committee assessed all the available data, including findings from the literature and cases of amenorrhea reported to EudraVigilance after the administration of Comirnaty and Spikevax.
Overall, the PRAC considered that the available data does not support causal association and an update of the product information for either vaccine.
The committee will continue to carefully monitor this issue and has requested the marketing authorisation holders to include it in the next periodic safety update reports (PSURs) for Comirnaty and Spikevax.

New safety information for healthcare professionals

As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed a direct healthcare professional communications (DHPCs) containing important information for Neofordex and Xalkori.

Neofordex: change of tablet due to risk of possible stability issues and reduced efficacy
This DHPC informs healthcare professionals of the removal of the score-line on Neofordex (dexamethasone) tablets.

Xalkori: Vision disorders, including risk of severe visual loss, need for monitoring in paediatric patients
This DHPC informs healthcare professionals of the risk of ocular toxicity, severe visual loss and the need for monitoring in paediatric patients with Xalkori.