New pharmacovigilance signals under study

France – Status update on vaccine surveillance against Covid-19 Covers the period from November 26 to December 9, 2021^[1]and ANSM and the French CRPV Network, reviewing adverse effects reported during this period by healthcare staff and patients. In addition to notification of new indications with Comirnaty, Spikevax and Vaxzevria, the rapporteurs are reviewing menstrual disturbances observed with mRNA vaccines.

3870 cases of menstrual disorders

A new trial was conducted for cases of menstrual disorders. Since the beginning of the vaccination campaign, 3870 cases of menstrual disorders were observed after vaccination with Kommernate and 562 cases after vaccination with Specifax. “The available data do not allow to establish a direct link between the vaccine and the occurrence of these menstrual cycle disturbances” but “these events remain under observation,” ANSM notes.

The main manifestations are abnormal bleeding (uterine bleeding, menorrhagia), delayed menstruation and amenorrhea. These effects occurred after the first injection and after the second injection.

The rapporteurs described these events as “mostly unserious, short-lived, and self-limiting”.

ANSM advises healthcare professionals who experience any symptoms of menstrual disorders:

– if the patient is taking hormonal therapy: make sure that there is no poor compliance or vomiting that could cause discontinuation of therapy;

– If the patient is not taking hormonal therapy or if the treatment is not interrupted:

– check that it is not an acute symptom;

– Checking the absence of pregnancy (delayed menstruation, frequent bleeding).

– Consider the possibility of the patient having a gynecological disease (PCOS, hyperprolactinemia, etc.) – in conjunction with vaccination. If symptoms persist in the following month, it is necessary to initiate investigations to consider such an underlying disease.

New Signals with Comirnaty, Spikevax and Vaxzevria

Besides menstrual disorders, new signs of pharmacovigilance have emerged.

The follow-up committee identified autoimmune hepatitis associated with Comirnaty and Spikevax vaccines and pseudomembranous arthritis as possible indications for Comirnaty vaccine. “These two signals, at this point, are not considered relevant to vaccines. They will be carefully monitored and will be shared with the EMA,” ANSM notes.

Finally, the Surveillance Committee identified sarcoidosis and Still’s disease as possible indications for the Vaxzevria vaccine. These two signals, at this point, are not considered relevant to the vaccine and monitoring will continue.

Image credit for Une: Dreamstime