New pharmacovigilance signals under study

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

3870 cases of menstrual disorders

New expertise in reported cases of menstrual disorders has been maintained. Since the vaccine campaign began, 3,870 cases of menstrual disorders have been observed after the Comirnaty vaccine and 562 cases after vaccination with Spikevax. “Available data do not allow to identify a direct link between the vaccine and the incidence of these disorders of the menstrual cycle” but “these events are under surveillance”, the ANSM notes.

The main manifestations are abnormal bleeding (metrorrhagia, menorrhagia) and late periods and amenorrhea. These effects occurred after the first injection and after the second injection.

Reporters described these events as “mostly non-serious, short-lived and self-limiting”.

ANSM advises health care professionals experiencing any symptoms of menstrual disorders:

If the patient is taking hormone therapy: check that there is no poor compliance or vomiting that could interrupt the treatment;

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

– Check that it is not a serious symptom;

-Check for absence of pregnancy (late period, recurrent bleeding);

– Keep in mind that the patient is more likely to develop gynecological disease (polycystic ovary syndrome, hyperprolactinemia, etc.) – similar to the vaccine. If symptoms persist for the next month, it may be necessary to initiate research to consider such underlying pathology.

New codes with Comirnaty, Spikevax and Vaxzevria

In addition to menstrual disorders, new pharmacovigilance signs have emerged.

The follow-up committee identified autoimmune hepatitis and rhizomelic pseudopolyarthritis associated with the Caminaria and Spikevax vaccines as potential signals for the Caminaria vaccine. “Both of these signs, at this stage, are not considered vaccine-related. They will be carefully monitored and partnered with EMA, ”ANSM said.

Finally, the Monitoring Committee identified sarcoidosis and still disease as potential signs of a vaccine against the vaccine. Both of these signs are not considered vaccine-related at this stage and will continue to be monitored.

Une’s Image Credit: Dreamstime