Az Európai Gyógyszerügynökség
álláspontja:
Menstrual disorders
No evidence for causal relationship with Comirnaty
PRAC assessed cases reported as menstrual disorders occurring after
vaccination with Comirnaty.
Until 30 August 2021, a total of 16,263 cases had been reported
worldwide (16,226 as spontaneous reports; 6,118 as serious), of which
1,665 (10.2%) were medically confirmed by a healthcare professional as
menstrual disorder (around 1,220 million doses of Comirnaty were
estimated to have been administered worldwide by 31 August 2021).
Spontaneously reported cases concern suspected side effects, i.e. medical
events that have been observed after vaccination, but which are not
necessarily related to or caused by the vaccine.
The assessment of all cases included an analysis of the type of symptoms
and their time to onset; no specific pattern of menstrual cycle
disturbances could be identified. In about half of the cases, past or current
relevant medical conditions or concurrent medication were considered
plausible explanations for menstrual disorders.
An observed-to-expected
(O/E) analysis for the 6,050 cases reported as ‘heavy menstrual bleeding’
(which was the most frequently reported disorder at 34.7%) resulted in an
O/E ratio below 1; this means the number of cases reported after
vaccination in relevant time windows was below the number of events
expected to occur in an unvaccinated female population of the same size
(based on observational data collected from the general population).
Based on the assessment of all data, PRAC concluded that there is
currently no evidence suggesting a causal relationship of menstrual
disorders with Comirnaty.
Menstrual disorders are very common in the general population and can
occur without an underlying medical condition. Causes can range from
stress and tiredness to conditions such as fibroids and endometriosis.
An assessment carried out in August 2021 by the Medicines & Healthcare
products Regulatory Agency (MHRA) in the United Kingdom (UK) also
concluded that the number of case reports in the UK were low in relation
to both the number of vaccinated women and how common menstrual
disorders are generally, that the symptoms were transient and that the
data did not support a causal link between changes to menstrual periods
and the COVID-19 vaccines available in the UK, including Comirnaty.