The Norwegian Medicines Agency has received more than 1,200 reports of menstrual disorders after the coronary vaccine. – We do not rule out a connection, says chief physician to Nettavisen.
In a survey TV 2 has performed among 200 women who have experienced menstrual disorders after vaccination, it is told about everything from violent hot flashes to pain so severe that they faint on the bathroom floor.
“I lost my period for a month and a half. When I finally got it, there were extreme amounts of blood and pain “, says one of the women according to TV 2.
Has processed 1264 messages
In June, the Norwegian Medicines Agency began a systematic survey of these reports.
– We still receive many reports of menstrual disorders and unexpected abdominal bleeding after vaccination. We have so far processed 1264 reports of menstrual disorders and 97 reports of abdominal bleeding after menopause (postmenopausal bleeding), the Norwegian Medicines Agency reported on its website on 28 October.
– Do not trivialize
– It is simply not easy to clarify for sure whether there is a connection between the coronary vaccines and these side effects, says chief physician Sigurd Hortemo at the Norwegian Medicines Agency to Nettavisen on Wednesday.
– We must not downplay this. There are significant ailments, but menstrual disorders are a common phenomenon. Therefore, it is difficult to come to a definite conclusion, he says when asked why this takes time.
Applies to all vaccines
Hortemo says the side effect reports of menstrual disorders are related to all three vaccines that are used and have been used in the Norwegian vaccination program, and that it is currently not possible to say that any of these stand out.
Same vaccine advice as before
So far, there are no changes in the advice of women when it comes to taking coronary vaccine. Norwegian health authorities insist that all adults over the age of 18 should take the coronary vaccine.
– These side effect reports do not change this advice, says Hortemo.
He says that the European Medicines Agency (EMA) has a strong focus on these side effect reports and uses a lot of resources to map them. If the EMA concludes that there is a connection, then this will be discussed in product reviews and package inserts, but not before, according to Hortemo.
– Until then, we use other channels to inform about the messages we have received, he says and refers, among other things, to the Norwegian Medicines Agency’s theme page about the case.
– We do not rule out that there may be a connection between the vaccines and menstrual disorders, he says.
328 messages from health professionals
Hortemo says the number of reports of menstrual disorders after coronary vaccine is high, but at the same time points out that a large number of doses of coronary vaccine have now been set, 8 million doses in Norway and thus around 4 million for women. A total of 38,000 reports of suspected side effects have been received by the Norwegian Medicines Agency. This applies to all types of side effects after coronary vaccine so far (figures as of 28 October). 11,000 of these have been reported by health personnel, including doctors who have treated the patients. Of these 11,000 reports from healthcare professionals, 328 reports concern menstrual disorders.
The Norwegian Medicines Agency has gone into the reports of menstrual disorders and examined a selection of them in more detail. Most messages come from women between the ages of 20 and 49. 7 per cent come from women under the age of 20 and 7 per cent from women over the age of 49. When it comes to reports of postmenopausal bleeding, the majority of these (70 per cent) come from women aged 50-59 years.
– Waiting for results of cohort studies
The Norwegian Medicines Agency assures that they follow this up closely. Since June, they have informed about this, created a theme page and had a close dialogue with Norwegian experts and European drug authorities. The Norwegian Institute of Public Health has conducted cohort studies to try to clarify whether there is a connection between coronary vaccines and bleeding disorders. The result of this work is not yet clear.
Read more on the theme page about coronary vaccines and menstrual disorders at Legemiddelverket.no
Has mapped 200 women
TV 2 has asked over 200 women with menstrual disorders after the coronary vaccine what they have experienced. 70 percent report a changed cycle / irregular menstruation. 55 percent have had heavier bleeding, 53 percent have had prolonged bleeding and 43 percent have had heavier menstrual pain, according to TV 2.
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