The latest Aemps Pharmacovigilance Report also includes urticaria as a possible adverse reaction to ‘Spikevax’ and facial paralysis as a possible reaction to ‘Jcovden’
The Spanish Agency for Medicines and Health Products (Aemps) has published the 18 Pharmacovigilance report on vaccines against Covid-19, which updates information about various security issues. One of them is the profuse menstrual bleeding as a possible adverse reaction of mRNA vaccines (Comirnatyby BioNTech/Pfizer, e Spikevaxby Moderna) against Covid.
EMPS indicates that this conclusion was reached after the European Medicines Agency (EMAfor its acronym in English), through the Committee for Risk Assessment in Pharmacovigilance (PRACfor its acronym in English), completed the assessment of all available data and determined the existence of this possible adverse reaction. For this reason it is recommended to include it in the technical data sheet and package leaflet of these vaccines. However, he throws a clarification: “there is no evidence suggesting that menstrual disorders have some impact on a woman’s reproduction or fertility. The risk/benefit ratio of Comirnaty yes Spikevaxremains favourable“.
According to the data collected in this new report, there have been reports around 9,000 cases worldwide of heavy menstrual bleeding after the administration of any dose of these vaccines (both in the first and second doses, and in booster doses). In a small number of women, this heavier bleeding occurred with both the initial dose of the vaccine and after the second dose. The available information indicates that the vast majority of these cases “are transient and self-limiting, without seriousness”say from Aemps.
In the case of Spain, the agency specifies: “Until October 9, 2022, there had been 921 notifications of this type of disorder after administration of Comirnaty yes 299 notifications after the administration of Spikevaxin women aged 12 to 49 years. Until that same date they had been administered over 15.6 million of dose of Comirnaty yes 6.2 million of dose of Spikevax in this same population.
Along with this, she explains that, in general, menstrual disturbances “are frequent” throughout a woman’s life and can occur “due to a wide variety of factors, including other diseases and medications” that may be present in women in precedence. “Anyone concerned about these changes or experiencing post-menopause bleeding you should consult your doctor“adds Aemps.
Urticaria, in less than 1%
Another security issue that is updated in the new Aemps report is that it identifies the urticaria as a possible hypersensitivity reaction after receiving Spikevax. As explained, its frequency of appearance is infrequent (less than 1 in 100 vaccinated people) and hypersensitivity in general is already included in the technical data sheet and package leaflet of this vaccine.
“The cases that have been observed can appear a few days after vaccination or later, up to about two weeks after. In Spain, until November 13, 2022, there were 292 reports of urticaria after the administration of Spikevax. Until that same date they had been administered more than 24 million of dose of Spikevax“, specifies the Spanish agency.
This report also states that the facial paralysis as a possible adverse reaction to the vaccine Jcovdenby Jansen. For this reason, the PRAC has recommended that the data sheet and package leaflet of this vaccine be updated to include temporary facial paralysis, usually on one side of the face (including Bell’s palsy) as a possible adverse reaction.
“According to data from clinical trials, this possible adverse reaction is rare (in less than 1 in 1,000 people)”, underline from Aemps and add: “In Spain, until November 13, 2022, they registered 12 notifications of facial paralysis after administration of Jcovden. Until that same date they had been administered about 2 million doses of this vaccine”.
in his 18 Pharmacovigilance report on Covid-19 vaccines Aemps indicates that, until November 13, 2022, they were administered in Spain 108,694,855 doses of vaccineshaving registered 83,093 notifications of adverse events.
“Events most frequently reported continue to be general disorders (fever and malaise), of the nervous system (headache and dizziness) and of the locomotor system (myalgias and arthralgias) “, the agency points out.
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