Medicines Agency: Severe allergies as a possible side effect of AstraZeneca
6:02 p.m., March 12, 2021
The European Medicines Agency EMA reported on Friday suspicions that AstraZeneca’s vaccine could cause allergies. Anaphylaxis and hypersensitivity reactions should be included in the list of possible side effects of the vaccine, the EMA said on Friday.
She bases her statement on data from Great Britain, where over nine million people have already been vaccinated with the vaccine. Accordingly, there have been several such incidents in the United Kingdom that AstraZeneca had already approved in December. There are reports on 41 possible anaphylaxis cases among five million vaccinees in the UK. After carefully analyzing the data, the vaccine risk assessment committee considered a link between the allergic reaction and vaccination to be likely in at least some of these cases.
Known side effects with other vaccinations as well
At the same time, the EMA pointed out that severe allergic reactions are a known rare side effect even with vaccinations against other diseases. The Astrazeneca package insert already recommends that patients still have a vaccination under observation for at least 15 minutes should stay in order to be able to react to possible allergic reactions. Incidentally, this is also done when vaccinating with other Covid vaccines, for example during the vaccination campaign with Biontech / Pfizer in the Schwaz district.
The Federal Office for Safety in Health Care (BASG) also explained in a statement that anaphylaxis is a known side effect that can occur very rarely with vaccines. The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA has recommended an update of the information for healthcare professionals: Anaphylaxis and hypersensitivity (allergic reactions) should not only be listed as side effects in the section “Special warnings and precautions for use”, but also in the section “Side effects” become.
For the other Covid-19 vaccines that have already been approved, this information is already given in the product information, reported the BASG. This update is only intended to show that cases of anaphylaxis have also been reported with the Astrazeneca vaccine.
Astrazeneca, meanwhile, denied concerns about serious side effects related to clotting disorders of its corona vaccine. “An analysis of our safety data of more than ten million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis”a spokesman said on Friday. This applies to all age groups, genders, countries or batches of the Astrazeneca vaccine. “In fact, these events occur less frequently among vaccinated people than in the general population,” it said.
Denmark and other countries had suspended vaccinations with the substance. The reason given was reports of death and serious illness from blood clots after vaccination. However, it is not yet possible to determine whether there is a connection between the vaccine and the blood clots, it said.
The European Medicines Agency (EMA) came to the conclusion that the proportion of thrombosis sufferers after vaccination with the Astrazeneca preparation corresponds to the spontaneous occurrence of this disease in the normal population. As of March 10, the EMA had recorded 30 cases of “thromboembolic events” in nearly five million people vaccinated with the Astrazeneca drug.