This was reported on the regulator’s website.
“Following reports of safety concerns regarding cases of anaphylaxis (severe allergic reactions) with the AstraZeneca COVID-19 vaccine, PRAC recommends updating the product information to include anaphylaxis and hypersensitivity (allergic reactions) as side effects in section 4.8,” said message.
This decision was made due to reports of possible anaphylaxis, which was observed in about five million vaccinated.
“After careful examination of the data, the PRAC concluded that at least some of these cases have a vaccine-related relationship,” the regulator said.
As previously reported, the EU countries are massively stopping the use of the drug from the coronavirus company AstraZeneca. Refused vaccination already in Denmark, Norway, Italy, Iceland, Bulgaria, Romania, and Thailand.