European drug regulators on Friday identified another rare blood condition as a potential side effect of AstraZeneca’s COVID-19 vaccine and investigated cases of heart inflammation after all coronavirus shots were inoculated. Said that.
The European Medicines Agency’s (EMA) Safety Commission has stated that it is necessary to add capillary leak syndrome as a new side effect to the labeling of the AstraZeneca vaccine known as Vaxzevria.
The EMA added that people who previously maintained fluid leaks from the smallest blood vessels, causing swelling and lowering blood pressure, should not receive shots.
Regulators first began investigating these cases in April, and recommendations are AstraZeneca’s distress after the vaccine is associated with very rare and potentially fatal cases of blood clotting with low platelet counts. Is increasing.
Last month, the EMA advised people with coagulation, known as thrombosis with thrombocytopenia syndrome (TTS), not to use a second AstraZeneca shot.
The Commission examined six validated cases of capillary leak syndrome in people who underwent Vaxzevria, primarily women, including one death. Three had a history of the condition.
AstraZeneca refused to comment immediately.
In the European Union, Liechtenstein, Iceland and Norway, and the United Kingdom, more than 78 million doses of Vaxzevria have been administered.
UK regulator MHRA said Thursday that it received eight reports of capillary leak syndrome associated with more than 40 million doses of the AstraZeneca vaccine and is currently unrelated. It was.
Separately, the EMA will continue to investigate cases of cardiac inflammation known as myocarditis and pericarditis, primarily after vaccination with Pfizer / BioNTech and Modern RNA shots, as well as after vaccination with J & J and AstraZeneca vaccines. Said that.
U.S. health officials said Thursday that they could not establish a causal relationship, but registered a higher than expected number of heart inflammation cases in young men who received a second dose of mRNA shots.
The Israeli Ministry of Health said this month it found that it was likely related to the condition of a young man who was shot by Pfizer / BioNTech.
Both Pfizer and Modana acknowledged the observations, but stated that a causal link to their vaccine had not been established.
BioNTech said adverse events such as myocarditis and pericarditis are regularly and thoroughly reviewed by businesses and regulators.
“The Pfizer-BioNTech COVID-19 vaccine has been administered more than 300 million times and our vaccine’s benefit risk profile continues to be good.”
The United States and Israel are months ahead of the EU in vaccination of men under the age of 30, especially those who are prone to heart inflammation, and may have more cases to analyze.