The European regulatory body on Friday identified another very rare blood condition as a potential side effect of AstraZeneca̵
The European Medicines Agency (EMA) Safety Committee has stated that capillary leakage syndrome (CLS) should be added as a new side effect to the labeling of the AstraZeneca vaccine, known as Vaxzevria.
People who have previously maintained a condition in which fluids leak from the smallest blood vessels, causing swelling and a drop in blood pressure, should not receive the shot, the EMA added.
The regulator first began reviewing these cases in April, and the recommendation added to AstraZeneca’s woes after its vaccine was linked to very rare and potentially fatal blood clotting cases that come with low platelet counts.
Last month, the EMA recommended not giving AstraZeneca a second shot to people with this clotting condition, known as thrombosis with thrombocytopenia syndrome (TTS).
The Committee examined six confirmed cases of CLS in people, mainly women, who received Vaxzevria, including one death. Three had a history of this condition.
More than 78 million doses of Vaxzevria have been administered in the European Union, Liechtenstein, Iceland and Norway and the United Kingdom.
In a statement, AstraZeneca noted the extreme rarity of CLS in less than 1 in 10 million people vaccinated.
“We are working actively, in cooperation with regulators, on risk minimization measures … which include information on vaccinated … information to encourage early diagnosis and intervention and appropriate treatment,” the company said.
The UK regulator, MHRA, said it was considering precautionary advice for people with a history of CLS, but saw no causal link to the vaccine.
Two of the eight reports of capillary leakage syndrome after vaccination against AstraZeneca in the UK were in people with a history of the disease and 40 million doses of the vaccine were given, the report said.
Separately, the EMA said it was continuing its study in cases of heart inflammation known as myocarditis and pericarditis, mainly after inoculation with Pfizer / BioNTech (PFE.N), (22UAy.DE) and Moderna mRNA images, but also after J&J (JNJ). .N) and AstraZeneca vaccines.
U.S. health officials said Thursday that they had reported more than expected cases of heart inflammation in young men who received a second dose of mRNA shots, although no causal link could be established. Read more
The Israeli Ministry of Health said this month that it had found a possible link to the condition in young men who received the Pfizer / BioNTech shot. Read more
Both Pfizer and Moderna acknowledged the observations, but said no causal link to their vaccines had been established.
BioNTech said that adverse events, including myocarditis and pericarditis, are regularly and thoroughly reviewed by companies and regulators.
“More than 300 million doses of Pfizer-BioNTech COVID-19 have been administered worldwide and the risk and benefit profile of our vaccine remains positive.”
The United States and Israel have been months ahead of the EU in vaccinating men under the age of 30 who are particularly prone to heart inflammation, giving them potentially more cases to analyze.
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