Europe’s drug regulator on Friday identified another very rare blood condition as a potential side effect of the AstraZeneca (AZN.L) COVID-1
The European Medicines Agency (EMA) safety committee said capillary leakage syndrome (CLS) should be added as a new side effect to the labeling of AstraZeneca’s vaccine, known as Vaxzevria.
People who had previously maintained the condition where 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 only began investigating these cases in April, and the recommendation adds to AstraZeneca’s troubles after the vaccine was associated with very rare and potentially fatal cases of platelets with low platelet counts.
Last month, the EMA had advised against giving another AstraZeneca shot to people with this coagulation condition, known as thrombosis with thrombocytopenia syndrome (TTS).
The committee reviewed six validated cases of CLS in humans, mostly women who had received Vaxzevria, including one death. Three had a history of the condition.
More than 78 million doses of Vaxzevria have been administered in the European Union, Liechtenstein, Iceland & Norway and the United Kingdom.
In a statement, AstraZeneca pointed to the extreme rarity of CLS cases in less than 1 in 10 million vaccinated individuals.
“We are actively working with regulators on risk minimization measures … which include information for those being vaccinated … information to create early diagnosis and intervention and appropriate treatment,” the company said.
The UK regulator, the MHRA, said it was considering precautionary advice for people with a history of CLS but did not see a causal link with the vaccine.
Two out of eight reports of capillary leakage syndrome following AstraZeneca vaccination in the UK were in people with a condition of the condition and 40 million doses of the vaccine had been given, it said.
Separately, the EMA said it continued its probe for cases of myocarditis known as myocarditis and pericarditis, primarily after inoculation with Pfizer / BioNTech (PFE.N), (22UAy.DE) and Modern mRNA shots, but also after J&J (JNJ). N) and AstraZeneca vaccines.
U.S. health officials said on Thursday they had registered a higher-than-expected number of cases of heart inflammation in young men who received a different dose of the mRNA shots, even though a causal link could not be established. Read more
The Israeli Ministry of Health said this month that it had found a likely link to the condition of young men receiving the Pfizer / BioNTech shot. Read more
Both Pfizer and Moderna have acknowledged the observations, but said a causal link with their vaccines has not been established.
BioNTech said adverse reactions, including myocarditis and pericarditis, are regularly and thoroughly reviewed by companies and regulators.
“More than 300 million doses of the Pfizer-BioNTech COVID-19 vaccine have been administered globally and the distribution risk 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, potentially giving them more cases to analyze.
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