By Pushkala Aripaka and Ludwig Burger
(Reuters)-European drug regulators on Friday identified another very rare blood condition as a potential side effect of AstraZeneca’s (NASDAQ :) COVID-19 vaccine and inoculated all coronavirus shots. He said he was investigating a case of later heart inflammation.
The European Medicines Agency (EMA) Safety Commission has stated that it is necessary to add capillary leak syndrome (CLS) 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 giving people with their coagulation state, known as thrombosis with thrombocytopenia syndrome (TTS), a second AstraZeneca shot.
The Commission reviewed six validated cases of CLS in people who underwent Vaxzevria (mainly women), including one death. Three had a medical history.
In the European Union, Liechtenstein, Iceland, Norway and the United Kingdom, more than 78 million doses of Vaxzevria have been administered.
In a statement, AstraZeneca noted that CLS cases are extremely rare and that less than 1 in 10 million individuals are vaccinated.
“We are working with regulators to actively work on risk minimization measures, including information for vaccinated people … to promote early diagnosis and intervention, and appropriate treatment. Information, “the company said.
MHRA, a UK regulator, is considering preventative advice for people with a history of CLS, but said it has not seen a causal link to the vaccine.
Two of the eight reports of capillary leak syndrome after AstraZeneca vaccination in the United Kingdom stated that people with a history of this condition had been vaccinated with 40 million doses.
Separately, the EMA said it is continuing to investigate cases of heart inflammation known as myocarditis and pericarditis, primarily after Pfizer / BioNTech inoculation. Modana (NASDAQ :) After mRNA shots, as well as J & J (NYSE :) and AstraZeneca vaccines.
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 (NYSE :) and Moderna acknowledged the observations, but stated that a causal link to the 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.
EU adds another rare blood condition as a side effect of AstraZeneca shot by Reuters
Source link EU adds another rare blood condition as a side effect of AstraZeneca shot by Reuters