Thursday, October 21, 2021

EU regulators unable to confirm whether women face increased clot risk after AstraZeneca shot

Europe’s drug regulator said Friday it could not confirm whether AstraZeneca’s COVID-19 vaccine has any effect on women and young adults at higher risk of abnormal blood clots associated with low levels of blood platelets. No.

The European Medicines Agency (EMA) said in a statement that it was requested by the European Commission to provide a scientific opinion following initial reports of thrombosis with AstraZeneca’s COVID-19 vaccine-associated thrombocytopenia syndrome (TTS) , which is called Waxjeveria.

“The evidence did not allow the EMA to identify specific risk factors that make TTS more likely,” the drug regulator said.

“Although spontaneous reports … have suggested that the risk may be higher in women and young adults, and may be lower after the second than the first dose, limitations in the way the data were collected mean that these No difference can be confirmed.”

A committee responsible for broadening the EMA’s opinion on all issues regarding medicinal products for human use also conducted a further analysis of whether delaying a second dose of vaxazevaria has any effect on the risk of TTS.

“There is no evidence that delaying the second dose has any effect on the risk of TTS,” the committee said.

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The European Health Agency said it was reiterating that a second dose could be given between four and 12 weeks after the first dose. It also said that no definitive recommendation can currently be made on the use of a different vaccine for the second dose than for the first time with the shot of AstraZeneca.

The EMA said the study was based on all available data related to TTS, including a database focused on collecting suspected adverse reactions to drugs that have been authorized or studied in clinical trials in the European Economic Area. are going.

AstraZeneca’s Vaxzevria is a two-shot vaccine developed with the University of Oxford.

The drug regulator first began looking into the adverse conditions in April, when dozens of blood clots, including deaths, were reported in people after getting the shot.

Potentially jab-related adverse reactions prompted more than a dozen countries to halt the use of AstraZeneca’s COVID-19 vaccine as a precaution, while investigators noted the risk of blood clots among vaccinated people. investigated the cases.

Reuters contributed to this report.

from ntd news



This News Originally From – The Epoch Times

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