On 1 October the European Union’s drug regulator recommended updating the label for Johnson & Johnson’s COVID-19 vaccine, with warnings for two more serious health conditions associated with the vaccine.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that J&J vaccine use is possibly associated with vein clotting and an immune condition that causes the immune system to attack blood platelets.
The committee meeting highlighted, “PRAC has concluded that there is a possible link of rare cases of venous thromboembolism (VTE) with the COVID-19 vaccine Janssen.”
Venous thromboembolism is “a condition in which a blood clot forms in a deep vein, usually in a leg, arm, or groin, and can travel to the lungs, causing a blockage in the blood supply, potentially life-threatening.” with threatening consequences,” the committee said.
Janssen, J&J Company, did not respond to a request for comment.
COVID-19 is a disease caused by the CCP (Communist Party of China) virus, commonly known as the novel coronavirus.
After reviewing the new evidence, PRAC concluded that there is a “reasonable possibility” that clotting conditions are associated with vaccination using the J&J vaccine. The Committee recommended the listing of venous thromboembolism as a rare side effect in the product information for J&J Vaccine.
The committee also found that the use of the J&J and AstraZeneca vaccines is associated with an immune condition that causes the body’s immune system to target healthy platelets needed for normal blood clotting.
“Very low levels of blood platelets may be associated with bleeding, and may have serious health consequences,” the committee said.
The PRAC recommends listing the immune status as “adverse reaction with unknown frequency” for both the J&J and AstraZeneca vaccines.
The regulator agreed to send warning statements directly to health care practitioners about both clotting and immune status.
The Communications About Immune Thrombocytopenia (ITP) noted that cases of the condition have been reported in the first four weeks after vaccination and include “severe cases with very low platelet counts.”
“If a person has a history of ITP, healthcare professionals should consider the risk of developing low platelet levels before vaccinating. In individuals with a history of ITP, vaccination with the COVID-19 vaccine Janssen It is recommended to monitor the platelet levels after this,” said in a direct communication to doctors.
In the message to doctors about venous thromboembolism (VTE), instances of the condition were rare, but the risk of the condition should be considered for people with risk factors for blood clots. The message also states that patients presenting with one of the two conditions should be screened for the other.
“This is important, to assess the possible diagnosis of thrombosis with thrombocytopenia syndrome (TTS), which requires specialized clinical management,” the communication said.
The US Food and Drug Administration (FDA) authorized the J&J vaccine for emergency use on February 27, 2021. Less than two months later, on April 23, the FDA amended the authorization to include information “about a very rare and serious type.” Blood clot in people receiving the vaccine.” The clotting status in that case was different from the one flagged by the European regulator on 1 October.
The FDA did not respond to a request for comment.
This News Originally From – The Epoch Times