European Union drug regulators are recommended that changes in product information for the COVID-19 vaccine from AstraZeneca and Johnson & Johnson include a warning of a rare spinal cord condition called transverse myelitis. Is shown.
TM is a rare condition with inflammation of one or both sides of the spinal cord. Symptoms include weakness in the limbs, tingling, numbness, pain and loss of sensation of pain, and problems with bladder and bowel function.
The Pharmacovigilance and Risk Assessment Committee (PRAC), a committee of the European Medicines Agency (EMA) that evaluates the safety of human medicines, said that the causal relationship between the two vaccines and TM is “at least a reasonable possibility. “
Changed the product information for COVID-19 shots (AstraZeneca’s Vaxzevria and Johnson & Johnson’s Janssen) to include the warning “Very rare cases of transverse myelitis (TM) reported after vaccination”. I recommend it. TM is also added to the vaccine profile as a side effect at an unknown frequency.
At the three-day meeting, the Commission reviewed information on cases reported worldwide for both vaccines, including data from the scientific literature and information from the European database on suspicious side effects of vaccines.
PRAC said it believes a total of 38 TM cases have been reported worldwide. 25 were reported in Vaxzevria and 13 in Janssen. “These numbers indicate suspicious and unarbitrated cases of TM.” This is the 1,391 billion doses of Vaxzevria and the estimated 33,584,049 doses of Janssen worldwide. It was said to be one of the administrations of.
“Healthcare professionals need to pay attention to the signs and symptoms of TM and enable early diagnosis, supportive care, and treatment,” EMA said. “People who are vaccinated with any of these vaccines are advised to see a doctor immediately if symptoms occur.”
The risk and benefit profiles of both vaccines have not changed, EMA said.
December 2021, EMA Recommended A booster vaccination with the Janssen vaccine will be considered at least 2 months after the first vaccination of persons over the age of 18.
On January 14, PRAC also revised AstraZeneca’s Vaxzevria product information to indicate that thrombotic events with thrombocytopenia (TTS) have not been reported since the second time compared to the first. Recommended to be careful. TTS is a rare and severe blood clot with thrombocytopenia.
This was added as a rare side effect to the Vaxzevria taken in June 2021. According to data reported to the UK Government by August 4, 2021, the overall incidence of TTS is approximately 14.9 per million people After the first or unknown dose of Vaxzevria.
Research Published in the journal Science Advances on December 1, 2021, it suggests that the threat of TTS can be significantly reduced if the adenoviral vector contained in the AstraZeneca vaccine is modified.