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Recently, the official website of the European Medicines Agency (EMA) released the minutes of its Pharmacovigilance Risk Assessment Committee (PRAC) meeting from January 10 to 13, 2022
.
According to the minutes, the PRAC recommends that rare transverse myelitis (TM) be added to the product information for 2 COVID-19 vaccines (AstraZeneca Vaxzevria and Johnson & Johnson COVID-19 Vaccine Janssen) to improve medical professionals and the awareness rate of rare TM cases in the public after vaccination with these two vaccines
TM is a rare neurological disorder characterized by inflammation of one or both sides of the spinal cord that may cause weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain, or analgesia), or problems with bladder or bowel function
.
The PRAC reviewed available information on reported cases globally for the two COVID-19 vaccines, including cases in the European Adverse Drug Event Reporting Database (EudraVigilance), and data from the scientific literature
.
The PRAC concluded that there is at least a reasonable probability of a causal relationship between the two COVID-19 vaccines and TM
The PRAC states that healthcare professionals should be alert for signs and symptoms of TM for early diagnosis, supportive care and treatment
.
The PRAC advises that people who have been vaccinated with both vaccines should seek immediate medical attention if they develop symptoms
In addition, the PRAC noted that a small number of thrombosis with thrombocytopenia (TTS) cases were reported following the second dose of AstraZeneca's COVID-19 vaccine Vaxzevria
.
The PRAC recommends updating the product information for Vaxzevria to add more information about the very rare cases of TTS that have occurred following this vaccine
A review of cumulative data highlights that globally most suspected TTS incidents are reported after the first dose
.
Fewer TTS events were observed after the second dose
Based on current product information, a second dose of Vaxzevria is contraindicated in people who develop TTS after receiving Vaxzevria
Source: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022 Share
