The European Union’s (EU) drug watchdog is looking to warn general public about a ‘very rare’ possibility of leading to spinal cord inflammation after getting vaccinated with coronavirus vaccines manufactured by AstraZeneca and Johnson & Johnson.
For this, the European Medicines Agency is also considering to place warning labels on these Covid jabs.
It also said that there was a “reasonable possibility” that they may have resulted in a spinal inflammation on rare occasions.
On Friday, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) after holding three days of meetings and discussions said that it wants to include a warning for “very rare cases of transverse myelitis (TM) reported following vaccination” with Vaxzevria and Janssen jabs.
The panel also added that the condition was an “adverse reaction of unknown frequency” to the vaccine profile.
It comes as PRAC reviewed information on reported cases in the world and scientific literature.
According to the EMA, TM is a rare neurological condition, which is characterised by an “inflammation of one or both sides of the spinal cord.” It can cause weakness in arms or legs, numbness, tingling, pain or loss of pain sensation and problems with bowel and bladder function.
It concluded that “a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility.” However, it said the “benefit-risk profile of both vaccines remains unchanged.”
(With inputs from agencies)