The European Medicines Agency (EMA) is once again putting under its microscope the coronavirus vaccines made by AstraZeneca and Johnson & Johnson, saying there is a “reasonable chance” they have caused spinal inflammation in rare cases.
After three days of meetings and discussions, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) said on Friday it intended to include a warning about “very rare cases of transverse myelitis (TM) reported after vaccination” with vaccines (Vax AsraZeneca) and Janssen (Johnson & Johnson). He added that the condition was an “undesirable side effect of unknown frequency” on the vaccine profile.
EMA describes TM as a rare neurological condition characterized by “inflammation of one or both sides of the spinal cord”, which can cause weakness in the arms or legs, tingling, numbness, pain – or loss of pain – and problems with the gut and bladder function.
The recommendation comes after PRAC reviewed available information on reported cases worldwide and the scientific literature, concluding that “a causal link between these two vaccines and transverse myelitis is at least a reasonable possibility.” However, he said that “the benefit-risk profile of both vaccines remains unchanged”.
The warning is aimed at “raising the awareness of health professionals and people receiving vaccines”. Doctors have been alerted to alert for signs and symptoms of TM, and recipients are urged to “seek immediate medical attention” if they experience such symptoms.
Last month, the EMA approved the Janssen booster vaccine for people aged 18 and over, which will be given at least two months after previous vaccinations.
PRAC also reviewed AstraZeneca Vaxzevria information, noting that there were far fewer cases of thrombocytopenia (TTS) – a blood clot with a low platelet count – after the second dose of the plunger compared to the first.
The use of the AstraZeneca vaccine, developed with the University of Oxford, has already been reduced due to the “extremely rare” side effect, which UK government statistics last summer estimated at around 14.9 per million doses of the vaccine.