A rare spinal cord condition could be amongst the vaccine’s adverse side effects, according to an EU drug regulatory authority. The committee even, who reviewed the data over a three day conference, made a suggestion addressing vaccine manufacturers to add a warning and spread awareness.
A change to the product information has been indicated by the European Union’s drug regulator, for COVID-19 vaccines from AstraZeneca and Johnson & Johnson, recommends to include a warning of a rare spinal cord condition called transverse myelitis.
Transverse Myelitis is a rare condition that involves inflammation of one or both sides of the spinal cord. Symptoms can include tingling and weakness in the limbs, pain or numbness, loss of pain sensation, or issues with bowel and bladder function.
The change was recommended by Pharmacovigilance and Risk Assessment Committee (PRAC), the European Medicines Agency’s (EMA) committee that assesses the safety of human medicines, on Jan. 14 after concluding that a causal link between the two vaccines and TM is “at least a reasonable possibility.”
It recommends changing the product information for the COVID-19 shots — Johnson & Johnson’s Janssen and AstraZeneca’s Vaxzevria – to include a warning of “very rare cases of transverse myelitis (TM) reported following vaccination.” TM will also be added as an adverse reaction with an unknown frequency to the vaccine profile.
The committee reviewed the information on globally reported cases for both vaccines, including information from the European database for suspected vaccine side effects as well as data from the scientific literature, over three days of meetings.
The PRAC said it considered that a total of 38 TM cases were reported globally—25 with Vaxzevria, 13 with Janssen. “These numbers refer to suspected and not adjudicated cases of TM.” This is out of 33,584,049 doses for Janssen and 1.391 billion doses for Vaxzevria that have been estimated to have been administered globally, it said.
“Health care professionals should be alert to signs and symptoms of TM, allowing early diagnosis, supportive care, and treatment,” the EMA announced. “People receiving either of these vaccines are advised to seek immediate medical attention if they develop symptoms of the condition.”
The risk-benefit profile of both vaccines remains unchanged, the EMA noted.
The EMA recommended, in December 2021, a booster dose of the Janssen vaccine to be considered for people aged 18 and above at least two months after the first dose.
It was recommended by the PRAC on Jan. 14 that the product information for AstraZeneca’s Vaxzevria be revised to note that fewer events of thrombosis with thrombocytopenia (TTS) have been reported after the second dose compared to the first.
It was added as a rare side effect to the Vaxzevria shot in June 2021. Overall incidence of TTS of around 14.9 per million after first or unknown doses of Vaxzevria, were reported as per data reported to the UK government up to Aug. 4, 2021.
An adenovirus vector in AstraZeneca’s vaccine, if adjusted, might greatly minimise the threat of TTS, according to a study published in the journal Science Advances on Dec. 1, 2021.
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