EU Adds Rare Spinal Condition to J&J COVID-19 Side Effects

The European Medicines Agency (EMA) has recommended including transverse myelitis, a rare form of spinal inflammation, to the list of Johnson & Johnson (J&J) COVID-19 vaccine side effects.

Transverse myelitis previously cropped up as a safety issue during vaccines trials from J&J and AstraZeneca, whose shot also employs adenovirus-based technology. In fact, both drugmakers temporarily paused U.S. late-stage trials in fall 2020 over concerns patients may have contracted the rare neurological condition (DID, Sept. 16, 2020).

When asked about the EMA’s new recommendation, J&J confirmed to FDAnews that “rare cases of transverse myelitis” have been reported following vaccination and pledged to cooperate with the EMA’s Pharmacovigilance Risk Assessment Committee and other relevant health authorities.

“While the chances of experiencing these conditions are very low, the product information of COVID-19 Vaccine Janssen will be updated to include important information about the signs and symptoms of transverse myelitis,” said the company spokesperson, adding that the drugmaker “strongly” supports raising awareness of rare events so they can be “quickly identified and effectively treated.”

Neither J&J nor the EMA provided FDAnews with the total number of transverse myelitis reports in the European Economic Area. But current EMA data show that more than 16.3 million doses have been administered to people in the EU, with 28,244 overall side effects reported.

Though reported cases include suspected adverse events, it is important to note that they are not always caused by the vaccine in question.

In other J&J news, the company has struck a deal with Gavi, the Vaccine Alliance, which administers the World Health Organization-backed COVAX vaccine-sharing program. Under the pact, J&J will supply up to 900 million doses of its COVID-19 shot to the developing world through 2022. Deliveries are set to begin within days.

“We believe our single-shot COVID-19 vaccine has a critical role to play in conflict zones and other humanitarian settings that can’t be reached by government vaccination campaigns,” said Paul Stoffels, J&J’s chief scientific officer. ― Jason Scott