- Europe's top drug regulator on Tuesday confirmed a "possible link" between Johnson & Johnson's coronavirus shot and an extremely rare, yet serious side effect that caused the U.S. to pause vaccinations last week.
- The side effect in question involves a life-threatening combination of unusual blood clots and very low counts of platelets. As of April 13, eight cases had occurred in the U.S. after roughly 7 million vaccinations, according to the European Medicines Agency. The events all happened in people under 60 years old, the majority of whom were women.
- The EMA affirmed, however, that the benefits of J&J's vaccine and its efficacy in preventing COVID-19 still outweigh the risks, and recommended only that a warning be added to the product information for the shot. J&J quickly followed with a statement saying it would resume shipments to Europe of its vaccine, with the updated labeling.
While warnings of adverse events are seldom good news, the EMA's reiteration Tuesday that the benefits of J&J's vaccine outweigh the risks is an important vote of support from a major regulator. J&J's shot is one of four vaccines cleared for emergency use in the U.S. or Europe, and the only one backed by evidence that it could protect against COVID-19 after one dose.
The EMA didn't recommend any restrictions on J&J's vaccine based on age or gender, choosing only to add warnings about blood clots in the presence of low levels of platelets, the sticky cells that help blood coagulate. The side effect seen are "very similar" to those that have occurred with AstraZeneca's vaccine, according to the EMA.
In recommending a warning, the agency took a similar approach as it did with AstraZeneca's vaccine. Many European countries that suspended its use following the blood clot reports began using it again after the EMA supported its use.
On Tuesday, J&J said it will resume plans to roll out its vaccine in Europe — plans the company set aside after the Food and Drug Administration and Centers for Disease Control and Prevention on April 13 called for vaccinations to be paused in the U.S.
As with AstraZeneca's vaccine, the investigation into the adverse events and the suspension of immunizations may cause the public to be more hesitant to receive J&J's shot — a concern J&J executives sought to calm on Tuesday.
"It's an extremely rare event, and we hope, by making people aware, as well as putting clear diagnostic and therapeutic guidelines in place that we can restore the confidence in our vaccine," said Paul Stoffels, J&J's chief scientific officer, during a conference call on the company's first quarter earnings.
In the U.S., J&J's vaccine remains suspended while regulators try to determine several things, including how many people have been stricken by the clots, the comparable rate of cases in the non-vaccinated population, who is most at risk of the clots and the underlying mechanism that might cause them.
A CDC panel is set to meet again Friday to review more data and potentially make recommendations, after declining to vote on any further advice at a meeting last week.
Note: This story has been updated to reflect Johnson & Johnson's statement.