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Johnson &Johnson’s COVID-19 shot hit again as feds plan to tag Guillain-Barré warning on label: reports

Johnson & Johnson’s COVID-19 vaccine has encountered numerous setbacks ranging from manufacturing issues to an emergency safety review. Use of the vaccine hasn’t met initial expectations as a result, and, now, authorities are reportedly set to highlight an additional concern.

The FDA plans to add a warning to the shot’s label about the rare risk of Guillain-Barré syndrome (GBS) after vaccination, The Washington Post reports. The news comes after officials recorded about 100 preliminary GBS cases out of more than 12 million vaccine recipients, the newspaper reports.

GBS is a rare but potentially life-threatening disorder in which the body’s immune system attacks nerve cells.

The condition has been associated with the use of other widely used vaccines such as GlaxoSmithKline’s Shingrix. So far, officials think GBS is about three to five times more likely to appear among J&J COVID-19 vaccine recipients than among the general public, The New York Times reports.

Despite the risk, the shot’s benefits still outweigh the risks, authorities said.

It’s the latest in a string of hits for the shot since its emergency authorization in late February. Originally hailed as a simple, one-dose alternative to the mRNA powerhouses from Moderna and Pfizer, J&J’s shot ran into production issues early on.

In late March, The New York Times reported that J&J’s production partner Emergent BioSolutions had to throw out millions of doses’ worth of ingredient because of a manufacturing mishap. Emergent’s snafu led to intense scrutiny of its Baltimore plant, where manufacturing still hasn’t resumed.

Things took a turn for the worse for J&J’s shot in April when U.S. authorities paused the rollout to review rare blood clots that were occurring in some recipients alongside bleeding. Authorities later tagged the shot with a warning over the rare clots, but they maintain that the vaccine’s benefits outweigh risks.

When J&J’s shot made it back into distribution 10 days later, its momentum had been derailed. Before the pause, about 7 million people had received J&J’s one-dose vaccine. In the months that have followed, the total has reached 12.8 million. That compares with more than 320 million doses administered of Pfizer’s and Moderna’s mRNA offerings, each of which are two-dose regimens.

While Monday’s news represents a setback for J&J’s program, it also comes at a sensitive time during the U.S.’ battle with the pandemic. About 59% of the adult population is fully vaccinated, and officials are urging remaining holdouts to consider vaccination as a way to halt the troubling delta variant.