J&J Vaccine Linked To Rare Nerve Syndrome: What It Means

WASHINGTON, DC — The U.S. Food and Drug Administration on Monday issued a warning linking the Johnson & Johnson coronavirus vaccine to a rare neurological condition known as Guillain-Barré syndrome.

The agency said in a statement that while “the available evidence suggests an association” between the Johnson & Johnson vaccine and increased risk of Guillain–Barré syndrome, “it is insufficient to establish a causal relationship,” The New York Times reported.

The warning is the latest blow against the J&J vaccine in the United States.

Earlier this year, the FDA along with the Centers for Disease Control and Prevention briefly paused use of the vaccine after reports of a rare blood clotting complication. The pause was lifted in April after regulators determined the risk was low and the condition was treatable.

In March, about 15 million doses of the J&J vaccine were contaminated at Emergent BioSolutions, a Maryland-based biopharmaceutical company that had committed to produce 100 million doses by June.

Should this rare complication keep someone from getting the vaccine? Here’s what we know:

How many people have received the J&J vaccine?

About 12.8 million people — or about 8 percent of the fully vaccinated population in the United States — have received the Johnson & Johnson shot, according to The New York Times.

For comparison, about 146 million have been fully vaccinated with Pfizer’s or Moderna’s vaccines, both of which require two doses.

What is Guillain-Barré syndrome?

Guillain-Barré is a rare disorder in which your body's immune system attacks your nerves, according to the Mayo Clinic. Weakness and tingling in your extremities are usually the first symptoms. These sensations can quickly spread, eventually paralyzing your whole body.

The exact cause of Guillain-Barre syndrome is unknown. Most people report symptoms of another infection in the six weeks prior to onset.

There's no known cure for Guillain-Barre syndrome, but several treatments can ease symptoms and reduce the duration of the illness. Most people also recover from it.

How many cases have been linked to the J&J vaccine?

The CDC has received about 100 reports of Guillain-Barré in recipients of the J&J vaccine, according to The Washington Post. Of these cases, 95 required hospitalization, and one person died.

The cases mostly have been reported about two weeks after vaccination and mostly in men age 50 and older, the Post reported.

Have side effects like this been reported in other vaccines?

There has been no reported evidence or risk of Guillain–Barré syndrome in vaccines manufactured by Pfizer-BioNTech or Moderna; however, those vaccines rely on a different technology to combat the coronavirus.

The Pfizer and Moderna vaccines are both mRNA, which teach our cells how to make a protein that triggers an immune response inside our bodies, according to the CDC. Meanwhile, the J&J vaccine is a viral vector vaccine, meaning it uses a modified version of a different virus to deliver instructions to our cells.

Both types of vaccines carry a similar benefit: Those vaccinated gain protection without ever having to risk the serious consequences of getting sick with COVID-19.

About 1,000 cases of myocarditis and pericarditis — or an enlarged heart — have been reported in adolescents and young adults who received the Pfizer and Moderna vaccines, according to the CDC.

Should I skip this vaccine or is it still safe to receive?

The Guillain-Barré cases will be discussed as part of the July 22 meeting of the CDC’s Advisory Committee on Immunization Practices, the Post reported.

Meanwhile, in its statement, the FDA was clear: The “known and potential benefits clearly outweigh the known and potential risks” of the J&J vaccine.

Still, as Americans remain deeply divided on whether to get the vaccine, some are worried this will do little to assuage hesitancy.

“What worries me most is that it reinforces the lack of confidence that people had,” Dr. Steven Black, an emeritus professor of pediatrics at Cincinnati Children’s Hospital Medical Center and the co-director of the Global Vaccine Data Network, told The New York Times. “They’ll say, ‘Aha, see, I was right.’ But they’re not right.”