The U.S. Food and Drug Administration added a new warning to documentation for Johnson & Johnson's Janssen COVID-19 vaccine Monday after 100 recipients reported Guillain-Barré syndrome. And while the number of preliminary reports is very low compared to the more than 12 million doses administered, the warning could deliver another blow to public confidence in the safety of vaccines as state and federal authorities urge unvaccinated Americans to get their shot.
Guillain-Barré syndrome is a rare disorder "in which your body's immune system attacks your nerves," according to the Mayo Clinic, leading to "weakness and tingling" in extremities that "can quickly spread, eventually paralyzing [a person's] whole body."
Preliminary reports of Guillain-Barré syndrome were received through the Centers for Disease Control and Prevention's Vaccine Adverse Event Reporting System (VAERS). Of the 100 reported cases 95 resulted in hospitalization and one individual died, according to the FDA.
The language added to the fact sheet for healthcare providers notes that "Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination."
It also notes that "the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship," adding "no similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines."
The new warning comes after the use of Johnson & Johnson's vaccine — the third vaccine to be given emergency use authorization for vaccinating Americans against the Wuhan coronavirus — was "paused" by health officials in April over concerns of a side effect that saw a handful out of roughly seven million recipients at the time develop blood clots.
A CDC panel reviewed the evidence and ultimately lifted the pause, but not before the J&J one-shot, and COVID vaccines in general, had taken a hit to their trustworthiness.
The Johnson & Johnson/Janssen vaccine is currently approved for individuals 18-and-up.