Dem Donor: Oh, I Know Obama and Pelosi Didn't Want Kamala
GOP Needs To Fight For Trump’s Nominees, Then Hold Them Accountable
Biden Pardons His Son, and the Press Begs Us to Pardon Their Coverage...
The American Tradition of the Gingerbread House Comes Alive in Bedford
Trump Should Call for a New American Patriotism
They All Share Blame for This Corrupt Administration
Why Do Conservative Politicians Move Left?
President Trump Crushed the Witch Hunts
Climate Alarmists Are More Desperate Than Ever
'Sanctuary' Leaders Vow to Resist Immigration Enforcement. This Time They Have Few Followe...
Institutions vs. We the People
Meta’s Risky Dance With Free Speech and Power
Trump Makes It Clear He's No Fan of, Vows to Block Sale of...
Adam Schiff's Past Comments on Pardons Come Back to Haunt Him
Trump Announces Quite the International Trip for This Weekend
Tipsheet

FDA Adds Warning of Rare Nerve Syndrome to Johnson & Johnson COVID Vaccine

AP Photo/Hans Pennink

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.

Advertisement

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."

Advertisement

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.

Join the conversation as a VIP Member

Recommended

Trending on Townhall Videos

Advertisement
Advertisement
Advertisement