The CDC and FDA Just Issued a Warning About a New Delayed Vaccine Side Effect
A new concerning side effect has been potentially linked to the Johnson & Johnson vaccine.
The Johnson & Johnson COVID vaccine has faced its fair share of issues, from the potential of causing blood clots to its lower efficacy rate. Now, officials are saying the one-dose regimen could also have another new concerning side effect. On Monday, July 12, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) released a new warning about a potential reaction to the Johnson & Johnson vaccine that's cropped up among a certain demographic, weeks after they've gotten the shot.
The FDA updated the label for the Johnson & Johnson COVID vaccine to warn of the possible increased risk of Guillain-Barré syndrome. "Today, the FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination," the agency said in a statement sent to CNN.
According to the Mayo Clinic, Guillain-Barré syndrome is a "rare disorder in which your body's immune system attacks your nerves." The first symptom of the disease is often weakness and tingling in your extremities. The illness can lead to muscle weakness and sometimes paralysis, but the vast majority of patients recover.
The updated label on the Johnson & Johnson vaccine reads: "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."
The CDC said in a statement to the Associated Press that it has received reports that 100 people who got the Johnson & Johnson vaccine developed Guillain-Barré syndrome. While this is only a tiny fraction of the almost 13 million people in the U.S. who have received the Johnson & Johnson vaccine, it's still notable. The AP reports that most of the cases of Guillain-Barré syndrome following Johnson & Johnson inoculation were seen two weeks later in men over 50 years old. But as the FDA warning notes, it could show up as much as six weeks later.
Interestingly, in the spring, shortly after the Johnson & Johnson vaccine was granted emergency use authorization from the FDA, there were increased anecdotal reports of numbness and tingling in the hands and fingers. In a case study published in April in the journal Neurology, scientists examined an instance of a 60-year-old woman who received the Johnson & Johnson vaccine during a Dec. 2020 trial and developed Guillain-Barré syndrome, but recovered.
"The case in our report may have been a coincidence," Anthony Amato, MD, a neurologist at Harvard Medical School in Boston and lead author of the case study, told HealthDay at the time. "With approximately one billion people worldwide expected to be vaccinated against COVID-19, we anticipate there could be thousands of cases of Guillain-Barré syndrome that will occur around the time of the vaccination only by coincidence. Based on experience with other vaccination initiatives and the data in the adverse monitoring systems of the COVID-19 vaccines gathered so far, we are certain that the benefits of vaccination outweigh the risks of COVID-19 infection."
According to the AP, the CDC said the other COVID vaccines in the U.S. don't show a risk of causing Guillain-Barré syndrome. In December, the CDC's guidelines on COVID vaccines, which only included Pfizer and Moderna at that point, read: "To date, no cases of Guillain-Barre syndrome (GBS) have been reported following vaccination among participants in the mRNA COVID-19 vaccine clinical trials," referring to Pfizer and Moderna. "With few exceptions, the independent Advisory Committee on Immunization Practices (ACIP) general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines," the agency said. Of course, Johnson & Johnson was not yet approved for emergency use.
The Washington Post reports that the CDC's ACIP plans to discuss the potential link between Guillain-Barré syndrome and the Johnson & Johnson vaccine at an upcoming meeting.
The CDC says an estimated 3,000 to 6,000 people develop Guillain-Barré syndrome each year. It can be triggered by various infections such as flu, cytomegalovirus, and Zika virus. However, there have also been cases where people develop the disease after receiving some vaccines.