Johnson & Johnson’s beleaguered COVID-19 vaccine could also be related to a small elevated threat of Guillain-Barré syndrome, a uncommon however doubtlessly critical neurological situation, federal officers stated Monday. The Food and Drug Administration has added a warning about the potential side effect to its truth sheets concerning the vaccine.
The threat seems to be very small. So far, there have been 100 studies of the syndrome in individuals who had acquired the Johnson & Johnson vaccine. Nearly 13 million doses of the vaccine have been administered within the United States.
Here are solutions to some widespread questions concerning the syndrome and its connection to vaccination.
What is Guillain-Barré syndrome?
Guillain-Barré is a uncommon situation during which the physique’s immune system assaults nerve cells. It could cause muscle weak spot and paralysis. Although the signs typically go inside weeks, in some instances, the situation could cause everlasting nerve injury. In the United States, there are sometimes 3,000 to 6,000 instances of the syndrome per 12 months, in accordance to the Centers for Disease Control and Prevention. It is commonest in adults over 50.
The exact explanation for the syndrome is unknown, however in lots of instances the situation follows one other sickness or an infection, such because the flu. It has additionally been reported in folks with COVID-19.
What does it have to do with vaccination?
This shouldn’t be the primary vaccine that has been linked to Guillain-Barré, though the danger seems to be tiny. A big swine flu vaccination marketing campaign in 1976 led to a small uptick within the incidence of syndrome; the vaccine brought about roughly one further case of Guillain-Barré for each 100,000 folks vaccinated. The seasonal flu shot is related to roughly one to two extra instances for each 1 million vaccines administered.
“I think the data are pretty compelling that the flu vaccine causes Guillain-Barré syndrome, but it’s a very small risk,” stated Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University.
The shingles vaccine Shingrix may additionally improve the danger of the situation.
It shouldn’t be fully clear why some vaccines might trigger Guillain-Barré. “We don’t really understand the biological mechanism,” Salmon stated. “It’s an incredible frustration.”
What can we know about its connection to the COVID-19 vaccines?
One hundred studies of the syndrome after vaccination with the Johnson & Johnson shot have been submitted to the federal Vaccine Adverse Event Reporting System (VAERS), officers stated Monday. Of these, 95 instances resulted in hospitalization, and one was deadly.
The syndrome was usually reported about two weeks after vaccination, primarily in males, lots of whom had been 50 or older, officers stated. There shouldn’t be but sufficient proof to set up that the vaccine causes the situation, however the FDA will proceed to monitor the scenario, the company famous in a press release.
There shouldn’t be but any information to recommend a hyperlink between the situation and COVID vaccines made by Pfizer-BioNTech or by Moderna, which depend upon a unique know-how, the FDA stated.
What indicators and signs ought to I look out for?
The syndrome is almost certainly to seem inside 42 days of vaccination, the FDA notes in its revised truth sheet for sufferers. You ought to seek the advice of with a physician if you start to expertise weak spot or tingling in your arms and legs, double imaginative and prescient or issue strolling, talking, chewing, swallowing, or controlling your bladder or bowels.
Should I nonetheless get a COVID-19 vaccine?
If the hyperlink between the vaccine and Guillain-Barré is actual, it seems to be far outweighed by the dangers of COVID-19, consultants stated. In the United States, nearly all hospitalizations and deaths from COVID-19 are taking place in those that are unvaccinated, the CDC stated in a press release. The company recommends that everybody who’s 12 or older be vaccinated.
“Everything has risks,” Salmon stated. “And the key to decision-making is to optimize the benefits and reduce the risks.” He added, “COVID is a pretty nasty disease that’s killed 600,000 people.”