New warning outlined for J&J’s COVID vaccine
CDC: Small risk of contracting neurological disorder
Federal regulators Monday announced additional warnings for providers and recipients of Johnson & Johnson’s COVID-19 vaccine about an observed increased risk of a rare neurological disorder known as GuillainBarré syndrome.
The new reports — while rare and considered still preliminary — are another setback for the single-shot vaccine that was temporarily halted in use in
April over concerns about rare instances of potentially deadly blood clots.
Here’s what you should know about the latest risk.
Q
How many people have had the J&J vaccine compared with the others by Pfizer and Moderna?
A
Across the U.S., 12.7 million have had the J&J shot. In California, it’s about 1.6 million. Nationally, about
147 million people have been vaccinated with the two-dose vaccines, including 18.6 million in California.
Q What is GuillainBarré syndrome? A
According to the U.S. Centers for Disease Control and Prevention, Guillain-Barré syndrome, often referred to as GBS, is a rare disorder in which a person’s immune system damages the nerves, causing muscle weakness and sometimes paralysis. Symptoms can last for a few weeks to several years. Q
How common is Guillain-Barré syndrome? A
According to the CDC, it affects only about 1 in 100,000 people, with an estimated 3,0006,000 people developing the syndrome each year in the United States, where it is more common in men and adults older than 50. Q
How dangerous is it?
A
The CDC says most people recover fully, but some have permanent nerve damage, and people have died from it.
Q
What causes GuillainBarré syndrome? A
While its cause is not fully understood, Guillain-Barre syndrome often follows infection with a virus or bacteria, including influenza, cytomegalovirus, EpsteinBarr virus and Zika virus, as well some vaccines, including for the flu, according to the CDC. But most commonly it is associated with an infection with Campylobacter jejuni, the leading cause of diarrhea. The CDC says 40% of GBS cases follow Campylobacter illness, with about 1 in 1,000 of Campylobacter cases leading to GBS.
Q
What’s the risk from the Johnson & Johnson COVID-19 vaccine?
A
The U.S. Food and Drug Administration says it was analyzing 100 preliminary reports of Guillain-Barré syndrome following vaccination with the Johnson & Johnson shot after about 12.5 million
doses had been administered across the U.S.; 95 were serious enough to require hospitalization. There was one reported death. The accounts were reported by doctors and patients in what’s known as the Vaccine Adverse Event Reporting database, which serves as an early warning system for potential vaccine-related problems. The New York Times reported that the rate of GBS appears to be several times higher among recipients of the Johnson & Johnson vaccine than among the general U.S. population.
Q
Is the risk just with Johnson & Johnson’s COVID-19 vaccine?
A According to reports, Guillain-Barré syndrome also has been reported following the AstraZeneca COVID-19 vaccine, which is used in Europe but not the U.S. and uses similar technology to Johnson & Johnson’s shot. The FDA said no similar link to GuillainBarré syndrome has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines, which use a newer and different messenger-RNA technology. The FDA, however, has previously added warnings of a likely link to rare heart inflammation particularly in young men and teens after those mRNA vaccines.
Q
I had the J&J shot — what symptoms should I be concerned about?
A
The FDA says vaccine recipients should seek medical attention right away if they develop any of the following symptoms within 42 days after receiving the J&J COVID-19 vaccine: weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function.
Q I had the J&J shot months ago. How long do I need to worry?
A The FDA fact sheet indicates symptoms appeared within 42 days,
and the CDC says cases have largely been reported about two weeks after vaccination. Daniel Salmon, a professor of public health at Johns Hopkins University and director of the Institute for Vaccine Safety, who has studied the Guillain-Barré syndrome link to flu vaccines, said most cases following the 2009 flu shots appeared within 7-21 days.
“Based on that experience,” Salmon said, “if you got the vaccine a long time ago, I wouldn’t worry about it.”
Q
Is Guillain-Barré syndrome associated with other vaccines or illnesses?
A The CDC says there was a small increased risk of Guillain-Barré syndrome after the swine flu vaccination in 1976, about one additional case for every 100,000 people vaccinated. The FDA says it also has been linked to a shingles vaccine. The CDC monitors for GBS every flu season and says that while the risk varies season to season, even at elevated risk it ranges from 1-2 additional cases per million flu vaccine doses administered.
The CDC says studies suggest the risk of GBS is higher from getting the flu than the flu vaccine.
Q
Isn’t this the second problem linked to the J&J shot? Why is it still being offered?
A
The FDA and CDC in April advised a 10day suspension in giving the J&J shots after reports of rare instances of potentially deadly blood clots but has since resumed administration of the vaccines with a warning of the risk. The FDA said Monday that although the available evidence suggests an association between the J&J vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. The FDA said it has evaluated the available information for the J&J COVID-19 vaccine “and continues to find the known and potential benefits clearly outweigh the known and potential risks.” The company said in a statement Monday that “the chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree.”