FDA Adds Warning to J&J Vaccine Over Very Rare Side Effect

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  • Guillain-Barré syndrome is a very rare side effect known to occur after other infections and vaccinations.
  • There have been 100 reports of Guillain-Barré syndrome out of the 12.8 million people who have been vaccinated with the one-dose Johnson & Johnson (J&J) vaccine.
  • Health experts widely agree that the benefits of receiving the Johnson & Johnson far outweigh the risks.

The Food and Drug Administration (FDA) is issuing a new warningTrusted Source for the Johnson & Johnson shot suggesting an increased risk of Guillain-Barré syndrome, an autoimmune reaction in which the immune system attacks the nervous system.

There have been 100 reports of Guillain-Barré syndrome out of the 12.8 million people who have been vaccinated with the one-dose Johnson & Johnson vaccine.

Most of the cases occurred in men over the age of 50 around 2 weeks after being vaccinated.

Most people who develop Guillain-Barré syndrome recover successfully after being treated in the hospital.

Health experts widely agree that the benefits of receiving the Johnson & Johnson vaccine far outweigh the risks.

People who have a history of Guillain-Barré syndrome and want to receive a COVID-19 vaccine should talk with their doctor, as there are two other vaccines — Pfizer and Moderna — to choose from.

What is Guillain-Barré syndrome?

Guillain-Barré syndrome, or GBS, is an autoimmune reaction in which the immune system mistakenly attacks the nerves.

The symptoms begin with a tingling, numbing sensation in the feet that quickly travels up the body. In rare cases, it can cause paralysis.

“Another sign of GBS is a loss of reflexes, which is usually tested by a neurologist. It can be potentially dangerous since weakness in the diaphragm can lead to difficulty breathing,” said Dr. Huma Sheikh, a board certified neurologist and assistant professor at Icahn School of Medicine at Mount Sinai.

Guillain-Barré syndrome is a very rare side effect known to occur after other infections, like influenza, gastrointestinal infections, and other respiratory infections. It can also occur after vaccinations, such as the flu shot and pneumococcal vaccine.

Each year, about 3,000 to 6,000 people develop Guillain-Barré syndrome.

“It occurs when the body confuses a protein on the nerves sheath (covering of the nerve) with a similar protein on a virus or vaccine and begins to attack it,” Sheikh said.

Most people who develop Guillain-Barré syndrome recover, though some may experience lingering pain and weakness.

Treatment typically involves being hospitalized and receiving an infusion of immunoglobulins to calm the immune system’s reaction.

Another procedure called plasmapheresis can remove the antibodies that are formed by the immune system.ADVERTISEMENT

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What’s the link between the Johnson & Johnson shot and Guillain-Barré syndrome?

Two people developed Guillain-Barré syndrome in the Johnson & Johnson clinical trial — one of the patients received the placebo injection and the other received an active vaccine.

The researchers said there was insufficient evidence to determine a causal relationship between the Johnson & Johnson shot and Guillain-Barré syndrome.

Since then, about 100 cases of Guillain-Barré syndrome out of 12.8 million Johnson & Johnson vaccine doses have been reported. Most of the patients were men over age 50. The patients developed the illness about 2 weeks after vaccination.

“It’s a side effect of activating the immune system; it’s not entirely clear why it happens in a few people but not the large majority who are vaccinated,” Dr. Eric Cioe-Peña, the director of global health with Northwell Health in New Hyde Park, New York, said.

Cioe-Peña said this information should guide every patient in making an informed decision.

The benefits of the shot outweigh the risks

Officials from the FDA state that the benefits of the Johnson & Johnson shot outweigh the potential risks.

Guillain-Barré syndrome after vaccination is extremely rare, and the shot provides strong protection against severe illness and death.

“This is a known side effect of other vaccines, and the benefits still far outweigh risk,” Cioe-Peña said.

If you have a history of Guillain-Barré syndrome, there are two other vaccines to choose from — Moderna and Pfizer.

There is no known link between these mRNA vaccines and Guillain-Barré syndrome.

“The benefits of the J&J shot are many, many times the risk of getting any of the known side effects,” Cioe-Peña added.

Scientists will continue to track the occurrence of Guillain-Barré syndrome in recently vaccinated individuals.

“Observational studies showing the rates of Guillain-Barré syndrome with the Johnson & Johnson vaccine are important, as well as trying to figure out which part of the vaccine triggers the immune response that leads to Guillain-Barré syndrome,” said Sheikh.

The bottom line 

The FDA is issuing a new warning for the Johnson & Johnson shot suggesting that it is linked to an increased risk of Guillain-Barré syndrome, an autoimmune reaction in which the immune system attacks the nervous system.

The side effect is extremely rare — just 100 people have reported the reaction out of the 12.8 million people who have received the J&J shot.

Health experts say the benefits of the J&J shot far outweigh the risks, but people who have a history of Guillain-Barré syndrome should talk with their doctor, as there are two other great shots to choose from.

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