FDA Adds Nerve Disease Warning to Johnson & Johnson COVID-19 Vaccine

The Food and Drug Administration added a warning to the fact sheet for the Johnson & Johnson COVID-19 vaccine saying the vaccine may lead to an increased risk of a nerve disease called Guillain-Barré syndrome. The agency says the benefits of the vaccine always outweigh the risks.

About 100 cases of the syndrome have been reported among the approximately 12.6 million people who have received the Johnson & Johnson vaccine, the Centers for Disease Control and Prevention said in a statement. at The Washington Post. It’s a very rare complication, but the people who have been hit seem to be around 3-5 times more likely to develop Guillain-Barré syndrome than the general population.

There is no sign that Moderna or Pfizer / BioNTech vaccines carry a similar risk.

In Guillain-Barré syndrome, the body’s immune system attacks the nerves. This can cause tingling in the hands and feet, weakness, and problems with coordination. Most people make a full recovery, but it can lead to permanent nerve damage in some cases.

The syndrome has been linked to vaccines in the past. United States stopped using a swine flu vaccine in 1976 after reports that people who took the vaccine developed Guillain-Barré. Some years ago a small increased risk of the syndrome with the seasonal flu vaccine – usually about one or two more cases for every million flu shots given. The CDC notes that people may be more likely to develop Guillain-Barré from the flu than from the flu shot.

This is the second health risk associated with the Johnson & Johnson vaccine. Recommended U.S. Health Agencies suspend administration suddenly in April after he was linked to a rare bleeding disorder. The company added a warning about the risk of trouble and the hiatus was lifted after 10 days.

The agencies did not recommend a break on the vaccine this time around. The vaccine remains available and will simply carry an additional warning label. In the United States, people also have access to Moderna and Pfizer / BioNTech vaccines.

Experts were hoping the Johnson & Johnson vaccine would play a major role in the US vaccination campaign because it only takes one dose, instead of the two doses needed for Moderna or Pfizer / BioNTech. So far it has been administered to less than 10 percent of people vaccinated in the United States.

The number of people vaccinated daily in the United States fell to about 500,000, from a peak of about 3 million in April. The number of COVID-19 cases has started climbing again while the Delta variant is settling across the country.