FDA to add waning label to J&J shot

July 12, 2021

The FDA is planning to add a warning label to J&J’s COVID-19 vaccine about the risk of a rare neurological condition.

According to a report in the Wall Street Journal, the agency said that the warning will pertain to Guillain-Barre syndrome, a known risk with other vaccines such as influenza and shingles shot. Guillain-Barre, which can also be triggered by common viruses and bacteria infections, causes the body’s immune system to mistakenly attack nerves and in severe cases, can lead to paralysis. So far, the estimated rate of contracting the condition is about three-five cases per one million J&J shots administered. In the general public, the rate is about 1 in one million.

Federal officials said that AstraZeneca’s shot, which is also an adenovirus vector vaccine, has been linked to an increased risk of Guillain-Barre, but it has not been approved for use in the U.S.

The warning label could be another struggle in J&J’s rollout of the shot, which was paused in April while the CDC and FDA investigated instances of rare blood clots associated with the vaccine.

Last month, the FDA also announced plans to add a warning label to the COVID-19 vaccines made by Moderna and Pfizer due to increased chances of developing a rare heart condition.