Sumary of FDA adds warning about rare reaction to JJ COVID-19 vaccine:
- Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it’s not entirely clear the shot caused the problem.
- The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis.
- Health officials described the side effect as a “small possible risk” for those getting the shot.
- The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine.
- J&J said in a statement it has been discussing the reports with the FDA and other health regulators around the world.
- The government said the vaccines most used in the U.S., made by Pfizer and Moderna, show no risk of the disorder after more than 320 million doses have been administered.
- Vaccines historically provide broad protection with little risk but come with occasional side effects just like other drugs and medical therapies.
- The three COVID-19 vaccines used in the U.S. were each tested in tens of thousands of people, but even such huge studies can’t rule out extremely rare side effects.