U.S. health officials are issuing a new warning about the rare neurological reaction of people receiving the Johnson & Johnson unique vaccine.
U.S. regulators have added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction.
The Food and Drug Administration (FDA) announced the new warning on Monday, marking reports of Guillain-Barre syndrome, an immune system disorder that can cause muscle weakness and occasional paralysis. Health officials described the side effect as a “small possible risk” for those receiving the strike.
The new warning will be included in brochures given to people receiving the Johnson & Johnson shot. Regulators should seek medical attention if they experience symptoms such as tingling sensations, trouble walking, and double vision.
The action comes after the FDA and the Centers for Disease Control and Prevention (CDC) reviewed reports of nearly 100 people developing the syndrome after receiving the single-dose vaccine. The FDA said almost all were hospitalized and one person died.
Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that is usually temporary. According to the CDC, it is estimated that every year in the United States there is a syndrome of 3,000 to 6,000 people who develop the syndrome.
The number of cases reported in connection with the Johnson & Johnson vaccine represents a small fraction of the nearly 13 million people in the U.S. who have received the sting. Most cases were recorded in men (mostly those who were 50 years or older) and usually two weeks after vaccination.
Johnson & Johnson said in a statement that it has been discussing reports with the FDA and other health regulators around the world.
The CDC said it would ask its group of external vaccination experts to review the issue at an upcoming meeting.
The government said the most widely used vaccines in the United States, made by Pfizer and Moderna, do not show a risk of developing the disorder after the administration of more than 320 million doses.
Historically, vaccines offer broad protection with little risk, but they do have 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 cannot rule out extremely rare side effects.
The CDC and the FDA have been monitoring reports of side effects submitted by doctors, drug manufacturers and patients to a federal vaccine safety database.
Guillain-Barre can be triggered by several infections, including the flu, cytomegalovirus, and Zika virus. But there have been rare cases where people develop the disorder days or weeks after receiving certain vaccines.
Johnson & Johnson’s vaccine was highly anticipated because of its “complete” formulation and easy-to-ship refrigeration. But at first, it was linked to another rare risk: blood clots, and the company has not been able to produce everything that was expected due to problems at a Baltimore factory that helps make the shots.
The news comes as demand for COVID vaccines in the U.S. continues to decline, as only about 430,000 shots are administered per day. The maximum seven-day average was about 3.5 million, in April.
Cases are rising rapidly in the low-vaccinated states of the southwest and southwest of the country, with the highly contagious delta variant now dominant.