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U.S. health officials are issuing a new warning about a rare neurological reaction in people receiving the Johnson & Johnson single-injection vaccine.
U.S. regulators have added a new warning to Johnson & Johnson’s COVID-19 vaccine regarding links to a rare and potentially dangerous neurological reaction.
The Food and Drug Administration (FDA) announced the new warning on Monday, signaling reports of Guillain-Barre syndrome, an immune system disorder that can cause muscle weakness and sometimes paralysis. Health officials have described the side effect as a “possible small risk” for those who get the vaccine.
The new warning will be included in brochures given to people who get shot by Johnson & Johnson. They should see a doctor if they experience symptoms, including tingling sensations, difficulty walking and double vision, regulators said.
The action comes after the FDA and the Centers for Disease Control and Prevention (CDC) examined reports of around 100 people developing the syndrome after receiving the single-dose vaccine. Almost all of them were hospitalized and one person has died, the FDA said.
Guillain-Barré syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis which is usually temporary. An estimated 3,000 to 6,000 people in the United States develop the syndrome each year, according to the CDC.
The number of reported cases related to the Johnson & Johnson vaccine is a tiny fraction of the nearly 13 million people in the United States who have received the vaccine. Most cases have been reported in men – mainly those aged 50 and over – and usually around two weeks after vaccination.
Johnson & Johnson said in a statement that it is discussing relationships with the FDA and other health regulators around the world.
The CDC said it would ask its group of external vaccine experts to consider the matter at a future meeting.
The government has said the most widely used vaccines in the United States, manufactured by Pfizer and Moderna, pose no risk of disease after more than 320 million doses have been administered.
Vaccines historically offer 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 United States have each been tested in tens of thousands of people, but even such huge studies cannot rule out extremely rare side effects.
The CDC and the FDA monitor side effect reports submitted by physicians, drug makers, and patients to a federal vaccine safety database.
Guillain-Barre can be triggered by a number of infections, including influenza, cytomegalovirus, and Zika virus. But there have been rare cases in which people develop the disorder days or weeks after receiving certain vaccines.
Johnson & Johnson’s vaccine was eagerly awaited due to its one-and-done formulation and easy-to-ship refrigeration. But early on, it was linked to another rare risk – blood clots – and the company was unable to produce as much as expected due to problems at a Baltimore plant that helps make the shots.
The news comes as demand for COVID vaccines in the United States continues to decline, with only about 430,000 injections per day. The maximum seven-day average was around 3.5 million in April.
Cases are increasing rapidly in the under-vaccinated states of the Midwest and South of the country, with the highly contagious Delta variant now dominant.
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