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The Food and Drug Administration plans to warn that Johnson & Johnson’s coronavirus vaccine could lead to an increased risk of a rare neurological condition known as Guillain-Barré syndrome. Problems and a temporary security pause earlier this year, according to several people familiar with the plans.

While regulators have found the chance of developing the condition to be low, it appears to be three to five times higher among those who receive the Johnson & Johnson vaccine than in the general population in the United States, according to people familiar with the decision.

Federal officials have identified nearly 100 suspected cases of Guillain-Barré disease among Johnson & Johnson recipients. federal monitoring system relies on patients and healthcare providers to report adverse effects of vaccines. Reports are considered preliminary. Most people who develop the condition recover.

Under President Barack Obama, former acting chief scientist of the FDA, Dr. “It’s not surprising to find such vaccine-related side effects,” said Luciana Borio. Data collected so far by the FDA has suggested that the benefits of the vaccine “continue to far outweigh the risks.”

Database reports on Guillain-Barré symptoms developed approximately three weeks after inoculation. A 57-year-old Delaware recipient, who had suffered both a heart attack and stroke in the past four years, died in early April after being vaccinated and developing Guillain-Barré syndrome. database.

The Biden administration is expected to issue the new warning early Tuesday. The FDA has concluded that the vaccine’s benefits in preventing serious illness or death from coronavirus still far outweigh the risk, but plans to include this condition in drug information sheets for providers and patients. European regulators may soon follow suit. No link was found between Guillain-Barré syndrome and the coronavirus vaccines developed by two other federally authorized manufacturers, Pfizer-BioNTech or Moderna. These are based on a different technology.

About 13 million people in the United States have received the Johnson & Johnson vaccine, but 92 percent of fully vaccinated Americans have received vaccines developed by Pfizer-BioNTech or Moderna. Despite requiring only one dose, Johnson & Johnson’s vaccine was marginalized by production delays and a 10-day pause as researchers investigated whether it was linked to a rare but serious blood clotting disorder in women. This investigation also resulted in a warning added to the fact sheet.

The new security concern is emerging very quickly in the country’s fight against Covid-19. The pace of vaccines has slowed significantly, as a new, more infectious variant, called delta, spread rapidly in undervaccinated areas. Federal health officials are concerned that the news may make some people even more hesitant to accept vaccines developed by Pfizer-BioNTech or Moderna, although more than 100 million people have received these vaccines, according to the Centers for Disease Control and Prevention.

Almost a third of adults in the country are unvaccinated. The Biden administration has moved away from reliance on mass vaccination centers and is now involving community workers in door-to-door campaigns, providing doses to primary care doctors, and expanding mobile clinics to persuade the unvaccinated to accept vaccines.

Johnson & Johnson’s vaccine played a minor role in the country’s vaccine campaign, in part because its Baltimore plant, which was supposed to supply the United States with most doses, was shut down for three months due to regulatory violations. Operated by a subcontractor, Emergent BioSolutions, the factory had to discard the equivalent of 75 million doses due to suspected contamination, severely delaying deliveries to the federal government.

Demand also dropped After the April security pause. At that time, 15 women in the United States and Europe who had received the Johnson & Johnson vaccine had been diagnosed with the disease. Three of them were dead.

The regulators ultimately decided that the risk was remote and far outweighed the benefits. They added a warning to the drug and made it available, but government officials said the perception that the vaccine might be unsafe had hurt it.

Alex Gorsky, CEO of Johnson & Johnson, said last month that he was still hopeful that a vaccine would be found. Used in 27 countries So far, it will help contain the pandemic abroad. The company has promised doses up to 400 million doses to the African Union. Separately, the global vaccine sharing program Covax take hundreds of millions of doses.

Studies have shown that the Johnson & Johnson vaccine protects people against more contagious virus variants, including the Delta variant, and is highly effective in preventing severe Covid-19, hospitalizations and death.

The FDA shares its jurisdiction over vaccines with the Centers for Disease Control and Prevention, but is responsible for issuing product warnings. The Guillain-Barré cases are expected to be discussed at the upcoming meeting of a committee of outside experts advising the CDC.

The FDA has also added a warning to the Pfizer-BioNTech and Moderna vaccines, though some health officials have described it as less serious than the warnings on Johnson & Johnson. Last month, the agency warned of an increased risk of inflammation in the heart or surrounding tissue — diseases known as myocarditis and pericarditis — especially among adolescents and young adults who have received the Pfizer-BioNTech or Moderna vaccine. But the CDC said that in most cases, symptoms improve immediately after simple rest or medication.

Officials said Guillian-Barré syndrome is more likely to result in medical attention. It occurs when the immune system damages nerve cells, causing muscle weakness and the occasional paralysis. according to the FDA In the United States, several thousand people — or about 10 out of every million residents — develop the condition each year. Most recover completely from even the most severe symptoms, but in rare cases, patients can experience almost complete paralysis.

Suspected cases were reported in the Vaccine Adverse Event Reporting System or the 30-year-old VAERS. federal monitoring system. So far, researchers have not identified a specific demographic pattern, but most reports in the public database show patients being hospitalized.

Guillain-Barré syndrome has also been associated with other vaccines. The Centers for Disease Control and Prevention said flu vaccines, including the 1976 swine flu vaccine, lead to a small increase in the risk of contracting the syndrome, but some studies have suggested that people develop Guillain-Barré more often than the flu than the flu. from flu vaccines. Earlier this year, the FDA warned GlaxoSmithKline’s shingles vaccine Shingrix may also increase the risk of the disease.

Only about five million people in the US have had the Johnson & Johnson vaccine since the pause was lifted in April. The millions of doses distributed by the federal government remain unused and will expire this summer.

Apoorva Mandavilli and Carl Zimmer contributed to the reporting.