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FDA to attach Guillain-Barré syndrome warning to Johnson & Johnson vaccine

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The Food and Drug Administration plans to warn that Johnson & Johnson’s coronavirus vaccine may lead to an increased risk of a rare neurological disease known as Guillain-Barré syndrome, another setback for a vaccine that has been largely set aside in the United States.

Although regulators have found that the chances of developing the disease are low, they appear to be three to five times higher in recipients of the Johnson & Johnson vaccine than among the general population in the United States, according to people familiar with the decision. .

Federal authorities have identified around 100 suspected cases of Guillain-Barré disease among Johnson & Johnson vaccine recipients through a federal surveillance system that relies on patients and healthcare providers to report vaccine adverse reactions. Reports are considered preliminary. Most people who develop the disease recover.

The FDA has concluded that the vaccine’s benefits in preventing serious illness or death from the coronavirus still far outweigh any danger, but it plans to include the reservation in drug fact sheets for providers. and patients.

“It’s not surprising to find these types of adverse events associated with vaccination,” said Dr. Luciana Borio, former acting chief scientist of the FDA under President Barack Obama. Data collected so far by the FDA, she added, suggests that the benefits of the vaccine “continue to far outweigh the risks.”

In a statement released Monday, the Centers for Disease Control and Prevention said the cases were widely reported around two weeks after vaccination and primarily in men, many of whom are 50 years of age and older.

Reports from the database indicate that Guillain-Barré’s symptoms developed within three weeks of vaccination. One recipient, a 57-year-old man from Delaware 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, according to a report deposited in the database.

The Biden administration is expected to announce the new warning as early as Tuesday. European regulators may soon follow suit. No link has been found between Guillain-Barré syndrome and coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally licensed manufacturers. These are based on different technology.

Almost 13 million people in the United States have received the Johnson & Johnson vaccine, but 92% of Americans who have been fully vaccinated have received vaccines developed by Pfizer-BioNTech or Moderna. Even though it only requires a single dose, Johnson & Johnson’s vaccine has been marginalized by manufacturing delays and a 10-day hiatus as investigators study whether it is linked to a rare blood clotting disorder. but serious in women. This investigation also resulted in a warning added to the fact sheet.

The new security issue comes at a rushed time in the country’s fight against Covid-19. The pace of vaccinations has slowed dramatically as a new, more contagious variant called Delta is spreading rapidly in under-vaccinated areas. Federal health officials fear the news will make some people even more hesitant to accept vaccines developed by Pfizer-BioNTech or Moderna, even though more than 100 million people have received these vaccines, according to the Centers for Disease Control and Prevention .

Almost a third of the country’s adults are still not vaccinated. The Biden administration has stopped relying on mass vaccination sites and is now recruiting community workers in door-to-door campaigns, providing doses to primary care doctors and expanding mobile clinics in an attempt to convince the unvaccinated to accept vaccines.

Johnson & Johnson’s vaccine played a minor role in the country’s inoculation campaign in part because the Baltimore plant that was supposed to provide most of the doses in the United States was shut down for three months due to violations of the regulations. The plant, operated by Emergent BioSolutions, a subcontractor, was forced to throw away the equivalent of 75 million doses due to suspected contamination, significantly delaying deliveries to the federal government.

Demand for the shot also fell after the April safety break. By that time, 15 women in the United States and Europe who had received the Johnson & Johnson vaccine had been diagnosed with the disease. Three were dead.

Regulators ultimately decided that the risk was low and outweighed by the benefits. They attached a warning to the drug and cleared it for use, but state officials said the perception that the vaccine might be dangerous hurt him.

Alex Gorsky, chief executive of Johnson & Johnson, said last month he still hopes the vaccine, which has been used in 27 countries so far, would help contain the pandemic overseas. The company has pledged up to 400 million doses to the African Union. Separately, Covax, the global vaccine sharing program, is said to receive hundreds of millions of doses.

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

The FDA shares 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 an upcoming meeting of a committee of external experts who advise the CDC

The FDA also attached a warning to the Pfizer-BioNTech and Moderna vaccines, but some health officials described it as less serious than the warnings for Johnson & Johnson. Last month, the agency warned of an increased risk of inflammation of the heart or the tissues around it – diseases known as myocarditis and pericarditis – especially in adolescents and young adults who had received Pfizer-BioNTech or Moderna injections. But the CDC said that in most cases, symptoms improved quickly after simple rest or medication.

Guillian-Barr̩ syndrome is more likely to result in medical intervention, officials said. It occurs when the immune system damages nerve cells, causing muscle weakness and occasional paralysis, according to the FDA. Several thousand people Рor about 10 in a million people Рdevelop the disease each year in the United States. Most recover completely from the more severe symptoms, but in rare cases, patients may experience near total paralysis.

The suspected cases were reported to the Vaccine Adverse Event Reporting System, or VAERS, a 30-year-old federal surveillance system. So far, researchers have not identified any particular demographic pattern, but numerous reports in the publicly available database indicate that patients have been hospitalized.

Guillain-Barré syndrome has also been linked to other vaccines. The Centers for Disease Control and Prevention said influenza vaccines, including the 1976 swine flu vaccine, had a slight increased risk of getting the syndrome, although some studies suggest people are more likely to develop Guillain-Barré from the flu itself as flu shots. Earlier this year, the FDA warned that GlaxoSmithKline’s shingles vaccine, Shingrix, could also increase the risk of the disease.

In the United States, only about five million people have taken the Johnson & Johnson photo since the April hiatus was lifted. Millions of doses that have been distributed by the federal government are unused and will expire this summer.

Apoorva Mandavilli and Carl Zimmer contributed reporting.