The US Food and Drug Administration will attach the warning of rare neurological syndrome to the Johnson & Johnson vaccine

[ad_1]

The Food and Drug Administration plans to warn that Johnson & Johnson’s coronavirus vaccine could increase the risk of developing a rare neurological condition known as Guillain-Barré syndrome, another setback for a vaccine that has been largely sidelined in the United States due to manufacturing problems and a temporary safety shutdown. earlier this year, according to several people familiar with the plans.

Although regulators have found the chances of contracting the condition low, it appears to be three to five times higher among Johnson & Johnson vaccine recipients than 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 dose recipients through a federal monitoring system that relies on patients and health care providers to report adverse effects of vaccines. Reports are preliminary. Most people who develop this condition recover.

The Food and Drug Administration has concluded that the benefits of the vaccine in preventing severe illness or death from the coronavirus still far outweigh any risk, but it plans to include the requirement in fact sheets about the drug for providers and patients.

“It is not surprising to find these kinds of adverse events associated with vaccination,” said Dr. Luciana Borio, a former acting chief scientist at the Food and Drug Administration under President Barack Obama. She added that data collected by the Food and Drug Administration so far indicates that the benefits of the vaccine “continue to greatly outweigh the risks.”

In a statement issued on Monday, the Centers for Disease Control and Prevention said, cases were reported largely about two weeks after vaccination, mostly in males, many of whom are aged 50 and over.

The database reports that Guillain-Barré’s symptoms developed within three weeks of vaccination. One of the recipients, a 57-year-old man from Delaware who had had a heart attack and stroke within the past four years, died in early April after being vaccinated with Guillain-Barré syndrome, according to a report submitted to 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 approved manufacturers. These are based on a different technology.

Nearly 13 million people in the United States have received the Johnson & Johnson shot, but 92 percent of fully vaccinated Americans have received shots developed by Pfizer-BioNTech or Moderna. Although it only requires a single dose, the Johnson & Johnson vaccine has been sidelined by 10-day manufacturing delays and downtime while researchers studied whether it was linked to a rare but serious disorder of blood clotting in women. This investigation also led to the addition of a warning to the fact sheet.

The new concern for safety comes at a critical moment in the nation’s fight against Covid-19. The pace of vaccinations has slowed dramatically as a new, more contagious type called delta spreads rapidly in unvaccinated areas. Federal health officials are concerned that the news may make some people more reluctant to accept vaccines developed by Pfizer-BioNTech or Moderna, even though more than 100 million people have received them, according to the Centers for Disease Control and Prevention.

updated

July 12, 2021, 2:12 PM ET

Nearly a third of the country’s adults remain unvaccinated. The Biden administration has shifted away from relying on mass vaccination sites and is now recruiting community workers for door-to-door campaigns, providing doses to primary care physicians and expanding mobile clinics in an effort to persuade the unvaccinated to accept the injections.

The Johnson & Johnson vaccine has played a minor role in the country’s vaccination campaign in part because the Baltimore plant that was supposed to supply most doses to the US has been closed for three months due to regulatory violations. The plant, operated by Emergent BioSolutions, a subcontractor, has been forced to dispose of the equivalent of 75 million doses due to suspected contamination, severely delaying deliveries to the federal government.

Demand for the shot also fell after the safety halt in April. At the time, 15 women in the United States and Europe had been diagnosed with the disorder. Three of them died.

Regulators eventually decided the risks were remote and the benefits far outweighed them. They attached a warning to the drug and released it for use, but state officials said the perception that the vaccine might be unsafe was hurting it.

Alex Gorsky, CEO of Johnson & Johnson, said last month that he remains hopeful that the vaccine, which has been used in 27 countries so far, will help contain the epidemic abroad. The company promised to provide 400 million doses to the African Union. Separately, Covax, the global vaccine sharing program, is supposed to receive hundreds of millions of doses.

Studies have shown that the Johnson & Johnson dose protects people from more infectious virus variants, including the delta variant, and is highly effective in preventing severe Covid-19, hospitalization and death.

The Food and Drug Administration shares jurisdiction over vaccines with the Centers for Disease Control and Prevention but is responsible for issuing product warnings. Guillain-Barré’s issues are expected to be discussed at an upcoming meeting of the panel of outside experts advising the CDC

The FDA also included a warning for the Pfizer-BioNTech and Moderna vaccines, but some health officials called this less serious than warnings about Johnson & Johnson. Last month, the agency warned of an increased risk of developing inflammation of the heart or surrounding tissues — diseases known as myocarditis and pericarditis — especially among teens and young adults who received Pfizer-BioNTech or Moderna injections. But the CDC said that in most cases, symptoms improved immediately after simple rest or treatment.

Officials said Guillian-Barré syndrome is likely to lead to medical intervention. It occurs when the immune system damages nerve cells, causing muscle weakness and occasional paralysis. According to the U.S. Food and Drug Administration, several thousand people — or roughly 10 out of every million people — develop the condition each year in the United States. He fully recovers from even the most severe symptoms, but in rare cases patients can experience almost complete paralysis.

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 several 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, slightly increased the risk of developing the syndrome, although some studies have indicated that people are more likely to get Guillain-Barré from the flu itself. of influenza vaccines. Earlier this year, the U.S. Food and Drug Administration warned that GlaxoSmithKline’s shingles vaccine, Shingrix, may also increase the risk of the disease.

Only about five million people in the US have picked up the Johnson & Johnson shot since the suspension was lifted in April. Millions of doses distributed by the federal government are not being used and will expire this summer.

Apoorva Mandavilli and Carl Zimmer contributed to this report.

[ad_2]