The Food and Drug Administration plans to warn that Johnson & Johnson’s coronavirus vaccine may lead to an increased risk of a rare neurological condition known as Guillain-Barré syndrome, another setback for a vaccine used in the United States has been largely marginalized due to manufacturing issues and a temporary security hiatus earlier this year, according to several people familiar with the plans.
Although regulators have found the chances of developing the disease are slim, recipients of the Johnson & Johnson vaccine appear to be three to five times higher than the general population in the United States, according to the decision trusted people.
Federal officials have identified approximately 100 suspected cases of Guillain-Barré disease among recipients of the Johnson & Johnson shot through a federal surveillance system that relies on patients and healthcare providers to report vaccine side effects. The 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 the risk, but plans to include the reservation in fact sheets about the drug for providers and patients
“It is not surprising that these types of vaccination-related adverse events are found,” said Dr. Luciana Borio, a former acting FDA chief scientist under President Barack Obama. The data collected so far by the FDA indicated 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 mainly reported around two weeks after vaccination and mostly in men, many aged 50 and over.
The database reports indicate that symptoms of Guillain-Barré Developed within about three weeks of vaccination. A recipient, a 57-year-old Delaware man who had suffered both a heart attack and a stroke for the past four years, died in early April after being vaccinated and developing Guillain-Barré syndrome, according to one to the Database.
The Biden administration is expected to announce the new warning on Tuesday. The European regulators could soon follow suit. No association was found between Guillain-Barré Syndrome and the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two government-approved manufacturers. These rely on a different technology.
Nearly 13 million people in the United States received the vaccination from Johnson & Johnson, but 92 percent of Americans who were fully vaccinated received vaccinations developed by Pfizer-BioNTech or Moderna. Although only one dose is required, Johnson & Johnson’s vaccine was marginalized by manufacturing delays and a 10-day hiatus while investigators investigated whether it was linked to a rare but serious bleeding disorder in women. This investigation also resulted in a warning that was added to the data sheet.
The new security concern comes at a steep moment in the nation’s fight against Covid-19. The pace of vaccination has slowed significantly, while a new, more contagious variety called Delta is spreading rapidly in undervaccinated areas. Federal health officials are concerned that the news may make some people even more reluctant to accept vaccines developed by Pfizer-BioNTech or Moderna, even though well over 100 million people have received these vaccines, according to the Centers for Disease Control and Prevention.
Updated
July 12, 2021, 2:12 p.m. ET
Almost a third of the country’s adults remain unvaccinated. The Biden government has moved away from reliance on mass vaccination centers and is now engaging community workers in door-to-door campaigns, supplying general practitioners with doses, and expanding mobile clinics to convince the unvaccinated to accept vaccinations.
The Johnson & Johnson vaccine has played a minor role in the country’s vaccination campaign, in part because the Baltimore plant, which was supposed to ship most of the doses to the United States, was shut down for three months for violating the law. The factory, operated by Emergent BioSolutions, a subcontractor, was forced to discard the equivalent of 75 million cans on suspicion of contamination, severely delaying deliveries to the federal government.
Demand for the shot also collapsed after the safety break in April. At that time, 15 women in the US and Europe who had received the Johnson & Johnson injection were diagnosed with the disease. Three had died.
Regulators eventually decided that the risk was low and the benefits far outweighed it. They included a warning on the drug and cleared it for use, but state officials have said the perception that the vaccine might be unsafe is harming it.
Alex Gorsky, CEO of Johnson & Johnson, said last month he was still confident that the vaccine, which has been used in 27 countries so far, will help contain the pandemic overseas. The company has pledged up to 400 million cans to the African Union. Regardless, Covax, the global vaccine exchange program, is set to receive hundreds of millions of doses.
Studies have shown that the Johnson & Johnson shot protects people from more contagious variants of the virus, including the Delta variant, and is highly effective in preventing serious Covid-19, hospitalizations and deaths.
The FDA shares responsibility for vaccines with the Centers for Disease Control and Prevention, but is responsible for issuing product alerts. The Guillain-Barré cases are expected to be discussed at an upcoming meeting of a committee of external experts advising the CDC
The FDA has also included a warning on the Pfizer-BioNTech and Moderna vaccines, but some health officials have described this as less severe than the warnings on Johnson & Johnson. Last month, the agency warned of an increased risk of inflammation of the heart or surrounding tissues – diseases known as myocarditis and pericarditis – especially in adolescents and young adults who have received Pfizer BioNTech or Moderna injections. But the CDC said in most cases that symptoms improved immediately after simple rest or medication.
Guillian-Barré syndrome is more likely to lead to medical intervention, officials said. It occurs when the immune system damages nerve cells, leading to muscle weakness and occasional paralysis, according to the FDA. Several thousand people – or about 10 in a million people – develop the disease each year in the United States. Most make full recovery from even the most severe symptoms, but on rare occasions patients can experience near-total paralysis.
The suspected cases were reported in the Vaccine Adverse Event Reporting System (VAERS), a 30-year-old federal surveillance system. So far, the researchers have not identified a specific demographic pattern, but the many reports in the public database indicate that the patients have been hospitalized.
Guillain-Barré syndrome has also been linked to other vaccines. The Centers for Disease Control and Prevention have said that flu vaccines, including the 1976 swine flu vaccine, resulted in a marginally increased risk of developing the syndrome, although some studies have suggested that people are more likely to feel the Guillain-Barré Flu itself develop as from flu vaccines. Earlier this year, the FDA warned that Shingrix, GlaxoSmithKline’s shingles vaccine, could also increase the risk of the disease.
Only about five million people in the US have shot since Johnson & Johnson’s April hiatus was lifted. Millions of cans distributed by the federal government sit unused and expire this summer.
Apoorva Mandavilli and Carl Zimmer contributed to the coverage.
