F.D.A. Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine

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The New York Times 12 July, 2021 - 03:10pm 22 views

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

The Food and Drug Administration is planning to warn that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain–Barré syndrome, another setback for a vaccine that has largely been sidelined in the United States because of manufacturing problems and a temporary safety pause earlier this year, according to several people familiar with the plans.

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

Federal officials have identified roughly 100 suspected cases of Guillain-Barré disease among recipients of the Johnson & Johnson shot through a federal monitoring system that relies on patients and health care providers to report adverse effects of vaccines. The reports are considered preliminary. Most people who develop the condition recover.

The F.D.A. has concluded that the benefits of the vaccine in preventing severe disease or death from the coronavirus still very much outweigh any danger, but it plans to include the proviso in fact sheets about the drug for providers and patients

“It’s not surprising to find these types of adverse events associated with vaccination,” said Dr. Luciana Borio, a former acting chief scientist at the F.D.A. under President Barack Obama. The data collected so far by the F.D.A., she added, suggested that the vaccine’s benefits “continue to vastly outweigh the risks.”

In a statement released Monday, the Centers for Disease Control and Prevention said the cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.

The database reports indicate that symptoms of Guillain-Barré developed within about three weeks of vaccination. One recipient, a 57-year-old man from Delaware who had suffered both a heart attack and a stroke within the last four years, died in early April after he was vaccinated and developed Guillain-Barré syndrome, according to a report filed 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 the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally authorized manufacturers. Those rely on a different technology.

Nearly 13 million people in the United States have received Johnson & Johnson’s shot, but 92 percent of Americans who have been fully vaccinated received shots developed by Pfizer-BioNTech or Moderna. Even though it requires only one dose, Johnson & Johnson’s vaccine has been marginalized by manufacturing delays and a 10-day pause while investigators studied whether it was linked to a rare but serious blood clotting disorder in women. That investigation also resulted in a warning added to the fact sheet.

The new safety concern comes at a precipitous moment in the nation’s fight against Covid-19. The pace of vaccinations has slowed considerably just as a new, more contagious variant called Delta is spreading fast in under-vaccinated areas. Federal health officials are worried that the news could make some people even more hesitant to accept the vaccines developed by Pfizer-BioNTech or Moderna, even though well over 100 million people have received those vaccines, according to the Centers for Disease Control and Prevention.

Almost one-third of the nation’s adults remain unvaccinated. The Biden administration has shifted away from relying on mass vaccination sites and is now enlisting community workers in door-to-door campaigns, supplying doses to primary care doctors and expanding mobile clinics in an attempt to convince the unvaccinated to accept shots.

Johnson & Johnson’s vaccine has played a minor role in the nation’s inoculation campaign partly because the Baltimore plant that was supposed to supply most of the doses to the United States has been shut down for three months because of regulatory violations. The factory, operated by Emergent BioSolutions, a subcontractor, has been forced to throw out the equivalent of 75 million doses because of suspected contamination, severely delaying deliveries to the federal government.

Demand for the shot also plummeted after the April safety pause. At that time, 15 women in United States and Europe who had received the Johnson & Johnson shot had been diagnosed with the disorder. Three had died.

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

Alex Gorsky, Johnson & Johnson’s chief executive, said last month that he was still hopeful that the vaccine, which has been used in 27 countries so far, would help contain the pandemic overseas. The company has promised up to 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 showed that the Johnson & Johnson shot protects people against more contagious virus variants, including the Delta variant, and is highly effective at preventing severe Covid-19, hospitalizations and death.

The F.D.A. 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 in an upcoming meeting of a committee of outside experts who advise the C.D.C.

The F.D.A. has also attached a warning to the Pfizer-BioNTech and Moderna vaccines, but some health officials described that as less serious than the warnings about Johnson & Johnson. Last month, the agency warned about an increased risk of inflammation of the heart or the tissue surrounding it — diseases known as myocarditis and pericarditis — particularly among adolescents and young adults who had received Pfizer-BioNTech or Moderna shots. But the C.D.C. said in most cases, symptoms promptly improved after simple rest or medication.

The Guillian-Barré 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 F.D.A. Several thousand people — or roughly 10 out of every one million residents — develop the condition every year in the United States. Most fully recover from even the most severe symptoms, but in rare cases patients can suffer near-total paralysis.

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

Guillain-Barré syndrome has also been linked to other vaccines. The Centers for Disease Control and Prevention has said that flu vaccines, including the 1976 swine flu vaccine, led to a small increased risk of contracting the syndrome, although some studies suggested that people are more likely to develop Guillain-Barré from the flu itself than from flu vaccines. Earlier this year, the F.D.A. warned that GlaxoSmithKline’s shingles vaccine, Shingrix, could also increase the risk of the disease.

Only about five million people in the U.S. have taken Johnson & Johnson’s shot since the April pause was lifted. Millions of doses that have been distributed by the federal government are sitting unused and will expire this summer.

Apoorva Mandavilli and Carl Zimmer contributed reporting.

Read full article at The New York Times

FDA to issue new warning of rare autoimmune disorder developing from Johnson & Johnson vaccine, report says

The Independent 12 July, 2021 - 02:08pm

The FDA was expected to issue a new warning about a rare autoimmune disorder developing in people after they received the single-dose Johnson & Johnson Covid-19 vaccine, The Washington Post reports.

Guillain-Barre, the rare autoimmune disorder, causes the immune system to attack the nerves.

About 100 preliminary cases of Guillain-Barre have been detected in Americans after they received one in the more than 12.8 million Johnson & Johnson doses distributed according to the publication. These cases occurred about two weeks following vaccination and largely impacted men over the age of 50 years old.

One case that was reported through the federal monitoring system was a 57-year-old man from Delaware who suffered a heart attack and stroke within the last four years. He died in early April after he was vaccinated and developed the rare autoimmune disorder.

Regulators said that cases were extremely rare, but it appeared to be three to five times higher among people who received a Johnson & Johnson vaccine compared to the general population.

Typically the US records about 60 to 120 cases of Guillain-Barre per week, with about 3,000 to 6,000 people developing the rare disorder per year.

The Biden administration was expected to issue a warning about the Johnson & Johnson vaccine as early as Tuesday, according to the report.

Copyright 2021 The Associated Press. All rights reserved.

FDA to announce new warning on J&J Covid vaccine related to a rare autoimmune disorder, report says

CNBC 12 July, 2021 - 01:46pm

The Food and Drug Administration is expected to announce a new warning for Johnson & Johnson's Covid-19 vaccine, saying the shot has been linked to a serious, but rare, autoimmune disorder, the Washington Post reported Monday, citing four unnamed sources.

About 100 preliminary reports of Guillain-Barré syndrome have been detected after 12.8 million doses of the J&J vaccine were administered, the Centers for Disease Control and Prevention said in a statement to NBC News. Guillain-Barré is a rare neurological disorder in which the body's immune system mistakenly attacks part of the nervous system.

It is estimated to affect about one person in 100,000 each year, and most people eventually recover from the disorder, according to the National Institute of Neurological Disorders and Stroke.

The cases reported after receiving the J&J shot largely occurred about two weeks after vaccination and mostly in males, many aged 50 years and older, according to the CDC. Available data do not show a similar pattern with Pfizer's or Moderna's vaccine, the agency said.

U.S. regulators are expected to emphasize that the J&J vaccine is safe and that its benefits clearly outweigh the potential risks, the Post reported, citing people familiar with the situation.

The FDA and J&J did not immediately respond to CNBC's request for comment.

"Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine," the CDC said in a statement to NBC News.

The anticipated new warning is just the latest setback for J&J, which has suffered from production problems of its vaccine as well as public concerns about a rare, potentially life-threatening, blood clotting disorder linked to its shots.

After its authorization in late February, the vaccine was touted as a blessing since it could be stored at refrigerator temperatures for months and takes just one dose — unlike Pfizer's and Moderna's, which require more complicated transportation methods and are two doses.

More than 12 million of the J&J shots have been administered in the U.S., according to data compiled by the CDC.

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J&J Covid-19 vaccine may trigger neurological condition in rare cases

STAT 12 July, 2021 - 01:45pm

Exclusive analysis of biotech, pharma, and the life sciences

By Helen Branswell July 12, 2021

Reports to a database operated jointly by the agency and the Centers for Disease Prevention and Control suggest there may be a link between the inoculations and Guillain-Barré syndrome, a form of progressive paralysis that is generally reversible, the FDA said in a statement.

The agency said there have been about 100 preliminary reports of GBS, as the condition is often called, in people who have received the J&J vaccine. To date, about 12.8 million doses of the J&J vaccine have been used in the United States, suggesting a rate of about one case of GBS per 128,000 people vaccinated.

In most cases, the people reporting the condition developed it about two weeks after receiving the one-dose vaccine. Most are older males, which fits with the known pattern of GBS, said John Moore, an immunologist at Weill Cornell Medicine.

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“A rare, but very probably real consequence of the vaccine,” said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia. “Again, the benefits of the vaccine clearly and definitely outweigh its very rare risks.”

The FDA’s statement comes after a similar signal of GBS was identified with AstraZeneca’s Covid vaccine. Last week the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee recommended adding a warning to the label of the AstraZeneca vaccine, Vaxzevria, to inform health care providers. Its statement said it is not currently clear if the AstraZeneca vaccine triggers the condition. “At this stage the available data neither confirms nor rules out a possible association with the vaccine,” the EMA said.

Both the AstraZeneca and J&J vaccines are what are known as viral-vectored vaccines — meaning they carry harmless genetic material from the SARS-CoV-2 virus into the body to trigger an immune response. The fact that both these vaccines now appear to be associated with GBS suggest it could be a class effect — something one might expect to see with other viral-vectored Covid vaccines, Offit said.

The FDA said to date there has been no signal to suggest the messenger RNA vaccines — those made by Moderna or Pfizer and its partner BioNTech — trigger GBS.

There are multiple known causes of Guillain-Barré syndrome. Some viral infections, including influenza, have been shown to increase one’s risk of developing GBS, as have some gastrointestinal infections. And several vaccines have been shown to, on rare occasions, induce the condition.

Most famously, the 1976 swine flu vaccination program in the United States was halted after a number of cases of Guillain-Barré syndrome were reported in people who received the vaccine. It was later estimated that the syndrome occurred at a rate of about one case per 100,000 doses of the swine flu vaccine. Though some flu seasons there is no signal of increased GBS cases linked to vaccination, other years there does appear to be an increase. In those cases, it has been estimated that there are one or two additional cases of GBS for every 1 million doses of vaccine given, the CDC estimates.

Between 3,000 and 6,000 people in the United States develop GBS every year. The underlying cause of the condition causes nerve inflammation that can result in pain, numbness, muscle weakness, and difficulty walking.

Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development.

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