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F.D.A. Approves Xywav, a GHB drug, for Uncommon Sleeping Dysfunction

On the black market, homemade GHB — also known as liquid ecstasy, goop and G — can be bought by the capful for $5 to $25. But nightly treatments of Xyrem and Xywav cost roughly $100,000 a year. The new approval will make it much easier for hypersomnia patients to get insurance coverage for Xywav.

Many doctors and patients have never heard of idiopathic hypersomnia, Mr. Cozadd said, but Jazz will aim to change that. “There’s an educational effort that we’ll be part of,” he said, “which is really making sure there’s a better understanding among treaters and among patients of the condition and its treatment.”

The F.D.A. said its decision was significant because it is the first drug approved to treat the disorder.

“Idiopathic hypersomnia is a lifelong condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” said Dr. Eric Bastings, deputy director of the agency’s Office of Neuroscience, in a statement.

In March, Jazz and the Hypersomnia Foundation, a patient advocacy group, began an awareness campaign — “I have IH” — which included an online survey of health care providers’ knowledge of the condition (it was low), and advertisements in Times Square.

“I never thought I’d live to see that day — it was very emotional,” said Betsy Ashcraft, the treasurer of the foundation’s board of directors, whose adult son has idiopathic hypersomnia. (Jazz paid the foundation for board members’ time consulting on the campaign, she said.)

GHB is an old drug, first synthesized by a Russian chemist in 1874. A century later, it was sold as a dietary supplement in the United States, and academic researchers began reporting that it greatly improved the nighttime sleep of people with narcolepsy and curbed their daytime attacks of paralysis, called cataplexy.

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Testing Britney Spears: Restoring Rights Can Be Uncommon and Tough

Her voice quaking with anger and despair, the pop star Britney Spears has asked repeatedly in court to be freed from the conservatorship that has controlled her money and personal life for 13 years. What’s more, she asked the judge to sever the arrangement without making her undergo a psychological evaluation.

It’s a demand that legal experts say is unlikely to be granted. The mental health assessment is usually the pole star in a constellation of evidence that a judge considers in deciding whether to restore independence.

Its underlying purpose is to determine whether the conditions that led to the imposition of the conservatorship have stabilized or been resolved.

The evaluation process, which uneasily melds mental health criteria with legal standards, illustrates why the exit from strict oversight is difficult and rare. State laws are often ambiguous. And their application can vary from county to county, judge to judge, case to case.

Yes and no. A judge looks for what, in law, is called “capacity.” The term generally refers to benchmarks in a person’s functional and cognitive ability as well as their vulnerability to harm or coercion.

Under California law, which governs Ms. Spears’s case, a person deemed to have capacity can articulate risks and benefits in making decisions about medical care, wills, marriage and contracts (such as hiring a lawyer), and can feed, clothe and shelter themselves.

Annette Swain, a Los Angeles psychologist who does neuropsychological assessments, said that because someone doesn’t always show good judgment, it doesn’t mean they lack capacity. “We all can make bad decisions at many points in our lives,” she said. “But that doesn’t mean that we should have our rights taken away.”

Even so, Ms. Spears’s professional and financial successes do not directly speak to whether she has regained “legal mental capacity,” which she was found to lack in 2008, after a series of public breakdowns, breathlessly captured by the media. At that time, a judge ruled that Ms. Spears, who did not appear in court, was so fragile that a conservatorship was warranted.

Judges authorize conservatorships usually for one of three broad categories: a severe psychiatric breakdown; a chronic, worsening condition like dementia; or an intellectual or physical disability that critically impairs function.

Markers indicating a person has regained capacity appear to set a low bar. But in practice, the bar can be quite high.

“‘Restored to capacity’ before the psychotic break? Or the age the person is now? That expression is fraught with importing value judgment,” said Robert Dinerstein, a disability rights law professor at American University.

Records detailing grounds for the petition from Ms. Spears’s father, Jamie Spears, to become his daughter’s conservator are sealed. A few factors suggest the judge at the outset regarded the situation as serious. She appointed conservators to oversee Ms. Spears’s personal life as well as finances. She also ruled that Ms. Spears could not hire her own lawyer, though a lawyer the singer consulted at the time said he thought she was capable of that.

Earlier this month, Los Angeles Superior Court Judge Brenda Penny said Ms. Spears could retain her own counsel.

Yes. Some states, like California, detail basic functional abilities. Others do not. Colorado acknowledges modern advances like “appropriate and reasonably available technological assistance.” Illinois looks for “mental deterioration, physical incapacity, mental illness, developmental disability, gambling, idleness, debauchery, excessive use of intoxicants or drugs.”

Sally Hurme of the National Guardianship Association noted: “You could be found to be incapacitated in one state but not in another.”

Ideally, a forensic psychiatrist or a psychologist with expertise in neuropsychological assessments. But some states just specify “physician.” Psychiatrists tend to place greater weight on diagnoses; psychologists emphasize tests that measure cognitive abilities. Each reviews medical records and interviews family, friends and others.

Assessments can extend over several days. They range widely in depth and duration.

Eric Freitag, who conducts neuropsychological assessments in the Bay Area, said he prefers interviewing people at home where they are often more at ease, and where he can evaluate the environment. He asks about financial literacy: bill-paying, health insurance, even counting out change.

Assessing safety is key. Dr. Freitag will ask what the person would do if a fire broke out. “I’d call my daughter,” one of his subjects replied.

Ms. Spears has not been able to choose her evaluators in the past because the conservator has the power to make those decisions. However, if she moves to dissolve the conservatorship, she can select the evaluator, to help build her case. If the conservator, her father, opposes her petition and objects to her selection, he could nominate a candidate to perform an additional assessment. Ms. Spears would likely pick up both tabs as costs of the conservatorship.

To avoid a bitter battle of experts and the appearance that an assessor hired by either camp would be inherently biased — plus the strain of two evaluations on Ms. Spears — the judge could try to get both sides to agree to an independent, court-appointed doctor.

Many states explicitly say that a diagnosis of a severe mental health disorder is not, on its own, evidence that a person should remain in conservatorship.

Stuart Zimring, an attorney in Los Angeles County who specializes in elderlaw and special needs trusts, noted that he once represented a physician with schizophrenia and bipolar disorder who was under a conservatorship. The doctor’s rights were eventually restored after he proved he was attending counseling sessions and taking medication.

“It was a joyous day when the conservatorship was terminated,” said Mr. Zimring. “He got to practice medicine again, under supervision.”

The association between the diagnosis of a severe mental disorder and a determination of incapacity troubles Dr. Swain, the Los Angeles psychologist.

“Whatever they ended up diagnosing Britney Spears with, was it of such severity that she did not understand the decisions that she had to make, that she could not provide adequate self-care?” she asked. “Where do you draw that line? It’s a moving target.”

No, but judges usually do.

In most states, when a judge approves a conservatorship, which constrains a person’s autonomy, the evidence has to be “clear and convincing,” a rigorous standard just below the standard of “beyond a reasonable doubt.”

But when a conservatee wants those rights restored, many experts believe the standard should be more lenient.

Some states indeed apply a lower standard to end a conservatorship. In California, a judge can do so by finding it is more likely than not (“preponderance of evidence”) that the conservatee has capacity. But some states say that the evidence to earn a ticket out still has to be “clear and convincing.”

Most states do not even set a standard.

“There’s an underlying assumption that if you can get the process right, everything would be fine and we wouldn’t be depriving people of rights,” said Jennifer Mathis, deputy legal director of the Bazelon Center for Mental Health Law. “Our take is that the process is fundamentally broken and that we shouldn’t be using guardianship in so many cases.”

Yes and no. “Judges are haunted by people they have had in front of them who have been released and disaster happens,” said Victoria Haneman, a trusts and estates law professor at Creighton University. “So they take a conservative approach to freedom.”

Describing the Kafkaesque conundrum of conservatorship, Zoe Brennan-Krohn, a disabilities rights lawyer with the American Civil Liberties Union, said: “If she’s doing great, the system is working and should continue. If she is making choices others disagree with, then she’s unreliable and she needs the system.”

Or, as Kristin Booth Glen, a former New York State judge who oversaw such cases and now works to reform the system, put it, “Conservatorship and guardianship are like roach motels: you can check in but you can’t check out.”

At times. Judge Glen once approved the termination of a guardianship of a young woman originally deemed to have the mental acuity of a 7-year-old. After three years of thoughtful interventions, the woman, since married and raising two children, had become able to participate fully in her life. She relied on a team for “supported decision making,” which Judge Glen called “a less restrictive alternate to the Draconian loss of liberty” of guardianship.

A supported decision-making approach has been hailed by the Uniform Law Commission, which drafts model statutes. It has said judges should seek “the least restrictive alternative” to conservatorship.

To date, only Washington and Maine have fully adopted the commission’s recommended model.

Samantha Stark contributed reporting.

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F.D.A. Attaches Warning of Uncommon Nerve Syndrome to Johnson & Johnson Covid Vaccine

The database shows only one possible death of a recipient of the Johnson & Johnson shot from Guillain-Barre Syndrome. But the man, a 57-year-old Delaware man, had also suffered a heart attack and stroke in the past four years, which raised questions about his April death.

Although it only requires a single dose and is easier to store than Pfizer and Moderna vaccines, Johnson & Johnson vaccination played only a minor role in the US vaccination campaign. One of the reasons for this is that a plant in Baltimore that was supposed to supply most of the cans in the country was closed 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, significantly delaying deliveries to the federal government.

At the same time, demand for the shot collapsed after the safety break in April. At that time, 15 women in the United States and Europe who received the Johnson & Johnson injection were diagnosed with the coagulation disorder; three died. The CDC has now confirmed 38 cases of the disorder.

Regulatory authorities and federal health officials warned that women under the age of 50 in particular should be aware of the “rare but increased” risk of clotting. In the nearly three months since the hiatus ended, only about five million people in the U.S. have taken Johnson & Johnson’s recording, and state officials report that people are much more cautious. Millions of cans distributed by the federal government sit unused and expire this summer.

Alex Gorsky, CEO of Johnson & Johnson, said last month he was still confident that the vaccine, which has been used in 27 countries, 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 syringe protects people from more contagious variants of the coronavirus, including the Delta variant, and is highly effective in preventing severe Covid-19, hospitalizations, and death.

The Food and Drug Administration shares responsibility for vaccines with the CDC, but is solely responsible for issuing product warnings. The Guillain-Barré cases will be discussed at an upcoming meeting of a committee of external experts advising the CDC, the agency said.

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F.D.A. Will Connect Warning of Uncommon Nerve Syndrome to Johnson & Johnson Vaccine

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.

Updated 

July 12, 2021, 2:12 p.m. ET

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.

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FDA provides warning of uncommon coronary heart irritation to Pfizer, Moderna vaccines

Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021.

Dado Ruvic | Reuters

The U.S. Food and Drug Administration on Friday added a warning to patient and provider fact sheets for the Pfizer and Moderna Covid-19 vaccines to indicate a rare risk of heart inflammation.

For each vaccine, the fact sheets were revised to include a warning about myocarditis and pericarditis after the second dose and with the onset of symptoms within a few days after receiving the shot.

Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue surrounding the heart. Health officials said the benefits of receiving the vaccine still outweigh any risk.

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Janet Woodcock, acting FDA commissioner, said in a statement.

“The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications,” she said.

The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday. 

There have been more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received the shots, according to presentation slides from the CDC meeting.

About 300 million shots had been administered as of June 11, according to the CDC. There have been just 12.6 heart inflammation cases per million doses for both vaccines combined.

— CNBC’s Berkeley Lovelace Jr. contributed reporting

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Coronary heart Issues After Vaccination Are Very Uncommon, Federal Researchers Say

The coronavirus vaccines manufactured by Pfizer-BioNTech and Moderna could have caused heart problems in more than 1,200 Americans, including about 500 who were under 30, according to data reported Wednesday by researchers at the Centers for Disease Control and Prevention .

Still, the benefits of vaccination far outweighed the risks, and CDC advisors strongly recommended vaccination for all Americans 12 and older.

The reported heart problems are myocarditis, which is inflammation of the heart muscle; and pericarditis, inflammation of the lining of the heart. The risk is higher after the second dose of an mRNA vaccine than after the first, the researchers reported and much higher in men than in women.

Overall, however, the side effect is very rare – only 12.6 cases per million second doses given. The researchers estimated that out of a million second doses given to boys ages 12-17, the vaccines could cause a maximum of 70 cases of myocarditis, but would prevent 5,700 infections, 2,215 hospitalizations, and two deaths.

Agency researchers presented the data to members of the Advisory Committee on Immunization Practices, which makes recommendations on vaccine use in the United States. (The scientists grouped pericarditis with myocarditis for reporting purposes.)

Most of the cases were mild, with symptoms like fatigue, chest pain, and irregular heartbeat that cleared up quickly, the researchers said. Of the 484 cases reported in Americans under the age of 30, the CDC has definitely linked 323 cases to vaccination. The rest are still being investigated.

“These events are really very rare, extremely rare,” said Dr. Brian Feingold, an expert on pediatric heart inflammation at UPMC Children’s Hospital in Pittsburgh. “That has to be seen in the context of illness and morbidity and mortality in connection with Covid.”

Separately, more than a dozen state and professional medical organizations said in a joint statement Wednesday that myocarditis “is an extremely rare side effect and affects an extremely small number of people after vaccination.”

Federal researchers also presented early safety data on Wednesday on the six million vaccine doses given to children ages 12 to 15. The side effects – usually fatigue and pain at the injection site – were similar to those seen in young people aged 16-25.

“So far, the Covid-19 vaccines approved in the USA have shown a high level of safety,” said Dr. Matthew F. Daley, Principal Investigator at Kaiser Permanente Colorado and a member of the Advisory Committee.

The CDC advisors met when the Biden administration publicly admitted that it expects to miss its target of at least partially vaccinating 70 percent of Americans by July 4, will be immunized.

About two in 100,000 people aged 15 to 18 – about two-thirds of them male – are hospitalized with myocarditis each year, according to data presented at the meeting. Patients with the most severe cases may need mechanical assistance, such as a ventilator or a heart transplant.

Even people with mild symptoms may have to abstain from exercise for about six months after recovery. It is unclear what typically causes the condition or why it is more common in young men than women.

Updated

June 23, 2021 at 4:46 p.m. ET

The first cases of coronavirus vaccine-related myocarditis were reported in Israel, mostly in young men ages 16-19. Israel recorded 148 cases, 95 percent of them mild, from December to May.

In the United States, too, myocarditis was more common in men and boys: up to 80 percent of the cases diagnosed after the second dose were in men. There was also a marked difference in age, with the side effect becoming more common in people in their late teens and early 20s.

As of June 21, about 318 million doses of coronavirus vaccine had been administered in the United States and 150 million people are considered fully protected. Most symptoms of myocarditis appeared within about four days of the first or second dose.

“We have clear evidence here that vaccinated cases started within the first week,” said Dr. Tom Shimabukuro, a vaccine expert at the CDC, who presented the new data. There is also a dose effect, he said, adding, “The rates are higher with both vaccines after the second dose.”

The vast majority of patients with the side effect made a full recovery, noted Dr. James de Lemos, a cardiologist at the University of Texas Southwestern Medical Center at Dallas, who reported one of the first cases in January.

Covid-19 itself can cause heart problems in young people. A large study of college athletes showed that 2.3 percent of those who recovered from Covid-19 had heart abnormalities associated with myocarditis.

“Even in young men, myocarditis will be far more common if you get Covid than if you get a vaccine,” said Dr. de Lemos.

More than 4,000 children infected with the coronavirus developed a multisystem inflammatory syndrome that includes cardiac symptoms. Some children have also died while none died from the vaccination, noted Dr. Fine gold. “You can say no to the vaccine, but you take different risks.”

The CDC recommends vaccination for all Americans over the age of 12. But on Wednesday officials suggested that anyone who develops myocarditis after the first dose should postpone a second dose until they discuss the risks with a doctor.

The CDC’s recommendations may influence decisions about whether to vaccinate children under 12 years of age when vaccines become available for that age group. Some experts have questioned whether the benefits to children outweigh the potential risks, as the chances of developing serious illness from the virus in young children are small.

Still, the agency reported this month that Covid-19-related hospitalizations among teenagers in the United States were about three times higher than influenza-related hospitalizations in the last three flu seasons.

The total number of infections has fallen sharply since January, but as more adults have been vaccinated, the proportion of children in the total has increased. About a third of the new infections reported in May were in Americans ages 12 to 29, and there have been 316 deaths in that age group since April.

Vaccination becomes an even more pressing priority given more contagious variants of the coronavirus now circulating in the United States, said Dr. Paul Offit, a member of the Food and Drug Administration’s Vaccination Safety Committee, in an interview.

“We’re still a long way from where we need to be” in terms of the percentage of Americans who should be vaccinated, said Dr. Offit, who is also a pediatrician at the Philadelphia Children’s Hospital. “And you will go into winter when you have a generally underinoculated population.”

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CDC says there’s seemingly hyperlink between uncommon coronary heart irritation in younger folks after Covid shot

A CDC safety group said there was a “likely link” between rare heart inflammation in adolescents and young adults, mostly after they received their second Covid-19 vaccine, citing the latest available data.

There have been more than 1,200 cases of myocarditis or pericarditis, mostly in those under 30 who have the Covid- Vaccine received from Pfizer or Moderna have practices methods exercises.

Myocarditis is the inflammation of the heart muscle while pericarditis is the inflammation of the membrane that surrounds the heart.

“The clinical picture of myocarditis cases after vaccination was variable and most often appeared within a week of the second dose, with chest pain being the most common,” said Dr. Grace Lee, Chair of the Committee’s Security Group. CDC officials are collecting more data to fully understand the potential risks, how to deal with them and if there are any long-term issues, she said.

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The agency said 267 cases of myocarditis or pericarditis were reported after receiving one dose of the mRNA vaccines and 827 cases after two doses by June 11. There are 132 additional cases where the number of doses received is unknown, the CDC said.

The agency announced that around 300 million shots had been administered by June 11.

“This is still a rare occurrence,” said Dr. Tom Shimabukuro at the meeting. For both vaccines combined, there were 12.6 cases of heart inflammation per million doses. Cases were more common among Moderna vaccine recipients at 19.8 cases per million than eight cases per million at Pfizer, he said.

Men under 30 make up the bulk of cases, the CDC said, and most cases appear to be mild. Of the 295 people who developed the disease and were discharged, 79% made a full recovery, according to the presentation. Nine people were hospitalized, according to the agency, two of them in the intensive care unit.

CDC officials said the benefits of the Covid vaccine still outweigh the risks.

Cases in younger people are increasing as older people are vaccinated at higher rates. The US vaccinated 177.6 million people with at least one dose, according to the CDC, that’s about 53% of the population. Only 13.6% of 18- to 24-year-olds in the United States received at least one dose of vaccine, compared with 26% of people ages 50 to 64, the data shows.

While hospitalization rates have decreased in older age groups, they have barely moved in adolescents and young adults, said Dr. Megan Wallace from the CDC.

“Teenagers and young adults make up a larger proportion of the total cases, 33% of the cases reported in May were people ages 12-29, compared with 28% last December,” she said. Since the pandemic began, 2,767 people aged 12 to 29 have died of Covid, she said, noting that 316 of these deaths had occurred since April 1.

The CDC is coordinating its investigation with the Food and Drug Administration, which last month approved the Pfizer BioNTech vaccine for adolescents ages 12-15. Symptoms like chest pain and shortness of breath usually develop within a week of receiving the vaccination, with most developing within four days, the agency said.

This is a developing story. Please check again for updates.

CNBC’s Rich Mendez contributed to this article.

Correction: Most of the cases of people who had myocarditis occurred in people under the age of 30. In a previous version, the age was incorrectly stated. The number of cases per million doses administered was 12.6. In an earlier version, the number was incorrectly specified.

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C.D.C. Advisers to Focus on Uncommon Coronary heart Issues in Vaccinated Youth

Advisors to the Centers for Disease Control and Prevention will meet on Wednesday to address reports of rare heart problems in young people immunized with Pfizer-BioNTech and Moderna’s coronavirus vaccines.

The reports pertain to conditions called myocarditis, inflammation of the heart muscle; and pericarditis, inflammation of the membrane surrounding the heart. Most of the cases were mild, with symptoms such as fatigue, chest pain, and irregular heartbeat that go away quickly. The agency is tracking nearly 800 reports, although not all of them have definitely been linked to the vaccines.

The CDC advisors meeting comes as the Biden administration publicly recognizes it expects to miss its goal of partially immunizing 70 percent of Americans by July 4th.

Experts have said that the benefits of vaccination far outweigh the risk of potential problems, but they are expected to revisit this debate, especially for adolescents and young adults.

More than half of heart problems were reported in Americans ages 12 to 24, while that age group accounted for only 9 percent of the millions of doses given. The numbers are higher than one would expect for this age.

As of May 31, 216 people had developed myocarditis or pericarditis after a dose of either vaccine and 573 after the second dose. While most of the cases were mild, 15 patients remained in hospitals at this point. The second dose of Pfizer BioNTech vaccine was associated with approximately twice as many cases as the second dose of Moderna’s vaccine.

“We look forward to more clarity about the potential risk of myocarditis after mRNA vaccines in order to increase vaccination confidence and rates,” said Dr. Yvonne Maldonado, Chair of the Committee on Infectious Diseases at the American Academy of Pediatrics.

Recommendations from CDC advisors after Wednesday’s meeting may also influence decisions about immunizing children under 12 if vaccines are available for that age group. Some experts have questioned whether the benefits to children outweigh the potential risks given the low likelihood of serious illness in young children.

The CDC strongly recommends Covid-19 vaccines for Americans 12 and older. The agency reported this month that Covid-19-related hospitalizations among teenagers in the United States were about three times higher than influenza-related hospitalizations for the past three flu seasons.

By June 10, according to the American Academy of Pediatrics, nearly 17,000 children in 24 states had been hospitalized for Covid-19 and 330 children had died.

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C.D.C. advisers are anticipated to debate uncommon coronary heart issues in vaccinated youthful individuals.

Advisors from the Centers for Disease Control and Prevention are due to meet on Wednesday to discuss reports of rare heart problems in young people immunized with Pfizer-BioNTech and Moderna’s coronavirus vaccines.

The reports pertain to conditions called myocarditis, inflammation of the heart muscle; and pericarditis, inflammation of the membrane surrounding the heart. Most of the cases were mild, with symptoms such as fatigue, chest pain, and irregular heartbeat that go away quickly. The agency is tracking nearly 800 reports, although not all of them have definitely been linked to the vaccines.

The CDC advisors meeting comes as the Biden administration publicly recognizes it expects to miss its goal of partially immunizing 70 percent of Americans by July 4th.

Experts have said that the benefits of vaccination far outweigh the risk of potential problems, but they are expected to revisit this debate, especially for adolescents and young adults.

More than half of heart problems were reported in Americans ages 12 to 24, while that age group accounted for only 9 percent of the millions of doses given. The numbers are higher than one would expect for this age.

As of May 31, 216 people had developed myocarditis or pericarditis after a dose of either vaccine and 573 after the second dose. While most of the cases were mild, 15 patients remained in hospitals at this point. The second dose of Pfizer BioNTech vaccine was associated with approximately twice as many cases as the second dose of Moderna’s vaccine.

“We look forward to more clarity about the potential risk of myocarditis after mRNA vaccines in order to increase vaccination confidence and rates,” said Dr. Yvonne Maldonado, Chair of the Committee on Infectious Diseases at the American Academy of Pediatrics.

Recommendations from CDC advisors after Wednesday’s meeting may also influence decisions about immunizing children under 12 if vaccines are available for that age group. Some experts have questioned whether the benefits to children outweigh the potential risks given the low likelihood of serious illness in young children.

The CDC strongly recommends Covid-19 vaccines for Americans 12 and older. The agency reported this month that Covid-19-related hospitalizations among teenagers in the United States were about three times higher than influenza-related hospitalizations for the past three flu seasons.

By June 10, according to the American Academy of Pediatrics, nearly 17,000 children in 24 states had been hospitalized for Covid-19 and 330 children had died.

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Dr. Scott Gottlieb on uncommon coronary heart irritation in younger Covid vaccine recipients

Rare instances of heart inflammation in young people after receiving their second Covid vaccine dose require further inquiry, Dr. Scott Gottlieb told CNBC on Friday.

However, the former Food and Drug Administration commissioner said the cases have mostly been mild and should not dissuade people from signing up for the two-shot regimens from Pfizer and Moderna.

“At this point, the risk/benefit still favors vaccination certainly in this age group,” Gottlieb, a Pfizer board member, said in an interview on “Squawk Box.” “That’s what CDC and FDA have also affirmed.”

A day earlier, the Centers for Disease Control and Prevention indicated it has seen a higher-than-projected number of cases of heart inflammation in 16-to-24-year-olds following their second Covid shot—  275 recorded occurrences compared with expectations of 10 to 102.

In people age 30 and below, there’s been 475 total reports of myocarditis or pericarditis, which according to the CDC involves inflammation of the heart muscle or the lining around it. Men make up the vast majority of reported instances of post-vaccine myocarditis or pericarditis.

Of the 270 people who developed the conditions and have been discharged from the hospital, 81% have fully recovered, according to CDC data. The remaining 19% either still have symptoms or their status is not known. Fifteen people are still hospitalized, the CDC said.

Symptoms, which include chest pain and shortness of breath, typically develop when a few days of receiving the vaccine, according to the CDC.

Gottlieb said many questions remain about the connection between the heart inflammation and the Covid vaccines from Pfizer and Moderna.

“I think at this point you need to assume there’s a causal relationship between the vaccine and these observations until you can prove otherwise,” said Gottlieb, who led the FDA from 2017 to 2019 in the Trump administration.

Gottlieb said what’s not known yet is whether there’s something specific about the vaccines that are causing heart inflammation. “We know the vaccine induces inflammatory response. That’s why you get a fever. That’s why you get injection-site pain because your immune system is stimulated.”

“Is this a more generalized inflammatory response from the vaccine that’s localizing in the heart in some patients?” Gottlieb asked. “Or is this something that’s more direct, where the vaccine itself is triggering some kind of very targeted immune reaction and it’s manifesting in this way? We don’t have the answers to these questions.”

It’s possible additional cases haven’t been recorded, Gottlieb said, but “we are probably capturing most of the severe cases.” He added, “When you look at the number of people who are having severe cases of pericarditis, it’s very small numbers right now.”

Roughly 141.5 million people in the U.S. have been fully vaccinated against Covid, according to CDC data. The vaccines have been critical in driving down the number of coronavirus cases in the U.S. to their lowest levels since early in the pandemic.