FDA to Add Myocarditis Warning to mRNA COVID-19 Vaccines


Medscape 23 June, 2021 - 08:01pm 47 views

The US Food and Drug Administration (FDA) is adding a warning to the fact sheets for the Pfizer/BioNTech and Moderna mRNA COVID-19 vaccines as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys.

Doran Fink, MD, PhD, deputy director of the FDA's Division of Vaccines and Related Products Applications, told a Centers for Disease Control and Prevention (CDC) expert panel Wednesday that the FDA is finalizing language on a warning statement for healthcare providers, vaccine recipients, and parents or caregivers of teens.

The incidents are more likely to follow the second dose of the Pfizer or Moderna vaccine, with chest pain and other symptoms occurring within several days to a week, the warning will note.

"Based on limited follow-up, most cases appear to have been associated with resolution of symptoms, but limited information is available about potential long-term sequelae," Fink said, describing the statement to the Advisory Committee on Immunization Practices (ACIP), independent experts who advise the CDC.

"Symptoms suggestive of myocarditis or pericarditis should result in vaccine recipients seeking medical attention," he said.

Although no formal vote occurred after the meeting, the ACIP members delivered a strong endorsement for continuing to vaccinate 12- to 29-year-olds with the Pfizer and Moderna vaccines despite the warning.

"To me it's clear, based on current information, that the benefits of vaccine clearly outweigh the risks," said ACIP member Veronica McNally, president and CEO of the Franny Strong Foundation in Bloomfield, Michigan, a sentiment echoed by other members.

As ACIP was meeting, leaders of the nation's major physician, nurse, and public health associations issued a statement supporting continued vaccination: "The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.

"Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe."

ACIP heard the evidence behind that claim. According to the Vaccine Safety Datalink, which contains data from more than 12 million medical records, myocarditis or pericarditis occurs in 12- to 39-year-olds at a rate of 8 in a million after the second Pfizer dose and 19.8 per million after the second Moderna dose.

The CDC continues to investigate the link between the mRNA vaccines and heart inflammation, including any differences between the vaccines.

Most of the symptoms resolved quickly, said Tom Shimabukuro, deputy director of CDC's Immunization Safety Office. Of 323 cases analyzed by the CDC, 309 were hospitalized, 295 were discharged, and 218, or 79%, had recovered from symptoms.

"Most post vaccine myocarditis has been responding to minimal treatment," pediatric cardiologist Matthew Oster, MD, MPH, from Children's Healthcare of Atlanta, Georgia, told the panel.

Overall, the CDC has reported 2767 COVID-19 deaths among people aged 12 to 29 years, and there have been 4018 reported cases of the COVID-linked inflammatory disorder MIS-C since the beginning of the pandemic.

That amounts to one MIS-C case in every 3200 COVID infections — 36% of them among teens aged 12 to 20 years and 62% among children who are Hispanic or Black and non-Hispanic, according to a CDC presentation.

The CDC estimated that every one million second-dose COVID vaccines administered to 12- to 17-year-old boys could prevent 5700 cases of COVID-19, 215 hospitalizations, 71 intensive care unit admissions, and two deaths. There could also be 56 to 69 myocarditis cases.

The emergence of new variants in the United States and the skewed pattern of vaccination around the country also may increase the risk to unvaccinated young people, noted Grace Lee, MD, MPH, chair of the ACIP's COVID-19 Vaccine Safety Technical Subgroup and a pediatric infectious disease physician at Stanford Children's Health.

"If you're in an area with low vaccination, the risks are higher," she said. "The benefits [of the vaccine] are going to be far, far greater than any risk."

Individuals, parents, and their clinicians should consider the full scope of risk when making decisions about vaccination, she said.

As the pandemic evolves, medical experts have to balance the known risks and benefits while they gather more information, said William Schaffner, MD, an infectious disease physician at Vanderbilt University School of Medicine in Nashville, Tennessee, and medical director of the National Foundation for Infectious Diseases.

"The story is not over," Schaffner told Medscape Medical News. "Clearly, we are still working in the face of a pandemic, so there's urgency to continue vaccinating. But they would like to know more about the long-term consequences of the myocarditis."

Meanwhile, ACIP began conversations on the parameters for a possible vaccine booster. For now, there are simply questions: Would a third vaccine help the immunocompromised gain protection? Should people get a different type of vaccine — mRNA versus adenovirus vector — for their booster? Most important, how long do antibodies last?

"Prior to going around giving everyone boosters, we really need to improve the overall vaccination coverage," said Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University School of Medicine. "That will protect everyone."

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CDC safety group says there's a likely link between rare heart inflammation in young people after Covid shot

CNBC 24 June, 2021 - 09:56am

A CDC safety group said there's a "likely association" between a rare heart inflammatory condition in adolescents and young adults mostly after they've received their second Covid-19 vaccine shot, citing the most recent data available.

There have been more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received Pfizer's or Moderna's Covid vaccine, according to a series of slide presentations published Wednesday for a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Myocarditis is the inflammation of the heart muscle, while pericarditis is the inflammation of the membrane surrounding the heart.

"Clinical presentation of myocarditis cases following vaccination has been distinct, occurring most often within one week after dose two, with chest pain as the most common presentation," said Dr. Grace Lee, who chairs the committee's safety group. CDC officials are gathering more data to fully understand the potential risks, how to manage it and whether there are any long-term issues, she said.

Roughly 300 million of the shots had been administered as of June 11, the agency said.

"This is still a rare event," Dr. Tom Shimabukuro said at the meeting. For both vaccines combined, there were 12.6 heart inflammation cases per million doses. The cases were more frequent among Moderna's vaccine recipients at 19.8 cases per million versus eight cases per million for Pfizer's, he said.

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Men under 30 make up the bulk of the cases, the CDC said, and most cases appear to be mild. Of the 295 people who have developed the condition and have been discharged, 79% of them have fully recovered, according to the presentation. Nine people were hospitalized, with two in intensive care as of June 11, according to the agency.

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

Cases among younger people are on the rise as older people get vaccinated at higher rates. The U.S. has vaccinated 177.6 million people with at least one dose, roughly 53% of the population, according to the CDC. Just 13.6% of 18- to-24-year-olds have had at least one vaccine dose in the U.S., compared with 26% of people ages 50 to 64, the data shows.

While older age groups have seen hospitalization rates fall, they've barely budged among adolescents and young adults, said the CDC's Dr. Megan Wallace.

"Adolescents and young adults make up a greater proportion of total cases; 33% of cases reported in May were in persons aged 12 to 29 years, compared with 28% last December," she said. Since the beginning of the pandemic, 2,767 people ages 12 to 29 years old have died from Covid, she said, noting that 316 of those fatalities have happened since April 1.

After Wednesday's meeting, the Department of Health and Human Services released a statement co-signed by the CDC and several medical professional groups that stressed the heart condition is extremely rare.

"Only an exceedingly small number of people will experience it after vaccination," HHS said. "Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe."

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

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These are the two key groups now being hit hardest by Covid-19

CNN 24 June, 2021 - 09:56am

Updated 6:47 AM ET, Thu June 24, 2021

CNN's Deidre McPhillips, Jacqueline Howard, Maggie Fox, Jamie Gumbrecht and Naomi Thomas contributed to this report.

Federal health officials cite ‘likely association’ between coronavirus vaccines and rare heart issues in teens, young adults

The Washington Post 23 June, 2021 - 06:35pm

Federal health officials said Wednesday there is a “likely association” between two coronavirus vaccines and increased risk of a rare heart condition in adolescents and young adults, the strongest assertion so far on the link between the two.

Data presented to advisers to the Centers for Disease Control and Prevention adds to recent findings, most notably from Israel, of rare cases of myocarditis — inflammation of the heart muscle — predominantly in males ages 12 to 39, who experience symptoms after the second dose of the Moderna or Pfizer-BioNTech vaccine.

Most cases have been mild and have taken place several days to a week after the second shot, officials said. Chest pain is the most common symptom. Patients generally recover from symptoms and do well.

There have been 1,226 reports of myocarditis out of about 300 million mRNA doses administered in the United States, as of June 11, according to Tom Shimabukuro, a CDC vaccine safety official. Of those, 267 were reported after the first dose and 827 after the second, and 132 reports did not indicate which dose.

Experts and health officials said the additional data needs to be understood in the broader context of risk: With virus variants increasing, and adolescents and young adults making up a greater percentage of covid-19 cases, unvaccinated teens and young adults are far more likely to contract the disease. Getting covid-19 puts someone at far greater risk of heart inflammation and other serious medical problems than the risk of getting myocarditis from vaccination, they said.

The CDC and the Department of Health and Human Services, together with 15 of the country’s leading medical and public health organizations — including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association and the American Nurses Association — issued a joint statement after the meeting saying they “strongly encourage everyone 12 and older” to get the shots because the benefits far outweigh any potential harms.

“Especially with the troubling Delta variant increasingly circulating, and more readily impacting younger people, the risks of being unvaccinated are far greater than any rare side effects from the vaccines,” the statement said.

The CDC and the Food and Drug Administration plan to do a three-month follow-up of these cases, officials said. Both agencies are also updating their fact sheets for providers and patients to reflect the additional data about the condition.

“The choice to avoid an mRNA vaccine in order to avoid myocarditis ignores the fact that both covid and MIS-C [a rare inflammatory condition diagnosed in some children after covid infections] cause myocarditis, and far more commonly,” said Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia. “There are no risk-free choices.”

The additional data on myocarditis is part of continued safety monitoring by federal health agencies as they consider recommending the coronavirus vaccines for younger children in coming months.

A presentation from the vaccine safety work group of the Advisory Committee on Immunization Practices noted the “likely association” of myocarditis with mRNA vaccination in adolescents and young adults.

In males 12 to 39, the risk of myocarditis after the second dose of any mRNA vaccine was 32 cases per million, or about 1 in 31,000, according to a CDC analysis of data from one of several vaccine safety monitoring systems. For females in that age group, there were 4.7 cases per million, or about 1 in 212,000.

By comparison, the estimated incidence of the rare inflammatory syndrome in children is about 1 in every 3,200 covid-19 infections — with 36 percent of cases reported in those ages 12 to 20, according to CDC data. More than 4,000 cases of MIS-C have been reported since the pandemic began.

Treatment for myocarditis is largely supportive care. CDC officials said individuals should follow the guidelines of the American Heart Association and the American College of Cardiology, which recommend “restriction from competitive sports for about three to six months or until you can show documentation that the heart has recovered from this acute process,” said Matthew Oster, a CDC physician.

Some experts noted that the evolving data and unknowns make it harder to answer questions from anxious parents.

We worry a little bit about, are we going to make the community nervous, or have them be more hesitant to vaccinate?” said Patricia Stinchfield, director of infectious-disease control at Children’s Minnesota, a liaison from the National Association of Pediatric Nurse Practitioners.

But, she added, the discussion “allows us to have conversations. … And the parents that I have talked to, which are numerous about this, are very appreciative of that. And [they] do go ahead and vaccinate and are very, very happy that we’re doing this kind of deep analysis, even on rare events.”

Now that many older adults have been vaccinated, adolescents and young adults — those 12 to 29 — have the highest incidence of covid-19, according to CDC data. Since the beginning of the pandemic, at least 7.7 million covid cases have been reported in this age group — with 2,767 covid-19 deaths.

Of those deaths, 316 have been reported since April 1.

In a risk-benefit analysis, CDC officials found that for every million second doses of mRNA vaccinations given to females 18 to 24, vaccinations would prevent:

They also would result in four to five myocarditis cases.

For every million second doses given to males 18 to 24, vaccinations would prevent:

They also would result in 45 to 56 myocarditis cases.


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