CDC weighs in on rare heart inflammation following COVID-19 vaccine l GMA

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ABC News 24 June, 2021 - 09:07am 54 views

Despite decreasing COVID-19 anxiety, 4 in 10 Americans are still wearing masks, poll shows

USA TODAY 24 June, 2021 - 11:02am

Of those Americans vaccinated against COVID-19, 41% are wearing masks as often as they did before new CDC guidance in May, according to a new poll.

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Workers in Japan hung from a 187-foot statue to put a face mask on its nose and mouth in hopes it will speed up to the end of COVID-19. Storyful

As cases continue to drop in the United States, Americans are less anxious about COVID-19 affecting their family members, according to a new Monmouth University poll.

Only 23% of Americans said they were “very concerned” about a family member experiencing severe illness due to COVID-19, compared to 60% in January, according to the poll published Monday.

Another finding: Four in 10 Americans haven’t changed their mask-wearing habits since the Centers for Disease Control and Prevention dropped mask requirements for vaccinated people in mid-May.

“As the CDC has loosened its mask restrictions for people who have had the vaccine, we're finding more of the unvaccinated are using that as an opportunity to take off their masks as well, because you can basically blend in with the crowd,” Patrick Murray, director of the Monmouth University Polling Institute, told USA TODAY.

Of those that have been vaccinated, 41% are wearing masks as often as they did before the new guidance, according to the poll. Among the 1 in 5 Americans who said they won’t get vaccinated, only a quarter reported wearing their mask as often as in the past, and nearly half reported wearing a mask only rarely during the pandemic.

That could be why despite lessening anxiety, 26% of those polled were “very concerned” and 31% were “somewhat concerned” about another surge if enough people aren't vaccinated. Nearly three-quarters of those who have been vaccinated expressed concern over another surge.

The poll also showed half of Americans believe the recent decrease in cases is due to vaccines being more widely available, while nearly a quarter attribute the decline to the virus “running its course.” For those who are unvaccinated, that number is as high as 55%.

Among those 1 in 5 Americans who say they won’t get the vaccine, 69% either lean or identify with the Republican Party.

“There needs to be a significant change in messaging from Republican leadership about the vaccine. Unfortunately, it doesn't look like it's coming, and even if it does come at this point, it might be too little too late,” Murray said.

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FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines

Reuters 24 June, 2021 - 11:02am

U.S. Centers for Disease Control and Prevention (CDC) advisory groups, meeting to discuss reported cases of the heart condition after vaccination, found the inflammation in adolescents and young adults is likely linked to the vaccines, but that the benefits of the shots appeared to clearly outweigh the risk.

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Pfizer, whose vaccine has been authorized for use in Americans as young as 12, said in a statement that it is aware of the reports of myocarditis and pericarditis after mRNA vaccination. It said that the benefit risk profile of the Pfizer/BioNTech vaccine "remains positive".

Moderna said it is aware of reports of heart inflammation cases following administration of mRNA vaccines and is working with regulators.

Health regulators in several countries have been investigating whether the Pfizer/BioNTech and Moderna shots using new mRNA technology present a risk and, if so, how serious.

The CDC said that patients with heart inflammation following vaccination generally recover from the symptoms and do well.

The U.S. Department of Health And Human Services, joined by leading U.S. doctors groups and public health officials, put out a statement underscoring that the vaccines are safe and effective and that the heart side effect is "extremely rare."

"We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated," it said.

Doctors and hospitals have been warned by the CDC to watch for symptoms of myocarditis or pericarditis, and the FDA warning will further raise awareness.

Concerns about the more highly transmissible Delta coronavirus variant taking hold in the United States, and its impact on younger people, have added to the urgency to increase vaccinations even as the inoculation effort here has slowed considerably. read more

"Based on the available data, a warning statement in the factsheets for both healthcare providers and vaccine recipients and caregivers would be warranted," FDA official Doran Fink said at the advisory committee meeting.

Fink, deputy director of the agency's vaccines division, said the FDA expects to move quickly to add the warning after the meeting concludes.

The cases of heart inflammation appear to be notably higher in the week after the second vaccine dose and in males. The CDC identified 309 hospitalizations from the heart inflammation in persons under the age of 30, of which 295 have been discharged.

Dr. Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said in a presentation that data from one of the agency's safety monitoring systems - Vaccine Safety Datalink (VSD) – suggests a rate of 12.6 cases per million in the three weeks after the second shot in 12- to 39-year-olds.

"We're observing this in the younger age groups, mainly in people in the teens and early 20s, and observing it more in males, compared to females," Shimabukuro said. "This effect largely kind of disappears once you get into these older age groups - individuals 50 and over."

The CDC has been investigating heart inflammation cases mainly in young men for several months. The Israeli health ministry earlier this month said it saw a possible link between such cases and Pfizer's COVID-19 vaccine. read more

The CDC said it was still assessing the risk from the condition and did not specifically confirm a causal relationship between the vaccines and the heart issue.

It did, however, say that a much-higher-than expected number of young men between the ages of 12 and 24 have experienced heart inflammation after their second vaccine dose.

According to data from the U.S. Vaccine Adverse Event Reporting System (VAERS), there were 347 observed cases of heart inflammation in the week after the second vaccine dose in males aged 12 to 24. That compares with expectations of 12 or fewer cases for males in that age range based on U.S. population background incidence rates, the CDC said.

Over 138 million Americans have so far been fully vaccinated with one of the two mRNA vaccines, according to CDC data as of Monday.

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Federal health officials find vaccine benefits outweigh small cardiac risk for 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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