Florida’s decision not to preorder vaccines for young children will create access issues: White House

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(TALLAHASSEE, Fla.) — Florida was the first state to advise against vaccinating healthy kids for COVID-19.
Florida was the only state in the U.S. that didn’t preorder any COVID-19 vaccines for young children, federal officials said Thursday.

The Florida Department of Health did not want to be involved in a “convoluted vaccine distribution process,” a representative from the department told ABC News in a statement on Wednesday.

“The Florida Department of Health (Department) has made it clear to the federal government that states do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” the representative said.

In March, the state’s Surgeon General, Dr. Joseph A. Ladapo, announced Florida would become the first state to officially advise against vaccinating healthy children for COVID-19.

“Already the rates were low. So, we’re kind of scraping at the bottom of the barrel particularly with healthy kids, in terms of actually being able to quantify with any accuracy and any confidence, the infinite potential of benefit,” Ladapo said at the time.

The representative for the state health department reiterated the health department still does not recommend the COVID-19 vaccine for all children.

“It is also no surprise we chose not to participate in distribution of the COVID-19 vaccine when the Department does not recommend it for all children,” the representative wrote.

Doctors will be able to order vaccines as they are needed, the department said. However, the representative noted that there are currently no orders in the Department’s ordering system for the COVID-19 vaccine for these young kids.

On Thursday, the White House quickly pushed back on Florida’s decision not to order any shots for young children.

“By being the only state — this is Florida — not preordering, which means that pediatricians, for example, in Florida will not have immediate ready access to vaccines, some pharmacies and community health centers in the state get access through federal distribution channels, but those options are limited for parents. We encouraged Florida on several occasions to order vaccines … and we will continue to do so,” White House press secretary Karine Jean-Pierre said during a press briefing on Thursday.

Jean-Pierre said the White House has been working with states for “some time” to ensure that if the vaccines are authorized by the Food and Drug Administration and the Centers for Disease Control and Prevention, the doses will be “shipped to places like pediatricians and children’s hospitals, places where parents would get health care for their youngest or as quickly as possible.”

With Florida not preordering vaccines, it will make it more difficult for parents to get a hold of vaccines for their young children, Jean-Pierre added.

Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor, concurred, adding that access to the shots will be critical to uptake.

“Vaccines access and confidence are tightly linked. If you make it harder for parents to vaccinate their kids, it will reduce the likelihood they will, especially if on the fence. By not making preorders available to Florida vaccination clinics, you are doing a disservice to so many families who have waited over two years to vaccinate their youngest kids,” Brownstein said.

Issues of equity may also be exacerbated, as some lower-income families may have a harder gaining access to the shots, Brownstein said.

“This rollout was already going to be the most challenging yet, especially with pharmacies playing a more limited role. By removing the state from the ordering equation, you are shifting a cumbersome process to pediatric frontline health care that is already stretched way too thin,” Brownstein added. “More challenging access will unfortunately only serve to exacerbate health disparities. Minority and low-income communities that already have a more challenging time accessing vaccines will have less options available.”

A committee of advisors to the FDA voted on Wednesday to recommend the Moderna vaccine for children under 6, which is a two-dose vaccine, and the Pfizer vaccine for kids under 5, which is a three-dose vaccine.

If FDA leadership chooses to officially authorize the vaccines, the administration can start shipping out vaccines to states. On Friday and Saturday, the CDC’s advisers will meet to review the data on both vaccines for children.

Thus far, states have preordered 3.8 million doses of vaccines for the youngest children, according to the U.S. Department of Health and Human Services.

ABC News’ Cheyenne Haslett and Sasha Pezenik contributed to this report.

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COVID-19 vaccines for kids under 5: Pediatricians answer parents’ questions

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(WASHINGTON) — COVID-19 vaccinations for kids under age 5 could be available as early next week after an advisory committee for the Food and Drug Administration (FDA) voted Wednesday to recommend authorization for both Pfizer and Moderna’s vaccines.

Before shots can be administered to kids, the FDA must issue its official authorization, which could happen within days.

This Friday and Saturday, an advisory committee for the Centers for Disease Control and Prevention (CDC) will meet and then present its recommendation to CDC Director Dr. Rochelle Walensky, who gives the final green light.

At the start of the pandemic, scientists studied vaccines in adults first because they have a higher risk of dying of COVID-19. That means parents of children under the age of 5 have waited over two years, since the start of the pandemic, for a COVID-19 vaccine for their kids.

Now that the vaccine is one step closer to being available, parents may have questions about everything from which vaccine and how many doses their child should receive to how safe and effective the vaccines are.

Here are answers from pediatricians across the country to common questions from parents.

1. Which vaccine should my child get, Pfizer or Moderna?

The short answer is that both the Pfizer and Moderna vaccines are safe and good options for kids under 5, pediatricians say.

“Basically, they’re both very good choices,” Dr. Yvonne Maldonado, professor of pediatrics at Stanford University and chair of the American Academy of Pediatrics Committee on Infectious Diseases, told ABC News. “It’s always a great idea to have a choice for vaccines.”

Among the factors that will come into play on vaccine choice include which vaccine is available locally, parents’ preference and pediatricians’ recommendations, according to Maldonado.

The main difference between the two is that Moderna’s vaccine is delivered in two shots, taken 28 days apart, and Pfizer’s vaccine requires three shots over the course of around three months.

Pfizer’s data shows that fuller protection against COVID-19 does not kick in until the third shot, meaning a child who gets that vaccine will take longer to be protected against the virus.

Moderna says its vaccine is about 40 to 50% effective after two shots, and the company expects to roll out a booster, or third shot, in the coming months.

The Pfizer vaccine has already been available for those who are 5 and older but would now be available for kids ages 6 months through 4 years.

Moderna’s vaccine has previously been available only for people ages 18 and older. The latest vaccine authorization will be for kids ages 6 months to 5 years.

2. Does it matter that Pfizer and Moderna’s vaccines have different doses?

No, according to Dr. Vandana Madhavan, a pediatric infectious disease specialist at Mass General Hospital and professor at Harvard Medical School.

“What is most important is that both vaccines have the lowest doses given to the youngest children so that they are protected without increased side effects,” she said. “The actual dose is less important than the level of protective antibody that a particular vaccines pushes the immune system to make.”

The Pfizer vaccine is 3 micrograms — one-tenth of the adult dose — given in three doses.

The Moderna vaccine is 25 micrograms — one-fourth of the adult dose — given in two doses.

3. Will my child have side effects from the vaccine?

The side effects in children who get vaccinated against COVID-19 are typically mild, according to Madhavan.

“The most common side effect from the COVID-19 vaccine in all age groups is a sore arm at the site of an injection,” said Madhavan. “Children might get a low-grade fever, generalized fatigue and crankiness but these side effects are less common and self-resolved, going away in a couple of days.”

4. Why does my child need to be vaccinated against COVID-19 at such a young age?

While COVID-19 has had a more deadly impact on older adults, there have still been nearly 500 deaths in kids under 5 and over 30,000 hospitalizations in the U.S.

“One of the main issues is parents thinking that COVID-19 is a very mild disease, and the vaccines are very unsafe,” said Dr. Diego R. Hijano, pediatric infectious disease specialist at St. Jude Children’s Research Hospital. “And we cannot emphasize that the opposite is true.”

Dr. Tanya Altmann, a California-based pediatrician and school physician, said getting a child vaccinated against COVID-19 can not only help prevent immediate illness but also protect them from longstanding complications from the virus.

“Kids under age 5 deserve and need protection just as older kids and adults against the potentially serious complications from COVID-19 infection,” said Altmann. “The vaccine has reduced hospitalizations from COVID-19 in all other age groups and emerging data also shows a decrease in long COVID.”

Madhavan stressed that it is important to get as many children vaccinated as possible amid summer travel and camps and a return to school in the fall.

“We can’t predict what the summer and fall will bring with respect to new variants and how transmissible, how serious these variants will be,” said Madhavan. “We do know that thus far, vaccines are very effective at preventing serious disease from all variants.”

5. How do experts know the vaccine is safe for young kids?

Both Pfizer and Moderna released data to the FDA prior to Wednesday’s advisory meeting. The data shows the vaccines proved safe in clinical trials for kids ages 6 months through 4 years, or 5 years for the Moderna shot.

Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri-Kansas City School of Medicine and a member of the FDA advisory committee, called the vaccines “very safe to use.”

“Our question today is, does the benefit outweigh the risks of this vaccine? And I think that the evidence is pretty clear,” Portnoy said at Wednesday’s meeting. “For preventing severe disease, hospitalization, emergency visits, this vaccine is very effective, very safe to use.”

6. How do I get a vaccine for my child?

Parents should talk to their child’s pediatrician about where and how to get a vaccine.

Pediatricians’ offices, children’s hospitals and family doctors’ offices will all be among the top sites for kids under 5 to get vaccinated.

If the authorization process for Pfizer and Moderna’s vaccines moves forward as planned, vaccines could be available for kids as early as Tuesday.

“Remember, pediatricians get vaccines all the time. It’s a large part of what they do,” said Maldonado, adding that the American Academy of Pediatrics has already been working with the CDC and local health departments to coordinate the vaccine rollout for kids under 5. “They’re used to rolling out new vaccines on a regular basis.”

7. If my child had COVID, do they still need to get vaccinated?

Yes, pediatricians say.

“Individuals who have a combination of infection and vaccines have the best protection of all,” said Hijano, describing a concept called hybrid immunity. “They are better than those who only got the vaccines and significantly better than those who only got infected.”

According to Hijano, getting kids vaccinated, including those have already had COVID-19, will be especially important as the virus contains to change and new variants emerge.

Kids can get vaccinated as soon as they are out of isolation from COVID-19. They do not have to wait a certain amount of time, according to Hijano.

Priya Jaisinghani, M.D., is an endocrinologist at New York Presbyterian-Weill Cornell and a contributor to the ABC News Medical Unit.

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Low levels of testing may be hiding a COVID wave in Texas: Experts

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(NEW YORK) — Looking at data from the Centers for Disease Control and Prevention would give the impression that COVID-19 is generally under control in Texas.

The federal agency’s map of levels of COVID-19 spread in the community shows most counties in the state are classified as “low” or “medium.”

But public health experts said this doesn’t tell the true story and that case counts are artificially low in Texas due to low levels of testing reported to public health officials.

“There are limitations to this metric by the CDC,” Dr. Luis Ostrosky-Zeichner, an infectious disease specialist at UTHealth Houston and Memorial Hermann Texas Medical Center, told ABC News. “The primary diver for the first part of the metric is the number of cases and then you get into hospitalizations and percentage of occupancy by COVID-19 patients.”

He continued, “Until you see a high number of hospitalizations, you don’t even get to the medium level. And we know that there has to be significant underreporting at this point for the number of cases.”

According to the CDC, as of June 7 — the latest date for which data is available — Texas is currently performing 20,535 new COVID-19 tests per day with a seven-day rolling average of 24,352.

This is half as many as the average of 55,842 tests being performed three months ago.

Doctors told ABC News that testing is very different at this point in the pandemic, with fewer people testing at government-run sites and more people testing at home.

“Many people have access to testing through other means rather than going through one of the government screening centers,” Dr. Robert Atmar, a professor of medicine and infectious diseases at Baylor College of Medicine in Houston, told ABC News. “People have access to home kits; they can buy them at the pharmacy.”

This means some Americans are testing positive for COVID-19 on at-home rapid tests and not reporting their results to public health officials either because there is no mechanism to report results, or they just fail to do so.

Additionally, if people need treatments, such as antiviral pills like Paxlovid, they are getting prescriptions from their doctor rather than going to a hospital to receive them, doctors said.

“This is partly good news because people are not getting sick enough to require health care, but the downside is you cannot track the amount of disease in the community,” Atmar said.

This means the CDC data on COVID-19 community levels is somewhat unreliable.

“The current national risk map may provide a false sense of relief,” said Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor. “Many areas with high rates of transmission are deemed to be low risk only because of data reporting gaps and lags.”

He added, “The shift to home testing compounds these issues as that data is unlikely to make it into public health surveillance systems.”

Experts said this is one reason why wastewater data, which shows virus levels in wastewater samples, may be a more accurate representation of levels of COVID-19 in a community.

Although wastewater data is not representative of the entire U.S. — with many areas not even having treatment plants — it does give an idea of hidden waves across the country.

According to data from a Houston wastewater monitoring dashboard — run jointly by the Houston Health Department and Rice University — levels of COVID-19 in wastewater samples in the city, as of June 6, are 502% compared to baseline in July 2020.

This is similar to levels seen during the delta surge, which peaked at 539% compared to levels in July 2020.

Dr. Wesley Long, medical director of microbiology at Houston Methodist Hospital, told ABC News that because transmission levels are high — not low or medium as indicated by the CDC in most Texas counties — it’s important for more people to get tested.

“What I would like to see change is for people to still be mindful,” he said. “Certainly, if they have symptoms, even if they’re mild symptoms, to get tested so that they know they’re negative or so that they can take the proper precautions and don’t continue to spread the virus.”

Dr. James Cutrell, an infectious disease physician at UT Southwestern Medical Center in Dallas, told ABC News he recommends people not just look at the CDC transmission map but also data on trends to see if cases are rising or falling and assess their personal risk.

“People who are fully vaccinated and boosted may be able to be more liberal in terms of what they feel comfortable whereas others who may have medical conditions or live with those who are more medically vulnerable need to consider being a bit more cautious,” Cutrell said.

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Gay men push back on body shaming amid high rates of body dysmorphia, eating disorders

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(NEW YORK) — A growing number of gay men are publicly pushing back against what they say is bullying within the gay community over how they look, and in many cases using social media to do so.

Sam Coffie, who calls himself full-figured and posts his body with pride on social media, said as a gay man he has seen his dating life impacted by his appearance.

“I’ve had someone actually say, ‘If you lost a little bit more weight, I think we could go on a date,'” Coffie told ABC News’ Good Morning America.

Coffie said he feels gay culture in the United States has an “unwritten” and “unspoken” Adonis complex. The term refers to the anxiety and insecurity boys and men experience about their appearance and body image, according to The Adonis Complex, a book published in 2000 that gave the condition its name.

“People internalize, ‘I have to create this body image. I have to live up to this. I have to fight for this. I have to strive for this. I have to starve for this. I have to almost die for this in order for me to have my moment of worth here,'” said Coffie.

Nicko Cassidy said he has also faced body shaming as a gay man, explaining that body expectations he faced in college led him to extreme dieting.

“I think it’s definitely deep rooted the shame from childhood and growing up just to be who we are,” said Cassidy, adding that he faced taunts of being “so gay” and “fat” while in college. “And I think that shame kind of comes out and portrays it as like a little bit more of a superficial.”

Data shows that gay men have higher rates of eating disorders and other body image issues.

According to the National Eating Disorder Association (NEDA), gay males are thought to only represent 5% of the total male population but among males who have eating disorders, 42% identify as gay.

In addition to facing eating disorders, gay men had lower self-esteem related to their bodies and greater concerns for physical attractiveness when compared to straight men, according to a study published in the Journal of Consulting and Clinical Psychology.

As with all populations, body dysmorphia and eating disorders in the gay community can often be fueled by social media, experts say, including dating apps and posts that showcase a false notion of the perfect man.

Experts say the body shaming some gay men experience comes with medical risks.

“The pursuit of the ideal body or the pursuit of perfection can certainly be damaging,” said Jason Whitesel, an Illinois State University professor and the author of Fat Gay Men: Girth, Mirth, and the Politics of Stigma. “When you think about body dysmorphia, it may be associated with eating disturbances and that kind of pursuit can lead to depression, anxiety, self-esteem issues.”

Dr. Jennifer Ashton, ABC News chief medical correspondent and a board-certified OBGYN, described body shaming in the gay community as a “medical issue.”

“There are associated medical risks here. It’s not just a cosmetic issue,” said Ashton, noting that body dysmorphia is associated with an increased risk of depression, anxiety, substance abuse and a higher associated risk of death.

According to Ashton, a misconception when it comes to body image and eating disorder struggles is that friends and family can help by trying to reason with the person, when those struggles are in fact psychological conditions.

“The theory in psychology and psychiatry is that this is a detachment from reality,” said Ashton. “Oftentimes it’s the only way that person can exert any control over his or her life, by controlling what they look like and what they eat.”

She continued, “It’s not as simple as you’re just wanting to look like a magazine ad. It’s a true psychiatric and psychological condition.”

For people who are struggling, Ashton said her number one advice is to seek professional help.

“As intimidating and scary as that may seem, there is help available,” she said.

The National Eating Disorder Association has an eating disorder screening tool that is free and available online for people ages 13 and older.

The association also has a free helpline that is available by phone and text at 800-931-2237 and online chat HERE.

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Dr. Anthony Fauci tests positive for COVID

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(WASHINGTON) — Dr. Anthony Fauci, a senior adviser to the president on the pandemic, has tested positive for COVID-19.

Fauci, 81, hasn’t had recent close contact with President Joe Biden or other senior officials, according to the National Institute of Allergy and Infectious Diseases.

Fauci, who has mild symptoms, tested positive via a rapid antigen test, according to the NIAID.

He’s fully vaccinated and received two boosters, the NIAID said in a statement.

“Dr. Fauci will isolate and continue to work from his home,” the statement said. “Dr. Fauci will follow the COVID-19 guidelines of the Centers for Disease Control and Prevention and medical advice from his physician and return to the NIH when he tests negative.”

This is a developing story. Check back for updates.

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Process begins to get vaccines to kids under 5, the last remaining group

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(WASHINGTON) — Parents with young kids are one step closer to getting them vaccinated following a grueling wait for the last remaining group to be authorized for a vaccine.

The process for authorization and recommendation from the regulatory agencies kicked off Wednesday with a meeting of the Food and Drug Administration’s committee of independent experts.

The committee is scheduled to review the data on both the Moderna vaccine for kids under 6, which is a two-dose vaccine, and the Pfizer vaccine for kids under 5, which is a three-dose vaccine.

Though kids have generally had less-severe cases of COVID-19 than older adults, there have still been nearly 500 deaths in kids under 5 and over 30,000 hospitalizations in the U.S.

“We are dealing with an issue where I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important. And vaccine-preventable deaths are ones that we would like to try to do something about,” said Dr. Peter Marks, who runs the vaccine division at the FDA.

“Granted, it’s a population that has been much less affected than the older populations, particularly the oldest population, but one nonetheless that has also been affected. And I think for those who have lost children to COVID-19, our hearts go out to them, because these are — each child that’s lost essentially fractures a family,” Marks told the committee on Wednesday.

Officials from Pfizer and Moderna stressed Wednesday that their vaccines are safe and effective at protecting young children against COVID-19.

Both companies reported mild reactions to the shots. Among young children, fevers and pain at the injection site were the most common symptoms reported following the shot, with most post-vaccination symptoms resolving in a matter of days.

“These pediatric groups represent a more vulnerable population, so it is particularly important to minimize reactions, including fever, while achieving an immune response likely to provide protection against COVID-19,” said Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer.

Neither Moderna or Pfizer reported any cases of myocarditis among the youngest children.

And the impact spans wider than the statistics. Parents with kids too young to be vaccinated have dealt with constant child care interruptions from COVID-19 scares and two years of mitigation strategies even after most people in the country dropped their masks.

Once the FDA committee votes on Wednesday, the process moves to FDA leadership to officially authorize the vaccines. If that happens, the administration can start shipping out vaccines to states.

Then, on Friday and Saturday, the Centers for Disease Control and Prevention’s advisers will meet to review the data on both vaccines.

The final step in the process is a recommendation from CDC Director Rochelle Walensky, after which shots can be administered in doctors’ offices, clinics, hospitals, pharmacies and other locations.

Vaccines are expected to be available as early as the week of June 21, if the review processes find the vaccines safe and effective.

The Biden administration estimates that 85% of children under the age of 5 live within 5 miles of a potential vaccination site, an administration official said.

But it will be an uphill battle to convince parents to vaccinate their young kids, if polling is any indication. A recent survey from KFF found that just 1 in 5 parents are eager to vaccinate their kids right away.

Federal officials said they plan to lean into existing networks to get vaccine information out to families, like the American Academy of Pediatrics, mom blogs and PTAs, as well as groups specific to communities of color, like the League of United Latin American Citizens.

“We have learned from our previous campaigns, and one of the most important lessons that we’ve learned is that we know who people listen to when making decisions, and there are trusted people in their lives,” a senior administration official said.

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Study on child hepatitis cases points to prior COVID infection, but experts say too soon to know

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(NEW YORK) — A new study points to prior COVID-19 infection as a possible culprit for the global wave of severe hepatitis cases among children — though experts caution the true cause is still a medical mystery.

Researchers in Israel added evidence for the theory in a small study published in the Journal of Pediatric Gastroenterology and Nutrition, suggesting some children might develop liver inflammation in the weeks after recovering from a mild COVID-19 infection.

While the root cause of the pediatric hepatitis outbreak is still unknown, experts say the leading theories include COVID-19 infection, infection with a common cold virus, or an interplay between the two infections, according to Dr. Alok Patel, a pediatric hospitalist at Stanford Health and an ABC News medical contributor.

In a new twist, a U.S. Centers for Disease Control and Prevention analysis published Tuesday found that there may not be a spike in cases at all — at least not in the United States. CDC scientists said the number of severe hepatitis cases observed in recent weeks is relatively consistent with pre-pandemic levels, but urged public health authorities to continue to monitor the situation.

“I think it is too early as CDC [is] looking at U.S. data and U.S. has not been hit as hard as other countries like U.K.,” said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco.

More than 700 children across the globe have been found to have probable cases of severe hepatitis with an unknown cause, officials from the World Health Organization said in a press conference last Wednesday.

At least 38 children have required a liver transplant, and 10 children have died, the WHO says. Additionally, 112 cases are also under investigation, and a total of 34 countries have reported cases to date.

As the mystery deepens, scientists across the globe are racing to understand whether — and why — children are falling ill with severe hepatitis in higher numbers.

Severe hepatitis, or liver inflammation, is often prompted by an infection, but not always. It is unusual among children, and most often seen in adults who have been living with alcoholism or an undiagnosed infection for decades, slowly causing liver damage.

During a global investigation, the WHO found that about two-thirds of children tested positive for a common cold virus called adenovirus 41 — which quickly became one of the leading theories. Only about 12% of children had COVID-19 at the time they developed severe hepatitis.

Because most of the children were too young to be vaccinated, the COVID-19 vaccine was ruled out as a possible cause.

“The latest Israeli study adds just a little gasoline to the fire to try to understand the causes of the mysterious hepatitis in children,” said Chin-Hong.

However, he said the study was too small to be conclusive.

In the study, researchers described five cases of children ranging from 3 months to 13 years old who recovered from COVID-19 and later developed severe liver inflammation, some requiring liver transplants.

If true, this type of delayed reaction to a COVID-19 infection would mirror the rare multi-organ syndrome MIS-C that affects children weeks and sometimes months after COVID-19 infection.

It’s possible children may be experiencing “an autoimmune reaction from a viral infection causing hepatitis, where the child’s immune system attacks their own liver cells in an attempt to combat the virus,” said Dr. Madhu Vennikandam, a gastroenterology fellow at Sparrow Health System.

However, the CDC cautions the cause remains unknown and a global research effort spearheaded by the WHO is ongoing.

“The silver lining in all of this is that vaccines for children under 5 are on the cusp of approval in the U.S.,” said Chin-Hong.

If COVID-19 indeed “has a central role to play in all of this, we should eventually start seeing cases drop,” he said.

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WHO to assess whether monkeypox outbreak is a public health emergency

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(NEW YORK) — The World Health Organization said it is planning to assess whether the monkeypox outbreak spreading around the world is a public health emergency.

According to Global Health, more than 1,700 monkeypox cases have been identified in non-endemic countries, mostly in Europe and North America.

In the U.S., there are 65 confirmed or suspected cases in 17 states and the District of Columbia, data from the Centers for Disease Control and Prevention shows.

Because of the highly unusual nature of the outbreak, WHO Director-General Dr. Tedros Adhanom Ghebreyesus said he has decided to convene an emergency committee under the International Health Regulations next week.

“The global outbreak of monkeypox is clearly unusual and concerning,” he told reporters during a briefing on Tuesday held in Geneva. “I think it’s now clear that there is an unusual situation meaning even the virus is behaving unusually from how it used to behave in the past.”

He continued, “But not only that, but it’s also affecting more and more countries and we believe that it needs also some coordinated response because of the geographic spread.”

The first case of monkeypox among humans was recorded in the Democratic Republic of the Congo in 1970, and the illness has since spread to several other nations, mostly in central and western Africa.

Typically, the disease does not naturally occur on other continents, and infections are usually identified among people who recently traveled to countries where monkeypox is more commonly found.

However, lately the virus has been identified in people with no history of travel or known contact with anyone who tested positive for monkeypox, which many indicate evidence of community transmission.

According to the National Library of Medicine, between 2007 and 2020, there have been six events declared public health emergencies of international concern.

These include the H1N1 influenza pandemic of 2009; the Ebola outbreak in West Africa from 2013 to 2015; the Ebola outbreak in the Democratic Republic of the Congo from 2018 to 2020; the Zika outbreak in 2016; the ongoing spread of poliovirus that started in 2014; and the ongoing COVID-19 pandemic.

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FDA committee clears the way for kids 6-17 to get another vaccine option in Moderna

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(WASHINGTON) — A committee of advisers at the Food and Drug Administration voted unanimously Tuesday in favor of authorizing the Moderna vaccine for kids ages 6 through 17, paving the way to add one more vaccine to the options available for this age group.

Currently, only Pfizer’s vaccine is available for kids over 5 years old. Moderna’s vaccine, which was stalled in the regulatory process for months, would give parents another option.

The process to get Moderna’s vaccine out to pharmacies and clinics now moves to FDA leadership, which must decide whether to issue an official emergency use authorization of the vaccine.

After that, the Centers for Disease Control and Prevention’s team of advisers will review Moderna’s data, and finally, CDC Director Rochelle Walensky will issue her recommendation.

It’s not clear whether adding Moderna as another option in the vaccine arsenal will move the needle for uptake in the kids and adolescent age group.

More than 25.4 million eligible kids between the ages of 5 and 17 are still unvaccinated, and only about 44% have been fully vaccinated.

At the meeting before FDA’s advisory committee on Tuesday, though, Moderna representatives argued there was a significant need for a second vaccine because of the continued threat of COVID-19 among kids.

“Recent data have shown that approximately 25% or one in every four children and adolescents hospitalized due to COVID-19 require ICU intervention,” said Carla Vinals, Moderna’s vice president of regulatory affairs strategy for infectious diseases.

Emory associate professor Dr. Evan Anderson, who works with Moderna, presented an analysis showing that COVID-19 is worse than the flu — killing more children ages 5 to 17 than any other vaccine-preventable disease.

Moderna scientists said their vaccine would prevent pediatric hospitalizations if authorized. They estimate the two-dose Moderna vaccine would prevent 95 hospitalizations per 1 million kids ages 5 to 11 and 200 hospitalizations per 1 million kids ages 12 to 17.

The FDA also cleared the air on the issue that delayed Moderna’s authorization for this age group — the potential for the rare incidence of heart inflammation called myocarditis.

Data for international surveillance had suggested a higher risk for myocarditis following vaccination with Moderna compared to the Pfizer-BioNTech vaccine. But after looking into it, those concerns subsided.

The FDA did not find a “statistically significant” difference in risk when comparing the two vaccines, officials said Tuesday.

The risk of myocarditis is also primarily seen among males 18 to 25. Moderna’s vaccine is only for kids and adolescents ages 6 to 17.

If authorized, Moderna’s vaccine dosing would be 100 micrograms for 12- to 17-year-olds, or the same as the adult dose, and 50 micrograms for 6- to 11-year-olds, which is half the adult dose.

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Surgeon general says kids need to be part of solution amid youth mental health crisis

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(LOS ANGELES) — Facing a growing mental health crisis among America’s teens and young adults, U.S. Surgeon General Dr. Vivek Murthy says the problem is not something adults can fix alone.

Adults need “to make sure that we’re hearing from kids so that their stories are our guiding light,” Murthy said. “Ultimately, we will know when we’ve reached the finish line when they’re doing well and they tell us they’re doing well and when data tells us that as well.”

After declaring a national advisory on the youth mental health crisis late last year, Murthy is now participating in a two-day conference called the Youth Mental Wellness Now! Summit, hosted by The California Endowment.

“I’m also particularly excited that we’re going to have a chance to hear from young people here in L.A. today,” Dr. Murthy told ABC News.

According to Murthy, adults need to hear directly from the youth what the problems are, and what they can do to help. The summit will feature actors and activists including Kendrick Sampson, best known for his roles in Insecure, The Vampire Diaries and How to Get Away with Murder, and Jordyn Woods, a model, actress and mental health advocate.

They will join California-based youth leaders Ja’Nell Gore from South Kern Sol whose parent company is YR Media, and Xochitil Larios from Communities United for Restorative Youth Justice in a fireside chat with the surgeon general.

The purpose of the youth-led summit is to create a national movement around youth mental health led by young people through the sharing of stories and to galvanize organizations to commit to support. They have concrete commitments in excess of $255 million.

Other organizations partnering with The California Endowment to host the event include The Steve Fund, California Children’s Trust, Youth Organize! California, YR Media and Revolve Impact.

Sometimes, the voice of young people is missing from initiatives to help them, but a strength of this summit is the central role young voices have.

“We wanted young people center stage,” said Dr. Bob Ross, CEO of The California Endowment. “We wanted to make sure that any go-forward strategy for investing in access to mental health services and optimizing the mental health and well-being of young people would be informed with young people as the experts, and additionally, having important and key adult allies more as listeners than talkers. You know, a lot of times you have these conferences, and it’s the expert adults that are doing all the talking.”

Gore emphasized that one importance of this summit is that “youth need to be able to hear other young people tell them that it’s OK to struggle with things.”

“This [is] like one of the first conferences of its kind,” said Jasmine Dellafosse, a nationally recognized youth activist who will emcee the summit.

“Often young people across California have been showing up and trying to address these issues for decades,” she said. “It’s actually an opportunity to connect policy and change with actual voices on the ground, and young people who were championing, you know, the issues in their communities while also still being extremely under-resourced.”

Murthy blames the youth mental health crisis on loneliness, isolation, economic hardship, uncertainty, and online and offline bullying, which were exacerbated by the coronavirus pandemic. Other existential challenges like climate change, racism and violence in the community have also caused youth to lose hope.

In addition to these factors, Ross highlights “exposure to trauma in early childhood,” often rooted in race, social factors, the criminal justice system and violence, as being a primary cause of the crisis. He also acknowledged the “stigma behind mental health and seeking mental health supports” as perpetuating the crisis.

Murthy said the government’s three-pronged approach to addressing the crisis is to “expand access to treatment,” “invest in prevention,” “and eradicate the stigma around mental illness, which still prevents youth from coming forward and asking for help.”

In a show of solidarity, more than 30 organizations to date have announced 75 commitments in response to the surgeon general’s call-to-action.

To aid with expanding access to mental health services, the Vista Group has committed to investing $250 million over the next three years into U.S. providers of adolescent and youth mental health services. Pinterest has also designated more than a third of their $10 million commitment to advance emotional well-being to support NGOs (non-government organizations) and nonprofits focused on youth to expand access.

The UCLA Center for Scholars & Storytellers will partner with Disney Branded Kids, CAA, Joy Coalition, YouTubeKids and leading showrunners to research best practices on how to incorporate mental health messaging to positively impact youth through their programming and marketing. The CW is committed to developing storylines in its programming to inform and support audiences.

Other organizations are committed to supporting youth utilizing digital technologies. Meta plans to enhance parental supervision controls and introduce a new feature called “nudges,” which are notifications that encourage teens to switch to a different topic if they’re repeatedly looking at the same topic.

“Today, again, it’s just a step forward,” Murthy said. “We’re not done until every child in America has access to good mental health care.”

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