Health

(NEW YORK) — Current COVID-19 cases are just a fraction of what they were at the peak of the omicron wave.

But many people in the country may be noticing what seems to be a flood of cases in their social circles.

Health experts say this anecdotal evidence may not be simply coincidence, as the U.S. may be in a “hidden” wave — one much larger than reported data would suggest.

“There’s a lot of COVID out there. I see it in my social circles, in my kids’ schools and in the hospital employee infection numbers,” Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center in Boston, told ABC News. “We are clearly in a wave.”

Although it is clear that infection rates have been steadily rising in recent weeks to their highest reported level since mid-February, scientists acknowledge that it is difficult to know how high COVID-19 case and even hospitalization numbers truly are, given the likely “substantially” undercounting of infections.

This is due in part to changes in data collection and reporting and the proliferation of at-home tests. Some state officials report that health departments and healthcare facilities have also ended traditional tracking of COVID-19 patients, which epidemiologists say make it more difficult to know how many patients are coming into hospitals in need of care.

Last month, former Food and Drug Administration Commissioner Dr. Scott Gottlieb estimated that officials were likely only picking up “one in seven or one in eight” infections.

And President Joe Biden’s new coronavirus response coordinator, Dr. Ashish Jha, acknowledged that there are “a lot of infections” last week, likely the result of highly infectious omicron subvariants spreading across the country.

“We know that the number of infections is actually substantially higher than that. It’s hard to know exactly how many but we know that a lot of people are getting diagnosed using home tests,” Jha explained.

More than 100,000 Americans officially testing positive every day

The nation’s reported daily case average, which officials say consists largely of PCR tests, now stands at more than 100,000 new cases reported a day, according to data from the Centers for Disease Control and Prevention (CDC).

In recent weeks, nearly every state in the country has reported an increase in COVID-19 infections and the number of virus-positive people who are admitted to the hospital.

The Northeast remains the nation’s most notable known COVID-19 hotspot, though surges in some cities, like Boston, appear to be showing initial signs of slowing.

Nationally, according to the CDC’s community levels, more than 45% of Americans live in an area with a medium or high COVID-19 risk.

The high community level suggests there is a “high potential for healthcare system strain” and a “high level of severe disease,” and thus, the CDC recommends that people wear a mask in public indoor settings, including schools.

Hospitalization numbers have been increasing in recent weeks, but not at a rate as significant as infections.

However, over the course of the spring and winter, hospitalization data, too, has become less accessible, leading some experts to suggest patient totals could also be undercounted.

Earlier this year, the Department of Health and Human Services ended the requirement for hospitals to report several key COVID-19 metrics, including a daily total of the number of COVID-19 deaths, the number of emergency department overflow and ventilated patients and information on critical staffing shortages.

Further, certain states have stopped outright reporting of statistics including hospital bed usage and availability, COVID-19 specific hospital metrics and ventilator use.

However, Doron said a possible significant surge in infections, without an overwhelming number of hospitalized COVID-19 patients, could be a promising sign.

“If cases are really a lot higher than what we are seeing, it means the ratio of hospitalizations to cases and deaths to cases is even lower than what we are seeing, and we are already seeing a ‘decoupling’ between cases and hospitalizations and deaths,” Doron said, which could indicate the virus is moving closer to a form that Americans can live with.

Even so, Doron added, “at a population level, however, COVID poses more risk because there are so many cases, and hospitals are already so full with both COVID and non-COVID patients.”

A shift away from traditional testing

In recent months, states from coast to coast, have moved to shutter public testing sites, with an abundance of rapid COVID-19 tests now available in pharmacies and through the federal government.

“While home testing has created broader population access to infection status and hopefully better access to treatment, it has also created a major blind spot in our public health surveillance efforts,” John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital and an ABC News contributor, said. “The latest BA.2 surge was masked by the shift in testing behavior and likely delayed decisions on public health interventions.”

The shift away from traditional COVID-19 testing has left some health experts worried about continued issues of access to adequate healthcare and preventative health tools, such as testing and antiviral treatments, to protect vulnerable communities.

According to ABC News’ analysis last summer of pharmacy locations across the country, there are 150 counties where there is no pharmacy, and nearly 4.8 million people live in a county where there’s only one pharmacy for every 10,000 residents or more.

“What concerns me even more is what might be happening in communities and among families with fewer resources. Public testing sites have closed, home tests are expensive at the drugstore, and navigating the system to order free tests or get tests reimbursed by insurance requires literacy and technology,” Doron said.

Broader insights on infection through home testing and wastewater sampling will be critical in the future to fully understand the scope of surges and protect all Americans, Brownstein said.

Virus not disappearing in low-transmission counties

This winter, following the omicron surge, the CDC released a new risk level map, which shifted away from focusing on the level of transmission within a community, and rather shifted the attention to hospital capacity and admission levels.

The rollout of the new map, which aims to help people and local officials assess when to implement potential mitigation measures, caused controversy among some Americans, explained Doron. While some people argued the shift in metrics was long overdue and a sign of the times, others said the move was premature.

“Some people were happy because they felt that we were beyond the time period in which we needed to reimpose restrictions and mandates every time cases increased, given widespread population immunity from vaccination and infection,” Doron said. “It made other people angry because a transition to a medium or high-risk status now requires increases in hospitalizations, which are lagging indicators, in other words there can be a lot of cases before hospitals get full, and some people might choose to take extra precautions sooner.”

Brownstein noted that given the shift away from transmission rates, some Americans may not be fully aware of the continued dangers of the virus, as a green county is not necessarily indicative of the virus simply disappearing.

“While the CDC map reflects decreased risk of severe complications from COVID infection, it unfortunately hides places with high community transmission,” Brownstein said. “This masking of risk may provide a false sense of security especially to those at high risk of hospitalization and death.”

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(NEW YORK) — At least 19 children and two adults are dead after a shooting at Robb Elementary School in Uvalde, Texas, according to the Texas Department of Public Safety.

The 18-year-old suspect, who is also dead, was a student at Uvalde High School, according to Texas Gov. Greg Abbott.

The governor said the suspect also allegedly shot his grandmother before entering school premises, but did not give any details about her condition.

In the wake of the deadly mass shooting, many parents are left grappling with how to explain the horrific act of gun violence — at a setting where most kids spend a majority of their days — to their children and teens.

“For the majority of students, school is a safe and supporting environment,” Dr. Robin Gurwitch, a licensed clinical psychologist and professor at Duke University Medical Center, told ABC News in 2018, after 17 people, including students, were killed at Marjory Stoneman Douglas High School in Parkland, Florida.

“So when a shooting happens at a school, it undermines our sort of worldview about where I can be that is a safe place,” she added.

Gurwitch, a member of the National Child Traumatic Stress Network, broke down how parents can discuss the news with their children, and how to help them to feel safe in the aftermath of the harrowing headlines.

Parents should initiate a conversation

Gurwitch stressed that in situations like a mass tragedy, it is “extremely important” for parents and caregivers — especially those with children in high school — to “be willing to bring this topic up.”

“We really want to want to wrap our arms around them and make them feel safe,” she added. “But part of being a parent is willingness to discuss difficult topics.”

“To believe that our children don’t know that these events occur is wishful thinking,” Gurwitch said. “We live in an age where we can go online and see live feed of people leaving the school, of responders, it’s updated every few moments.”

Gurwitch suggests that if you are watching the news with your children, turn it off and talk about the events calmly in order to get an idea of what they know, where they are coming from, and what misconceptions they may have already heard.

It is also critical to reassure children that parents and adults at their school “are going to do everything we can to make you safe,” Gurwitch added.

“Let them know that their school has plans in place to do everything to the best of their ability to make them safe,” she said.

Adapt the conversation based on your child’s age

Gurwitch emphasized that the conversation about the news should vary based on the age of your child.

“I use the analogy ‘it is the same as having a conversation about where do babies come from’ — it is a very different conversation if I’m talking to a preschool or elementary school student than if I’m talking to a high school student,” Gurwitch said.

When it comes to children preschool age and below, she added that parents should limit their media exposure.

“Preschoolers may not understand instant replays,” she said. “So that loop of children running out of the school, if they don’t know that that’s a replay, they think that school has thousands and thousands of students.”

For high school and older middle school age students, Gurwitch recommends addressing the incident directly, saying that you want to talk to them about the school shooting that happened and asking them what they know about it.

For children younger than that, Gurwitch recommended initiating the conversation by saying, “There was a very sad thing that happened at a school … today. It is very sad because people were hurt and people were killed, and I just want you to know about it if you hear kids talking about it at your school, and if you have any questions, you can talk to me.”

Regardless of your child’s age, Gurwitch stressed that parents should “most importantly show a willingness to answer questions,” and listen to their children’s concerns.

“Younger children may ask the same question over and over again,” she added. “That is how they process information.”

How to respond if your child says they don’t feel safe going back to school

If your child or teen says they do not feel safe going back to school, Gurwitch emphasized that it is important not to invalidate their feelings, but to talk about them.

“Say, ‘Tell me what it is that you’re worried about? What it is that you don’t feel safe about?'” she said. “Validate why your child may not feel safe. If we just discount it with a throwaway, ‘You are going to be fine,’ we shut down the conversation.”

Gurwitch added that you can reassure your child that “nowadays schools do have safety plans, and schools do practice shooting drills.”

“Some people are concerned about practicing these drills, but it’s like fire drills, it doesn’t make kids more scared that fires are going to break out, it makes students feel more secure that they have a plan in place,” she said.

“Be patient and supportive as children are trying to make sense of how something so horrific can happen at a setting where I go to be with friends, to learn,” she added.

Check back in

“I think that is really important to check back in tomorrow, to check back in the next day, to find out what are your friends talking about related to this school shooting,” Gurwitch said. “It is very important to get an understanding of how children are coping.”

“When there is a tragedy … a one-and-done conversation is not sufficient,” she added. “Let your child or teenager know that ‘I really do care about you and I am open to having this discussion.'”

If you notice your child or teen is distressed for a longer period of time, and Gurwitch added this may show up in “problems with sleep, problems with attention and focus, and increased irritability,” she recommends that parents reach out to their school guidance counselor, a local psychological association or even their pediatrician for further help.

The National Child Traumatic Stress Network offers comprehensive resource guides for parents, caregivers and educators to support students. Click HERE for resources related to school shootings.

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(NEW YORK) — A recent viral TikTok food hack has been dubbed unsafe by the U.S. Food and Drug Administration.

Videos of halved avocados submerged in bowls or containers of water have bubbled up on TikTok and other social media platforms over the past few months. Creators and commenters alike were stunned to see the vibrant green flesh of the popular fruit still seemingly perfect after removing it from the water to use it without scraping off its usual oxidized brown layer.

But an FDA official told ABC News’ Good Morning America the agency “does not recommend this practice.”

“The main concern is with the possibility that any residual human pathogens (i.e. Listeria monocytogenes, Salmonella spp., etc.) that may be residing on the avocado surface may potentially multiply during the storage when submerged in water,” the official said in a statement to GMA.

“In addition, research performed by FDA scientists has shown that Listeria monocytogenes has the potential to infiltrate and internalize into the pulp of avocados when submerged in refrigerated dump tanks within 15 days during refrigerated storage,” they added. “In this case, even surface disinfecting the avocado skin prior to slicing would not be able to remove the contamination.”

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(NEW YORK) — Billie Eilish is opening up about living with Tourette’s syndrome.

In a new episode of David Letterman’s series My Next Guest Needs No Introduction, the singer, who was diagnosed at the age of 11, spoke about her tics and living with the disorder.

During the interview, Eilish appeared to start “ticcing.” When Letterman asked about it, she said, “It’s really weird; I haven’t talked about it at all.”

She added, “I’m very happy to talk about it. I actually really like answering questions about it because it’s really interesting, and I am incredibly confused by it. I don’t get it.”

The “Happier Than Ever” singer then detailed her various tics, including wiggling her ear, raising her eyebrow, clicking her jaw, moving her head, opening her mouth and flexing various muscles in her arms.

“These are things you would never notice if you’re having a conversation with me, but for me, they’re very exhausting,” she said.

Eilish said she had been unhappy with her tics, but now, she told Letterman, they’re a “part” of her. “I have made friends with it, so now I’m pretty confident in it,” she said.

“So many people have it and you’d never know. A couple [other] artists have come forward and said, ‘I’ve always had Tourette’s,'” Eilish revealed. “And I’m not going to out them because they don’t want to talk about it. But that was really interesting to me because I was like, ‘You do? What?'”

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(NEW YORK) — Pfizer’s release of data showing its three-shot COVID-19 vaccine is 80% effective among children under the age of 5 is welcome news for parents anxious to get their young children vaccinated more than two years into the COVID-19 pandemic.

With the Food and Drug Administration (FDA) set to meet in June to review data from both Pfizer and Moderna, a COVID-19 vaccine could be widely available to everyone in the United States ages 6 months and older by July.

The news comes as the U.S. is experiencing another COVID-19 wave, with cases rising in nearly every state and official infection numbers up to more than 100,000 per day, according to the Centers for Disease Control and Prevention (CDC).

In the U.S., 28% of 5- to 11-year-olds and 58% of 12- to 17-year-olds are fully vaccinated against COVID-19, according to the American Academy of Pediatrics’ analysis of CDC data.

“I think we all want to be done with this pandemic but unfortunately, it’s not quite done with us,” said Dr. Sean O’Leary, vice-chair of the AAP’s committee on infectious diseases. “We are in a much different place than we were two years ago in terms of both the therapeutics that are available to treat the disease and the vaccines, showing a decreased spread of the disease and a decrease in hospitalizations.”

O’Leary, also a pediatrician and professor of pediatrics at the University of Colorado and Children’s Hospital Colorado, spoke to ABC News’ Good Morning America to answer parents’ top trending questions about the COVID-19 vaccine and kids.

1. What does the Pfizer vaccine efficacy news mean?

Earlier this year, Pfizer moved forward with studying three doses of its COVID-19 vaccine for kids 6 months to under 5 years old after disappointing data on a two-dose vaccine.

The new data released by the company Monday shows the three-dose vaccine is effective in kids, which means the vaccine is one step closer to being authorized by the FDA, according to O’Leary.

“This was really the news we’ve been waiting for from Pfizer on whether or not this third dose was going to meet the requirements required from the FDA,” he said. “The immune response that the vaccine provided for the children in the trial was similar to the immune response that we saw in older adolescents and adults in who we know the vaccine is effective in preventing infection, hospitalization and death.”

In addition to being effective, the new data also shows the three-dose vaccine “appears to be safe,” O’Leary said.

2. What happens next for the Pfizer and Moderna vaccines for young kids?

Next month, FDA advisers will meet to discuss the COVID-19 vaccine applications for kids from both Pfizer and Moderna, which submitted its request to the FDA in April.

The FDA has tentatively scheduled the meetings for June 14 and 15, during which advisers will review applications for Moderna’s COVID-19 vaccine for kids ages 5 to 17 and ages 6 months to under 6 years, as well as Pfizer’s vaccine for kids ages 6 months to under 5 years.

Within one or two days of the FDA meetings, the applications go to a CDC advisory committee. From there, the director of the CDC, Dr. Rochelle Walensky, decides on whether or not to grant emergency use authorization for the vaccines.

With that timing, we could see a vaccine for kids under age 5 approved by the beginning of July, according to O’Leary.

Pfizer’s vaccine is currently available for people ages 5 and older, while Moderna’s vaccine is authorized for people ages 18 and older.

3. Do kids under 5 get the same vaccine as adults?

The dosage of the vaccine is different for children than it is for adults, but the vaccine itself is the same for everyone, according to O’Leary.

If authorized, Pfizer’s vaccine dosage for kids ages 6 months to under 5 years would be three shots of 3 micrograms each. Each dose is one-tenth the adult dose.

Moderna’s vaccine for kids under age 6, if authorized, would be a two-dose, 25-microgram shot, about one-quarter of the dose used for adults, given 28 days apart.

4. How do I know the COVID-19 vaccine is safe for my child?

Pfizer’s newly-released data on its three-dose vaccine for kids under age 5 showed “no significant safety” concerns, according to O’Leary.

The fact that a vaccine for the youngest children is coming after the vaccine has already been delivered to hundreds of millions of people around the world should bring comfort to parents, O’Leary said.

“There is no reason to expect in this age group that we’re going to have some kind of different safety profile than what we saw in children, for example, 5 and older, in whom millions and millions of doses have been given,” he said. “So we have a pretty good understanding of the safety profile.”

The CDC has also released multiple studies over the past year showing COVID-19 vaccines are safe and effective for older children.

Overall, O’Leary said parents should remember that, based on data, the benefits of the COVID-19 vaccine in protecting kids outweigh any potential risks.

“I think we all know that the disease is most severe in the elderly and people who have problems with their immune system, but that’s not to say that COVID-19 is a benign illness in children,” he said. “We’ve seen tens of thousands of hospitalizations in children, and the risk to children under 5, actually, for hospitalization is higher than it is for older children, so absolutely there is a need to protect those children with the vaccine.”

For parents of children of all ages who may be on the fence about getting their child vaccinated, O’Leary said to speak with your child’s pediatrician.

“The best thing you could do is make an appointment with your pediatrician and talk with them about about the vaccine,” he said. “I think it is important to get those kids vaccinated but, on the other hand, I do understand why parents have some questions, and your best source of information is going to be your child’s pediatrician.”

5. How long after having COVID-19 can my child get a vaccine?

If a child has not been vaccinated against COVID-19 and contracts the virus, they can get vaccinated “as soon as they’re out of their isolation period, based on when they were infected and had symptoms,” according to O’Leary.

“It doesn’t need to necessarily be the next day but, in general, as soon as as they can to provide that protection,” he said.

For people who are not vaccinated, CDC guidelines are to quarantine at home for five full days.

6. How do I know if my child needs a booster vaccine?

A booster dose of Pfizer’s vaccine was authorized earlier this month for children ages 5 to 11 years old.

A child in that age range must wait at least five months after completion of a primary series to receive the booster, according to the FDA.

“I do think it’s important,” O’Leary said of fully vaccinated people ages 5 and older receiving a booster dose. “The data have been fairly clear over the last several months, and particularly during this omicron wave, that this booster really matters in terms of prevention of the severe outcomes.”

7. What precautions should my family take until a vaccine for young kids is authorized?

O’Leary said families should continue to practice safety protocols including mask wearing for children ages 2 and older, hand-washing and social distancing.

“We know that crowded, indoor settings where people are not masked is one of the higher-risk places, so try to avoid those types of environments,” he said.

O’Leary also said parents should make sure their kids of all ages are up to date on all their vaccinations.

“Honestly, for children, a lot of the diseases, although we don’t see them anymore, are actually more severe in kids than COVID-19, things like measles,” he said. “Going into the summer is a perfect time to make an appointment with your pediatrician for a checkup and make sure your kids are up to date on their vaccines.”

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(NEW YORK) — The number of births increased in the United States for the first time in seven years, according to a new federal report.

Provisional data published Tuesday from the Centers for Disease Control and Prevention’s National Center for Health Statistics found there were 3,659,289 babies born in 2021, a 1% increase from 2020.

It also marks the first rise in births since 2014. Prior to this report, the number of births had been decreasing by an average of 2% per year.

The report did not explain why the number of births increased, but Pew Research Center polls have suggested Americans delayed having babies during the first year of the pandemic due to public health and economic uncertainty, so the rising number could be the result of a rebound.

“​​When it comes to changes in fertility behavior, we’re limited,” Dr. Brady Hamilton, from the NCHS Division of Vital Statistics and lead author of the report, told ABC News. “That’s where you need a survey about what’s behind the decision-making process.”

The report also showed the fertility rate — the number of live births per 1,000 women between the ages 15 and 44 — was 56.6. This is up from 56 in 2020 and the first increase since 2014, according to the CDC.

However, the total fertility rate — the number of births a hypothetical group of 1,000 people would have over their lifetimes — was 1,663.5 births per 1,000 women.

This is still below what experts refer to as replacement level, the level a population needs to replace itself, which is 2,100 births per 1,000 women.

The team found birth rates among women aged 25 and older increased while decreasing for those aged 24 and younger.

“That sort of suggests [that] when we saw the decline in births from 2019 to 2020, probably a lot of births were postponed,” Hamilton said. “People were waiting to see what happened [with the pandemic] and rates rose in older women as they may have proceeded to have that child.”

Among teenagers aged 15 to 19, the rate of birth declined 6% from 15.4 per 1,000 to 14.4 per 1,000 — a record low for this age group.

Teenage births have been continuously falling since 2007 by an average of about 7% through last year.

“When you look at it across time, that’s a 77% decline since 1991 and 65% decline since 2017. That’s astonishing,” Hamilton said. “That’s certainly good news. And it will be interesting to see when we go into next year if it continues on.”

Meanwhile, for tweens and teens aged 10 to 14, the rate of birth was 0.2 per 1,000, which is unchanged since 2015, the report found.

Additionally, researchers also looked at births by race and found that white and Hispanic women each saw the number of births increase by about 2% from 2020 to 2021.

Meanwhile, Black and Asian women saw the number of births decline by 2.4% and 2.5%, respectively, over the same period, while American Indian/Alaskan Native women saw their numbers fall by 3.2%.

The report also examined the type of delivery and how early the babies were born.

Data showed that 32.1% of babies were born via cesarean delivery in 2021, up from 31.8% in 2020 and the second increase in a row after the rates had declined from 2009 to 2019.

The percentage of C-sections increased among all racial and ethnic groups, with the highest seen among Black women, from 36.3% to 36.8%.

While C-sections can lower the risk of death in women with high-risk pregnancies, they are associated with complications such as infection or blood clots, according to the Cleveland Clinic.

The preterm birth rate also rose by 4% in 2021 from 10.09% to 10.48%, which is the highest reported rate since 2007. Increases were seen in babies born early preterm, which is before 34 weeks gestation, and later preterm, which is 34 to 37 weeks gestation.

Premature babies are at a greater risk for problems with feeding, breathing, vision and hearing, as well as behavioral issues.

“Whenever you see an increase in preterm births, that’s concerning,” Joyce Martin, from the Division of Vital Statistics and co-author of the report, told ABC News. “And we saw an increase in early-term babies, and they’re at greater risk than later-term babies of not surviving the first year of life.”

Martin said it’s not clear what’s behind the rise in preterm birth rates but said mothers younger than 18 and older than 35 are more likely to have premature babies.

“And we did see an increase in older moms’ birth rates. It’s not clear if it influences this change yet,” she said.

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(NEW YORK) — With seven people in the U.S. now confirmed or presumed to have monkeypox, officials from the Centers for Disease Control and Prevention say the risk remains low and there’s no evidence the virus has evolved to be more transmissible.

“This is not COVID,” Jennifer McQuiston, deputy director of the Division of High-Consequence Pathogens and Pathology at the CDC, said during a media briefing Monday.

There is one confirmed positive case in Massachusetts. There is one presumptive positive case in New York, one in Washington state, two in Utah and two in Florida.

The CDC said Monday that the government is in the process of releasing some vaccines from its national stockpile. There is no need to vaccinate the general public against monkeypox, officials said. Rather, those vaccines will be used among a small number people who have been exposed.

Still, CDC officials cautioned that more cases are likely, and the agency is now raising awareness among men who identify as gay or bisexual.

“I think that we need to pay close attention to the communities in which this might be circulating, so that we can communicate effectively with them and help bring this outbreak under control,” McQuiston said.

Monkeypox is not a sexually transmitted infection, and anyone can become infected regardless of sexual orientation.

The virus, a less-transmissible cousin of smallpox, is passed through close contact with another person, including hugging, touching or prolonged face-to-face contact.

An early cluster of monkeypox cases in London was among a nuclear family who lived in the same household.

But health officials say many early clusters in Europe and Canada happened among groups of men who have sex with men, with some ongoing transmission reported in this community.

“Anyone — anyone can develop and spread monkeypox infection,” Dr. John Brooks, medical epidemiologist, Division of HIV/AIDS Prevention at the CDC, said. “But, many of those affected in the current global outbreak identify as gay and bisexual men. We want to help people make the best-informed decisions to protect their health.”

Specifically, the CDC is now warning people to watch out for a distinctive rash in the genital region, which could be confused with an STI.

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(NEW YORK) — In the wake of Pfizer’s new pediatric COVID-19 vaccine data for children under the age of 5, which was released on Monday, the Food and Drug Administration has set new, tentative dates for when its advisers will meet to discuss the COVID-19 vaccine applications for children.

The FDA said it expects its independent Vaccines and Related Biological Products Advisory Committee to convene in mid-June to discuss both Pfizer and Moderna’s pediatric COVID-19 vaccines.

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, said in a statement on Monday.

Although children 5 years and older already have access to a COVID-19 vaccine — and now a booster shot — through Pfizer’s two-dose vaccine, on June 14, the committee will meet to discuss Moderna’s emergency use authorization request for children ages 6 to 17 years of age.

The next day, on June 15, the committee will meet to discuss both Moderna’s emergency authorization request for children ages 6 months to under 6 years of age and Pfizer and BioNTech’s authorization request for children ages 6 months to under 5 years of age.

The new dates confirm the FDA anticipates that its advisers will review both Moderna and Pfizer’s applications for young children at the same time, which would indicate that both vaccines could be authorized by the end of June.

The FDA emphasized the dates are tentative, but officials noted that should any of the submissions be completed in a “timely manner and the data support a clear path forward following our evaluation,” the agency will move forward and convene the committee at an earlier or later date.

On June 8, 21 and 22, the FDA has held dates for its advisers to meet to discuss updates to the Moderna and Pfizer-BioNTech emergency use authorization requests. As more data and information is submitted by the companies, additional scheduling details will be released, officials wrote.

“The agency is committed to a thorough and transparent process that considers the input of our independent advisers and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed,” Marks said.

Ahead of an anticipated fall and winter surge, the FDA also announced new dates for the committee to discuss a possible new generation of COVID-19 vaccines, which could address already circulating variants.

The FDA also plans to convene its advisers on June 28 to discuss whether the COVID-19 strain composition of the vaccines should be modified for the fall.

Federal regulators are expected to decide on a new COVID-19 vaccine design in early July, which would allow vaccine companies to begin production for rollout this fall and winter.

“We’ll have to make some decision by early July to make sure that the manufacturers know what we’re looking to do, so that they know what they have to start producing in large quantities,” Marks told ABC News in an interview, last week.

Additionally, the FDA’s advisers are expected to meet on June 7 to discuss an EUA request for a COVID-19 vaccine manufactured by Novavax to protect against COVID-19 in individuals 18 years of age and older.

Novavax asked for emergency authorization of its protein-based vaccine earlier this year in January.

Novavax was part of the Trump administration’s Operation Warp Speed — the multibillion-dollar program that was created at the onset of the pandemic to quickly bring safe and effective vaccines to market.

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(NEW YORK) — In long-awaited data, Pfizer said its 3-dose vaccine was 80% effective against symptomatic omicron COVID-19 infection among children 6 months to under 5 years old.

The company cautioned that estimate was preliminary and could be adjusted as more data is collected. The trial wasn’t big enough to estimate protection against severe disease, which experts expect to be higher.
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For all age groups, vaccine efficacy against more mild breakthrough infections waned in the face of the highly transmissible omicron variant, but efficacy against severe disease and death remained high for most age groups.

Pfizer announced in December that it would not move forward with a two-dose vaccine after disappointing data, instead opting to study three doses for this age group. The company will submit the new data as part of its ongoing “rolling” submission to the FDA.

For anxious parents, the Pfizer news offers reassurance that the vaccine help protect young children currently not eligible for vaccination.

The news doesn’t change the overall timeline for when vaccines for this age group could be available. For the youngest Americans, vaccines from both Pfizer and Moderna are expected to be authorized in June or July, likely as a two-dose vaccine for Pfizer and a three-dose vaccine for Moderna, though Moderna is also studying a third dose.

Pfizer also said its vaccine was safe, with a similar safely profile as placebo shots. If authorized, this vaccine would be 3 shots of 3 micrograms each. Each dose is one-tenth the adult dose.

“We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” said Albert Bourla, Pfizer’s chairman and chief executive officer, in prepared remarks.

Moderna, meanwhile, asked the FDA for authorization on April 28 for a two-dose vaccine for this age range. Moderna’s preliminary analysis found its two-dose pediatric vaccine was 51% effective against symptomatic COVID-19 among children 6 months to under 2 years old, and 27% among children 2 to 5 years old — roughly the same efficacy seen in adults during the omicron surge. Protection against serious disease and death was higher.

“I anticipate a lot of parents will be asking whether they should choose a two-dose Moderna vaccine or the three-dose Pfizer vaccine,” said Dr. Alok Patel, pediatric hospitalist at Stanford Children’s health and an ABC News contributor. “I would recommend that parents pay attention to the FDA and CDC’s guidance and what final analysis reveals for both vaccines.”

Experts caution that vaccine efficacy against symptomatic infection is a high bar, and experts expect these vaccines will offer excellent protection against severe illness, just as they do for adults.

This development means Pfizer is one step closer to submitting its vaccine for an emergency use authorization. It will likely be reviewed by the FDA’s advisers at meetings on June 21 and 22, and if authorized, be available sometime in early July.

It’s possible that the FDA’s advisers could review Moderna’s data even earlier — on June 8 — but no agenda has been released. It also depends on the time it takes FDA to sift through Moderna’s application, which includes a request to authorize its vaccine not only for the youngest kids, but also kids 6 to 17.

Though the FDA’s leaders have repeatedly said they would not unnecessarily hold up Moderna’s authorization, it’s possible that the FDA’s panel of independent experts call for authorizing Moderna and Pfizer side-by-side.

Because they’re both for the same general age group but are different vaccines with different levels of protection, some experts believe it will be easier to authorize them together and allow parents to choose which vaccine to give their kids with all of the information available.

But many parents and pediatricians want the vaccine that’s available soonest, after two grueling years of waiting.

Though children under five is the last remaining age group that’s yet to be vaccinated, polls indicate there could be sluggish uptake.

A recent survey from KFF found that just under 1 in 5 parents are eager to get their children under five vaccinated right away.

However, the KFF poll more than half of parents said that they feel they do not have enough information about the vaccines’ safety and efficacy for children under age 5 — which could change after the public FDA advisory meetings to discuss the pediatric data.

“Parents should also be aware that this preliminary data will be supplemented by additional data in June, which will then be thoroughly reviewed by both the FDA and the CDC,” Patel said.

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(NEW YORK) — Another child in the U.S. has died in connection with the mysterious cases of severe hepatitis that have been occurring among children around the country and the globe, officials from the Centers for Disease Control and Prevention confirmed on Friday.

Investigators learned of the additional death on Thursday, Dr. Jay Butler, deputy director for infectious diseases for the CDC, told reporters during a phone briefing.

Officials had previously reported that the deaths of five other children were under investigation in connection to the disease.

“Unfortunately, the illness in many of these patients is severe … and the extent of the injury to the liver can be quite extensive. And so, this is clearly a severe disease that we’re taking very carefully for that reason, and the proportion of these, despite treatment, do unfortunately die,” said Dr. Umesh Parashar, chief of the viral gastroenteritis branch at the CDC’s Division of Viral Diseases.

As reported earlier this week, the CDC is now investigating at least 180 cases of severe hepatitis with unknown cause among children across 36 states and territories — an increase from the 109 cases that were reported earlier this month. Fifteen of the 180 children who are connected to the investigation in the U.S. have required a transplant, officials said Friday. At this time, there is no epidemiological link between the cases.

The “vast majority” of these cases are retrospective, as far back as October 2021, officials said, while only 7% of cases have been over the past two weeks.

“I know we’re all eager for information, especially regarding what’s causing these illnesses in young children. We continue to work with clinicians and our state and local public health partners to gather more detailed data, but I want to caution that it does take time to assess the evidence,” Butler explained.

“This is an evolving situation and an ongoing investigation, but it’s important to note that severe hepatitis and children remain rare,” Butler said.

Investigators continue to work to identify whether the outbreak represents a true increase in the number of severe hepatitis cases in children, or whether an existing pattern has now been uncovered, thanks to improvement in detection of these cases.

“While rare, children do sometimes get serious hepatitis, and it’s not uncommon … for the cause to be unknown,” Butler added.

There is no evidence to suggest, so far, he said, that the word “spike” is appropriate to describe the current emergence of cases.

“The question of whether or not this is something that has been ongoing for even longer, and we’re just recognizing that now I think is a very reasonable one. So, I think ultimately, really all we can say for sure at this point in time is we’re not seeing a dramatic increase in the number of cases,” Butler said

The “leading hypothesis” remains adenovirus, with evidence “accumulating” that it may have a role, though that exact role continues to be investigated. Also, under consideration is whether a prior infection of COVID-19 is playing a role, as well as the impact of mitigation measures, as many children have not been exposed to viruses in recent years due to quarantines, and thus, there may be a “catch-up” factor, Butler added.

There are numerous other lines of investigation into whether there could be a further connection with COVID-19, or other co-factors, officials reported.

Butler reiterated that any connection to COVID-19 vaccines seems “really unlikely to be playing a direct role,” particularly given that most of these children are too young to receive the vaccine.

The CDC continues to encourage parents to be on the lookout for the symptoms of hepatitis, such as vomiting, dark urine, light colored stool and yellowing of the skin, and to contact their child’s pediatrician if they are at all concerned.

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