(MIAMI) — Twin sisters Hadley and Delaney Robertson created the BraceTrack app to help people who use scoliosis braces.
The twins, 15, from Miami were both diagnosed with scoliosis at age 12 during their annual checkup in January 2018. According to the American Association of Neurological Surgeons, scoliosis affects 2-3% of the population, or an estimated 6 to 9 million people, in the United States. It can develop as early as infancy but is typically onset between 10 and 15 years old.
While Delaney’s scoliosis didn’t require treatment, Hadley was diagnosed with idiopathic scoliosis and the curve of her spine was greater than 20 degrees. Doctors prescribed her a back brace that needed to be worn for 18 hours a day to stop the progression, Hadley told Good Morning America.
“Getting used to wearing a brace can be a little daunting,” Hadley, who was able to stop bracing in June 2020, said. “It’s made of a hard plastic so it can be hot to walk around in on a daily basis and it makes it a little bit difficult to do activities like sports.”
Fortunately, if Hadley needed to take off her brace for any reason, she could wear it for extra hours another day to make up for lost time. The true difficulty was in keeping track of not just those banked hours, but also her daily use.
“One thing about that I found really difficult was figuring out how to track the time that I wore it,” Hadley said. “I tried using a lot of different things. I think we tried using a notepad, a whiteboard, and I even tried looking for an app on the app store to see if there was something that could help me track that but there really wasn’t one so we decided to develop one ourselves.”
That same year, the twins began to research more about scoliosis and app development to figure out what functions would best serve people with the condition. While the girls were previously interested in STEM, they had no prior experience with building an app.
“I think one common misconception around this sort of thing is that you have to know everything about an idea to get into it,” Delaney said. “We really didn’t know everything about app development, or scoliosis even. We just jumped in and started doing a lot of research.”
They then worked with an app developer to make sure they had everything they needed to get the app into app stores across all devices, and it officially launched in May 2019.
“Since BraceTrack is a medical app, it was really important that we were HIPAA compliant and that we had all of those things in order,” Delaney said. “So we found an app developer that would be able to help us actualize all of the vision, all of the designs that we had.”
BraceTrack has several functions to assist users. It can keep track of how long a person wears their brace each day as well as how many banked hours they have, which can be applied to other days where they’ve needed to take their brace off.
It even keeps a log of past history of brace use and creates average trend data based off that. Users also have the ability to create a report with all of the data the app collects, which they can save and send to a doctor, relative, or the like.
“These reports make it more easy to interpret and understand where you could be wearing your brace more or where you’re wearing it a lot,” Delaney said.
The app has been downloaded over 1,000 times, the sisters said, and had around 500 active users last week. Currently, BraceTrack has a 4.9 out of 5-star rating on Apple’s App Store with a myriad of positive reviews.
“We’ve been really amazed by the response we’ve gotten to the app,” Hadley said. “People have said that’s made their brace experience a lot easier and that they’re able to track their time and understand better where they are with that.”
Hadley and Delaney also founded Brace for Impact in January 2021, which is a nonprofit that aims to provide funding for scoliosis braces for children and families who are unable to afford them.
“Bracing journeys can be really expensive since braces cost anywhere from $3,000 to $10,000,” Delaney said, adding that braces are custom-fitted and kids may need multiple braces as they grow.
She continued, “It can be a real financial investment and we were sort of thinking about what we could do to support kids who aren’t able to afford these braces since insurance doesn’t always cover them and they’re really important to your spinal health.”
Brace for Impact has raised $120,000 to date to for four of its partner scoliosis centers: Nicklaus Children’s Hospital, Shriners Hospital for Children, Children’s Diagnostic and Treatment Center and Joe DiMaggio Children’s Hospital.
“We’ve just been really amazed by the places we’ve been working with,” Delaney said. “The doctors and hospital staff that we’ve been talking to about this have just been so amazing and so inspiring.”
“It’s been really amazing so far to watch how Brace for Impact has been able to help kids,” Hadley said.
(WASHINGTON) — The Biden White House is continuing to push back against Florida Gov. Ron DeSantis over his handling of the COVID-19 pandemic.
ABC News reported earlier this week that the state of Florida had requested 300 ventilators from the federal government to help handle the recent increase in COVID-19 related hospitalizations in the state. DeSantis said Tuesday, though, that he was unaware of that request.
On Wednesday, White House press secretary Jen Psaki responded to DeSantis, saying that “as a policy, we don’t send ventilators to states without their interest in receiving the ventilators.”
“I think the most important question here is why would you oppose receiving ventiltators when you clearly need those in your state, given the percentage of hospitalizations that are occuring in Florida,” she added. When asked whether it was possible that DeSantis could have been unaware of the request, she suggested the question was better posed to DeSantis and his office.
The pushback, Psaki said, wasn’t a personal attack on DeSantis.
“Our war is not on [him]. It’s on the virus, which we’re trying to kneecap, and he does not seem to want to participate in the effort to kneecap the virus.”
DeSantis has also instituted a statewide ban on mask requirements. Earlier this week, he suggested that the state Board of Education could withhold pay from school leaders who implement mask mandates for students.
(ATLANTA) — The Centers for Disease Control and Prevention on Wednesday announced new evidence that strengthens its recommendation for pregnant people to get vaccinated.
“CDC recommends that pregnant people should be vaccinated against COVID-19, based on new evidence about the safety and effectiveness of the COVID-19 vaccines. COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant, breastfeeding, or trying to get pregnant now or might become pregnant in the future,” the CDC said in a summary of its updated guidance.
The update is based on further research that found pregnant people can receive an mRNA vaccine with no increased risk to themselves or their babies. Getting the vaccine early in pregnancy, including anytime before 20 weeks, poses no increased risk for miscarriage, CDC scientists found, and there are no safety concerns for pregnant people vaccinated late in pregnancy, or for their babies.
Preliminary: New CDC study found no increased risk of miscarriage after #COVID19 vaccination during early pregnancy. These findings can help inform discussions about COVID-19 vaccination during pregnancy between pregnant people & healthcare providers: https://t.co/pBVlI6STf8pic.twitter.com/kruX8OJvyl
“In a new analysis of current data from the v-safe pregnancy registry, scientists did not find an increased risk for miscarriage among people who received an mRNA COVID-19 vaccine before 20 weeks of pregnancy. This adds to the growing evidence of the safety of these vaccines,” the CDC said.
Until Wednesday, the CDC’s guidance for pregnant women was that they were eligible and could get vaccinated. The new guidance, which is that pregnant women should get vaccinated, is armed with more data and safety assurances. It also comes as the nation sees a significant spike in COVID cases and hospitals near capacity in states like Texas and Florida.
The risk of severe illness from COVID is much higher for pregnant women.
Pregnant women are more likely to be hospitalized and need critical care, including ventilation and admission to the intense care unit (ICU), according to the CDC, and COVID-19 during pregnancy increases the risk for preterm birth of the infants — a birth that is three or more weeks ahead of the expected due date.
Last week, two of the nation’s leading women’s health organizations, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), came out in full support of vaccinations for pregnant women.
“ACOG is recommending vaccination of pregnant individuals because we have evidence of the safe and effective use of the vaccine during pregnancy from many tens of thousands of reporting individuals, because we know that COVID-19 infection puts pregnant people at increased risk of severe complications, and because it is clear from the current vaccination rates that people need to feel confident in the safety and protective value of the COVID-19 vaccines,” ACOG president Dr. J. Martin Tucker said in a statement. “Pregnant individuals should feel confident that choosing COVID-19 vaccination not only protects them but also protects their families and communities.”
Both ACOG, a national membership organization for more than 60,000 OBGYNs, and SMFM, a global organization with more than more than 5,000 physicians, scientists and women’s health professionals, previously recommended that pregnant people have access to vaccines and should “engage in shared decision-making” about the vaccine with their doctors.
Currently, the rate of vaccination among pregnant women is very low. Just 23% of pregnant women received one dose of a vaccine during pregnancy as of July 31, per CDC data.
(NEW YORK) — As the number of pediatric COVID-19 cases continues to rise across the United States, parents are adding face masks to the top of their back-to-school shopping lists.
For the 2021-2022 school year, the Centers for Disease Control and Prevention (CDC) now recommends all students ages 2 and older wear face masks indoors, regardless of vaccination status.
The American Academy of Pediatrics, an organization of nearly 70,000 pediatricians, has also called on schools to enforce universal masking mandates.
Dr. Allison Bartlett, a pediatric infectious diseases physician at University of Chicago Medicine, is the mother of three sons who are all under age 12 and therefore not yet able to be vaccinated. Bartlett said her sons will be attending in-person school in the fall and will be wearing face masks.
“The whole COVID pandemic has changed with the delta variant and the very high levels of spread,” Bartlett told ABC’s Good Morning America, explaining the increased urgency for mask wearing. “It’s true that most kids don’t get sick, but most kids are not all.”
“I hope that parents understand that no kid likes wearing masks, but the kids that I have interacted with completely understand why they’re doing this, that they’re doing this to protect other people,” she said. “It’s a team effort and everyone has to contribute.”
With unvaccinated children at risk, parents have questions about which types of face masks will keep their children and those around them the safest.
GMA spoke with Bartlett along with Dr. Richard Malley, a pediatric infectious disease specialist at Boston Children’s Hospital, and Dr. Edith Bracho-Sanchez, a pediatrician at Columbia University, to break down what parents need to know.
1. Children do not need N95, KN95 masks.
All three experts agreed that while N95 and KN95 masks, the types of masks often used in hospitals, provide the best protection, they are not designed nor needed to be used by children.
“N95 masks on a child may not fit and even if they do fit, they’re not as comfortable,” said Malley. “We don’t want to be recommending masks that kids are not willing to wear.”
Both Malley and Bartlett also pointed out N95 and KN95 masks do not work if they do not fit properly, which is why medical staff who wear them undergo intense fitting procedures to make sure they are secure.
“Absolutely an N95 that has been fitted to you provides the most protection. It is true in a healthcare setting but not relevant to kids and schools,” said Bartlett. “They don’t really make child size N95s and unless you’ve gone through the fit testing, it doesn’t really provide any extra protection.”
2. The mask your child will wear is the best mask.
All three experts also agreed that whatever face mask your child is willing to wear indoors at school is the best mask for them, whether it is surgical, cloth or disposable.
“It all comes down to if they’re not going to wear it, it doesn’t matter how high quality the mask is,” said Bartlett, adding as an example, “A well-fitted cloth mask works much better than a poorly-fitted surgical mask.”
Malley suggests letting a child pick out their own masks can help motivate them to wear them and help them feel part of the solution.
“Everybody recognizes that [mask wearing] is an inconvenience for kids, so one way to help the process is to let the child choose,” he said. “Go online or go to the store and have the child select the mask they’re going to wear.”
3. Parents and kids need to regularly check the fit of the mask.
In order for a mask to be effective, it needs to fit over the nose and cover under the chin, according to Malley.
“You want something that covers the nose and mouth and when they speak or laugh, that the mask is not falling off their face,” he said. “You want the jaw to be able to move.”
The face mask should also lay flat on the skin, according to Bartlett.
“In my experience, sometimes the surgical masks tend to gape more at the side because they’re rectangular,” she said. “And sometimes fabric masks work better because they fit better and are softer or more comfortable to fit the face.”
Both experts also noted it is perfectly fine for kids to use clips or bands to relieve pressure on their ears when wearing a mask.
4. Face masks can be re-worn by kids.
“As long as your mask is fitting well, as long as the mask is taut and you have a good fit at the top and at the bottom, you can keep washing it and wearing it,” said Bracho-Sanchez.
5. A sun test can help check the quality of your child’s face mask.
One technique to check the quality of your child’s mask is hold the mask up to the sun. If you can see light through the mask as you hold it stretched, it’s not thick enough.
6. Children will not get sick from wearing face masks.
Concerns about children not being able to breathe while wearing face masks or risking illness from germs in their masks are not founded in science, according to Bartlett.
“There is not a risk to kids of CO2 [carbon dioxide] retention or not getting enough oxygen,” she said. “There is no medical concern to having your face covered with a mask like this.”
When it comes to germs, Bartlett said the masks prevent foreign pathogens from coming in, so the only germs kids could have in their masks are the same germs from their body.
She did suggest though that parents send their children to school with clean, spare masks so they have one on hand to swap out if, for example, they sneeze in the mask.
“Send kids to school with a few masks and, at home, wash masks regularly and have a constant supply of masks on hand,” said Bartlett.
(NEW YORK) — When the pandemic began more than a year ago, the country changed overnight. For teens everywhere, there were a lot of unexpected adjustments — schools closed, extracurricular activities were non-existent and friendships were reduced to Zoom hangouts and virtual TikTok challenges.
The uncertainty of when or if school would resume in person, and then the reality that for many teens, an entire school year would be lost to the pandemic triggered feelings of anxiety, isolation and depression, experts said.
“For the extrovert kids who were used to being out and about, the pandemic brought a lot of anxiety and depression because of decreased social interaction,” Dr. Chioma Iheagwara, division chief of child and adolescent psychiatry at Belmont Behavioral Health System, told “Good Morning America.”
On the other hand, “some kids who were struggling or being bullied in school started to thrive when removed from the school environment,” Iheagwara said. “Now they might be fearful about going back to school because the bullying could resume. The pandemic has been challenging for all kids, so how to support each teen really depends on where they started.”
5 tips to help support teens’ transition back to in-school environment
1. Re-establish routines and create a sense of normalcy
Creating routines can help minimize anxiety as teens start the school year.
“Normalize life as much as possible within the confines of dealing with the pandemic,” Iheagwara said. “Normalcy right now might be wearing a mask. Doing activities — enjoying life whenever possible, but that’s normalcy.”
According to the Centers for Disease Control and Prevention, re-establishing routines with sleep, family meals and other social activities, while helping teens to take personal responsibility to protect themselves and others can also help.
2. Look out for changes from baseline
Parents should keep an eye out for new eating habits — eating too much or too little — as well as new social habits or increased sensitivity. All of these could be signs of what mental health experts call “maladaptive” coping strategies, which are short-term attempts to reduce negative symptoms, without addressing or resolving those symptoms.
“If you know your child has anxiety, you know they are still going to have some level of anxiety and you prepare for that. But your teen who now looks more anxious, who’s now more isolated or irritable – if there’s a significant shift from the child that you know, something’s going on there and needs to be explored,” Iheagwara said.
3. Make a plan as a family.
With different rules around mask wearing from school to school, it’s important to know what’s happening in your teen’s school or school system.
Have “real honest and earnest conversations about what’s beneficial for you as a family — you might decide that means wearing masks no matter what the local guidelines.” said Iheagwara. “Discuss with your teen what the school expectations are around infection control and then what the household policies will be, including how you want to handle any illnesses that pop up in the family.”
4. Check in.
The pandemic has been a constantly changing and confusing landscape for over a year. It’s important to create safe spaces for teens to feel all the emotions associated with this experience. The first day of school might look very different a week or a month later, so checking in regularly on how a teen is handling the transition back to in-person learning will be important.
Pediatricians say parents can play an important role in setting the tone in the household. Expressing extreme doom or fear can affect your teen, but together, identifying self-care activities and productive ways to process any stress or anxiety can go a long way. “Keeping a normal routine and keeping lines of communication open between parents and teens is the most important thing,” Iheagwara said.
5. Get extra support.
Families should reach out to their pediatrician, or a mental health provider if available.
“School counselors and school behavioral health counselors can also offer support or additional resources – for emergencies, many states have crisis response centers, as an alternative to a traditional hospital emergency departments,” Iheagwara said.
There are also apps and online resources for teens at the ready that can be beneficial.
Companies like Limbix, Akili and Pear Therapeutics have digital products offering support for several adolescent mental health concerns.
(TUCSON, Ariz.) — A family of colorless and tasteless man-made chemicals — largely unregulated by the U.S. Environmental Protection Agency — has become a growing concern for drinking water safety in thousands of American communities, as scientists increasingly see links to liver damage, high cholesterol, weakened immune systems and cancer.
“They basically fulfill the characteristics of a ticking time bomb,” said Dr. Bo Guo, a University of Arizona hydrologist and expert on per- and polyfluoroalkyl substances, or PFAS, which are commonly used in hundreds of consumer products and in firefighting foams, a top source of PFAS contamination.
“They’re very dangerous and they’re migrating very slowly,” Guo said of the heat-resistant chemicals.
While the health concerns around PFAS are not new, greater detection of the chemicals in water systems nationwide in recent years has begun to alarm state and local leaders and prompted Congress to consider urgent action.
Last month, the city of Tucson, Arizona, abruptly shut down a major water treatment facility that delivered drinking water to 60,000 residents because of a sudden surge in PFAS contamination that threatened to overwhelm groundwater filtration systems.
“We don’t have enough confidence to go to drinking water supply at this time,” said John Kmiec, interim director of Tucson Water. “We know that there’s this contamination out there. We don’t know exactly what it does, but we know it’s not going away.”
Some level of PFAS, widely known as “forever chemicals” because they do not break down in the environment, have been found in water samples of 2,790 communities across 49 states, according to an analysis by the Environmental Working Group (EWG), an independent research and consumer watchdog organization pushing to limit exposure to chemicals through water, food and household products.
The contamination is likely much more widespread, experts said, because the EPA does not require testing for the chemicals and has not set a mandatory limit for how much PFAS are safe to drink in tap water.
“It’s likely an issue in every community, and that’s why we need testing to find out,” said Sydney Evans, an EWG water quality analyst who has conducted PFAS testing across the country.
In 2016, concerned by emerging health study data, the EPA issued an advisory to local water systems warning that prolonged exposure to the chemicals over 70 parts-per-trillion (ppt) may result in “adverse health effects.” The agency encouraged utilities to voluntarily monitor and filter to below that level, but does not enforce a standard.
President Joe Biden pledged during the 2020 campaign to accelerate the study and regulation of PFAS, but his EPA has yet to designate the class of substances as hazardous under the Safe Drinking Water Act.
There is growing momentum in Congress to pressure the agency over the issue. In a bipartisan vote last month, the House approved a bill that would force the EPA to establish mandatory national limits for PFAS in drinking water within two years, requiring more water systems to start filtering the chemicals out. The Senate’s pending bipartisan infrastructure bill would include billions to help communities get the job done.
“The thing that gives me the greatest concern is not every community or every water company in the U.S. is actively testing for PFAS,” said Kmiec. “So, there’s a lot of small to medium sized utilities that may have no idea if they even have a problem in their watershed.”
The chemicals have been detected on the shores of Michigan lakes, in the neighborhoods around old Naval Air Stations in Pennsylvania and even in the groundwater of a New Mexico dairy farm whose owner alleges in federal court documents that PFAS has poisoned the cows.
Water samples Evans collected and tested in March found elevated PFAS levels in the taps of some Virginia suburbs around the nation’s capital. A firefighting foam spill at a small regional airport is a suspected source of the contamination.
“It’s in the backyard of the people who are working on these issues,” Evans said.
Groundwater contamination, like that in Tucson, has often been linked to industrial sites, landfills, airports and military bases where the chemicals may have seeped into the ground years ago. Analysts with EWG estimated that more than 200 million Americans could be drinking some amount of PFAS in their tap water every day.
“We don’t want them in our bodies because we know that they can make some people sick,” said Dr. Jamie DeWitt, an East Carolina University toxicologist and pharmacologist leading cutting-edge research into how PFAS affect human bodies.
“Some of the effects that have been uncovered through studies of people who are exposed are different types of cancer. The ones that are most strongly linked are kidney and testicular cancer,” DeWitt said. “We know they can produce negative effects on the liver; affect levels of cholesterol in the body; affect your body’s immune system. They can also have effects on developing babies and on women while they are pregnant.”
The EPA declined ABC News’ request for an interview but said in a statement that addressing PFAS in drinking water is “a top priority” and that the agency is “developing a multi-year strategy to deliver critical public health protections.”
The agency said it is moving “as expeditiously as possible” while balancing the law, industry interests and the science. The EPA recently announced steps to collect more data on PFAS in drinking water systems and said they plan to move forward with regulations on two specific, older types of the chemicals linked to known health problems.
The American Chemistry Council, an industry trade group representing PFAS manufacturers, said in a statement responding to this ABC News report that it’s “committed to the responsible production, use and management” of the substances and supports the EPA consideration of national drinking water standards for two of the more than 4,000 types of PFAS chemicals.
“Most health effects that have been attributed to PFAS related to legacy substances that have been voluntarily removed from the market,” the group said in a statement.
Many environmental and consumer advocates said the EPA’s delay in regulating the chemical class more broadly is highly troubling.
“I think that the EPA — we need to hold their feet to the fire because nothing is going to change, nothing will go forward until they set those limits,” said Yolanda Herrera, a longtime Tucson community advocate for safe drinking water. “It’s going to take all of us together to go to Congress, to go to the EPA to make major changes that need to be done.”
Remediation of PFAS in water systems can be time-consuming and costly. The lack of an EPA-mandated drinking water standard complicates the process, state and local officials told ABC News, because there is not a clear benchmark for how much needs to be cleaned up and what resources governments need to meet it.
“We have no way of removing PFAS from the body,” said Dr. Philippe Grandjean, a top environmental health expert and leading researcher on PFAS at the Harvard University School of Public Health. “We need to do everything we can to protect women … against these compounds so that they are not burdening the next generation.”
Estimates for eliminating the toxins in soil and water at sites nationwide exceed tens of billions of dollars.
“We have been cleaning and remediating PFAS with our own dime,” said Tucson Mayor Regina Romero, “but the residents of our community should not be left holding the bag of something that they did not create.”
Arizona state and local officials believe PFAS-laden firefighting foam deployed in training exercises and emergencies decades ago at Tucson’s International Airport and Air National Guard complex is only now reaching groundwater wells miles away.
“The firefighting foam — (the Air Force) has told us that they either, if it was used on the runway, they’d hose this stuff into the soil. If it was used in the hangars, they’d dilute it and dump it down the sewer system,” said Tucson Councilman Steve Kozachik about the facility, which is home to one of the largest F-16 training installations in the world.
The base is one of an estimated 687 military installations with known or suspected PFAS contamination, according to Pentagon data published by the Government Accountability Office in June.
A June 2021 report by the Arizona Department of Environmental Quality found PFAS concentrations in groundwater samples around the Tucson airport at 10,000 ppt — far above the EPA’s 70 ppt advisory. Scientists believe a plume of PFAS in the soil has been slowly migrating underground north and west toward wells that feed into the city’s now-shuttered water treatment plant.
“The PFAS people see in groundwater is just a little fraction of the total PFAS at those contamination sites,” Guo said.
The Defense Department said it is investigating the scope of known or suspected contamination at or near hundreds of facilities but needs more time before it can launch a large-scale clean-up plan. Five years ago, the military began deploying what it calls a “new, environmentally responsible” firefighting foam, however it is not yet PFAS-free.
“Tucson is a bellwether. We’re the canary in the coal mine right now,” said Kozachik. “We’re saying to every other city in the country, this is an issue if you’ve got a military base in your community.”
The indefinite shutdown of the water treatment facility on Tucson’s south side because of PFAS has resurfaced old fears.
In 1983, the EPA listed Tucson as a Superfund site after the city’s tap water was poisoned by an industrial spill of the chemical solvent trichloroethylene, or TCE. The pollution, which went undetected for years, is linked to cancer cases and deaths across the city’s south side.
Hundreds of residents received financial settlements in major lawsuits, and state and local governments later funded construction of the water treatment facility. It has been cleaning up the water ever since — until PFAS arrived.
“How is this being allowed to happen?” said Tucson native Pattie Daggett, 47, who was diagnosed with a rare form of blood cancer in 2014 that her doctor linked to TCE exposure in the water.
“They haven’t even finished cleaning up the chemicals that were in the water before,” said Daggett. “We’ve got PFAS now. Like, what? I wish I could tell you how worried I am.”
(WASHINGTON) — As the delta variant spreads, posing a heightened risk to everyone who isn’t vaccinated, demand has skyrocketed for a vaccine that will protect young children who are not yet eligible — a group facing more cases than ever before during the pandemic.
And while experts still consider it uncommon for children to get severely sick from the virus, being unvaccinated leaves them more vulnerable. Over 94,000 children were diagnosed with COVID last week, according to the American Academy of Pediatrics, and hospitals nationwide are reporting more and more children in their pediatric COVID units.
Here’s what we know so far about when a safe and effective vaccine for children under 12 will be authorized by the Federal Drug Administration:
First shots for young kids expected in late fall, early winter
Pfizer has said it will submit vaccine safety data on 5- to 11-year-olds by the end of September. Moderna has said it will do so in the middle of the fall. It will then be up to the FDA on how quickly it grants the authorization.
In general, federal and industry officials said they expect the first vaccine shots for children ages 5-11 could happen by the end of this year or early 2022. Timing on a vaccine for children younger than 5 is less certain, but officials have said they hope a greenlight for toddlers and infants will follow soon after.
But the precise timing is fluid. Clinical trials are still ongoing, and the FDA has signaled it wants to expand the pool of children signed up as volunteers. A larger pool of volunteers makes it more likely that even the rarest of side effects could be detected before it rolls out nationwide.
The vaccine for children ages 5 through 11 would be the same composition, but a smaller dose. For Pfizer, children under 12 would receive 10 micrograms, while everyone 12 and older receives a 30-microgram dose.
FDA is under extraordinary pressure to move fast.
Some have urged the FDA to move more quickly to authorize the shot because of the toll the delta variant is taking on children. In a recent letter to the head of the FDA, the president of the American Academy of Pediatrics said that last week showed the “largest week-over-week percentage increase in pediatric COVID-19 cases since the start of the pandemic,” at 72,000 pediatric COVID cases in a week, up from around 39,000 reported in the previous week.
“Simply stated, the Delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults,” AAP President Lee Savio Beers wrote in a letter to the acting FDA Administrator Janet Woodcock.
In an effort to speed up the authorization, Beers suggested the FDA authorize the vaccines with the data from the children already enrolled, and then continue to monitor an expanded, second group of children.
In an interview with ABC News Live on Monday, Beers said the AAP was worried that the recent FDA decision to double the children participating in the vaccine trials would delay the timing for a vaccine at a critical time and that “the data is there” with the current cohort for the FDA to act very soon.
“We really think that we need to be approaching the trials in the authorization of the COVID vaccine for children with the same urgency that we did with adults,” Beers said in the interview.
FDA insists it won’t cut any corners
While the FDA insists it won’t cut any corners, according to a government official, requesting more children to participate in the trials isn’t expected to hold up the vaccine authorization process. That’s because parents have been eager to enroll their children to receive the vaccine.
The FDA also isn’t likely to require an extended period of safety data collection for the younger age group, a consideration that the FDA ultimately decided wasn’t necessary so long as more children were enrolled in the trial.
The FDA’s vaccine chief, Peter Marks, has repeatedly defended the FDA’s timeline and decision-making process, saying the agency is going to be thorough.
“Just so everyone understands, we are going to be very careful as we get down to smaller children,” he said in a May event with the group BlackDoctor.org, a health resource that focuses on outreach to African Americans.
“We have to reduce the dose of the vaccine, we’re more cautious about side effects, it takes longer to do the development,” Marks said.
(NEW YORK) — Unvaccinated COVID-19 patients are sharing their stories of battling the dangerous virus and why the experience changed their minds about the shot.
‘This isn’t fun’
Curtis Cannon, a 75-year-old COVID-19 patient at Willis-Knighton Medical Center in Shreveport, Louisiana, spoke to ABC News from his hospital bed on Aug. 5.
Cannon said he was at first skeptical about the vaccine. But now, struggling to breathe and suffering severe chest pains, he realizes how “real” COVID-19 is.
Cannon said he’d tell others who are skeptical: “They need to get vaccinated, because this isn’t fun.”
Cannon said he’ll get vaccinated once he is released from the hospital.
‘I was wrong’
Travis Campbell, an unvaccinated COVID-19 patient, spoke to ABC News from his hospital bed at the Bristol Regional Medical Center Hospital in Tennessee.
“When you feel like you have to fight for your life, you don’t realize that you’re fighting for every single breath all day long,” he said.
The 43-year-old husband and dad said he regrets not getting vaccinated.
“We thought it wasn’t an urgent matter to get the vaccine and I was wrong,” Campbell said.
“I would rather be covered and protected and if something does happen and I have to worry about repercussions of the vaccine versus being buried in seven days,” he said. “I beg you, please see your doctor and make an evaluated decision and protect your family or prepare yourself for your next life.”
‘Have a fighting chance’
Marquis Davis, a 28-year-old husband and father from Florida, died from COVID-19 on July 26, 2021. He wasn’t vaccinated.
Davis had been hesitant to take the vaccine. He told his wife in the hospital that he wanted to get the shot after he recovered.
To honor his memory, his family turned his funeral into a vaccine and testing event.
“This could have been prevented, so let’s get vaccinated so it doesn’t happen to you,” his wife, Charnese Davis, told ABC News.
“At least have a fighting chance. Protect yourself. Protect your family. This is nothing to be to be playing around with,” she said.
‘I never expected to be a widow at the age of 25’
Braderick Wright, a 28-year-old Georgia man who was hesitant to get the vaccine, died of COVID-19 on Aug. 7, 2021, reported ABC Atlanta affiliate WSB.
“He was deep into TikTok conspiracy theories and, for him, he just didn’t want to get [vaccinated],” his wife Brittany Wright told WSB.
“I never expected to be a widow at the age of 25,” she told WSB.
Brittany Wright said her husband’s dying wish was for more people to get vaccinated.
‘Please just get vaccinated’
Lateasa McLean, a 51-year-old in Lincoln County, North Carolina, was hospitalized twice after testing positive for COVD-19.
“My grandson and my granddaughter, they’re wheeling me out and I’m thinking, ‘Is this going to be the last time that I see them?'” she told ABC Charlotte affiliate WSOC.
While in the hospital, McLean said she realized, “I should have gotten vaccinated. And now I’m putting my family through this, for something I could have prevented.”
McLean, who works as a patient representative/patient safety sitter at a hospital, said she plans to get vaccinated.
“I just want everybody to listen to my story and please just get vaccinated,” she told WSOC.
(TALLAHASSEE, Fla.) — Public health experts and state officials are raising alarms about a surge in COVID hospitalizations among children — now at their steepest and seeing the most significant increase since the onset of the pandemic.
After declining in the early summer, child COVID-19 cases have steadily increased again in recent weeks — just as many kids head back to the classroom.
In a newly released weekly report, which compiles state-by-state data on COVID-19 cases among children, the American Academy of Pediatrics (AAP) and the Children’s Hospital Association (CHA) found that nearly 94,000 new child COVID-19 cases were reported last week, a continued “substantial” increase.
Some of the worst numbers are in Louisiana and Florida but could get worse elsewhere fast as public health officials express concerns with the highly contagious delta variant amid continued vaccine hesitancy.
“This is not your grandfather’s COVID,” Dr. Mark Kline, the physician in chief of Children’s Hospital New Orleans told ABC’s “Good Morning America” Monday. Louisiana is facing the nation’s highest rate of new COVID-19 cases with the Children’s Hospital in New Orleans describing what they’re seeing as “an epidemic of very young children.”
“We are hospitalizing record numbers of children,” Kline continued. “Half of the children in our hospital today are under two years of age. Most of the others are between five and ten years of age — too young to be vaccinated just yet.”
In Florida, the state with the highest number of confirmed pediatric COVID-19 hospitalizations in the country, 179 patients are receiving care, according to federal data. As of Monday morning, Nicklaus Children’s Hospital in Miami had one child on a ventilator.
Dr. Marcos Mestre, the hospital’s vice president and chief medical officer, told ABC News that in recent weeks, his teams have seen a “significant uptick” in pediatric COVID-19 cases. He said some children are alone in the hospital because their parents, also unvaccinated, are battling COVID-19 at another hospital.
“It’s tough,” he said, and places “undue social stress on the child, as you can imagine, not having the parents around.”
Texas follows Florida closely behind with 161 confirmed pediatric patients hospitalized across the state, and in California, there are 98 confirmed pediatric patients receiving care.
It comes as the country’s daily case average for Americans increased to nearly 100,000 cases a day for the past four days — up by 31.7% in the last week and nearly nine times higher than the average was in mid-June. For children 17 and under, the rate of pediatric hospital admissions per capita is 3.75 times higher than it was just a month ago — now equal to its highest point of the pandemic, in January 2021.
While severe illness due to COVID-19 remains “uncommon” among children, experts say the increased trend is concerning.
“While severe outcomes of COVID-19 infection in pediatric populations continue to be relatively low compared to adults, the current exponential growth in hospitalizations is a very worrisome trend,” explained Dr. John Brownstein, an epidemiologist at Boston Children’s Hospital and an ABC News contributor. “As the remaining population ineligible for the vaccine, children will, unfortunately, be the main vectors of virus spread creating risk to both themselves and the rest of the population.”
The Food and Drug Administration has not yet approved vaccines for children under 12, leaving a large youth population susceptible to COVID-19. But following data released by the AAP last week showing the massive increase in COVID-19 cases among kids, the organization wrote a letter to the head of the FDA urging authorization of vaccines for 5-11-year-olds as fast as possible.
“We understand that the FDA has recently worked with Pfizer and Moderna to double the number of children ages 5-11 years included in clinical trials of their COVID-19 vaccines. While we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group,” wrote Dr. Lee Savio Beers, president of the AAP.
“Simply stated, the delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults,” she said.
Beers told ABC News Live’s “The Breakdown” Monday that hospital workers are inundated with the massive increase in COVID-19 cases among kids particularly in areas where vaccinations are low.
“They’re seeing just a lot of kids who are very ill with COVID. They’re seeing children in their ICUs. They’re seeing children who are in pretty significant distress,” she said, reiterating the organization’s position that the FDA could approve vaccines for 5 to 11 years olds based on previous trials.
“We know that [COVID] can be severe in children, and so we should do those things that we need to do to help prevent the spread and help keep our kids and our whole community safe,” she added.
Dr. Ashish Jha, who supports expanding vaccinations for those 5 to 11, reiterated on ABC’s “Good Morning America” Monday the position widely shared by public health experts that the first step to getting kids back to school safely is with vaccinations for everyone who is eligible.
“Kids who can’t get vaccinated, you protect them by making sure everyone around them is vaccinated,” he said.
A recent CDC national immunization survey from late July found that among parents of children 13 to 17, 49.8% had children vaccinated or definitely plan to vaccinate, 25.4% were “probably will get their children vaccinated or are unsure”, and 24.8% are reluctant, “probably or definitely will not get children vaccinated.”
Despite the delta surge, a recent Kaiser Family Foundation poll found among unvaccinated adults, nearly half, 46%, say they definitely won’t get a shot, 15% call it very unlikely and 10% somewhat unlikely. In another question, one in five of the unvaccinated say news about variants has made them more apt to get a jab.
As pediatric hospitalizations rise, especially where vaccination rates are low, Dr. Peter Hotez of Baylor College of Medicine called what’s unfolding in the South a “humanitarian catastrophe.”
“As schools act as an accelerant you should assume we’re going to see pediatric intensive care units all across the South completely overwhelmed and even a possibility of small tent cities of sick adolescents and kids,” he told MSNBC’s “Morning Joe,” adding the slope is “going up and up.”
Less than 30% of Americans ages 12 to 15, and only 41% of Americans 16 to 17 are fully vaccinated, according to the CDC.
“And now schools are going to be an extraordinary accelerant,” he added. “If your adolescent kid is unvaccinated, you should assume there’s a high likelihood that that child is going to get COVID.”
The nation’s top infectious disease expert, Dr. Anthony Fauci, hopes that full approval to the coronavirus vaccine will be granted by the end of August, he said Sunday, and predicted the move will encourage and new wave of vaccinations.
“I hope — I don’t predict — I hope that it will be within the next few weeks. I hope it’s within the month of August,” Fauci said of full FDA approval on NBC’s “Meet the Press.” “If that’s the case, you’re going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that. The time has come.”
But there’s opposition — and it could be heard by the Supreme Court.
A group of eight unvaccinated University of Indiana students made an 11th-hour appeal to the Supreme Court last week to block the school’s vaccination mandate for anyone on campus this fall. They put forth various arguments for why the mandate allegedly violates their constitutional rights and heightened legal scrutiny, including that it’s contrary to FDA’s emergency use authorization terms for the vaccines — which public health experts are hoping changes soon. The students asked for a decision by Friday.
ABC News’ Gary Langer, Cheyenne Haslett and Devin Dwyer contributed to this report.
(NEW YORK) — The dangerous wildfires erupting across large portions of the Western U.S. are bringing major health risks to the residents.
The Dixie Fire near the Feather River Canyon in Northern California is now the second-largest fire in state history after it sparked last month. Whether you live in California, Oregon or Montana, here are some tips from doctors:
Dr. Zab Mosenifar, a lung specialist at Cedars-Sinai medical director of the Women’s Guild Lung Institute, says those in immediate danger are the residents within 25 miles of a fire.
Small particles in the air can travel hundreds of miles, and depending on the winds, particles can float for up to two weeks after a fire has been extinguished, Mosenifar warned.
Those especially in danger are children, the elderly and people with chronic respiratory problems, Mosenifar said.
“Breathing in smoke, spot and particulate matter in high concentration and/or for prolonged periods of time can result in short or long term lung damage,” said ABC News chief medical correspondent Dr. Jennifer Ashton.
“People who smoke, vape or have asthma are at higher risk for problems,” Ashton said.
“I recommend that anyone in the area wear an N95 particulate mask if possible,” she added.
Ashton urges residents with persistent coughing, shortness of breath, wheezing or chest tightness to seek medical attention and to wear goggles for eye protection.
“If your eyes are hurting or vision is impaired, seek medical attention immediately and do not rub your eyes as this could cause more damage,” she said.
Mosenifar recommends that residents use an air filter in their home or set their air conditioner to recirculate the air.