Health

(CHICAGO) — COVID-19 cases during the first week of the 2022-23 school year in Chicago Public Schools are much higher compared to the same time last year.

According to CPS data, 449 students have tested positive for the virus during the first week of the new school year — 3.3 times higher than the 135 students who tested positive during the first week of the 2021-22 school year.

Additionally, 315 adults — including people such as faculty and administrators — have contracted COVID-19, CPS data shows. That’s 4.8 times higher than the 65 adults who had COVID during the same period last year.

Doctors told ABC News it’s not surprising more cases of the virus are cropping up compared to last school year for a couple of reasons.

One reason is because the BA.5 variant, an offshoot of the original omicron variant, is continuing to spread — making up 90% of cases in the Midwest, according to the Centers for Disease Control and Prevention.

“Obviously COVID is still circulating in the community and the variant of COVID that is circulating, BA.5, is extremely transmissible, so that one person that’s infected can infect a lot more individuals,” Dr. Tina Tam, a professor of pediatrics at Feinberg School of Medicine of Northwestern University and a pediatric infectious diseases physician at Ann & Robert Lurie Children’s Hospital of Chicago, told ABC News.

The second reason is because mitigation measures have been loosened.

During a media briefing earlier this month, the CDC said it was no longer recommending unvaccinated people quarantine after exposure, instead suggesting they mask up for 10 days and get tested five days after they were being exposed.

Following the news, CPS announced there would no longer be a requirement for students exposed to the virus to quarantine unless they test positive.

Additionally, masks continue to be optional for students and staff in school buildings and on school buses after CPS dropped its mask mandate in March.

Tan said some of these mitigation measures may need to be reinstated if COVID-19 cases continue to rise.

“If someone’s exposed and they’re not symptomatic, they can still go to school, but they should be wearing a mask,” she said. “How many kids are actually doing that? I don’t know. But I think that if the numbers continue to rise the way they’re rising, one of the probably best things to consider is to put back into place a mask mandate.”

The Chicago Teacher’s Union said the increase in cases is concerning and, if infections continue to climb, it will demand that a mask mandate be reestablished.

“There is nothing stopping the district and we have advocated for this to immediately reimpose a mask mandate, if they are seeing spread,” CTU vice president Jackson Potter told local affiliate ABC 7 Chicago.

The CTU did not immediately reply to ABC News’ request for comment.

Tan said she also wants to encourage parents to vaccinate their kids, especially considering the low vaccination rate among students.

CPS data shows only about 51% of eligible students at district-runs schools are fully vaccinated against COVID-19.

The percentages vary widely depending on age. More than 63% of students aged 12 to 17 are fully vaccinated compared to a little more than 14% of children ages 4 and under.

“People just need to remember that COVID is still circulating in the community,” Tan said. “Yes, this particular variant tends to cause mild disease. However, there are normal healthy children that will develop more severe disease with BA.5 and may be hospitalized from it.”

She continued. “So, the best way to protect their children is to vaccinate them.”

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(HARRIS COUNTY, Texas) — An adult resident of Harris County, Texas, who had been diagnosed with monkeypox, has died, state health officials announced on Tuesday.

The patient was severely immunocompromised, according to the Texas Department of State Health Services, and died at a Harris County hospital.

The official cause of death is still unknown. Although this person was a presumptive positive for monkeypox, it is still unknown whether the person’s death was due to or related to monkeypox, officials said.

“What we’re looking to be able to determine is the specific cause of death. We know that this patient had monkeypox as a diagnosis, what we do not know for sure is that the patient passed away from monkeypox,” county officials said during a press conference on Tuesday.

The case is currently under investigation to “determine what role monkeypox may [have] played in the death,” according to state officials. An autopsy is in progress, and the final report will be available in the next few weeks, according to the Harris County Department of Health.

“Monkeypox is a serious disease, particularly for those with weakened immune systems,” Dr. John Hellerstedt, DSHS commissioner, said in a statement. “We continue to urge people to seek treatment if they have been exposed to monkeypox or have symptoms consistent with the disease.”

Local officials in Harris County reported that they have been collaborating with state and federal health officials from the Centers for Disease Control and Prevention (CDC), to investigate the case.

“We are sharing this information to err on the side of transparency and to avoid potential misinformation about this case,” Harris County Judge Lina Hidalgo wrote in a statement. “The best way for us to fight this virus is through vaccines. Our goal is still to get as many people who qualify vaccinated as quickly as possible — I have always felt that vaccines are the key to reducing spread.”

Officials urged anyone who is immunocompromised to consider getting vaccinated, as they are at higher risk of severe disease.

“Monkeypox can affect those who are immunocompromised, and because of that, we would certainly encourage anyone who fits the criteria, including being immunocompromised, to seek vaccination,” officials added.

In a statement to ABC News, a representative from the CDC wrote that the agency is aware of the reported death and working with Texas officials to investigate.

“Our thoughts are with the family during this heartbreaking time,” the representative said.

Officials from the CDC cautioned that the strain of monkeypox responsible for the current outbreak is “rarely fatal,” and most people who become infected with this form of the disease will likely survive.

However, officials wrote that people with weakened immune systems are at a higher risk of becoming seriously ill or dying.

During a press briefing on Tuesday, officials from the White House’s Monkeypox Response Team further emphasized that “only a handful” of monkeypox deaths have been reported globally throughout the current outbreak.

“It’s serious and our hearts certainly go out to this family who’ve lost a loved one, and while we are doing further investigation to find out what role monkeypox may have played, it’s important to focus that we have mitigation measures in place to prevent monkeypox,” said Dr. Jennifer McQuiston, CDC monkeypox response incident manager.

So far, the majority of cases in the current monkeypox outbreak have been detected in gay, bisexual or other men who have sex with men. However, officials stress that anyone exposed to the virus can become infected with monkeypox.

Across the globe, nearly 49,000 cases of monkeypox have now been reported, including 18,100 cases in the U.S. — the most of any country, according to the CDC.

Monkeypox primarily spreads through prolonged skin-to-skin contact with infected people’s lesions or bodily fluids, according to the CDC. The virus can also spread through bedding and towels contaminated by infected lesions.

In addition to lesions, which can appear like pimples or blisters, the most common symptoms associated with monkeypox are swollen lymph nodes, fever, headache, fatigue and muscle aches.

ABC News’ Sony Salzman and Justin Gomez contributed to this report.

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(NEW YORK) — After securing enough doses in the national stockpile to vaccinate the most at-risk Americans against monkeypox, the federal government says it has begun training its sights on the next steps of the outbreak.

“We’re watching this very, very closely and will be prepared to move out against any outbreak that might happen in additional populations,” Assistant Secretary for Response and Preparedness Dawn O’Connell told ABC News.

That includes watching college campuses as students head back to school and keeping an eye on cases that spill outside of the current at-risk community of mostly gay and bisexual men.

“If we begin to see an outbreak in a college campus, we will make vaccines available on that college campus — absolutely,” said O’Connell, who leads monkeypox response within the Department of Health and Human Services.

At the same time, with cases in the U.S. passing 17,000, there are “very active internal conversations” about expanding the targeted population for vaccines, O’Connell said.

Those conversations are only possible because of the milestone the administration hit on Friday when it announced that — while facing criticism from advocates over the response so far — there were finally enough vaccines in the strategic national stockpile to fully inoculate all of the nearly 1.7 million Americans that the Center for Disease Control and Prevention has deemed at-risk.

But it’s been a rocky four months to get to that point. The Biden administration had only a few thousand vaccines on hand when the first monkeypox case was detected in the U.S. The rest of the stockpile — 1.1 million vials — was abroad in Denmark, where supply was bottlenecked with Bavarian Nordic, the only manufacturer of the JYNNEOS vaccine in the world.

The U.S. began to ease those supply constraints with a new dose-stretching policy authorized earlier this month by the Food and Drug Administration, which has allowed clinics to start extracting up to five doses from each vial by using a shallower injection method that the FDA says is just as safe and effective.

The U.S. is also underway on starting up the very first domestic facility to begin manufacturing monkeypox vaccine doses outside of Denmark, using raw materials from Bavarian Nordic but completing the “fill and finish” process in Grand Rapids, Michigan.

Grand Rapids Aseptic Manufacturing (GRAM), which O’Connell visited on Monday, will be up and running in about three months — one-third of the typical time it takes to build out a process to make vaccine, the company said.

GRAM is expected to have doses ready to ship out sometime in December, contingent on final approval from the FDA.

By March, the Michigan-based manufacturer hopes to have shipped out about 2.5 million vials, which could be used as up to 12.5 million shots under the new dose-stretching strategy.

It’s all part of an effort to move public health preparedness onto U.S. soil, O’Connell told ABC, rather than rely on other countries for resources that become scarce when they’re needed most.

“Every time I sit down with a member of Congress, I talk about the needs that I have. The strategic national stockpile is at the top,” O’Connell said.

“Making sure that the stockpile is well-funded is one of the cornerstones of my tenure in [my] position,” O’Connell said.

The stockpile, she said, has “been chronically underfunded, and it is responsible for maintaining preparedness against multiple threats.”

And while O’Connell defended the country’s early monkeypox response, saying the federal government ordered 36,000 vaccines when there were only two known cases in the U.S., she also acknowledged that there were some “lessons learned.”

“That’s not to say we haven’t made mistakes,” she said.

“I’m always worried about preparedness — making sure that I have enough for wherever this disease may go,” she said.

Still, the millions of doses being manufactured in Michigan this winter will be coming after thousands, if not tens of thousands, of Americans have already been infected.

To that, O’Connell said it’s about the medium- and long-term preparedness.

“That’s one of the reasons why I’m here is to make sure we’ve got this capacity now and in the future coming online and ready to go against whatever population is affected next,” O’Connell said, referring to the Grand Rapids facility.

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(NEW YORK) — With the end of summer nearing, and Labor Day around the corner, U.S. health officials are preparing to roll out millions of new COVID-19 boosters as health experts grow concerned over a potential viral resurgence in the fall and winter.

The Food and Drug Administration is expected, as soon as this week, to authorize Pfizer and Moderna’s new bivalent booster shots, which target both the original Wuhan strain that emerged at the onset of the pandemic, as well as the omicron subvariants, BA.4 and BA.5, that are currently dominant globally.

Advisers to the Centers for Disease Control and Prevention (CDC) are set to meet on Thursday and Friday, and if both agencies greenlight the new shots, doses could be shipped out in the days to come and administered soon after Labor Day weekend.

Unlike the original vaccines and boosters, these new shots will not go through a lengthy clinical trial process, where thousands of Americans are dosed with the vaccines to test the safety and long-term effectiveness of the vaccines. However, federal health officials stress that these new shots will still be just as safe as the original vaccines because the underlying vaccine platform, mRNA, is the same.

“Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe. As we know from prior experience, strain changes can be made without affecting safety,” FDA Commissioner Robert Califf tweeted earlier this week.

“When available, new boosters are expected to help provide greater protection against the currently circulating strains. We encourage all who are eligible to consider a booster,” Califf wrote.

Because the vaccines have already been studied and administered in millions of people, and the new boosters use the same foundation but change the targeted variant, the FDA is not requiring the same process for authorization.

Health experts say that the decision not to use time-consuming clinical trials for each new shot is also a strategic move, in an effort to keep vaccines up to date with the rapidly evolving variants — a process that will likely mimic how the flu vaccine is altered each year.

Across the country, 108 million Americans — or more than half of those eligible to be boosted — have yet to receive their first booster shot, according to data from the CDC.

Although the immunity provided by COVID-19 vaccines continues to wane with time, data published by the CDC shows that COVID-19 booster doses are still offering protection against severe forms of disease and death, particularly among older Americans.

Among people ages 50 years and older, the unvaccinated had a risk of dying from COVID-19 that was 14 times higher than their fully vaccinated and double-boosted peers.

In people ages 50 years and older, vaccinated people with one booster dose had a risk of dying from COVID-19 that was three times higher than those fully vaccinated and double boosted.

More than 61 million people over the age of 50 are eligible to receive their second COVID-19 booster shot, but just a third of people have actually done so. Since second booster doses were authorized in mid-March, a total of 23.1 million Americans have received their second booster.

In May, the CDC announced that it was “strengthening” its recommendation for Americans over the age of 12, who are immunocompromised, and those over the age of 50, to receive their second booster shot.

Younger populations are also benefiting from boosters, data shows.

In June, unvaccinated people ages 12 years and older had a risk of dying from COVID-19 that was eight times higher, compared to people who were fully vaccinated and boosted with their first dose.

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(STURGIS, Mich.) — Abbott is announcing Friday their Sturgis, Michigan plant is restarting production of their largest and most popular infant formula, Similac.

Previously, the troubled plant had only restarted a fragment of its production, after bacterial contamination concerns inside the facility had prompted a months-long voluntary recall and shutdown.

The closure at the largest formula manufacturer in the country ricocheted across the infant formula industry and exacerbated the supply shortage, forcing families to scramble for alternatives in the hyper-concentrated formula market.

Then in June — less than two weeks after it had finally restarted some of its formula production — severe weather and flooding forced the plant to close once again to “assess damage,” “clean and re-sanitize the plant.”

In July, Abbott announced they were opening the lines for their specialty hypoallergenic formula, EleCare, along with some metabolic formulas — but still, not its most popular and widely used Similac.

The company is now announcing it has restarted Similac production, paving the way for an eventual infusion of formula into the U.S. market, once the plant gets back up to full speed — after what has been a months-long scarcity on American grocery shelves.

The discovery of Cronobacter sakazakii bacteria inside Abbott’s Sturgis plant prompted a massive voluntary formula recall in February, after four babies who had consumed Abbott’s formula contracted a Cronobacter infection. Two of the infants subsequently died, although Abbott maintains there has not been conclusive evidence that its formula caused the infant illnesses, since none of the Cronobacter strains found at their plant matched the two samples genetically sequenced from the sickened infants. Ultimately, it was the combined findings of Cronobacter inside Abbott’s plant — along with a pattern of serious operational deficiencies and consumer complaints — which led to its closure.

Now that they are reopening Similac production, Abbott estimates it will take about six weeks for them to begin shipping it to retail locations “as it enters into production, enhanced pre-and post-production testing, and cycles through shipping and retail distribution networks,” a spokesperson said.

Abbott tells ABC News that during its shutdown and systems overhaul, there have been “a couple” instances where they have again found Cronobacter within batches of their formula. In each case, they say they have found it, addressed the issue, and destroyed the affected product.

This is, essentially, the oversight system at work: Cronobacter can be widely found in the environment — but in infants, it can be deadly — which is why rigorous safety and quality control procedures at plants like these are so important, experts have previously told ABC News.

“Restarting a large manufacturing facility after a several-month shut down is a complex process, and it takes time to ensure that equipment, processes and production are functioning smoothly and sustainably,” an Abbott spokesperson said in a statement to be posted tonight on their site. “It’s taken us time to ramp up production consistently to these high standards. There have been – and likely will be – stops and starts from time to time. We’ve experienced events like severe weather, we’ve had to make mechanical adjustments, and we’ve had to discard some early production batches that didn’t meet our standards.”

“As we’ve said, we have a zero-tolerance policy for Cronobacter or any pathogen in our plants. Cronobacter is naturally and commonly found in the environment and our quality systems are designed to find it and destroy it when it’s present, as it sometimes is with all manufacturers. That is why we test for it regularly and take steps to eliminate it if and when we find it, is why we took the steps we did in Sturgis in February, and is what guides our approach today,” the spokesperson said.

“If our quality systems detect the presence of Cronobacter in product testing, we suspend production while we investigate and coordinate closely with the FDA. Since our restart, this has occurred with a couple of batches, and in those cases we found the issue, addressed it and no affected product has been or will be distributed. This confirms our quality systems work.”

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(NEW YORK) — Knowing what to put on a baby’s plate and when can be daunting and nerve-racking for new parents. Now experts recommend regularly offering non-choking forms of foods containing common allergens between 4 and 6 months of age.

“Allergies are a part of a child’s life in the United States today, unfortunately. We know about 8% of American children, by the time they go off to college, carry a diagnosis of food allergy,” Dr. Wendy Sue Swanson, a mother of two and a board-certified pediatrician, told ABC News’ Good Morning America.

“We know that feeding all different kinds of foods, including common allergens in the beginning of life, tends to down regulate or decrease the risk of food allergies dramatically,” added Swanson.

New guideline changes on early allergen exposure

The advice to incorporate common allergens between 4 and 6 months is a dramatic shift from what doctors previously told parents and caregivers. In 2000, the American Academy of Pediatrics advised parents to delay the introduction of common food allergens for the purpose of preventing allergic disease. For example, experts previously recommended delaying cow’s milk until age 1 year; eggs until age 2 years; and peanuts, tree nuts, and fish until age 3 years.

New evidence since 2000 shows that the practice of delaying introduction of highly allergenic foods may actually increase rather than decrease the incidence of food allergies. A research study from 2018 suggested that the increased likelihood of peanut allergy seen in younger siblings of a peanut allergic child may be due in part to the practice of delayed introduction rather than genetics alone.

“For example, when you have food in the tummy, in the gut, those food proteins are exposed to the immune system and a baby’s body grows up exposed to them and tolerant to them,” emphasized Swanson.

Nine types of highly allergic foods

While any food can cause an allergy, knowing common triggers may help parents and caregivers identify a potential food-related allergic reaction.

“In general, you can develop an allergy to any food. In fact, there are more than 200 foods that we know humans are allergic to but there is a certain subset of foods that tend to be more provoking when it comes to allergies,” said Swanson.

The most common food allergy that starts in childhood and persists into adulthood in the United States is peanuts. Contrary to popular belief, peanuts are actually not a tree nut. They are a type of legume.

Besides peanuts, the other common food allergens among children in the U.S. are:

• Soy beans
• Tree nuts (cashews, walnuts, pistachios etc.)
• Cow milk
• Eggs
• Wheat
• Fish
• Shellfish
• Sesame seeds

Sesame seeds, which is one of the fastest growing food allergies in the U.S. according to Dr. Swanson, are increasingly recognized as the ninth major food group that causes allergies.

Currently, the first eight food groups mentioned in the list above make up around 90% of all food allergies and must be declared on U.S. product labels.

How to introduce allergens safely

The first step in introducing any “complementary foods,” the term referring to all solid and liquid foods other than breast milk or infant formula, is assessing an infant’s developmental readiness such as adequate ability to hold one’s body upright, ability to indicate desire for food by opening the mouth and leaning forward and the ability to swallow safely.

The next step is making sure the infant tolerates a few of the more “typical” complementary foods such as cereals, fruits and vegetables.

When introducing allergens, “you want to just make sure that you’re creating a texture and a consistency that’s easy and safe for your baby,” said Swanson. “And then making sure if you are using things like nuts or nut butters, that you are just thinning those nut butters to a way that they are not a choking risk.”

For high-risk children, i.e., children with a strong family history or children who have a personal history of moderate-severe eczema or egg allergy, the latest Dietary Guidelines for Americans published by the United States Department of Agriculture (USDA) advise parents to speak with a pediatrician before giving their infants peanuts.

For reasons unrelated to allergies, cow milk or fortified soy beverages should not be offered to infants younger than age 12 months, the USDA says.

What to know and what to do if a baby has a reaction

Reassuringly, “90% or more of babies will never develop an allergy or have any kind of reaction to food,” said Swanson.

“Now, if you are at home and if you think your baby might have a reaction, there are two symptoms that a baby will show if they are likely having a reaction to food: hives, or vomiting, or both within about minutes to two hours,” said Swanson.

Almost always, allergic reactions are not life-threatening and can be managed safely at home. However, if an infant is exhibiting signs of a severe allergic reaction such as mouth or tongue swelling, trouble breathing or wheezing, hoarse voice, or trouble swallowing or drooling, call 911 right away.

“How you feed your baby with all those common allergens in early life will continue to protect them to stay that way,” said Swanson.

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(NEW YORK) — A dad mourning the loss of his 26-year-old daughter is sharing an emotional message on mental health.

David Sheats shared on Instagram that his daughter, Savannah Sheats, died by suicide.

“I’ve been reluctant to express that, but I think it’s important,” he wrote in a message shared by another daughter, Alex. “With a young child, a skinned knee is one thing. A hug and a band aid will normally cure the tears. As that child becomes a young lady, the task becomes more difficult. There are no cuts, bruises, bumps you can make better. The pain is internal.”

Savannah Sheats, of Atlanta, was reported missing by her family on Aug. 17, and was found by police one day later, according to local ABC affiliate WSB-TV.

Her father described her as a “giver, overachiever, and genuine person,” who “never met a stranger.”

Describing his family’s loss, David Sheats wrote that their hearts are “broken into a million pieces.”

He wrote that while he remembers his daughter and mourns her death, he wants to, “bring awareness for others in similar situations, so that their outcome is a positive one.”

“As a dad and parent, I’ve learned a difficult lesson,” he wrote. “When your child or anyone reaches out for help, take it seriously. I knew there were issues but I could have done more.”

Citing the coronavirus pandemic as a time that people have felt disconnected and anxious, David Sheats also urged people to help one another.

“Help at least one person. Do it today. Don’t wait,” he wrote. “Everyone needs help at points. As the saying goes, ‘no man is an island.’ We need each other.”

In the United States, suicide is the 12th leading cause of death, according to the American Foundation for Suicide Prevention.

Over the last two years, a more widespread focus has been placed on suicide prevention and mental health care in acknowledgment of the pandemic’s impact on Americans’ mental health.

In July, a new three-digit phone number, 988, was launched as a way to make mental health care more accessible.

People can now call or text 988 and access a free and confidential help line, now known as the Suicide and Crisis Lifeline, that is available 24 hours a day, seven days a week.

“988 is easy to remember,” Jessica Rosenworcel, chairwoman of the Federal Communications Commission, said in July when the new number launched. “Now we have to make it clear to the entire country that it is a sign of strength to call it and use it, and not a sign of weakness.”

If you are experiencing suicidal, substance use or other mental health crises please call or text 988. You will reach a trained crisis counselor for free, 24 hours a day, seven days a week. You can also go to 988lifeline.org or dial the current toll free number 800-273-8255 [TALK].

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(ATLANTA) — A multi-state E. coli outbreak associated with romaine lettuce in sandwiches from Wendy’s has grown, with dozens more infections reported in the past week, according to federal health officials.

Since Aug. 17, when the outbreak was first publicized, 47 more illnesses in the outbreak have been reported to the U.S. Centers for Disease Control and Prevention — bringing the total number of reported infections to 84, the agency said Thursday.

Among those, 38 people have been hospitalized, including eight people in Michigan who have a type of kidney failure called hemolytic uremic syndrome, the CDC said. No deaths have been reported so far.

The infections have been reported to the CDC from four states: Michigan (53); Ohio (23); Indiana (six); and Pennsylvania (two).

CDC investigators are working to confirm the source of the outbreak, though many of those who became sick reported eating at Wendy’s, the CDC said.

“A specific food has not yet been confirmed as the source of this outbreak, but many sick people reported eating sandwiches with romaine lettuce at Wendy’s restaurants in Indiana, Michigan, Ohio, and Pennsylvania before getting sick,” the CDC said in its notice.

Among 62 people interviewed by investigators, 52 of them (84%) reported eating at a Wendy’s the week before they became sick, the CDC said. Of 17 people with detailed information about what they ate there, 15 (88%) reported eating romaine lettuce served on burgers and sandwiches.

As a precaution, the fast food chain has removed the romaine lettuce used in sandwiches from restaurants in that region. A different type of romaine lettuce is used in salads.

In a statement on its website Friday, Wendy’s confirmed that it was “fully cooperating with public health authorities on their ongoing investigation of the regional E. coli outbreak reported in certain midwestern states,” adding that it was “taking the precaution of discarding and replacing the sandwich lettuce at some restaurants in that region.”

“The lettuce that we use in our salads is different, and is not affected by this action. As a company, we are committed to upholding our high standards of food safety and quality,” the statement read.

The CDC is not advising that people stop eating at Wendy’s or to stop eating romaine lettuce in general.

“At this time, there is no evidence to indicate that romaine lettuce sold in grocery stores, served in other restaurants, or in people’s homes is linked to this outbreak,” the CDC said.

Most people infected with E. coli experience severe stomach cramps, vomiting and often bloody diarrhea, which typically start three to four days after ingesting the bacteria.

The CDC is urging people to call their health care provider immediately if they have severe symptoms, such as diarrhea for more than three days, diarrhea and a fever higher than 102 degrees, vomiting to the point where you can’t keep liquids down and signs of dehydration.

Most recover without treatment within a week, though some people may develop kidney failure.

ABC News’ Eric Strauss contributed to this report.

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(NEW YORK) — Pfizer announced Thursday that its vaccine candidate for respiratory syncytial virus was more than 85% effective in preventing lower respiratory tract illness in older adults.

The New York-based pharmaceutical company released findings from the Phase 3 clinical trial investigating its RSV vaccine candidate when administered to participants ages 60 and up. The investigational vaccine targets both A and B strains of the virus, making it bivalent.

“We are delighted that this first bivalent RSV vaccine candidate, RSVpreF, was demonstrated to be efficacious in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adults,” Dr. Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer, said in a statement Thursday.

RSV is a common virus that affects the lungs and breathing passages, usually causing mild, cold-like symptoms but sometimes leading to serious conditions. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults, according to the Centers for Disease Control and Prevention.

Each year, an estimated 177,000 older adults are hospitalized with RSV across the United States and 14,000 of them die. The virus is the most common cause of bronchiolitis and pneumonia in children under the age of 1 in the U.S. There is currently no approved vaccine for RSV, according to the CDC.

Four companies — Pfizer, GSK, Johnson & Johnson and Moderna — are in late-stage trials for their respective RSV vaccine candidates.

Pfizer said in a press release Thursday that a vaccine efficacy of 85.7% was observed in participants with more severe primary disease endpoint of lower respiratory tract illness, or LRTI-RSV, defined by analysis of three or more RSV-associated symptoms. The investigational vaccine was also well-tolerated, with no safety concerns, according to the press release.

Based on the findings, Pfizer said it plans to seek regulatory approval from the U.S. Food and Drug Administration this fall.

“Scientists and researchers have worked to develop RSV vaccines with little success for over half a century,” Anderson added. “These findings are an important step in our effort to help protect against RSV disease and we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults.”

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(ATLANTA) — Three children in Georgia have now tested positive for monkeypox, newly updated state data has revealed.

The Georgia Department of Health did not immediately respond to ABC News’ request for comment on these cases.

Newton County School System, which went back to school in early August, confirmed to ABC News that at least one child at Mansfield Elementary in Mansfield, Georgia, has tested positive for the virus, and one student at Flint Hill Elementary in Oxford, Georgia, is currently undergoing testing.

It is unclear if these cases are at all connected. The schools are located approximately 13 miles apart. Additional information on how the students may have contracted or been exposed to the virus is unavailable at this time, due to privacy concerns, according to school officials.

The school district has notified parents, officials said, and parents of students considered to be close contacts will receive separate communications instructing them on next steps.

“NCSS facilities employees will thoroughly clean and disinfect classrooms and other areas at both schools this afternoon to ensure ongoing safe and healthy learning and work environments for students and staff. Both schools will be open tomorrow,” the school district wrote in a statement on Tuesday.

Across the state of Georgia, at least 15 children, ages 17 years and younger, have received their first monkeypox vaccine dose, state data shows.

Separately, in Texas, officials confirmed that a previously confirmed monkeypox case had actually turned out to be a false positive.

Across the country, at least 13 children have now tested positive for monkeypox. Nine states and jurisdictions have reported pediatric monkeypox cases.

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