Health

(ATLANTA) — Pregnant people and people who were recently pregnant or are trying to get pregnant need to prioritize getting vaccinated against COVID-19, according to an “urgent health advisory” released Wednesday by the Centers for Disease Control and Prevention (CDC).

Currently, only 31% of pregnant people in the U.S. have been vaccinated against the virus, and that number drops down to 15% for Black pregnant people, according to the CDC.

At the same time, more and more pregnant people are being hospitalized due to COVID-19, which causes a two-fold risk of admission into intensive care and a 70% increased risk of death for pregnant people, the agency said.

Amid a COVID-19 surge in the U.S. brought on by the more contagious delta variant, nearly two dozen pregnant people died due to the virus in August alone, according to the CDC.

Since the start of the pandemic, the CDC reports there have been more than 125,000 confirmed cases of COVID-19 in pregnant people, including more than 22,000 hospitalizations and 161 deaths.

“Pregnancy can be both a special time and also a stressful time – and pregnancy during a pandemic is an added concern for families,” CDC Director Dr. Rochelle Walensky said in a statement. “I strongly encourage those who are pregnant or considering pregnancy to talk with their healthcare provider about the protective benefits of the COVID-19 vaccine to keep their babies and themselves safe.”

In August, the CDC strengthened its recommendation for COVID-19 vaccination during pregnancy, citing new evidence of safety with the vaccines.

The nation’s two leading health organizations focused on the care of pregnant people — American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) — also issued new guidelines calling on all pregnant people to get vaccinated against COVID-19.

Here is what pregnant and breastfeeding people may want to know about the COVID-19 vaccines to help them make informed decisions.

1. When can pregnant people get a COVID-19 vaccine?

Everyone 12 years of age and older, including pregnant people, is now eligible to get a COVID-19 vaccination, according to the U.S. Centers for Disease Control and Prevention (CDC).

Pregnant people can get the COVID-19 vaccine at any point in their pregnancy, and the vaccine does not need to be spaced from other vaccines, like the flu shot or Tdap booster.

2. What is the science behind the COVID-19 vaccine?

Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter the human DNA. Instead, it sends a genetic instruction manual that prompts cells to create proteins that look like the virus a way for the body to learn and develop defenses against future infection.

They are the first mRNA vaccines, which are theoretically safe during pregnancy, because they do not contain a live virus.

The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.

This same type of vaccine has been authorized for Ebola, and has been studied extensively for other illnesses — and for how it affects women who are pregnant or breastfeeding.

The CDC has concluded that pregnant people can receive the Johnson & Johnson one-shot vaccine after reviewing more than 200 pages of data provided by the company and the U.S. Food and Drug Administration (FDA).

Vaccine experts interviewed by ABC News said although pregnant women are advised against getting live-attenuated virus vaccines, such as the one for measles, mumps and rubella, because they can pose a theoretical risk of infection to the fetus, the Johnson & Johnson vaccine doesn’t contain live virus and should be safe.

3. Are there studies on pregnant women and the COVID-19 vaccine?

In its new recommendation that all pregnant people get vaccinated, the CDC said in a statement, “A new analysis of current data from the v-safe pregnancy registry assessed vaccination early in pregnancy and did not find an increased risk for miscarriage among people who received an mRNA COVID-19 vaccine before 20 weeks of pregnancy.”

“Miscarriage rates after receiving a COVID-19 vaccine were similar to the expected rate of miscarriage,” the statement continued. “Additionally, previous findings from three safety monitoring systems did not find any safety concerns for pregnant people who were vaccinated late in pregnancy or for their babies.”

In addition, two recent studies found Pfizer and Moderna’s COVID-19 vaccines appear to be “completely safe” and effective for pregnant people, according to Dr. Francis Collins, director of the National Institutes of Health (NIH).

Collins wrote in a blog post that the Pfizer and Moderna vaccines, which both use mRNA technology, were found to provide in pregnant people the levels of antibodies and immune cells needed to protect them against COVID-19.

The vaccines were also found to likely offer protection as well to infants born to a vaccinated person, according to Collins.

“Overall, both studies show that COVID-19 mRNA vaccines are safe and effective in pregnancy, with the potential to benefit both mother and baby,” he wrote, later adding, “While pregnant women are urged to consult with their obstetrician about vaccination, growing evidence suggests that the best way for women during pregnancy or while breastfeeding to protect themselves and their families against COVID-19 is to roll up their sleeves and get either one of the mRNA vaccines now authorized for emergency use.”

One study cited by Collins in his blog post was led by researchers at Northwestern University studying people who had been fully vaccinated during pregnancy.

The study, published May 11 in the journal Obstetrics & Gynecology, is believed to be the first to examine the impact of the COVID-19 vaccines on the placenta, according to the university. Researchers found the vaccine had no impact on pregnancy and no impact on fertility, menstruation and puberty.

The second study cited by Collins, led by researchers at Beth Israel Deaconess Medical Center and Harvard Medical School, looked at more than 100 women who chose to get either the Pfizer or Moderna vaccines. Researchers found that the women’s antibodies against COVID-19 after being fully vaccinated were also present in infant cord blood and breast milk, “suggesting that they were passed on to afford some protection to infants early in life,” according to Collins.

An earlier study, a study published in the American Journal of Obstetrics & Gynecology in March found the Pfizer and Moderna vaccines are safe and effective in pregnant and lactating people and those people are able to pass protective antibodies to their newborns.

Researchers studied a group of 131 reproductive-age women who received the Pfizer or Moderna vaccine, including 84 pregnant, 31 lactating and 16 non-pregnant women and found antibody levels were similar in all three groups. No significant difference in vaccine side effects were found between pregnant and non-pregnant study participants.

The study had some limitations. It was small and participants were primarily white health care workers from a single city. On the other hand, it’s the largest study of a group that was left out of initial vaccine trials.

4. What are health groups saying about the COVID-19 vaccine?

In their joint recommendation issued in July, ACOG and SMFM said pregnant people should “feel confident” in getting vaccinated against COVID-19.

“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.”

“COVID-19 vaccination is the best method to reduce maternal and fetal complications of COVID-19 infection among pregnant people,” Dr. William Grobman, president of SMFM, said in a statement announcing the new recommendation, also noting the vaccines are safe before, during and after pregnancy.

The World Health Organization (WHO) also says pregnant people can be vaccinated against COVID-19, adding, “in consultation with their healthcare provider.”

“Limited data are currently available to assess the safety of COVID-19 vaccines in pregnancy. However, based on what we know about the kinds of vaccines being used, there is no specific reason for concern,” WHO says on its website. “None of the COVID-19 vaccines authorized to date use live viruses, which are more likely to pose risks during pregnancy.”

5. What will clinical trials be like for pregnant people?

Pfizer’s phase 2/3 trial will enroll approximately 4,000 women within weeks 24-34 of their pregnancy, the company announced in a press release.

Half will get the vaccine, and half will get a placebo.

The study will include healthy, pregnant woman age 18 and older in the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the United Kingdom and Spain.

Participants in the vaccine group will receive two doses at 21 days apart — and each woman will be followed for at least 7-10 months in order to continuously assess for safety in both participants and their infants.

Infants will also be assessed, up until 6 months of age, for transfer of protective antibodies from their vaccinated mother.

Women enrolled in the trial will be made aware of their vaccine status shortly after giving birth to allow those women who originally received placebo to be vaccinated while staying in the study.

6. Why weren’t pregnant people included in early clinical trials?

Not recruiting parents-to-be in clinical trials and medical research is nothing new, according to Dr. Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics and a bioethicist who studies the ethics of pregnancy and vaccines.

“For a very long time, pregnant women were not included in biomedical research evaluation efforts or clinical trials, both for concerns about fetal development and what would be the implications of giving a pregnant women an experimental drug or vaccine and also for legal liability worries from manufacturers and pharmaceutical companies,” Faden told “GMA” last month. “There’s a huge gap between what we know about the safety and effectiveness of a new drug or a new vaccine for the rest of the population and what we know about it specific to pregnancy.”

In the case of the COVID-19 vaccines, health experts have only one of the three sources of evidence that are used to evaluate safety and efficacy during pregnancy: the data on non-pregnant people who were enrolled in the clinical trials, according to Faden.

From that, Faden said, health experts can try to glean what side effects may happen to people who are pregnant, but it is not an exact science.

However, it’s considered typical — and many argue ethically appropriate — to study an unknown substance first in healthy adults and then progressively in broader and broader populations. Pregnant people and children are often tested later down the line because of concerns about potential long-term harm.

Some of the volunteers in prior COVID-19 vaccine trials that didn’t include pregnant women directly may still become pregnant during the trial. This will also give researchers some insights about the vaccine’s safety among this group.

7. What risk factors should pregnant people consider?

A pregnant or breastfeeding person may consider a number of factors, including everything from the trimester, risk factors for COVID-19, ability to remain socially distanced in their lifestyle and occupation, guidance from federal and state officials and recommendations from a person’s own physicians, experts say.

Similar to the flu vaccine, which was not tested on pregnant people in clinical trials, health experts are relying on continuously incoming data to make decisions around how safe the COVID-19 vaccines are during pregnancy.

Officials are doing the same for the general population, considering the speed at which the COVID-19 vaccines were developed, according to Faden.

The COVID-19 vaccines can be taken during any trimester.

8. Is COVID-19 more dangerous for pregnant people?

The CDC has shared data showing that pregnant people infected with COVID-19 are at an increased risk for “intensive care unit admission, invasive ventilation, extracorporeal membrane oxygenation, and death,” compared to nonpregnant people.

Health experts say that with or without the vaccine, pregnant people need to continue to remain on high alert when it comes to COVID-19 by following safety protocols, including face mask wearing, social distancing and hand washing.

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(DAYTON, Ohio) — Although coronavirus-related hospitalizations are beginning to trend down nationally among all age groups, the rate of pediatric infections remains at an “exceptionally high” level, according to experts.

Across the country, federal data shows that nearly 2,000 children are currently hospitalized with confirmed or suspected cases of COVID-19. In recent weeks, as the viral surge in the South is finally showing signs of abatement, pediatric hospital admissions have fallen by more than 30%. However, on average, more than 250 children continue to be admitted to the hospital each day with the virus.

In Ohio, which currently has the country’s second highest total of pediatric COVID-19 hospitalizations, the crisis among children remains at a critical level.

Front-line workers at Dayton Children’s Hospital told ABC News they have seen a “record number” of virus-positive patients, since the highly infectious delta variant hit the state over the summer.

“We’re seeing an increase in our census that’s been astronomical,” said charge nurse Will Andres. “[It’s] pretty hard to keep our heads above water, day in and day out.”

As of Wednesday, more than 210 children are hospitalized with COVID-19, across the state.

“We are seeing more and more positive results. We’re seeing more and more people coming in and requesting testing. It’s just overwhelming,” Amy Temple, a pediatric emergency room nurse, said.

Earlier this month, the CEOs of Ohio’s six children’s hospitals joined together with the Ohio Children’s Hospitals Association to raise the alarm about the significant increase in hospitalized kids with the coronavirus.

“This is a reality for us today. And it’s threatening the capacity of our pediatric safety net in ways we have never experienced before,” the group wrote in a letter.

Many front-line workers reported that children appear to be getting sicker than at previous points in the pandemic — particularly adolescents who have not been vaccinated.

“Some of these kids are getting very sick. They’re requiring extra assistance to make them able to breathe. We’re having to do a lot of extra intervention, whether it’s either putting in a breathing tube and putting on a ventilator or with just a mask to provide oxygenation and ventilation,” Hilary O’Neill, a respiratory therapist at Dayton Children’s Hospital, explained. “There are definitely a lot sicker than we had ever seen before.”

The influx of patients in need of care has left some front-line workers feeling overwhelmed, overworked and mentally drained.

“At this point, I’m emotionally exhausted. Kids keep getting sicker, and we are busy, and every day we come in and there just doesn’t seem to be a light at the end of the tunnel anymore,” Temple said.

Michele Nadolsky, a clinical team leader in the emergency room, and a 28-year veteran of the hospital, added that she feels an “overwhelming sense of defeat,” particularly as a “large” number of nurses leave the business, resulting in staffing shortages.

Although severe disease among children remains “uncommon,” according to the American Academy of Pediatrics and the Children’s Hospital Association, the potential for long-term consequences among children who test positive for the virus is still concerning.

“One of our biggest concerns is what’s going to happen in six months to a year from now, after child has recovered from the acute illness of COVID-19, and what kind of symptoms or long-term effect is it going to have on them as they continue to grow and mature,” Nadolsky said.

Another worrying trend, one doctor said, is the notable number of children who are often forced to stay alone in the hospital because their parents are battling COVID-19.

“I think most of the time, the children who have COVID infections have another family member, often an adult, who is also sick with COVID,” Amit Vohra, a pediatric intensivist at the hospital, said. “Those parents are unable to visit the children at the hospital. Oftentimes, nobody’s here with them for some hours of every day. So those are the times that I think our nurses step in to provide that emotional level of support that the children need … These kids are often short of breath, they’re hurting in their chest. They’re breathless, they’re anxious, they’re concerned: Are they ‘going to die?'”

The most difficult aspect of this all, according to Karen Davis, a pediatric intensive care nurse, has been watching so many children suffer through the illness.

“I’m a mother and a grandmother, so I just feel for the kids that are struggling so hard … I take care of them, like I would want them to take care of my child,” said an emotional Davis. “One of the biggest fears parents have to take care of their children is that they may die, and they may not get out of the hospital alive.”

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(WASHINGTON) — Several popular baby food brands contain “high levels” of toxic heavy metals — and they are not doing enough to stop the practice, according to a new report released Wednesday by a U.S. House Oversight subcommittee.

Brands including Gerber, Plum Organics, Beech-Nut and Walmart are named in the report, which calls on baby food manufacturers to begin voluntarily testing their products for toxic heavy metals and to phase out products that contain large amounts of ingredients that test high in toxic heavy metals.

The report also calls on the U.S. Food and Drug Administration (FDA) to hurry in releasing its standards for heavy metals in baby foods and to, in the meantime, require baby food makers to test their finished products for heavy metals.

“Today’s report reveals that companies not only under-report the high levels of toxic content in their baby food, but also knowingly keep toxic products on the market,” Rep. Raja Krishnamoorthi, D-Ill., chairman of the Subcommittee on Economic and Consumer Policy, said in a statement. “The facts speak for themselves, and the fact of the matter is that the baby food industry has consistently cut corners and put profit over the health of babies and children.”

The FDA announced in April its Closer to Zero plan, which has a goal of reducing exposure to toxic elements in foods eaten by kids and babies “to the lowest possible levels.”

In response to the call to action in the subcommittee’s report, the FDA told ABC News it plans to announce “soon” the date for a public meeting that will “address questions around the scope of the Closer to Zero plan.”

“We have continued our sampling to help inform our process to set levels, and we are working to strengthen our relationships with federal partners, industry and advocates to ensure that we make meaningful and lasting reductions in exposure to toxic elements from foods,” the FDA said in the statement.

The new report is a follow-up to a report released in February by the same subcommittee that found baby foods from several leading brands contained “significant” levels of toxic heavy metals, including lead, mercury, cadmium and arsenic.

Congressional investigators requested test results and internal company documents from seven of the largest baby food manufacturers in the U.S. in November 2019, following reports alleging baby foods contain high levels of toxic heavy metals.

In some cases, some of the baby food products analyzed carried as much as 91 times the allowable arsenic level, 177 times the lead level, 69 times the cadmium level and up to five times the mercury level, the report said.

Exposure to toxic heavy metals poses a specific risk to toddlers and infants because they absorb more than adults and their brains are still developing, according to the National Institutes of Health (NIH).

Experts point out though that heavy metals are found all over, and in order to suffer detrimental effects, a person would have to be exposed to toxic heavy metals for a prolonged period of time, and a one-time ingestion of the levels found in baby food products would not be considered dangerous.

The American Academy of Pediatrics (AAP) recommends screening for elevated lead levels in children 9 to 12 months old, and again around age 2.

The AAP also has guidelines for parents to help shield their children from toxic heavy metals, which enter food through water and soil as well as from during the manufacturing and packaging processes.

In the new report released Wednesday, the subcommittee says Beech-Nut recalled just two of its six infant rice cereal products that tested over the FDA’s limit of inorganic arsenic earlier this year, while Gerber did not recall either of its two products that also tested over the limit.

In response to the report, a Beech-Nut spokesperson told ABC News in a statement, “Our process of manufacturing baby food does not contribute heavy metals to the final product. Heavy metals are found naturally in our environment. They are in the soil, the water, the air — and are therefore unavoidable in our overall food supply.”

As part of its continuous improvement practices, Beech-Nut continues to work with the FDA to identify the best practices, which may include “finished product testing,” according to the statement.

Gerber told ABC News that it is “committed to reducing the levels of heavy metals in our baby foods to the lowest levels possible.”

“The FDA made us aware of their contact from the State of Alaska about a sample of our rice cereal that tested slightly above the guidance level for inorganic arsenic set by the FDA, and was referenced in the report. The FDA retested the sample, was unable to confirm the result by Alaska and confirmed to Gerber that no action was needed,” the company said in a statement. “While the Subcommittee report notes proposed limits on specific heavy metals, those are based on proposed standards from the Baby Food Safety Act, which are not current law or regulation. All Gerber foods have and continue to meet all applicable guidelines and limits set by the FDA, the governing body for safety regulations in the food industry.”

The subcommittee report also names Plum Organics, whose products it says are “tainted with high levels of toxic heavy metals.” It also calls out Walmart for weakening its arsenic standard in baby food products, calling the decision “an extreme course reversal on efforts to protect babies’ neurological development.”

Sun-Maid, which purchased Plum Organics in May from Campbell Soup Co., did not respond to ABC News’ request for comment.

Campbell Soup Co. told ABC News that it continues to “support the FDA’s efforts in setting clear and specific science-based federal standards.”

“For more than 150 years, Campbell has placed the safety of our consumers above all else,” the company said in a statement. “We have cooperated with the subcommittee throughout this process and will continue to do so. In fact, we released the data highlighted in this report in February 2021 and published it on our web site at that time.”

Walmart said in response to the report’s findings that it has “always required that our suppliers’ products meet the guidelines established by the FDA.”

“Our specifications have always been aligned with or below the FDA requirements for naturally occurring elements and the FDA noted in April that its testing shows that children ‘are not at an immediate health risk to exposure,” Walmart said in a statement to ABC News. “We are encouraged the FDA launched a collaborative process to establish science-based standards for infant and baby foods and look forward to further guidance.”

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(NEW YORK) — The debate over requiring children to wear masks at schools rages on, but not among doctors or scientists — or teachers.

Multiple recent studies have shown that masks effectively slow virus transmission and prevent school closures. Three such studies were just published in the Centers for Disease Control and Prevention’s weekly report on infectious diseases.

Kara McCormick-Lyons, a seventh grade teacher and president of the White Plains Teachers’ Association in Westchester County, said the new findings weren’t surprising.

“Of course it works,” McCormick-Lyons said. “Physical distancing, masking, being outdoors when you can, all of these things make a difference.”

Whatever mild discomfort children may experience from wearing a mask, she added, is a small price to pay and “if that’s what we have to do to all stay here [in school], then it’s well worth it.”

One recent study from Arizona found the odds of an outbreak were 3.5 times higher in learning environments without a mask requirement. Additionally, schools that implemented mask mandates before school restarted in the fall have had fewer outbreaks compared to schools that more recently adopted the policy.

J. Mac McCullough, an associate professor at Arizona State University and co-author of the study in Arizona, said the results further bolster existing guidelines.

The research “aligned with the CDC’s recommendation for masking in schools as one part of a layered approach to preventing COVID-19 outbreaks in K-12 schools,” he added.

Another study that examined multiple states found the number of schools reporting COVID-related closures in August and early September was greatest in the South, where fewer mandates are in effect. States including Tennessee, Texas and Georgia have reported upwards of 200 COVID-related school closures.

Another nationwide study showed COVID cases were higher in counties without mandatory masking. For every 100,000 kids, there were 18 fewer COVID cases per day in counties where schools had mask mandates, although the study’s authors did note that it’s difficult to conclude masks alone are responsible for that discrepancy when factoring in social behaviors and other potential variables among communities.

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(NEW YORK) — Recent cases of lead poisoning have been associated with the use of traditional or handmade ceramic ware, a recent health advisory from the New York City Department of Health and Hygiene found.

On Monday, the department issued an announcement saying that it had identified 15 new cases of lead poisoning in children and adults, with elevated blood lead levels as high as 53 micrograms per deciliter, associated with the use of traditional ceramic ware used for cooking and serving foods or drinks.

According to the U.S. Food and Drug Administration, there is no identified safe blood level, but the Centers for Disease Control and Prevention recommends that doctors monitor children who have a blood lead level measured as 5 micrograms per deciliter and take steps to reduce the exposure to lead.

Exposure to lead can cause serious health problems. While patients may not look or feel sick, lead exposure can cause learning and behavior problems in children. For adults, it can increase blood pressure and affect the brain, kidneys and reproductive organs. For women who are pregnant, it can increase the risk of miscarriage and affect the unborn baby.

The NYC Department of Health and Hygiene identified that ceramic ware from countries including Mexico, Ecuador, Turkey, Morocco and Uzbekistan, have been found to contain lead levels thousands of times higher than regulatory limits.

To control the exposure of lead, the New York City Department of Health is asking health care providers to “ask their patients, particularly individuals of Latin American, North African and Eastern European descent,” about the type of ceramic ware used to prepare, cook, store or serve foods. If patients indicate that they indeed use these types of cookware, health care providers should consider giving patients a blood lead test and advise them to immediately stop use.

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(NEW YORK) — With schools back in session again, many parents around the country on edge — dreading the news of a positive coronavirus case in their children’s classes.

Coronavirus outbreaks have led to hundreds temporary school closures across the country, with tens of thousands of students forced to quarantine, just within the first weeks of school year.

With more than 48 million children under the age of 12 still ineligible to be vaccinated, and another 14 million eligible adolescents still unvaccinated, the quarantine process has left many families and educators frustrated at the prospect of another school year spent partially online, disruptions to work schedules and additional childcare expenses.

While many school districts are following guidance from the Centers for Disease Control and Prevention (CDC), which recommends that those who are unvaccinated and had close contact with an infected individual quarantine for 14 days, some are adopting a different approach called “Test to Stay.”

Under that protocol, being adopted by school districts from Utah to Massachusetts, asymptomatic students who are identified as close contacts of an infected student or staffer are allowed to remain in school, provided they take a daily rapid test for seven days, and adhere to other mitigations, such as mask wearing. If the student tests negative, they are cleared to be at school for the day.

It’s a protocol that has yet to be endorsed by the CDC, which is awaiting more data, but has the support of some parents, educators and medical experts.

Here’s what we know:

Test to Stay lauded by educators and experts

The new program has been supported by several studies, including recent findings out of the United Kingdom, which suggests that daily contact testing, following exposure at school, is “a safe alternative to home isolation.” According to the study, the rates of infection in school-based contacts were quite low.

The new protocol is currently used statewide in Massachusetts, and at The Park School, in Brookline, where weekly pool tests are administered for students and staff and the Test to Stay program is used when there is a case.

“We’ve actually had a number of cases, as we’ve come back into the school year,” Scott Young, the head of school at Park, told ABC News.

Outside the school building, socially distanced students, who may have been in contact with a COVID-19 positive person at school, are given rapid antigen tests. It takes 15 minutes for the test to register, and if it comes back negative, students are allowed in class.

In Utah, state law mandates that schools initiate Test to Stay when schools with 1,500 or more students have 2% of their students test positive for COVID-19, and when schools with fewer than 1,500 students have 30 students test positive for COVID-19, within a 14-day period.

Earlier this month, one high school in Tooele, Utah was forced to hold a Test to Stay event after a number of students tested positive. District school officials considered the program a “success” after it detected 30 cases among students when the testing session at Tooele High School.

“Last year, we had so many days where we had kids out of classes. And we see that in our data, we had numbers drop this year. A lot of this comes from our governor saying, our focus is education. We really want our students to be in class. We want our teachers teaching,” Marie Denson, a representative for the Tooele County School District told ABC News.

Such daily rapid testing has been shown to be an effective tool in prioritizing in-person learning, while seeking to maintain a safe learning environment, particularly when layered with additional measures, like masking and good ventilation, according to John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital and an ABC News contributor.

“While rapid tests aren’t perfect, they do provide a robust measure of viral shedding which is a key measure of concern when trying to limit spread in a school,” Brownstein said. “If the goal is to keep kids in schools while reducing transmission, rapid tests actually may provide more value. And when you add the issue of improved timeliness and reduced costs, the utility of rapid tests becomes even more obvious.”

In addition, the seven consecutive days of testing diminishes the danger stemming from potential false negatives, Brownstein added.

Quarantines are highly disruptive, some say

Jami Wolf-Dolan, a psychologist and parent of two young children currently attending an elementary school in Brooklyn, New York, knows firsthand how incredibly disruptive quarantining can be for the entire family, explaining that she is “beyond slammed, right now,” after her son was abruptly shifted to remote schooling, when a classmate became infected in the first weeks of school.

“I have no childcare, I work from home and I have another kid in Pre-K. The impact of this reverberates,” she said.

Across the country, with pediatric coronavirus cases surging, thousands of children are being forced back into quarantine.

While over 21,000 K-12 students have tested positive since the onset of the school year in South Carolina, another 86,000 had to quarantine because of close contact with an infected individual, according to state data. And in Texas, more than 183,000 students have tested positive for the virus, since the onset of the academic year, impacting tens of thousands of other families.

Removing COVID-19 negative students from in-person learning for prolonged periods of time can affect a student’s educational, social and mental well-being, according to educational experts.

“The optimal place for students to learn is in school, because they are social beings, and that human connection is one of the things that is at the foundation, one of the most important components of effective instruction,” said Young. “When students are remote, they lose out on that human connection, on the opportunity to collaborate, the opportunity to work with their teacher closely, for the teacher to really be able to observe them closely.”

Lydia Alvarez, another parent in Brookyln, New York, concurred, explaining that her 7-year old son was forced to quarantine after attending school for only four days. The quarantine was an unwelcome reminder of last year, when remote learning forced her to quit her job to help her son with school.

“He absorbed nothing,” Alvarez told ABC News in regard to the last school year. “The greatest negative impact of homeschooling was a real resistance to learning. There was no joy associated with learning. I feel now that each time he gets yanked out for five days, that joy of learning gets kind of receded.”

“The best way for families to be supported is for them to know that their children can be in school,” Young said.

Mixed support among officials, but parents applaud the efforts to keep kids in school

Dr. Lee Savio Beers, the president of the American Academy of Pediatrics, has expressed her support for the “Test to Stay” approach.

“I think that it can be a really effective strategy to help make sure children are in school as much as possible. Again it has to be in the context of other important strategies, including vaccination and at least for right now masking, but testing can really help us keep our kids in school,” Beers said, testifying before Congress for a House at a subcommittee hearing on pediatric COVID, earlier this month.

The CDC, on the other hand, is not yet on-board with the Test to Stay protocol, awaiting more evidence before endorsing it.

“At this time, CDC does not recommend or endorse a Test to Stay program. CDC recommends all identified close contacts in the K–12 setting follow current quarantine guidance,” the CDC wrote in a statement to ABC News. “However, to gather more information, CDC is working with multiple jurisdictions who have chosen to use these approaches of more frequent testing to allow close contacts to remain in the classroom.”

But for many parents, the Test to Stay program is an effective way for children to experience the critical continuity and regularity of in-person school.

“The reaction of the community has been incredibly positive,” said Young. Parents, he said, “feel both a sense of safety, which is important, and they really do value the fact that their children can be in school, knowing that it is the best place for them.”

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(NEW YORK) — The frozen DiGiorno Crispy Pan Crust pepperoni pizza has been found to contain textured soy protein, a known allergen that is not declared on the label, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced Monday.

Nestle USA Inc. is recalling 27,872 pounds of the pizza product after a consumer complaint found that the frozen pepperoni pizza product carton may actually contain the frozen three-meat pizza, according to the FSIS release.

The recalled pizza products were produced on Jun. 30, 2021 and shipped nationwide.

There have been no confirmed reports of adverse reactions, the release stated.

ABC News reached out to Nestle for comment, but has not received word at this time.

 

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(WASHINGTON) — Pfizer CEO Albert Bourla said on ABC’s “This Week” Sunday it’s possible to provide both COVID-19 booster shots as well as doses for people who have not yet been vaccinated.

“I think it is also not the right thing to try to resolve it with an ‘or’ when you can resolve it with an ‘and,'” Bourla told ABC’s George Stephanopoulos. “It’s not, ‘Shall we give boosters or give primary doses to other people.’ I think the answer should be, ‘Let’s give both boosters and doses for other people.’”

With millions more Americans now newly eligible for a booster COVID-19 shot from Pfizer, Bourla’s optimism punctuates what’s become a protracted, hot-button issue amongst the scientific community over who needs the boost and when.

Just after midnight Friday, Centers for Disease Control and Prevention Director Rochelle Walensky endorsed her independent advisory panel’s recommendation for seniors and other medically vulnerable Americans to get a booster shot of Pfizer’s COVID-19 vaccine six months after their second dose.

In a notable departure, Walensky partially overruled the panel by adding a recommendation for a third dose for people who are considered high risk due to where they work, such as nurses and teachers — a group the panel rejected in its recommendation.

The CDC’s final sign-off marked the starting gun for sleeves to start rolling up for a third shot at retail pharmacies and doctors’ offices across the country.

It also in part buttoned up what has become a seething scientific debate after the Biden administration announced there would be “boosters-for-all” before any review from the regulatory bodies or their independent groups. While the White House’s political appointees had endorsed President Joe Biden’s timeline, some of their career scientists and advisers vehemently objected to the incomplete data they were being asked to assess.

The booster debate has played out as the delta variant sweeps across states and threatens hard-fought gains against the virus here at home and as the World Health Organization continues to call for a moratorium on booster shots in the interest of more equitable distribution of primary vaccinations, as many still countries struggle with providing first and second doses.

Gathering world leaders virtually Wednesday on the U.N. General Assembly’s sidelines, Biden announced the U.S. would donate another half billion doses of Pfizer vaccine to lower-income nations.

Pfizer, the first vaccine maker to administer shots in the U.S. more than nine months ago, had cited data from Israel and elsewhere showing the vaccine’s robust protection began to wane with time. In April, Bourla predicted a third coronavirus dose was “likely” to be needed within a year of the primary two-dose course. In July, the company announced plans to ask the FDA to authorize a booster shot of the original vaccine six months after the second dose.

Earlier this month, Pfizer’s submitted brief to the FDA made the case that it’s time to “restore” full protection from the COVID-19 vaccines, even though they are still protecting most vaccinated people from being hospitalized.

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(NEW YORK) — One week after getting her first COVID-19 vaccine shot, Bernadette Ann Bowen said she started her period one day early.

Then, Bowen, a 31-year-old Ph.D. student at Bowling Green State University, said she experienced some of the worst menstrual cramps of her life.

“I started getting a headache and then started feeling cramps coming on,” Bowen told Good Morning America. “My nausea and abdominal pain became so severe at the peak of my cramps that I could barely stomach a few sips of water, as I laid there feeling like I was going to pass out from it all.”

After Bowen saw people on TikTok discussing similar changes in their menstrual cycles after being vaccinated, she said she was “stricken with fear” over what could happen when she received her second dose of the vaccine.

“A lot of people I saw said their experience was after the second shot, so I was literally stricken with fear for a whole month wondering what would happen,” she said. “I was so afraid that it would continue.”

Bowen though, like most women who have reported menstrual changes after the vaccine, experienced only the one-time change to her period.

Nonetheless, she described it as “unacceptable” that people who menstruate did not know ahead of time that the vaccine may cause changes to the timing or severity of their menstrual cycles, even if temporary.

“Not getting a single warning is unacceptable,” she said. “It would be one thing if we were given a single consideration, but just knowing the design of medicine is so biased that this wouldn’t have been reported as a warning, it’s telling.”

Now, nearly one year after the COVID-19 vaccines began to be distributed in the U.S., the National Institutes of Health (NIH) has committed $1.6 million in funding to “explore potential links between COVID-19 vaccination and menstrual changes,” according a news release.

The funding, announced last month, comes as the U.S. Food and Drug Administration authorized Pfizer booster shots Wednesday for high-risk Americans and adults over age 65. FDA’s acting commissioner, Dr. Janet Woodcock, said the list of high-risk Americans should include health care workers, teachers and grocery story workers, all industries with largely female workforces.

The research funding also comes months after people began to share on social media their experiences of short-term period side effects after being vaccinated.

Tens of thousands of people documented their side effects in an online database created by researchers Katharine Lee, of Washington University in St. Louis, and Kathryn Clancy, of the University of Illinois Urbana-Champaign, who each said they experienced unexpected menstrual cycles after receiving the COVID-19 vaccine, and began to collect data.

The newly announced NIH funding, for which Lee and Clancy applied but were not selected, will go to researchers at five institutions: Boston University, Harvard Medical School, Johns Hopkins University, Michigan State University and Oregon Health and Science University.

The researchers will study everything from menstrual cycle changes reported on period tracking apps like Clue to menstrual changes in people with endometriosis and people trying to get pregnant, people who have not been vaccinated and teenagers. They will be examining how the vaccines may have affected flow, cycle length and pain, as well as exploring why COVID-19 vaccines may cause changes, according to Candace Tingen, Ph.D., program director of the Gynecologic Health and Disease Branch at the National Institute of Child Health and Human Development.

“Exactly like you’d see on a medication, that it may cause drowsiness, we want to say to women, ‘If you get a booster, if you get a vaccine, you might have a slightly heavier period for a cycle or two,'” Tingen said. “That’s what we want when we go in to get vaccinated, so we know how to prepare.”

Data on menstrual side effects was not widely collected during clinical trials for COVID-19 vaccines, which were conducted by the companies behind the vaccines, Pfizer and BioNTech, Moderna and Johnson & Johnson, according to Tingen.

She said the NIH was motivated to fund research both from reports of menstrual side effects as well as the misinformation that followed around menstrual changes and fertility.

“There was a lot of misinformation out there, and NIH sees its mandate as countering misinformation with accurate information,” Tingen said. “[Research] is something that we could do to step in and provide some real information about whether or not this is this is accurate.”

Experts in the medical community agree menstrual changes potentially linked to COVID-19 vaccines are likely to be temporary, and current evidence suggests that the vaccine has no impact on current or future fertility.

A possible explanation for temporary changes to period timing, flow and pain may have to do with how the body responds to physical and emotional stresses. Prior studies indicate that COVID-19 itself can be a stressor, leading to irregular menstrual cycles for some people.

Menstrual changes are also controlled by the hypothalamus and the pituitary gland in the brain, along with the ovaries, which use hormones as signals. These hormone signals can be disrupted when the body goes through changes that occur with an infection, and even a vaccine.

The research funded by NIH to help solidify these theories will include as many as 500,000 participants, some of whom are already involved in clinical studies, according to Tingen. She said because of the studies’ reach, transgender and nonbinary people will be included.

Dr. Laura Payne, director of the Clinical and Translational Pain Research Lab at McLean Hospital and an assistant professor in the department of psychiatry at Harvard Medical School, is one of the five researchers receiving NIH funding.

She is studying teens ages 14 to 19 to explore why the COVID-19 vaccines may cause changes in periods.

Specifically, Payne is looking at whether the vaccines cause inflammatory markers to be released, which then affect estrogen, which then affects menstrual cycles.

“Right now, the data on this particular mechanism is pretty limited to animal studies so we don’t really know how inflammation affects estrogen,” Payne said. “I think if we can show that inflammation has an effect on the menstrual cycle, that can help us just better understand the different things that affect the menstrual cycle.”

“In the bigger scheme of things, we’re just putting the menstrual cycle and menstrual health to the forefront as an important part of medical research, and it just hasn’t been,” she said. “It’s certainly an additional variable, but it’s really important and it’s important for women even if it’s not causing any kind of dangerous condition, it’s an important measure of health for women.”

Payne called it a “miss” that changes to menstrual cycles were not looked at during the vaccine trials, but said she is hopeful that the work being done now will help prioritize menstrual research in the future.

“In the vaccine trials, what I’m guessing is that they were just looking for indicators of pretty severe health complications that would land somebody in the hospital and they didn’t feel like changes in the menstrual cycle were part of that,” she said. “There’s certainly an argument to be made for that, but I think with the anecdotal reports and with the research that myself and the other [principal investigators] will be doing, hopefully this will inform future trials to say maybe this isn’t a life-or-death situation, but it’s important to women and it’s important to include.”

In addition to speaking out like so many people did when it came to menstrual changes with the vaccines, Payne said people can also volunteer for clinical research in order to move research on menstruation forward.

“Volunteering for clinical research is one of the best things that you can do to support the type of research that you want to see,” she said. “One of the biggest obstacles that we face in clinical research is finding ways to access participants, particularly participants from diverse backgrounds, and that’s something that we really are focusing on and NIH is really committed so we get an understanding from diverse samples of people.”

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(NEW YORK) — A new study found that children whose mothers experienced depression during and soon after pregnancy are more likely to experience depression themselves.

While experts said more research is needed on the subject, they emphasized that this new finding reinforces the urgent need to identify and treat depression among pregnant women — not just for their sake, but potentially for the sake of their child as well.

“It’s definitely been proven that there’s genetic linkage for psychiatric disorders,” Dr. Gabrielle Shapiro, a child psychiatrist from the American Psychiatric Association, told ABC News. “And identifying [depression] in early childhood would be the best way to have an impact on … lifetime trajectory functioning” for children with mental illness.

In the study, researchers in the U.K. reviewed survey data from a large database of women who gave birth during the early 1990s. They focused on a subset of over 5,000 mothers and assessed their reported symptoms of depression, both during pregnancy and after they gave birth.

The children were also surveyed throughout childhood and young adulthood. Researchers found that children of depressed mothers not only had more symptoms of depression themselves but also that the symptoms escalated faster in them than they did in children without exposure to maternal depression.

“We found that the depression scores of offspring of mothers … increased at a greater rate over time — in other words, their scores went up by more points each year than offspring of non-depressed mothers,” Dr. Rebecca Pearson, co-author of the study, told ABC News.

The data also revealed a potential association between a father’s depression and childhood depression, though the study was not constructed to assess that relationship fully.

Although previous research has looked at the link between parental depression and childhood mental health, this study is the first to indicate that the timing of when a parent has depressive symptoms may contribute to a child’s mental health in a unique way.

In a press release, Dr. Joanne Black, chair of the Faculty of Perinatal Psychiatry at the Royal College of Psychiatrists, said the study “shows that the timing of depression in parents (during pregnancy, after childbirth or both) and if the mother, father or both were affected, are all important risk factors for the child’s future mental health.”

Exactly why this timing appears to be important is still unknown, but may point to the importance of screening for depression during the peripartum period and supporting mothers with mental health conditions. It also begs the question: Are genetic factors that lead to depression passed from mother to child in the womb?

Although the findings are intriguing, it remains unclear if the results are applicable to the population at large, as this study was conducted in a part of the U.K. with little socioeconomic or racial diversity.

This matters to Shapiro, who stressed the importance of recognizing racial disparities in childhood mental health.

“It’s even more important to screen our [Black, indigenous, people of color] population and make it more acceptable for them to have early intervention and be OK with treatment discussions,” she said.

Moving forward, the study’s findings may help health care providers identify and treat children through supporting families with mental health needs.

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