Health

(NEW YORK) — She was an animal lover in Kentucky who was a “bright ray of sunshine” to all who knew her. He was a father of two and “young soul” in Florida who could often be found out on the water on his boat. They were excited about the next chapters in their lives — for her, a wedding; for him, his first grandchild.

Samantha Wendell and Shane O’Neal both also resisted getting vaccinated against COVID-19 for months, stemming from feelings of either fear or fearlessness, before deciding to make an appointment to get the shot. But before they could, they contracted COVID-19 and, following weeks of severe illness, died last month after doctors exhausted all options, their families said.

Their two tragic tales were shared publicly on social media and to news outlets by grieving family members trying to make sense of what happened, and maybe prevent others from going through the same loss.

They also represent a population that public health experts are still trying to reach, as millions in the United States remain unvaccinated against COVID-19 as the more contagious delta variant continues to spread.

‘Misinformation killed my cousin’

Days after returning home from her Nashville bachelorette party in July, Wendell, a surgical technician from Grand Rapids, started to feel sick, her cousin, Maria Vibandor Hayes, told ABC News. Her fiance, Austin Eskew, also fell ill, she said, about a month before the two college sweethearts were set to tie the knot on Aug. 21.

Eskew recovered, but Wendell’s illness progressed to the point where she was having trouble breathing and needed to be hospitalized the second week in August, according to Vibandor Hayes. The next month was a “rollercoaster” of progress and setbacks, her cousin said. Wendell was moved to a hospital in Indiana, where she was put on a BPAP (bilevel positive airway pressure) machine to help with her breathing, but the week of her wedding she was intubated and put on a ventilator, Vibandor Hayes said.

After a few more weeks of ups and downs, Wendell’s condition didn’t improve and doctors told the family they had done everything they possibly could, her cousin said. She died on Sept. 10 from COVID-19 at the age of 29.

“I didn’t think that this would be our story,” Vibandor Hayes said. “Surely, we’re gonna have a wedding to attend before the end of the year, Sam is gonna wake up and she’ll be better and we’re going to celebrate and live life. But that was not what was the case.”

“I just never want another family to experience what our family has gone through, to say goodbye to somebody on the phone,” she said.

It was particularly hard to see what her cousin went through because Vibandor Hayes is a COVID-19 long hauler, after contracting the virus in March 2020. “I remember how I felt, I remember how I thought I could possibly die,” said Vibandor Hayes, who still suffers from brain fog.

The couple had appointments to get vaccinated after Wendell returned from her bachelorette party, but then they both got sick, Vibandor Hayes said. They had previously hesitated due to concerns of infertility, but Wendell’s mother had encouraged them to get vaccinated ahead of their wedding and honeymoon, the cousin said.

Wendell was not alone in her fears of the vaccine — others have hesitated on getting the shot due to unfounded rumors that it might lead to infertility. Medical experts and the Centers for Disease Control and Prevention have stressed there is no link between the vaccines and fertility.

“Misinformation killed my cousin,” Vibandor Hayes said. “She is a smart young woman, she always has been. I feel like if she was able to look at things from another perspective and that if she had all the information at her hand, that she would have eventually not hesitated for so long.”

Delta variant a turning point

Shane O’Neal was an avid outdoorsman who could often be found fishing, jet skiing or hunting, his daughter, Kylie Dean, told ABC News.

The resident of Maxville, outside Jacksonville, wasn’t too concerned about getting vaccinated against COVID-19 — he mostly kept to himself on his boat when he wasn’t at his construction company, Dean said.

“He knew [COVID-19] was real, and he knew what was going on, but I don’t think he lived his life in fear of it,” Dean said.

The “turning point,” she said, was the delta variant, which has fueled a surge of cases and hospitalizations, particularly in the Jacksonville area.

“He knew people affected by it, that it’s not something that’s going away, it’s actually coming back with a vengeance almost,” Dean said. “So that’s why he was like, you know what, I’m just going to go ahead and do it.”

The week O’Neal planned to get the vaccine, though, he tested positive for COVID-19 in early August, his daughter said. He was hospitalized a week later and eventually put on a ventilator. He was a good candidate for extracorporeal membrane oxygenation (ECMO) treatment, a last resort for COVID-19 patients, though his hospital didn’t have the machine available, Dean said. After she put out a plea for an ECMO bed, doctors were able to find him one. But his condition deteriorated, and he died in the early morning hours of Sept. 3 at the age of 40.

About 20 minutes after he died, Dean gave birth to her baby boy, O’Neal’s first grandchild.

“I literally broke down, hysterically crying,” Dean said of when she got the call that her dad was going to pass soon. “I didn’t want him to die alone.”

The family is still “in shock,” Dean said. Her father was young and had no comorbidities, but his illness progressed rapidly.

Dean, an intensive care unit nurse, hopes to improve access to ECMO therapy and has been speaking out to warn others about the virus and urge them to protect themselves. “It’s a monster and people need to be careful,” she told ABC News Jacksonville affiliate WJXX.

Personal perspective

Wendell’s and O’Neal’s stories are akin to others shared by family members. Other recent reports of people who planned to get vaccinated but died after contracting COVID-19 include a 53-year-old former Texas councilman, a 39-year-old Illinois teacher, a 48-year-old teacher in Florida, and a 20-year-old college student in North Carolina.

Nearly all COVID-19 hospitalizations and deaths are among people who are unvaccinated, as health care workers and in some cases those hospitalized themselves plead for vaccination.

As of Wednesday, some 70 million people who are eligible to get the COVID-19 vaccine remain unvaccinated, according to federal data. Over 65% of those ages 12 and up are fully vaccinated nationwide, which is low considering the level of access to free vaccines in the U.S., Rupali Limaye, director of Behavioral and Implementation Science at the International Vaccine Access Center, based at the Johns Hopkins Bloomberg School of Public Health, told ABC News.

At this stage, two main forces may get someone who is hesitant vaccinated, Limaye said — one is hearing about someone regretting not getting the vaccine, the other a vaccine mandate.

“If someone they know themselves is dealing with a very severe case, and someone they know dies from it or they’re close to death, I think that tends to change their mind,” Limaye said. “Or the vaccine mandate, because then that’s sort of an economic sanction.”

Hesitancy continues to be fueled by safety concerns and distrust of the vaccine development process, as well as the belief that preventative measures are unnecessary, she said. Public health experts continue to work to dispel misinformation, but hearing personal stories could be impactful.

“If it is someone that you know where you can hear from a friend, ‘This is what happened to my mom,’ I think that puts it into perspective for people a lot versus just public health folks saying you should get it,” Limaye said. “I think it makes it much more real.”

Vibandor Hayes said she has received “hate mail” from strangers after urging people to get vaccinated, but wants to continue to speak out to help prevent another family from experiencing the same heartbreak.

“If this is the gift she has left us, to share with others, then that’s what we’ll do,” Vibandor Hayes said.

Copyright © 2021, ABC Audio. All rights reserved.

(NEW YORK) — A breast cancer survivor has created a mobile app, called Feel For Your Life, to help women conduct breast self-exams.

“I found out there were three reasons women weren’t doing self exams,” Jessica Baladad, 36, told Good Morning America. “They were afraid of finding something and not knowing what to do, they weren’t comfortable with their bodies, and they didn’t know how because no one’s ever showed them or talked to them about the importance of a exam, so I thought, ‘I need to advocate for this.'”

According to the National Cancer Institute, breast cancer is one of the three most common cancers in women. The NCI estimates there will be more new cases of female breast cancer than any other cancer in 2021, with a projection of 281,550 new cases.

Breast cancer is primarily detected through a mammogram, ultrasound, MRI or biopsy, and usually involves a combination of testing to ensure an accurate diagnosis. Mammograms can often detect tumors before a lump appears, so screenings are crucial for early detection.

“As a supplementary tool for women of all ages, self-breast exams can increase women’s awareness of their body and what their breasts normally feel like,” Dr. Elizabeth Comen, breast medical oncologist at Memorial Sloan Kettering, told GMA. “As a screening strategy, it helps women identify any concerning findings such as new changes in the shape, skin, or nipple as well as any concerning lumps which may require further imaging and work-up.”

Most guidelines recommend women begin routine annual screenings once they’re 45 years old; a recommendation that can leave younger women vulnerable to missing early detection of the disease.

For those under the recommended age for screening, Comen said that self-exams can have an important role in picking up breast abnormalities and prompt patients to seek out further care from their doctor.

“This is particularly true for women under the age of 40, for whom there’s no routine breast cancer imaging screening recommendations,” she said. “Since most of these women aren’t indicated to have mammograms, many of these cancers are actually detected by women themselves, through self-breast exams.”

Baladad has done regular self-exams ever since she had surgery to remove a benign fibroadenoma tumor in her breast when she was 18 years old, she said.

“I had a pain in my breast and I ran to the bathroom real quick, right before class, and I noticed there was a lump and it scared me,” she recalled, adding that she immediately went to health services after class and it was from there that doctors discovered the tumor. “It was that experience that got me into the habit of doing self-breast exams throughout the rest of adulthood.”

A personal connection to breast cancer

Breast cancer runs in Baladad’s family on her father’s side, with her great-grandmother, grandmother, five grand-aunts, and two aunts all having lived with the disease, she said. Fifteen years later after that initial scare, Baladad was diagnosed with breast cancer herself.

In March 2018, Baladad said she didn’t do her routine self-exam that month because she was scheduled to see her nurse practitioner around then.

“I thought, ‘Who better than my practitioner to do a clinical breast exam?’ and when I saw her, she didn’t say anything about a lump to me so I thought I was good to go,” she said.

When Baladad did a self-exam in the shower just two weeks after her appointment, however, she found a lump in her left breast.

“I just started freaking out like ‘This is it, it’s cancer,'” Baladad said. “But then I thought, ‘Wait. I’m working out in the gym almost every day. I take care of myself. I eat well. I just saw my doctor, surely she would’ve said something about this.'”

After calming herself down, Baladad went on with her life. But when an acquaintance posted about shaving their head due to having breast cancer, Baladad said she decided to get her own lump checked out in August 2018.

“She was a year older than me,” she said. “If she’s young enough to get breast cancer then I’m young enough to get breast cancer.”

This time, Baladad went to a different doctor and had a mammogram, ultrasound and a biopsy. The lump was confirmed as breast cancer, making her one of the millions of women in the United States living with the disease at the time.

“I found out later that my original practitioner didn’t tell me about the lump in my breast because she thought I was too young to have breast cancer and she thought I’d be fine,” Baladad, who was 33 when diagnosed, said. “A self-exam saved my life.”

According to the Centers for Disease Control and Prevention, most breast cancers are found in women 50 and older, though age is not the ultimate determining factor. In 2018, CDC data found that there were 184 new cases of breast cancer in women ages 20-24; 1,173 in ages 25-29; and 3,300 in ages 30-34, with the number of cases continuing to increase thereafter.

“Most breast cancers are identified in women over age 50. That being said, younger women can get breast cancer too,” Comen said. “Any woman, or any patient for that matter, who has an inkling that they need a second opinion, should get a second opinion. Intuition and trusting your doctor are critical for a therapeutic doctor-patient relationship.”

Fortunately, Baladad’s cancer has been in remission since May 2019 — but the road there wasn’t easy.

“I did 16 rounds of chemo, a double mastectomy, 24 rounds of radiation, a hysterectomy, and back in February I had a 10-hour flap reconstruction procedure done where they took fat, tissue, and blood vessels from my abdomen and placed them in my chest,” she said. “I have phase two of that surgery in October.”

From a social media project to app launch

Baladad originally created Feel For Your Life as a social media project during her cancer journey, where she would share her story, as well as cancer statistics, and encourage women to perform self-exams and get checked out by a doctor.

“One night I was in the shower literally watching my life go down the drain as I watched my hair come off my head and the idea just kind of came to me,” she said. “I felt like I was called to do it.”

The idea to build an app came last year after Breast Cancer Awareness Month in October. Baladad said she “wanted to reach more women” and thought the way to do so was through an app.

Over the following months, she researched how to build an app, the features she wanted it to have, and consulted tech-savvy people who helped her with the process. It officially launched on Apple and Android app stores in September 2021.

“I just thought about [the app] from a woman’s experience, and I wanted it to be really intuitive for how a woman may want to use it,” she said. “I’m not a coder or developer, I’m an advocate. I look at the app as an advocacy tool that women can use to communicate with their physicians. I’m not a doctor and I’m not trying to be a doctor — my mission is to help women advocate for their breast health.”

The information on the app is sourced from the CDC, the National Breast Cancer Foundation, and Johns Hopkins Medicine. There are instructions on how and when to do a self-exam and information on genetic testing and counseling, types of breast screenings, risk-reducing surgical procedures, breast reconstruction options and more.

Other features of the app include the ability to set reminders for self-exams and a space to track any changes. There’s also a section where users can share their advocacy wins with Baladad, plus a community feature where users can talk to others about what they’re doing.

“I also have reminders throughout the app that if you find anything, please talk to your doctor,” Baladad said.

Baladad hopes to one day include a telehealth feature within the app, where users can connect with medical professionals in real time.

“If a woman is doing a self-exam and she finds a lump, she may get scared or have anxiety,” she said. “I want to be able to connect her with a physician and they can put her on the right track to help her [with] getting the answers that she needs.”

Copyright © 2021, ABC Audio. All rights reserved.

(NEW YORK) — Taking a course of a particular antiviral pill over five days, shortly after COVID-19 diagnosis, may slash the risk of being hospitalized or dying of the virus by 50%, according to preliminary results announced by pharmaceutical companies Merck and Ridgeback.

If this pill — called molnupiravir — is ultimately authorized by the Food and Drug Administration, it would be the first antiviral pill people can take at home to reduce their risk of winding up in the hospital from the coronavirus. The medication would require a prescription and likely be for people with mild or moderate symptoms of COVID-19.

“It’s really exciting,” Dr. Carlos Del Rio, the executive associate dean and a global health expert at the Emory School of Medicine, said.

Right now, most COVID-19 patients are sent home and told to monitor their symptoms. Having an effective pill to offer them would “make a difference,” Del Rio added.

Merck Thursday morning announced the results of an ongoing Phase 3 study are so compelling that an independent monitoring board recommended, in consultation with the FDA, ending the trial early so the companies can swiftly seek authorization. The full set of data would become available to the public at that time.

Other companies, including Pfizer and Roche, are also working on antiviral pills that could become available soon. Merck plans to seek emergency authorization in the U.S. “as soon as possible” so that it can start mass distributing its antiviral pill.

The company has started producing the pills with the goal of having 10 million courses of the medication by the end of the year. The U.S. has already asked for 1.7 million doses, at a cost of over $1 billion.

Currently, doctors have some treatments to help those who are already sick with the virus, but those treatments are cumbersome, as they’re typically administered via intravenous infusion and usually reserved for patients who are hospitalized or have a high risk of becoming so.

“What we really need is the Tamiflu, if you will, for COVID-19,” Dr. Todd Ellerin, the director of infectious diseases at South Shore Health and an ABC News Med Unit contributor, said. “It’s possible that molnupiravir could be the agent.”

Molnupiravir is an antiviral drug, meaning it works by slowing the replication of the virus that causes COVID-19.

In an early analysis of 775 volunteers in a late-stage clinical trial, people who tested positive for COVID-19 within the last five days were split into two groups. The first group got the drug and the second got a placebo pill.

About 14% of people who got the placebo were hospitalized or died, compared to just over 7% of those who got the real drug.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world,” Robert M. Davis, the chief executive officer and president of Merck, said.

“I think this is exciting,” Ellerin said, “because we need an oral antiviral. We desperately need an oral antiviral that can be given early in the course.”

Copyright © 2021, ABC Audio. All rights reserved.

(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.

Copyright © 2021, ABC Audio. All rights reserved.

(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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