(WASHINGTON) -- Moderna announced Thursday that it's launched early-stage clinical trials of an HIV mRNA vaccine.
The biotechnology company has teamed up with the nonprofit International AIDS Vaccine Initiative to develop the shot, which uses the same technology as Moderna's successful COVID-19 vaccine.
The first participants in the Phase I trial were given doses at George Washington University School of Medicine and Health Sciences in Washington, D.C., according to a company statement.
"We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna's mRNA platform," Dr. Mark Feinberg, president and CEO of IAVI, said in a statement. "The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine."
Nearly 38 million people worldwide -- including about 1.3 million in the U.S -- are living with HIV, or human immunodeficiency virus, which can lead to the potentially fatal disease AIDS.
Being diagnosed with HIV was once considered a death sentence. During the height of the U.S. AIDS epidemic in the mid-1990s, more than 50,000 deaths occurred every year, according to the Centers for Disease Control and Prevention.
Today, HIV is much more manageable with medications that can reduce viral loads to undetectable so the virus can't be transmitted, as well as pills that can be taken to prevent infecting those who are HIV-negative.
But despite decades of research, no vaccine has ever been developed. Several candidates have entered clinical trials but failed in later stages.
The new vaccine uses mRNA, or messenger RNA, which teaches the body's cells how to make proteins that trigger immune responses.
Researchers have developed not only a primary vaccine but also a booster to deliver HIV immunogens -- molecules that elicit an immune response -- via mRNA.
The hope is this process can induce specific white blood cells, called B cells, which can then turn into what are known as broadly neutralizing antibodies that can neutralize the virus.
According to the statement, Phase I of the trial will enroll 56 healthy, HIV-negative adult participants at GWU and three additional sites: Hope Clinic of Emory Vaccine Center in Atlanta; Fred Hutchinson Cancer Research Center in Seattle; and the University of Texas-Health Science Center at San Antonio.
Of the volunteers, 48 will receive one or two doses of the mRNA vaccine, and 32 also will receive the booster. The remaining eight will receive just the booster.
Researchers will then monitor for safety and efficacy of the new vaccine for up to six months after participants receive their final dose.
Moderna did not immediately respond to ABC News' request for comment.
ABC News' Sony Salzman contributed to this report.
(SACRAMENTO, Calif.) -- A new bill in California would allow children to get vaccinated against diseases including COVID-19 without their parents' consent.
Currently, kids in the state between ages 12 and 17 must receive permission from a parent or a guardian to get a vaccine, unless it is to prevent a sexually transmitted infection.
However, the new bill -- introduced Friday by state Sens. Scott Wiener (D-San Francisco) and Richard Pan (D-Sacramento) -- would allow Californians aged 12 and older to receive vaccines that meet specific federal agency criteria on their own.
Under the bill, adolescents could get vaccinated as long as the shots are approved by the U.S. Food and Drug Administration and recommended by the Centers for Disease Control and Prevention's advisory committee.
As of Wednesday, about 63% of Californians aged 12-17 are fully vaccinated, according to the state department of health -- but at least 28% are not.
"There are nearly 1 million teenagers in California who are not vaccinated against COVID-19, and that jeopardizes their own health. It makes our schools less safe," Wiener told ABC News. "A lot of these teenagers would like to get vaccinated, but their parents either won't let them or their parents aren't making the time to go with them to get vaccinated."
He added, "This legislation will allow teens to protect their own health and to get vaccinated against COVID-19, against the flu and other serious diseases."
Washington, D.C., currently allows minors to receive vaccines on their own starting at age 11. San Francisco also allows kids aged 12 and older to receive COVID-19 shots without parental consent when consent is unavailable.
Additionally, five states allow minors to get vaccinated without parental consent. Alabama allows teens to receive vaccines on their own starting at age 14; Oregon at age 15; and Rhode Island, North Carolina and South Carolina at age 16.
Elizabeth Tobin-Tyler, an associate professor of health services, policy and practice at Brown University, said these laws are often the result of a "mature minor" doctrine, which allows minors to give consent provided they can show they are mature enough to make decisions on their own.
"The idea is there are minors that might be quite mature at age 12 or 14 and have the capacity to make their own decision," she told ABC News. "States have recognized there are situations where we don't want to have someone make a decision at just 18."
Dr. Georges Benjamin, executive director of the American Public Health Association, said most kids of that age are mature enough to understand medical information that is given to them.
"When you're dealing with kids and medical care, you want to be able to give them with some graduated autonomy about their health," he told ABC News.
If the bill passes, California would become the state with the youngest age for children to get vaccinated on their own without permission from an adult.
"It will serve as an example for other states," Benjamin said. "California has often been on the cutting edge of legislation that has become law in other parts of the country. So it will certainly be an exemplar in that area and it will serve as a model for other states, particularly as we see the numbers of kids vaccinated grow."
However, not everyone is in favor of the bill.
"It just seems like this is part of this ongoing war against parents by some Democratic elected officials," California Republican Assemblyman James Gallagher told ABC News. "This bill is not about letting children make some sort of decision in a vacuum whether or not they want to get vaccinated. It's about eliminating parents from that decision-making process."
He described the bill as a "slippery slope" and said it could lead to kids having autonomy to take other medications without parental consent.
"What other drugs, what other things would a child be able to decide at school or some other place without their parents' consent?" Gallagher asked.
Under California law, minors aged 12 and older are already allowed to be vaccinated against hepatitis B and human papillomavirus (HPV) and to receive birth control and treatments for STIs, mental health disorders and substance abuse.
But Wiener said he doesn't believe the new bill would curb parents' input when it comes to their children's health because most teens speak to their parents when it comes to making medical decisions.
"The vast majority of teens -- even if they have the ability to get a vaccine -- will talk to their parents about the issue," Wiener said. "We want parents to be involved in their kids' health care, and I am confident that many, many teens will talk to parents about it."
He continued, "Sadly there are some teens who are not in a position to talk to their parents about it. For whatever reason, they can't have those conversations and in those situations, a teenager should be able to protect their own health."
Benjamin said the idea of providing teens with autonomy is not new or radical and could actually help teenagers think critically and analytically.
"We do this a lot in other areas in our lives," he said. "We give them driver's licenses as they are able to mature both emotionally and physically. Parents should think of this as part of allowing their kids to have more control over their health decision-making. From a mental health and psychological perspective, this should be thought of as giving kids more responsibility, and I think overall it's a good thing."
ABC News' Ivan Pereira contributed to this report.
(DENVER) -- A major new study has found that more and more young people are being diagnosed with late-stage colon cancer, prompting renewed calls among doctors for early detection and screening.
Researchers from University of Colorado School of Medicine analyzed data from more than 100,000 people with adenocarcinoma, a more aggressive cancer that's more likely to be caught in later stages.
They found that young patients 20-29 years old have had the highest increase in rates of new colon cancer cases diagnosed and are more likely to be in the distant stage of cancer when diagnosed, meaning the cancer has already spread. In particular, subgroups of non-Hispanic Black and Hispanic participants had the highest increases.
"Studying cases of adenocarcinoma alone is important, because those are the ones we're trying to prevent with screening and risk factor identification," explained study author Dr. John Karlitz, chief of gastroenterology at Denver Health Medical Center.
The United States Preventive Services Task Force (USPSTF), the leading organization on preventative medicine, recently changed the screening guidelines for colon cancer from age 50 down to age 45, after reviewing these recent trends of increasing cases of colon cancer in younger people.
As for why these rates might be rising, risk factors such as obesity, diet, or environmental factors could be playing a role, said Dr. Jay Bhatt, a primary care physician and ABC News contributor.
Karlitz noted another factor that could explain this trend is delay in diagnosis.
At the first symptom, younger people may not seek colon cancer screening immediately because of a misconception that it's an unlikely diagnosis. This can delay diagnosis, which gives the cancer time to progress to a later stage. These delays can be avoided with timely screening, according to Karlitz.
Common symptoms to look out for include rectal bleeding, persistent abdominal pain or fullness, and unexplained weakness.
"I actually discuss it with all patients over 40 to prepare them and if they had early colon cancer diagnosis in their family, it is even more important," Bhatt said about colon cancer screening.
This study does not factor in family history. If a family member has colon cancer, it can significantly raise the risk of developing colon cancer. Doctors recommend people with risk factors like family history and genetic syndromes such as Lynch syndrome to speak to their doctors as they may need earlier screening. Karlitz suggests holidays and family gatherings are a great time to be proactive and ask your family their medical history.
"If you're 45 years old, get screened on time -- do not wait. If you are under 45, report concerning symptoms to your provider and report your family history to your provider -- it can be lifesaving and impactful to prevent the development of colorectal cancer or at least advanced disease," added Karlitz.
Vanya Jain is a medical student from New Jersey Medical School, working with the ABC News Medical Unit.
(NEW YORK) -- As the coronavirus pandemic upends a third consecutive school year, Adam Solovoy, of Chicago, said learning loss due to the pandemic is something he has witnessed firsthand in his two daughters, ages 10 and 9.
"When they do take the standardized testing that they take every year, their scores were, in certain areas, behind where they were supposed to be," said Solovoy, whose daughters have gone through a mix of school closures, remote and in-person learning since March 2020.
Experts said that for children across the country, the lack of a routine due to the pandemic is taking a toll on their education.
Nationwide, children are scoring about 9 to 11 percentile points lower in math and 3 to 7 percentile points lower in reading compared to historic averages, according to studies led by Karyn Lewis, Ph.D., a senior research scientist for NWEA, a nonprofit organization focused on education policy.
Lewis said the education gaps are largely due to what she calls "unfinished learning," a result of remote learning, quarantines, school closures and teacher shortages brought on by the pandemic.
"Students have lost out on instructional opportunities,” Lewis told ABC News. “They have unfinished learning relative to what we’d expect in a typical year if they got the full dose.”
Many students in the U.S. are also facing disproportionate educational adversity, according to Jacques Steinberg, a former New York Times education journalist and author of "The College Conversation.”
“It’s a particularly hard time if you are a student from a low-income or other marginalized background where there were already inequities in your education before any of us had ever heard of the coronavirus,” Steinberg said. “Those have only been exacerbated over the last two years.”
With most schools now doing in-person learning, thanks to the success of mitigation strategies like masking, social distancing and regular COVID-19 testing, teachers are now more able to help their students get up to speed.
But experts like Lewis warn that closing the gap will not happen overnight, with long-term solutions like increased access to summer enrichment programs, Saturday academies and tutoring needed.
"This is not a one to two-year endeavor to get kids back on track," she said. "This is going to take a really sustained effort.”
Parents who are concerned about their children's learning loss can also take a proactive role by monitoring their behaviors, according to parenting expert Rachel Simmons, author of the bestselling book "Odd Girl Out."
Specifically, parents can watch for changes related to their children and school like sudden anxiety and hesitation around school work, frustration, negative self-talk and changes in grades, according to Simmons.
"Be in touch with your child’s teacher," Simmons said Wednesday on Good Morning America. "Find out how they’re doing relative to their peers and even how they’re doing relative to last year."
Behavioral changes are also something to watch for, according to Simmons, who noted that kids may have trouble adjusting to socialization amid the pandemic.
"No kid is born knowing how to be friends and when we don’t use a muscle, we lose it," she said. "If you’re noticing your child has fallen back, they’re worried about unstructured play especially, like going to the playground or a sleepover, that’s a sign not that they can’t do it, but that their muscle is out of practice. They’re going to need to take smaller steps to get back to where they were."
Simmons recommends talking and brainstorming with children before they get into a challenging situation, and having honest conversations about their feelings.
"We have to tell our kids it’s okay to feel anxious and frustrated," she said. "This is a really anxiety-provoking and frustrating time."
Most of all, Simmons encourages parents to "be patient" as their child works through pandemic-related difficulties.
"It is so scary to watch your kid fall behind, but by putting pressure on them and visiting our anxiety on them, it’s not going to get them where they need to go," she said. "Stay connected with their teachers and get professional help if your child can’t do day-to-day activities."
(BOSTON) -- The family of a Boston man is speaking out after they say their 31-year-old son was struck from a waitlist for a heart transplant because he was not vaccinated against COVID-19.
DJ Ferguson, who was diagnosed with arrhythmia four years ago, was admitted to Brigham and Women's Hospital after suffering heart failure this winter, his parents told ABC News. But after reviewing Ferguson's medical history, which showed he had not received a coronavirus shot, hospital staff told Ferguson that his vaccination status made him ineligible for a new heart, according to his parents.
Tracey and David Ferguson insisted their son does not oppose vaccines; he just worries the COVID-19 shot would complicate his heart condition, they said.
"He's not an anti-vaxxer. He has all of his vaccines, and he's an informed patient who is concerned because of his current cardiac crisis," Tracey Ferguson said.
However, doctors say the risk of severe illness and inflammation of the heart from contracting COVID-19 is much more likely than the low risk of heart inflammation from the vaccine, which is usually temporary.
National transplant associations recommend the COVID-19 vaccines before transplants, as do many medical centers, because after a transplant, the patient’s immune system can become compromised from medications necessary to keep the organ and the patient alive, making the individual at risk for severe illness and death if they become infected with COVID-19.
The coronavirus vaccine is just one of several vaccinations required for patients who receive a transplant at Brigham and Women's Hospital, a spokesperson at the facility told ABC News. These requirements "create both the best chance for a successful operation and optimize the patient's survival after transplantation, given that their immune system is dramatically suppressed," spokesperson Serena Bronda wrote in an email.
Since only about half of people waiting for an organ transplant will receive one, according to the hospital, doctors try to ensure that the organs go to people with the best chance of survival after the operation.
While the hospital could not comment on Ferguson's case, citing HIPAA privacy law, Bronda said that all patients seeking transplants undergo a "comprehensive evaluation" to determine if they are eligible for the operation.
Transplant seekers are also screened for certain "lifestyle behaviors" that might disqualify them, such as substance use and active smoking, she added.
Evaluating patients seeking organ transplants is a common practice in most hospitals -- and a necessary one, experts told ABC News, as there are not enough organs for everyone who needs one.
"You're trying to get the most life saved with a very, very scarce resource," Dr. Arthur Caplan, a professor of bioethics at New York University, said. "This is not about discrimination."
Jennifer Miller, a bioethicist at Yale, told ABC News that hospitals must "allocate prudently" when it comes to organ transplants. "If you end up giving a heart to somebody who then dies, not only that person died, another person didn't get that heart," she said.
On Tuesday, DJ Ferguson was in open-heart surgery to receive a mechanical heart pump, called a left ventricular assist device, which should keep him alive for up to five years, according to his parents, who worry about the toll the device will have on their son's quality of life.
"For the foreseeable future, he won't be able to shower, he won't be able to swim. He won't be able to have a life," David Ferguson said.
Tracey Ferguson said it was "devastating" when she learned that her son was not eligible to receive a new heart.
(GENEVA) -- Even as the omicron COVID-19 variant continues to sweep the globe, scientists are now monitoring a new mutation of omicron, dubbed BA.2.
The World Health Organization maintains that BA.2 is not a "variant of concern," meaning there is no current evidence to suggest this new subvariant will worsen COVID-19 transmission, illness severity, or efficacy of vaccines and public health efforts like masking and social distancing.
BA.2 numbers around the world are rising, with at least 40 countries reporting cases to a global variant tracking database, but the subvariant has spread rapidly in Denmark and the UK, with almost half of recent cases in Denmark attributed to BA.2.
The subvariant has already been detected in several U.S. states, with Washington State confirming two cases Monday.
While over 8,000 BA.2 cases have been identified since November 2021, it is unclear where BA.2 originated. Even though the first sequences were submitted from the Philippines, numerous cases have since been detected in various places, from Europe to South Asia.
Given the rising numbers, health care organizations, like the WHO, are asking scientists to watch and study the new subvariant separately from omicron, to see if it behaves differently.
"It is the nature of viruses to evolve and mutate, so it's to be expected that we will continue to see new variants emerge as the pandemic goes on," said Dr. Meera Chand, the COVID-19 incident director at the UK Health Security Agency, in prepared remarks. "So far, there is insufficient evidence to determine whether BA.2 causes more severe illness than Omicron BA.1, but data is limited."
The evolution of COVID-19 subvariants is not new. The delta variant also had several subvariants, but scientists referred to all of them as delta. BA.2, however, has earned its own designation due to rising numbers across several nations.
Although it's been called the "stealth" omicron variant, the new subvariant, "can absolutely be detected through traditional surveillance mechanisms whether through rapid testing or PCR," said Dr. John Brownstein, chief innovation officer at Harvard University's Boston Children's Hospital and ABC Medical Correspondent.
Conventional COVID-19 tests can show a positive or a negative result, but they can't determine specific variants. For that, scientists need to do additional genetic sequencing. Conveniently, the omicron variant has a particular genetic signature that allows scientists to quickly and easily determine if the sample is omicron or not.
The new BA.2 subvariant does not have that feature, meaning scientists can no longer use this shortcut -- though they can still identify the subvariant using genetic sequencing technology. Because of this, the BA.2 subvariant has sometimes been referred to as the "stealth" variant. But for the general public, conventional COVID-19 tests will still work to detect the new subvariant.
Ultimately, while scientists and public health officials are urging continued research and surveillance, experts say there is little reason to worry.
"BA.2 is important from a public health perspective, but it doesn't fundamentally change at this moment, how we think about the impact in the population," Brownstein said. "A lot more work needs to be done to understand severity, breakthrough infections, and immunizations before you can make any statement about clinical relevance."
"While it's important to understand that in the family of omicron, there is a sub-lineage that is potentially more transmissible, it's not necessarily a cause for panic," Brownstein added.
Nitya Rajeshuni, M.D., M.S., a pediatrics resident at the Children's Hospital of Philadelphia, University of Pennsylvania, is a contributor to the ABC News Medical Unit.
(OMAHA, Neb.) -- Dani Donovan, a 30-year-old woman from Omaha, Nebraska, said she spent the better part of a decade going to different doctors to seek help for chronic pain.
At each visit, according to Donovan, she would be told she needed to lose weight, a discouraging cycle that she said kept her from seeking more medical care.
"I was in pain and all doctors would say to me is that I need to lose weight," Donovan told "Good Morning America," noting the experience would often lead her down a cycle of binge eating due to her frustration and pain." "I felt like doctors wouldn’t listen to me and it was making me not go to want to see the doctors."
That changed in December, according to Donovan, when she went to a new primary care physician.
While in the waiting room at that doctor's office, Donovan saw what are called "Don't Weigh Me" cards, business cards that are designed for a patient to hand to a nurse or doctor.
The cards read on the front, "Please don't weigh me unless it's (really) medically necessary. If you really need my weight, please tell me why so that I can give you my informed consent."
On the back of the card is a list of reasons why a person may not want to be weighed, including the risk of weight stigma and stress and that "most health conditions can be addressed" without knowing a patient's weight, according to the card.
The cards were a game-changer for Donovan, who said she felt empowered to stand up for herself and not have her weight be the focus of the doctor's appointment.
"I had heard online that you could ask doctors not to weigh you, but I still felt really intimidated to say that out loud," said Donovan. "You're used to going to the doctor's office and them herding you onto the scale. It's just part of the routine."
"I was able to just show the card to the woman who was bringing me back and it was like OK and we continued on," she said.
Donovan said she went onto have an hourlong appointment with the doctor, who sent her to a specialist, whom Donovan said ultimately diagnosed her with Ehlers Danlos syndromes, a a group of inherited connective tissue disorders, according to the National Institutes of Health.
"It just made a huge difference to have been heard," said Donovan, adding that she now feels comfortable going to see her doctors.
It was a similar experience with weight stigma at doctors' offices that led Ginny Jones to create the "Don't Weigh Me" cards nearly four years ago.
Jones, the founder of More-Love.org, an eating disorder-focused resource for parents, said she suffered from an eating disorder and began asking to not be weighed at doctors' offices when she started her recovery.
"I decided I would not be weighed unless it was necessary," said Jones, explaining that at first she told her doctors verbally. "Very interestingly, in many, many years of asking not to be weighed, it's never been required for my care."
"I'm open to it if it is required for my care, but so far it really hasn't been an issue for me," she said.
Jones said that as she began working with parents and people in recovery from eating disorders, she saw she was not alone in not wanting weight to be the focus of doctors' appointments. She launched the cards as a way for people to have something in their pocket they could just easily hand to a doctor or nurse.
"I posted them on my website kind of thinking maybe a couple people would be interested," said Jones. "And they have had a huge demand."
The cards, which are available for sale on Jones's website, have been purchased by not just individuals but also therapists, dietitians and doctors, according to Jones.
Dr. Lesley Williams-Blackwell, an Arizona-based family medicine physician and eating disorder specialist, carries the cards in her office so that patients can take them and use them with other doctors.
Williams-Blackwell said she started doing automatic blind weights -- meaning the patient is weighed but the number on the scale is not shown to them -- after one incident in which a patient fled the office after being weighed.
"She was so upset that she fled the office," said Williams-Blackwell. "That just illustrated for me that you don't know, especially if it's your first time meeting someone, how [weight] being the first piece of data that they're presented with, even before you have an opportunity to meet them, could be very triggering or upsetting."
Williams-Blackwell said when she takes her three children, ages 9 to 12, to doctors' appointments, she asks that their weights not be shown or discussed.
She said, in her experience, it is important for doctors and patients to look beyond a single number when it comes to someone's health.
"I really would challenge people to look at health in a more holistic way and to not feel that they have to get so pigeonholed into weight as the sole marker of how healthy someone is," said Williams-Blackwell. "Because the reality is that there's so much more to health."
Chelsea Kronengold, a spokeswoman for the National Eating Disorders Association, said doctors' focus on weight can often not only miss other conditions that may be present, but can also lead to weight stigma and eating disorder behaviors.
"Weight stigma is discriminating or stereotyping someone based on their weight, which we know that medical providers frequently do, as well as the general public," said Kronengold. "And weight stigma can increase body dissatisfaction, which is a leading risk factor in the development of eating disorders."
Nearly 30 million Americans will have an eating disorder in their lifetime, and over the past two years of the coronavirus pandemic, eating disorders have been on the rise in the U.S., according to NEDA.
Jones said she hopes the conversation around weight changes in society to the point that it puts her "Don't Weigh Me" cards venture out of business.
"My dream and my vision is that we actually live in a society that respects bodies regardless of weight, and that being weighed at the doctor's office is not an assumed first step," she said. "I don't want to be in business in 10 years selling cards. My vision is actually that we change the conversations at a much deeper level, and that doctors start to recognize the harm that being weighed [in their offices] can cause."
(NEW YORK) -- A new study adds to the growing evidence that COVID-19 vaccines are safe for both pregnant people and people hoping to become pregnant.
The study, which looked at more than 2,000 couples in the United States and Canada, found "no adverse association" between getting vaccinated against COVID-19 and fertility, for both men and women.
On the other hand, men who contract COVID-19 may experience a temporary reduction in fertility. Couples who had a male partner test positive for COVID-19 within 60 days of their partner's menstrual cycle were 18% less likely to conceive in that cycle, according to the study, published on Jan. 20 in the American Journal of Epidemiology.
"The findings provide reassurance that vaccination for couples seeking pregnancy does not appear to impair fertility," Dr. Diana Bianchi, director of the National Institute of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study, said in a statement. "They also provide information for physicians who counsel patients hoping to conceive."
The myth that COVID-19 vaccines may negatively impact fertility was one that was spread largely on social media.
More and more research has now shown that not only do the vaccines not affect fertility, they also do not impact pregnancy.
A study released Jan. 4 by the Centers for Disease Control and Prevention (CDC) found no increased risk of preterm or low-weight birth among babies born to pregnant people who got a COVID-19 vaccine shot, compared to babies born to unvaccinated pregnant people.
The study's researchers at Yale University looked at the health data of more than 40,000 pregnant women and did not identify any safety issues with getting vaccinated while pregnant, no matter which trimester a woman was in when vaccinated, or how many vaccine doses she got during her pregnancy. Researchers noted most of the women included in the analysis were vaccinated in the second or third trimester, and the study didn't include booster doses.
In a health warning issued in September urging pregnant people to get vaccinated, the CDC said data shows there is also no increased risk for miscarriage linked to receiving a COVID-19 vaccine.
"Miscarriage rates after receiving a COVID-19 vaccine were similar to the expected rate of miscarriage," the CDC said at the time. "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 studies released last summer found Pfizer and Moderna's COVID-19 vaccines appear to be safe and effective for pregnant people, and were also found to likely offer protection to infants born to a vaccinated person.
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.
The World Health Organization (WHO) also says pregnant people can be vaccinated against COVID-19.
"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," the 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."
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 part of the virus as 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.
The COVID-19 virus has also proven to be more dangerous for pregnant people, especially if they are not vaccinated.
According to the CDC, COVID-19 causes a two-fold risk of admission into intensive care and a 70% increased risk of death for pregnant people.
A study led by researchers in Scotland, and published this month in Nature Medicine, found that unvaccinated pregnant people who contracted COVID-19 not only were at risk of more severe illness themselves, but also were more likely to experience pregnancy loss or preterm birth compared to other women.
(SEATTLE) -- Seattle doctors say hospitals are reaching their breaking points as they deal with a crush of COVID-19 patients amid the latest surge fueled by the omicron variant.
Between Jan. 13 and Jan. 19, there has been an average of 64 new hospitalizations per day with a total of 449 during the week, according to county health department data.
This is a 460% increase from the 80 hospitalizations that were occurring over a one-week period just a month ago.
Additionally, 19.9 per 100,000 residents have been hospitalized over the seven-day period, according to health data.
As of this weekend, UW Medicine -- which has four hospitals across its system -- reported more than 200 COVID-19 patients for the first time ever.
By comparison, at the end of November, there were about 30 patients infected with the virus across the system, according to Dr. John Lynch, an infectious disease expert at Harborview Medical Center in Seattle and UW Medicine medical lead for the COVID-19 response.
"I think we're closer now to a crisis -- like a true crisis in health care -- we're closer than we've ever been during this entire pandemic," Lynch told ABC News.
He said this is due to several factors, including the number of patients getting sick, hospitals reaching capacity, an exhausted health care workforce and the frustration of COVID patients being admitted to hospitals who are unvaccinated.
Before the omicron surge, unvaccinated King County residents were nine times more likely to be hospitalized and die, according to Public Health Seattle. During the omicron surge, unvaccinated people are now 12 times more likely to be hospitalized and 20 times more likely to die.
"We have these incredible vaccines that are so good at protecting us from serious disease and death, and yet people continue to ... not get vaccinated and that ends up leading to them in the hospital," Lynch said. "Health care workers don't want to see people suffer and it is just so hard to see a big group of folks in the ICU because of something that was completely preventable."
Lynch said most hospitals across Washington state were already very full when the omicron surge struck compared to other times during the pandemic, making it even more challenging to find enough beds, secure enough resources and prevent understaffing.
"My facility at Harborview, we were already about 100 patients over our normal capacity when the omicron surge hit," he said. "Then the omicron surge came and so you basically had to absorb all these more patients, all of whom required precautions."
Lynch urged residents to help ease the burden on hospitals by wearing masks indoors, getting vaccinated and boosted and avoiding large gatherings so they don't potentially contract the virus and get seriously ill.
"We need your help in health care right now, in hospitals, in clinics, in emergency departments," he said. "We need to slow down the number of new cases of COVID-19. That means please take every precaution not to get infected, not to end up in the hospital."
(LOS ANGELES) -- Students in Los Angeles public schools must wear a non-cloth mask with a nose wire at all times, including during sports, beginning Monday, the district announced in a letter to families this weekend.
Schools will give surgical-style masks to students and employees who need them, Los Angeles Unified's interim superintendent, Megan K. Reilly, wrote on Saturday.
The U.S. Centers for Disease Control and Prevention said this month that loosely woven cloth masks provide the least amount of protection.
LA County schools will also continue weekly testing for students and staff through February, Reilly said.
The interim superintendent said "in-school case rates dropped 7% since our baseline testing and current rates of students and staff are half of those in the general community due to the safety measures in place."
COVID-19 cases in LA County remain high, with 39,117 new daily cases reported Saturday.
As Los Angeles County schools ban cloth masks, masks will be optional starting this week at Fulton County schools in Atlanta.
In-person learning resumed in Fulton County last week.
"Maintaining face-to-face instruction is a top priority for our district," the school system said. "Though some employees have been out due to COVID, we intend to stay open, providing we have the staff to safely operate our schools."
Of everyone PCR tested in Fulton County between Jan. 3 and Jan. 16, 2022, 25.2% were positive, according to county data.
(NEW YORK) -- Dr. Anthony Fauci, the nation's top infectious disease specialist, said Sunday he is "as confident as you can be" about the prospect of most states reaching a peak of omicron cases by mid-February.
"You never want to be overconfident when you're dealing with this virus," Fauci told ABC This Week co-anchor Martha Raddatz, adding that the COVID-19 virus has "surprised us in the past."
"Things are looking good. We don't want to get overconfident, but they look like they're going in the right direction right now," he said.
Fauci said there are states in the northeast and in the upper midwest where cases have already peaked and declined "rather sharply" but that cases are still rising in southern and western states.
"There may be a bit more pain and suffering with hospitalizations in those areas of the country that have not been fully vaccinated or have not gotten boosters," he warned.
When Raddatz asked "what should life look like" going forward and about the "long-term strategy" for dealing with future peaks and variants, Fauci said the hope is the level of infection will be below what he calls an "area of control."
"Control means you're not eliminating it, you're not eradicating it, but it gets down to such a low level, that it's essentially integrated into the general respiratory infections that we have learned to live with."
Fauci said the aspiration is that future variants won't "disrupt society" or "create a fear of severe outcomes that are broad" but that the country should still be "prepared for the worst-case scenario."
"We'd like it to get down to that level where it doesn't disrupt us in the sense of getting back to a degree of normality. That's the best-case scenario."
As the Biden administration begins to ship out free COVID-19 tests to Americans and provide free masks across the country, Fauci told Raddatz these kinds of protections could help keep future variants at a "lower level."
"What about the next booster shot?" Raddatz pressed, noting that it's now been five months since some Americans received their booster. "How soon should we get another one?"
"We don't know," Fauci responded, adding that it's unclear whether an additional booster shot will be recommended since scientists are still trying to determine how much protection is provided by the first booster. But, he said, it's "quite conceivable, and I hope it's true, that the third shot boost will give a much greater durability of protection."
"We may need to boost again, but before we make that decision, we want to determine what the durability is," Fauci added.
Data released on Tuesday shows that nearly 1 million children tested positive for COVID-19 last week, according to new a weekly report by the American Academy of Pediatrics and the Children's Hospital Association, and 28.8 million eligible children still remain completely unvaccinated.
Some schools in the U.S. are opting to remove mask mandates, and when asked by Raddatz if it is "safe to send your kids back to school without masks," Fauci stressed their importance, along with other mitigation efforts.
"You surround the children with people who are vaccinated. For the children who are eligible to be vaccinated, get them vaccinated. And provide in the school masks where you can have children protected, as well as ventilation to make sure that you can get a respiratory infection at its lowest level of infectivity. All of those things go together. And masking is a part of that."
(HOUSTON) -- Battle against omicron variant pushes hospitals, health care workers to the brink
COVID-19 cases have soared to new records with nearly 800,000 new infections per day.
A 55-year-old Minnesota man, who was transferred to a Texas hospital earlier this month, after a judge blocked a local hospital from taking him off a ventilator, died on Saturday, at a hospital in Houston, a family attorney has confirmed to ABC News.
"On behalf of the family of Scott Quiner, I would like to thank the public for the outpouring of love and support during this difficult time. The family now requests privacy as they grieve the loss of their beloved husband and father," Marjorie J. Holsten, the Quiner’s family attorney, told ABC News on Sunday.
Eleven days ago, Scott Quiner's wife, Anne, was granted a temporary restraining order against Mercy Hospital in Coon Rapids, preventing the hospital from taking her husband off a ventilator, after healthcare providers advised her that they “intend[ed] to take actions on Thursday, January 13, 2022, that [would] end [her] husband’s life.”
Representatives from Allina Health, which operates Mercy Hospital, told ABC News on Sunday that they are saddened to hear about Quiner's death.
"We are saddened to hear about the passing of Scott Quiner and our deepest condolences go out to family, friends and loved ones. His passing marks yet another very sad moment as collectively we continue to face the devastating effects of the pandemic," a representative said.
Previously, an Allina Health representative told ABC News that they had "great confidence" in their team's work.
The family attorney told ABC News last week that legal action against the hospital had "not been ruled out."
(NEW YORK) -- As the recent COVID-19 wave begins to ebb on the East Coast and in the Midwest, Los Angeles County is still being battered by the virus.
The county reported 102 new COVID deaths Thursday, the highest number recorded in a single day since March 10, 2021, and more than double the 45 fatalities reported one week ago.
The majority of deaths occurred in people aged 50 and older, according to a news release from the Los Angeles County Department of Public Health.
More than 90% of the deaths reported Thursday were among residents who contracted the virus after Christmas Eve, indicating a high likelihood they were infected with the omicron variant, the department said.
Dr. Jeffrey Smith, executive vice president of hospital operations and chief operating officer at Cedars-Sinai Medical Center, said the rise in the total number of deaths is not because omicron is more deadly than previous variants.
"We're still seeing a mortality rate of about 1.4%. It's just the sheer number of people who are infected is extremely high so 1.4% of a very, very large number gives you a higher number of absolute deaths," he told ABC News.
COVID hospitalizations are also on the rise, with 4,814 recorded Thursday, a figure not seen since Feb. 2, 2021. Of those patients, nearly one-third are in intensive care units, an increase from the week before.
Smith said Cedars-Sinai currently has about 220 COVID-19 patients, making up 25% of total patients.
"That had dropped as low as probably 5% to 10% prior to this most recent peak," he told ABC News.
Smith added that, of the people in the ICU, almost all of them are unvaccinated or have not yet been fully vaccinated, meaning two doses of the Pfizer-BioNTech or Moderna vaccines or one shot of the Johnson & Johnson vaccine.
The surge has caused many hospitals in Los Angeles to face staffing shortages, either because there are not enough health care workers to take care of patients or because so many workers have gotten sick and need to stay home.
"It's a dual crisis because staff have been furloughed or told to stay home because of positive tests, and then you have people who are unvaccinated, who have succumbed to infection and need hospitalization," Dr. Jeffrey Klausner, a professor of medicine at the David Geffen School of Medicine at the University of Southern California, told ABC News.
He continued, "And then you have this third piece of people coming in for a stroke or heart attack or something and then they test positive. But, because of the staffing crisis, the hospital is unable to see as many people as it typically would."
According to LA Public Health, about 50% of patients statewide were admitted for non-COVID reasons and only found out they were infected while undergoing routine testing.
County Public Health Director Barbara Ferrer noted during a virtual media briefing Thursday that whether originally admitted due to the virus or not, the high number of COVID patients puts a strain on hospital staff and resources.
"It limits where people can be housed, what room they can be in, it limits some staffing, it changes the kind of medical and doctor interventions because people still have to practice infection control for an airborne pathogen," Klausner explained.
Meanwhile, the seven-day rolling average of COVID-19 cases sits at 33,000.
While the daily test-positivity rate declined from more than 20% in late December to 18.5% Thursday, it still means about 1 in 6 people in LA County are testing positive for COVID-19.
The figure is also eightfold higher than the positivity rate of 2% that was being recorded a little over one month ago.
Klausner said until LA County and California come out of this wave, people with COVID symptoms should get tested and, if they do test positive, seek early treatment.
"We actually just did a survey of 10,000 people who tested positive and 25% of people stopped treatment and, of the treatments they stopped, the overwhelming majority were getting vitamins," he said. "That's really disappointing when we have known, proven interventions that can reduce people's risk of going to the hospital."
Smith also stressed the importance of testing -- but urged people not to visit already overcrowded emergency rooms -- as well boosting and mask-wearing.
He said he's been encouraged by declining COVID-19 rates in places such as New York City and hopes Los Angeles isn't far behind.
"We've seen rates declining in some parts of the country and we're hoping that our experience will be similar to what was seen in South Africa or the U.K., where the rates dropped almost as quickly as they rose," Smith said.
(NEW YORK) -- A peanut allergy treatment often used on children 4 years old and up in the U.S. appears to be safe for toddlers too, a new study has found.
Around 2% of children in the country suffer from the allergy, some to a debilitating degree, which is why the discovery is "extremely exciting," said Dr. David Stukus, professor of clinical pediatrics and director of the Food Allergy Treatment Center at Nationwide Children's Hospital.
In the study, conducted by the National Institute of Allergy and Infectious Diseases across multiple hospitals, researchers added powder containing peanuts to the daily diets of children, and found that over time, a large majority of them became desensitized to peanuts.
A smaller group of children even achieved full remission, meaning they were no longer allergic to peanuts at all.
While almost all the children studied had reactions to the peanut products, most were mild to moderate in severity, experts said.
The study also found that the younger the patients were when they started the treatment, the better they were able to tolerate peanuts, and the more likely they were to achieve full remission.
This means the treatment may be more effective if started while children's immune systems are still developing.
"This suggests that if we do start treatment younger, there is a potential to help some children become non-allergic," said Dr. Lisa Wheatley, section chief at the NIAID Division of Allergy, Immunology and Transplantation.
Pediatric immunology experts interviewed by ABC News said they believe the study marks an important step in allergy research; still, they said more studies are needed to better understand young children's immune systems and how they change.
The experts said children with a history of severe allergic reactions were excluded from the study, and warned that adding peanut products to the diets of children with known peanut allergies can cause serious reactions and should only be done under the guidance of a physician.
They added that while the study's findings are promising, there is no one-size-fits-all treatment plan for children with peanut allergies, and parents must weigh the risks, benefits and expectations before letting their kids receive a treatment of any kind.
Aubrie Ford is an emergency medicine resident at Northwell Health, in New York, and a contributor to the ABC News Med Unit.
(NEW YORK) -- There's no denying therapy can be a valuable resource for guiding you through life's ups and downs.
However, it's also important to recognize that your first meeting with a therapist may not feel like the perfect match for your needs.
For Emily Maldonado, a 27-year-old New York City-based public relations and marketing manager, it took almost a year before she realized her first therapist was not a good fit. After opting to discontinue services, she realized what she actually was looking for in therapy, and that helped her evaluate other therapists with a clearer direction.
"Now, I love my therapist and we've been going strong for over a year," said Maldonado. "My original therapist just listened, but now I know I'm the type that appreciates action items and homework."
She added, "My current therapist is also Latinx like me so there are some things she just gets.”
Licensed therapist, relationship expert and New York Times bestselling author Nedra Glover Tawwab told Good Morning America the process of finding the best therapist can be done like speed dating.
"It's a way for you to figure out pretty quickly, in 15 or 20 minutes by phone or video, if this person will be a good fit," said Tawwab. "You just talk for 15 or 20 minutes and sort of figure out if it would be a good situation -- and yes, you can talk to a few therapists within the same week to figure out who might be the best fit."
What to know before you go to your first therapy session
Experts agree that nerves are normal as you're talking to a stranger and telling them very deep, personal information.
"There is no other space in which we do that, so there's nothing to compare it to. So it is an awkward and uncomfortable encounter, initially," said Tawwab.
Talkspace therapist Elizabeth Keohan advised that you shouldn't expect immediate resonance in the beginning.
"It takes time to acquire a good fit with a therapist, so an openness to feeling emotionally challenged can help navigate whatever is causing tension," she said.
Kate Rosenblatt, another Talkspace therapist, suggested doing a pre-interview to ask questions such as, "What would our therapy look like together? And have you worked with other people in a similar situation? How were the outcomes?"
It's generally recommended to attend a minimum of three sessions before evaluating if a therapist is or isn't right for you.
Once you've had a few sessions, and you are unsure if your therapist is the right fit, Rosenblatt shared that there are quite a few factors to consider before choosing to "break up" with your therapist.
Three key questions to ask yourself before moving on
1. Am I making progress in therapy?
"If you're not where you want to be, and you've brought this up to your therapist and you've tried something new in therapy, but nothing has changed, it might be time to consider finding a new therapist," said Rosenblatt. Or, alternatively, if you have made incredible progress, she suggests letting your therapist know it might be time for a break.
2. What do I want more of in therapy that I'm not currently getting?
It's common for your focus to change throughout therapy, but it's important to work with someone qualified to support the specific needs you'd like to focus on.
"If you speak with your therapist about your needs, and your therapist cannot adequately meet them, it might be time to find a therapist who can best support you," said Rosenblatt.
3. Is therapy in general making me feel uncomfortable, or am I feeling uncomfortable with my therapist?
As therapy can bring up some difficult memories or experiences, Rosenblatt highlighted that you're not going to leave every session feeling better immediately. However, she also advised that it is important to distinguish between your experience in therapy versus with your therapist.
"If your therapist has said or done things that feel unprofessional, uncomfortable or demonstrate a lack of cultural competency, see if it would feel right for you to address these with your therapist and then go from there," she recommended.
After closely examining your experience, and coming to the conclusion that you'd prefer to move on from your therapist, Tawwab said that it's truly a matter of preference when it comes to "breaking up" and your therapist, as a professional, is prepared for your relationship to end on your terms. "Believe it or not, therapists are ghosted all the time," she said.
"It's a part of the culture. We know everyone won't come back," added Tawwab. Still, she suggests that it is helpful to give feedback to aid the therapist in understanding where things might not have aligned.
Once you've parted ways with your initial therapist, there are a few tips to help navigate the process of finding someone new without getting discouraged.
Rosenblatt's best practices to keep in mind include being clear on your priorities in what you want, sourcing therapist referrals from your communities and doing your own research.
With patience and hope, many people have found amazing therapists after some trial and error, and experts concur that one bad experience shouldn't be the end-all when it comes to taking care of your mental health.
"Meeting the right therapist is like any sort of relationship where you're learning someone else," said Tawwab. "If you're in school, it's going to be 20 people in your class and you may have one to two friends."
"If you're dating, every relationship won't work out and it's that same sort of thing," she continued. "You keep going. Hopefully, you don't give up on dating or making friends or any of these sort of things, so please don't give up on finding the right therapist."