(NEW YORK) — A new study points to prior COVID-19 infection as a possible culprit for the global wave of severe hepatitis cases among children — though experts caution the true cause is still a medical mystery.
Researchers in Israel added evidence for the theory in a small study published in the Journal of Pediatric Gastroenterology and Nutrition, suggesting some children might develop liver inflammation in the weeks after recovering from a mild COVID-19 infection.
While the root cause of the pediatric hepatitis outbreak is still unknown, experts say the leading theories include COVID-19 infection, infection with a common cold virus, or an interplay between the two infections, according to Dr. Alok Patel, a pediatric hospitalist at Stanford Health and an ABC News medical contributor.
In a new twist, a U.S. Centers for Disease Control and Prevention analysis published Tuesday found that there may not be a spike in cases at all — at least not in the United States. CDC scientists said the number of severe hepatitis cases observed in recent weeks is relatively consistent with pre-pandemic levels, but urged public health authorities to continue to monitor the situation.
“I think it is too early as CDC [is] looking at U.S. data and U.S. has not been hit as hard as other countries like U.K.,” said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco.
More than 700 children across the globe have been found to have probable cases of severe hepatitis with an unknown cause, officials from the World Health Organization said in a press conference last Wednesday.
At least 38 children have required a liver transplant, and 10 children have died, the WHO says. Additionally, 112 cases are also under investigation, and a total of 34 countries have reported cases to date.
As the mystery deepens, scientists across the globe are racing to understand whether — and why — children are falling ill with severe hepatitis in higher numbers.
Severe hepatitis, or liver inflammation, is often prompted by an infection, but not always. It is unusual among children, and most often seen in adults who have been living with alcoholism or an undiagnosed infection for decades, slowly causing liver damage.
During a global investigation, the WHO found that about two-thirds of children tested positive for a common cold virus called adenovirus 41 — which quickly became one of the leading theories. Only about 12% of children had COVID-19 at the time they developed severe hepatitis.
Because most of the children were too young to be vaccinated, the COVID-19 vaccine was ruled out as a possible cause.
“The latest Israeli study adds just a little gasoline to the fire to try to understand the causes of the mysterious hepatitis in children,” said Chin-Hong.
However, he said the study was too small to be conclusive.
In the study, researchers described five cases of children ranging from 3 months to 13 years old who recovered from COVID-19 and later developed severe liver inflammation, some requiring liver transplants.
If true, this type of delayed reaction to a COVID-19 infection would mirror the rare multi-organ syndrome MIS-C that affects children weeks and sometimes months after COVID-19 infection.
It’s possible children may be experiencing “an autoimmune reaction from a viral infection causing hepatitis, where the child’s immune system attacks their own liver cells in an attempt to combat the virus,” said Dr. Madhu Vennikandam, a gastroenterology fellow at Sparrow Health System.
However, the CDC cautions the cause remains unknown and a global research effort spearheaded by the WHO is ongoing.
“The silver lining in all of this is that vaccines for children under 5 are on the cusp of approval in the U.S.,” said Chin-Hong.
If COVID-19 indeed “has a central role to play in all of this, we should eventually start seeing cases drop,” he said.
(NEW YORK) — The World Health Organization said it is planning to assess whether the monkeypox outbreak spreading around the world is a public health emergency.
According to Global Health, more than 1,700 monkeypox cases have been identified in non-endemic countries, mostly in Europe and North America.
In the U.S., there are 65 confirmed or suspected cases in 17 states and the District of Columbia, data from the Centers for Disease Control and Prevention shows.
Because of the highly unusual nature of the outbreak, WHO Director-General Dr. Tedros Adhanom Ghebreyesus said he has decided to convene an emergency committee under the International Health Regulations next week.
“The global outbreak of monkeypox is clearly unusual and concerning,” he told reporters during a briefing on Tuesday held in Geneva. “I think it’s now clear that there is an unusual situation meaning even the virus is behaving unusually from how it used to behave in the past.”
He continued, “But not only that, but it’s also affecting more and more countries and we believe that it needs also some coordinated response because of the geographic spread.”
The first case of monkeypox among humans was recorded in the Democratic Republic of the Congo in 1970, and the illness has since spread to several other nations, mostly in central and western Africa.
Typically, the disease does not naturally occur on other continents, and infections are usually identified among people who recently traveled to countries where monkeypox is more commonly found.
However, lately the virus has been identified in people with no history of travel or known contact with anyone who tested positive for monkeypox, which many indicate evidence of community transmission.
According to the National Library of Medicine, between 2007 and 2020, there have been six events declared public health emergencies of international concern.
These include the H1N1 influenza pandemic of 2009; the Ebola outbreak in West Africa from 2013 to 2015; the Ebola outbreak in the Democratic Republic of the Congo from 2018 to 2020; the Zika outbreak in 2016; the ongoing spread of poliovirus that started in 2014; and the ongoing COVID-19 pandemic.
(WASHINGTON) — A committee of advisers at the Food and Drug Administration voted unanimously Tuesday in favor of authorizing the Moderna vaccine for kids ages 6 through 17, paving the way to add one more vaccine to the options available for this age group.
Currently, only Pfizer’s vaccine is available for kids over 5 years old. Moderna’s vaccine, which was stalled in the regulatory process for months, would give parents another option.
The process to get Moderna’s vaccine out to pharmacies and clinics now moves to FDA leadership, which must decide whether to issue an official emergency use authorization of the vaccine.
After that, the Centers for Disease Control and Prevention’s team of advisers will review Moderna’s data, and finally, CDC Director Rochelle Walensky will issue her recommendation.
It’s not clear whether adding Moderna as another option in the vaccine arsenal will move the needle for uptake in the kids and adolescent age group.
More than 25.4 million eligible kids between the ages of 5 and 17 are still unvaccinated, and only about 44% have been fully vaccinated.
At the meeting before FDA’s advisory committee on Tuesday, though, Moderna representatives argued there was a significant need for a second vaccine because of the continued threat of COVID-19 among kids.
“Recent data have shown that approximately 25% or one in every four children and adolescents hospitalized due to COVID-19 require ICU intervention,” said Carla Vinals, Moderna’s vice president of regulatory affairs strategy for infectious diseases.
Emory associate professor Dr. Evan Anderson, who works with Moderna, presented an analysis showing that COVID-19 is worse than the flu — killing more children ages 5 to 17 than any other vaccine-preventable disease.
Moderna scientists said their vaccine would prevent pediatric hospitalizations if authorized. They estimate the two-dose Moderna vaccine would prevent 95 hospitalizations per 1 million kids ages 5 to 11 and 200 hospitalizations per 1 million kids ages 12 to 17.
The FDA also cleared the air on the issue that delayed Moderna’s authorization for this age group — the potential for the rare incidence of heart inflammation called myocarditis.
Data for international surveillance had suggested a higher risk for myocarditis following vaccination with Moderna compared to the Pfizer-BioNTech vaccine. But after looking into it, those concerns subsided.
The FDA did not find a “statistically significant” difference in risk when comparing the two vaccines, officials said Tuesday.
The risk of myocarditis is also primarily seen among males 18 to 25. Moderna’s vaccine is only for kids and adolescents ages 6 to 17.
If authorized, Moderna’s vaccine dosing would be 100 micrograms for 12- to 17-year-olds, or the same as the adult dose, and 50 micrograms for 6- to 11-year-olds, which is half the adult dose.
(LOS ANGELES) — Facing a growing mental health crisis among America’s teens and young adults, U.S. Surgeon General Dr. Vivek Murthy says the problem is not something adults can fix alone.
Adults need “to make sure that we’re hearing from kids so that their stories are our guiding light,” Murthy said. “Ultimately, we will know when we’ve reached the finish line when they’re doing well and they tell us they’re doing well and when data tells us that as well.”
After declaring a national advisory on the youth mental health crisis late last year, Murthy is now participating in a two-day conference called the Youth Mental Wellness Now! Summit, hosted by The California Endowment.
“I’m also particularly excited that we’re going to have a chance to hear from young people here in L.A. today,” Dr. Murthy told ABC News.
According to Murthy, adults need to hear directly from the youth what the problems are, and what they can do to help. The summit will feature actors and activists including Kendrick Sampson, best known for his roles in Insecure, The Vampire Diaries and How to Get Away with Murder, and Jordyn Woods, a model, actress and mental health advocate.
They will join California-based youth leaders Ja’Nell Gore from South Kern Sol whose parent company is YR Media, and Xochitil Larios from Communities United for Restorative Youth Justice in a fireside chat with the surgeon general.
The purpose of the youth-led summit is to create a national movement around youth mental health led by young people through the sharing of stories and to galvanize organizations to commit to support. They have concrete commitments in excess of $255 million.
Other organizations partnering with The California Endowment to host the event include The Steve Fund, California Children’s Trust, Youth Organize! California, YR Media and Revolve Impact.
Sometimes, the voice of young people is missing from initiatives to help them, but a strength of this summit is the central role young voices have.
“We wanted young people center stage,” said Dr. Bob Ross, CEO of The California Endowment. “We wanted to make sure that any go-forward strategy for investing in access to mental health services and optimizing the mental health and well-being of young people would be informed with young people as the experts, and additionally, having important and key adult allies more as listeners than talkers. You know, a lot of times you have these conferences, and it’s the expert adults that are doing all the talking.”
Gore emphasized that one importance of this summit is that “youth need to be able to hear other young people tell them that it’s OK to struggle with things.”
“This [is] like one of the first conferences of its kind,” said Jasmine Dellafosse, a nationally recognized youth activist who will emcee the summit.
“Often young people across California have been showing up and trying to address these issues for decades,” she said. “It’s actually an opportunity to connect policy and change with actual voices on the ground, and young people who were championing, you know, the issues in their communities while also still being extremely under-resourced.”
Murthy blames the youth mental health crisis on loneliness, isolation, economic hardship, uncertainty, and online and offline bullying, which were exacerbated by the coronavirus pandemic. Other existential challenges like climate change, racism and violence in the community have also caused youth to lose hope.
In addition to these factors, Ross highlights “exposure to trauma in early childhood,” often rooted in race, social factors, the criminal justice system and violence, as being a primary cause of the crisis. He also acknowledged the “stigma behind mental health and seeking mental health supports” as perpetuating the crisis.
Murthy said the government’s three-pronged approach to addressing the crisis is to “expand access to treatment,” “invest in prevention,” “and eradicate the stigma around mental illness, which still prevents youth from coming forward and asking for help.”
In a show of solidarity, more than 30 organizations to date have announced 75 commitments in response to the surgeon general’s call-to-action.
To aid with expanding access to mental health services, the Vista Group has committed to investing $250 million over the next three years into U.S. providers of adolescent and youth mental health services. Pinterest has also designated more than a third of their $10 million commitment to advance emotional well-being to support NGOs (non-government organizations) and nonprofits focused on youth to expand access.
The UCLA Center for Scholars & Storytellers will partner with Disney Branded Kids, CAA, Joy Coalition, YouTubeKids and leading showrunners to research best practices on how to incorporate mental health messaging to positively impact youth through their programming and marketing. The CW is committed to developing storylines in its programming to inform and support audiences.
Other organizations are committed to supporting youth utilizing digital technologies. Meta plans to enhance parental supervision controls and introduce a new feature called “nudges,” which are notifications that encourage teens to switch to a different topic if they’re repeatedly looking at the same topic.
“Today, again, it’s just a step forward,” Murthy said. “We’re not done until every child in America has access to good mental health care.”
(NEW YORK) — In recent months, several strict abortion laws have been passed across the United States, banning the procedure after a certain number of weeks.
Most have limited exceptions, such as in cases of incest or rape, and some only allow abortion to “save the mother’s life.” If the Supreme Court overturns Roe v. Wade, which it seems poised to do over the summer, this could be one of the only exceptions for abortion in many places.
For example, Arizona’s 15-week ban only includes exemptions for medical emergencies when continuing with the pregnancy would “create serious risk of substantial and irreversible impairment of a major bodily function” for the mother.
And a new Oklahoma ban classifies a “medical emergency” as a condition in which an abortion “is necessary to preserve the life of a pregnant woman whose life is endangered by a physical disorder, physical illness, or physical injury, including a life-endangering physical condition caused by or arising from the pregnancy itself.”
Proponents of anti-abortion bills say the language is clear and is not open to interpretation.
“The exceptions definition is very clear, specific, allows for the physician’s good faith clinical judgment, and it has been upheld by the courts and is typically included in laws regulating abortion,” Arizona state Sen. Nancy Barto, a Republican who sponsored the state’s 15-week ban, told ABC News.
But doctors told ABC News the language of these laws is vague and makes it unclear what qualifies as a mother’s life being in danger, what the risk of death is, and how imminent death must be before a provider can act.
“We’ve taken the Hippocratic oath to do no harm, and these types of laws and this type of language actually do harm,” Dr. Melissa Simon, vice chair for research in the department of obstetrics and gynecology at Northwestern University Feinberg School of Medicine in Chicago, told ABC News. “I do not — nor do my patients want me to — stop what I’m doing and think about what the judge would do: ‘Will the judge sentence me to jail if I were to perform an abortion?'”
“It sounds like it’s straightforward criteria, but it’s not in practice,” said Dr. Lisa Harris.
A professor of obstetrics and gynecology at the University of Michigan, Harris told ABC News, “None of this is straightforward. It’s very nuanced and complex, and it’s really hard for a one-size-fits-all rule or law to generate what all patients are going to need.”
Doctors ABC News spoke with said laws that only allow exceptions to save the mother’s life will put the onus on the provider to prove the pregnant person is in danger of dying. In some states, providers could face charges.
Dr. Leilah Zahedi, a maternal-fetal medicine physician in Chattanooga, Tennessee, and a spokesperson for the Society for Maternal-Fetal Medicine, said the anti-abortion rights laws don’t make it clear if a woman’s risk of death has to be 100% for the procedure to be performed or not.
“When I see patients, for instance, who have a major cardiac problem, a lot of the time they have a risk of a major cardiac event of up to 15% to 25%, even up to 50%,” she told ABC News. “At the moment they’re fine. But as they get further into pregnancy, that’s going to put their life more and more at risk.”
She continued, “So do I have to wait until they’re on death’s doorstep, or can I intervene at that point to prevent more harm and more damage to them?”
There are typically three categories pregnant people fall into when they need to have abortions to save their lives, doctors told ABC News.
First are people who have serious underlying conditions — such as heart disease, kidney failure and pulmonary hypertension, a type of high blood pressure that affects the lungs — before getting pregnant. Continuing pregnancies would significantly threaten their health.
The second category is those who didn’t have conditions before getting pregnant but now do, such as pre-eclampsia, a potentially dangerous pregnancy complication characterized by high blood pressure, or placenta accreta, which is when the placenta attaches to the uterus and potentially grows through it to other organs.
The third category includes pregnancies in which fetuses would not survive if they were born. This includes an ectopic pregnancy, which occurs when a fertilized egg implants and grows outside the uterus.
Oklahoma state Rep. Jim Olsen, a Republican who sponsored a bill that would make it a felony to perform abortions, said Oklahoma doesn’t have specific definitions of what might constitute “lifesaving” to make sure an example isn’t missed.
“If we tried to specify as legislators exactly what qualifies and limit it only in these situations, there’s a very real possibility we could miss one … and we don’t want to inadvertently exclude something that is actually a danger to the life of the woman,” he told ABC News.
He continued, “We want to fully respect the woman’s right to life and all her rights, but at the same time, we must also respect the rights of the baby, and the baby has a right to life.”
Medical groups have argued that what qualifies as an exception is often subjective to lawmakers, but not to the physician.
“The science of medicine is not subjective, and a strongly held personal belief should never outweigh scientific evidence, override standards of medical care, or drive policy that puts a person’s health and life at risk,” the American College of Obstetricians and Gynecologists said in a 2019 statement on abortion sometimes being “medically necessary.”
The exceptions raise concerns about timing for abortions, doctors said.
Doctors said these exceptions make it unclear whether they have to wait to perform an abortion if a pregnancy is only dangerous once it reaches later terms.
For example, Harris said a woman diagnosed with placenta accreta is not in any imminent risk of dying before 20 weeks, but the risk is greatly heightened in the later stages.
“There is a threat to their life, but it might be months away,” she said. “How imminent does that threat have to be for you to qualify for an abortion under the term ‘lifesaving’?”
Another uncertainty of these laws is what occurs when a pregnant woman is diagnosed with cancer. Women who need to undergo surgery, chemotherapy and radiation may decide they want abortions so they can begin treatment immediately, Harris said.
“The threat to the life of the patient isn’t imminent, meaning the pregnancy and illness are not life-threatening at the moment,” she said. “But if someone, for example, were to delay treatment for eight or nine months, the cancer may advance in that instance and then they have a worse cancer when they begin to treat it.”
Harris continued, “In the case of cancer, it may be that someone survived their cancer only two years as opposed to 20 years because they delayed treatment. And so that is a risk to their life if they could cut their life short.”
The death of Savita Halappanavar in Ireland prompted questions about the clarity of these exceptions.
In 2012, 17 weeks pregnant with her first child, she went to University Hospital Galway complaining of back pain.
Doctors told the 31-year-old dentist that her cervix was fully dilated and that amniotic fluid was leaking. Because of this, it was unlikely her baby would survive and a miscarriage was inevitable — but her body did not expel the fetus.
She asked if doctors could terminate the pregnancy, but they said they were forbidden to do so under Irish law because a fetal heartbeat could be detected.
“Under Irish law, if there’s no evidence of risk to the life of the mother, our hands are tied so long as there’s a fetal heart,” an OB-GYN consultant said, according to an investigation into Halappanavar’s case by the Ireland Health Service Executive, adding that “we can’t predict who is going to get an infection.”
Within days, Halappanavar developed sepsis, went into cardiac arrest and died.
The HSE investigation stated: “There is difficulty in interpretation of law in relation to ‘what constitutes a potential major hazard or threat to mother’s life.’ This needs clarification.”
Halappanavar’s death sent shockwaves throughout Ireland, spurring the Parliament to pass an updated, clarified exception to the country’s abortion ban. Six years after her death, the country voted to overturn its ban on abortion, with many voters citing Halappanavar as the reason for their vote.
Barto, of Arizona, said she does not know the specifics of the case, but believes this is a case of improper medical care rather than what can result from a denied abortion.
“I can only speculate that this woman’s tragic death should and could have been avoided with proper and timely medical care and decision-making,” Barto said. “Her family deserves someone to be held accountable.”
Simon, of the Northwestern University Feinberg School of Medicine, said if doctors are not allowed to perform abortions because the procedure does not fall within the limits of a save the mother’s life exception, maternal mortality rates in the U.S. will rise.
Data from the Centers for Disease Control and Prevention shows that between 2013 and 2018, the national case-fatality rate was 0.41 abortion-related deaths per 100,000 legal abortions. Comparatively, the mortality rate was 17.35 pregnancy-related deaths among mothers per 100,000 live births.
“Abortion is extremely safe. It is a safer procedure taking an appendix out, and that’s a very common medical procedure,” Simon said. “I just can’t emphasize enough how safe these procedures are and how well-studied they are.”
She added that maternal mortality rates in the U.S. “are embarrassing enough.”
(NEW YORK) — A Connecticut woman has died from the rare tick-borne disease Powassan virus, the state’s Department of Public Health announced.
This is the first fatality recorded in the state and the second in the U.S. this year after a Maine resident died from POWV in April.
According to the DPH, the patient was bitten by a tick and the insect was removed two weeks prior to the onset of symptoms.
The woman, who was in her 90s, first exhibited symptoms in early May including fever, chills, headache, altered mental state, chest pain and nausea, the department said.
She was admitted to a local hospital where her health rapidly deteriorated, according to the DPH.
She “became unresponsive over the next two weeks” and passed away May 17.
After the patient’s death, tests performed by a Centers for Disease Control and Prevention laboratory in Fort Collins, Colorado, confirmed she had antibodies to POWV.
POWV is typically spread by black-legged ticks and deer ticks. Most cases in the U.S. occur in the Northeast or Great Lakes regions typically between mid-spring and early fall.
Between 2011 and 2020, CDC data shows 194 cases of POWV were identified, 22 of which resulted in death.
DPH Commissioner Dr. Manisha Juthani wrote in the release that the virus can be transmitted from tick to human in as little as 15 minutes after the bite, but it can take anywhere from one week to one month before symptoms emerge.
Most patients experience either no symptoms or mild flu-like symptoms, the press release said. But, in severe cases, POWV can cause encephalitis, which is inflammation of brain tissue, or meningitis, which is swelling of the membranes around the brain and spinal cord.
According to the DPH, approximately one in every 10 cases of severe illness result in death and around half of patients who survive severe illness report long-term health problems.
There are currently no specific treatments for POWV — aside from helping relieve symptoms — and no vaccines to prevent the disease.
“This incident reminds us that residents need to take actions to prevent tick bites now through the late fall,” Juthani said in a statement. “DPH stresses the use of insect repellent this summer and avoiding high-risk areas, such as tall grass, where ticks may be found.
She added, “It’s also important to check carefully for ticks after being outside which can reduce the chance of you and your family members being infected with this dangerous virus.”
The CDC recommends showering within two hours of having been outdoors to reduce the risk of tickborne disease and to either wash clothes in hot water or tumble dry low to kill any ticks that may have been carried indoors.
This is the second case of POWV reported in Connecticut this year after a man in his 50s fell ill with the disease in late March.
He was hospitalized with central nervous system problems, but was eventually discharged and recovered at home, health officials said.
(WASHINGTON) — The Biden administration is lifting pre-departure COVID-19 testing requirements for international travelers to the United States, according to a senior White House official.
Effective Sunday, those traveling to the U.S. will no longer need a negative COVID-19 test one day before their flight to the country.
(TEL AVIV, Israel) — When Nurit Argov-Argaman was raising three young children while trying to advance in her career, she was struggling with time-management issues involving baby formula versus breast milk.
“Infant formula was one of the best options that I had,” said Argov-Argaman, the chief technology officer of the Israeli dairy alternative startup Wilk.
Argov-Argaman, who is a lactation scientist by training, decided she could “help bridge the gap” between baby formula and breastmilk by making a product that more closely resembled the latter.
The majority of women in the U.S. bottle-feed their children, according to the Centers for Disease Control and Prevention, although both the World Health Organization and the American Academy of Pediatricians recommend women exclusively breastfeed their babies for the first six months.
Three startups, Wilk, Biomilq and Haliana, are using bioengineering to create new baby formula products that scientists hope will be a better substitute for breastmilk in the future.
Wilk and Biomilq use human breast cells as their starting point, coaxing the cells to produce milk on their own in a lab, while Haliana uses yeast to produce the proteins found in human breast milk.
Wilk, which has its lab outside of Tel Aviv, has been using breast milk and mammary cells that have been removed during breast reduction surgeries and provided by a local hospital.
“Basically we are enabling them to do the same thing they do naturally in the breast,” Argov-Argaman told ABC News reporter Maggi Rulli, “just in a plastic vessel and later on in a bioreactor.”
Just like Wilk, U.S.-based startup Biomilq grew out of a mother’s desire to create an alternative baby formula product when founder Leila Strickland realized the products on the market were “not meeting what she wanted to feed her children,” says co-founder Michelle Egger.
“Formula really hasn’t changed much since about the 1950s,” says Egger, “and we’ve just continued to see consolidation in the supply chain that, as we saw with the shortage, really does harm to families and parents.”
More than 40% of baby formula was out of stock in the United States in May, according to a report by the data firm Datassembly. The shortages, which are being caused by a mixture of supply chain issues and the fact that the market is concentrated among three major producers, have meant parents are being forced to pay higher prices, travel long distances for formula or simply go without.
This current crisis is so severe – and unique with a major producer shut down for possible contamination and supply chain constraints because of a global pandemic – that it has led to the activation of the Defense Production Act by the Biden Administration, which provides the president with additional powers to increase domestic manufacturing capacity during emergencies.
The White House states Operation Fly Formula will mobilize over 300,000 pounds of formula from overseas to try and meet the needs families are currently facing.
Although alternative baby formula products have been cast into the spotlight by a national baby formula shortage, the products being created are still multiple years from the market, so they cannot alleviate the strain of the current crisis, and they will eventually need to be scrutinized by the FDA before having a chance of being approved for use in the U.S.
One factories’ shutdown in Michigan, due to a possible bacterial contamination that was suspected of killing two babies, threw the entire industry into disarray. The factory belonged to Abbott Nutrition, a company that controls nearly half of the baby formula market in the U.S., and only opened last week after being closed for more than three months.
Abbott has announced that after an investigation, “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses.”
Haliana, which uses a different technique based on a process of fermentation, is hoping to get to “commercial scale over the course of this year,” says founder Laura Katz.
The company is attempting to recreate the proteins found in breastmilk by “training” yeast using the same DNA code that makes breast milk proteins. Katz says these proteins could have the added benefit of immunities typically present in breastmilk, which traditional baby formulas don’t have.
Sarah Fleet, a pediatric gastroenterologist and director of the Growth and Nutrition Program at Boston Children’s Hospital says that nutritionally, traditional baby formula and breastmilk are “generally thought to be pretty equivalent.”
Yet Fleet sees many different valuable aspects of alternative breast milk. First and foremost, the majority of baby formula on the market is derived from cow milk, which can cause severe intestinal disease that affects “a large number of babies” in her practice, she says. Cow’s milk protein allergy is estimated to occur in 2-3% of children under 4 years old.
Second, formula products synthesized from breast cells could have “immune system properties,” she says, adding an additional benefit to the child’s health.
Neither Wilk or Biomilq discussed potential immune system benefits of their products during interviews with ABC News.
And finally, given the recent national shortage, it is an example of putting more options on the market for parents, babies, and for doctors.
“Having more tools in our toolbox,” she says, “is never a bad thing.”
(NEW YORK) — Cases of monkeypox are continuing to crop up around the globe as the outbreak of the rare disease keeps spreading.
As of Thursday, at least 1,260 cases have been detected in countries where the virus is not endemic, with the overwhelming majority reported in North America and Europe.
São Paulo authorities confirmed to ABC News Wednesday that the first case of monkeypox has been confirmed in Brazil in a 41-year-old man who recently traveled to Spain.
In the United States, 40 infections are suspected or confirmed in 14 states and the District of Columbia, according to the Centers for Disease Control and Prevention.
New York has the most cases at nine, followed by California with eight, Florida with four, and Illinois and Colorado with three each.
During a briefing Wednesday, World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus said the window of opportunity to contain the outbreak is closing.
“The risk of monkeypox becoming established in non-endemic countries is real,” he said. “But that scenario can be prevented. WHO urges the affected countries to make every effort to identify all cases and contacts to control this outbreak and prevent onward monkeypox spread.”
Public health experts currently do not expect the virus to become a major health threat, but are concerned about the recent spread.
“I think any time there’s an outbreak that is ongoing with no evidence of control, I think we should be concerned,” Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University Mailman School of Public Health in New York, told ABC News. “I think that’s different from being panic-stricken. But I think the continued increase in numbers of cases of monkeypox and continued increase in countries reporting cases is certainly of concern.”
If the outbreak isn’t contained, this means the virus could be ever-present in a community, circulating at low levels.
But Dr. Scott Roberts, an assistant professor and the associate medical director of infection prevention at Yale School of Medicine, said he does not envision the outbreak as being similar to the COVID-19 pandemic because of the different mechanisms of spread.
COVID-19 generally spreads through the air via tiny droplets and can require as little as 15 minutes of face-to-face contact. In the current outbreak, most of the spread has come from coming into contact with infected people’s lesions.
“It’s not like you’ll pass someone in the elevator, and you’ll get monkeypox,” Roberts told ABC News. “That’s pretty unlikely. The classic COVID definition was within six feet for 15 minutes. This one is more like within six feet for three hours, is what the CDC has said, or contact with the infected lesions.”
Many cases have been reported among men who identify as gay, bisexual or men who have sex with men, but there is currently no evidence monkeypox is a sexually transmitted infection — and the experts emphasize anyone can be infected.
But, most importantly, they said the virus is not spreading uncontrollably yet.
“The important thing to keep in mind is that it’s a containable outbreak,” Dr. Mark Dworkin, a professor of epidemiology at the University of Illinois Chicago, told ABC News. “There have been outbreaks and they have been successfully controlled.”
Dworkin referenced a 2003 outbreak in which 47 confirmed and probable cases were reported among six U.S. states, the first human cases reported outside of Africa.
All the infections occurred after coming into contact with pet prairie dogs, which became infected “after being housed near imported small mammals from Ghana,” according to the CDC.
“We have a relatively strong public health system for dealing with this kind of problem,” Dworkin said. “We had a monkeypox outbreak that was multi-state and successfully controlled without the use of a vaccine but through contact tracing and isolation so I’m optimistic.”
Currently, there are two smallpox vaccines approved by the U.S. Food and Drug Administration that people who have been exposed to monkeypox can take to reduce their risk of infection.
“The thing with monkeypox is it’s a very long incubation period,” said Roberts. “It’s usually one to two weeks, but it can be up to three weeks between getting exposed and having symptoms.”
He continued, “So that actually gives you a window to vaccinate after you’ve been exposed to ramp up your immunity and really get rid of the virus before it becomes a true blow infection.”
The CDC has previously said the federal government has enough vaccines and treatments for anyone who is exposed but is not recommending a mass vaccination campaign at this time.
ABC News’ Aicha Elhammer contributed to this report.
(NEW YORK) — In the early months of the COVID-19 vaccine rollout, breakthrough cases among fully-vaccinated people were a statistical anomaly.
Preliminary clinical trial data offered an optimistic outlook for the months ahead, with many Americans hoping a vaccine would be their ticket to a return to normalcy.
However, last summer, when the highly infectious delta variant became dominant, the number of people experiencing a breakthrough infection began to grow, and those totals only increased with the omicron surge.
Now, with the majority of the country vaccinated, and immunity gradually waning over time, once-scarce breakthrough infections — which the Centers for Disease Control and Prevention (CDC) define as when a fully vaccinated person gets infected with COVID-19 — have become a regular occurrence associated with the pandemic.
As a result, the notion early on that vaccination could be relied upon to prevent all coronavirus infection has been somewhat eroded. But vaccines have remained largely highly protective against severe illness and death.
Experts also say the sheer volume of cases now puts even the vaccinated who are vulnerable in danger and underscores the urgency of people both getting their primary series and boosters.
An ABC News analysis of data collected by the CDC found that the share of breakthrough COVID-19 cases has reached its highest point since the vaccines were introduced, with more cases occurring among the vaccinated in March and April 2022, than among the unvaccinated, partially because of the significant number of people who are now vaccinated.
However, even with overall totals increasing, per capita, unvaccinated Americans still have a greater risk of contracting and dying of COVID-19.
Increasing rates of breakthrough cases
In June 2021, prior to the emergence of the delta variant, breakthrough cases represented only 12% of new cases. By October, as the delta variant continued to dominate, and with an increasing number of people further out from their original vaccine series, breakthrough infections represented about a third of cases.
When the even more transmissible omicron variant emerged in November 2021, the percentage of breakthrough cases began to steadily grow, and by March, breakthrough infections among the vaccinated represented the majority of new cases. Between April 2021 and April 2022, the percentage of breakthrough cases grew from 3% to more than 60%.
With more vulnerable and older Americans further out from their primary series, the rate of breakthrough deaths has also grown. During April 2021, just 8% of deaths were the result of breakthroughs, but by March 2022, that number had increased to more than 41% of the month’s recorded deaths.
Breakthrough cases and deaths among the boosted have also been on the rise, albeit at a slower rate.
In September 2021, less than 1% of COVID-19 of cases and deaths occurred among Americans who had been fully vaccinated and boosted with their first dose. By April 2022, the percentage for cases had increased to more than 52%, while the proportion of deaths had grown to nearly 31%.
Health experts said the increase in breakthrough infections and deaths is expected with more Americans reaching full vaccination status and higher-risk populations getting further away from their initial vaccination series and first booster.
In March 2022, unvaccinated adults were 10 times more likely to die of COVID-19 compared to vaccinated individuals and in April 2.3 times more likely to test positive, according to data from the CDC.
The CDC notes that there are limitations to this data, including a higher prevalence of previous infection among the unvaccinated and unboosted groups, a difficulty in accounting for time since vaccination and waning protection, potential differences in use of at-home tests and prevention behaviors by age and vaccination status.
Yet to receive their first booster
During an interview with CBS News last month, Dr. Anthony Fauci, the White House’s chief medical advisor, acknowledged there has been an increase in the number of vaccinated people who are dying of COVID-19, many of whom are elderly, immunocompromised or have underlying conditions.
“As long as you have vulnerable people in the population, even though the unvaccinated are going to be much more at risk, even vaccinated with underlying conditions and a high degree of susceptibility to severe disease will account for those deaths,” he said.
Unvaccinated Americans also continue to become severely ill and die of the virus, Fauci said. He stressed that a large proportion — about a third of Americans — have not been fully vaccinated, while about half of eligible Americans are still unboosted with their first dose.
According to an ABC News analysis, the vast majority — between 80% and 90% — of the vaccinated Americans who are dying from COVID-19 are people over the age of 65.
Last month, the CDC announced that it is “strengthening” its recommendation for Americans over the age of 12 who are immunocompromised and those over the age of 50 to receive their second booster shot.
“Only 38% of those 50 to 64 and 43% of those 65 and older have received a vaccine dose in the past six months. This leaves about 60% of older Americans without the protection they may need to prevent severe disease, hospitalization, and death,” CDC director Dr. Rochelle Walensky said during a meeting of the agency’s independent advisors in May. “We know immunity wanes over time, and we need to do all we can now to protect those most vulnerable.”
According to CDC data, since second booster doses were authorized in mid-March, a total of 15.4 million Americans have received their second booster. Some 14.7 million of those who have received second boosters are people over the age of 50, and 10.3 million of them are over the age of 65.
“The numbers we are keeping an eye on are the numbers of individuals with breakthrough disease that requires hospitalization, intensive care, or that results in death,” C. Buddy Creech, director of the Vanderbilt Vaccine Research Program and associate professor of pediatric infectious diseases, told ABC News.
“We can anticipate some degree of this among the elderly, those with complicated underlying medical conditions and those that are immunocompromised; however, if we begin to see high numbers among otherwise healthy individuals, it may be a sign that current vaccines aren’t working as well against new variants of concerns,” he added.
The increase in the number of vaccinated people falling ill and dying underlines the urgency for high-risk Americans to get boosted, health experts said.
“For those that are immunocompromised, at high risk for complications, over 50 years of age, or who received their third dose months ago, a fourth dose reduces the likelihood of infection and complications from disease,” Creech said.
‘Vaccines are still working’
The drop in efficacy may come as a shock to some Americans who still envision protection levels of over 90% against symptomatic infection that were initially reported by vaccine makers Pfizer and Moderna in late 2020.
“Vaccine efficacy in clinical trials has been very high, vaccine effectiveness in the real world is always going to be a bit lower. In clinical trials, we typically exclude those that are severely immunocompromised or medically fragile. We also measured vaccine efficacy during a time prior to the emergence of variants and when more risk mitigation strategies were in place,” Creech explained.
However, Creech noted that even with the diminution, “vaccine effectiveness remains quite high,” adding that given the reality that COVID-19 vaccines do not provide complete protection against all disease, he is not surprised that effectiveness for mild or moderate symptoms is lower than what was reported during the trials.
Given delta and omicron’s highly infectious nature, “nearly everyone who has not been vaccinated has now been infected – many people twice, three times, or more,” David Dowdy, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health, told ABC News.
“That previous infection does provide some protection — but also at the cost of often getting very sick. Over time, more people are also getting vaccinated, so the number of unvaccinated people is getting smaller and smaller. But vaccines are still working,” Dowdy explained.
People should still get vaccinated, experts say
Health experts stressed that even though more breakthrough cases are occurring, Americans should not be dissuaded from getting vaccinated.
“People should absolutely still get vaccinated and boosted if you haven’t already. Vaccines are still highly effective, and for people who have been infected already, vaccines are known to give extra protection,” Dowdy said.
For those who have yet to receive a third dose, “now is the time to get boosted,” Creech said.
Looking ahead to the fall, as the vaccine companies look to develop new and improved shots, Creech said it is important for people to assess when they should get their booster shots.
“There’s hope that they will be even more effective – but in terms of preventing serious illness, the current vaccines are still working very well,” Dowdy added.
For those who have recently received a third dose or who are a few weeks out from having COVID-19 infection, waiting until variant boosters are available might be a more reasonable approach, Creech said.
“We’re not out of the woods yet; however, vaccines have gotten us to a point where our healthcare system can withstand COVID-19 waves without reaching a breaking point,” Creech said.
