(NEW YORK) — Taylor Dayne is known on stage for her ’80s top-hits like “Tell It to My Heart,” “Prove Your Love” and “Love Will Lead You Back,” but now she is stepping back into the spotlight for a different reason. The Grammy-nominated singer wants to raise awareness about the importance of self-advocacy and routine screenings — which could be lifesaving.
“Life is precious,” Dayne told ABC News’ Good Morning America.
In July, the 60-year-old singer was diagnosed with colon cancer after a routine colonoscopy, a procedure that she has twice a year after doctors found benign polyps in the past. This time, she said doctors discovered a polyp that held an aggressive cancer.
Dayne said her world went “dark” at the word “cancer,” but said that her doctor re-assured her they had found her illness early, which increases the chance of positive treatment outcomes.
“He never even said the stage,” said Dayne, who thought back to her last colonoscopy. “All I could do is [think], ‘OK, five months ago, I know there was nothing. So this is early detection.”
Colon cancer is the third most leading cause of cancer-related deaths in the U.S., according to the American Cancer Society, but also highly treatable and curable, if found early through a colonoscopy.
Dayne said weeks after she discovered her cancer, she underwent surgery that removed 10 inches of her colon and was declared cancer free right after the procedure.
Although she said she didn’t have to undergo chemo or radiation, she said she experienced a “complication” during her recovery and developed an infection post-operation.
“I ended up staying in the hospital for about 15 days, 20 days,” said Dayne. “There’s no guarantees when they open you up, what’s going to happen. That’s really the truth.”
Once Dayne was released from the hospital, she said she had to focus on getting better, not just physically, but emotionally. Her hospitalization brought her back to traumatic memories from her childhood when she suffered from terrible kidney infections.
“For me, being back, I felt like I was four years old again back in the hospital, basically locked inside my own body without a voice,” said Dayne. “So, this has challenged me mentally, emotionally. I am now back in a therapy program.”
Now, Dayne said she is feeling stronger and wants others, especially women, to talk to their doctors about their own personal risk factors and when they should be screened for things like colon cancer — just in case.
“When you’re really sick, you don’t have the energy, you’re really relying on your champions around you, your soldiers, your people,” she said. “Find the doctor that will tell you the truth. Be a warrior for yourself.”
(NEW YORK) — Filmmaker Cynthia Lowen began the process of making the new documentary film “Battleground” with a genuine curiosity about the anti-abortion movement.
Lowen wanted to understand how, despite being in the minority, anti-abortion movement organizers “were being so successful in advancing their agenda,” she told ABC News Correspondent Phil Lipof.
The new documentary “Battleground,” which was released this year in theaters and is now available on streaming platforms, began in the summer of 2019, a full three years before Roe v. Wade was overturned.
Lowen said she started filming in Alabama, where the team was focused at first on documenting the abortion-rights movement.
She quickly realized, she told ABC News, how crucial it would be to frame the film from a minority perspective by including multiple important voices from the anti-abortion movement.
A recent survey by Pew Research Center found that 62% of Americans think abortion should be legal in all or most cases. A 2017 study by the Guttmacher Institute found that nearly 1 in 4 women will have an abortion in their lifetime.
“Battleground” features three women in influential positions within the anti-abortion movement: the president of an influential anti-abortion lobbying organization, the founder of the largest anti-abortion youth organization in the country, and the founder of Pro-Life San Francisco.
Part of the goal of the film is to challenge assumptions and notions about the anti-abortion movement by showing organizers that are neither religious nor conservative about other beliefs.
“What I discovered that really surprised me is that there are a lot of women who are leading the anti-abortion movement,” said Lowen.
One example is Terrisa Bukovinac, the founder of Pro-Life San Francisco, who identifies as an atheist, a feminist and a Democrat with progressive values. “[She] is a very different face of the anti-abortion movement than many people expect,” Lowen said.
“She represents,” Lowen added, “what the movement is trying to do in terms of appealing to young people as single-issue voters.”
“If they don’t grow their base and appeal to non-religious people, to young people and cultivate those single-issue voters,” she added, “they may not continue to have the kind of success and inroads that they’ve had legislatively.”
Despite representing a minority opinion, the anti-abortion movement has been very successful. Roe v. Wade was overturned in June 2022, opening up the opportunity for dozens of states across the country to restrict access to legal abortions.
One of the scenes in the documentary includes audiotape of Lowen’s team obtained from a conversation between evangelical leaders and former President Donald Trump, who was a presidential candidate at the time.
“You really hear this deal being made,” Lowen said, “which is that if Donald Trump will advance the agenda and the priorities of Christian right, the Christian white right will rally their base to get out and vote for him.”
Trump’s success in appointing three conservative Supreme Court justices was instrumental in the anti-abortion movement’s success in overturning Roe v. Wade.
The documentary also includes interviews with leaders from the abortion-rights movement, including President and CEO of Planned Parenthood Alexis McGill Johnson.
Lowen told ABC News she personally disagrees with the anti-abortion movement, saying it “deprives other people of their rights and other people of the opportunity to make health care decisions for themselves that are in their own best interests.”
(NEW YORK) — A COVID-19 outbreak has hit a U.S. station in Antarctica, despite being in one of the most remote areas of the world.
According to the National Science Foundation, which manages McMurdo Station — the largest base on the continent — at least 98 people have tested positive since the beginning of October out of 993 workers.
Of the cases, 64 are active. The NSF said most of the employees have mild symptoms and are isolating in their rooms. It’s unclear how the outbreak began.
To contain the outbreak, the NSF is pausing all inward travel to Antarctica for the next two weeks except for essential travel required for health and safety reasons.
In a statement, the foundation said this is “to lower the density of the population to reduce the possibility of transmission” during which time it will “reassess the situation.”
It’s unclear if the travel pause will affect any research projects. It comes as many scientists head down to the continent for their summer field season, where they work for two to three months.
It is also unknown if the pause will be extended past two weeks.
Those who test positive are required to isolate for five days and then wear a mask for an additional five days.
They are allowed to return to work after receiving two negative tests.
What’s more, the foundation said that its “expert epidemiologist” highly recommends all workers on the base wear KN-95 masks at all times and NSF “will ensure these are available to all residents at McMurdo.”
This is not the first instance of a COVID-19 outbreak occurring in Antarctica.
In December 2020, at least 11 of 33 workers at Belgium’s Princess Elisabeth Polar Station tested positive for the virus.
Additionally, during the same month, 36 cases of COVID-19 were confirmed among staff members at Chile’s Bernardo O’Higgins research station on the Antarctic Peninsula.
McMurdo Station was established in 1955 and is one of three year-round science facilities in Antarctica run by the United States.
According to the NSF, the station is made up of 85 buildings including laboratories, dormitories, repair facilities, a power plant, a firehouse and a water distillation. It also contains a harbor, two landing areas and a helicopter paid.
Scientists focus on research at McMurdo in many fields including biology, geospace sciences, glaciology and climate systems.
(NEW YORK) — A Michigan hospital system has limited the number of young visitors as cases of respiratory viruses continue to spike throughout the state and the country.
Under a new rule that took effect Monday morning, hospitals under the Corewell Health East system will not allow any visitors under the age of 5 to enter buildings.
The only exceptions will be for certain circumstances, such as if a parent or sibling is severely ill or if there is an end-of-life situation.
Cases of respiratory viruses have been increasing across the United States, mostly linked to respiratory synclinal virus, or RSV, and the flu.
According to data from the Centers for Disease Control and Prevention, weekly RSV cases rose from 5,845 for the week ending Oct. 1 to 7,679 for the week ending Oct. 29.
Additionally, over the same period, positive tests for influenza reported to the CDC by clinical laboratories have jumped from 2,083 to 7,504, data shows.
What’s more, the cumulative hospitalization rate for flu in the U.S. is currently 2.9 per 100,000, the highest it has been since the 2010-11 season, according to the CDC.
Corewell Health East told local affiliate WXYZ there has been a 500% increase in positive tests for upper respiratory infections among pediatric patients, one of the reasons that led to the implementation of the new rule.
“We’re seeing an unprecedented number of patients in our emergency departments and upper respiratory infection caused by RSV,” Dr. Matthew Denenberg, chief of pediatrics at Corewell Health East, said. “It’s been a really early and severe year for RSV. Worse than any other year that I’ve seen. I’ve been doing this 20 years.”
According to state data, 72.2% of pediatric hospital beds across Michigan are occupied. Denenberg said the pediatric intensive care unit at his hospital has reached capacity.
“Our pediatric intensive care unit here at Corewell East in Royal Oak has been full consistently for the last few weeks,” he said in reference to a hospital 17 miles northwest of Detroit. “In fact, we have some ICU patients that are, you know, boarding over in the adult spaces.”
Corewell Health did not immediately respond to ABC News’ request for comment.
Last week Michigan health officials revealed that a 6-year-old boy died after developing complications from RSV.
The child is from Macomb County, which is made up of northern Metro Detroit and the immediate surrounding area.
According to the CDC, between 100 and 500 pediatric deaths occur from RSV every year.
At the time, Denenberg told “Good Morning America” deaths are not common and usually occur among those with pre-existing conditions.
“Very, very few children die from RSV, and the kids that get that sick, it’s usually a child that has an underlying illness,” he said.
(NEW YORK) — Across the country, pediatric bed occupancy is the highest it’s been in two years, with 78% of the estimated 40,000 beds filled with patients, according to data from the U.S. Department of Health and Human Services.
The rise in occupancy — a 2% increase from last week and a 7% increase from mid-October — comes amid a nationwide surge in cases of respiratory syncytial virus, or RSV, influenza and rhinovirus/enterovirus (RV/EV).
Amid the surge, five states — Arizona, Rhode Island, Minnesota, Kentucky and Texas — continue to be using at or above 90% of pediatric hospital beds.
Late last week, the Centers for Disease Control and Prevention issued an official health advisory in response to the rise in respiratory infections in children.
The health advisory warned that “Co-circulation of respiratory syncytial virus (RSV), influenza viruses, SARS-CoV-2, and others could place stress on healthcare systems this fall and winter.”
This year, rates of RSV-associated hospitalizations began to increase during late spring and continued to increase through the summer and into early fall. Preliminary data from October shows weekly rates of RSV-associated hospitalizations among children younger than 18 years old are higher than rates observed during similar weeks in recent years.
While RSV activity appears to be plateauing in some places, the timing, intensity and severity of the current RSV season are uncertain.
RSV is a contagious virus that can spread from viral respiratory droplets transferred from an infected person’s cough or sneeze; from direct contact with the virus, like kissing the face of a child with RSV; and from touching surfaces, like tables, doorknobs and crib rails, that have the virus on them and then touching your eyes, nose or mouth before hand-washing, according to the CDC.
People infected with RSV are usually contagious for three to eight days, but some infants can continue to spread the virus even after they stop showing symptoms, for as long as four weeks, according to the CDC.
Among children, premature infants and young children with weakened immune systems or congenital heart or chronic lung disease are the most vulnerable to complications from RSV.
According to the CDC, death from RSV is rare. There are between 100 to 500 pediatric deaths and 14,000 adult deaths each year related to RSV, with the actual figure likely being higher due to undercounting.
At the same time as RSV cases are surging, positive tests for influenza reported to the CDC by clinical laboratories jumped from 2,083 to 7,504 in October, data shows.
What’s more, the cumulative hospitalization rate for flu in the U.S. is currently 2.9 per 100,000, the highest it has been since the 2010-11 season, according to the CDC.
Experts told ABC News that a combination of waning immunity to COVID and lack of exposure to other viruses, combined with close gatherings indoors, is fueling a “perfect storm.”
“Mostly the issue is there’s low population immunity and kids are, once again, gathered again, and this is facilitating rapid spread of viruses like RSV,” Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor, said. “And because of the sheer volume of infection, when you have that larger denominator, you have a situation where a portion of those kids are going to require hospital treatment. And because of that, our hospitals are spread thin, not only for bed capacity, but also for critical staffing, of those beds.”
He added, “So the combination of shortages, bed capacity and rising viral illness all make for an unfortunate perfect storm that we’re seeing happen everywhere right now.”
In Michigan, a hospital system on Monday began limiting the number of young visitors as cases of respiratory viruses continue to spike throughout the state and the country.
Under a new rule, hospitals under the Corewell Health East system will not allow any visitors under the age of 5 to enter buildings.
The only exceptions will be for certain circumstances, such as if a parent or sibling is severely ill or if there is an end-of-life situation.
(NEW YORK) — Amid a nationwide surge in cases of respiratory syncytial virus, or RSV, comedian and actress Amy Schumer revealed that her 3-year-old son was hospitalized due to the virus.
Schumer shared in an Instagram post Sunday that her son Gene was taken to the emergency room and hospitalized the same week she was in rehearsals to host Saturday Night Live.
“I missed Thursday rehearsals when my son was rushed to ER and admitted for RSV,” Schumer wrote. “Shout out to all the parents going though this right now.”
She shared a photo of herself sitting in the hospital with Gene, wearing a respiratory mask.
Schumer, who gave birth to Gene, her only child, in May 2019, later wrote that her son is “home and better.”
The U.S. is seeing more than twice as many cases per week compared to the same period last year, according to ABC News contributor Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital.
Late last week, the Centers for Disease Control and Prevention issued an official health advisory in response to the rise in respiratory infections in children.
In addition to RSV, the number of cases of influenza and rhinovirus/enterovirus (RV/EV) are higher than usual for this time of year, especially among children, according to the CDC.
Respiratory illnesses are appearing earlier and in more people than in recent years. The federal health agency says there have also been early increases in flu activity across most of the U.S., with indications that this season could be much more severe than the recent seasons.
What parents should know about RSV
RSV is a contagious virus that can spread from viral respiratory droplets transferred from an infected person’s cough or sneeze; from direct contact with the virus, like kissing the face of a child with RSV; and from touching surfaces, like tables, doorknobs and crib rails, that have the virus on them and then touching your eyes, nose or mouth before hand-washing, according to the CDC.
People infected with RSV are usually contagious for three to eight days, but some infants can continue to spread the virus even after they stop showing symptoms, for as long as four weeks, according to the CDC.
Among children, premature infants and young children with weakened immune systems or congenital heart or chronic lung disease are the most vulnerable to complications from RSV.
According to the CDC, death from RSV is rare. There are between 100 to 500 pediatric deaths and 14,000 adult deaths each year related to RSV, with the actual figure likely being higher due to undercounting.
“Pretty much all kids have gotten RSV at least once by the time they turn 2, but it’s really younger kids, especially those under 6 months of age, who can really have trouble with RSV and sometimes end up in the hospital,” Dr. William Linam, pediatric infectious disease doctor at Children’s Hospital of Atlanta, told ABC News last year. “That’s where we want to get the word out, for families with young children or children with medical conditions, making sure they’re aware this is going on.”
In the first two to four days of contracting RSV, a child may show symptoms like fever, runny nose and congestion.
Later on, the symptoms may escalate to coughing, wheezing and difficulty breathing.
Parents should also be alerted to symptoms including dehydration and not eating, according to Linam.
“Not making a wet diaper in over eight hours is often a good marker that a child is dehydrated and a good reason to seek medical care,” he said. “Sometimes kids under 6 months of age can have pauses when they’re breathing and that’s something to get medical attention for right away.”
Infants and toddlers can usually recover at home with RSV unless they start to have difficulty breathing, are not eating or drinking, or appear more tired than usual, in which case parents should contact their pediatrician and/or take their child to the emergency room.
At-home care for kids with RSV can include Tylenol and Motrin for fevers, as well as making sure the child is hydrated and eating.
Parents can help protect their kids from RSV by continuing to follow as much as possible the three Ws of the pandemic: wear a mask, wash your hands and watch your distance, according to Linam.
Infants who are either born prematurely (less than 35 weeks) or born with chronic lung disease may benefit from a medication to prevent complications of RSV since they are at increased risk of severe disease. Parents should discuss this with their pediatrician.
(NEW YORK) — For the past three months, Lauryn Bosstick, a Texas-based mom of two, has added a new step to her nightly routine: taping her mouth shut.
Bosstick, an entrepreneur and founder of The Skinny Confidential — a lifestyle product line, book and podcast — said she considers the technique, called mouth taping, a positive addition to her wellness routine.
She said she wakes up with more energy and feels like she can breathe better throughout the day.
“The first time I did it, I woke up with more energy,” Bosstick told ABC News’ Good Morning America. “It’s actually not hard once you start doing it. I’m surprised, but I actually want to do it each night.”
Bosstick said she first heard about mouth taping at night from multiple wellness experts she interviewed for her podcast, who each praised it as a way to reap the health benefits of nose breathing.
One of those experts, Andrew Huberman, Ph.D., a neurobiology professor at Stanford University, has touted the benefits of nasal breathing on social media and on his own podcast, “The Huberman Lab.”
Huberman proposes that breathing through the nose instead of the mouth may not only help prevent the spread of infection but may also help improve teeth hygiene, facial alignment and, at night, provide deeper sleep.
Dr. Gregory Levitin, a board-certified otolaryngologist at New York Eye and Ear Infirmary of Mount Sinai, echoes some of those beliefs, suggesting that nasal breathing has some well-researched medical benefits.
“Functionally, it’s healthier to breathe through your nose,” said Levitin. “There are many studies that have shown that not only does the nose warm the air and filters the air and moisturizes the air for us, it’s also associated with healthier sleep.”
There have been small studies linking mouth taping with modest improvements in snoring and sleep apnea, but no large-scale trial has been able to prove its benefits, for which reason it is not universally recommended.
The do’s and don’ts of mouth taping
Dr. Raj Dasgupta, fellow of the American Academy of Sleep Medicine and assistant professor of clinical medicine at the Keck School of Medicine at the University of Southern California, said people should always consult a doctor before trying mouth taping.
The main danger with the technique, he said, is if someone has undiagnosed sleep apnea and therefore would have difficulty breathing overnight.
“Before you put any tape over your mouth, talk to your doctor or health care provider to see if it’s going to be safe for you,” said Dasgupta, adding that women especially are often underdiagnosed because they don’t always present with the classic symptoms of obstructive sleep apnea, like loud snoring.
Levitin said too that a person trying mouth taping is likely trying to feel better, in which case they should seek medical care to see if there is a reason they are not properly nasal breathing.
He cautioned that mouth taping should be looked at as a diagnostic tool, not as a permanent fix or something to be done long-term.
If a person feels better after trying mouth taping for a night or two, they should see a doctor, according to Levitin, who noted there are now non-surgical options to help people breathe better.
“It’s an indicator of perhaps maybe taking the next step and actually going to see somebody determine if there’s a problem that can be fixed,” he said.
Levitin stressed that people should not use commercial tape, duct tape or any other non-medical tape for the technique. If people do decide to try mouth taping, porous tape is recommended, as it is intended for use on human skin.
Both Levitin and Dasgupta said that people can also improve their nasal breathing through lifestyle modifications, instead of resorting to mouth taping.
Meditation and yoga as well as healthy diet and consistent exercise each contribute to better breathing, the experts said.
The trend
Levitin said it’s easy to see why a tool like mouth taping may become popular, because people are trying to feel better by breathing better.
Signs that a person may not be properly breathing through their nose at night include waking up tired after a full night’s sleep or waking up with a dry mouth, sore throat or bad breath, according to Levitin.
“Millions if not billions of people don’t breathe properly every day,” he said. “It results in inefficient sleep. It makes us more tired. It also may contribute to airway disease like asthma and allergies because we’re not clearing the pathogens, or germs and dust that filter through the air.”
Bosstick said in her experience, mouth taping does not hurt, and is not as awkward as she thought it would be when she first heard it described. She places an H-shaped piece of medical tape on her lips each night.
“I think people imagine this huge piece of masking tape over their mouth. That’s not how it is,” said Bosstick. “You can essentially breathe out of the sides of your mouth, but your mouth is just closed.”
She shared her own journey with nightly mouth taping in a TikTok video that has over 21,000 likes.
Bosstick said she sees more and more people giving mouth taping a try. After doing it consistently for three months, she said she plans to keep the technique as part of her nightly routine.
“I’m a multitasker and a habit stalker,” she said. “So if I can do something while I’m asleep that’s going to make me have more energy, make me feel better and affect my facial symmetry over time and help me remain more youthful, I’m all about it.”
(NEW YORK) — The “fall back” from daylight saving is linked to an uptick in car accidents and poor mood, but doctors say careful attention to sleep hygiene and a gradual adjustment of your bedtime may help.
As clocks across America “fall back” an hour at 2 a.m. on Nov. 6, internal clocks may lag behind.
“Changes, even small ones, in your sleep can impact almost every area of your body from your skin to your cardiovascular system,” said Dr. Marri Horvat of the Cleveland Sleep Disorders Clinic.
Daylight saving time is less aligned with our natural circadian rhythm. The sun rises later and light lasts longer in the evening, but our bodies are more attuned to light in the mornings and darkness in the evenings. Each switch changes sleep patterns abruptly.
The good news, doctors say, is that the upcoming change from daylight saving to standard time is less harmful for your health than the spring switch, largely because you gain an hour of sleep. The bad news is that either switch can have negative impacts on your health.
Researchers estimate that the switch to and from daylight saving time contributes to thousands of car accidents and 300 deaths each year. Meanwhile, researchers who have studied the fall switch specifically say it’s linked with an 11% increase in depressive episodes. Interestingly, doctors report that while the spring switch was linked with a 24% increase in heart attacks the day after, the fall switch has been linked with a 21% decrease in heart attacks. The benefit may lie in the extra hour of sleep gained with the fall switch.
What can you do to get better sleep?
Sleep specialists say it’s a good idea to establish a nighttime routine leading up to and following the switch. Horvat recommends “making the shift slowly over several days” by “going to bed and waking up 10 to 15 minutes later each day.” Ideally, this routine would include a “winding down” period of at least an hour before bedtime when you stop screen time, turn down the thermostat (between 60-75 degrees), and do a relaxing activity. The greatest relaxation technique before bedtime is listening to soothing music.
Another tip is to exercise outdoors. Moderate intensity aerobic exercise during the day, as long as it’s at least two to four hours before bedtime, increases sleep quality and duration. Also, exercising outdoors is recommended since natural sunlight during the day can help with the switch.
According to doctors, avoiding caffeine and alcohol in the evenings can also help and it’s best to avoid snacks close to bedtime.
Although napping can’t replace a good night’s sleep, it can help supplement it. Even a five-minute nap shows improved attention and short-term memory.
“Healthy sleep begins with attitude and awareness,” said Dr. Emerson Wickwire, director of the American Academy of Sleep Medicine. “Set aside 7.5 or 8 hours for sleep and enjoy it!”
Alicia Zellmer, MD, and Joy Liu, MD, are resident physicians in Internal Medicine, and members of the ABC News Medical Unit.
(NEW YORK) — American pharmaceutical company Pfizer and its German partner BioNTech announced Friday that a booster dose of their bivalent COVID-19 vaccine performs better against two circulating versions of the omicron variant, compared with a booster shot of their original vaccine.
According to a joint press release, updated data from a Phase 2-3 clinical trial shows the Pfizer-BioNTech bivalent vaccine produced antibody responses against the BA.4 and BA.5 omicron subvariants that were three- to four-fold higher, compared with the original formula, when measured in adults approximately one month after receiving a booster dose. The safety and tolerability profile of the bivalent booster remains favorable and similar to the original vaccine, Pfizer and BioNTech said.
“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Pfizer chairman and CEO Albert Bourla said in a statement Friday. “These updated data also provide confidence in the adaptability of our mRNA platform and our ability to rapidly update the vaccine to match the most prevalent strains each season.”
Other smaller studies by independent scientists have suggested there is very little difference between antibody responses produced by the original and updated shots, though both boosted antibody protection.
All of these studies are conducted by taking blood samples from recently vaccinated people and measuring antibodies in a lab. They give us a hint of how well the vaccines might work, but do not tell the full story of their effectiveness. Vaccines are still expected to offer a high level of protection against severe illness.
In late August, the U.S. Food and Drug Administration authorized two updated booster vaccines — the one developed by Pfizer and BioNTech, and another by American biotechnology company Moderna — that were designed to be a better match against the BA.4 and BA.5 subvariants. Since then, just over 26 million eligible Americans have received the updated booster shots, according to the Centers for Disease Control and Prevention.
The BA.5 subvariant currently is estimated to account for half of all new COVID-19 cases in the United States, according to the CDC, but it’s unlikely to remain the dominant viral strain for much longer. Newer versions of the omicron variant, such as BQ.1 and BQ.1.1, are slowly overtaking as a proportion of estimated cases. These subvariants are descendants of BA.5, but it remains unclear how well the bivalent boosters will work against them.
As the world nears its third year of the COVID-19 pandemic and the virus continues to evolve, booster shots are expected to bolster protection against severe illness but not necessarily mild or asymptomatic breakthrough infections.
“These data demonstrate that our BA.4/BA.5-adapted bivalent vaccine works as conceptually planned in providing stronger protection against the Omicron BA.4 and BA.5 sublineages,” BioNTech CEO and co-founder Ugur Sahin said in a statement Friday. “In the next step and as part of our science based approach we will continue to evaluate the cross-neutralization of the adapted vaccine against new variants and sublineages. Our aim is to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron and other circulating strains.”
(NEW YORK) — In what could signal the promise of progress to come for newborn infants at risk for RSV, a new monoclonal antibody is being granted approval in Europe as a preventative measure to protect against RSV infection in very young babies — those most at risk of contracting the virus — during their first RSV season.
Developed jointly by Sanofi and AstraZeneca, commercially called “Beyfortus®,” this monoclonal antibody is given via a single dose intramuscular injection to infants aged 0 to 12 months, to protect against RSV before they get infected, from birth up through their first RSV (respiratory syncytial virus) season. The European Commission announced Friday morning it had approved the drug.
This does not mean it is an option for American babies, at least not yet. Sanofi and AstraZeneca will still have to go through the U.S. regulatory process for that — Food and Drug Administration approval, and recommendation by advisory panels like the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
While the European approval does not impact the US regulatory process — FDA makes its own decisions — this new European approval shows it’s good enough to get the green light there, and could get the green light here as well.
If and when the FDA does approve this antibody, it won’t be in time for this season’s surge. But it could get approved in time for next year.
Sanofi tells ABC News they and AstraZeneca have already submitted their clinical trial data to the FDA. They expect to finalize their submission to the FDA by the end of this year, with the hopes of it being approved and available by the fall/winter of 2023/2024.
“It’s really exciting news. We’ve been looking for solutions to be able to prevent RSV for close to 50 years,” Dr. Michael Greenberg, a pediatrician and vice president, Sanofi’s Medical Head of Vaccines for North America, told ABC News in an interview.
He noted that once available, it could offer an important “first tool that we have to be able to protect all babies going into their first RSV season.”
This monoclonal antibody, called Beyfortus, is a lab-made, synthetic version of RSV immunity that newborn babies don’t have time to develop on their own, with their short time on earth.
That could change once a maternal RSV vaccine is approved and available — but for now — it could offer an important stopgap of protection for a vulnerable population, especially looking ahead from amid the current influx of pediatric RSV infections currently surging in the U.S.
A sampling of national CDC data shows RSV cases recorded for all ages are occurring more than twice as high at this point this year compared to last year, with more than twice as many cases per week, and likely leading towards more severe cases, especially in pediatric emergency departments and pediatric hospitalizations, which have limited resources to begin with, according to Chief Innovation Officer at Boston Children’s Hospital and ABC News Contributor, Dr. John Brownstein.
Newborn infants are at the highest risk of RSV infection, especially those who are born prematurely or immune compromised. Their heads are big, their airways small, and they have no built-up immunity. It is a leading cause of hospitalization in infants in the U.S.
This monoclonal could be a notable measure of protection for babies, wherever it’s approved, available and accessible to those who need it.
“Speaking as a pediatrician as someone who’s worked in public health, we always try to prevent, rather than having to treat — which is why we use vaccines for example — it’s better to prevent illnesses than to treat it,” Greenberg said.
“The idea is that a baby would get it for example, if they’re born during the time when RSV is circulating, like now, they would get it before they leave the hospital after being born, or if they’re born before the RSV season, they would get it in their pediatricians office during a normal well child visit,” Greenberg continued. “It’s designed to be able to protect from a very rapid standpoint, for that first RSV season.”
It is designed to keep RSV from being as serious as it can be in the population most vulnerable to severe infection — newborns.
So, while Beyfortus may not prevent all infections, like milder ones, it does buy important time for the most vulnerable tiny babies to grow larger and stronger and less likely to get hit as hard by RSV.
During the pandemic, many kids weren’t as exposed to many of the viruses they would have been otherwise, during the course of a normal childhood — because of masking, social distancing, remote learning, etc. during their very early years.
One theory to explain the unusually high number of RSV infections says that babies who would have been affected earlier on in life in a normal setting were instead born into the COVID bubble — which may have caused a delay in their built-up immunity, experts say.
Now, as the masks have come down, the infection rates are going up at even higher rates, and experts emphasize how COVID-19 has thrown the typical seasonality of our respiratory viral waves.
There is also no vaccine for RSV yet, while there is, of course, for COVID and the flu.
“The holy grail for durable RSV protection remains the illusive vaccine which now seems to be on the horizon,” Brownstein said. “Nonetheless the availability of these therapies will play an important role as a stop gap, likely an important tool to protect high risk babies from complications of RSV infection.”
There have been recent and promising developments with the data on Pfizer’s maternal RSV vaccine candidate — and while they can now move forward with the approval process, that vaccine won’t be immediately available to families worried about the current surge. FDA approval and CDC recommendation are possible next year.
And in the newborns most at risk for severe RSV, they have not lived long enough for a vaccine given directly to them to have enough time to build sufficient immunity.
Enter, alternatives like this monoclonal antibody: a synthetic version of that immunity which can help ward off infection.
In a randomized placebo-controlled phase 2/3 trial, Beyfortus showed an efficacy of more than 77% (77.3%) against infants’ RSV lower respiratory tract infection hospitalizations.
“I think we just have to be able to be prepared, and have tools like this to be able to respond,” Greenberg said. “So that whatever the epidemiology is, we’ve got the means to be able to protect all infants going into the RSV season, whenever the RSV season happens.”
