Respiratory viruses, such as influenza and respiratory syncytial virus (RSV), tend to pick up during fall. On top of that, COVID-19 is still circulating, with cases increasing in recent weeks. To fight off what some are calling a “tripledemic” of all three viruses, state and federal health officials are urging people to protect themselves with vaccines.
In an interview, Bernard Camins, MD, Professor of Medicine (Infectious Diseases), and Jennifer Duchon, MD, Associate Professor of Pediatrics (Newborn Medicine), at the Icahn School of Medicine at Mount Sinai, provided additional background about vaccines that will be available this fall.
COVID-19
COVID-19 cases and hospitalizations are not as high as they used to be at the height of the pandemic. But hospitalization counts—which are still being reported—have risen in recent weeks.
“We can’t just forget about COVID-19 yet,” says Dr. Camins.
On Monday, September 11, the U.S. Food and Drug Administration (FDA) cleared updated COVID-19 vaccines for use that are formulated to more closely target currently circulating variants. The FDA approved the Pfizer and Moderna vaccines—known as “messenger RNA” or “mRNA” vaccines for the type of technology they use—for people 12 and over. It granted emergency use authorization to the same vaccines for people six months to 11 years old.
On Tuesday, September 12, a panel of the Centers for Disease Control and Prevention (CDC) voted to recommend the updated vaccines for everyone six months and older. The CDC recommended that most people get one dose of the new vaccine, at least two months after their most recent vaccine dose. People who are immunocompromised, and parents of young children, should consult their doctor for recommended dosing.
Dr. Camins said the updated COVID-19 shots from Pfizer and Moderna are monovalent vaccines—meaning they are designed to target a single variant of SARS-CoV-2, the virus that causes COVID-19—but are expected to provide broad protection against the other currently dominant circulating variants of SARS-CoV-2 as well. He said patients should check with their primary care doctor’s office or local pharmacy to find out how and when they can get the new vaccines.
“Based on past developments, it could be within a matter of days for the shots to be available to the public once the recommendation is made,” says Dr. Camins.
The number of people hospitalized due to COVID-19 has been rising steadily in the city in August. Source: NYC Department of Health and Mental Hygiene
RSV
The respiratory syncytial virus commonly causes mild, cold-like symptoms in most healthy adults and goes away after a few days. However, for infants and older adults with pre-existing heart disease or lung disease, RSV can cause severe disease. This year, new vaccines are available for these vulnerable groups.
“RSV is ubiquitous,” says Dr. Duchon. “You can try to prevent it, but even then options are limited. While parents can practice good hand hygiene and stay away from other sick people, babies often have siblings who go to school or go to daycare.”
Most of the deaths or severe disease—typically lower-respiratory-tract disease—from RSV occur in infants ages 0 to 6 months, says Dr. Duchon.
In July, the FDA approved Beyfortus™ (nirsevimab-alip), marketed by Sanofi in the United States, for use in infants entering their first RSV season and up to 24 months of age for those in vulnerable groups. In August, the FDA approved Abrysvo™, from Pfizer, as a maternal vaccine to protect infants from birth through six months of age. Beyfortus is administered directly to infants after they are born, while Abrysvo is given to mothers at 32 weeks through 36 weeks of gestation.
ACIP has recommended that Beyfortus be given to all infants younger than 8 months born during—or entering—their first RSV season, typically fall through spring. For children 8 to 19 months who are at increased risk of severe RSV disease, such as those who are immunocompromised, a second dose is recommended.
Abrysvo has yet to receive ACIP recommendation, though news reports have stated that meeting could likely occur in September.
~1-3%
of children under 12 months of age in the U.S. are hospitalized each year due to RSV
~60,000-120,000 hospitalizations and ~6,000-10,000 deaths
among adults 65 years of age and older are due to RSV
Source: CDC
It is possible that the ACIP could recommend Abrysvo on top of Beyfortus. “We are hoping that the infant vaccine will help prevent severe disease, and that the maternal vaccine will add an additional layer of protection,” says Dr. Duchon. However, she notes that given how the clinical trials were set up, the expert panel will likely examine the data closely and deliberate on the messaging.
“This could be a shared decision-making situation between a mother and her doctor,” Dr. Duchon adds.
For older adults, the FDA approved Arexvy™ as a vaccine for people ages 60 and older, in May. “Particularly for people with heart or lung disease, RSV can exacerbate their conditions,” says Dr. Camins.
Older people in that vulnerable group should speak with their health provider on whether they should take the vaccine, especially as RSV season approaches, says Dr. Camins.
Influenza
The influenza virus season from fall 2022 to spring 2023 was marked by an early peak in November and December last year, according to the CDC. When the 2023-2024 flu season will peak is hard to pinpoint, but the CDC issued a recommendation in August for people to receive their flu shots in September or October.
“We are starting to see some influenza A cases here in our health system, which has a connection to how influenza A and B trends might play out through fall and winter,” says Dr. Camins. It is not a prediction of an early or bad flu season by any means, but he recommends that unless contraindicated, everyone older than six months of age take the flu shot.
The annual flu vaccine has been updated with a new formula, as is common, to target strains most likely to circulate this season. Anyone six months and older is recommended to receive it, according to the CDC.
“Even if you’re not at high risk for complications from the flu, getting the vaccine may prevent you from getting sick, or even if you do get sick, your symptoms will be milder if you take the shot than if you didn’t,” says Dr. Camins. “Everyone should be getting the flu vaccine.”
As the back-to-school season approaches, it’s not uncommon for young children to experience butterflies in their stomachs. Back-to-school feelings of anxiety are a natural and often healthy response to change.
The team at the Mount Sinai Parenting Center at Mount Sinai Kravis Children’s Hospital has developed some simple and effective ways to help your child learn how to get through the discomfort of uncertainty. Remember your job as a parent is not to spare your child the anxiety, it is to help them prepare for, sit with, and manage their feelings of anxiety.
Blair Hammond, MD, Co-Founding Director for the Mount Sinai Parenting Center and pediatrician in the Department of Pediatrics
Aliza Pressman, PhD, Co-founder, Mount Sinai Parenting Center, and Assistant Clinical Professor, Pediatrics, Icahn School of Medicine at Mount Sinai
Mariel Benjamin, LCSW, Director of Programs, Mount Sinai Parenting Center
Here are 10 simple tips to make the process smoother for both you and your child:
Create a Routine: Start by establishing a consistent daily routine a few weeks before school begins. Set regular mealtimes, playtimes, and bedtimes. Predictability provides some certainty in an uncertain experience. Click here to watch a special video about sticking to consistent morning and bedtime routines.
Feelings: Get Hold of Our Own Feelings and All Are Welcome: Make sure you have support managing some of the anxiety that comes with watching kids try new things and feel new feelings. Model and remind your child that there are no “bad” feelings and that feelings serve to give us information. Let them know it makes sense to feel a little nervous with new experiences. Share your own stories of first-day jitters from your childhood, showing them that many people feel this way.
Keep Sleep Sacred: Help make sure your child is getting enough sleep. A tired brain is more vulnerable to anxiety and has fewer resources to call on the tools that will help them manage their anxiety.
Play “School” at Home: Incorporate pretend play to familiarize your child with the idea of school. Take turns playing the teacher and student, using stuffed animals or dolls as classmates. This playful approach can ease their fear of the unknown.
Explore the School Together: Arrange a visit to the school before the first day. Walk around the campus, visit classrooms, and playgrounds. Let your child ask questions and share their thoughts. Familiarity can ease their apprehensions.
Get Creative with Supplies: Involve your child in choosing their school supplies, backpack, and lunchbox. Letting them make decisions empowers them and creates excitement about the upcoming adventure.
Positive Stories and Imagery: Read age-appropriate books or tell stories about positive school experiences. Use positive imagery and stories to help your child envision a happy and exciting school day.
Practice Separation: If separation anxiety is a concern, practice short separations at home. Leave them with a trusted caregiver for a brief period and gradually extend the time. This can help them build confidence in being apart. Remember not to sneak out, but to explicitly state when you will be away and when you will be reunited.
Encourage Friendship Building: Arrange playdates with potential classmates or neighbors. Familiar faces on the first day can make a big difference in how comfortable your child feels.
Teach Relaxation Techniques: Simple techniques like taking deep breaths or holding a soft toy can help soothe anxious feelings. Practice these techniques together so they can use them when needed.
Back-to-school feelings of anxiety in young children is a natural part of growing up. By implementing these tips, you can help your child transition with ease and excitement.
Your support and understanding play a crucial role in making this new experience a positive one. With your guidance, your child can step into the classroom with confidence and enthusiasm.
On Friday, August 4, 2023, the U.S. Food and Drug Administration (FDA) approved Zurzuvae™ (zuranolone), developed by pharmaceutical firms Biogen and Sage Therapeutics, to treat postpartum depression. The treatment is a pill taken once daily for 14 days, and is the first oral treatment approved for this condition.
“We’re happy there’s attention for a disease that has not gotten much attention thus far,” says Veerle Bergink, MD, PhD, Director of the Women’s Mental Health Program, and Professor of Psychiatry, and Obstetrics, Gynecology and Reproductive Science at the Icahn School of Medicine at Mount Sinai. Zurzavae had received Fast Track and Priority Review designations from the FDA, deemed as having potential to address a serious unmet need.
Veerle Bergink, MD, PhD (left) and Kimberly Mangla, MD (right)
Postpartum depression occurs often enough in mothers, yet the public’s understanding of it remains limited, says Kimberly Mangla, MD, Clinical Director of the Women’s Mental Health Program at Icahn Mount Sinai. “I’m glad we have an additional, possibly effective treatment for patients, and hopefully it will raise conversations and awareness of postpartum depression resources and treatment options,” she adds.
Drs. Bergink and Mangla explain what postpartum depression is, and how Zurzuvae could potentially treat it.
What is postpartum depression?
Postpartum depression can appear similar to other forms of clinical depression, with symptoms that include general low mood, lack of enjoyment, low energy, and low motivation, says Dr. Mangla. But there are unique aspects, such as difficulty bonding with the baby.
Postpartum depression is also different from what is commonly called “baby blues,” which is a common phenomenon of feeling overwhelmed, tearful, or being “hormonal,” notes Dr. Mangla. Baby blues tend to go away after two weeks. “What would be alarming might be feelings of hopelessness, suicidality, or a complete disconnect from the baby that aren’t necessarily a component of baby blues—those are reasons to seek support for what might be postpartum depression,” Dr. Mangla says.
While regulatory or insurance entities might define postpartum depression as occurring within four weeks after delivery, experts in the field—clinicians and researchers—agree that onset can be highly variable, even up to 12 months after delivery, says Dr. Bergink.
“From a psychological or physiological point of view, we know that it could take half a year for a woman’s hormones and immune system to go back to normal,” says Dr. Bergink. “And we have heard women say it could take up to a year before they feel like the person they were before delivery, and psychologically used to the new state of being a mother.”
What is Zurzavae, and how does it work?
Many current antidepressants work by targeting the serotonin system, but this drug works by targeting the gamma-aminobutyric acid receptor GABAA. While there are other drugs in this class of antidepressants, this is the first one approved for postpartum depression, says Dr. Bergink.
How common is postpartum depression?
One in Eight
or about 13 percent of women, have symptoms of depression after birth of baby.
>15 percent
of women in NYC experience depression symptoms after childbirth.
One in Five
women were not asked about depression during a prenatal visit.
>50 percent
of pregnant women with depression were not treated.
Source: Centers for Disease Control and Prevention
However, it is important to note that while this differs from serotonergic antidepressants, there have been no comparative studies done to demonstrate that Zurzavae is any better or worse than other antidepressant treatments out there, she points out. It is also unknown to what extent there is an antidepressant effect beyond the sedative effect, she adds.
What treatment options had been available for postpartum depression?
If the depression is not so severe, options include support therapy, such as cognitive behavioral therapy or psychotherapy, says Dr. Bergink. If it is more severe, then the doctor might consider using antidepressants, such as selective serotonin reuptake inhibitors (SSRIs).
How might Zurzavae differ from other antidepressants?
The way the drug has been marketed is that it works more rapidly than SSRIs, says Dr. Mangla. “Whether or not that’s true, and whether or not that benefit is sustained, we still have no idea,” she says, “but it would be wonderful to have a medication that starts working in three days instead of a few weeks.”
There are still some open questions clinicians might have with Zurzuvae at this point, notes Dr. Bergink. These include its effect on women who are breastfeeding, and whether the drug will keep depression away long beyond the study period, which was 45 days, she says.
What sources of support can mothers experiencing depression seek?
Generally, a mom experiencing depression symptoms should talk to anyone who is in her support system, says Dr. Mangla. This could include friends and family, but also a primary care doctor who might be able to make a referral to a general psychiatrist.
“Because the treatment of depression in postpartum is so similar to treatment of depression outside of postpartum, the disease is often well treated by general practitioners or general psychiatrists,” says Dr. Mangla.
Seeking help from social workers can be useful too. There are many ways mothers can access social workers, including through a local health institution, or even via online resources, such as Postpartum Support International, notes Dr. Mangla.
“Postpartum depression is a very treatable condition,” says Dr. Bergink. “We should do all we can to help mothers feel comfortable about reaching out for support.”
Zurzuvae was approved based on data from two randomized, placebo-controlled trials in postpartum depression.
Here are the efficacy and safety highlights:
Both studies achieved their primary endpoint: a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAMD-17) total score, a 17-item questionnaire on depression symptoms compared to placebo.
In one study, Zurzuvae achieved a significant reduction in depressive symptoms as early as day three.
Most common side effects of patients on Zurzuvae included drowsiness, dizziness, diarrhea, fatigue, and urinary tract infection.
The FDA has included a warning on Zurzuvae’s label that instructs health care providers to advise patients that the drug causes driving impairment due to sedative effects, and patients should not engage in activities that require mental alertness until at least 12 hours after the 14-day treatment.
Avi Ma’ayan, PhD, Director of the Mount Sinai Center for Bioinformatics at the Icahn School of Medicine at Mount Sinai
Birth defects can be linked to many factors—genetic, environmental, even pure chance. Characterizing the links of any factor to congenital abnormalities is a daunting task, given the vastness of the problem.
In the face of this challenge, a team of researchers at the Icahn School of Medicine at Mount Sinai tapped artificial intelligence (AI) methods to shed light on associations between existing medications and their potential to induce specific birth abnormalities.
“We wanted to improve our understanding of reproductive health and fetal development, and importantly, warn about the potential of new drugs to cause birth defects before these drugs are widely marketed and distributed,” says Avi Ma’ayan, PhD, Professor of Pharmacological Sciences and Director of the Mount Sinai Center for Bioinformatics at Icahn Mount Sinai.
The team developed a knowledge graph—a descriptive model that maps out the relationships between entities and concepts—called ReproTox-KG to integrate data about small-molecule drugs, birth defects, and genes. In addition to constructing the knowledge graph, the team also used machine learning, specifically semi-supervised learning, to illuminate unexplored links between some drugs and birth defects.
Here’s how ReproTox-KG works as a knowledge graph to predict birth defects.
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The study examined more than 30,000 preclinical small-molecule drugs for their potential to cross the placenta and induce birth defects, and identified more than 500 “cliques”—interlinked clusters between birth defects, genes, and drugs—that can be used to explain molecular mechanisms for drug-induced birth defects. Findings were published in Communications Medicine on July 17, and the platform has been made available on a web-based user interface.
In this Q&A, Dr. Ma’ayan, senior author of the paper, discusses ReproTox-KG and its potential impacts.
What was the motivation for your study?
The motivation for the study was to find a use case that combines several datasets produced by National Institutes of Health (NIH) Common Fund programs to demonstrate how integrating data from these resources can lead to synergistic discoveries, particularly in the context of reproductive health.
The study identifies some relationships between approved drugs and birth defects to identify existing drugs that are currently not classified as harmful but which may pose risks to the development of a fetus. It also provides a new global framework to assess potential toxicity for new drugs and explain the biological mechanisms by which some drugs known to cause birth defects may operate.
What are the implications?
Identifying the causes of birth defects is complicated and difficult. But we hope that through complex data analysis integrating evidence from multiple sources, we can improve our understanding of reproductive health and fetal development, and also warn about the potential of new drugs to cause birth defects before these drugs are widely marketed and distributed.
What are the limitations of the study?
We have not yet experimentally validated any of the predictions. There are currently no considerations of tissue and cell type, and the knowledge graph representation omits some detail from the original datasets for the sake of standardization. The website that supports the study may not be appealing to a large audience.
How might these findings be put to use?
Regulatory agencies such as the U.S. Environmental Protection Agency or the Food and Drug Administration may use the approach to evaluate the risk of new drug or other chemical applications. Manufacturers of drugs, cosmetics, supplements, and foods may consider the approach to evaluate the compounds they include in products.
What is your plan for following up on this study?
We plan to use a similar graph-based approach for other projects focusing on the relationship between genes, drugs, and diseases. We also aim to use the processed dataset as training materials for courses and workshops on bioinformatics analysis. Additionally, we plan to extend the study to consider more complex data, such as gene expression from specific tissues and cell types collected at multiple stages of development.
Learn more about how Mount Sinai researchers and clinicians are leveraging machine learning to improve patient lives
AI Spotlight: Guiding Heart Disease Diagnosis Through Transformer Models
AI Spotlight: Forecasting ICU Patient States for Improved Outcomes
Summer is a time for kids to have fun, enjoy vacations, and especially their favorite outdoor activities. It’s also a time for parents to take notice, as many outdoor injuries and health hazards are preventable.
Chris Strother, MD, and Lauren Zinns, MD, emergency medicine specialists at The Mount Sinai Hospital and associate professors in emergency medicine and pediatrics at the Icahn School of Medicine at Mount Sinai, share five key takeaways to help parents, caregivers, and families recognize and avoid common injuries and health hazards.
Young children are at a high risk of choking
Common things they choke on are hot dogs, grapes, and small round toys. Ensure that food is cut into small pieces and that young children are supervised when they are eating.
If your child is unable to cough or breathe while choking, call 911 first, then try these maneuvers:
For children younger than one year old: Place the infant face down on your arm resting on your thigh. With the palm of your other hand, give the baby five short, yet forceful, blows between the shoulder blades. If that is unsuccessful, place the infant on the back, put two of your fingers in the center of the chest below the nipples and press five times. Continue five back blows and five chest thrusts until the foreign body is removed. Never place your finger inside the infant’s mouth as that could push the foreign body in further.
For children older than one year of age: Stand behind the child with your arms around the child’s waist. Make a fist and place it below the chest just above the navel. Grab the fist with your other hand and push upward repeatedly until the food particle or toy is removed.
Click here for more information about how to help someone who is choking and for helpful illustrations.
Bug bites and insect stings can cause mild to severe allergic reactions in kids
Experts recommend bug spray on all exposed areas of skin, especially in the evenings when flying bugs are out the most, or in wooded areas where ticks are more likely to be found.
If your child has a tick, try to remove it as soon as possible.
Call your pediatrician if you notice a target-like lesion, as this could represent early signs of Lyme disease.
Mosquito bites will often cause a local allergic reaction at the site, this is usually not dangerous. If the area becomes very large, is very painful, or if your child develops a fever, the site might be infected. Call your pediatrician or go to the Pediatric Emergency Department.
Practice safety in the water
The American Academy of Pediatrics (AAP) reports that drowning is the single leading cause of death among children ages 1 to 4. Adult supervision is critical at all times.
Always swim with others.
Learn to swim at a young age and practice.
Wear a life jacket.
Be aware of weather conditions.
Make sure there is a lifeguard. If you aren’t watching the water, make sure someone else is watching for you, particularly with young children.
Wear a helmet when riding a bike or scooting. Accidents can happen fast.
Keep your bike “tuned up.” Make sure brakes work well and tires are inflated and in good condition.
Always obey traffic laws; ride with traffic if riding in the street.
Wear bright colors when in the street so cars can see you.
Heat awareness: Make sure to hydrate
Hydrate before and after you are in the heat. People don’t often think to drink before they go out, but it makes a huge difference to prevent dehydration.
Look for shade if possible, and take frequent breaks from activity to rest.
Sunblock is essential. Ensure that children are covered with sunscreen 30 SPF or greater to prevent burns, pain, and skin cancer later in life. Reapply frequently after swimming.
If you are noticing that people you know are getting COVID-19, you are probably not alone. In fact, the number of cases in the New York area has risen recently. But this type of periodic fluctuation has been expected and is generally not a reason for concern, experts say.
“There is no reason to dramatically change our behavior when it comes to basic safety precautions and protecting vulnerable people,” says Bernard Camins, MD, MSc, Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai and the Medical Director for Infection Prevention for the Mount Sinai Health System.
Among the possible reasons for an uptick in hospitalizations could be the recent extreme hot weather that pushed people to stay indoors, or that people are gathering more because of summer travel.
The New York City Department of Health and Mental Hygiene reports hospitalizations in New York surged in July, but the number is still a small fraction of what it was in January of 2022 during the last big surge. There have been virtually no deaths for several months.
You may have heard about a new variant of COVID-19, known as Eris. Mutations or changes in the virus are normal and expected, and experts track them closely. In this case, there does not seem to be anything significantly different about this new subvariant. It causes the same symptoms, and people do not get sicker when infected by it.
Most important, Dr. Camins’ recommendations remain unchanged:
Those at risk of complications from COVID-19 may want to wear a protective mask (N95 or KN95) in crowded areas.
Always wash your hands when you get home or arrive at work.
Individuals at high-risk should talk with their health care provider and have a plan for how to get antiviral medications if they become infected, as these prescription medications must be taken within the first five days of symptom onset. Those at high-risk include older adults, those with chronic medical conditions, such as diabetes, and those with reduced ability to fight infections, such as those being treated for some cancers.
If you feel stick, stay at home.
Bernard Camins, MD, MSc
Here are four key takeaways from Dr. Camins and heath care experts about how we are all living with COVID-19 now.
It’s endemic
COVID-19 is now considered endemic in our society, which means it is a constant presence, and we should expect it to come and go, such as the common cold or the seasonal flu. The U.S. Centers for Disease Control and Prevention (CDC) officially declared the end of the pandemic in May, 2023. A pandemic refers to a disease that spreads rapidly and beyond control around the world.
Be sure to check the right number
Since the official end of the pandemic, health authorities are no longer reporting the daily cases of COVID-19. One reason is those figures are no longer an accurate measure because so many people are testing at home if they suspect they may be infected. Hospitalizations are still being reported. Ongoing measurements of the level of SARS-CoV-2 virus in wastewater may be a better measure of how widespread the virus is in the population, and that has shown a slight uptick in recent weeks, according to Dr. Camins.
New vaccines are on the way
The U.S. Food and Drug Administration (FDA) is working with vaccine manufacturers to prepare a new COVID-19 vaccine booster for the fall that will target the latest variants. Any new vaccine must be approved for use by the FDA and then recommended by the CDC and state health authorities before you can get it.
Don’t forget your flu shot
Now is the time to begin thinking about getting your flu shot. September and October are the best times to get the flu shot, according to the CDC. In addition, you may want to talk with your provider about the a vaccine against Respiratory Syncytial Virus (RSV), a common respiratory virus that usually causes mild, cold-like symptoms but can be serous for infants and older adults. The CDC is recommending the vaccine for older adults, adults with chronic heart or lung disease, with weakened immune systems, or those living in nursing homes or long-term care facilities. A CDC advisory committee has recommended the vaccine for infants under eight months.
If you are noticing that people you know are getting COVID-19, you are probably not alone. In fact, the number of cases in the New York area has risen recently. But this type of periodic fluctuation has been expected and is generally not a reason for concern, experts say.