The U.S. Food and Drug Administration amended the terms of its emergency use authorizations for the Pfizer and Moderna bivalent vaccines on Tuesday, allowing people ages 65 and older and certain people with weakened immunity to get additional doses before this fall’s vaccination campaigns.
The bivalent vaccines made by Pfizer and Moderna carry instructions for fighting both the original strain of the Covid-19 virus as well as Omicron and its spinoffs.
They have been available in the United States since September under emergency use authorizations, or EUAs, which tightly restrict how the vaccines may be given.
On Tuesday, the FDA changed the terms of the authorizations for those vaccines so that certain individuals could get an additional dose ahead of most others.
Namely, adults ages 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months following their first dose.
Most individuals with certain degrees of immunocompromise who have received a first dose of a bivalent vaccine can get a second at least 2 months later. Additional doses may be administered at the discretion of their healthcare provider.
Dr. Peter Hotez, who co-directs the Center for Vaccine Development at Texas Children’s Hospital, has been calling on the FDA to increase access to the bivalent boosters for those who want them. He says for the most part, today’s guidance from the agency makes sense.
“My only question is why the 65 year age cutoff? What was that based on? Ordinarily I would have preferred that it be brought down to 60 or even 50,” Hotez said in an email to CNN.
“For those Americans who understand its importance, we should make second bivalent boosters available. Finally, we’ll soon need guidance about another annual fall booster. Presumably that information comes sometime this summer,” he added.
For immunocompromised children ages 6 months through 4 years, eligibility for additional bivalent doses will depend on the vaccine previously received, the FDA said in a news release.
Another big change is that most unvaccinated individuals may now receive a single dose of a bivalent vaccine, rather than mutiple doses of the original single-strain vaccines, the agency said. The FDA simplified its recommendation for unvaccinated individuals after recognizing that most Americans now have some immunity against Covid-19, even if its just through past infections.
“Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death,” said Dr. Peter Marks, head of FDA’s Center for Biologics Evaluation and Research, in a news release.
Children ages 6 months through 5 years who have not yet been vaccinated may now receive a two-dose series of the Moderna bivalent vaccine as their primary series, or a three-dose series of the Pfizer-BioNTech bivalent vaccine if they are 6 months through 4 years of age. Children who are age 5 may receive two doses of the Moderna bivalent or a single dose of the Pfizer-BioNTech bivalent vaccine.
Children ages 6 months through 5 years who got started on their monovalent vaccines, can now get a dose of a bivalent vaccine, but the number of doses they qualify for will depend on the number of doses they’ve already had and what kind of vaccine they got.
The agency stressed that most people who have gotten one dose of a bivalent vaccine are not currently eligible for a second dose.
And they encouraged everyone who hasn’t yet gotten their first dose of a bivalent vaccine to do so, and many Americans are still in that bucket.
Only about 17% of those eligible, less than 1 in 5 Americans, has gotten a recommended dose.
As time has passed, adults with reduced immune function because of their age or an underlying health problem have been asking doctors whether they need another dose of the bivalent vaccines.
The United States Center for Disease Control and Prevention has reported early data showing that the effectiveness of the bivalent vaccines, even against emergency room visits and hospitalizations, has already started to wane.
But the agency has not been free to make what’s known as a “permissive use” recommendation about the boosters, which would allow doctors to offer additional doses to vulnerable patients because of the terms of the EUA.
The updated terms give the CDC and its Advisory Committee on Immunization Practices (ACIP) greater freedom to recommend additional doses of the bivalent vaccines. The ACIP is holding a meeting on the Covid-19 vaccines Wednesday and is expected to endorse the FDA’s changes.
For everyone not covered by today’s changes, the FDA says it intends to make decisions about future vaccinations after receiving recommendations on the fall strain composition from its advisory committee in June.
Both Canada and the United Kingdom have offered another round of bivalent boosters to those at highest risk from Covid-19 this spring.
Effie Schnacky was wheezy and lethargic instead of being her normal, rambunctious self one February afternoon. When her parents checked her blood oxygen level, it was hovering around 80% – dangerously low for the 7-year-old.
Her mother, Jaimie, rushed Effie, who has asthma, to a local emergency room in Hudson, Wisconsin. She was quickly diagnosed with pneumonia. After a couple of hours on oxygen, steroids and nebulizer treatments with little improvement, a physician told Schnacky that her daughter needed to be transferred to a children’s hospital to receive a higher level of care.
The physical and mental burnout that occurred during the height of the Covid-19 pandemic has not gone away for overworked health care workers. Shortages of doctors and technicians are growing, experts say, but especially in skilled nursing. That, plus a shortage of people to train new nurses and the rising costs of hiring are leaving hospitals with unstaffed pediatric beds.
But a host of reasons building since well before the pandemic are also contributing. Children may be the future, but we aren’t investing in their health care in that way. With Medicaid reimbursing doctors at a lower rate for children, hospitals in tough situations sometimes put adults in those pediatric beds for financial reasons. And since 2019, children with mental health crises are increasingly staying in emergency departments for sometimes weeks to months, filling beds that children with other illnesses may need.
“There might or might not be a bed open right when you need one. I so naively just thought there was plenty,” Schnacky told CNN.
The number of pediatric beds decreasing has been an issue for at least a decade, said Dr. Daniel Rauch, chair of the Committee on Hospital Care for the American Academy of Pediatrics.
By 2018, almost a quarter of children in America had to travel farther for pediatric beds as compared to 2009, according to a 2021 paper in the journal Pediatrics by lead author Dr. Anna Cushing, co-authored by Rauch.
“This was predictable,” said Rauch, who has studied the issue for more than 10 years. “This isn’t shocking to people who’ve been looking at the data of the loss in bed capacity.”
The number of children needing care was shrinking before the Covid-19 pandemic – a credit to improvements in pediatric care. There were about 200,000 fewer pediatric discharges in 2019 than there were in 2017, according to data from the US Department of Health and Human Services.
“In pediatrics, we have been improving the ability we have to take care of kids with chronic conditions, like sickle cell and cystic fibrosis, and we’ve also been preventing previously very common problems like pneumonia and meningitis with vaccination programs,” said Dr. Matthew Davis, the pediatrics department chair at Ann & Robert H. Lurie Children’s Hospital of Chicago.
Pediatrics is also seasonal, with a typical drop in patients in the summer and a sharp uptick in the winter during respiratory virus season. When the pandemic hit, schools and day cares closed, which slowed the transmission of Covid and other infectious diseases in children, Davis said. Less demand meant there was less need for beds. Hospitals overwhelmed with Covid cases in adults switched pediatric beds to beds for grownups.
Only 37% of hospitals in the US nowoffer pediatric services, down from 42% about a decade ago, according to the American Hospital Association.
While pediatric hospital beds exist at local facilities, the only pediatric emergency department in Baltimore County is Greater Baltimore Medical Center in Towson, Maryland, according to Dr. Theresa Nguyen, the center’s chair of pediatrics. All the others in the county, which has almost 850,000 residents, closed in recent years, she said.
The nearby MedStar Franklin Square Medical Center consolidated its pediatric ER with the main ER in 2018, citing a 40% drop in pediatric ER visits in five years, MedStar Health told CNN affiliate WBAL.
In the six months leading up to Franklin Square’s pediatric ER closing, GBMC admitted an average of 889 pediatric emergency department patients each month. By the next year, that monthly average jumped by 21 additional patients.
“Now we’re seeing the majority of any pediatric ED patients that would normally go to one of the surrounding community hospitals,” Nguyen said.
In other cases, it’s the hospitals that have only 10 or so pediatric beds that started asking the tough questions, Davis said.
“Those hospitals have said, ‘You know what? We have an average of one patient a day or two patients a day. This doesn’t make sense anymore. We can’t sustain that nursing staff with specialized pediatric training for that. We’re going to close it down,’” Davis said.
Saint Alphonsus Regional Medical Center in Boise closed its pediatric inpatient unit in July because of financial reasons, the center told CNN affiliate KBOI. That closure means patients are now overwhelming nearby St. Luke’s Children’s Hospital, which is the only children’s hospital in the state of Idaho, administrator for St. Luke’s Children’s Katie Schimmelpfennig told CNN. Idaho ranks last for the number of pediatricians per 100,000 children, according to the American Board of Pediatrics in 2023.
The Saint Alphonsus closure came just months before the fall, when RSV, influenza and a cadre of respiratory viruses caused a surge of pediatric patients needing hospital care, with the season starting earlier than normal.
The changing tide of demand engulfed the already dwindling supply of pediatric beds, leaving fewer beds available for children coming in for all the common reasons, like asthma, pneumonia and other ailments. Additional challenges have made it particularly tough to recover.
Another factor chipping away at bed capacity over time: Caring for children pays less than caring for adults. Lower insurance reimbursement rates mean some hospitals can’t afford to keep these beds – especially when care for adults is in demand.
Medicaid, which provides health care coverage to people with limited income, is a big part of the story, according to Joshua Gottlieb, an associate professor at the University of Chicago Harris School of Public Policy.
“Medicaid is an extremely important payer for pediatrics, and it is the least generous payer,” he said. “Medicaid is responsible for insuring a large share of pediatric patients. And then on top of its low payment rates, it is often very cumbersome to deal with.”
Medicaid reimburses children’s hospitals an average of 80% of the cost of the care, including supplemental payments, according to the Children’s Hospital Association, a national organization which represents 220 children’s hospitals. The rate is far below what private insurers reimburse.
More than 41 million children are enrolled in Medicaid and the Children’s Health Insurance Program, according to Kaiser Family Foundation data from October. That’s more than half the children in the US, according to Census data.
At Children’s National Hospital in Washington, DC, about 55% of patients use Medicaid, according to Dr. David Wessel, the hospital’s executive vice president.
“Children’s National is higher Medicaid than most other children’s hospitals, but that’s because there’s no safety net hospital other than Children’s National in this town,” said Wessel, who is also the chief medical officer and physician-in-chief.
And it just costs more to care for a child than an adult, Wessel said. Specialty equipment sized for smaller people is often necessary. And a routine test or exam for an adult is approached differently for a child. An adult can lie still for a CT scan or an MRI, but a child may need to be sedated for the same thing. A child life specialist is often there to explain what’s going on and calm the child.
“There’s a whole cadre of services that come into play, most of which are not reimbursed,” he said. “There’s no child life expert that ever sent a bill for seeing a patient.”
“When insurance pays more, people build more health care facilities, hire more workers and treat more patients,” Gottlieb said.
“Everyone might be squeezed, but it’s not surprising that pediatric hospitals, which face [a]lower, more difficult payment environment in general, are going to find it especially hard.”
Dr. Benson Hsu is a pediatric critical care provider who has served rural South Dakota for more than 10 years. Rural communities face distinct challenges in health care, something he has seen firsthand.
A lot of rural communities don’t have pediatricians, according to the American Board of Pediatrics. It’s family practice doctors who treat children in their own communities, with the goal of keeping them out of the hospital, Hsu said. Getting hospital care often means traveling outside the community.
Hsu’s patients come from parts of Nebraska, Iowa and Minnesota, as well as across South Dakota, he said. It’s a predominantly rural patient base, which also covers those on Native American reservations.
“These kids are traveling 100, 200 miles within their own state to see a subspecialist,” Hsu said, referring to patients coming to hospitals in Sioux Falls. “If we are transferring them out, which we do, they’re looking at travels of 200 to 400 miles to hit Omaha, Minneapolis, Denver.”
Inpatient pediatric beds in rural areas decreased by 26% between 2008 and 2018, while the number of rural pediatric units decreased by 24% during the same time, according to the 2021 paper in Pediatrics.
“It’s bad, and it’s getting worse. Those safety net hospitals are the ones that are most at risk for closure,” Rauch said.
In major cities, the idea is that a critically ill child would get the care they need within an hour, something clinicians call the golden hour, said Hsu, who is the critical care section chair at the American Academy of Pediatrics.
“That golden hour doesn’t exist in the rural population,” he said. “It’s the golden five hours because I have to dispatch a plane to land, to drive, to pick up, stabilize, to drive back, to fly back.”
When his patients come from far away, it uproots the whole family, he said. He described families who camp out at a child’s bedside for weeks at a time. Sometimes they are hundreds of miles from home, unlike when a patient is in their own community and parents can take turns at the hospital.
“I have farmers who miss harvest season and that as you can imagine is devastating,” Hsu said. “These aren’t office workers who are taking their computer with them. … These are individuals who have to live and work in their communities.”
Back at GBMC in Maryland, an adolescent patient with depression, suicidal ideation and an eating disorder was in the pediatric emergency department for 79 days, according to Nguyen. For months, no facility had a pediatric psychiatric bed or said it could take someone who needed that level of care, as the patient had a feeding tube.
“My team of physicians, social workers and nurses spend a significant amount of time every day trying to reach out across the state of Maryland, as well as across the country now to find placements for this adolescent,” Nguyen said before the patient was transferred in mid-March. “I need help.”
Nguyen’s patient is just one of the many examples of children and teens with mental health issues who are stayingin emergency rooms and sometimes inpatient beds across the country because they need help, but there isn’t immediately a psychiatric bed or a facility that can care for them.
It’s a problem that began before 2020 and grew worse during the pandemic, when the rate of children coming to emergency rooms with mental health issues soared, studies show.
Now, a nationwide shortage of beds exists for children who need mental health help. A 2020 federal survey revealed that the number of residential treatment facilities for children fell 30% from 2012.
“There are children on average waiting for two weeks for placement, sometimes longer,” Nguyen said of the patients at GBMC. The pediatric emergency department there had an average of 42 behavioral health patients each month from July 2021 through December 2022, up 13.5% from the same period in 2017 to 2018, before the pandemic, according to hospital data.
When there are mental health patients staying in the emergency department, that can back up the beds in other parts of the hospital, creating a downstream effect, Hsu said.
“For example, if a child can’t be transferred from a general pediatric bed to a specialized mental health center, this prevents a pediatric ICU patient from transferring to the general bed, which prevents an [emergency department] from admitting a child to the ICU. Health care is often interconnected in this fashion,” Hsu said.
“If we don’t address the surging pediatric mental health crisis, it will directly impact how we can care for other pediatric illnesses in the community.”
Funding for children’s hospitals is already tight, Rauch said, and more money is needed not only to make up for low insurance reimbursement rates but to competitively hire and train new staff and to keep hospitals running.
“People are going to have to decide it’s worth investing in kids,” Rauch said. “We’re going to have to pay so that hospitals don’t lose money on it and we’re going to have to pay to have staff.”
Virtual visits, used in the right situations, could ease some of the problems straining the pediatric system, Rauch said. Extending the reach of providers would prevent transferring a child outside of their community when there isn’t the provider with the right expertise locally.
Increased access to children’s mental health services
With the ongoing mental health crisis, there’s more work to be done upstream, said Amy Wimpey Knight, the president of CHA.
“How do we work with our school partners in the community to make sure that we’re not creating this crisis and that we’re heading it off up there?” she said.
There’s also a greater need for services within children’s hospitals, which are seeing an increase in children being admitted with behavioral health needs.
“If you take a look at the reasons why kids are hospitalized, meaning infections, diabetes, seizures and mental health concerns, over the last decade or so, only one of those categories has been increasing – and that is mental health,” Davis said. “At the same time, we haven’t seen an increase in the number of mental health hospital resources dedicated to children and adolescents in a way that meets the increasing need.”
Most experts CNN spoke to agreed: Seek care for your child early.
“Whoever is in your community is doing everything possible to get the care that your child needs,” Hsu said. “Reach out to us. We will figure out a way around the constraints around the system. Our number one concern is taking care of your kids, and we will do everything possible.”
Nguyen from GBMC and Schimmelpfennig from St. Luke’s agreed with contacting your primary care doctor and trying to keep your child out of the emergency room.
“Anything they can do to stay out of the hospital or the emergency room is both financially better for them and better for their family,” Schimmelpfennig said.
Knowing which emergency room or urgent care center is staffed by pediatricians is also imperative, Rauch said. Most children visit a non-pediatric ER due to availability.
“A parent with a child should know where they’re going to take their kid in an emergency. That’s not something you decide when your child has the emergency,” he said.
After Effie’s first ambulance ride and hospitalization last month, the Schnacky family received an asthma action plan from the pulmonologist in the ER.
It breaks down the symptoms into green, yellow and red zones with ways Effie can describe how she’s feeling and the next steps for adults. The family added more supplies to their toolkit, like a daily steroid inhaler and a rescue inhaler.
“We have everything an ER can give her, besides for an oxygen tank, at home,” Schnacky said. “The hope is that we are preventing even needing medical care.”
If you drive down a busy suburban strip mall or walk down a street in a major city, chances are you won’t go long without spotting a Concentra, MedExpress, CityMD or another urgent care center.
Demand at urgent care sites surged during the Covid-19 pandemic as people searched for tests and treatments. Patient volume has jumped 60% since 2019, according to the Urgent Care Association, an industry trade group.
That has fueled growth for new urgent care centers. A record 11,150 urgent care centers have popped up around the United States and they are growing at 7% a year, the trade group says. (This does not include clinics inside retail stores like CVS’ MinuteClinic or freestanding emergency departments.)
Urgent care centers are designed to treat non-emergency conditions like a common cold, a sprained ankle, an ear infection, or a rash. They are recommended if patients can’t get an immediate appointment with their primary care doctor or if patients don’t have one. Primary care practices should always be the first call in these situations because they have access to patients’ records and all of their health care history, while urgent care sites are meant to provide episodic care.
Urgent care sites are often staffed by physician assistants and nurse practitioners. Many also have doctors on site. (One urgent care industry magazine says, in 2009, 70% of its providers were physicians, but that the percentage had fallen to 16% by last year.) Urgent cares usually offer medical treatment outside of regular doctor’s office hours and a visit costs much less than a trip to the emergency room.
Urgent care has grown rapidly because of convenience, gaps in primary care, high costs of emergency room visits, and increased investment by health systems and private-equity groups. The urgent care market will reach around $48 billion in revenue this year, a 21% increase from 2019, estimates IBISWorld.
The growth highlights the crisis in the US primary care system. A shortage of up to 55,000 primary care physicians is expected in the next decade, according to the Association of American Medical Colleges.
But many doctors, health care advocates and researchers raise concerns at the proliferation of urgent care sites and say there can be downsides.
Frequent visits to urgent care sites may weaken established relationships with primary care doctors. They can also lead to more fragmented care and increase overall health care spending, research shows.
And there are questions about the quality of care at urgent care centers and whether they adequately serve low-income communities. A 2018 study by Pew Charitable Trusts and the Centers for Disease Control and Prevention found that antibiotics are overprescribed at urgent care centers, especially for common colds, the flu and bronchitis.
“It’s a reasonable solution for people with minor conditions that can’t wait for primary care providers,” said Vivian Ho, a health economist at Rice University. “When you need constant management of a chronic illness, you should not go there.”
Urgent care centers have been around in the United States since the 1970s, but they were long derided as “docs in a box” and grew slowly during their early years.
They have become more popular over the past two decades in part due to pressures on the primary care system. People’s expectations of wait times have changed and it can be difficult, and sometimes almost impossible, to book an immediate visit with a primary care provider.
Urgent care sites are typically open for longer hours during the weekday and on weekends, making it easier to get an appointment or a walk-in visit. Around 80% of the US population is within a 10-minute drive of an urgent care center, according to the industry trade group.
“There’s a need to keep up with society’s demand for quick turnaround, on-demand services that can’t be supported by underfunded primary care,” said Susan Kressly, a retired pediatrician and fellow at the American Academy of Pediatrics.
Health insurers and hospitals have also become more focused on keeping people out of the emergency room. Emergency room visits are around ten times more expensive than visits to an urgent care center. During the early 2000s, hospital systems and health insurers started opening their own urgent care sites, and they have introduced strategies to deter emergency room visits.
Additionally, passage of the Affordable Care Act in 2010 spurred an increase in urgent care providers as millions of newly insured Americans sought out health care. Private-equity and venture capital funds also poured billions into deals for urgent care centers, according to data from PitchBook.
Urgent care centers can be attractive to investors. Unlike ERs, which are legally obligated to treat everyone, urgent care sites can essentially choose their patients and the conditions they treat. Many urgent care centers don’t accept Medicaid and can turn away uninsured patient,s unless they pay a fee.
Like other health care options, urgent care centers make money by billing insurance companies for the cost of the visit, additional services, or the patient pays out of pocket. In 2016, the median charge for a 30-minute new insured patient visit was $242 at an urgent care center, compared with $294 in a primary care office and $109 in a retail clinic, according to a study by FAIR Health, a nonprofit that collects health insurance data.
“If they can make it a more convenient option, there’s a lot of revenue here,” said Ateev Mehrotra, a professor of health care policy and medicine at Harvard Medical School who has researched urgent care clinics. “It’s not where the big bucks are in health care, but there’s a substantial number of patients.”
Mehrotra research has found that between 2008 and 2015, urgent care visits increased 119%. They became the dominant venue for people seeking treatment for low-acuity conditions like acute respiratory infections, urinary tract infections, rashes, and muscle strains.
Some doctors and researchers worrythat patients with primary care doctors – and those without – are substituting urgent care visits in place of a primary care provider.
“What you don’t want to see is people seeking a lot care outside their pediatrician and decreasing their visits to their primary care provider,” said Rebecca Burns, the urgent care medical director at the Lurie Children’s Hospital of Chicago.
Burns’ research has found that high urgent care reliance fills a need for children with acute issues but has the potential to disrupt primary care relationships.
The National Health Law Program, a health care advocacy group for low-income families and communities, has called for state regulations to require coordination among urgent care sites, retail clinics, primary services, and hospitals to ensure continuity of patients’ care.
And while the presence of urgent care centers does prevent people from costly emergency department visits for low-acuity issues, Mehrotra from Harvardhas found that, paradoxically, they increase health care spending on net.
Each $1,646 visit to the ER for a low-acuity condition prevented was offset by a $6,327 increase in urgent care center costs, his research has found. This is in part because people may be going to urgent care for minor illnesses they would have previously treated with chicken soup.
There are also concerns about the oversaturation of urgent care centers in higher-income areas that have more consumers with private health care and limited access in medically underserved areas.
Urgent care centers selectively tend not to serve rural areas, areas with a high concentration of low-income patients, and areas with a low concentration of privately-insured patients, researchers at the University of California at San Francisco found in a 2016 study. They said this “uneven distribution may potentially exacerbate health disparities.”
A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.
The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.
The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.
Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.
This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.
Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.
People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.
The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.
Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.
Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.
“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”
Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.
Others feel that convenience is important but also stressed that data supported the switch.
“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.
Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.
“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.
Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.
The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.
The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.
“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.
“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.
In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.
For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?
The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.
Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.
“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”
The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.
One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.
Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.
Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.
Another puzzle will be how to pick the strains that are in the vaccines.
The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.
“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”
Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.
At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.
The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.
In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.
After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.
At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.
The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.
When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.
Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.
The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.
Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.
Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.
Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.
Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.
What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.
The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.
“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.
Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.
The FDA confirmed that the agency is taking a closer look.
“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.
The FDA did not give a time frame for when these studies might have results.
Editor’s Note: Dr. Eloise Chapman-Davis is director of gynecologic oncology at NewYork-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine. Dr. Denise Howard is chief of obstetrics and gynecology at NewYork-Presbyterian Brooklyn Methodist Hospital and a vice chair of obstetrics and gynecology at Weill Cornell Medicine. The views expressed in this commentary are their own. Read more opinion on CNN.
CNN
—
As doctors who specialize in women’s reproductive health, we are on the front lines of a preventable crisis. Imagine treating a woman with advanced cancer who has a five-year survival rate of 17%, knowing that she should have never developed the deadly disease in the first place.
This is what we are facing with cervical cancer. Yet we have the clinical tools not only to lower but also eliminate nearly all the roughly 14,000 new cases and 4,300 deaths from cervical cancer each year.
We have effective screenings: the traditional Pap smear and the HPV test. If these screening tests are abnormal, additional tests can determine who needs further treatment to prevent the development of cancer. Importantly, we have the HPV vaccine, which protects against high-risk human papillomavirus (HPV) types that cause the majority of cervical cancer cases and is nearly 100% effective, according to the National Cancer Institute.
A report published earlier this month shows the vaccine’s tremendous impact. The US saw a 65% drop in cervical cancer rates from 2012 through 2019 among women ages 20-24, the first to have received the vaccine. The vaccine, combined with screening, could wipe out cervical cancer and make it a disease of the past.
But the percentage of women overdue for their cervical cancer screening is growing, and, alarmingly, late-stage cases are on the rise.
We have had the heartbreaking experience of seeing mothers in the prime of life die from this avoidable disease, leaving small children behind — even women who had an abnormal screening but never received follow-up care. It’s devastating to see an otherwise healthy person slowly die from a preventable cancer.
Simply put, cervical cancer should never occur. This Cervical Cancer Awareness Month, we should commit to making that a reality. Here is what needs to happen.
Eliminating cervical cancer requires commitment at multiple levels, from public awareness campaigns with culturally appropriate messaging that broadcasts the power of the vaccine and screenings to prevent cancer to resources that ensure all women have easy access to routine health exams.
Timely screening reminders and systems to prioritize follow-up care are essential. Too many women with abnormal screenings don’t receive their results, reminders or follow-up instructions they understand and, therefore don’t receive the proper treatment. Barriers also include logistical challenges like transportation and language issues. Studies suggest that 13% to 40% of cervical cancer diagnoses result from lack of follow-up among women with an abnormal screening test.
Gynecology and primary care practices should be vigilant about reaching and monitoring patients with suspicious test findings. Large health systems can leverage the power of the electronic health record to track abnormal tests and ensure these women receive the proper follow-up.
Pediatricians should encourage parents of children 9 and older to get the HPV vaccine and stress its safety. About 60% of teenagers are up to date on their HPV vaccines, according to the US Centers for Disease Control and Prevention. Physicians not recommending the vaccine and parents’ rising concerns about its safety, despite more than 15 years of evidence that it is safe and effective, have been cited as top reasons why more children aren’t receiving this lifesaving vaccine.
College campuses should do large-scale, catch-up vaccination outreach. These students are at high risk for contracting HPV, yet only half report having received the full HPV vaccine series. This service should be provided at no cost to students.
Stark racial disparities also must be addressed. As Black women physicians, we are frustrated that Black women continue to be more likely to die from the disease than any other race, according to the American Cancer Society. The system failures contributing to this tragedy range from Black women receiving less aggressive treatment to barriers around access to affordable routine health care and the high-quality, specialized treatment needed to treat cancer. Everyone deserves access to quality care.
Older patients should be told that approval of the HPV vaccine has been extended up to age 45 and to discuss with their doctor whether it’s right for them. Insurance providers should cover the cost of the vaccine for these older ages.
Women should see a gynecologist on a regular basis well into their older years. We see patients with cervical cancer in their 60s and 70s who haven’t been screened in 20 years. Many people stop seeing a gynecologist after childbearing or menopause, but this shouldn’t be the case. Getting quality gynecological exams throughout a woman’s life is critical to preserving it.
We also need to empower women to be their own advocates through health education. Women should receive their screening result with an explanation of what it means and any next steps clearly delineated. No news after a screening is not good news. In an ideal world, women would see their HPV status as essential information with the power to save their lives.
Education makes a difference. At NewYork-Presbyterian and Weill Cornell Medicine, we produced a series of easy-to-understand, publicly available videos on cervical cancer and the HPV vaccine. We showed several of the vaccine videos to more than 100 parents in one of our pediatric practices that serves mostly low-income families as part of a pilot study. Their knowledge scores on a questionnaire about the vaccine and HPV that they completed before and after watching the videos increased nearly 80%, and roughly 40% of the unvaccinated children received the HPV vaccine within one month. We aim to expand this effort.
We have the tools to prevent cervical cancer but fail to use them effectively. It’s unacceptable, and we can no longer ignore the problem. It’s time for a full-scale offensive focused on all fronts to make cervical cancer a disease of the past.
Crucial union negotiations between Mount Sinai Hospital and the New York State Nurses Association appear to be at a standstill and both parties say the other is refusing to return to the bargaining table.
As the impasse continues between the hospital and union, the most vulnerable patients – newborns in Mount Sinai’s neonatal intensive care unit – are caught between the opposing sides, causing worry among families, one Mount Sinai nurse, who declined to provide her name out of fear of repercussions, told CNN.
With thousands of New York nurses poised to strike early Monday morning, one of Manhattan’s famed hospitals announced Friday it would transport newborns in its intensive care unit to other area hospitals in preparation for the strike.
A Mount Sinai Health System spokesperson confirmed to CNN Friday that neonatal intensive care unit infants would be transferred to other area hospitals because of the strike notice.
“We are seeking a resolution [to the strike.] The impact is great,” the spokesperson told CNN.
A NICU nurse at Mount Sinai Hospital told CNN that families of patients in the unit have been deeply concerned about moving their sick infants from one hospital to another. Moving the babies to a different facility can be “very stressful” for a NICU patient, the nurse said, as well as the parents.
“They’ve asked us all week what’s going to happen to their babies, and what’s going to happen next week,” the nurse said.
“It’s a big journey for a baby who’s never been outside the hospital,” she told CNN. “It’s not anything that we want to happen. We want our babies to stay. We want to be taking care of them. And it’s kind of shocking, and actually a little infuriating, that the hospital is letting it get to this point.”
The more critical the baby’s condition is, the more complicated and riskier a transfer to another hospital becomes, the nurse explained.
“You would need at least a doctor or nurse practitioner, a respiratory therapist if the patient is on respiratory support and a transport nurse to work the pumps and administer medicine if needed,” she said.
The nurses who care for the sick infants often grow close to the families and develop a trusting relationship with them, especially because some babies spend weeks or even months in the NICU, the nurse told CNN.
“They’re comfortable leaving their babies with us when they aren’t able to be there,” she said. “We keep in contact with the families after their babies have gone home – so we really do develop a close bond to these families.”
“We treat our babies in the hospital like they’re our own kids. We’re very protective of them,” she added.
New York State Nurses Association President Nancy Hagans has said the goal of the negotiations is to improve patient care and staffing, get fair wages and to recruit and retain nurses.
Negotiations between the health system and the nurse’s union have been ongoing since September, a Mount Sinai Health System spokesperson told CNN Saturday, but low staffing levels have afflicted the NICU unit for years, the nurse told CNN.
“For over three years now, we’ve been understaffed,” she said.
The number of patients in the unit surges and falls regularly, according to the nurse, but as patient levels rise, staffing levels stay the same. The unit can surge to 64 patients, she said.
“You feel like you’re not actually giving your all to your patients,” she said. “You’re really pulled very thin.”
Paying close attention to infant patients is especially important, according to the nurse, because unlike other patients – even small children – they can’t verbalize pain or discomfort.
“You really have to be on top of their vital signs and general assessment. And when you’re not able to spend as much time as you need to with them, some things do get missed,” she said. “And it’s very unfortunate.”
CNN has reached out to the hospital regarding the nurse’s comments on low staffing.
More than 8,700 nurses are prepared to strike Monday morning if tentative contract agreements are not reached at several hospitals, Hagans, the union president, said at a virtual news conference Saturday morning.
As of Saturday, negotiations across New York’s hospitals were continuing at Montefiore Bronx and the Mount Sinai Morningside and West campuses, according to the nurse’s union.
But the president of the nurse’s union told reporters Saturday the main Mount Sinai Hospital complex left the bargaining table late Thursday and no further bargaining sessions have been scheduled since.
A Mount Sinai Health System spokesperson told CNN that hospital management is “waiting for the union to come back to us” to resume negotiations.
The hospital said it put forth a deal at Thursday evening’s bargaining session was the same one the union agreed to for nurses at the NewYork-Presbyterian Hospital. Tentative agreements have also been reached with union nurses at Maimonides Medical Center in Brooklyn and Richmond University Medical Center in Staten Island.
Mount Sinai also said it has offered a 19.1% compounded pay raise over three years, which is the same offer other hospital systems in the city have made.
The NICU nurse at Mount Sinai said that nurses in her unit don’t want to strike and are hoping that they can come to an agreement with the hospital before Sunday night.
“It truly breaks our heart having to strike and leave our patients, but unfortunately you have to do some drastic things sometimes,” she told CNN.
President Joe Biden and first lady Jill Biden met with patients at Children’s National Hospital in Washington on Friday, carrying on a longstanding tradition during the holiday season.
The first couple, sporting cloth masks, met with pediatric patients, their families and hospital staff, greeting leadership and emergency department workers. Dr. Biden read Ezra Jack Keats’ “The Snowy Day” before the Bidens visited with children and their families in the cardiac intensive care unit.
“Thanks for coming and listening to me read and have the president hold the book,” she said after reading, as Biden deadpanned, “It’s my job.”
And the president chimed in with a message for parents in the room before departing, saying, “To all you parents, be strong. We spent a lot of time in children’s hospitals with patients too, It’s going to be OK.”
The Bidens’ travel within Washington comes as much of the nation – including the nation’s capital – faces extreme cold weather, such as frigid temperatures, high winds and heavy snow.
According to the White House, President Biden’s visit last year marked the first time a sitting president made a holiday visit to Children’s National.
Biden emphasized in his speech that “we’re surely making progress” and “things are getting better.”
“Covid no longer controls our lives. Our kids are back in school. People are back to work. In fact, more people are working than ever before,” he said. “Americans are building again, innovating, dreaming again.”
Still, he acknowledged that, for some, “Christmas can be a time of great pain and terrible loneliness,” drawing on his own experience with loss over the holidays – the deaths of his first wife and daughter 50 years ago this week.
“I know how hard this time of year can be … no one can ever know what someone else is going through, what’s really going on in their life, what they’re struggling with, what to try and overcome. That’s why sometimes the smallest act of kindness can mean so much,” Biden remarked.
“So, this Christmas, let’s spread a little kindness.”
CORRECTION: This story and headline have been updated to correct the name of the hospital to Children’s National Hospital.
Editor’s Note: Alice Paul Tapper, 15, is a high school sophomore in Washington, DC. She is the daughter of CNN’s Jake Tapper. The opinions expressed in this commentary are solely hers. View more opinions on CNN.
CNN
—
I almost died around Thanksgiving last year, and it was entirely preventable.
It started one weekend in November 2021 with stomach cramping, a low fever, chills and vomiting. Soon it became clear I needed to go to the emergency room. By the time I got there, I had low blood pressure, an elevated heart rate, intense abdominal pain and a high white blood cell count.
I was given IV fluids to combat my dehydration, but I didn’t get better. The doctor and nurses didn’t know what was wrong and stood around me confused, as if they were waiting for me to tell them what to do. The sharp cramping pains and the throbbing feeling in my stomach got worse, so they transferred me to another hospital.
With guidance from my pediatrician, my parents told the doctors to check for appendicitis. But since I was tender all over my abdomen — not just on my right side — the doctors ruled it out. My parents kept pressing, so a doctor told me to stand up and jump. I could barely get an inch off the ground. The doctors concluded that what I had must be a viral infection and would eventually just go away.
It didn’t. I got sicker and my skin started turning a pale green. As Monday turned into Tuesday, I was only given Tylenol for my pain. My mom asked the doctors why I couldn’t get a sonogram to see what was happening inside my abdomen; they said it wasn’t needed. My dad asked why I couldn’t get antibiotics; the doctors said for a viral infection they could do more harm than good. My parents kept pushing for a gastroenterologist who might have more insight about my condition to evaluate me, but one never came.
I felt helpless. My condition wasn’t the only thing that alarmed me; so did the lack of recognition I received from the hospital. I was not being heard; when I described to the doctors how much pain I was in, they responded with condescending looks.
On Tuesday night, my dad went home to be with my brother, but it wasn’t long before my mom called him in tears. I was in agony and was only being treated with a heating pad. My dad got the phone number for the hospital administrator and begged for a gastroenterologist, for imaging — for anything. The phone call worked, and at the hospital administrator’s orders, I was finally taken to get an abdominal X-ray. The imaging showed this was no viral infection.
In the middle of the night, I was rushed to get an ultrasound that revealed I had a perforated appendix that was leaking a poisonous stream of bacteria throughout my internal organs. When I learned my diagnosis, I was almost relieved. At least the doctors now had a plan.
Finally, the surgical team took over. The next couple of hours were a blur. A CT scan was followed by emergency surgery; two laparoscopic drains were inserted in my body to get rid of the toxic leakage. I had sepsis and we would later learn I was going into hypovolemic shock — which can cause organs to stop working. That night was the scariest night of my life.
Once I was well enough to leave the ICU, I stayed in the hospital for another week, bedridden with uncomfortable drains in my body and horribly sharp cramping pains, for which I was given morphine. I could barely walk. I didn’t recognize the helpless, hunchbacked, green, exhausted girl I saw in the hospital mirror.
Why did this all go so horribly wrong?
My mom soon learned about research conducted by Dr. Prashant Mahajan, vice chair of Emergency Medicine and division chief of Pediatric Emergency Medicineat University of Michigan Health C.S. Mott Children’s Hospital. Mahajan’s research notes that, despite being the most common surgical emergency in children, appendicitis can be missed in up to 15% of children at initial presentation. Up to 15%!
This is because there are so many possible reasons for abdominal pain. Appendicitis can mimic several common conditions including constipation and acute gastroenteritis, which my hospital pediatricians mistakenly thought I had. According to Mahajan, up to half of appendicitis patients may not exhibit the classic signs of right lower quadrant pain, fever and vomiting.
Hospitals need to change the way they assess and diagnose appendicitis because it can frequently present in atypical ways. Anupam Kharbanda, pediatric emergency medicine doctor at Children’s Minnesota, came up with what’s called the pARC (pediatric Appendicitis Risk Calculator) score to help assess a child’s probability of appendicitis, using variables such as sex, age, duration of pain, pain migration, white blood cell count and more.
The pARC score could be an important piece of changing diagnostic practices and saving lives.
In 2018, a 5-year-old girl in England, Elspeth Moore, was sent home by a pediatrician even though she complained her stomach “felt like it was on fire.” The doctor diagnosed a viral infection. She died of peritonitis, sepsis and acute appendicitis two days later.
My story has a less tragic ending. Luckily, I wasn’t sent home without monitoring like Elspeth was, and I finally got the care I needed. Months after my first hospitalization, I had an appendectomy at a new hospital — Children’s Hospital of Philadelphia. My health has returned to normal. But I have a new mission to spread awareness about misdiagnoses of appendicitis — because what happened to Elspeth could have happened to me, too.
The X-ray machine was down the hall, the CT machine just a floor below, the sonogram machine just steps away and the antibiotics I needed were just one phone call away. But doctors didn’t utilize these tools to quickly diagnose and treat me and, as a result, I almost died. It breaks my heart to think about the boys and girls who don’t have parents who can get the phone number of the hospital administrator — who can’t make their voices break through.
I still can’t believe this happened to me — and I don’t want it to happen to anyone else.
