The federal agency says it will mandate randomized, controlled clinical trials for vaccination of younger, healthy individuals
It’s been a confusing past few weeks in terms of what the general public’s access to COVID-19 vaccinations will be like in the future.
Public health experts have been verbally jousting with the federal Department of Health and Human Services (HHS) about moves its health officials made recently regarding the vaccines. This could put clinical laboratories on the front lines to help determine whether COVID cases—particularly severe ones—eventually rise as a result.
Food and Drug Administration (FDA) commissioner Martin A. Makary, MD, MPH, and Vinay Prasad, MD, MPH, who leads the agency’s vaccine oversight, announced on May 20 that the agency will require randomized, controlled clinical trials before approving COVID vaccines for healthy individuals under age 65.
“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” Makary and Prasad wrote in NEJM.
Under the new framework, they noted, the agency expects that it will continue to approve vaccines for adults over 65 as well as younger people with health conditions that put them at high risk of severe outcomes from COVID-19.
The range of diseases is “vast, including obesity and even mental health conditions such as depression,” they wrote. “Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner.”
In their NEJM commentary, FDA commissioner Martin Makary, MD (left), and Vinay Prasad, MD (right), wrote, “Moving forward, the FDA will adopt the following COVID-19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titers in people.” (Photo copyrights: Wikimedia Commons.)
Former CDC APIC Member Pushes Back
The announcement drew criticism from public health and medical experts.
“The FDA guidance presented in the NEJM was not released in the Federal Register, did not invite comment, and provided only a general outline for COVID-19 vaccine licensure,” wrote pediatrician and vaccinologist Kathryn M. Edwards, MD, in a commentary for STAT. Edwards is a former member of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), which makes vaccine recommendations to the agency.
On June 9, in an opinion piece for The Wall Street Journal, HHS Secretary Robert F. Kennedy Jr. announced that he’s removing all 17 current members of ACIP.
“The FDA mandate is to ensure safe and effective vaccines based on the clinical studies performed, but not to develop specific recommendations for their use,” Edwards added. “Providing recommendations on vaccine use for the civilian population is the mandate of the ACIP.”
Edwards contended that extensive data is already available on the safety and effectiveness of COVID-19 vaccines. She stated that “there is no precedent for mandating continued placebo-controlled randomized clinical trials for vaccines that have already been licensed.”
New Policy Announcement Raises Questions
The New York Times notes that many questions remain about the specifics of the new policy and how broadly the vaccines will be available.
A likely scenario, the paper reported, is that health insurers will play a role as “gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.” Without insurance coverage, people would likely pay approximately $140 per shot out of pocket.
This stands in contrast to European countries, where outreach campaigns target specific populations based on public health recommendations. according to Forbes. However, “in virtually all instances, COVID-19 vaccines can be gotten free of charge across Europe regardless of health or age status,” the article notes.
In their NEJM commentary, Prasad and Makary noted that adoption of the annual COVID-19 booster shot is already low. The CDC reported that 23% of Americans 18 and older received vaccinations in the 2024-2025 season, up slightly from 21.6% in 2023-2024.
Kennedy Steps In
On May 27, Kennedy announced in a video on X that the CDC would remove the COVID-19 vaccine from the recommended immunization schedule for healthy children and healthy pregnant women. Previously, the CDC recommended the vaccine for everyone ages six months and older.
Kennedy was joined in the video by Makary and National Institutes of Health director Jay Bhattacharya MD, PhD.
However, CDC staffers were “blindsided” by the announcement, NPR reported, citing an agency official who requested anonymity.
“Hours after the post on X, CDC staffers received a directive from Secretary Kennedy—dated May 19, but sent May 27—rescinding the department’s 2022 acceptance of the CDC’s recommendations for the use of COVID shots in children and during pregnancy,” NPR reported.
It now appears that HHS has at least partially backtracked on Kennedy’s announcement.
The CDC’s immunization schedule now states that vaccination of healthy children should be a matter of “shared clinical decision-making” between the doctor and parent or patient.
“After confusing, mixed messages from leaders at HHS earlier this week, we are relieved to see today that the CDC updated its schedules for child and adolescent immunizations to allow families to maintain the choice to immunize their children against COVID in consultation with their doctor,” American Academy of Pediatrics president Susan Kressly said in a statement from the organization.
In a June 1 interview with the CBS News program “Face the Nation,” Makary confirmed that the recommendation to vaccinate “should be with the patient and their doctor.”
However, he also criticized ACIP as a “kangaroo court where they just rubber stamp every single vaccine put in front of them.”
Demographic shifts are most acute in Europe and East Asia but could be a harbinger of things to come for US healthcare as well
Across the globe, major shifts in many countries’ demographics are starting to drive notable changes in how healthcare is delivered in these nations. Having fewer pediatric patients and more senior citizens is fundamentally altering what types of tests are in greatest demand from the medical laboratories in these countries. It is the population trend writ large on a global scale.
For example, in countries as diverse as Sweden, Hungary, Japan, and South Korea, birthrates are declining as fewer young people decide to have kids, or they choose to have smaller families. Thus, demand for pediatric care is declining in those countries.
Meanwhile, populations around the world continue to age as greater numbers of people reach their retirement years. Not only does this create the need to expand medical services designed to serve the elderly, but there are important economic consequences. That’s because each wave of retirees leaves fewer people in the workforce to support the healthcare of ever-growing numbers of senior citizens.
According to The New York Times (NYT), this trend is likely to accelerate. In “Long Slide Looms for World Population, with Sweeping Ramifications,” the paper reported that “All over the world, countries are confronting population stagnation and a fertility bust, a dizzying reversal unmatched in recorded history that will make first-birthday parties a rarer sight than funerals, and empty homes a common eyesore.”
The NYT added that, “With fewer births, fewer girls grow up to have children, and if they have smaller families than their parents did—which is happening in dozens of countries—the drop starts to look like a rock thrown off a cliff.”
In countries such as the US, Canada, and Australia, this is partially mitigated by immigration, the NYT reports. However, some nations, such as Germany and South Korea, have instituted programs aimed at boosting birthrates, though with varying degrees of success.
According to demographer Frank Swiaczny, Dr. rer. nat., Senior Research Fellow at the Federal Institute for Population Research in Germany, countries around the world—especially in Europe and East Asia—“need to learn to live with and adapt to decline.”
“A paradigm shift is necessary,” he told the NYT.
The graphic above, taken from the US Census Bureau’s 2018 report, “The Graying of America: More Older Adults than Kids by 2035,” illustrates the rate at which America’s elder population is catching up with the rest of the world. It will soon exceed younger portions of the population, thus shifting demand for healthcare from pediatrics to geriatrics. Anatomic pathology groups and clinical laboratories will be impacted by this trend. (Graphic copyright: US Census Bureau.)
The authors, which included Terry Fulmer PhD, RN, FAAN, and John Auerbach, Director of Intergovernmental and Strategic Affairs at the CDC, noted that in 2018, adults 65 or older were 15.6% of the population. This will rise to 20% by 2030, when, according to the authors, seniors will outnumber the portion of the population that is younger than age five.
Foster an “expanded and better-trained workforce” to care for older adults, through enhanced training as well as “scholarships, loan forgiveness, and clinical internships.”
Adapt the public health system to account more for the needs of an aging population, such as by “improved coordination and collaboration with Area Agencies on Aging and key healthcare providers.”
Address disparities and inequities in healthcare access, such as social isolation “caused or exacerbated by social, economic, and environmental conditions.”
Facilitate advances in telehealth and other technologies to improve care delivery. “The lack of access to technology, low digital health literacy, and design barriers in patient portals and apps have disproportionately affected older adults, especially those in underserved communities,” the authors wrote.
Improve palliative and end-of-life care. “Many older adults are living with serious illness,” the authors wrote, and “most will live for years with their illnesses, resulting in a high burden of physical and psychological distress, functional dependence, poor quality of life, high acute care use, loss of savings, and caregiver distress.”
Reform long-term care, by improving conditions in long-term care facilities and making it easier for older adults to stay at home.
A perspective in the journal NPJ Urban Sustainability, titled “Ageing and Population Shrinking: Implications for Sustainability in the Urban Century,” notes that these trends have led some cities or countries to adopt technological innovations in healthcare, such as “socially assistive robots and virtual entertainment for mental health, roadside AI services for healthcare, and a series of innovations for house-based healthcare, digital nursing, and monitoring.”
The graphic above, taken from PopulationPyramid.net, illustrates the stark differences in the age of populations in two countries at opposite ends of the progressing demographic shift. Italy’s population pyramid (left) shows how the senior population makes up a substantial proportion of total population, while Nigeria’s 2030 population pyramid (right) shows the classic pyramid of a wide base of younger people trailing off to a small number of the elderly at the top of the pyramid. Medical laboratories in those nations will continue to be affected by how these demographic shifts taking place worldwide are changing the type of healthcare in highest demand. (Graphic copyright: PopulationPyramid.net.)
Impact on Pediatrics
At the other end of the age spectrum, a recent presentation from the American Academy of Pediatrics noted a 13% decline in the US birthrate between 2007 and 2019. But a white paper from physician search firm Merritt Hawkins suggests this has not necessarily resulted in reduced demand for pediatric services, at least not in the US.
Despite the decline, “there are still about four million births in the US annually, and immigration adds to the number of children in the population,” the white paper notes. Even rural areas with aging populations “have far fewer pediatricians per capita than they require.”
However, according to The New York Times, in South Korea, “expectant mothers in many areas can no longer find obstetricians or postnatal care centers.” And the town of Agnone, Italy, no longer has a maternity ward because the number of births—just six this year—is below the national minimum.
This is important to note. If there are developed countries around the world where demographics point to a steady decline in population, then the type of healthcare provided will be different than what is currently used. Clinical laboratories and pathology groups in those regions can expect changes and should prepare for them.
A hospital in Virginia now offers a genetic service to new parents that could impact clinical pathology laboratories if it develops into a trend
Here’s a first in the rapidly-developing field of pharmacogenomics testing. A hospital in Virginia announced that it would offer a free pharmacogenomics test to newborns. This is a development that will catch the attention of clinical pathologists and medical laboratory professionals at other hospitals across the country.
Inova Women’s Services at the Inova Woman’s Hospital on the Inova Fairfax Medical Campus in Falls Church, VA, has begun offering free MediMap tests to newborns. MediMap is a pharmacogenomics (PGx) test that looks for variations in seven genes that could indicate a child might process certain drugs differently than the majority of the population.
The program is an example of a well-known and often-used marketing tactic: “Buy X and get Y free!” Given the choice between a new free diaper bag and a free, painless test that, as Inova’s website states, “personalizes prescriptions to more effectively treat and manage illnesses in the future,” what new mother would choose the diaper bag? (more…)
Many Dark Daily readers remember “Marcus Welby, M.D.” This popular TV show ran from 1969 to 1976 and starred actor Robert Young in the role of Marcus Welby, M.D. His sidekick was assistant Steven Kiley, M.D. (played by James Brolin). Dr. Welby was the dedicated family practice physician who treated patients as individuals in an age of specialized medicine and uncaring doctors.
Now, there is a movement among physicians to return to the caring compassion displayed by Marcus Welby, M.D. These physicians are endorsing a new model of patient care known as the “medical home.” The medical home is gaining momentum nationwide as an alternative to the current system of jumbled provider networks, says the Association of American Medical Colleges (AAMC). In addition to the AAMC, such organization as the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, and the American Osteopathic Association, are promoting the concept of the medical home.
The AAMC defines the medical home as one that: 1) includes an ongoing relationship between a provider and patient; 2) provides around-the-clock access to medical consultation; 3) respects a patient’s cultural and religious beliefs; 4) provides a comprehensive approach to care; and, 4) coordinates care through providers and community services.
The medical home model puts the emphasis on primary care. It changes reimbursement to physicians so that they have an incentive to promote the early detection of illness and active intervention. This is similar to a major effort by the United Kingdom’s National Health Service (NHS). In recent years, the NHS has shifted funds away from acute and specialist care at the hospital trusts and transferred those funds to primary care trusts. In this way, the NHS has made primary care physicians responsible for early diagnosis, as well as pro-active management of patient care.
On July 21, USA Today reported that, here in the United States, individual states, the federal government, and private insurers are experimenting with ways to pay primary care physicians more money to oversee and coordinate patients’ care. The federal Centers for Medicare & Medicaid Services plans a demonstration project in 2010 to test whether paying primary care doctors more per month to treat patients with chronic illnesses in medical home settings results in better care and lower costs, compared with traditional clinical practices. The Tax Relief and Health Care Act of 2006 (TRHCA) mandates a demonstration in as many as eight states. This demonstration project will provide targeted, accessible, continuous, and coordinated family-centered care to Medicare beneficiaries who are deemed to be high need (that is, with multiple chronic or prolonged illnesses that require regular medical monitoring, advising or treatment.)
If the patient-centered medical home concept gains support, it could mean that clinical laboratories will see a greater demand for near-patient and point-of-care testing capabilities. That’s because, as caregivers visit patients in various settings, including patients’ homes, caregivers will want both fast access to lab test results and the ability to view those test results remotely.
