John Parkinson

Unlike ever before, the current Health and Human Services (HHS) leadership has muddied the waters as it relates to the agency's longstanding intentions regarding access to vaccines for Americans. 

A microcosm of this new federal public health policy can be seen with the recent events around the hepatitis B virus vaccine (HBV) during the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meetings earlier this month.

During these meetings, the committee voted on 3 recommendations around the birth dose of the hepatitis B virus (HBV) vaccine. The biggest and most newsworthy vote was the one that changed the previous CDC recommendation to move the first HBV immunization from a universal birth dose at 12-24 hours of life back to 2 months of age for neonates whose mothers tested negative for hepatitis B. Also, the committee emphasized individual-based decision-making after consultation between the mothers and clinicians on vaccination.

The prior guidance of the HBV birth dose immunization was widely viewed as a successful public health policy. It had been in existence for decades and led to a significant reduction in disease. Between 1991 and 2019, HBV infection among children and adolescents dropped 99%, preventing tens of thousands of cases of cirrhosis, liver cancer, and death.

Looking at this new individual-based decision-making recommendation, Robert Hopkins Jr, MD, medical director of the National Foundation for Infectious Diseases (NFID) believes this unnecessarily complicates the process.

“I think the one [vote] that concerns us most, recommended a change from universal hepatitis B vaccination of newborns to a much more complicated set of decision-making for clinicians,” Hopkins said. “They recommended individual-based decision-making, which is the construct of this new [ACIP] committee on what we've known as shared decision-making for many years.”

During the ACIP meetings, no safety data was presented to warrant the changes they made.

Prior to this new CDC HBV birth dose recommendation, a modeling analysis was conducted on the potential health and economic consequences of delaying the infant HBV birth dose vaccine. The findings—based on a model of 2024 US births—show that even short delays in vaccination lead to substantially more infections, severe long-term health complications, and sharply increased health care spending.

The analysis came from a partnership with HepVu, the Hepatitis B Foundation, and the National Viral Hepatitis Roundtable, and the findings show: By delaying the birth dose to 2 months among infants whose mothers are not known to be living with hepatitis B, there could be at least 1400 preventable hepatitis B infections among children, 300 excess cases of liver cancer, 480 preventable deaths, and over $222 million in excess health care costs for each year the revised recommendation is in place.

For each year, this delayed birth dose policy is in place, it could result in at least 62 preventable deaths and 39 cases of liver cancer annually, and cost at least $21.6 million in health care.

“I think the change in timing of the hepatitis B vaccine to infants is going to result in many more children getting infected with hepatitis B at birth,” said Sharon Nachman, MD, chief of pediatric infectious diseases, Stony Brook Children's Hospital. She also mentions another consideration is if parents do decide to delay the HBV vaccine to 2 months, they will be taking other vaccines during that wellness visit, which is often scheduled at 2 months.

Typically, during this 2-month check-up, babies are given the following: RSV immunization, (if eligible and in season), as well as their first dose of Rotavirus vaccine, Diphtheria, tetanus, and acellular pertussis vaccine, Haemophilus influenzae type b vaccine, Pneumococcal conjugate vaccine and inactivated poliovirus vaccine. In the past, for babies who missed their second dose of the HBV vaccine at 1month, they could be given this dose at 2 months.

Although the aims of the current HHS and ACIP is to give less vaccines, under the new recommendation, babies would be given all those immunizations plus the first dose of the HBV vaccine during the 2-month well-visit.

Additionally, Nachman says the message from CDC’s ACIP is deferment of HBV vaccines. “That message of deferment tells families you don't need it now; I don't know that you need it later; and I don't know when you need it,” she said.

After the ACIP meetings, the CDC awarded an unsolicited, single-source grant to the University of Southern Denmark to support a large randomized clinical trial evaluating the health effects of neonatal monovalent hepatitis B vaccination. Unsolicited grants are problematic as they can be seen as bias.

The study will be conducted in Guinea-Bissau, a low-income country where the World Health Organization recommends administration of 3 vaccines at birth: Bacille Calmette-Guérin (BCG), oral polio vaccine (OPV), and hepatitis B vaccine. BCG and OPV have been studied for broader effects on child health, the CDC noted that evidence regarding non–hepatitis-specific health effects of HBV remain limited.

The University of Southern Denmark collaborates with the Bandim Health Project which has been criticized for focusing on non-specific effects (NSEs) of vaccines, defined as health effects beyond protection against their target pathogens. 

A subsequent analysis by outside researchers found problems associated with their studies, including methodological concerns, unpublished primary outcomes, outcome switching, reliance on statistically fragile subgroup analyses, selective emphasis on secondary findings when primary outcomes were null, and underpowered sample-size calculations based on optimistic assumptions.

The concerns are the current ACIP is adapting ideology over what the science data is showing. And this is not just going to affect hepatitis B infections and the potential increases. We are now witnessing the results of long-time, ongoing anti-vaccine campaigns that have led to more measles and pertussis (whooping cough) cases, including severe disease and some deaths.

These changes to the childhood vaccine schedule will affects a greater number of Americans. And for those who feel they don’t have a stake, the cost of health care will certainly affect taxpayers through Medicare and Medicaid as there will be a greater burden of disease.

In the end, everyone wears a seatbelt for protection against potential accidents. You hope to never get in one, but you wear it to be sure. Vaccines are prevention that have been some of the greatest public health interventions ever put forth.

Despite the science demonstrating efficacy and safety for the birth dose hepatitis B vaccine, the ACIP’s ideology won out and a 2-month delay or beyond for the first HBV vaccine is now the recommendation from the CDC.The new recommendation and its long-term consequences may not be realized for a generation with delayed infections happening when this current generation of newborns become infected with hepatitis B. Nachman points to this youngest generation growing up potentially unvaccinated then participating in risky behaviors, and getting infected as teens or young adults.

“We are going to see children who do not get the birth dose, whose mothers are truly not infected with hepatitis B, so their risk at birth of acquiring it is zero, or close to zero. But, if they don't get the vaccine at 2 months, or at 2 years or some other time, they're going to grow up to be adolescents and adults with no memory that they've never gotten this vaccine. They're going on to have behaviors that may include some risk, and they're going to acquire this infection—which is silent at an age when they're quite vulnerable—and get chronic active Hepatitis B, a disease that we could have easily prevented,” Nachman said.

“We will not see a change in children's health over the next 5 to 10 years, and that means 20 plus years from now, when that cohort of children starts getting sick, we're never going to remember who caused this damage, because it's going to be lost into the annals of history."

References

APHA joins GW and dozens of public health and policy experts urging the CDC to maintain universal newborn hepatitis B vaccination. Press release. American Public Health Association. December 2, 2025. Accessed December 10, 2025. 

https://www.apha.org/news-and-media/news-releases/apha-news-releases/public-health-and-policy-experts-urge-the-cdc-to-maintain-universal-newborn-hepatitis-b-vaccination

New analysis shows delaying the hepatitis B birth dose may lead to thousands of preventable infections and hundreds of millions in avoidable healthcare costs. HepVu. December 1, 2025. Accessed December 2, 2025.


https://hepvu.org/news-updates/new-analysis-shows-delaying-the-hepatitis-b-birth-dose-may-lead-to-thousands-of-preventable-infections-and-hundreds-of-millions-in-avoidable-healthcare-costs/

Start strong with routine checkups and vaccines. Pfizer. Accessed December 23, 2025. 
https://www.babycheckupscount.com/0-2-months

Notice of Award of a Single Source Unsolicited Grant to Fund University of Southern Denmark (SDU). CDC. December 18, 2025. Accessed December 23, 2025. 

https://public-inspection.federalregister.gov/2025-23245.pdf

Abene S. CDC Awards Grant to Study Neonatal Hepatitis B Vaccination Outcomes in Guinea-Bissau. 

. December 21, 2025. Accessed December 23, 2025.


https://www.contagionlive.com/view/cdc-awards-grant-to-study-neonatal-hepatitis-b-vaccination-outcomes-in-guinea-bissau

Articles

Recent changes in CDC recommendations for the hepatitis B virus (HBV) vaccine have shifted from a universal birth dose to a more individualized approach, delaying the first dose to 2 months for neonates with hepatitis B-negative mothers. This decision has sparked concerns about increased HBV infections, healthcare costs, and potential long-term health impacts. Critics argue that the new policy complicates decision-making and may lead to preventable infections. Additionally, a controversial study funded by the CDC in Guinea-Bissau raises questions about the influence of ideology over scientific evidence.

New CDC recommendations on hepatitis B vaccination raise concerns over increased infections and healthcare costs, complicating public health efforts.

New Hepatitis B Vaccine Recommendation Serves as a Blueprint for Federal Vaccine Policy Going Forward 

Antimicrobial resistance (AMR) is a slow-moving train that is picking up steam and in its path are all patients battling bacterial infections. AMR is a multifactorial problem that includes many aspects, and potentially chief among them is the missing communication and disconnect with the public, who do not understand the nature of how it happens nor the consequences of the misuse of antibiotics.

One of the disconnects is the public’s lack of responsibility in the usage of antibiotics and AMR. While the lay population understands the potential problem theoretically, in practice, nearly half of people polled don’t know their actions can lead to resistance. In a poll conducted by the Kaiser Family Foundation, it was found that 67% of respondents were aware of the negative implications when overusing antibiotics, which could lead to patients having to take stronger therapies, and about 6 in 10 saying it will lead to longer lasting and more dangerous bacterial infections (63%) and an increasing amount of bacteria resistance to antibiotics (62%). However, a larger number of people believe the responsibility of protecting people from resistance belongs with drug companies and health care providers.

In the same poll, 45% of respondents say they have not taken their antibiotics as prescribed by their clinician, which can, of course, lead to resistance. 

One of the issues on the clinicians’ side has been in dentistry. Dentists have often prescribed antibiotics for prophylaxis purposes for patients undergoing surgical procedures. In the past, there were concerns over bacterial endocarditis in patients with heart issues who were given antibiotics to protect against this. However, newer studies around this topic have shifted the need for antibiotics in these patients. In a 2022 paper, Rutherford et al noted that “Guidance by the National Institute for Health and Care Excellence (NICE) in England and Wales states that antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures.”

In trying to reduce issues associated with antibiotic prescribing practices, Debra Goff, PharmD, a professor of pharmacy practice at The Ohio State University Wexner Medical Center, has been studying the subject of dentistry and antimicrobial stewardship for several years. She has become an advocate for the field and teaches dentists to understand fully the nuances of stewardship and how antimicrobial prescribing practices have changed.

“The [Centers for Disease Control and Prevention] published a great study that said, ‘25 million prescriptions a year are prescribed by dentists.’ But, when I looked into the details of that, that only represents general dentists working in the VA health care system,” said Goff, in an interview with 

. “I'm working with private practice dentists, which represent 80% of dentists in the United States, and the specialists, the oral surgeons, the periodontists, and the endodontists who need antibiotics… they prescribe a phenomenal volume of antibiotics. Some of them are necessary, but a lot of them [are not]. And the durations they're using are the old football scores—10 and 14 days, and they can do better. There's no evidence to support those long durations.”

She says dentists have largely been receptive to her presentations. “It's been so fun teaching them simple concepts of how they can be a steward, and they are helping me spread this message all across the United States,” Goff said. She has educated 3000 private practice dentists to date and continues to do so.
To help the public better understand the importance of this issue, and providing clinicians with a call to arms, she wrote an 

 issue earlier this year, describing antibiotics as the sheep, the pharmacists and physician stewards as the dogs, and that the stewards needed to protect new antibiotics from the wolf, which is, of course, antimicrobial resistance.
“We have to be that herding dog that rallies for our patients, protecting them from antibiotic resistance,” Goff said.

These shortcomings don’t stop the AMR train’s approach. In fact, it is expected that the problem of AMR will grow exponentially, and with it will come greater mortality. A few months back, a study published in 

 looked at mortality associated with AMR from the present day up to the year 2050, with an estimation of the number of deaths in the next 25 years. This modeling study predicted that more than 39 million people could die from AMR globally in that time.

According to the investigators, more than 1 million people died each year because of AMR between 1990 and 2021. The study also estimates 1.91 million people could potentially die as a direct result of AMR in 2050, an increase of almost 70% per year compared with 2022. Over the same period, the number of deaths in which AMR bacteria play a role will increase by almost 75% from 4.71 million to 8.22 million per year.

A Personal Tragedy Grows into a Professional Mission

Diane Shader Smith is a publicist, and didn’t realize the magnitude of AMR until after her daughter Mallory’s death. Her daughter given a diagnosis of cystic fibrosis (CF) when she was 3 years old, explained Shader Smith, but it did not become problematic until the pathogen 

 was found in her lungs when she was 12 years old.

When people with CF become colonized with a bacteria such as 

, they are often put in a situation where it becomes a revolving door of medical encounters including hospitalizations, lung treatments, and antibiotic therapy. Unfortunately, antibiotic treatment can see diminishing returns as previously effective therapies are no longer working against the bacteria and a greater antimicrobial resistance is seen against a pathogen that never leaves the lungs.

Through the years, Mallory had been hospitalized to treat infections and, eventually, she became a candidate for a double-lung transplant. She had a successful surgery, but even with new lungs, the pathogen was back and sadly, Mallory succumbed to AMR at the age of 25.

Despite a growing spotlight around AMR, Shader Smith says it is hard for everyone to see this as one major issue. She launched the 

, which allows people to tell their individual medical stories about AMR.

“We're trying to push the global AMR diary as a way to get people to engage with the stories—to connect. But it's challenging because it's an amorphous problem that people don't really understand,” Diane Shader Smith said in an interview with 

Since getting involved in advocacy, she has given hundreds of presentations to different walks of life to everyone—from high school kids to grandparents—to let them know the scope and severity of the problem. Along with her talks, she has been involved in getting Mallory’s memoir, 

, published after her death, and a documentary with the same name about her daughter’s experience.

And while some people are more vulnerable to infections that can lead to resistance including those who are immunocompromised and seniors, Shader Smith makes the point everyone is vulnerable.

“It can strike anyone, anywhere,” Shader Smith said.It isn't just a problem for people like Mallory who had CF or someone with cancer, although those who have health conditions with compromised immune systems might be more at risk, and those in underserved communities are at higher risk, but the average person walking down the street could take a fall, cut their knee, and bacteria that's either in the hospital or in the community, can get into their system and cause them to be septic. I've met many people who have lost their lives or lost their limbs because of resistant bacteria, and they were perfectly healthy to begin with.”

Despite the daunting prognostications, large systemic changes may reduce resistance. One of the major issue of antibiotics is the supply side and the need for more therapies; however, the development of them has inherent challenges such as costs, time to develop them, smaller biopharmaceutical companies involvement—as opposed to larger companies—and quick resistance to newer antibiotics, as typically, they become resistant to evolving pathogens just a few years after introduction of them into the market.
In trying to combat the development issue, there is a prospective bill in Congress called the Pasteur Act. The bill has been in Congress for a few years now, and it authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs, provides $6 billion over 10 years in appropriations for activities under the bill, and contains other related provisions.

 Last year, Senators Michael Bennet (D-CO) and Todd Young (R-IN) and Representatives Drew Ferguson (R-GA) and Scott Peters (D-CA), 

reintroduced the Pasteur Act in Congress.

 The bill was initially introduced in Congress by Bennet and Young in September 2020; the pair, along with Representatives Mike Doyle (D-PA) and Ferguson, then reintroduced the bill in June 2021.

After the bill’s reintroduction last year, 5 national organizations—the Biotechnology Innovation Organization, the Cystic Fibrosis Foundation, the Infectious Diseases Society of America (IDSA), the Partnership to Fight Infectious Disease, and The Pew Charitable Trusts—issued a statement on the topic. “Antimicrobial resistance is not a partisan issue. It is an increasingly challenging public health emergency that reverberates far beyond just healthcare settings. Every 15 minutes, a person in the United States dies from an infection resistant to treatment with existing antimicrobial drugs. This means that since PASTEUR’s last introduction on June 16, 2021, more than 64,000 Americans have died because they did not have adequate medications to treat their infections,” part of the statement read.

Amanda Jezek, senior vice president for Public Policy and Government Relations at IDSA does believe the Pasteur Act will pass and says it is better to do so now than deal with the consequences of increased mortality rates and the inability to perform procedures due to concerns over AMR. “I think it has to; the stakes are too high,” said Jezek, in an interview with 

. “Right now, we are trying to convince Congress to do the right thing and pass this while we have a little bit of lead time to protect modern medicine.”

Jezek says that along with being a major supporter of the Congressional bill, IDSA is involved in other AMR-related activities, including the US national plan to address AMR. They were also involved in the United Nations meeting last summer, which looked at AMR and a One Health approach. The United Nations and its member nations met back in August to address AMR.

Lori Russell, senior vice president for Public and Government Affairs and Compliance, 

, attended the UN and believes there were productive talks around reducing AMR. Her role within her diagnostics company is to lead initiatives to promote the value of diagnostics and work with stakeholders, including policy makers and industry leaders, focusing on advancing public health through diagnostics.

“I had the privilege of attending the [United Nations] high level meeting where we were able to provide an intervention highlighting the critical role of diagnostics in addressing the AMR crisis and the need for national action plans to include diagnostics as a pillar of their stewardship strategies,” she said in an interview with 

As with any big world problem with complexities associated with it, it is going to take consensus building and various approaches at the ground level up to systemic changes to slow down the AMR train or look to derail it. From the frontline clinicians to patients, to infectious disease organizations, up to country members of the UN—everyone is an interested stakeholder in this fight. The question remains: will enough be done to reduce resistance and stop or slow down a train that will affect millions of people in the coming years? 

Cailey Muñana, Ashley Kirzinger, Lunna Lopes, Liz Hamel, and Mollyann BrodieData Note: Public Awareness Around Antibiotic Resistance. Kaiser Family Foundation.

Rutherford SJ, Glenny AM, Roberts G, Hooper L, Worthington HV. Antibiotic prophylaxis for preventing bacterial endocarditis following dental procedures. 

. 2022;5(5):CD003813. Published 2022 May 10. doi:10.1002/14651858.CD003813.pub5
Naghavi, M, et al. Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050. 

. September 16, 2024. doi: 10.1016/S0140-6736(24)01867-1

Summary: S.1355 — 118th Congress (2023-2024). Congress.gov. Accessed September 5, 2024. https://www.congress.gov/bill/118th-congress/senate-bill/1355

Antimicrobial resistance (AMR) is a growing global health threat exacerbated by public misunderstanding and misuse of antibiotics. Despite awareness of AMR's dangers, many individuals fail to adhere to prescribed antibiotic regimens, contributing to resistance. Dentists' overprescription of antibiotics is highlighted as a significant issue, with efforts underway to educate them on antimicrobial stewardship. The potential impact of AMR is severe, with millions of deaths projected by 2050. Systemic changes, including legislative efforts like the Pasteur Act, are crucial to combat AMR, requiring collaboration across healthcare, policy, and global organizations.

Resistance is expected to worsen significantly, but can a combination of both ground-level clinician stewardship actions as well as systemic reforms such as the Pasteur Act at least slow down the train? 

The Slow-Moving Antimicrobial Resistance Train is Picking-up Morbidity and Mortality Steam

For the sickest of patients who might be battling multidrug-resistant, gram-negative bacterial infections—particularly those with comorbidities—time is of the essence to get to a diagnosis and optimal treatment. Yet, medical science is designed to move deliberately—to do no harm—and to practice within the economic realities presented to providers. However, this current treatment paradigm might be set up to continue and proliferate the antimicrobial resistance (AMR) crisis, especially in the aforementioned patient population as they continue to cycle through the health care system repeatedly and have multiple treatments with antibiotics.

Current clinical practice is set up to use first-line, well-established therapies, so this often means utilizing older therapies. Add to this the newer concept of antimicrobial stewardship, and you may have clinicians who may be reluctant to use newer antibiotics for a few reasons including being a good antimicrobial steward, or there may not be enough study data to fully understand adverse effects and the efficacy of the newer antimicrobials.

In addition, patients in some long-term care settings may be delayed in getting diagnosed, and often patients can be given broad-spectrum antibiotics that may be limited in efficacy and leads to switching antibiotics and more exposure to these therapies and the possibility of AMR.

“We see people with repeated multiple antibiotic exposures, multiple infections. Even if it started out as maybe a staph infection or was 

 over time with repeat infections and repeat courses of antibiotics, those [patients] are at greatest risk for a carbapenem-resistant pathogen,” Tom Lodise, PharmD, PhD, professor at the Albany College of Pharmacy and Health Sciences, and clinical pharmacy specialist at the Stratton VA Medical Center in Albany, New York, told 

. “These sort of [case scenarios] is where I think we need to be more aggressive…every day matters in the gram-negative space. We think about antibiotic stewardship—our fundamental pillar is getting it right up front. Despite this, we still find in over half of the patients with an antibiotic resistant gram-negative infection, they do not receive an active drug for the first 48 - 72 hours.”

Lodise says the time-to treatment concept which involves getting patients the diagnosis and on the correct antibiotic in a timely manner can be beneficial to patient outcomes.

“Every day matters with our gram-negative infections, and the longer we delay, there's substantial increases in both morbidity and mortality,” Lodise said.

Rapid diagnostics is an area where the advancement of technology has vastly improved and is becoming an emerging part of medicine. As the name suggests, they can quickly reveal pathogens and viruses.

“Such assays have relatively short performance times, provide results to inform clinical decision making, and enable management at the point-of-care (POC),” wrote authors of the Centers for Disease Control and Prevention’s (CDC) Yellow Book.

However, there are some inherent challenges. For starters, laboratories in medical settings vary. Whereas in a large teaching hospital these tests may be available and there may be adequate staffing of laboratory professionals to conduct them, in many smaller community or mid-sized hospitals there may be limited resources to have such tests and personnel.

The laboratory field itself has become even more crucial, especially as the number of tests has increased and the diagnostics have become more complex. According to the CDC, there are more than 14 billion clinical lab tests performed in the US annually.

 If one were to also consider the millions of COVID-19 tests administered over the last few years, this has put an enormous strain on medical laboratory professionals.

While the need for such vital personnel increases, the field has seen shortfalls.

“With the projected increases in the need for medical laboratory professionals, and the current high vacancy rates, the profession is suffering from a workforce shortage that is approaching crisis levels for medical laboratory technicians, medical laboratory scientists, histotechnicians and histotechnologists,” the American Society for Clinical Laboratory Science (ASCLS) wrote in a prior statement.

ASCLS stated some of the reasons for the shortages includes retirements, an increased demand for lab services, changes in the practice of clinical laboratory science due to technology advances, and vacancies that exceed the number of graduates.

“Our professionals are critical. We are often not thought of in direct patient care, because we're laboratory based, diagnostic detective types," Rodney E. Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSc regents’ professor, Texas State University, university distinguished chair & professor, Clinical Laboratory Science, told 

. “One of the things I like to tell people is that we’re the mechanics and the ground crew for that airplane you're getting on. You don't think about this every day, but you better hope they're alert, and they're doing their job.”

The FDA has approved novel gram-negative antibiotics in recent years, but they have not necessarily seen the adoption or uptake of use that therapies in other areas of care might.

Sameer S. Kadri, MD, MS, FIDSA, intensivist and head, Clinical Epidemiology Section, Critical Care Medicine Department, National Institutes of Health Clinical Center, and a team of investigators looked at the utilization of novel, gram-negative antibiotics in US hospitals, and he says that medical providers appear to go the route of prescribing well-established antibiotics and even using ones that could be potentially toxic.

“I think there was a degree of comfort level with some of the older agents, even though they were toxic, when there was no agent available as an alternative. Now that there are agents available, I think, there is evidence in the form of trials that have led to the approval of these novel agents,” Kadri told 

. “But you know, there's not that much representation of patients with highly-resistant pathogens in some of those trials, and that does result in a little bit of uneasiness around whether the evidence is generalizable to the patients with highly-resistant pathogens.”

This may present scenarios where newer and novel antibiotics might be sitting on the pharmacy shelves. Kadri said one of the key takeaways from the study was a potential strategy to overcome this reticence of clinicians to prescribe these newer agents.

“I think an important factor is that hospitals that opted for testing susceptibility against these novel agents tended to [have] greater use of these novel agents,” Kadri said. “It's a reminder that there needs to be wider implementation of susceptibility testing capabilities across the country against novel agents that are released, so that clinicians like myself feel confident that the drug that we're using in our patients actually works.”

Another potential strategy to address the greater adoption of new or novel antibiotics is the prospective Pasteur Act. Ideally, this act would entice pharmaceutical companies to develop more antibiotics by establishing an innovative payment contract (subscription model) where the federal government invests in highly novel antibiotics and antifungals through installment payments in exchange for free access to developers’ drugs in government programs once available.

The Pasteur Act was initially introduced in Congress in 2020, then reintroduced in both 2021 and earlier this year. When it was reintroduced back in April, 5 national organizations—the Biotechnology Innovation Organization, the Cystic Fibrosis Foundation, IDSA, the Partnership to Fight Infectious Disease, and The Pew Charitable Trusts—issued a joint statement on the topic.

“Antimicrobial resistance is not a partisan issue. It is an increasingly challenging public health emergency that reverberates far beyond just health care settings. Every 15 minutes, a person in the United States dies from an infection resistant to treatment with existing antimicrobial drugs. This means that since PASTEUR’s last introduction on June 16, 2021, more than 64,000 Americans have died because they did not have adequate medications to treat their infections,” the statement read.

Can We Change the Diagnostic and Treatment Paradigm?

The US is well-positioned and responsive to public health emergencies. We just witnessed this with the COVID-19 pandemic. Yes, missteps occurred—but in a public health emergency with a fluid, ever-changing situation with emerging variants to contend with, the country did its best to respond to it.

However, addressing slow-moving, serious issues where long-term planning is warranted is not something well-considered or brought to the forefront in American public health. Yes, there are public health officials thinking about these things, but a clarion call has not been heeded to address how we need to be thinking about the rise and severity of antimicrobial resistance.

Right now, all these challenges of limited laboratory professionals, slow adoption of newer antibiotics, and possibly an outdated treatment paradigm seem separate, but in reality, putting the pieces of the puzzle together can make the treatment pathway for patients with AMR infections more comprehensive.

The addition of susceptibility testing, the increase in the number of laboratory professionals, and the passage of the Pasteur Act may all be steps towards creating new treatment pathways and lead to better outcomes.

The question remains: should these problems be resolved with a larger public health initiative bringing it altogether, or can they come together organically and medical science evolve to address these issues without government involvement?

Rapid Diagnostic Tests for Infectious Diseases CDC Yellow Book 2024. CDC. Last reviewed May 1, 2023. Accessed December 18, 2023. https://wwwnc.cdc.gov/travel/yellowbook/2024/posttravel-evaluation/rapid-diagnostic-tests-for-infectious-diseases#:~:text=

Clinical Standardized Programs. CDC. Last reviewed March 15, 2023. Accessed December 19, 2023. https://www.cdc.gov/labstandards/csp/index.html#:~:text=In%20the%20United%20States%2C%20approximately,Amendments%20(CLIA)%2Dcertified%20laboratories

Addressing the Clinical Laboratory Workforce Shortage. ASCLS. Accessed December 19, 2023. https://ascls.org/addressing-the-clinical-laboratory-workforce-shortage/

The current treatment paradigm might need to evolve to adjust to rapid diagnostics and narrowing down the antibiotics to aid in optimal outcomes for sicker patients with gram-negative infections.

Multidrug Resistant Infections: Is the Clinical Infection Treatment Pathway Outdated?

Credit: US Centers for Disease Control and Prevention

This article was originally published in ContagionLive.

The US Centers for Disease Control and Prevention (CDC) has announced recommendations for screening and testing for hepatitis B virus (HBV), calling for all adults in the US to be universally tested for HBV at least once in their lifetime and to test for total antibody to HBcAg, which may determine HBV in the window period and pick-up recent infection.

The new guidance, which is the first update since 2008, is aimed at providing more awareness around HBV and getting more people involved in the continuum of care. CDC is also expanding continual risk-based testing to include more groups, activities, exposures, and conditions, while noting the limitations to risk-based testing.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is inefficient for providers to implement,” the authors wrote.

Listed below are the new screening/testing HBV recommendations put forth:



• HBV screening at least once during a lifetime for adults aged ≥18 years (new recommendation)
• During screening, test for hepatitis B surface antigen (HBsAg), antibody to HBsAg, and total antibody to HBcAg (total anti-HBc) (new recommendation)

• HBV screening for all pregnant persons during each pregnancy, preferably in the first trimester, regardless of vaccination status or history of testing

• Pregnant persons with a history of appropriately timed triple panel screening and without subsequent risk for exposure to HBV (i.e., no new HBV exposures since triple panel screening) only need HBsAg screening

• Testing for all persons with a history of increased risk for HBV infection, regardless of age, if they might have been susceptible during the period of increased risk
• Periodic testing for susceptible persons, regardless of age, with ongoing risk for exposures, while risk for exposures persists

HBV awareness remains a significant health care challenge, despite existing therapies to treat it as well as prophylactic HBV vaccines to prevent it. It’s estimated that more than half of patients with HBV are unaware of their infection, mainly because virus presents asymptomatically in the majority of positive cases. Some people do eventually develop chronic hepatitis (elevation of AST/ALT), cirrhosis, or liver cancer.

Although there is no cure for HBV, treatment with any of the number of multiple antivirals available can make the virus a manageable, chronic condition.

On the vaccine side, there are prophylactic HBV vaccines, but uptake is limited. It has been reported that 70% of adults in the US were unvaccinated as of 2018.

In addition to the comprehensive screening and testing updates, the authors would like to see continued collaboration with laboratories to bundle the three HBV tests so they can be ordered together. And they also acknowledge the need to understand hepatitis D (HDV) more effectively to guide future recommendations for HDV screening among persons with HBV infection.

Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations — United States, 2023. MMWR Recomm Rep 2023;72(No. RR-1):1–25. DOI: 

The new guidance is the first update since 2008, replacing the previous risk-based recommendations. 