This month’s cover story provides an in-depth approach for getting started with office hysteroscopy, an underutilized procedure with many advantages. 

Vol 66 No 9: September 2021

A Food and Drug Administration (FDA) committee is expected to vote on whether to suggest COVID-19 booster shots after hearing conflicting information on the move.

The FDA Vaccines and Related Biological Products Advisory Committee held an open meeting to discuss allowing third doses of the Pfizer COVID-19 vaccine, COMIRNATY. Previously, the Biden administration said the additional shots would be available to the general public Sept. 20.

 that plan has been in question due to a lack of consensus on whether the shots are necessary and effective and who would benefit from the boosters.

While the committee’s decision isn’t the sole factor in the additional shots being authorized, but a yes vote would pave the way for their rollout.

The agency has already expanded the emergency use authorization for the Pfizer and Moderna two-dose vaccines to allow for a third dose to the estimated 3 percent of Americans, or about 9 million, with weakened immune systems. The vaccines are believed to be less effective in this group of people, but the initial hope was that widespread vaccinations would protect the immunocompromised population. As of Sept. 17, slightly more than half of eligible Americans, or about 180 million, have been fully vaccinated.

On Aug. 23, the Food and Drug Administration (FDA) 

 the Pfizer-BionTech COVID-19 vaccine for use in people age 16 and older, the first COVID vaccine to receive such approval.

The Pfizer vaccine, along with one manufactured by Moderna, had been operating under an Emergency Use Authorization (EUA) since December 2020 for people age 16 and older, while Johnson & Johnson’s Jansen vaccine received an EUA in February 2021. The FDA is still reviewing Moderna’s application for full authorization. Johnson & Johnson has not yet applied for full authorization.

 from the National Institutes of Health found that the currently available COVID-19 vaccines have cut the number of fatalities due to the disease by nearly 140,000. The researchers estimate that the economic value of saving these lives was between $625 billion and $1.4 trillion.

The reduction in deaths varied in different states with vaccinations in New York leading to an estimated 11.7 fewer COVID-19 deaths per 10,000 while Hawaii saw the smallest reduction at just 1.1 fewer deaths per 10,000.

Meetings to discuss boosters of the Moderna and Johnson and Johnson have yet to be scheduled.

This article was originally posted on Medical Economics®.

Articles

The Vaccines and Related Biological Products Advisory Committee has yet to vote on whether to recommend the extra shots.

FDA discusses COVID-19 booster shot

Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

For many who have become ill with COVID-19 and recovered, all that remains is natural immunity. However, for others, “long COVID” becomes a fact of life, leaving many with fatigue, shortness of breath, “brain fog,” depression, and other symptoms. To study this condition, the National Institutes of Health has 

 the REsearching COVID to Enhance Recovery (RECOVER) Initiative and awarded roughly $470 million to create a national study population of diverse volunteers as well as support large-scale studies on long-term effects of COVID-19.1 The funding is supported by the American Rescue Plan.

The research will include children, adults, and pregnant people, who have been enrolled either during the acute or post-acute phases of infection. It is expected to look at incidence and prevalence of long COVID, symptoms, underlying causes, risk factors for having lingering symptoms, and outcomes. Data from the initiative’s cohort is expected to include clinical information, laboratory tests, and analyses of participants who were in various stages of recovery following infection. Access to this information is expected to help accelerate research.

In the press release for the program, Walter J. Koroshetz, MD, director of National Institutes of Health’s National Institute of Neurological Disorders and Stroke as well as one of the RECOVER co-chairs said, “given the range of symptoms that have been reported, intensive research using all available tools is necessary to understand what happens to stall recovery from this terrible virus. Importantly, the tissue pathology studies in RECOVER will enable in depth studies of the virus’s effects on all body systems.”

This article was originally posted on Contemporary Pediatrics®.

1.National Institutes of Health. NIH builds large nationwide study population of tens of thousands to support research on long-term effects of COVID-19. Published September 15, 2021. Accessed September 15, 2021. 

https://www.nih.gov/news-events/news-releases/nih-builds-large-nationwide-study-population-tens-thousands-support-research-long-term-effects-covid-19

Long COVID remains a mystery, more than a year after the condition first arose. To find answers, the National Institutes of Health (NIH) has created a research initiative, awarding grants totaling roughly $470 million.

NIH awards $470 million to long COVID research

The newly released US Commission on Civil Rights report, 

, analyzes the federal government’s responsibility to act in reducing racial maternal health disparities, including reducing maternal death and poor pregnancy-related health outcomes.

A public virtual briefing was held in November 2020

 by the Commission to gather information from experts such as health care providers, advocates, government officials, academics, and impacted persons.

“Testimony received by the Commission shows the federal government can play an influential role in reducing racial disparities in maternal health outcomes. Improving access to quality maternity care for women is critical, including preconception and inter-conception care to manage chronic illness and optimize health; prenatal care; delivery care; and postpartum care for 12 months post-delivery, all of which is necessary for improving pregnancy-outcomes,” Norma V. Cantú, chair of the U.S. Commission on Civil Rights, told 

According to the report, Black women are 3 to 4 times more likely to die than White women from pregnancy-related complications. Pregnancy-related complications are over 2 times more likely to kill Native American women.

The Commission’s research found that in 2004, 45% of US rural counties did not have obstetrics services in hospitals. It reported that services grew by 9% in 10 years, totaling 54% by 2014, but this growth is inadequate. The most severe impacts for maternal racial health disparities were in states with the strictest Medicaid eligibility requirements, and in largely Black counties. “Black women were found to be 10 times as likely as White women to live in a county that had no in-hospital obstetric services and 4 times as likely to live in a county where hospital obstetric services had recently closed,” the Commission reported. Reductions in care maintain and increase racial health care disparities, according to the Commission, “as many obstetrics services are being cut from hospitals that serve Black women in rural America, who experience some of the worst birth outcomes in the US.”

The Commission reported that Blacks and Latinos make up almost 1/3 of the US population, “yet Black and Latino health care professionals each make up only 3% to 6% of the total, and only about 9% of physicians identify as Black, Latino, or Native American.”

"At the federal level, efforts can be made to improve hospital quality, particularly for women of color if maternal health disparities are to be eliminated.” Cantú said in a 

. She noted that safety culture improvements are correlated with better maternal health outcomes. “One recommendation for improving safety in maternal health care is to implement standardized care practices across hospitals and health systems and to standardize data collection systems,” she said.

As a call to action, the Commission recommended the following to reduce racial maternal health outcomes as a distillation of the report in the email interview with 

Increase cultural competency training, including implicit bias training, among health care workforces.

Improve the quality of maternal health care through the development of a plan for collaborative partnerships with hospitals and their ambulatory providers to implement evidence-based, culturally sensitive training, education, and best practices.

Endorse the best practice of having a maternal ‘check-up’ prior to the standard 6-week infant check-up and continuing ‘maternal-focused’ checkups for at least 1 year postpartum.

Encourage health care providers to screen for postpartum depression in the first visit.

Provide physicians with objective checklists to screen for common postpartum complications such as cardiomyopathy, embolism, and infection.

Ensure that rural and Native-servicing health care centers have adequate resources to provide this more robust care.

A program in North Carolina is being hailed for promoting evidence-based quality maternity care and should be scaled and replicated nationwide, according to the Commission. The program is known as 

, which improves the quality of perinatal care among Medicaid customers and provides increased access to comprehensive care for women receiving Medicaid.

Develop a statewide framework for scaling home visiting programs. Home visiting has been shown to improve both maternal and infant health outcomes.

Invest in community-based programs to hire women from the community to provide doula support, home visiting, care navigation, breastfeeding, postpartum classes, and childcare assistance.

US Commission on Civil Rights. Racial disparities in maternal health, 2021. 

https://www.usccr.gov/files/2021/09-15-Racial-Disparities-in-Maternal-Health.pdf

. Published 2021. Accessed September 17, 2021.

The report released on September 15 reveals that racial maternal health disparities have greatly increased over the last 30 years, and the federal government has an active role to play in reducing them.

Government has important role in reducing racial maternal health disparities

We spoke with Hadine Joffe, MD, MSc about what to expect from this year's North American Menopause Society's (NAMS) Annual Meeting.

Here's what's coming up this week on Contemporary OB/GYN®.



This week on Contemporary OB/GYN®: Sept. 20 to Sept. 24

Mexico’s Supreme Court decriminalizes abortion

As parts of the United States enact tough anti-abortion legislation, Mexico’s Supreme Court 

President Biden Declares September 2021 National Ovarian Cancer Awareness Month

 means more funding for research initiatives.

Visby Medical gains FDA approval for Sexual Health Click Test

Associate Editor Lindsey Carr sat down with Gary Schoolnik, MD, Visby Medical’s Chief Medical Officer, to 

learn more about the device’s functionality and application

Balstilimab for patients with metastatic cervical cancer

 demonstrate that the anti-programmed death-1 (PD-1) antibody balstilimab from Agenus Inc. provides meaningful and durable clinical activity in patients with previously treated, recurrent/metastatic cervical cancer.

 as a physician during the second wave of COVID-19, and shares some insight into ways other health care professionals can cope.

It was a busy week for the Contemporary OB/GYN® team. 

In case you missed it: September 13 to September 17

Holly Wyatt, MD is a practicing physician and clinical researcher at Anschutz Health and Wellness Center in Aurora, Colorado. She also is co-founder and medical director for The State of Slim—a weight loss program designed with long-term strategies for weight loss. Her interests include obesity, weight management, and metabolism.

Although medicine is not often associate with mindset, Wyatt believes it is the most important factor of wellness. Wellness, according to Wyatt, is perfectly described by tao (pronounced “dow”). Tao is defined as a term used as a convention to refer to something that otherwise cannot be discussed in words. “It’s hard to put into words. That’s our challenge. It’s a way of being,” Wyatt emphasized. “In medicine, we like certainty. We like P values. We like to know if something is true or something is not true,” she said. "Wellness is not going to be that.”

Wyatt first began her career tackling obesity, rather than wellness, with patient-focused diet and exercise plans. She called this the “what

is actually what pauses [patients] to take on the 

” she said. The second half of Wyatt’s career was focused on motivation and healthy lifestyles, aligning the “what” with the “why.” “It can’t just be about losing the weight. We have to begin with the end in mind,” she said.

Wyatt emphasized transformative weight loss, which she describes as “the process of creating and aligning a new reduced body weight, a positive and emotionally resilient mindset, and a bigger purpose and spirit with your new way of living and being.

Mindset is crucial to wellness, Wyatt said, and it should focus not on what we want to prevent, or get rid of, but what we can accumulate and be. During her session, Wyatt said that “wellness involves turning around and thinking, ‘Where 

Wellness today has evolved to be more than improving health, or the absence of disease.

Wellness is a path and a mindset, more than a fixed algorithm or set of outcomes to achieve.

A wellness mindset involves turning around and seeing the possibilities that exist and taking action to move in a direction to experience it.

Wyatt, H. 2021, September 21. Session: The Tao of Wellness. North American Menopause Society 2021 Annual Meeting, Washington, D.C.

Holly Wyatt, MD’s session, "The Tao of Wellness," kicked off the North American Menopause Society’s (NAMS) 2021 Annual Meeting. It was the springboard for the Utian Translational Science Symposium, themed “Charting the Path to Health in Midlife and Beyond: The Biology and Practice of Wellness.”

Wellness requires a shift in mindset

The meeting will continue this week until September 25, 2021. To register or find get more information, visit 

As the leading medical conference dedicated to promoting women’s health at midlife and beyond, 

 offers comprehensive and exciting updates on the most relevant issues relating to menopause and midlife women’s health. 

This year’s Translational Science Symposium will focus on the biology and practice of 

during which attendees can expect to gain a novel, foundational framework for the concept of wellness and learn behavioral approaches to promote healthy aging in clinical practice.

The meeting is supported by The National Institute on Aging of the National Institutes of Health under Award Number R13AG069384.

as we cover critical topics in midlife women’s health, including:

Throughout the meeting, attendees will have the opportunity to earn 29 high-quality continuing education credit hours.

For registrants unable to attend the meeting in person, content also will be available on demand. The 

 will provide registrants with a digital library of presentations from the 2021 NAMS Annual Meeting, Pre-Meeting Symposium, and Menopause 101 Course.

Check in throughout the week for the latest coverage from the North American Menopause Society’s (NAMS) Annual Meeting, which is being held Sept. 22-25 in Washington, D.C. 

The North American Menopause Society’s 2021 Annual Meeting has officially begun

Hadine also is the Executive Director of the Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital. Her primary research interest is in the mechanisms, inter-relationships, and treatment of menopausal symptoms in healthy women and women with breast cancer.

The theme of this year’s meeting is “The State of Midlife Women’s Health,” which illustrates the interdisciplinary nature of the conference and NAMS as an organization.

“Although most of our membership is gynecology and primary care, we do include people who have expertise in other areas, including myself, as psychiatrists, and people who are involved in all aspects of the health of women,” Joffe told 

®. “We, as clinicians, are committed to the whole woman. We are midlife women’s health-focused. That reflects and represents the broad, whole person that we are thinking about and interested in.”

Among topics covered include midlife women’s policy and the intersection of clinical care, gene editing, and the art of end-of-life care.

“When we’re providing care to people in this age group and thinking about the science that informs the care that we give them, those are critical aspects,” Joffe said.

The conference began on Tuesday with a focus on wellness. Speaker Holly Wyatt, MD, discussed "The Tao of Wellness," during which she outlined a framework for identifying and measuring wellness with patients. “There is a lot of data that actually show that, how people enter, and what their health at midlife is, sets them up for success with aging, BMI, physical, mental, and social health,” Joffe said.

“Wellness is so much broader than just physically. It’s the whole person. The person in her world, in her community, her roles and identity, responsibilities in the society she lives in, and her sense of self. It’s a framework that’s very proactive,” Joffe said.

“Wellness is a broad construct,” she said, “and focuses on a sense of meaning and connection and effectiveness, and also knowing that there are challenges and limitations. It’s being able to be as resilient and resourced, personally and community-wise, with inevitable challenges.”

Check in to Contemporary OB/GYN® throughout the week to get the 

This week, Contemporary OB/GYN® will be covering the North American Menopause Society’s (NAMS) 2021 Annual Meeting, which is taking place Sept. 22-25 in Washington, D.C. We spoke with NAMS President Hadine Joffe, MD, MSc about wellness at midlife and why it is crucial in menopause. 

What you need to know about wellness at midlife

Rimola is a practicing ob-gyn with Inova Health System in Vienna, Virginia, and co-chair of the NHMA for the Washington, D.C., metro area. The NHMA will be stepping up its efforts to get the Hispanic population vaccinated during National Hispanic Heritage Month, which will be held from September 15 to October 15.

Videos

In this interview with Contemporary OB/GYN Senior Editor Angie DeRosa, Sergio Rimola, MD, discusses the Vaccinate4All campaign of the National Hispanic Medical Association (NHMA) and how ob-gyns can approach discussions with their LatinX patients. 

Vaccine campaign focuses on Hispanic population

In a recent study, “A novel sublingual vaccine will dramatically alter the clinical management of recurrent urinary tract infections in women,” presented at the 2021 AUA annual meeting, J. Curtis Nickel, MD, and a team of investigators found that the novel MV140 vaccine is a safe and effective strategy for treating rUTI in women.1 Nickel is a professor in the department of urology at Queen’s University and a urologist at Kingston and Hotel Dieu General Hospitals, Kingston, Ontario, Canada.

According to Nickel and his coinvestigators, MV140 is a polybacterial sublingual vaccine, consisting of E. coli, K. pneumoniae, E. faecalis and P. vulgaris, which induces a T-cell specific adaptive and an immune response at the genitourinary tract.

The findings shared at the AUA meeting included results from early uncontrolled studies, the first phase 3 multicenter, double-blind, placebo-controlled randomized controlled trial (RCT), ongoing safety monitoring from special access programs (SAP; 2014-2020), and the first North America (NA) clinical experience evaluating MV140 (Uromune) for the prevention of rUTI in women.

Across 5 uncontrolled studies, results found that 1408 women treated with MV140 had significantly higher UTI-free rates (35% to 90%) compared to 499 women treated with antibiotics (0% to 9%). Additionally, the RCT revealed UTI-free rates of 55.7% at 3 months and 58.0% at 6 months, while the placebo group exhibited a rate of 25%. The median number of UTIs in MV140-treated patients within this study were 0.0 (IQR, 0.0-1.0), compared to 3.0 for placebo patients (IQR, 0.5-6.0).

As for the ongoing SAP study, only 1.7% of over 20,500 patients reported adverse reactions. And in the NA study, patients experienced a 48% UTI-free rate with an overall 82% reduction in UTI episodes. Only 1 patient had 2 mild vaccine-related adverse reactions in this study.

Taken as a whole, these findings suggest a potential, evidence-based alternative to standard antibiotic regimens in treating patients with rUTI.

Further discussion with study investigator J. Curtis Nickel, MD

Please provide the background for this study.

Recurrent urinary tract infections in women are a major health care issue. It's not really associated with mortality; it's associated with a lot of morbidity. With more than half of women having a UTI sometime in their life, about 40% of them will be classified as having recurrent urinary tract infections. That's more than 3 per year, and for many that can be, on average, about 6 a year. So, 3 out of 100 women every year are classified of having recurrent urinary tract infections.

The way we manage those are using things like cranberry extract, probiotics, and certainly intervaginal estrogen for perimenopausal and postmenopausal women. But the only treatment that's really effective is antibiotics—either episodic antibiotics or long-term prophylactic antibiotics that are taken for weeks and months. The antibiotics themselves are problematic. There is cost to patient and society, there is the detrimental effect of antibiotics on the patient with adverse events or effects, sometimes being quite serious and even irreversible. Antibiotics only work as long as the patient is taking the antibiotic. And then we have the rising spectra of national and international antibiotic resistance, which is becoming a huge international medical issue.

In the abstract, the vaccine is described as “game changing.” Can you explain why that’s the case?

Right now, there is a huge unmet need in women's health for some way to prevent recurrent urinary tract infections. I mentioned the methods that we have, and the only one that really works well is intervaginal estrogen in peri- and postmenopausal women, but it doesn't work in all. We discussed the problems associated with antibiotics. So, what we're looking for is some safe and effective intervention that will completely change the way we manage recurrent urinary tract infections in women. I and others have always believed that the answer would be a vaccine. Over the last 20 years we've looked at vaccines, and there are vaccines available with some efficacy, but not enough to change the game from antibiotics to something safer and more effective. That's why I think this vaccine, with its effectiveness and safety, will be a major game changer.

What were some of the notable findings from this study? Were any of them surprising to you and your co-authors?

I am always surprised when a large, well-planned, randomized, placebo-controlled trial is positive or even more positive than we thought with early observational, uncontrolled studies. And we do have evidence from at least 5 studies that this sublingual vaccine is effective and safe. I have the only early clinical experience in North America, having had over 65 patients vaccinated and having followed them, some for over a year. So, I know the vaccine works. But we're always wondering whether or not it would show in a randomized, placebo-controlled study and this study met and exceeded the endpoint in reducing the risk and preventing urinary tract infections.

What is the next step? What will future research on MV140 focus on?

In this particular study, we were able to show that there was a very clinically significant decrease in the rate of UTIs in the vaccinated group, preventing UTIs in almost 60% of vaccinated patients. We found that if patients did get a UTI, and there was a significant median time to UTI that was many times greater in the vaccinated group, it was usually mild and self-limited. The study went for 9 months. Based on real world experience with this vaccine in special access programs outside North America, we believe that the vaccine efficacy may wear out after a year or 2. So, future studies are going to have to look at re-vaccinating patients who revert back to their recurrent urinary tract infection state.

Further, there is some evidence in observational studies that's effective and complicated, showing outcomes for UTIs in the frail elderly, in children and in men, we're going to have to look at all those groups. This could be a game-changer for recurrent urinary tract infections in children who rely on antibiotics. It could be a game changer in the frail elderly, particularly those in long-term care homes, where UTIs are a significant problem, even causing mortality and antibiotic over utilization. We'd also like to see it used in complicated UTIs in men. All these are going to have to be studied, and that's why it's so exciting. This vaccine has legs to run on.

What is the take-home message for the practicing urologist?

The take-home message for international urologists is that this vaccine is available on named patient programs or special access programs. Unfortunately, that's not the case for North America. Health Canada realizes the huge unmet need and is going to be looking at regulatory approval on an expedited basis based on the observation studies, the special access program safety audit on over 20,000 patients have already received this, the Canadian early experienced trial that we're doing and the RCT. We may have approval in Canada for this vaccine for Canadian women with recurrent UTIs sometime next year. The FDA is going to probably look at this data and advise whether or not further studies will be required in the United States before it's widely available in the United States either under special access programs, or across the board. It'll take a little time in the United States. Vaccines are a little more problematic in United States compared to the rest of the world.

Is there anything else you feel our audience should know about the research?

It's exciting research. The randomized, placebo-controlled study has replicated all the previous studies, looking at recurrent urinary tract infections and this vaccine. The other thing they should realize is that it is a vaccine that is self-administered by the patient sublingual over 3 months. That is why it appears to be so safe. It's not an injected vaccine. The immunity builds up very slowly over 3 months, and it persists for 9 months. We'll see how long that durability effect is over the long term, but keep your eyes and ears open because, like I said, this vaccine will be a game changer for women's health in the future.

1. Nickel JC, Lorenzo-Gómez MF, Foley S, Saz-Leal P. A novel sublingual vaccine will dramatically alter the clinical management of recurrent urinary tract infections in women. Paper presented at: 2021 American Urological Association Annual Meeting; September 10-13, 2021; virtual. Abstract PLLBA-02.

This article was originally published on Urology Times®.

Women who suffer from recurrent urinary tract infections (rUTIs) are typically treated with antibiotics. These treatment regimens, however, are associated with high rates of morbidity as the world faces rising antibiotic resistance.