The monkeypox vaccine Jynneos has emergency approval for use with adult patients determined to be at high risk for 

The U.S. Food and Drug Administration (FDA) announced an 

 (EUA) for Jynneos (Modified Vaccinia Ankara vaccine), first approved in 2019 for prevention of smallpox and monkeypox disease in adults aged 18 years and older. The EUA for a fraction of the dose administered by intradermal injection, will increase the total number of doses available by up to five-fold, according to the FDA’s Aug. 9 announcement.

 in patients younger than 18 years and determined to be at high risk of monkeypox infection. They will receive the vaccine by subcutaneous injection.

In both cases, two doses of the vaccine, given 28 days apart, are needed because there is no data to indicate one dose will provide long-lasting protection needed to control the current outbreak, according to FDA.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” FDA Commissioner Robert M. Califf, MD, said in the agency’s announcement. “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.”

A 2015 clinical study of the vaccine evaluated the two-dose series given intradermally compared to subcutaneously. Patients who received it intradermally received 1/5 the volume of those who received it subcutaneously, and both forms produced similar immune responses, according to FDA.

Patients with intradermal injection reported more redness, firmness, itchiness and swelling at the injection site, but less pain, and the side effects were manageable. “The FDA has determined that the known and potential benefits of Jynneos outweigh the known and potential risks for the authorized uses,” the agency’s announcement said.

The Jynneos vaccine involves 0.5mL for the subcutaneous administration, but 0.1mL for intradermal administration under the EUA, according to the federal 

Centers for Disease Control and Prevention

Another vaccine, ACAM2000, is approved for immunization against smallpox and is available for use against monkeypox under an Expanded Access Investigational New Drug (EA-IND) protocol, according to CDC.

For both vaccines, no data are available on the efficacy or effectiveness in the current outbreak. People who are vaccinated should continue to take steps to protect themselves against infection, including avoiding close, skin-to-skin contact and intimate contact with someone who has monkeypox, according to CDC.

As of Aug. 10, FDA was not recommending vaccination for the general public, but for 

 to monkeypox. “Currently, a high rate of the known cases in the U.S. are among gay and bisexual men and transgender and non-binary people, but this virus is not limited by sexuality or gender,” FDA said.

/orthopoxvirus cases, with 2,104 cases in New York, 1,310 cases in California, and 976 cases in Florida, leading the national count, according to CDC.

This article originally appeared on Medical Economics®. 

Image credit: The U.S. Food and Drug Administration published this image of a colorized scanning electron micrograph of monkeypox virus (orange) on the surface of infected VERO E6 cells (green). The image is credited to the National Institute of Allergy and Infectious Diseases.

Articles

Smaller dose given by intradermal injection creates five-fold increase in total supply, FDA says.

Monkeypox vaccine gets emergency approval to increase vaccine supply

Medical and insurance organizations generally reacted favorably to the Senate’s Aug. 7 approval of the 

This week, the House of Representatives is expected to begin deliberating on the law, which has at least three national-level effects on health care:

Medicare will be allowed to negotiate drug prices.

Seniors’ out-of-pocket spending on prescription drugs will be capped at $2,000.

Subsidies will continue for patients purchasing health insurance through the Affordable Care Act Marketplace.

The American College of Physicians (ACP) praised the legislation to improve access to health care and improve health for all Americans, President Ryan, D Mire, MD, FACP, said in a 

“We are glad to see that the final version of the legislation still includes many of the important provisions that we 

 when the agreement was announced,” Mire said. “Subsidies for health insurance plans under the Affordable Care Act will be extended for three additional years, Medicare will now be allowed to negotiate lower drug prices with manufacturers, and the legislation will help to reduce carbon pollution and advance clean energy solutions. We are also encouraged that the legislation will cap insulin costs for Medicare beneficiaries, allowing our senior patients to more easily afford this life-saving medication. We look forward to the House taking up the bill and call on them to swiftly pass it.”

The Association of American Medical Colleges (AAMC) said the legislation will invest $64 billion for the ACA insurance subsidies.

“As the COVID-19 pandemic has highlighted many disparities in access to coverage and care, we commend senators for agreeing on a bill that will allow patients and families to maintain access to affordable coverage, empowering them to seek care before treatable conditions become more complicated and costly,” AAMC President David J. Skorton, MD, said in a 

. “Additionally, the high cost of prescription drugs often prevents patients from obtaining the medications they need. We support efforts to lower drugs costs and increase access to affordable medications.”

Louise Norris, health policy analyst for consultant 

“This is excellent news for the 13 million Americans who rely on premium subsidies to make marketplace health coverage affordable. Larger and more widely available subsidies have led to record-high marketplace enrollment,” Norris said. “Without action from Congress, millions of people will likely see their subsidies decrease or disappear in 2023, and 3 million current enrollees might lose their coverage altogether. The Senate’s vote to pass this legislation is a step toward ensuring these hard working Americans will still be able to afford their health coverage next year, and we hope to see it pass quickly in the House.”

The Endocrine Society issued a statement praising the IRA for addressing high insulin costs. More than 7 million people rely on insulin to manage diabetes and live, and the U.S. Centers for Disease Control and Prevention logged 37.3 million people with diabetes – 11 % of the nation’s population.

Insulin nearly tripled in price from 2002 to 2013, with the upward trend continuing.

The Endocrine Society noted the Senate missed an important opportunity to also help children and adults with type 1 diabetes when 43 Republicans voted against including a provision that would have capped out-of-pocket costs for individuals with private insurance, that the society supported.

, President Joe Biden led with the potential health care benefits, noting the IRA will lower the costs of prescription drugs and health insurance, along with other provisions of the bill. Biden said he ran for the post “promising to make government work for working families again, and that is what this bill does – period.”

 the new law will have a negative effect on innovation in the pharmaceutical industry, which in turn will have consequences for health of Americans.

Using “savings” from drug price controls to cover ACA insurance “would lead to a massive loss of life, due to foregone medical innovation, and a reduction in the quality of care, due to the government gaining more control over people’s insurance coverage,” former White House economic adviser 

Medicare drug prices, insulin costs affected by Inflation Reduction Act.

Medical, insurance groups praise Senate action on health insurance

Benefytt Technologies, Inc., a marketer of health care plans, could have to refund $100 million to customers and face additional penalties under a complaint filed against the company by the 

According to an FTC news release, the complaint alleges that Benefytt, two subsidiaries, and two of its top executives lied about the coverage the company’s plans provided. It also says that Benefytt used deceptive lead generation websites to lure customers and charged for add-on products without customers’ permission. The complaint names former Benefytt CEO Gavin Southwell and former vice president of sales Amy Brady.

Benefytt, based in Tampa, Florida, sells association memberships and other health care-related products, often through telemarketing companies and lead generators. Southwell was president and CEO of the company from 2016 to 2021, while Brady was vice president of sales for more than a decade before also leaving in 2021.

“Benefytt pocketed millions selling sham insurance to seniors and other consumers looking for health coverage,” Samuel Levine, JD, director of the FTC’s Bureau of Consumer Protection, said in the release. “The company is being ordered to pay $100 million, and we’re holding its executives accountable for this fraud.”

The complaint alleges that Benefytt and its partners used high-pressure sales tactics to deceive consumers into believing they were buying comprehensive health insurance plans and charging hundreds of dollars per month for products and services that left them unprotected in a medical catastrophe. It charges that Benefytt’s sales process harmed consumers by:

 Agents claimed the plans were qualified under the Affordable Care Act, meaning they included benefits such as 

, when the plans were not even comprehensive health insurance

Bundling and charging fees for unwanted products:

 Plans often included products such as life or accident insurance and fitness programs, and did not clearly disclose the separate costs of these products so consumers were unaware they were buying them

 The complaint charges that consumers who called to cancel their plans were often transferred to the sales agents who deceived them in the first place.

The release says that Benefytt and two of its subsidiaries have agreed to a proposed court order that would require them to:

Pay $100 million to the FTC, which the FTC will refund to consumers harmed by the defendants’ practices

Notify current Benefytt customers of the FTC’s complaint against the company and allow them to cancel their enrollment. The company must also refund payments made after the court order is approved to customers who cancel immediately

Stop misleading consumers about their products’ features, including whether they are ACA-compliant, disclose facts such as total costs and limitations prior to purchase, and get customers’ 

Closely monitor all companies selling their products to ensure they aren’t using deceptive or misleading sales tactics

Separate proposed court orders would prohibit Southwell and Brady from playing any role in selling or marketing any health care-related product or service.

The complaint and proposed final orders were filed in the U.S. District Court for the Middle District of Florida. They become enforceable after they are signed by a judge.

Benefytt Technologies, Inc. would have to refund $100 million and stop misleading customers about coverage.

Health insurance marketer faces fines, sanctions for lying about plans it sells

The increases were highest for Hispanic and non-Hispanic Black women.

“We are very familiar with the potential and limitations of current data on maternal death,” said co-author Eugene Declercq, PhD, a professor of community health sciences at Boston University School of Public Health in Massachusetts. “Hence, we thought it relevant to use that experience to explore the potential impact of COVID on maternal deaths.”

The study, which used data from the National Center for Health Statistics (NCHS), stratified deaths by month or year: deaths before COVID (2018, 2019, and January to March 2020) and deaths during the pandemic (April to December 2020).

A total of 1,588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic versus 684 deaths (25.1 per 100,000 live births) during the pandemic, for a relative increase of 33.3%.

Late maternal mortality (between 43 and 365 days after birth) increased by 41%.

Absolute and relative changes were highest for Hispanic (increases of 8.9 per 100,000 live births and 74.2%, respectively) and non-Hispanic Black women (16.8 per 100,000 live births and 40.2%) compared to non-Hispanic White women (2.9 per 100 000 live births and 17.2%).

For underlying cause-of-death codes, the largest relative increase was among indirect causes (56.9%), specifically other viral diseases, diseases of the respiratory system and diseases of the circulatory system.

Relative increases in direct causes (27.7%) were mostly linked to diabetes in pregnancy (95.9%), hypertensive disorders (39.0%) and other specified pregnancy-related conditions (48.0%).

COVID-19 was also commonly listed as a secondary condition with other viral diseases and diseases of the respiratory system.

“The somewhat surprising finding was the high rate of COVID cases (32%) among Hispanic mothers and the 74% increase in maternal deaths in this population,” Declercq told 

. “For a number of years, Hispanic mothers have had a maternal mortality rate lower than non-Hispanic White mothers. However, during the 9 months of the pandemic, Hispanic maternal deaths rose so quickly that their maternal mortality ratio slightly exceeded that for non-Hispanic Whites.”

The study focused on public health rather than clinical concerns. “Our findings suggest that the notable efforts that maternity care providers have engaged in to improve hospital outcomes need to be extended to community-level care for prevention of not only COVID infections, but future infectious diseases as they arise,” Declercq said.

The expansion of women’s health services to reduce what the March of Dimes has described as “maternity care deserts” and allow for a more robust response to subsequent outbreaks can help reduce racial and ethnic disparities, according to Declercq, who noted that the pandemic exacerbated existing disparities.

“Mortality ratios for non-Hispanic Black mothers rose to an astonishing 59 per 100,000 during the first 9 months of the pandemic, a ratio that would rank close to 100th in the world,” he said. “While some of that increase appears related to COVID cases, the proportion of COVID cases as a multiple cause of death among Black women (13%) was not particularly high and therefore the jump in maternal mortality may be related to the continued limitations of care for women of color.”

The critical question is the degree to which clinicians can learn from the pandemic and “establish robust, integrated healthcare systems that serve women at the community and hospital levels, and provide needed supports throughout the lifespan,” Declercq said.

Thomas ME, Declercq ER. All-cause maternal mortality in the US before vs during the COVID-19 pandemic. 

. Published online June 28, 2022. doi:10.1001/jamanetworkopen.2022.19133

Maternal deaths in the United States rose by a staggering 33% after the onset of the COVID-19 pandemic in March 2020, which is a significantly higher percentage than the 22% overall excess death estimate linked to the pandemic, according to a research letter published in JAMA Network Open.

Maternal mortality before and during COVID pandemic

“A body of literature shows associations between neighborhood socioeconomic context and health outcomes,” said first author Mary Willis, PhD, MPH, a postdoctoral research scholar in environmental epidemiology at Oregon State University in Corvallis. “Dozens of studies examine health outcomes related to birth and asthma, for example. However, the world of fertility research is largely focused on individual-level interventions, mainly healthy eating or exercise, as opposed to structural-level interventions that may influence fertility for an entire population.”

The study is the first to directly examine fecundabilty, the per-cycle probability of conception, with respect to neighborhood deprivation, according to Willis. “We do not know what factors in the neighborhood environment may be most important for fecundability,” she told 

. “Our team hypothesized that it could be anything from crime levels to community poverty to green space access.”

The prospective preconception cohort study, which used baseline data from the Pregnancy Study Online, comprised 6,356 participants, aged 21 to 45 (mean baseline age 30.0 years), who were attempting conception without fertility treatment.

Overall, 83.3% of the participants were non-Hispanic White and 65.7% nulliparous.

Questionnaires were completed every 8 weeks for 12 months, until conception or a censoring event, between 2013 and April 2019.

A total of 3,725 pregnancies were reported for 27,427 menstrual cycles of follow-up.

Comparing the top decile to the bottom decile of disadvantaged neighborhood status, adjusted fecundability ratios were 0.79 (95% confidence interval [CI]: 0.66 to 0.96) for national-level area deprivation index (ADI) rankings and 0.77 (95% CI: 0.65 to 0.92) for within-state ADI rankings.

These connections were slightly stronger among participants with lower annual incomes of less than $50,000.

Willis noted that neighborhood context, including a socioeconomically disadvantaged neighborhood environment, “is a complex phenomenon that encompasses a variety of chronic stress exposure pathways.”

Public policies that influence decisions about neighborhood investment, as well as disinvestment like redlining, “may perpetuate a cycle of chronic stress and continued neighborhood socioeconomic disadvantage,” Willis said. “For instance, higher neighborhood unemployment has been associated with decreased population-level fertility rates.”

Likewise, less affluent areas often have higher concentrations of air pollution, resulting in adverse fertility outcomes.

“In addition, less affluent areas may have fewer amenities, such as green spaces, to restore capacity in residents to reduce stress,” Willis said.

By contrast, urban renewal programs demonstrate positive health benefits for local populations.

“Both income and educational attainment may be influenced by neighborhood disadvantage earlier in life; therefore, they are potential mediators of the exposure-outcome association,” Willis said. “However, our study examined neighborhood disadvantage in adulthood.”

If people are socially immobile, there would likely be similar ADI levels over time, “so we could argue that educational attainment and income in adulthood are mediators,” Willis said. “On the other hand, if we assume a noteworthy change in neighborhood context with the transition from adolescence to adulthood, it is more probable that these socioeconomic attributes, along with race and ethnicity, influence the neighborhoods in which people live as adults, although these residential locations may not be by choice.”

Therefore, adjusting for individual socioeconomic factors depends largely on the conceptual framework. “Disentangling the influence of individual versus neighborhood factors may not be possible,” Willis said. “Nonetheless, if our results can be confirmed by other studies, I hope it will inspire clinicians to think about fertility in a structural context.”

Willis MD, Orta OR, Ncube C, et al. Association between neighborhood disadvantage and fertility among pregnancy planners in the US. 

. Published online June 30, 2022. doi:10.1001/jamanetworkopen.2022.18738

Residing in a socioeconomically disadvantaged neighborhood was linked to moderately decreased fecundability, according to a study published in JAMA Network Open.

Neighborhood disadvantage and fertility rates

You can reach her a lcarr@mjhlifesciences.com.

Vivjoa approved for recurrent vulvovaginal candidiasis

Oteseconazole is a treatment option for those living with a previously unmet medical need.

Correct terms and education can help normalize the conversation for patients.

Smaller dose given by intradermal injection creates five-fold increase in total supply, FDA says.


In case you missed it: August 8 to August 12

Neonatal Antimicrobial Stewardship Programs (ASPs) can decrease antibiotic initiation at birth, according to a recent study published by the 

Early-onset sepsis is a condition which leads to greater chances of morbidity and mortality in preterm infants. ASPs are put into place for high-risk infants to mediate the adverse effects of antibiotic exposure with the need for empiric treatment.

In the study, preterm infants with a gestational age of less than 34 weeks were reviewed 6 months after ASP was implemented. The review consisted of comparisons for the presence of perinatal sepsis risk factors, along with the effectiveness of initial empiric antibiotics treatment.

There were 479 infants involved in the study, with an average gestational age of 30 weeks and a birth weight of 1400 g.

In the pre-ASP infants, there was a 73.6% presence of sepsis risk factors, while post-ASP infants had a 68.4% presence of sepsis risk factors. Initial antibiotics were not given to 42% of infants despite risk factors, while 20% did not have perinatal sepsis risk factors and were not treated.

Investigators encouraged neonatal ASP teams to think about the dangers of antibiotic use.

Stritzke A, Tierney A, Keister F, Srivastava A, Dersch-Mills D, Hamilton C. Antimicrobialstewardship at birth in preterm infants. 

. 2022;41(5)394-400. doi:10.1097/INF.0000000000003462


This article originally appeared on Contemporary Pediatrics®. 

ASP treatment lowered the presence of sepsis risk factors in preterm infants.

Antimicrobial Stewardship Programs decrease antibiotic initiation at birth

The psychological effect of birth weight leads to the most attention problems in children aged 9 to 10, according to a recent study.

In previous studies, children with lower birth weights were seen with more symptoms of attention-deficit/hyperactivity disorder (ADHD). This study set out to model the continuous dose–response association between birth weight and psychological outcomes.

Specificity was defined as one of the criteria for the study, to determine if the psychological effects caused by low birth weight are specific to attention problems. In many prior instances of association, other disorders were found in children, such as affective disorders, schizophrenia, substance-use disorders, and stress-related disorders. Because of this information, it is not certain that birth weight effects are specific to ADHD.

One study found that birth sex was associated with birth weight and issues of mental health that followed. Male children were more likely to have negative effects from lower birth weight than female children. Other studies contradicted this information, indicating that there was no difference in mental illnesses brought on by low birth weight between sexes. To address this contradiction, investigators tested for how sex might affect the outcome of the study.

Given the difference between gestational age and fetal growth, investigators wanted to determine which of these factors was associated with mental health issues because of low birth weight.

Data was analyzed from the Adolescent Brain Cognitive Development (ABCD) study, a study of children aged 9 to 10 years representing a wide range of demographic and socio-economic diversity within the United States. Just over 9000singleton-born participants wereselected to take part in the study.

Parents of the children in the study reported birth weight in pounds and ounces, which researchers converted into kilograms. If ounces were not included in the measurement, the number of pounds was rounded to the nearest number of kilograms. Children with an unlikely small weight or a gestational age lower than 28 weeks were excluded from the analysis.

Parents filled out a Child Behavior Checklist (CBCL) containing subscales on their children’s behavior patterns. These subscales included: anxious-depressed, withdrawn depressed, somatic complaints, social problems, thought problems, attention problems, rule breaking behavior, and aggressive behavior. The presence of autism spectrum disorder (ASD) was also noted in children. Finally, family history of mental illness and socioeconomic factors were asked about in the survey.

When examining birth weight, attention problems was the most common subscale noted. After controlling for gestational age alongside other variables, the only results observed were attention problems and somatic complaints. Of all the subscales, sex only had a major effect on attention problems, with male children having more attention problems than female children. ASD was also not associated with birth weight.

Investigators noted how the results of their study contrasted with prior studies. They recommended a variety of study designs on the subject.

Dooley, N., Clarke, M., Cotter, D. et al. Birth weight and childhood psychopathology in the ABCD cohort: association is strongest for attention problems and is moderated by sex. 

 50, 563–575 (2022). doi:10.1007/s10802-021-00859-0


This article originally appeared on Contemporary Pediatrics®.

Investigators found that symptoms of attention-deficit/hyperactivity disorder were more often seen in children with a lower birth weight.

Low birth weight associated with attention problems in children

 issues saw a massive increase during the height of the 

, largely due to eased restrictions on its use, a new report shows.

Insurance company UnitedHealth Group used data from its subsidiary Optum Behavioral Health to measure trends in in-network, outpatient behavioral health visits from 2019—the year before the pandemic-- through the second quarter of 2021. It found a 5,700% increase in telehealth visits during the period, more than offsetting a 55% decrease in office-based visits. The total number of visits grew by 26% during the period.

The biggest jump in telehealth visits as a percentage of all visits occurred between the end of 2019, when they were virtually nonexistent, and the second quarter of 2020, by which time they accounted for 74% of them. The percentage then gradually declined to 65% by the end of the period.

“Prior to the COVID pandemic, telehealth was broadly viewed as a potential strategy for improving access to behavioral health care,” the report says. “During the pandemic— which saw increased rates of depression, anxiety, and 

—federal and state policymakers and commercial health plans established temporary flexibilities to increase access to care, and patients and providers increased their use of virtual visits as an alternative to in-person office-based care.”

Measured by type of provider, the largest increase in visits—46%--occurred among counselors and therapists. That was followed by clinical social workers (30%), psychiatrists (10%), psychologists (9%), and psychiatric nurse practitioners (4%).

The report notes that telehealth, combined with greater flexibility in clinician licensing rules at the start of the pandemic, lessened the need for geographic proximity between patients and providers. From 2019 to 2020 there was a 32% increase in visits among patients and providers located in different states, and a 22% increase where patients and providers were in different counties in the same state.

The report cites three benefits of telehealth that may have contributed to the rise in its use as well as behavioral health visits overall:

Clinical effectiveness, which can be equal to or greater than office-based care;

Increased provider capacity due to reducing barriers to care resulting from provider availability and location and reduced patient no-show rates; and

Improved access to care by enabling patients to see providers in other states, to get treatment without missing work or incurring travel time and costs, and being able to receive care in a comfortable, private, and convenient location

The report notes that making the flexibilities introduced at the start of the pandemic permanent would improve access to behavioral care for both patients with commercial insurance and those covered by Medicare and Medicaid. But better access would also require addressing disparities in 

, improved digital literacy and increasing the number of behavioral health providers.

This article originally appeared on Medical Economics®.

Loosened restrictions during pandemic have eased access barriers, report finds

Outpatient behavioral health visits rise due to greater telehealth use

nflation rose 8.5% in July compared to a year ago, a slightly slower pace than last month. The decrease was mainly due to declining gasoline prices, which dropped 7.7%.

Prices were flat as energy prices declined 4.6%. This helped offset a 1.1% monthly gain in food prices and a 0.5% increase in shelter costs. Most economists expected the Consumer Price Index to rise 8.7%, so 8.5% was welcomed by investors.

The core CPI, which excludes food and energy prices because of their volatility, rose 5.9% annually and 0.3% monthly, compared to estimates of 6.1% and 0.5%.

Food continues to increase in price, with a jump of 10.9% over the last 12 months, a pace not seen since the late ‘70s. Electricity prices are up 15.2% compared to last year.

On the decline were used vehicle prices (0.4% monthly decline), apparel (0.1% decrease), and transportation services (0.5% decrease). Airline fares are down 7.8% compared to a year ago.

Overall, inflation is easing but is still near the highest level since the early ‘80s.

With the slightly improved inflation numbers, most economists think the Federal Reserve will limit the next interest rate hike to 0.5%.

Falling energy prices offset modest gains in other categories