Moderna aims for Fall release for omicron, variant-specific COVID-19 vaccine boosters

Moderna has set a broad timeline to deliver a variant-specific COVID-19 vaccine booster just days after asking the Food and Drug Administration (FDA) for authorization to use its vaccine for children. 

“We announced a couple weeks ago a new, variant-specific booster that we’ve been testing, and we have an additional candidate, our lead candidate, in testing now that I believe is going to be even more superior,” Moderna Chief Medical Officer Paul Burton said during an appearance on “Face the Nation.”

“We are confident that by the fall of this year, we should have large amounts of that new booster vaccine that will protect against omicron and other variants, and really protect Americans and people around the world as we go into the fall of 2022.” 

The FDA set a deadline of June for drug manufacturers to submit a formula for variant-specific vaccines. Doses of modified vaccines could cost the U.S. government between $5 billion and $12 billion, The New York Times reported. 

Moderna’s timeline could allow them to meet that deadline, should testing run smoothly and not uncover any issues in the current formulation. 

Modern also recently filed with the FDA applications for the youngest children, aged 6 or younger. 

“The data in the study has been completed, and typically what we then do is package the data electronically for the FDA so they can conduct their own reviews, their own analyses,” Burton said. “That will go in by May 9, but they have the data they need now to begin.”

The vaccine is 37% effective in children aged 2 to 5 and 51% effective on children under 2 years old. The lower effectiveness, Burton argued, is due to the strong virulence of the omicron variant. 

“What it means for parents or caregivers is that if they give the Moderna vaccine to these little kids, they would basically cut in half the risk of that children getting symptomatic COVID,” “I know that 50% is often lower than what we’re used to seeing with our vaccine, but it’s because this study was conducted during omicron.” 

“When we look at the U.K. data that was released last week … exactly there we see vaccine effectiveness of 50%, but when we look at vaccine effectiveness against hospitalization that number 89-95%, so that’s why I think we can be very reassured and very confident in this result.”

Right now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine.

 Medical company creates most accurate 3D model of female anatomy ever

Elsevier has launched “the most advanced 3-D full female model ever available,” according to a recent press release.

“This is the first time that a female model has been built with this level of detail in its entirety, to represent the female — versus replacing specific areas of the male anatomy with female features,” the Elsevier release stated. The company, which is a known leader in publishing research and information analytics, said in the release that this model would help educators for the first time teach, visualize, and edit anatomy entirely from the female perspective using a realistic detailed 3-D model.  

Historically, the female anatomy has been underrepresented in the study of the human body and the company said this is a major milestone in equal representation in helping prepare nursing, allied health and medical students with a complete understanding of the female anatomy, the release said.   

Elsevier says its 3D female model includes the following clear differences from male anatomy models:   

  • The skeletal system will accommodate changes to reflect the boney angles typically seen in the female and will demonstrate differences in areas that differ from males including in the pelvis and skull
  • Accurate portrayal of muscles. The overall volume of muscle mass for each muscle was reduced by approximately 30%, based on research findings comparing male and female demographics.
  • Visually detailed female-specific regions. The female-specific regions have been equally detailed to that of the male. The release stated that breast tissue can be hemisected or quartered to allow the student or instructor to see the underlying tissues with a more accurate distribution and representation of the mammary glands, now shown as nonlactating, unlike most anatomical resources, the release noted. The reproductive organs from the internal and external genitalia have also been remodeled
  • Comparative functionality. The release said that users could switch between the male and female models to allow comparisons throughout the different structures and systems.

“As an advocate for content that is diverse and inclusive, we are thrilled to offer this groundbreaking full female model to allow educators to teach anatomy in an equal and comprehensive way. Complete Anatomy is continuing Elsevier’s rich heritage of innovation in education by delivering on our vision of providing transformative medical education solutions,” Elizabeth Munn, Managing Director, Global Medical Education, Elsevier, said in the release.  

Lead subject-matter expert on the update, Yasmin Carter, PhD, Assistant Professor of Translational Anatomy at the UMass Chan Medical School, in Worcester, MA, said in the release, “One of the inherent dangers in using only the male body as ‘anatomical normal’ and the female body as a variation is perpetuating sexist attitudes. This unconscious bias will be carried by learners into their future interactions with the body, including potentially with patients.” 

Carter also said this model helped create a diverse, balanced, and accurate platform for instructors. Carter said this option would help “evolve equitable teaching practices by normalizing the female body. Complete Anatomy’s female model will support me in training the next generation of medical professionals to be more appropriate and inclusive.” 

The report also said the 3-D female anatomy offers educators a more comprehensive teaching approach and gives them the option to switch readily between teaching the female and male anatomy in their curriculum for comparative purposes. 

Debra McWilliams, MS, RN, CHSE, is a Certified Healthcare Simulation Educator and was not involved with the development of this model, but told Fox News that she relies on Artificial intelligence, 3-D technology and other digital platforms to teach nursing and other healthcare professionals at Long Island University’s School of Health Professions and Nursing in Brookville, New York. McWilliams, who is the Director of the Inter professional Simulation Center at the University, told Fox News that, “Elsevier has really looked ahead and created an all-inclusive, diverse and equitable environment in which students can experience excellence in teaching, learning and practice.”  

McWilliams also said “Virtual gaming, simulation, and other innovative teaching strategies, such as 3-D anatomical imaging have been able to increase student engagement and buy-in. The future of education requires visionaries and innovators to create engaging interactive environments for this century’s digitally-native generation of learners.”  

McWilliams told Fox News that using 3-D anatomy models bridges theory to practice and said the more realistic you can be, the better. The simulation director told Fox News, “I think it will improve patient outcomes because it will help them translate it into the real world.” 

The model is part of the company’s app based, 3D platform called Complete Anatomy, which is a top-selling cloud-based medical education app from 3D4 Medical by Elsevier. The model is being used in some first year medical programs in the UK, the release said.   

Does a daily aspirin help over 60s avoid heart disease and stroke? Expert recommendations just changed

Daily aspirin to prevent heart disease and stroke, also known as cardiovascular disease (CVD) is no longer recommended for those over 60 years old, according to new guidance from the US Preventive Service Task force (USPSTF) released Tuesday.

The panel of national experts released a statement report that reversed its standard guidance citing a slightly increased risk of internal bleeding after taking the medication daily. The report stated that although aspirin reduces the risk of cardiovascular events, it increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke.

The recent statement by the USPSTF comes nearly two decades after the Food and Drug Administration (FDA) recommended that aspirin should not be taken to prevent a first heart attack or stroke.

While the USPSTF report did not recommend a daily dose of aspirin for those 60+ years of age, it did recommend daily use of aspirin for individuals 40 – 59 years old with an estimated 10% or greater risk for cardiovascular disease who are not at risk for bleeds and who consult a doctor.

The report from the panel of experts stated, “The decision to initiate low-dose aspirin use for the primary prevention of CVD in adults aged 40 to 59 years who have a 10% or greater 10-year CVD risk should be an individual one. Evidence indicates that the net benefit of aspirin use in this group is small. Persons who are not at increased risk for bleeding and are willing to take low-dose aspirin daily are more likely to benefit.”

Task Force member John Wong, M.D. said in a news release, “People who are 40 to 59 years old and who don’t have a history of CVD but are at higher risk may benefit from starting to take aspirin to prevent a first heart attack or stroke.” Wong who is also a professor of medicine at Tufts University School of Medicine also said, “It’s important that they decide together with their healthcare professional if starting aspirin is right for them because daily aspirin use does come with possible serious harms.”

According to the report, CVD accounts for more than 1 in 4 deaths and is the leading cause of mortality in the US. They also said an estimated 605,000 Americans have a first heart attack and approximately 610,000 experience a first stroke each year.

The panel also stated these revised recommendations are not for individuals who already have had a stroke or currently have heart disease, or are already taking aspirin. The report said those patients should speak with their healthcare provider about their particular case.

“We want to emphasize that these recommendations are focused on starting aspirin to prevent
a first heart attack or stroke. Anyone who already takes aspirin and has questions about it should speak with their healthcare professional,” Wong said in the release.

Long-term antidepressant medication use may not help patients over the long haul, study says

After a period of time, antidepressant use in individuals with depression was not associated with better health-related quality of life, (HRQoL), compared to those with depression who did not take medications, a new study published in the open-access journal PLOS ONE suggested. 

“It is generally well known that depression disorder has a significant impact on the health-related quality of life (HRQoL) of patients. While studies have shown the efficacy of antidepressant medications for treatment of depression disorder, these medications’ effect on patients’ overall well-being and HRQoL remains controversial,” study author Omar Almohammed, PhD, who is an Assistant professor of clinical pharmacy at  King Saud University, in Saudi Arabia, and his colleagues said in a news release about their research study.

The researchers analyzed data from the 2005-2015 United States’ Medical Expenditures Panel Survey (MEPS), a type of longitudinal study that tracks the health services Americans use. During the time of the study, the authors found that 17.47 million adult patients were diagnosed with depression each year with two years of follow-up and 57.6% of those were treated with antidepressant medications. 

The investigators looked at the results of the mental component of the SF-12, a survey that tracks health-related quality of life. The release stated that they noted a positive change with the use of antidepressants however, the change in quality of life reported among those on the medication for over two years, was not significantly different from that reported among those not treated with antidepressants.

The researchers said in the published report that the primary purpose of using antidepressant medications or psychotherapy is to improve outcomes including the patient’s health-related quality of life and said in the release, “Although we still need our patients with depression to continue using their antidepressant medications, long-term studies evaluating the actual impact for pharmacological and non-pharmacological interventions on these patients’ quality of life is needed. With that being said, the role of cognitive and behavioral interventions on the long term-management of depression needs to be further evaluated in an effort to improve the ultimate goal of care for these patients; improving their overall quality of life.”

Dr. Lynn Bufka, PhD, ABPP, is a board certified licensed psychologist and Associate Chief, Practice Transformation at the American Psychological Association. Bufka was not involved with the study, but told Fox News in an interview that this report raises awareness that health professionals should be looking at quality of life as a patient outcome. She said more studies are needed regarding this issue.

Bufka also told Fox News that in treatment for depression, there are typically two goals that a professional is interested in: the symptoms and the problems that prompted the individual to seek the treatment. She further explained that there is an acute phase of depression where medication may be useful and then a maintenance phase where the medication dosage may need to be adjusted and combined with other interventions such as psychotherapy, exercise, and diet to help improve an individual’s quality of life. 

The psychologist told Fox News, “There are many people for whom medication is great and for others that medication can provide enough of a dent in depression that they can engage in psychotherapy.” 

Bufka also told Fox News, “People should be comfortable that medications can be beneficial but they don’t answer everything. You will get some changes, but medications alone won’t give you an amazing quality of life – it just gives us a glimpse.” Bufka explained that medication can be a tool, but is not a perfect tool and she stressed the importance of the patient discussing with their therapist their desired outcome when it comes to their treatment. 

Bufka also added that medication and psychotherapy have different effects on the body and it is vital to know which is more important to use at that particular moment. “Psychotherapy’s goal is to give the tools to address the challenges moving forward where medication helps to alter the biochemistry which can give you a different perspective and different approach,” the psychologist explained. 

Bufka also noted that studies show that a significant portion of prescribers of antidepressants are the patient’s primary care physician and not a psychiatrist, who specializes in medications and appropriate dosing in different stages of psychiatric conditions, including depression. She said this quite possibly could play a role in the study’s findings. 

Dr. Scott Krakower, DO, DFAACAP, is an attending Psychiatrist at Northwell Health Zucker Hillside Hospital and told Fox News, “It is hard to interpret the findings of this study and this should be interpreted with caution. Antidepressants do help with the treatment of depression.  This has been demonstrated with a plethora of studies.  While there has been concern with a large placebo effect of these agents, there does appear to be improvement to some extent with mood and other measurable outcomes.”

The psychiatrist explained that in severe cases of depression, medication may be warranted along with other interventions but in cases of mild depression, individual therapy may be tried alone to mitigate potential side effects of medicines. Krakower also told Fox News, “It has also been reported that medication may help to alleviate the amount of time being spent in therapy, to allow patients to live more productive lives. Therefore, medication may also be considered an option.” 

Krakower also said the best treatment for depression remains with medication and individual therapy. 

The study authors did note in the release that they were not able to separately analyze any subtypes or varying severities of depression and did say that future studies should investigate the use of non-pharmacological depression interventions used in combination with antidepressants. 

Staying hydrated may lower risk of heart failure, study says

Drinking water to maintain a healthy sodium level in the bloodstream may reduce the risk of heart failure, a chronic condition where the heart has difficulty pumping blood to match the body’s needs, according to a recent paper published in the European Heart Journal

Over 6.2 million Americans suffer from heart failure, which is more than 2% of the United States population and is more common in those ages 65 and older, according to a recent press release on the study. 

A team from the National Heart, Lung, and Blood Institute analyzed data from the Atherosclerosis Risk in Communities study, which has been following approximately 16,000 adults over thirty years to better understand atherosclerosis and heart disease. 

The Mayo Clinic notes healthy people maintain a sodium level between 135 and 145 mmol/L in the bloodstream, but as sodium increases, the body’s fluid levels decrease, so the researchers used sodium as a marker for fluid status to identify participants who had a higher risk for developing heart failure. 

The study focused on the participants with hydration levels that were within a normal range who did not have diabetes, obesity or heart failure when the study started. Filtering data to approximately 11,814 adults in the final analysis, it found 11.56% developed heart failure.

“Heart failure risk was increased by 39% if middle age serum sodium exceeded 143 mmol/L [millimoles per liter], corresponding to 1% body weight water deficit,” the study authors noted. 

They also found a serum sodium of 142.5–143 mmol/L in the middle-age cohort was associated with a 62% increase in odds to develop left ventricular hypertrophy, where the main pumping chamber of the heart, the left ventricle, thickens, leading to a potentially reduced pumping action of the heart and increase risk of heart failure, according to the Mayo Clinic.

The press release noted a sodium level in the bloodstream of 143 mmol/L correlated to a 102% increased risk of LVH and a 54% increase in the risk of heart failure. 

“Based on these data, the authors conclude serum sodium levels above 142 mEq/L in middle age are associated with increased risks for developing left ventricular hypertrophy and heart failure later in life,” the press release added.    

The study noted its main limitation was it could not prove a higher blood sodium level caused heart failure, only that it was associated with the chronic condition because the research was only observational and not a randomized controlled clinical trial.

“While fluid guidelines vary based on the body’s needs, the researchers recommended a daily fluid intake of 6-8 cups (1.5-2.1 liters) for women and 8-12 cups (2-3 liters) for men,” the press release said.

Although most healthy people who are dehydrated will be triggered to drink water, older people may not have the same thirst drive, according to Best Life. 

“Older people don’t sense thirst as much as they did when they were younger. And that could be a problem if they’re on a medication that may cause fluid loss, such as a diuretic,” said Dr. Julian Seifter, an associate professor of medicine at Harvard Medical School.

But if you are unsure if you are dehydrated, a sodium level can be checked easily with a routine blood test known as a basic metabolic panel that bundles common electrolytes in one blood test, including potassium, sodium, chloride and glucose, according to Best Life

“Similar to reducing salt intake, drinking enough water and staying hydrated are ways to support our hearts and may help reduce long-term risks for heart disease,” said lead study author Dr. Natalia Dmitrieva, a researcher for the National Heart, Lung, and Blood Institute.

The Centers for Disease Control and Prevention lists some tips here for healthy water habits. 

COVID shots still work, but researchers hunt new improvements

COVID-19 vaccinations are at a critical juncture as companies test whether new approaches like combination shots or nasal drops can keep up with a mutating coronavirus — even though it’s not clear if changes are needed.

Already there’s public confusion about who should get a second booster now and who can wait. There’s also debate about whether pretty much everyone might need an extra dose in the fall.

“I’m very concerned about booster fatigue” causing a loss of confidence in vaccines that still offer very strong protection against COVID-19’s worst outcomes, said Dr. Beth Bell of the University of Washington, an adviser to the U.S. Centers for Disease Control and Prevention.

Despite success in preventing serious illness and death, there’s growing pressure to develop vaccines better at fending off milder infections, too — as well as options to counter scary variants.

“We go through a fire drill it seems like every quarter, every three months or so” when another mutant causes frantic tests to determine if the shots are holding, Pfizer vaccine chief Kathrin Jansen told a recent meeting of the New York Academy of Sciences.

Yet seeking improvements for the next round of vaccinations may seem like a luxury for U.S. families anxious to protect their littlest children — kids under 5 who are not yet eligible for a shot. Moderna’s Dr. Jacqueline Miller told The Associated Press that its application to give two low-dose shots to the youngest children would be submitted to the Food and Drug Administration “fairly soon.” Pfizer hasn’t yet reported data on a third dose of its extra-small shot for tots, after two didn’t prove strong enough.

COMBINATION SHOTS MAY BE NEXT

The original COVID-19 vaccines remain strongly protective against serious illness, hospitalization and death, especially after a booster dose, even against the most contagious variants.

Updating the vaccine recipe to match the latest variants is risky because the next mutant could be completely unrelated. So companies are taking a cue from the flu vaccine, which offers protection against three or four different strains in one shot every year.

Moderna and Pfizer are testing 2-in-1 COVID-19 protection that they hope to offer this fall. Each “bivalent” shot would mix the original, proven vaccine with an omicron-targeted version.

Moderna has a hint the approach could work. It tested a combo shot that targeted the original version of the virus and an earlier variant named beta and found vaccine recipients developed modest levels of antibodies capable of fighting not just beta but also newer mutants like omicron. Moderna now is testing its omicron-targeted bivalent candidate.

But there’s a looming deadline. FDA’s Dr. Doran Fink said if any updated shots are to be given in the fall, the agency would have to decide on a recipe change by early summer.

DON’T EXPECT BOOSTERS EVERY FEW MONTHS

For the average person, two doses of the Pfizer or Moderna vaccine, plus one booster — a total of three shots — “gets you set up” and ready for what may become an annual booster, said Dr. David Kimberlin, a CDC adviser from the University of Alabama at Birmingham.

After that first booster, CDC data suggests an additional dose offers most people an incremental, temporary benefit.

Why the emphasis on three shots? Vaccinations trigger development of antibodies that can fend off coronavirus infection but naturally wane over time. The next line of defense: Memory cells that jump into action to make new virus-fighters if an infection sneaks in. Rockefeller University researchers found those memory cells become more potent and able to target more diverse versions of the virus after the third shot.

Even if someone who’s vaccinated gets a mild infection, thanks to those memory cells “there’s still plenty of time to protect you against severe illness,” said Dr. Paul Offit of the Children’s Hospital of Philadelphia.

But some people — those with severely weakened immune systems — need more doses upfront for a better chance at protection.

And Americans 50 and older are being offered a second booster, following similar decisions by Israel and other countries that offer the extra shot to give older people a little more protection.

The CDC is developing advice to help those eligible decide whether to get an extra shot now or wait. Among those who might want a second booster sooner are the elderly, people with health problems that make them particularly vulnerable or those who are at high risk of exposure from work or travel.

COULD NASAL VACCINES BLOCK INFECTION?

It’s hard for a shot in the arm to form lots of virus-fighting antibodies inside the nose where the coronavirus latches on. But a nasal vaccine might offer a new strategy to prevent infections that disrupt people’s everyday lives even if they’re mild.

“When I think about what would make me get a second booster, I actually would want to prevent infection,” said Dr. Grace Lee of Stanford University, who chairs CDC’s immunization advisory committee. “I think we need to do better.”

Nasal vaccines are tricky to develop, and it’s not clear how quickly any could become available. But several are in clinical trials globally. One in late-stage testing, manufactured by India’s Bharat Biotech, uses a chimpanzee cold virus to deliver a harmless copy of the coronavirus spike protein to the lining of the nose.

“I certainly do not want to abandon the success we have had” with COVID-19 shots, said Dr. Michael Diamond of Washington University in St. Louis, who helped create the candidate that’s now licensed to Bharat.

But “we’re going to have a difficult time stopping transmission with the current systemic vaccines,” Diamond added. “We have all learned that.”

WHO: 1 child has died in mystery liver disease outbreak

The World Health Organization says at least one death has resulted from a mysterious liver disease outbreak affecting children in Europe and the United States.

The U.N. health agency said late Saturday that it has so far received reports of at least 169 cases of “acute hepatitis of unknown origin” from a dozen countries.

The cases were reported in children between the ages of one month and 16, and 17 of those who fell ill required liver transplants. WHO did not say in which country the death occurred.

The first cases were recorded in Britain, where 114 children have been sickened.

“It is not yet clear if there has been an increase in hepatitis cases or an increase in awareness of hepatitis cases that occur at the expected rate but go undetected,” WHO said in a statement.

Experts say the cases may be linked to a virus commonly associated with colds, but further research is ongoing.

“While adenovirus is a possible hypothesis, investigations are ongoing for the causative agent,” WHO said, noting that the virus has been detected in at least 74 of the cases. At least 20 of the children tested positive for the coronavirus.

WHO said affected countries are stepping up their surveillance of hepatitis cases in children.

Study says,Time-restricted eating no more beneficial than caloric restriction in obese patients

Time-restricted eating limited to 8 a.m. and 4 p.m. did not lead to a greater reduction in body weight, body fat or metabolic risk factors compared to a daily caloric restriction, according to a study published in New England Journal of Medicine this week

The researchers at Southern Medical University in Guangzhou, China randomly assigned 139 obese patients to two groups: one group who participated in a time-restricted eating regimen where they ate only between 8 a.m. and 4 p.m. along with restricting their daily caloric intake and another group of participants who only engaged in daily caloric restriction without a time-restricting regimen. 

The male participants were instructed to restrict their daily caloric intake to only 1500 -1800 calories while women followed a caloric restriction of 1200 to 1500 calories every day.

The primary outcome of the study was the difference in body weight between the two groups from baseline and secondary outcomes were changes in waist circumference, body-mass index, amount of body fat, and measures of metabolic risk factors.

The participants were encouraged to weigh foods to ensure accurate reporting on calories, were required to keep a food diary and to photograph the food that they ate during the first six months of the study, and recorded food pictures and meals three times a week during the last six months.

118 out of 139 participants completed the study with researchers noting, “Changes in weight were not significantly different in the two groups at the 12-month assessment.”

“In addition, time-restricted eating and daily calorie restriction produced similar effects with respect to reductions in body fat, visceral fat, blood pressure, glucose levels, and lipid levels over the 12-month intervention period,” the researchers said. 

The authors added even though caloric intake restriction explained most of the beneficial effects associated with the time-restricted–eating, their findings suggested that time-restricted eating could be an alternative to restricting calories for weight management. 

“We speculate that these data support the importance of caloric intake restriction when adhering to a regimen of time-restricted eating,” the study noted.

The authors cautioned their study cannot be generalized to diabetic patients, to those with heart disease, to different periods of time-restricted eating while also noting their study was limited because physical activity was not controlled since total energy expenditure was not measured.

“Almost every type of diet out there works for some people,” said Dr. Christopher Gardner, director of nutrition studies at the Stanford Prevention Research Center.

“But the take-home supported by this new research is that when subjected to a properly designed and conducted study — scientific investigation — it is not any more helpful than simply reducing daily calorie intake for weight loss and health factors.” 

White House releases national drug control strategy

The Biden administration released its National Drug Control Strategy for the year. 

The White House said Thursday that President Biden had sent the inaugural plan to Congress

“The Strategy delivers on the call to action in President Biden’s Unity Agenda through a whole-of-government approach to beat the overdose epidemic,” the administration said in a release, noting it focuses specifically on untreated addiction and drug trafficking.

“It instructs federal agencies to prioritize actions that will save lives, get people the care they need, go after drug traffickers’ profits and make better use of data to guide all these efforts,” it said. 

The strategy calls for the expansion of high-impact harm reduction interventions including naloxone, ensuring that those at highest risk of overdose can access “evidence-based treatment” and improving data systems and research that guide drug policy development. 

“All too often, these drugs wind up in communities where naloxone isn’t readily available,” White House drug czar Dr. Rahul Gupta, who will oversee the strategy, said Wednesday, referring to the medication that can revive users who have overdosed, “where harm reduction services are restricted or underfunded, where there are unacceptable barriers to treatment.”

The American Medical Association (AMA) has advocated for naloxone to be made available over the counter. Test strips that prevent overdoses by checking drugs for fentanyl and clean syringe programs are other examples of harm reduction.

Gupta, who is the first physician to lead the Office of National Drug Control Policy, noted that harm reduction prevents overdoses, reduces the transmission of infectious diseases and “as declared in a recent congressional commission report, it has bipartisan support.”

In addition, the strategy builds on President Biden’s fiscal year 2023 budget request for a $300 million increase to support the work of Customs and Border Protection (CBP) and for a $300 million increase for the Drug Enforcement Administration. 

It aims to obstruct and disrupt the financial activities of transnational criminal organizations (TCOs) that manufacture illicit drugs and traffic them into the U.S., reduce the supply of illicit drugs through domestic and international collaboration and reduce the supply of illicit drugs smuggled across U.S. borders. 

The FAQ sheet noted that the strategy instructs federal agencies to expand efforts to prevent substance use among school-aged children and young adults, support community-led coalitions implementing evidence-based prevention strategies, establish a federal recovery research agenda, adopt flexible and responsive approaches to help those with substance use disorder and eliminate barriers and increase economic opportunities for people in recovery. 

“The Strategy includes specific actions to improve access to medication for opioid use disorder (MOUD) programs for jails and prisons; identify ways to advance racial equity in the investigation, arrest and sentencing for drug-related offenses without negatively impacting public safety; divert non-violent individuals from the criminal justice system and juvenile justice systems to treatment when appropriate and remove barriers and expand supportive services to help reintegrate people into society after incarceration,” the administration concluded.

Drug overdoses have killed 106,854 people in the most recent 12-month period.

CDC warns mysterious pediatric hepatitis outbreak could be linked to adenovirus

The Centers for Disease Control and Prevention (CDC) issued a Health Alert Network Health Advisory regarding a possible link between a mysterious cluster of children with hepatitis, which is inflammation of the liver, and a virus known as adenovirus, according to a recent press release.

“This health advisory serves to notify U.S. clinicians who may encounter pediatric patients with hepatitis of unknown etiology to consider adenovirus testing and to elicit reporting of such cases to state public health authorities and to CDC,” the CDC said. “Nucleic acid amplification testing (NAAT, e.g. PCR) is preferred for adenovirus detection and may be performed on respiratory specimens, stool or rectal swabs or blood.”

A large children’s hospital in Alabama in November 2021 notified the agency of five previously healthy pediatric patients with significant liver injury, including three with acute liver failure who were also positive for adenovirus, but none had COVID-19.

Hepatitis A blood test and treatment

Adenovirus most commonly causes respiratory illness, but can cause a range of other illnesses, including conjunctivitis — otherwise known as pink eye — acute gastroenteritis, cystitis and rarely neurologic disease, but there is no treatment other than symptomatic care, according to the CDC.

The virus is spread by close personal contact, respiratory droplets and fomites with more than 50 distinct types that can cause infections in humans.

But the virus type sequenced in the five pediatric patients, adenovirus type 41, commonly causes acute gastroenteritis, which typically presents as diarrhea, vomiting and fever, but can be associated also with respiratory symptoms.

“While there have been case reports of hepatitis in immunocompromised children with adenovirus type 41 infection, adenovirus type 41 is not known to be a cause of hepatitis in otherwise healthy children,” per the health advisory.

Four additional pediatric patients with hepatitis and adenovirus infection were identified at the Alabama children’s hospital for a total of nine hospitalized patients from October 2021 through February 2022, with two patients requiring a liver transplant. But no patients died.

The United Kingdom Health Security Agency (UKHSA), Public Health Scotland, Public Health Wales and the Public Health Agency reported a total of 108 cases of “sudden onset hepatitis” in children under the age of 10 who tested negative for common viruses known to cause hepatitis, including hepatitis viruses A, B, C, D, and E between January 2022 and April 12, 2022, according to a U.K. Health Security Agency press release.

U.K. authorities reported approximately 77% of their cases have tested positive for adenovirus infection.

“The United Kingdom has recently observed an increase in adenovirus activity, which is co-circulating with SARS-CoV-2, though the role of these viruses in the pathogenesis (mechanism by which disease develops) is not yet clear,” the World Health Organization noted. 

The release noted 79 of the confirmed cases are in England, 14 are in Scotland and the remainder are in Wales and Northern Ireland, with 8 children receiving a liver transplant. But none of the confirmed cases are known to be vaccinated against COVID-19.

“We are working with the NHS [National Health Service] and public health colleagues in Scotland, Wales and Northern Ireland to swiftly investigate a wide range of possible factors which may be causing children to be admitted to hospital with liver inflammation known as hepatitis,” said Dr. Meera Chand, director of clinical and emerging infections at UKHSA.

“Information gathered through our investigations increasingly suggests that this is linked to adenovirus infection. However, we are thoroughly investigating other potential causes.”

Spain and Denmark have also reported cases of unusual hepatitis in children, while France is investigating two suspected cases in Lyon and Israel is looking into a dozen children with unexplained hepatitis over four months, two needing liver transplants, according to a Stat report.

Hepatitis can be caused by viruses, alcohol, toxins, medications and other medical conditions. But, in the United States, the most common causes of viral hepatitis are hepatitis A, hepatitis B, and hepatitis C viruses, according to the CDC.

Signs and symptoms of hepatitis include nausea, vomiting, abdominal pain, turning yellow and dark urine, with treatment directed at underlying cause, per the agency.