Following the US Food and Drug Administration (FDA) approval last Friday, the Centers for Disease Control and Prevention (CDC) gave the go ahead last Saturday for Emergency Use Authorization (EUA) for two pediatric COVID-19 vaccines, one made by Pfizer-BioNTech (ages 6 months through 4 years old, a three-dose primary series with the initial two doses administered three weeks apart followed by a third dose administered at least eight weeks after the second dose, and is one-tenth the adult dosage with an estimated effectiveness of 80% after the third dose) and one by Moderna (ages 6 months through 5 years old, a two-dose series administered one month apart that is one-quarter the adult dosage and estimated effectiveness varies based on age). Side effects were generally mild with no serious side effects were identified, including cases of myocarditis/pericarditis. The Division of Public Health (DPH) has created a convenient chart on de.gov/youthvaccine explaining the differences between the two vaccines. Shipments of the vaccine began arriving in Delaware on Monday for delivery to those facilities and practices that pre-ordered one or both of the vaccines (not all practices have pre-ordered the vaccine initially). Some offices began vaccinating immediately while others indicated they will begin at a later date.

Physician offices that are not vaccinating children can direct patients to a DPH clinic, a physician or other health care professional who has agreed to vaccinate non-patients (those who are vaccinating are listed on de.gov/youthvaccine with new locations being added regularly), or to vaccines.gov to locate a participating pharmacy (Note: Not all pharmacies will vaccinate children under the age of 3. The website vaccines.gov will list minimum threshold there). The de.gov/youthvaccine website also has information on both vaccines regarding dosing and frequency, efficacy, and side effects.

Key messages in support of COVID-19 vaccination for children younger than 5 is available for your use. The FDA has created vaccine presentation wall charts as a quick reference for both the Moderna and Pfizer-BioNTech vaccines. The CDC has also prepared "At a Glance" sheets for Pfizer and Moderna vaccines that summarize basic storage, preparation, scheduling, administration, and dosage. Also from the CDC is a Vaccinate Your Family initiative that has graphics, talking points, and FAQs on the COVID-19 vaccine recommendation under 5 for your use. The materials are available in both English and Spanish. Included is an animated video which can help those to understand vaccine development and safety monitoring.

The Moderna vaccine is now available for ages 6 months through age 5 and for those age 18 and older. While the FDA authorized the Moderna applications for vaccines for those age 6 through 11 and 12 through 17, the CDC must still sign off. The CDC Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on June 23rd. Johnson & Johnson's vaccines are not yet approved for those under age 18.

The Fact Sheet for Moderna can be obtained via the following link: https://www.fda.gov/media/159307/download, and for Pfizer at https://www.fda.gov/media/159312/download. 

As part of a routine security audit of account access, the Delaware Health Information Network (DHIN) team is in the process of identifying practice logins that have been dormant. If your account is one identified as inactive and you wish to keep it active, please log in (or change your password and log in) immediately. TIP: Once de-activated, the DHIN Service Desk will not be able to re-activate your account. Only your practice manager/administrator will be able to request re-activation.

On Tuesday, the Biden-Harris Administration announced published plans for future potential regulatory actions that include the U.S. Food and Drug Administration’s (FDA) plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction and death. Each year, 480,000 people die prematurely from a smoking-attributed disease, making tobacco use the leading cause of preventable disease and death in the United States. Additionally, tobacco use costs nearly $300 billion a year in direct health care and lost productivity. While nicotine is not what makes smoking cigarettes so toxic, it’s the ingredient that makes it very hard to quit smoking. Addiction to nicotine in combusted products is the main driver of sustained use of these products. In fact, more than half of adult cigarette smokers make a serious quit attempt each year (quitting for at least a day), but most do not succeed due to the addictive nature of cigarettes. Such a product standard, if proposed and then finalized after a thorough process, would make those products minimally- or non-addictive. A paper published by the FDA in the New England Journal of Medicine in 2018 projected that by year 2100, a potential nicotine product standard could result in more than 33 million people not becoming regular smokers, a smoking rate of only 1.4%, and more than 8 million fewer people dying from tobacco-related illnesses. The current smoking rate is 12.5%.

Today, the FDA issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. These MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products. After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence whether the benefits to smokers outweigh the health damage to new users, including teenagers.

The American Academy of Pediatrics (AAP) has updated its safe-sleep guidelines for infants for the first time in more than five years, emphasizing that babies should sleep on their backs on flat, level surfaces to reduce their risk of Sudden Unexpected Infant Death Syndrome (SIDS). It is estimated that there are 3,500 sleep-related infant deaths in the United States each year. Many of those deaths are preventable, and the authors of the new guidelines are urging parents, grandparents, and other infant caregivers to take simple steps to help keep their children safe. The recommendations were published online Tuesday in the scientific journal Pediatrics and are consistent with prior guidelines with some updates based on new information. A full list of the AAP’s safe-sleep recommendations is available online. The guidelines are accompanied by a technical report that details the evidence used in developing the recommendations.

The U.S. Preventive Services Task Force (USPSTF) issued a recommendation statement against the use of beta carotene or vitamin E supplements for the prevention of CVD (cardiovascular disease) or cancer. The recommendations are consistent with those of the 2014 USPSTF recommendation statement on vitamin, mineral, and multivitamin supplements for the prevention of CVD and cancer. The USPSTF again concludes that the evidence is insufficient to assess the balance of benefits and harms of multivitamins and single- or paired-nutrient supplements (except beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. The USPSTF again recommends against the use of beta carotene or vitamin E supplements for the prevention of cardiovascular disease or cancer. The recommendations were published online June 21 in the Journal of the American Medical Association. 

On Tuesday this week, the US Food and Drug Administration (FDA) approved a second generic naloxone hydrochloride (HCI) intranasal spray. Naloxone HCI is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose.

A new study indicates children with COVID-19 had a higher risk of mortality than children with seasonal flu, but that actual mortality did not differ. Researchers analyzed data on critically ill children from 66 U.S. pediatric intensive care units and found there were nearly twice as many COVID-19/MIS-C admissions per quarter (about 400) during the pandemic’s first 15 months than flu admissions in the two years before it (about 200). The research was published in JAMA Network Open. 

Vice President Harris last week announced the launch of a task force dedicated to fighting the growing problem of online harassment and abuse, which can be a precursor to real-life violence and disproportionately target women, girls, and LGBTQI+ people. The new task force will address several issues, including prevention of online abuse and services for people who are targeted. In six months the members of the task force are to produce a blueprint detailing actions to address the problem, including more support for victims, prevention, and greater accountability for aggressors and platforms hosting them.

REMINDER: On July 16, 2022, the National Suicide Prevention Lifeline (1-800-273-8255) will transition to an easy-to-remember, 3-digit number (988), which necessitated the requirement to dial the "302" area code when calling within the state of Delaware. This represents an unprecedented opportunity to strengthen and expand the existing network of over 200 locally operated and funded crisis centers across the country. In advance of the 988 transition in July, the Lifeline suicide & crisis network is looking to bring on new volunteers and paid employees to answer calls, chats, and texts from people in crisis. All employees and volunteers receive training, so if you know someone who is a caring person who wants to help those in crisis, have them apply today. 

The Delaware Division of Public Health (DPH) is spreading awareness of free Self-Management Programs. Many people who are cancer survivors or who suffer with chronic pain or a chronic disease have difficulty managing their conditions. The inability to take control can affect both physical and psychological health, and increase health care expenditures. Patient education programs for specific conditions have been proven to increase healthful behaviors and improve health status — and in many cases, decrease health care costs. In Delaware, free Self-Management Programs are available for people who have survived cancer, have a chronic disease and/or living with chronic pain. A toolkit has been developed to provide you with information to use and to share with patients who could benefit from it. Printed materials delivered free of charge are available.

On June 29^th from 7 - 8:30pm ET the American Medical Association (AMA) will host a 90-minute webinar on the foundations of racism in medicine. Dr. Emily Cleveland Manchanda, the Director for Social Justice Education and Implementation at the AMA, will give a 60-minute didactic presentation followed by 30-minutes for Q&A. The presentation will include descriptions of:

Read Dr. Cleveland Manchanda’s bio.

If you are interested in attending this webinar, please register here. Registration is required to access the Zoom link for this event. Log-in or new account creation is required to register.

MSD has planned several upcoming social events for you to attend. It's been a while since we got together in person, let's discover what everyone has been doing over the past two years! In light of recent events, we are also taking this time to hear your thoughts on stopping gun violence in Delaware and across our nation, as well as what issues are important to you.

Time is running out to register to attend the upcoming second reception scheduled for Thursday, June 30th at Maple Dale Country Club in Dover. Our first event was held in May and turned out to be a very enjoyable, light hearted evening for all in attendance - something we

all need right now.

You and your guest have the opportunity to attend one (or both!) of the remaining in-person Presidential Receptions scheduled in Kent and Sussex Counties in June and September. Come join us! Events begin at 6:00 p.m. Dress is business casual.

Join global nutrition experts in person to learn the latest in nutrition education and enjoy delicious meals and networking opportunities. Leading health care experts from around the world will share engaging lectures on the latest research behind the power of nutrition. This program is jointly provided by the Physicians Committee for Responsible Medicine and the George Washington University School of Medicine and Health Sciences, with up to 20 continuing medical education credits available. Seating is limited. One complimentary registration is available. If you are interested, please contact Lynn Robinson, Director of Professional Education. The availability of the complimentary ticket is on a first come, first served basis. For those not lucky enough to have a complimentary registration, please register with the code MSD for 10% off the cost of full admission, just for Medical Society of Delaware members. Review the full schedule and reserve your spot at PCRM.org/ICNM.

Register today to participate in MSD’s first ever Beach Cleanup. The Department of Natural Resources and Environmental Control (DNREC) will host a public beach clean up at Herring Point, Cape Henlopen State Park on Saturday September 17^th from 10 am to 12 pm. MSD is looking for members to join in the fun while we help keep a Delaware landmark litter free! Join us after the event for lunch and an opportunity to catch up with your fellow MSD members! A small group is invited to join - please register soon - space if very limited!

The MSD Physician Emeritus Section gathered at the University and Whist Club on June 14th for their second luncheon of the year. Ms. Anne E. Boylan, Professor Emerita of History and Women and Gender Studies at the University of Delaware and a social historian of the United States, presented Delaware’s Suffrage Story. 2020 marked the one hundredth anniversary of Congress passing of the 19th Amendment, ratified in 1920, granting men and women equal voting rights. After 1920, there were exclusions based on race, national origin, and economic status that prevented substantial numbers of women from voting, despite the passage of the 19th Amendment. Not until the passage of the 24th Amendment in 1964 and the Voting Rights Act of 1965 were those practices eliminated. Pictured is the speaker, Ms. Anne Boylan.

A small but very energetic group of MSD Young Physician Section (YPS) members gathered at Frawley Stadium in Wilmington on Friday evening, June 17th to cheer on the Wilmington Blue Rocks as they defeated the Brooklyn Cyclones, 4-3. MSD members were offered front section seats to enjoy the game. YPS Chair, Dr. Anthony Tramontozzi threw out a first pitch before the game. And after the game, the group remained for a beautiful fireworks display while 20 Corvettes from the Corvette Club revved their engines on the field at the start of the show. A great time was had by all and we look forward to having more members join us next time! Pictured is Dr. Tramontozzi throwing out the first pitch.

Beebe Healthcare representatives were on hand June 14 as the healthcare system was recognized by Gov. John Carney and First Lady Tracey Quillen Carney as a Compassionate Champion. The Compassionate Champion Awards recognize individuals, organizations, and educational institutions across the State of Delaware that provide trauma-informed services.

ChristianaCare has opened a Gender Wellness Program to provide psychotherapy and support services for individuals age 13 and older who are exploring their gender identity or experiencing gender dysphoria—a sense of incongruence and distress that a person may have because of a mismatch between their gender identity and their sex affirmed at birth. The program also provides treatment for any behavioral health condition the individual may be struggling with, such as anxiety and depression. People who identify as transgender have higher rates of suicide attempts than individuals who do not identify as transgender, according to the National Institutes of Health.

To strengthen and diversify the health care workforce for years to come, ChristianaCare has provided $500,000 in scholarships to 10 students in Delaware who plan to pursue degrees in health care. The financial support, through ChristianaCare’s Future of Health scholarship program, provides $12,500 in support annually per student, plus a paid internship each summer, for students to attend historically Black colleges and universities (HBCUs).

MSD's Membership Department is pleased to announce the newest members of the Medical Society of Delaware. Welcome to the third oldest medical society in the country! If you know someone interested in joining MSD, please contact Michelle Seymour at (302) 224-4905 or Michelle.Seymour@medsocdel.org with any questions. You could be eligible for a referral discount!