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Issue 1,502: June 24, 2020

Top Stories
* FDA expands license for Gardasil 9 to include preventing oropharyngeal and other head-and-neck cancers caused by relevant HPV types
* ImmYounity, a new eLearning platform for healthcare providers about communicating effective, efficient, and confident vaccine recommendations for patients, now available
* IAC Spotlight! IAC’s Immunization Partners gateway page recognizes the many organizations working hard to promote immunization
* IAC’s Repository of Resources for Maintaining Immunization during COVID-19 Pandemic now includes ten dozen materials
* CDC updates Frequently Asked Influenza (Flu) Questions: 2020–2021 Season to include information about vaccinating during the COVID-19 pandemic and two new quadrivalent formulations
* HHS releases its National Influenza Vaccine Modernization Strategy (NIVMS) 2020–2030
* CDC issues Health Alert Network (HAN) advisory titled “Detection of Ciprofloxacin-Resistant, β-Lactamase-Producing Neisseria Meningitidis Serogroup Y Isolates, United States, 2019–2020” highlighting the importance of vaccination
* Not-to-miss immunization articles in the news
* Stay up to date on the latest coronavirus information

Featured Resources
* CDC develops new web page to alert parents that well-child visits and vaccinations should be continued during the pandemic
* In this week’s “Video of the Week,” the SciShow video explains how to make a COVID-19 vaccine
* “Shop IAC” on immunize.org offers many resources for your practice. Order laminated 2020 U.S. immunization schedules for your exam rooms today!

Journal Articles and Newsletters
* “The Dual Epidemics of COVID-19 and Influenza: Vaccine Acceptance, Coverage, and Mandates” published in JAMA

On the Lighter Side
* “Spot Prevention” 1966 animated video describes the development of measles vaccine

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Top Stories
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FDA EXPANDS LICENSE FOR GARDASIL 9 TO INCLUDE PREVENTING OROPHARYNGEAL AND OTHER HEAD-AND-NECK CANCERS CAUSED BY RELEVANT HPV TYPES

On June 12, the FDA approved a supplemental biologics licensure application ([link removed]) (sBLA) to add a new indication for Gardasil 9 (Merck): prevention of oropharyngeal and other head-and-neck cancers caused by human papillomavirus (HPV) types targeted by the vaccine.

Accelerated approval regulations require a post-licensure confirmatory study to verify and describe the clinical benefit for the indication. To satisfy this requirement, Merck is conducting a study to evaluate the efficacy of Gardasil 9 in men 20 through 45 years of age. FDA has accepted the prevention of oral persistent infection as an intermediate surrogate endpoint to predict the prevention of oropharyngeal and other head and neck cancers caused by HPV.

Gardasil 9 remains approved for use in individuals 9 through 45 years of age, with no other changes to the previously approved age-specific dosing regimens.

Related Links
* FDA approval letter ([link removed])
* Package insert for Gardasil 9 vaccine ([link removed])
* FDA web page for Gardasil 9 vaccine ([link removed])
* Merck news release ([link removed]) (6/12/20)
* IAC’s Package Inserts and FDA Product Approvals ([link removed]) gateway page

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IMMYOUNITY, A NEW ELEARNING PLATFORM FOR HEALTHCARE PROVIDERS ABOUT COMMUNICATING EFFECTIVE, EFFICIENT, AND CONFIDENT VACCINE RECOMMENDATIONS FOR PATIENTS, NOW AVAILABLE

ImmYounity is a new eLearning educational tool for healthcare providers ([link removed]) from Sanofi Pasteur designed to increase healthcare provider confidence, by helping them engage in conversations about vaccines, enhance trust, and improve vaccine acceptance. This training is designed for the entire healthcare community including physicians, physician assistants, nurse practitioners, nurses, pharmacists, medical assistants, office staff, and pharmacy technicians. This training tool is of particular importance as healthcare providers prepare for the upcoming influenza season. The materials are unbranded.

This eLearning curriculum is available on smartphones, tablets, and computers. The education is personalized to the learner based on their role and experience.

Ninety percent of patients surveyed stated that the number one reason they accept vaccination is because of the recommendation of their trusted healthcare provider. When patients have questions or concerns about vaccination, a healthy dialogue that develops trust is essential. ImmYounity eLearning—grounded in evidence-based vaccine science—is designed to teach a communication process that facilitates effective conversations. Since ImmYounity eLearning is available to all healthcare personnel, it can be used to help align entire practices with the knowledge and skills to support timely vaccination.

Visit ImmYounity.vaccines.com ([link removed]) today to register and start learning.

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IAC SPOTLIGHT! IAC’S IMMUNIZATION PARTNERS GATEWAY PAGE RECOGNIZES THE MANY ORGANIZATIONS WORKING HARD TO PROMOTE IMMUNIZATION

The IAC Immunization Partners ([link removed]) gateway page lists governmental and nonprofit organizations as well as professional societies that work in the field of immunization in the U.S. The current list includes partners with whom IAC has worked over the years. The alphabetical list includes short descriptions and links to the organizations' websites. If we inadvertently omitted your organization, please let us know by emailing us at [email protected].

Check out the IAC Immunization Partners ([link removed]) gateway page to see the breadth of immunization collaborators.

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IAC’S REPOSITORY OF RESOURCES FOR MAINTAINING IMMUNIZATION DURING COVID-19 PANDEMIC NOW INCLUDES TEN DOZEN MATERIALS

In May, IAC launched the Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic ([link removed]) to assist in maintaining routine immunization rates during the COVID-19 pandemic. Located on the website of the National Network of Immunization Coalitions ([link removed]), a project of IAC, this repository includes 120 links to both national and state-level policies and guidance; advocacy materials, including talking points, webinars, press releases, articles, and social media posts; and telehealth resources. These resources are intended for healthcare settings, state and local health departments, professional societies, immunization coalitions, advocacy groups, and the community to use in their efforts to sustain routine immunizations during the COVID-19 pandemic.

These resources can be sorted and searched by date, title, geographic area, source, type, age category, or setting.

If you have a resource to submit to the repository, please send a message to [email protected].

Access the repository to view the range of valuable resources available to support the patients, families, and communities you serve.

Related Link
* National Network of Immunization Coalitions ([link removed]) website

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CDC UPDATES FREQUENTLY ASKED INFLUENZA (FLU) QUESTIONS: 2020–2021 SEASON TO INCLUDE INFORMATION ABOUT VACCINATING DURING THE COVID-19 PANDEMIC AND TWO NEW QUADRIVALENT FORMULATIONS

CDC has updated its Frequently Asked Influenza (Flu) Questions: 2020–2021 Season ([link removed]) to include information about vaccinating during the COVID-19 pandemic and two new quadrivalent formulations. The section called “Flu and COVID-19” highlights the likelihood that influenza viruses and SARS CoV-2 will both circulate this fall and winter and that—while getting an influenza vaccine will not protect against COVID-19—influenza vaccination “will be more important than ever, not only to reduce your risk from flu but also to help conserve potentially scarce healthcare resources.”​

The updated “Flu Vaccine” section gives information on two newly licensed quadrivalent formulations of existing vaccine brands that will be available during the 2020–2021 influenza season. Both are licensed for use in adults 65 years and older. One is a quadrivalent high-dose vaccine that replaces the previously licensed trivalent high-dose vaccine; the other is a quadrivalent adjuvanted vaccine that is similar to the previously licensed trivalent vaccine but has one additional influenza B component.

Related Links
* CDC's Frequently Asked Influenza (Flu) Questions: 2020–2021 Season ([link removed])
* CDC's Seasonal Influenza (Flu) ([link removed]) gateway page
* IAC’s Vaccines: Influenza ([link removed]) gateway page

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HHS RELEASES ITS NATIONAL INFLUENZA VACCINE MODERNIZATION STRATEGY (NIVMS) 2020–2030

The U.S. Department of Human Health Services (HHS) released its National Influenza Vaccine Modernization Strategy (NIVMS) 2020–2030 ([link removed]) as directed by Executive Order (EO) 13887 on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health ([link removed]).

The NIVMS outlines three strategic objectives that align with four policy objectives in EO 13887. The NIVMS objectives aim to transform the U.S. influenza enterprise to adequately prepare for, prevent, detect, and respond to both seasonal influenza epidemics and potential pandemics over the next 10 years. The three objectives propose to:
* strengthen and diversify influenza vaccine development, manufacturing, and supply chain;
* promote innovative approaches and use of new technologies to detect, prevent, and respond to influenza;
* and increase influenza vaccine access and coverage across all populations.

Execution of this strategic approach over the next 10 years will require innovative partnerships, financial investments, and efficient utilization of resources.

Related Links
* National Influenza Vaccine Modernization Strategy (NIVMS) 2020–2030 ([link removed]) (17 pages; PDF)
* HHS's NIVMS Executive Summary ([link removed]) web page

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CDC issues Health Alert Network (HAN) advisory titled “Detection of Ciprofloxacin-Resistant, β-Lactamase-Producing Neisseria Meningitidis Serogroup Y Isolates, United States, 2019–2020” highlighting the importance of vaccination

On June 18, the CDC Health Alert Network (HAN) released Detection of Ciprofloxacin-Resistant, β-Lactamase-Producing Neisseria Meningitidis Serogroup Y Isolates, United States, 2019–2020 ([link removed]). Eleven meningococcal disease cases reported in the United States during 2019–2020 had isolates containing a blaROB-1 β-lactamase gene associated with penicillin resistance, as well as mutations associated with ciprofloxacin resistance. This health advisory highlights the importance of ACIP’s recommendations for vaccination against meningococcal serogroups ACWY.

Access the complete HAN health advisory for more background information and detailed guidance for healthcare providers: Detection of Ciprofloxacin-Resistant, β-Lactamase-Producing Neisseria Meningitidis Serogroup Y Isolates, United States, 2019–2020 ([link removed]).

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NOT-TO-MISS IMMUNIZATION ARTICLES IN THE NEWS

These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.

* New York Times: Slowing the Coronavirus Is Speeding the Spread of Other Diseases ([link removed]) (6/14/20)
* Kaiser Health News: Public Health Officials Face Wave of Threats, Pressure amid Coronavirus Response ([link removed]) (6/12/20)
* Wired: An Army of Volunteers Is Taking On Vaccine Disinformation Online ([link removed]) (6/15/20)
* USA Today: When There’s a Coronavirus Vaccine, How Will We Make Sure Everybody Gets It? That’s the Job of State Immunization Registries ([link removed]) (6/13/20)
* Science Codex: Study Finds Significant Parental Hesitancy about Routine Childhood and Influenza Vaccines ([link removed]) (6/14/20)
* United Press International: One in Four Parents Hesitant about Flu Vaccine, Survey Finds ([link removed]) (6/15/20)

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STAY UP TO DATE ON THE LATEST CORONAVIRUS INFORMATION

CDC, NIH, WHO, and Johns Hopkins are closely monitoring the SARS-CoV-2 ([link removed]) pandemic. Be sure to check the resources below for the latest information. Stay in touch with your local and state health departments.

Related Links
* CDC’s COVID-19 gateway page, CDC.gov/coronavirus ([link removed]), links to CDC’s Situation Summary ([link removed]) web page and Latest News ([link removed]) gateway page. The COVIDView ([link removed]) gateway page summarizes the epidemiologic intelligence.
* NIH's Coronavirus (COVID-19) ([link removed]) gateway page links to news releases on vaccine trials
* WHO's Coronavirus Disease (COVID-19) Outbreak ([link removed]) gateway page links to WHO’s Situation Reports ([link removed]) web page
* Johns Hopkins' Coronavirus Resource Center ([link removed]) gateway page links to the Coronavirus COVID-19 Global Cases CSSE ([link removed]) web page
* Eriksen's COVID-19 Resources to Support Accurate Translation ([link removed]) gateway page

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Featured Resources
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CDC DEVELOPS NEW WEB PAGE TO ALERT PARENTS THAT WELL-CHILD VISITS AND VACCINATIONS SHOULD BE CONTINUED DURING THE PANDEMIC

Pediatric outpatient visits and routine childhood vaccination have declined substantially during the COVID-19 pandemic, leaving children and communities at risk for outbreaks of vaccine-preventable diseases. CDC's National Center for Immunizations and Respiratory Diseases (NCIRD) has developed a suite of materials to remind parents that well-child visits and vaccinations are essential. These resources include a new web page titled Routine Vaccination during the COVID-19 Outbreak ([link removed]), a new web feature titled Well-Child Visits Are Essential ([link removed]), and social media graphics and content for partners to share.

Sample social media messages for parents:
* Recommended vaccines help your baby grow up healthy. Learn why well-child visits are essential during the COVID-19 outbreak: [link removed]
* Parents, is your baby up to date with their childhood vaccinations? As communities open up, it’s important to protect your child against vaccine-preventable diseases. Learn more: [link removed]
* As communities begin opening up, protect your baby against 14 serious childhood diseases, like measles and whooping cough, by staying up to date on vaccines. Learn more about vaccine-preventable diseases: [link removed]

Related Links
* CDC's new web page: Routine Vaccination during the COVID-19 Outbreak ([link removed])
* CDC's web feature: Well-Child Visits Are Essential ([link removed])
* CDC’s Interim Guidance for Immunization Services during the COVID-19 Pandemic ([link removed])
* IAC's Repository of Resources for Maintaining Immunization during the COVID-19 Pandemic ([link removed])

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In this week’s “Video of the Week,” the SciShow video explains how to make a COVID-19 vaccine

This April 2020 SciShow video ([link removed] ) (12:31 minutes) explains the way our immune system works as well as the types of COVID-19 vaccines being developed, using older and newer technologies. It emphasizes that three phases of testing are needed to ensure a vaccine is safe and effective, which slows our ability to produce a vaccine. The video concludes that until we have a SARS CoV-2 vaccine, finding effective treatments and taking preventive measures, such as physical distancing, will be needed.

Visit the VOTW archive ([link removed]).

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“Shop IAC” on immunize.org offers many resources for your practice. Order laminated 2020 U.S. immunization schedules for your exam rooms today!

On the Shop IAC ([link removed]) web page, you will find many resources such as laminated vaccination schedules, personal immunization record cards, pins for your lapel, and more! Your purchases will help IAC keep delivering free, educational materials to healthcare professionals and to the public.

IAC's laminated versions of the 2020 U.S. child/adolescent immunization schedule ([link removed]) and the 2020 U.S. adult immunization schedule ([link removed]) are ideal for use in any busy healthcare setting where vaccinations are given.

The schedules' coating can be wiped down, and they’re durable enough to stand up to a year's worth of use. Visit the Shop IAC: Laminated Schedules ([link removed]) web page for more information on the schedules.

IAC’s three personal immunization record cards—child & teen, adult, and lifetime ([link removed])—are printed on durable rip-, smudge-, and water-proof paper. Sized to fit in a wallet when folded, the cards are brightly colored to stand out. Give these nearly indestructible personal record cards to your patients. They're sold in boxes of 250.

You too can show your support for vaccination with IAC’s elegantly designed “Vaccines Save Lives” pin ([link removed]) on your lapel. The pin makes a refined statement in hard black enamel with gold lettering and edges, measuring 1.125" x 0.75”. Order yours today to show how much you value immunizations!

Related Links:
* IAC’s Laminated Child/Adolescent Immunization Schedule ([link removed])(0–18 years)
* IAC’s Laminated Adult Immunization Schedule ([link removed])(19 and older)
* IAC’s Laminated Schedules print-ready order form ([link removed])(PDF)
* IAC’s Child & Teen Immunization Record Cards ([link removed])
* IAC’s Adult Immunization Record Cards ([link removed])
* IAC's Lifetime Immunization Record Cards ([link removed])
* IAC’s “Vaccines Save Lives” pins ([link removed])
* IAC’s Shop IAC ([link removed]) gateway page

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Journal Articles and Newsletters
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“The Dual Epidemics of COVID-19 and Influenza: Vaccine Acceptance, Coverage, and Mandates” published in JAMA

On June 11, 2020, JAMA published The Dual Epidemics of COVID-19 and Influenza: Vaccine Acceptance, Coverage, and Mandates ([link removed]), by Lawrence O. Gostin and Daniel A. Salmon. The first paragraph is reprinted below.

The confluence of coronavirus disease 2019 (COVID-19) and seasonal influenza this fall and winter will result in considerable morbidity and mortality, stressing the health system. With more than 100,000 COVID-19–related deaths already, the U.S. could see a second wave of disease later this year. In 2018–2019 (a “moderate” year for influenza), the U.S. experienced 35.5 million influenza cases, with 490,600 hospitalizations and 34,200 deaths related to influenza. An effective COVID-19 vaccine is unlikely until 2021. Even though seasonal influenza vaccines have variable year-to-year effectiveness, they can significantly reduce morbidity and mortality, especially with high coverage.

Access the full article ([link removed]).

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On the Lighter Side
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“SPOT PREVENTION” 1966 ANIMATED VIDEO DESCRIBES THE DEVELOPMENT OF MEASLES VACCINE

Take a nostalgic look at vaccine education in this 14-minute CDC-produced animated feature describing the development of measles vaccine ([link removed]). This was produced by the U.S. Department of Health, Education, and Welfare in 1966 and is part of a PSA collection curated by vaccine expert William L. Atkinson, MD, MPH.

Previous videos mentioned in “On the Lighter Side” are available on IAC's Vimeo channel ([link removed]).

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Video of the Week
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How to Make a COVID-19 Vaccine: This April 2020 SciShow video explains the way our immune system works as well as the types of COVID-19 vaccines being developed, using older and newer technologies. It emphasizes that three phases of testing are needed to ensure a vaccine is safe and effective, which slows our ability to produce a vaccine. The video concludes that until we have a SARS CoV-2 vaccine, finding effective treatments and taking preventive measures, such as physical distancing, will be needed.

Visit the VOTW archive ([link removed])

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Follow Us

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Technically Speaking
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Read Dr. Wexler's column for the Vaccine Education Center's monthly newsletter,Vaccine Update

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Vaccinating Adults: A Step-by-Step Guide
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New! IAC's 142-page book available for free download ([link removed]).

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Calendar of Events
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Conferences, meetings, and training opportunities

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Patient Record Cards

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Record cards for patients --child & teen ([link removed]) , adult ([link removed]) , and lifetime ([link removed]) -- are printed on durable paper and sized to fit in a wallet when folded

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DVD: Immunization Techniques
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Every practice should have this award winning, "how-to" training video

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Protect Newborns Guidebook
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Comprehensive guide Hepatitis B: What Hospitals Need to Do to Protect Newborns ([link removed])

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Editorial Information

Editor
Deborah L. Wexler, MD ([email protected])

Associate Editors
Carolyn Bridges, MD, MPH ([email protected])
John Grabenstein, RPh, PhD ([email protected])
Sharon Humiston, MD, MPH ([email protected])

Consulting Editors
Taryn Chapman, MS ([email protected])
Marian Deegan, JD ([email protected])
Courtnay Londo, MA ([email protected])
Jane Myers, MA, EdM ([email protected])

Technical Editor
Liv Augusta Anderson, MPP ([email protected])

About IAC Express
The Immunization Action Coalition welcomes redistribution of this issue of IAC Express or selected articles. When you do so, please add a note that the Immunization Action Coalition is the source of the material and provide a link to this issue ([link removed]).

IAC Express is supported in part by Grant No. 6NH23IP922550 from the National Center for Immunization and Respiratory Diseases, CDC.

IAC Express Disclaimer ([link removed])
ISSN: 1526-1786

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