October 29, 2018



Genentech Announces FDA Approval of Xofluza for the Treatment of Acute, Uncomplicated Influenza in People 12 Years of Age and Older

On October 24, the U.S. Food and Drug Administration (FDA) approved Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.

Genentech will be hosting an informational webinar on Thursday, November 1 from 1–2 pm ET. To participate, please RSVP to receive a link.

Seqirus Receives FDA Approval of Afluria® Quadrivalent (Influenza Vaccine) for People Six Months of Age and Older in the U.S.

On October 17, Seqirus received FDA approval for the use of its Afluria® Quadrivalent (Influenza Vaccine) for use in people six months of age and older. This age expansion also applies to the trivalent formulation of Afluria®.

National HPV Roundtable Webinar on New HPV-9 Indication

On October 5, the FDA approved expansion of HPV vaccination with Gardasil 9 to men and women ages 27 through 45 years. On October 29, the National HPV Vaccination Roundtable will convene two experts, Dr. Debbie Saslow (ACS) and Dr. Rebecca Perkins (ACOG), for a half-hour webinar to discuss the recently approved age expansion for Gardasil 9 and the implications for clinical practice. The presenters will answer some important questions, including:

  1. What does the FDA label expansion do and what will it mean for clinical practice?
  2. What are the next steps and timing for the Advisory Committee on Immunization Practices (ACIP) regarding potential changes to the recommended age ranges?
  3. Will insurance companies cover the HPV vaccine for older ages?

NFID Hosts Webinar on Pneumococcal Vaccines: Strategies to Increase Adult Immunization Rates – October 30 at Noon ET

Join the National Foundation for Infectious Diseases (NFID) for a discussion about the importance of pneumococcal vaccines in adults, with a focus on strategies for determining which pneumococcal vaccine to give to whom and when.

NFID Medical Director William Schaffner, MD, will moderate the webinar with a presentation by Thomas M. File, Jr., MD, MS, Chair, Infectious Disease Division of Summa Health and Professor, Internal Medicine; Master Teacher; Chair, Infectious Disease Section of Northeast Ohio Medical University; NFID Past President; and President-Elect of the Infectious Diseases Society of America.

At the conclusion of the webinar, participants will be able to:

  • Discuss the epidemiology, clinical manifestations, and outcomes of pneumococcal infection
  • Interpret current Advisory Committee on Immunization Practices (ACIP) recommendations regarding the use of PCV13 and PPSV23 in older adults
  • Identify strategies for implementation of ACIP recommendations into practice

Updated Joint Clinical Report Released on Healthcare Transition from Adolescence to Adulthood Medical Home

The National Survey for Children’s Health reveals that only 15% of youth with and without special health care needs receive transition planning assistance from their health care providers. To address this gap, the American Academy of Family Physicians and American College of Physicians join the American Academy of Pediatrics in calling on clinicians to establish a structured process to ensure a planned transition from pediatric to adult health care as part of routine care for adolescents and young adults.

The updated 2018 clinical report, “Supporting the Health Care Transition from Adolescence to Adulthood in the Medical Home,” provides new practice-based quality improvement guidance on key elements of transition: planning, transfer, and integration into adult care. The clinical report is available online and will be published in the November 2018 issue of Pediatrics. A press release about this report also is available online.

Getting Flu Shot Annually Won’t Undermine Its Effectiveness in Kids

Researchers have found that getting the flu shot annually will not in any way reduce the flu-fighting strength of the current vaccine in children.

The conclusion follows three years spent monitoring flu vaccine effectiveness among nearly 3,400 children aged 2 to 17. The researchers said the findings strongly support current recommendations that children get vaccinated against the flu every year.

Fewer Adults Got the Flu Shot Last Year, Says CDC

The number of adults who got a flu shot declined last season, which was the deadliest in four decades, according to final estimates from the Centers for Disease Control and Prevention.

Estimates of flu vaccination coverage among adults shows 37.1 percent of Americans age 18 and older received a flu shot last season, down 6.2 percent from the previous season. Vaccine coverage for the 2017-18 flu season — when more than 80,000 people died from flu in the U.S. and 900,000 were hospitalized — was the lowest in seven flu seasons, said the CDC.

“It is important that providers prioritize flu vaccination for their patients,” said the CDC in a statement.


NEW Fact Sheet on Implementing the 16-Year-Old Immunization Visit Available from the Adolescent Immunization Initiative (AII)

A new fact sheet, Implementing the 16-Year-Old Immunization Visit: A How-To Tool for Health Care Practices, is now available from the Adolescent Immunization Initiative (AII). This new fact sheet joins AII’s previously published fact sheet, The Importance and Potential of the 16-Year-Old Immunization Visit.

The fact sheets, which will be posted on the AII website, raise awareness of the adolescent 16-year-old immunization platform and provide practical implementation strategies for practices.

Please feel free to share the fact sheets with peers and with associations/organizations with which you are affiliated.

ACIP Backs Routine Hepatitis A Shots for Homeless

Advisers to the Centers for Disease Control and Prevention (CDC) on Wednesday endorsed hepatitis A vaccines for people experiencing homelessness and also made tweaks to the current roster of recommendations on routine vaccinations. A full story on this issue is available in Medscape (registration necessary).

New 65+ Flu Defense Website Features Tools and Resources for Healthcare Professionals Serving Adults Age 65 and Older

Annual influenza vaccination is the best way to prevent influenza, but vaccination coverage among older adults in the U.S. has stagnated, and in some years has declined significantly over the previous season’s rate. In the 2016–2017 season, only 65.3% of adults age 65 and older were vaccinated against the flu.

However, seniors are at greater risk of severe complications from influenza, due both to their increased likelihood of having chronic conditions and to the decline of their immune systems with aging.

As a healthcare provider (HCP), your strong, confident recommendation for flu vaccine is a very powerful and persuasive tool in determining if your patients are vaccinated. To assist you in this effort, the new 65+ Flu Defense website has been launched. This project, a collaboration between IAC and Seqirus, aims to reach HCPs with information, tools, and resources they need to better communicate the impact of flu and its complications in older adults, and to proactively discuss flu vaccination with their patients age 65 and older.

65+ Flu Defense is divided into several easy-to-use topic areas, including:

Two new patient handouts are also available on the website:

Be sure to check out the information and printable materials for your patients available on the website to help your efforts in protecting this vulnerable population.

American Lung Association Initiates New Consumer Flu Awareness Campaign, MyShot

Staff from the American Lung Association (ALA) will join the Summit call on November 1 to speak briefly about the new website, MyShot.

The ALA is urging adults 50 years of age and older to get their annual flu shot through its new MyShot campaign, which shares the personal stories of adults in their 50s, 60s and 70s, and why they prioritize getting a flu shot. MyShot stories illustrate the potential impact of flu (severe illness, worsening of chronic health conditions, hospitalization and leading to missed work days) on this vulnerable group. The campaign reinforces the need for adults 50 years of age and older to talk with their healthcare providers about flu shot options that may be right for them.

MyShot, a collaboration with Sanofi Pasteur, the vaccines division of Sanofi, speaks directly to adults 50 years of age and older, because by the time adults turn 50 they are more likely to have one or more chronic health condition such as lung disease, heart disease or diabetes. When combined with the flu, these conditions can become worse and lead to serious illness. Vaccination is the best way to help protect against the flu. Yet, despite these potential dangers, vaccination rates for those 50 years of age and older have stagnated, hovering around 45 percent for adults ages 50-64 and 65 percent for adults ages 65 and older.

A press release about the new campaign is available online.


CDC Influenza Updates

The FluView report for Week 42 (ending October 20, 2018) is available on CDC’s website. A synopsis of this report follows below:

Influenza activity in the United States remains low. Influenza A(H1N1)pdm09, influenza A(H3N2), and influenza B viruses continue to co-circulate, with influenza A(H1N1)pdm09 viruses reported most commonly by public health laboratories during the most recent three weeks. Below is a summary of the key influenza indicators for the week ending October 20, 2018:

  • Viral Surveillance: Influenza A viruses have predominated in the United States since the beginning of July. The percentage of respiratory specimens testing positive for influenza in clinical laboratories was low.
  • Virus Characterization: The majority of influenza viruses characterized antigenically and genetically are similar to the cell-grown reference viruses representing the 2018–2019 Northern Hemisphere influenza vaccine viruses.
  • Antiviral Resistance: All viruses tested since late May show susceptibility to the antiviral drugs oseltamivir, zanamivir, and peramivir.
  • Influenza-like Illness Surveillance: The proportion of outpatient visits for influenza-like illness (ILI) remained low at 1.5%, which is below the national baseline of 2.2%. All regions reported ILI below their region-specific baseline level.
  • ILI State Activity Indictor Map: Puerto Rico and one state experienced low ILI activity; and New York City, the District of Columbia, and 49 states experienced minimal ILI activity..
  • Geographic Spread of Influenza: The geographic spread of influenza in four states was reported as local; the District of Columbia, Puerto Rico, the U.S. Virgin Islands and 42 states reported sporadic activity; four states reported no activity; and Guam did not report.
  • Pneumonia and Influenza Mortality: The proportion of deaths attributed to pneumonia and influenza (P&I) was below the system-specific epidemic threshold in the National Center for Health Statistics (NCHS) Mortality Surveillance System.
  • Influenza-associated Pediatric Deaths: No influenza-associated pediatric deaths were reported to CDC.

Also available are CDC’s influenza summary and technical key points from October 25, 2018 and frequently asked questions about the upcoming 2018–2019 season.

From the World Health Organization: Understanding Why People Do or Do Not Vaccinate – The First Step to Increasing Vaccination Coverage

Only when we know the root causes of low vaccination coverage can we address them. Despite this, only a few national immunization programs have conducted in-depth analysis to understand the barriers to vaccination in their countries.

The WHO Behavioral Insights Summer School (BISS), jointly organized with the University of Erfurt, Germany and held on 27–31 August 2018, sought to address this gap, offering guidance on how behavioral analyses such as these can be done.

Pfizer sponsors IDCareLive Educational Program on Optimizing Utilization and Implementation of Medicare’s Annual Wellness Visits

The program provides education on the background, structure, and benefits of performing the Annual Wellness Visit. It discusses how to incorporate AWV into practice, the role of AWV in quality reporting, and facts related to the underutilization of Medicare’s Annual Wellness visit. This program does not earn continuing education credits.

3 Pediatric Deaths Reported During 2018-19 Flu Season

Influenza activity in the United States remains low for the week ending October 20, 2018, says the Centers for Disease Control and Prevention (CDC). But, as of October 27, there have been 3 pediatric deaths reported in the USA for the 2018–2019 influenza season.

These deaths have been reported in these states:

  • Connecticut
  • Florida
  • New York

Insufficient Evidence to Recommend Ebola Vaccine for Pregnant Women, WHO Advisory Group Says

A committee that advises WHO on global immunization policy said there is insufficient evidence to recommend giving pregnant women an experimental Ebola virus vaccine — a timely issue given the ongoing deadly Ebola outbreak in the Democratic Republic of the Congo.

Research has showed that almost 90% of pregnant women infected with Ebola die from the disease, and there is only one documented case of a child born to an infected mother surviving for longer than 1 month.

Flu Mutations in a Single Cell Help to Predict Immune Response

The influenza virus mutates constantly, and work published this month on bioRxiv reveals that this viral volatility can affect whether, and how, a host cell responds to infection.

Genetic sequencing over the past decade has revealed that RNA viruses such as influenza don’t churn out billions of identical copies of their own genomes. Instead, the cells that the virus hijacks produce a messy swarm of viral offspring that carry small genetic errors. Those minor variations can add up as the viruses keep replicating. New mutations could affect how well a virus spreads to other people or how well a person’s immune cells respond. An additional story on this research is available in Nature.

Social Marketing Insights Help Solve the Puzzle of Low Influenza Vaccination Rates among Healthcare Workers in the West of Ireland

In 2016, a social marketing expert and a public health specialist joined forces to tackle a problem facing health authorities in Ireland. As in many countries across Europe, Ireland was seeing very low influenza vaccination rates among health workers and annual outbreaks of influenza in health-care settings.

The results speak for themselves: vaccination rates in the first year were down to 15% on average; in 2 years, they had doubled to more than 37%.

High-dose Influenza Vaccine Associated with Fewer Hospitalizations in Dialysis Patients

Results from a new study suggest that high-dose influenza vaccine is associated with lower risk for hospitalizations in kidney failure patients on dialysis. The findings appear in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN).

InvVax Achieves Preclinical Milestone with Universal Flu Vaccine Candidate

Arguably the most formidable characteristic of the influenza virus is its ability to rapidly mutate, owing to a high error rate of the enzymes which make copies of its genome. This leads to the generation of hundreds of circulating strains, and the constant shifting of those strains. Each year the World Health Organization predicts the most dominant circulating strains for inclusion in the next annual flu vaccine, but often those predictions are erroneous, causing the ineffectiveness of the vaccine. The constant genetic movement of the virus is known as “mutational escape.”

The solution that most flu vaccine companies and academic laboratories have taken to solve this problem is to go after so-called “conserved” regions of the virus. These are regions that are the same from strain to strain. While this promises to be an effective strategy to hit all strains of flu (thus “universal”), InvVax believes that it fails to account for the most important feature of the virus – its high mutation rate. Conserved regions are often mutable, meaning that they can mutate without destroying the virus, as was found in a genomic screen by the company’s Founder while at UCLA. In contrast, there are what is known as “invariant” regions: places where the virus, if it mutates, will self-destruct. The InvVax differentiator is to go after these regions to prevent viral mutational escape. InvVax’s proprietary regions, which they have exclusively licensed from UCLA, are the basis of the company’s universal flu vaccine program.

Three Slide Decks Available to Support New Standards for Adult Immunization Practice

The Summit’s Access and Collaboration workgroup has developed three separate slide decks with talking notes to support partners and others who wish to present on the Standards to their peers and colleagues. The three audiences targeted by the decks are: healthcare providers; patients/public; and public health. These are now available, along with tips and tools on how to use them, at the Summit website.

Also, do not forget that Medscape has produced two modules to support the implementation of the Standards:

Every Child By Two (ECBT) Compiles Media Information on Its Website

On a daily basis, ECBT assembles significant news media coverage on immunizations in their “Daily Clips.”  Summit partners may find this effort useful.

Summit Website Offers Wonderful Resources on Influenza Vaccination

Remember to visit the Summit website for the latest on influenza immunization resources. You also can find archived copies of The Summit Buzz there.


Summit calls are held weekly on Thursday at 3 pm ET throughout the influenza season unless cancelled. Call information and an agenda generally are sent the morning of the call. Call summaries are available shortly after each call on the Summit website.

Please email L.J Tan or LaDora Woods if you have any updates on activities to provide to the Summit.

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