Issue 1150: November 4, 2014

Ask the Experts–Question of the Week: The pneumococcal conjugate vaccine (PCV13) package insert says that in adults…read more


TOP STORIES
IAC HANDOUTS
VACCINE INFORMATION STATEMENTS
OFFICIAL RELEASES AND ANNOUNCEMENTS
FEATURED RESOURCES
JOURNAL ARTICLES AND NEWSLETTERS
EDUCATION AND TRAINING

TOP STORIES
Reminder: October issues of Needle Tips and Vaccinate Adults available online

The October 2014 issues of Needle Tips and Vaccinate Adults are available online. Vaccinate Adults is an abbreviated version of Needle Tips with the pediatric content removed.

Click on the images below to download the entire October issue (PDF) of Needle Tips and/or Vaccinate Adults.
Download the October issue of Needle TipsDownload the October issue of Vaccinate Adults
Needle Tips: View the table of contentsmagazine viewer, and back issues.

Vaccinate Adults: View the table of contentsmagazine viewer, and back issues.

If you would like to receive immediate email notification whenever new issues of Needle Tips or Vaccinate Adults are released, visit IAC's subscribe page to sign up.

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FDA approves the use of Trumenba in the U.S. to prevent serogroup B meningococcal disease

On October 29, FDA announced the approval of Trumenba (Pfizer), the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in people age 10 through 25 years. The following is an excerpt from a related FDA news release.

“Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”

Meningococcal disease can be treated with antibiotics to reduce the risk of death or serious long-term problems, but immediate medical attention is extremely important. Vaccination is the most effective way to prevent meningococcal disease. Until today, meningococcal vaccines approved for use in the United States have only covered four of the five main serogroups of
N. meningitidis bacteria that cause meningococcal disease: A, C, Y, and W.

The FDA used the accelerated approval regulatory pathway to approve Trumenba. Accelerated approval allows the agency to approve products for serious or life-threatening diseases based on evidence of a product’s effectiveness that is reasonably likely to predict clinical benefit, reducing the time it takes for needed medical products to become available to the public. In the FDA’s evaluation for accelerated approval, evidence of effectiveness was demonstrated by the ability of Trumenba recipients’ antibodies to kill the four representative
N. meningitidis serogroup B test strains. As part of the accelerated approval process, the manufacturer will conduct further studies to verify Trumenba’s effectiveness against additional strains of N. meningitidis serogroup B. 

Trumenba was granted breakthrough therapy status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition. Working closely with the company, the FDA was able to evaluate Trumenba’s safety and effectiveness and approve it in well under six months, the usual timeframe for a priority review....


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FDA approves expanded age indication for Flublok to include all adults age 18 years and older

On October 29, the FDA approved an expanded age indication for Flublok influenza vaccine to include all adults age 18 years and older, granting approval for use in people 50 years and older. Flublok is the only licensed influenza vaccine made using recombinant technology. ACIP has recommended use of FluBlok for people with serious egg allergies.

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IAC Spotlight! Access up-to-date vaccine package inserts on immunize.org

Looking for vaccine product information? IAC's Package Inserts web section provides up-to-date product information for all vaccines licensed for use in the United States.

This handy listing is part of IAC’s online Directory of Immunization Resources, which is a compendium of helpful immunization resources—such as apps (applications for mobile devices), blogs, books and periodicals, state and local immunization coalitions, email news services, and more—from a variety of organizations: government, professional associations, nonprofit organizations, private industry, and others.

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New website for medical assistants provides immunization information and training opportunities 

A new website for medical assistants was recently launched online: Medical Assistants Resources and Training on Immunization (MARTi). MARTi provides excellent immunization-related information, as well as a listing of training and education resources and continuing education opportunities. Topics include vaccine administration, vaccines for specific diseases, patient education, record keeping, vaccine safety, immunization schedules, storage and handling, upcoming events, and general information on immunization.

MARTi is funded through a cooperative agreement between CDC and the Association for Prevention Teaching and Research (APTR).

Visit the MARTi website at www.marti-us.org and be sure to recommend it to the medical assistants with whom you work and all others who administer vaccines! 


Connect with MARTi on FacebookTwitter, and Pinterest.

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National Influenza Vaccination Week will be held December 7–13

National Influenza Vaccination Week (NIVW) will be held this year on December 7–13. This event highlights the importance of continuing influenza vaccination throughout the season. CDC features useful resources on its NIVW web section. This site will be updated as December approaches, so check back frequently. The NIVW calendar of events submission form is now available, so don’t forget to share your plans with CDC and your colleagues.

Vaccination remains the single most effective means of preventing influenza, and is recommended for everyone age six months and older. If you don't provide influenza vaccination in your clinic, please recommend vaccination to your patients and refer them to a clinic or pharmacy that provides vaccines or to the HealthMap Vaccine Finder to locate sites near their workplaces or homes that offer influenza vaccination services.

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IAC HANDOUTS
IAC updates "Pneumococcus: Questions and Answers"

IAC recently updated Pneumococcus: Questions and Answers to include information related to ACIP's newest recommendations for the use of pneumococcal vaccines in people 65 years and older.

Related Links IAC's Handouts for Patients & Staff web section offers healthcare professionals and the public more than 250 FREE English-language handouts (many also available in translation), which we encourage website users to print out, copy, and distribute widely.

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IAC updates its staff education materials: "It's Federal Law! You must give your patients current Vaccine Information Statements" and "Current Dates of Vaccine Information Statements"

IAC recently revised Current Dates of Vaccine Information Statements as well as It's Federal Law! You must give your patients current Vaccine Information Statements to reflect the 10/22/2014 release date of the recently updated pediatric multi-vaccine VIS.

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VACCINE INFORMATION STATEMENTS
IAC creates Spanish-language large print version of inactivated influenza VIS

IAC recently formatted the Spanish-language translation of the VIS for inactivated influenza vaccine (IIV) to provide a large-print version. Related Links Back to top


IAC posts ten new VIS translations in the Amharic, Cambodian, Haitian Creole, Portuguese, and Tigrigna languages

IAC recently posted ten new VIS translations as detailed below:

Amharic Cambodian (Khmer) VIS translations Haitian Creole VIS translation Portuguese VIS translation Tigrigna IAC thanks Swedish Hospital, Seattle, Washington, for the Amharic and Tigrigna translations. The other translations were made available by IAC through its cooperative agreement with CDC's National Center for Immunization and Respiratory Diseases.

Visit IAC's VIS web section for VISs in more than 35 languages

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OFFICIAL RELEASES AND ANNOUNCEMENTS
CDC releases interim U.S. guidance for monitoring persons with potential Ebola virus exposure

CDC published an announcement titled Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola Virus Exposure in the October 31 issue of MMWR (page 984). The complete article is reprinted below.

On October 27, 2014, CDC released Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola Virus Exposure (available at http://www.cdc.gov/vhf/ebola/exposure/monitoring-and-movement-of-persons-with-exposure.html). This updated guidance focuses on strengthening the monitoring of persons potentially exposed to Ebola and evaluating their intended travel, including the application of movement restrictions when indicated. This interim guidance has been updated by establishing a “low (but not zero) risk” category; adding a “no identifiable risk” category; modifying the recommended public health actions in the “high risk,” “some risk,” and “low (but not zero) risk” categories; and adding recommendations for specific groups and settings.

Through these changes, CDC and state and local health departments seek to support persons who might have been exposed to Ebola, while also continuing to stop Ebola at its source in West Africa. These changes will help ensure that health care workers returning to the United States from West Africa are monitored, any symptoms they might develop are quickly identified, and that a system is in place to recognize when they need to be routed to care. These actions will better protect potentially exposed individuals and the U.S. public as a whole. A fact sheet regarding the new interim guidance is available at http://www.cdc.gov/media/releases/2014/fs1027-monitoring-symptoms-controlling-movement.html.


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FEATURED RESOURCES
Vaccine Education Center updates its ready-to-print fact sheet on influenza

The Vaccine Education Center (VEC) at Children's Hospital of Philadelphia recently released its updated 2-page fact sheet, Influenza: What you should know. It is also available in Spanish.

The fact sheet is available online for free downloading or can be ordered for $4 per 50-sheet tear pad, plus shipping.


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AAP releases enhanced Red Book app

On October 31, the American Academy of Pediatrics (AAP) released a new enhanced AAP Red Book app. The new app features upgraded search and browse functions and an updated design to align with the Red Book Online site.
  • Visit an Apple or Android app store to upgrade your current AAP Red Book app to the new enhanced AAP Red Book app
  • Access the Red Book Online website (Red Book Online requires a subscription for access to all of its features)
  • IAC's Immunization Apps web page
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JOURNAL ARTICLES AND NEWSLETTERS
October issue of CDC's Immunization Works newsletter now available

CDC recently released the October issue of its monthly newsletter Immunization Works and posted it online. The newsletter offers the immunization community information about current topics. The newsletter content is in the public domain and can be reproduced and circulated widely.

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CDC publishes "CDC National Health Report: Leading Causes of Morbidity and Mortality and Associated Behavioral Risk and Protective Factors—United States, 2005–2013"

CDC published CDC National Health Report: Leading Causes of Morbidity and Mortality and Associated Behavioral Risk and Protective Factors—United States, 2005–2013 in an October 31 MMWR Supplement. The first paragraph of the "Introduction" section is reprinted below.

In 2011, the 10 leading causes of death in the United States were, in rank order of prevalence, diseases of the heart (heart disease); malignant neoplasms (cancer); chronic lower respiratory diseases; cerebrovascular diseases (stroke); unintentional injuries; Alzheimer's disease; diabetes mellitus; pneumonia and influenza; nephritis, nephrotic syndrome, and nephrosis (kidney disease); and intentional self-harm (suicide). These 10 causes accounted for approximately 75% of all deaths in the United States. Seven of the 10 leading causes of death are chronic diseases, two of which (heart disease and cancer) account for approximately half of all deaths each year. Injuries (e.g., from motor-vehicle crashes, drug poisonings, and falls), violence, and infectious diseases (e.g., influenza, foodborne illness, health-care–associated infections, and sexually transmitted infections) further add to the preventable morbidity and mortality and have substantial consequences for U.S. health systems and overall population health. Much of this health burden could be prevented or postponed through improved nutrition, increased physical activity, improved vaccination rates, avoidance of tobacco use, adoption of measures to increase motor-vehicle safety, early detection and treatment of risk factors, and health-care quality improvement. Finally, ensuring the well-being of mothers and infants and preventing unintended pregnancies among teenagers are critical public health goals to establish better health of future generations.

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CDC publishes update on Ebola outbreak in West Africa

CDC published Update: Ebola Virus Disease Outbreak—West Africa, October 2014 in the October 31 issue of MMWR (pages 978–981). This report was previously published as an MMWR Early Release on October 28. The second paragraph is reprinted below.

According to the latest World Health Organization update as of October 22, 2014, a total of 9,911 Ebola cases have been reported as of October 19 from three highly affected West African countries (Guinea, Liberia, and Sierra Leone). The highest reported case counts were from Liberia (4,665 cases), followed by Sierra Leone (3,706) and Guinea (1,540).

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CDC reports on progress toward polio eradication in Afghanistan and Pakistan

CDC published Progress Toward Poliomyelitis Eradication—Afghanistan and Pakistan, January 2013–August 2014 in the October 31 issue of MMWR (pages 973–977). A summary made available to the press is reprinted below.

Afghanistan and Pakistan are two of three countries (including Nigeria) where circulation of WPV has never been interrupted. Conflict in both countries has made it difficult for vaccinators to get to the children who need vaccine. To eradicate polio and prevent outbreaks, all children must be vaccinated. Both Afghanistan and Nigeria have made significant strides towards control of WPV circulation, but continued vigilance and improved efforts to reach unvaccinated children are needed. The situation in Pakistan is worse in 2014 than it was in 2013. More than four times as many children were crippled with polio this year than last year and the case counts keep climbing. Unless Pakistan makes significant improvements to its program to vaccinate children, the global polio eradication goals will not be met.

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EDUCATION AND TRAINING
NFID offers two vaccine-related webinars in November

The National Foundation for Infectious Diseases (NFID), in collaboration with partner organizations, will be offering the following webinars in November:

November 17 at 12:00 p.m. (ET): "Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on College Campuses." Presenters will be NFID experts, Carol J. Baker, MD, and William Schaffner, MD.

November 18 at 11:00 a.m. (ET): "Flu Care in Day Care." Sponsored by the Childhood Influenza Immunization Coalition, in cooperation with the Association of Immunization Managers, and moderated by Carol J. Baker, MD.

Register for these webinars online.

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ASK THE EXPERTS
Question of the Week

The pneumococcal conjugate vaccine (PCV13) package insert says that in adults, antibody responses to Prevnar 13 (Pfizer) were diminished when given with inactivated influenza vaccine. Does this mean we should not give PCV13 and influenza vaccine at the same visit? 
 
Answer:  No. The available data have been interpreted that any changes in antibody response to either vaccines’ components were clinically insignificant. If PCV13 and influenza vaccine are both indicated and recommended they should be administered at the same visit. See ACIP recommendations at www.cdc.gov/mmwr/pdf/wk/mm6337.pdf, page 824. 


About IAC's Question of the Week

Each week, IAC Express highlights a new, topical, or important-to-reiterate Q&A. This feature is a cooperative venture between IAC and CDC. William L. Atkinson, MD, MPH, IAC's associate director for immunization education, chooses a new Q&A to feature every week from a set of Q&As prepared by experts at CDC’s National Center for Immunization and Respiratory Diseases.

We hope you enjoy this new feature and find it helpful when dealing with difficult real-life scenarios in your vaccination practice. Please encourage your healthcare professional colleagues to sign up to receive IAC Express at www.immunize.org/subscribe.

If you have a question for the CDC immunization experts, you can email them directly at nipinfo@cdc.gov. There is no charge for this service.

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About IZ Express

IZ Express is supported in part by Grant No. 1NH23IP922654 from CDC’s National Center for Immunization and Respiratory Diseases. Its contents are solely the responsibility of Immunize.org and do not necessarily represent the official views of CDC.

IZ Express Disclaimer
ISSN 2771-8085

Editorial Information

  • Editor-in-Chief
    Kelly L. Moore, MD, MPH
  • Managing Editor
    John D. Grabenstein, RPh, PhD
  • Associate Editor
    Sharon G. Humiston, MD, MPH
  • Writer/Publication Coordinator
    Taryn Chapman, MS
    Courtnay Londo, MA
  • Style and Copy Editor
    Marian Deegan, JD
  • Web Edition Managers
    Arkady Shakhnovich
    Jermaine Royes
  • Contributing Writer
    Laurel H. Wood, MPA
  • Technical Reviewer
    Kayla Ohlde

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