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Immunization Works January 2012 Issue

News and Summaries

FDA Expands Use of Prevnar 13 Vaccine for Adults Aged 50 and Older: Prevnar 13, a pneumococcal 13-valent conjugate vaccine (which contains 13 different serotypes of the bacterium Streptococcus pneumoniae), was approved on December 30, 2011, by the U.S. Food and Drug Administration (FDA) for adults aged 50 years and older to prevent pneumonia and invasive disease caused by the bacterium.

Pneumococcal pneumonia, caused when the bacterium Streptococcus pneumoniae infects the lungs, is the most common disease caused by this bacterium in adults. When the bacterium invades parts of the body that are normally sterile, such as the blood or spinal fluid, the disease is considered “invasive.”

The new use for Prevnar 13 was approved under the agency's accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.

In randomized, multi-center studies in the United States and Europe, adults aged 50 and older received either Prevnar 13 or Pneumovax 23, a licensed pneumococcal vaccine currently approved for use among adults 65 years of age or older and younger adults with chronic medical conditions. The studies showed that for the 12 serotypes common to both vaccines, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.

The safety of Prevnar 13 was evaluated in about 6,000 adults aged 50 and older who received Prevnar 13 and who had and had not previously received Pneumovax 23. Common adverse reactions reported with Prevnar 13 were pain, redness, and swelling at the injection site, limitation of movement of the injected arm, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain. Similar reactions were observed in those who received Pneumovax 23.

Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit in adults 50 years of age and older. An additional trial in 85,000 adults aged 65 and older, with no previous history of receiving Pneumovax 23, is underway to confirm the clinical benefit of Prevnar 13 in the prevention of pneumococcal pneumonia.

Prevnar 13 is already approved for use in children aged 6 weeks through 5 years for the prevention of invasive disease caused by 13 different serotypes of Streptococcus pneumoniae and for the prevention of otitis media caused by seven of the serotypes of the bacterium.

For additional information please visit the FDA-approved products web page and the FDA press announcement.

The Advisory Committee for Immunization Practices (ACIP) has not issued recommendations for Prevnar 13 use among adults. Background information and data for Prevnar 13 licensure for adults will be discussed at the ACIP meeting on February 22-23, 2012.

VTrckS Update: The National Center for Immunization and Respiratory Diseases (NCIRD) operates the largest and most complex vaccine supply chain in the United States, primarily funded by the Vaccines for Children (VFC) program and distributing more than 100 million doses annually. This management process connects 64 immunization programs, more than 44,000 provider sites, seven vaccine manufacturers and a centralized distributor with CDC's back office and internal business partners.

On December 13, 2010, CDC deployed the Vaccine Tracking System (VTrckS) to connect all of the components of this complex supply chain from purchasing and ordering to the fulfillment and management of the vaccine to the provider locations for four pilot grantees. One pilot provider, Colorado, has approximately 50% of its providers on VTrckS. VTrckS allows CDC to monitor real-time health-care provider usage of the vaccines during emergencies or special circumstances. CDC can now track a specific vaccine to its location or provider office, something that was unheard of before VTrckS. Its scope includes order entry and order management, forecasting, budget management, and contract management. VTrckS provides strong authentication to meet government security needs. VTrckS can also be scaled to meet CDC requirements and support deployment to tens of thousands of users.

These endeavors have not gone unnoticed by the government or the general public. The most recent honor was awarded in late 2011 by Government Computer News as a top federal IT project.

Influenza Information

Stay Informed! Influenza information is updated frequently. Please visit the Flu web site for the latest updates.

Meetings, Conferences and Resources

National Immunization Conference Online: The abstracts deadline is February 10, 2012, for the 1st National Immunization Conference Online. Please visit the NIC Online web page for information about the virtual conference, which will take place March 26-28, 2012.

Surveillance of Vaccine-Preventable Diseases: NCIRD presents the course Surveillance of Vaccine-Preventable Diseases which was produced by CDC in December, 2011. This self-study program provides information on case investigation, outbreak control, disease reporting, and case notification for vaccine-preventable diseases. The course discusses the epidemiologically important data that should be collected during case investigations and presents methods for enhancing surveillance. The course provides current surveillance guidance for HPV, measles, rotavirus, mumps, varicella, hepatitis B, pneumococcal disease, Haemophilus influenzae, pertussis, and meningococcal disease. The course is now available in web-on-demand format. A DVD format will be available for this course in the near future.

National Infant Immunization Week (NIIW): Mark your calendars: National Infant Immunization Week is April 21-28, 2012. This annual observance highlights the importance of protecting infants from vaccine-preventable diseases and celebrates the achievements of immunization programs and their partners in promoting healthy communities. Since 1994, NIIW has served as a call to action for parents, caregivers, and health-care providers to ensure that infants are fully immunized against 14 vaccine-preventable diseases. For more information, visit the NIIW web page.

ACIP Meeting: The next ACIP meeting will be held February 22-23, 2012. Please visit the ACIP meeting web page for additional information.

Save the Date: The 10th National Conference on Immunization and Health Coalitions (NCIHC) will be in New Orleans on May 23-25, 2012. Please visit the NCIHC NCIHC web site for additional information.

Updated Vaccine Storage and Handling Guide: NCIRD has released the updated Vaccine Storage and Handling Guide (formerly Vaccine Management). It is a comprehensive and authoritative document on storage and handling guidelines for specific vaccines (including combination vaccines). Available in this document are guidelines on vaccine-specific shipping requirements; arrival conditions; storage requirements; and information on shelf life, preparation, and special instructions. Please visit the Vaccine Storage and Handling web page [PDF-654KB, 77 pages] for the PDF ready-to-print version.

CDC and Medscape Videos: This special series of commentaries is part of a collaboration between CDC and Medscape and is designed to deliver CDC's authoritative guidance directly to Medscape's physicians, nurses, pharmacists, and other health-care professionals. In this series, experts from CDC offer video commentaries on current topics important to practicing clinicians. NCIRD has contributed to a variety of commentaries. A commentary on clarifying meningococcal booster dose recommendations was recently released.

Clinical Decision Support Project: In an effort to harmonize clinical decision support (CDS) tools and improve the timeliness of updates to their schedules, the American Recovery and Reinvestment Act (ARRA) Section 317 Immunization program appropriated funds to the Immunization Information System Support Branch (IISSB) for a CDS project including the creation of an expert panel. The Clinical Decision Support Expert Panel seeks to increase consistency and accuracy in results from immunization evaluation and forecasting systems and decrease the time and effort required for implementing and maintaining ACIP recommendations in CDS engines.

The panel kicked off in April, 2011 and was divided into the following three subgroups targeted to develop these specific artifacts by July 1, 2012:

• The Logic Specification Panel is developing a framework for use in automated, electronic systems and elsewhere to improve the clarity, accuracy, and consistency of on-going childhood immunization forecasting and evaluation.
• The Validation and Testing Panel is developing testing tools to validate that framework and enable long-term usage of the testing tools to allow for validation in conjunction with ACIP recommendation changes.
• The Process, Communication, and Sustainability Panel is developing an efficient, timely, and effective formalized two-way communication process among ACIP, CDC SMEs, and those maintaining CDS engines.

Members of the CDS panel participated in a very successful in-person session on November 7-10, 2011. The facilitated session included a discussion of ACIP schedule recommendations with the project's ACIP liaison. There was also a review of the various project artifacts, including but not limited to, a domain model, use cases, activity diagrams, decision tables, and system logic rules. Hands-on activities allowed panelists to practice successfully applying complex scenarios to the artifacts to test artifact viability as well as resolve relevant issues. Additional facilitated conversations included topics such as catch-up schedules, booster doses, and the method for selecting the best series for a particular antigen.

The panel is now focusing on developing business rules to represent the ACIP general recommendations in a way that works more precisely with computer systems. All of the developed tools will be supplemental to what ACIP already provides and will assist those with CDS engines in interpreting the clinical ACIP recommendations consistently, accurately, and more efficiently.

Current Issues in Immunization NetConference: The next netconference is scheduled for March 29, 2012. The moderator will be Andrew Kroger. The topics will be the 2012 Childhood/Adolescent Immunization Schedule Update, presented by Yabo Beysolow and the 2012 Recommended Adult Immunization Schedule, presented by Raymond Strikas. Please visit the immunization netconference web page for updates and archived netconferences.

ACP Immunization Webcasts: The American College of Physicians (ACP) invites interested providers to its series of four web casts. The first, on November 15, 2011, reviewed the new ACIP recommendations. The next webcast will be on February 23, 2012, and the topic will be Efficient Vaccine Ordering. Other webcasts will look at quality improvement, and risk-benefit communication. For more information, please visit the ACP Immunization Webinar Series web site.

Immunization Publications: Please visit the NCIRD publications order form for the latest immunization publications. Copies of the 2011 Immunization Update DVD, the 2011 Parents Guide to Childhood Immunizations, the 2011 Immunization Works CD, and other items are now available for ordering.

NIVS Immunization Excellence Awards: The National Influenza Vaccine Summit (NIVS) is soliciting candidates for the 2012 NIVS Immunization Excellence Awards. The 2012 awards recognize individuals and organizations that have made extraordinary contributions towards improved adult, and/or childhood influenza vaccination rates within their communities during the 2011-2012 influenza season. National winner and honorable mention recipients will be selected for each award category. The winners will be presented with their awards at the NIVS meeting in Atlanta, Georgia on May 15-17, 2012. National winners in each category will be invited to present their programs at the NIVS meeting.

There are four categories of award recognition:

• Overall Season Activities (activities related to early season and later season).
• Health-care Personnel Campaign (community or institutional-based activities).
• Immunization Coalitions/Public Health/Community Campaign (programs conducted within states and communities that demonstrate strong public and private collaboration).
• Corporate Campaign (programs developed by communication/public relations organizations and/or supported by manufacturers, distributors, or other for-profit entities (such as multi-practice site companies).

Nominations must be received by COB March 2, 2012. Please visit the online nomination form for additional information.

CDC Job Openings: CDC is committed to recruiting and hiring qualified candidates for a wide range of immunization and other positions. Researchers, Medical Officers, Epidemiologists, and other specialist are often needed to fill positions within CDC. For a current listing, including international opportunities, please visit CDC's employment web page.

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The Immunization Works database manager and editor can be contacted at nipimmzwrks@cdc.gov.

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