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Disclaimer: CME certification for these activities has expired. All information is pertinent to the timeframe in which it was released.

PCV-7 Vaccine: Changing The Epidemiology Of Acute Otitis Media

To provide physicians with information on the most recent developments regarding the prevention, diagnosis, and management of acute otitis media.

This activity is designed for pediatricians, otolaryngologists, and primary care physicians. No prerequisites required.

The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity. At the conclusion of this activity, participants should be able to:

  • Discuss the prevalence of acute otitis media (AOM) and its impact on patients.
  • Describe the pathophysiology of AOM.
  • Discuss the changing epidemiology of AOM, and how new studies can be applied
     to clinical practice.
  • Evaluate how new drugs and vaccines may be of benefit for patients with AOM.
  • Identify new patterns of antibiotic resistance.

The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Johns Hopkins University School of Medicine designates this educational activity for a maximum of 2 category 1 credits toward the AMA Physician's Recognition Award. Each participant should claim only those credits that he/she actually spent in the activity.

The estimated time to complete this educational activity: 2 hours.

Release date: December 15, 2004. Expiration date: December 15, 2006.

The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of the Johns Hopkins University School of Medicine name implies review of educational format, design, and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients.

This program is supported by an educational grant from Abbott Laboratories.

Full Disclosure Policy Affecting CME Activities:
As a provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of Johns Hopkins University School of Medicine to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. The Program Director and Participating Faculty reported the following:


William R. Bishai, MD, PhD
Associate Professor of Medicine
Division of Infectious Diseases
Co-Director, Center for Tuberculosis Research
Johns Hopkins University School of Medicine
Baltimore, Maryland
Dr Bishai reports receiving grants/research support from Abbott laboratories, Aventis, Bayer Pharmaceuticals Corporation, Merck & Co, Inc, and Pfizer Inc; and receiving honoraria from Abbott laboratories, Aventis, Bayer Pharmaceuticals Corporation, F. Hoffman LaRoche, Merck & Co, Inc, Ortho-McNeil Pharmaceutical Inc, and Pfizer Inc.


Stanley L. Block, Jr, MD, FAAP
President, Kentucky Pediatric Research
Bardstown, Kentucky
Clinical Professor of Pediatrics
University of Kentucky College of Medicine
Lexington, Kentucky
Associate Clinical Professor of Pediatrics
University of Louisville School of Medicine
Louisville, Kentucky
Dr Block reports receiving grants/ research support from Abbott Laboratories, GlaxoSmithkline, and Sanofi-Synthelabo Inc; serving as a consultant to Abbot Laboratories and Aventis; and receiving honoraria from Abbott Laboratories.

Stephen A. Brunton, MD
Clinical Professor of Family Medicine
University of California Irvine
Irvine, California
Dr Brunton reports serving as a consultant to Aventis and Ortho Pharmaceutical, Inc; and receiving honoraria from Abbott Laboratories.

W. Manford Gooch, III, MD
Clinical Professor of Pediatrics
University of Utah School of Medicine
Salt Lake City, Utah
Dr Gooch reports receiving grants/research support from Abbott Laboratories, Alcon, Inc, Bristol-Myers Squibb Company, Daiichi Pharmaceutical Corporation, Eli Lilly and Company, Fujisawa Pharmaceutical Co, GlaxoSmithKline, Hoescht Marion Roussel, Inc, Merck & Co, Inc, Ortho-McNeil Pharma-ceutical, Inc, Otsuka America Pharmaceutical, Inc, Pfizer Inc, Schering-Plough Corporation, TAP Pharmaceutical Products Inc, and Wyeth; and serving on the speakers' bureaus for Abbott Laboratories, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline, Merck & Co, Inc, and Wyeth.

Octavio Ramilo, MD
Associate Professor of Pediatrics
University of TexasSouthwestern Medical Center
Dallas, Texas
Dr Ramilo reports receiving grants/research support from Abbott Laboratories, GlaxoSmithKline, and MedImmune, Inc; and serving as a consultant to MedImmune, Inc.

Michael E. Pichichero, MD
Professor, Microbiology and Immunology
Pediatrics and Medicine
University of Rochester Medical Center
Rochester, New York

Notice: In accordance with the ACCME Standards for Commercial Support, the audience is advised that one or more articles in this continuing medical education activity may contain reference(s) to unlabeled or unapproved uses of drugs or devices. The following faculty member has disclosed that he has referenced the following unlabeled/unapproved uses of drugs or devices:

Dr Block—high-dose amoxicillin, ceftriaxone, clindamycin.

All other faculty have indicated that they have not referenced unlabeled/unapproved uses of drugs or devices.

Advanced Studies in Medicine provides disclosure information from contributing authors, lead presenters, and participating faculty. Advanced Studies in Medicine does not provide disclosure information from authors of abstracts and poster presentations. The reader shall be advised that these contributors may or may not maintain financial relationships with pharmaceutical companies.

Current Issues In Acute Otitis Media
William R. Bishai, MD, PhD*

T he 7-valent pneumococcal conjugate vaccine (PCV-7) was approved in February 2000 for use in children younger than 24 months to prevent invasive disease caused by the 7 pneumococcal serotypes 14, 6B, 19F, 18C, 23F, 4, and 9V. These serotypes cause 80% of invasive infections in children younger than 6 years of age. PCV-7 induces protective antibody responses (>.15 µg/mL) in more than 90% of infants after administration of 3 doses at 2, 4, and 6 months of age. An additional dose given at 12 to 15 months of age elicits a booster response and may enhance long-term immune memory.

An evaluation of 37 868 infants (PCV-7, n = 18 927; control, n = 18 941) found that PCV-7 was safe and effective for prevention of invasive disease, otitis media, and pneumonia in children younger than 5 years of age. Among fully vaccinated children (ie, 3 primary doses and a booster dose), the efficacy of PCV-7 was 97% against invasive pneumococcal disease for vaccine serotypes (P <.001). The risk of radiograph-positive pneumonia was reduced by 32% in the first year of life, by 23% in the first 2 years, but by only 9% in children older than 2 years. Among children who completed the primary series of 3 doses, PCV-7 was associated with a reduction of 6.6% in acute otitis media (AOM) episodes and 24% in tympanostomy tube placement.

Prior to the approval of PCV-7, studies using diagnostic tympanocentesis isolated Streptococcus pneumoniae from 25% to 55% of all middle ear aspirates from children with AOM. However, Finnish investigators found an 11% increase in Haemophilus influenzae isolates in children with AOM who were fully vaccinated with PCV-7 compared with children with AOM who had received hepatitis B vaccine. With routine implementation of PCV-7 in the United States, investigators in urban, suburban, and rural pediatric practices have also seen an increase in the proportion of cases of persistent or refractory AOM due to H influenzae, particularly beta-lactamase—producing strains.

In this issue of Advanced Studies in Medicine, we discuss the predominant bacterial pathogens in AOM prior to the introduction of PCV-7, how the epidemiology of AOM may be changing as a result of PCV-7, and how these changes may affect future treatment recommendations. In an interview, Stanley L. Block, Jr, MD, FAAP, whose participation in multiple clinical trials of PCV-7 and other vaccines has enabled his general pediatric practice to immunize 94% of the pediatric patients seen in his rural practice in Kentucky, describes the changes he has seen since the introduction of PCV-7 and how the emergence of H influenzae as the major pathogen in PCV-7—vaccinated children should influence the clinician's choice of antibiotics for AOM treatment failures.

*Associate Professor of Medicine, Division of Infectious Diseases; Co-Director, Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Address correspondence to: William R. Bishai, MD, PhD, Johns Hopkins University School of Medicine, 1503 E Jefferson St, Room 112, Baltimore, MD 21231. E-mail:

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