June 27, 2014
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ACIP recommends mass chemoprophylaxis combined with serogroup B meningococcal vaccines

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The CDC’s Advisory Committee on Immunization Practices is developing new guidelines for state and local health officials to evaluate and manage serogroup B meningococcal disease outbreaks, according to information presented at the June meeting.

In response to recent outbreaks of serogroup B meningococcal disease on college campuses, an ad-hoc meningococcal work group convened in January of 2014 to develop guidelines for use of meningococcal vaccines in an outbreak setting.

The working group had three main objectives: 1) review available data on recent epidemiology of meningococcal disease outbreaks; 2) develop guidance for use of serogroup B meningococcal vaccines under a CDC-sponsored investigational new drug application; 3) and update current meningococcal disease outbreak guidelines once a serogroup B meningococcal vaccine is licensed for use in the United States. The first two objectives have been completed and were presented at the meeting yesterday. The third objective will be completed once a serogroup B meningococcal vaccine is licensed in the United States, according to Jessica R. MacNeil, MPH, an epidemiologist with the CDC’s National Center for Immunization and Respiratory Diseases.

The interim guidelines, presented during the ACIP meeting on Thursday, differs from the current comprehensive outbreak guidelines. Changes to the guidelines include:

  • Recommendations for organizations are divided into two groups based on organizational size vs. requiring a calculation of an attack rate;
  • An increase in the timeframe during which cases may occur, from 3 months to 6 months;
  • Revised language regarding mass chemoprophylaxis, which allows for instances when it may be used in conjunction with a vaccination campaign.

The guidance is intended to facilitate prompt access to an unlicensed serogroup B vaccine, when appropriate, through the FDA’s expanded use investigational new drug protocol. When indicated for outbreak response, the CDC will work with state and local public health officials and the FDA to obtain the vaccine. ACIP plans to revise outbreak assessment and management guidance for all meningococcal disease subsequently, according to ACIP member Jeffrey S. Duchin, MD, professor in medicine at the University of Washington.

Jeffrey Duchin, MD 

Jeffrey S. Duchin

“The implications for clinicians are that serogroup B meningococcal vaccine is now the preferred outbreak control measure, along with prompt chemoprophylaxis of close contacts. Prompt recognition, diagnosis, and treatment of meningococcal disease and reporting of suspected and confirmed meningococcal cases to local public health authorities remain key roles for health care providers,” Duchin told Infectious Diseases in Children.

Interim guidance is intended for use among health care providers until a meningococcal B vaccine is licensed for use in the United States.

Regarding current status of licensure, “both Novartis and Pfizer have submitted licensing applications that are under current review. Because both products were given breakthrough therapy status, that review process is abbreviated,” according to Wellington Sun, MD, of the FDA. —by Amanda Oldt