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What is Bexsero? How common is meningococcal disease serogroup B?

With the eighth case of meningococcal meningitis confirmed at Princeton University yesterday, and at least seven confirmed as Neisseria meningitis serotype B (MenB) with the most recent still pending, health officials will allow the “not-FDA-approved” Bexsero to be used at the University to vaccinate the student population.

meningococcus

Neisseria meningitidis
Image/CDC

Earlier this year, the Novartis Bexsero vaccine was approved for use in the European Union and in Australia. The vaccine is the first to protect against MenB.

Meningococcal disease is a leading cause of bacterial meningitis. Five main groups of meningococcal bacteria (A, B, C, W-135 and Y) cause the majority of all cases around the world.

According to the European Medicines Agency, approximately 1.2 million cases of invasive meningococcal disease are recorded worldwide annually; of which 7,000 occur in Europe. Over 90% of cases of meningococcal meningitis and septicemia are caused by five of the 13 meningococcal serogroups, specifically groups A, B, C, W135 and Y.

In Europe, group B is the most prevalent meningococcal serogroup, with 3,406-4,819 cases reported annually between 2003 and 2007, according to a surveillance report published by the European Centre for Disease Prevention and Control.

Across Australia, approximately 85 percent of all meningococcal disease and sepsis cases have been caused by MenB, a percentage that has risen in recent years as the number of cases in other serogroups has fallen, according to the Australian Meningococcal Surveillance Program Annual Report 2011.

Currently, there are two vaccines in the United States ,meningococcal polysaccharide vaccine (Menomune®), and meningococcal conjugate vaccine (Menactra® and Menveo®), that protect against Neisseria meningitidis.

However, they only protect against Neisseria meningitidis Serogroups A, C, Y and W-135.

According to the Centers for Disease Control and Prevention (CDC),  the most common ones that cause disease in the United States are B, C, and Y. In 2012 there were about 500 total cases of meningococcal disease, and 160 of those cases were caused by serogroup B.

The US Food and Drug Administration (FDA) is allowing the use of the vaccine at Princeton University under an Investigational New Drug application.

The vaccine would be recommended for all Princeton University undergraduate students (those who live in dormitories or off-campus) as well as graduate students who live in dormitories. Although New Jersey regulation requires that all students who enter a four-year university and reside in a campus dormitory get the shot against the four serogroups, serogroup B is not covered and even if students have been vaccinated, Bexsero would be required to protect against the outbreak strain of meningitis serogroup B. The vaccine would be voluntary.

The CDC says  based on studies of serogroup B meningococcus that cause disease in the United States, this vaccine would cover 91% of circulating strains. Lab testing has been done to confirm that the vaccine would help protect against the exact strain of meningococcal bacteria that is causing the outbreak at the University. The outbreak strain at Princeton University is ST409.

On the CDC web page, Serogroup B Meningococcal Vaccine Questions and Answersthe agency answers the question, “Why is the vaccine not approved for use in the United States?” by directing it to Novartis and their plans to seek licensure in the United States.

Will a serogroup B meningococcal vaccine eventually be licensed for use in the United States?

The CDC says it is possible that manufacturers will get this type of vaccine licensed in the United States in the future. In April, 2011, an FDA advisory committee discussed the data available at that time about serogroup B meningococcal vaccines and approaches for getting those vaccines licensed in the United States.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the Outbreak News This Week Radio Show on http://1380thebiz.com/ Follow @bactiman63

Displaying 13 Comments
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  1. […] University will be administering the vaccine, which is not approved for use in the United States, during the second week of […]

  2. […] Related article: What is Bexsero? How common is meningococcal disease serogroup B? […]

  3. […] of meningococcal meningitis group B during a three week time frame in Nov. 2013, will be offering the unlicensed in the US, Novartis vaccine Bexsero starting Feb. 24, according to a UCSB Student Health announcement […]

  4. […] Related: What is Bexsero? How common is meningococcal disease serogroup B? […]

  5. […] FDA has approved vaccines for every strain of meningitis except MenB, which was responsible for 32 percent of meningitis cases in 2012. The agency’s inefficiency has left the government, universities, […]

  6. […] of meningococcal meningitis group B during a three week time frame in Nov. 2013, will be offering the unlicensed in the US, Novartis vaccine Bexsero starting Feb. 24, according to a UCSB Student Health announcement […]

  7. […] of meningococcal meningitis group B during a three week time frame in Nov. 2013, will be offering the unlicensed in the US, Novartis vaccine Bexsero starting Feb. 24, according to a UCSB Student Health announcement […]

  8. […] of meningococcal meningitis group B during a three week time frame in Nov. 2013, will be offering the unlicensed in the US, Novartis vaccine Bexsero starting Feb. 24, according to a UCSB Student Health announcement […]

  9. […] of meningococcal meningitis group B during a three week time frame in Nov. 2013, will be offering the unlicensed in the US, Novartis vaccine Bexsero starting Feb. 24, according to a UCSB Student Health announcement […]

  10. […] of meningococcal meningitis group B during a three week time frame in Nov. 2013, will be offering the unlicensed in the US, Novartis vaccine Bexsero starting Feb. 24, according to a UCSB Student Health announcement […]

  11. […] What is Bexsero? How common is meningococcal disease serogroup B? […]

  12. […] “In an outbreak caused by serogroup C or Y meningococcal disease, we would recommend the quadrivalent meningococcal vaccine to prevent additional cases.  Until very recently, there was no available and broadly effective serogroup B vaccine that could be used to help an outbreak in the United States.  However, there’s now a vaccine that was recently licensed for use in Europe and Australia, but… […]

  13. MUSAorg says:

    Our hearts and support go out to those affected by the terrible effects of meningitis. The Meningitis Foundation of America offers extensive information regarding diagnosis, immunization, recovery and the after effects of meningitis. MFA survives primarily by donations. For the past 16 years, we have assisted people through support groups, resources and advocacy in efforts to help those affected with meningitis overcome and those around them understand the journey ahead. We promote prevention and safety measure in at risk communities and help explain the short term, long term effects and recovery treatments of meningitis to the media and public at large. Meningitis is a dangerous & often times fatal infection that can lead to serious life-long physical problems and even death. We are here to provide emotional support to those who need it; please feel free to reach out to us at http://www.musa.org and [email protected]
    Daisi Pollard Sepúlveda-Low
    National President
    Meningitis Foundation of America, Inc.
    World Meningitis Day 24 April

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