The Battle for an FDA-Approved Serogroup B Meningococcal Vaccine

Pfizer and Novartis Duke It out for a Huge Purse


In the knock-down, drag-out world of Big Pharma, a new victor has emerged.  In a fight that came down to the wire, Pfizer’s Trumenba beat out Novartis’s Bexsero to become the first serogroup B meningococcal vaccine to be approved by the FDA.  Both Bexsero and Trumenba were granted breakthrough (fast-track) designations by the FDA in April 2014.  Both Bexsero and Trumenba applied for approval by the FDA in June 2014.

  Both Bexsero and Trumenba have already been approved for use in Europe, Canada and Australia.  But in the end, in the coveted U.S. market, Trumenba came out on top.

All of this is good news for Pfizer which hopes to expect another Prevnar-like, billion-dollar payout.  Pfizer’s next step is to convince the CDC to vaccinate all people aged 10 to 25 for the deadly meningitis B serotype. 

However, there’s more to this story.  Trumenba has not been approved for infants, an age group that researchers suggest may see most immediate benefit from such a vaccine.  Furthermore, researchers also suggest that the astronomical cost of vaccinating everybody for the meningitis B serogroup may be money better (ill?) spent.

What Is Meningococcal Disease?

N. Meningitidis is a leading cause of bacterial meningitis and results in meningococcal disease which usually affects adolescents and young adults.  Meningococcal disease is a life-threatening infection of the central nervous system (linings of the spinal cord and brain) and blood.

 This bacteria comes in several flavors: A, B, C, Y and W-135.  Currently, meningococcal vaccines cover 4 of these 5 serogroups--A, C, Y and W-135--and are administered to children, adolescents and adults.

Meningococcal disease is transmitted through secretions from the respiratory tract and throat (think coughing, kissing and so forth).

Meningococcal disease can cause epidemics and recent outbreaks at both Princeton University and the University of California at Santa Barbara have piqued interest in comprehensive vaccination for the disease; especially since, in the United States, serogroups B and C are the most likely causes of the disease. More specifically, the CDC estimates that of the 500 U.S. cases of meningococcal disease in 2012, 160 were caused by serogroup B.

Meningococcal disease usually begins as a mild upper respiratory infection, headache, nausea and soreness.  These flu-like symptoms are typically short lived and followed by fever and decreased alertness (obtundation).  Other acute symptoms can include vomiting, stupor and rash.  Meningococcemia occurs when N. Meningitidis infects the blood and can result in more dreaded systemic symptoms like septic shock and DIC.  In rare cases, infection can take a chronic course which results in episodic fever, rash, joint pain and joint swelling.

Meningococcal disease is diagnosed with blood and spinal fluid cultures.

  If left untreated, this disease is usually fatal.  Fortunately, people who receive treatment recover about 90% of the time.  On account of widespread penicillin resistance, the disease is usually treated with a third-generation cephalosporin (ceftriaxone or cefotaxime).

Is Vaccinating Everybody for Meningococcus Serogroup B Cost Effective?

Using mathematical and economic models, a group of British researchers examined whether the financial cost of vaccinating the U.K. population with Bexsero outweighed combined costs of treatment and care, loss of quality of life, litigation costs and so forth.  Of note, in 2011, there were 926 cases of meningococcal disease in England and Wales (almost double the 2012 U.S. number) of which 82% were caused by serogroup B.  Their findings suggest that infant and adolescent vaccination were worth the cost if the Bexsero vaccine was priced at about 5 GBP ($8) per dose ($32 total).  According to media reports, Bexsero plans to charge about $500 for four doses.  Although researchers modeled only Bexsero, it's essentially the same vaccine as Trumenba, and it's a safe bet that Trumenba will be quite pricey, too.

What Do These Findings Mean to You?

If you or someone you love is at risk for the potentially fatal meningococcal disease, no price is too high for immunization.  The results of the British modeling study underscore something we all know—medical treatment costs a lot of money.   The CDC has already approved vaccination for the other 4 meningococcal serogroups so routine immunization with the serogroup B vaccine—the only missing piece of the puzzle—is likely.


“Re-evaluating cost effectiveness of universal meningitis vaccination (Bexsero) in England: modeling study” by Hannah Christensen and colleagues from The BMJ published on October 10, 2014.  Accessed from PubMed on 11/3/2014.

Cohen MS, Rutala WA, Weber DJ. Chapter 180. Gram-Negative Coccal and Bacillary Infections. In: Goldsmith LA, Katz SI, Gilchrest BA, Paller AS, Leffell DJ, Wolff K. eds. Fitzpatrick's Dermatology in General Medicine, 8e. New York, NY: McGraw-Hill; 2012.  Accessed November 02, 2014.  Accessed 11/2/2014.  Accessed 11/2/2014.

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