Recently Licensed Meningitis B Vaccines: Latest Practice Guidelines and Implications Mary Koslap Petraco, DNP PNP BC CPNP FAANP Suffolk County Department of Health Services New York State Immunization Consortia Meeting March 17, 2015 Meningitis B Epidemiology B, C, and Y strains are the cause of meningitis in the U.S. A and W circulate globally MCV4 covers A, C, Y, W135 strains B strain is not contained in MCV4 because when added to vaccine inactivates vaccine for other strains 1
Meningitis B Epidemiology In 2012, there were 480 cases of bacterial meningitis in the United States, according to the CDC 160 were group b Most common in infants Epidemiology is changing for serotypes in US since the introduction of MCV4 vaccine Especially among adolescents and young adults Meningitis B Epidemiology Group Cused to be most common strain on college campuses Group B now is predominant strain Group B accounts for 30% of all meningococcal disease cases 2
B strain Is Cause of outbreaks in Colleges 2014 15 NJ (Princeton) 8 confirmed cases PA (Drexel University associated case with Princeton) confirmed case (fatality) 13,000 doses of serogroup b vaccine administered at Princeton using experimental protocol No meningitis b vaccine had been licensed in US as of this outbreak Meningitis B Epidemiology CA (University of California Santa Barbara) 4 cases 1 permanently disabled 14,000 doses of vaccine administered at University of California using experimental protocol Unusual according to CDC to have outbreaks from same strain at the same time on both coasts 3
Meningitis B Epidemiology RI (Providence University) most recent outbreak 1 confirmed case 1 probable case 3800 students on campus eligible for vaccine Meningitis B History CDC collaborated with local health departments to contain and control outbreaks on all campuses 4
Meningitis B Vaccine On October 29, 2014, the Food and Drug Administration (FDA) licensed the first serogroup b meningococcal vaccine (Trumenba ) Approved for 10 25 years of age as a 3 dose series On January 23, 2015, FDA licensed a second serogroup b meningococcal vaccine (Bexsero ) Approved for 10 25 years of age as a 2 dose series ACIP Recommendations for Meningitis B Vaccine No routine recommendation for serogroup b meningococcal vaccines at this time Cost benefit analysis indicates small number of cases does not warrant adding Meningitis B vaccine to the current ACIP schedule for routine use Providers can use these vaccines for people 10 25 years of age consistent with the labeled indication 5
ACIP Recommendations ACIP unanimously passed limited recommendation for meningitis b vaccine at the 2/26/15 meeting: Outbreak control of serogroup b meningococcal disease (on college campuses) High risk individuals (those with low immunity) Trumenba Approved for individuals 10 through 25 years of age Effectiveness based on serum bactericidal activity against four serogroup b strains representative of prevalent strains in the US 3 dose schedule first dose at 0 months, followed by doses at 2 and 6 months after the first dose IM Immunogenicity of concomitantly administered TRUMENBA and HPV4 was evaluated in adolescents 11 through 17 years of age 6
Trumenba Safety Information Severe allergic reaction after a previous dose of Trumenba is a contraindication Individuals with altered immunocompetence may have reduced immune responses to Trumenba Most common solicited adverse reactions: Pain at the injection site ( 85%) Fatigue ( 40%), headache ( 35%) Muscle pain ( 30%) Chills ( 15%) Trumenba Contraindication Allergic reaction to any component of the vaccine or after a previous dose Pregnancy category b Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and wellcontrolled studies in pregnant women 7
Trumenba Safety Information Sufficient data are not available on the safety and effectiveness of using Trumenba and other meningococcal group b vaccines interchangeably to complete the vaccination series Safety and effectiveness has not been established in pregnant women Syncope (fainting) can occur in association with administration Bexsero Approved for use in individuals 10 through 25 years of age Immune response measured by serum bactericidal activity against three serogroup b strains representative of prevalent strains in the United States 2 dose schedule at least one month apart IM The effectiveness of BEXSERO against diverse serogroup b strains has not been confirmed 8
Bexsero Safety Information Most common solicited adverse reactions: Pain at the injection site ( 83%) Myalgia ( 45%) Fatigue ( 35%) Headache ( 33%) Induration ( 28%) Nausea ( 18%) Arthralgia ( 13%). Meningitis B Vaccine Implications Many believe meningitis b vaccine should be given universally Current recommendations are just the beginning and vaccine recommendations will be revisited at next ACIP meeting June, 2015 9
Meningitis B Vaccine Implications National discussions are taking place among parents, providers, and public health professionals How do we respond to a parent who has lost a child to meningitis b but there was no universal recommendation for the vaccine? References Centers for Disease Control and Prevention. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2013;62(RR 2):1 28. Trumenba [prescribing information]. Philadelphia, PA: Pfizer Inc; January 2015. McNeil LK, Zagursky RJ, Lin SL, et al. Role of factor H binding protein in Neisseria meningitidis virulence and its potential as a vaccine candidate to broadly protect against meningococcal disease. Microbiol Mol Biol Rev. 2013;77(2):234 252. 10