Products Affected - Description

• • Menhibrix intramuscular lyophilized powder for solution for injection, GlaxoSmithKline Vaccines, 12.5 mcg/ 0.5 mL (2.5 mcg Haemophilus influenza type B and 5 mcg each of meningococcal groups C and Y), single dose vial, with one vial diluent, 10 count, NDC 58160-0801-11

Reason for the Shortage

• • Sanofi Pasteur has Menomune and Menactra available.[1]
  • GlaxoSmithKline acquired Bexsero and Menveo from Novartis Vaccines and Diagnostics in 2015.[2]
  • GlaxoSmithKline has Bexsero and Menveo available. [2]
  • GlaxoSmithKline discontinued MenHibrix due to low demand. MenHibrix will be available to order through February 2017 or until inventory levels are depleted.[2]
  • Pfizer has Trumenba available.[3]

Available Products

• • Bexsero intramuscular suspension for injection, GlaxoSmithKline Vaccines, 0.5 mL, single-dose prefilled syringe, 10 count, NDC 46028-0114-01
  • Bexsero intramuscular suspension for injection, GlaxoSmithKline Vaccines, 0.5 mL single-dose prefilled syringe, 1 count, NDC 46028-0114-02
  • Trumenba intramuscular suspension for injection, Pfizer, 0.5 mL single-dose prefilled syringe, 5 count, NDC 00005-0100-05
  • Trumenba intramuscular suspension for injection, Pfizer, 0.5 mL single-dose prefilled syringe, 10 count, NDC 00005-0100-10
  • Menactra intramuscular solution for injection, Sanofi Pasteur, 16 mcg/ 0.5 mL (4 mcg each of groups A/C/Y/W-135), single dose vial, 5 count, NDC 49281-0589-05
  • Menveo intramuscular solution for injection, GlaxoSmithKline Vaccines, 1 Kit (one vial of 10 mcg group A to be reconstituted with one vial of 5 mcg each of groups C/Y/W-135), 5 count, NDC 46028-0208-01
  • Menomune-A/C/Y/W-135 Vaccine, subcutaneous lyophilized powder for solution for injection, Sanofi Pasteur, 200 mcg/0.5 mL (50 mcg each of groups A/C/Y/W-135), single dose vial, with one 0.6 mL vial diluent, 1 count, NDC 49281-0489-01

• • All marketed presentations are available.

• • Menomune-A/C/Y/W-135 vaccine is labeled for patients 2 years and older for immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.[4] Menactra vaccine is labeled for patients 9 months to 55 years for immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.[5] Menveo vaccine is labeled for patients 2 months to 55 years of age for immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.[6] Menhibrix vaccine is labeled for patients 6 weeks of age to 18 months of age for immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups C Y and Haemophilus influenzae type b.7 Bexsero vaccine (MenB-4C) and Trumenba vaccine (MenB-FHbp) are labeled for use in patients age 10 to 25 years for immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroup B.[8-9]
  • The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with quadrivalent meningococcal conjugate vaccine (Menactra or Menveo) in all patients aged 11-18 years, with a booster dose at age 16 for patients who received the first dose before age 16.[10]
  • The ACIP also recommends meningococcal vaccinations covering serogroups A/C/Y/W-135 for patients 2 months of age and older at increased risk for meningococcal disease including asplenic patients, those with complement component deficiencies, college freshman living in dorms, military recruits, persons traveling to or residing in endemic areas, populations at risk because of a meningococcal disease outbreak, and microbiologists with occupational exposure.[10] The Table summarizes ACIP vaccination recommendations for patients at increased risk of meningococcal disease.
  • Two new recombinant vaccines provide active immunization against meningococcal disease caused by Neisseria meningitidis serogroup B.[8-9] ACIP guidelines from June 2015 recommend meningococcal group B vaccination for patients 10 years of age and older who are at risk for meningococcal disease including those with asplenia including sickle cell disease, complement component deficiencies including inherited or chronic C3, C5-9, properdin, factor D, or factor H deficiencies or those taking eculizumab, microbiologists with occupational exposure, and populations at risk because of a meningococcal disease outbreak.[11] The ACIP also provided an additional recommendation to discuss individually the use of meningococcal group B vaccination in patients aged 16 to 23 years to provide short-term protection against serogroup B meningococcal disease. The preferred age for meningococcal group B vaccination is 16 to 18 years.[12]

• • The meningococcal vaccine products are administered by different routes. Ensure that the proper administration route is used.

• • Supplies of alternative vaccines are sufficient to immunize recommended populations.
  • If no doses of vaccine are available, health care providers and clinic personnel should track the names of patients whose vaccinations have been delayed and notify patients when the vaccine is available.

  Table 1. 2013 ACIP Recommendations: Prevention of Invasive Disease Caused by N. Meningitidis Serogroups A, C, W, and Y in High Risk Patients10

  Age Group	Recommended Vaccine	Dosing and Treatment Considerations
  2 to 18 months of age	Menhibrix	4 dose primary series. Those traveling to or residing in areas requiring protection against serogroups A and W, should receive Menveo or Menactra before travel.10
  9 months to 55 years	Menactra or Menveo	Patient ages 9 to 23 months should receive 2 dose series with 12 week dosing interval. Patient ages 2 to 23 months of age with asplenia should receive either Menveo or Menhibrix or wait until 2 years of age to receive Menactra, in order to avoid interference with the immune response to pneumococcal conjugate vaccine. Patient ages 2 to 55 years should receive single dose or 2 dose primary series based on indication for vaccination.10
  56 years of age or greater who are vaccine naive and require only a single dose of meningococcal vaccine (travelers or those at risk because of community outbreak)	Menomune A/C/Y/W-135	Single dose of Menomune A/C/Y/W-135 recommended by ACIP.10 There are limited data for the use of quadrivalent meningococcal conjugate vaccines in patients > 56 years of age. Stamboulian et al13 randomized 326 meningococcal vaccine na¯ve patients aged 56 to 65 years to receive either Menveo (n=217) or Menomune A/C/Y/W-135 (n=109) as part of an exploratory analysis of a larger study. The percentage of seroresponders at 1 month post-vaccination was higher for Menveo compared to Menomune: group A 86% vs. 61%, group C 83% vs. 73%, group Y 77% vs. 54% and group W-135 61% vs. 54%.
  56 years of age or greater previously vaccinated or multiple doses anticipated	Menactra or Menveo	For patients with asplenia, complement component deficiencies, or microbiologists with ongoing exposure to N. meningitidis, a booster dose with a quadrivalent meningococcal conjugate vaccine is recommended every 5 years after completion of primary series.10

  
  

• 1. Sanofi Pasteur (personal communications). May 5, June 16, August 5, September 16 and 30, and December 15, 2015; January 20, February 24, April 5, May 10, June 28, September 13, October 11, and December 12, 2016; January 4 and March 20, 2017.
  2. GSK Vaccines (personal communications). May 5, June 16, July 9 and 29, and September 16 and 30, 2015; February 24, April 5, May 11, June 30, September 13, October 12, and December 12, 2016; January 3 and 31 and March 20, 2017.
  3. Pfizer (personal communications). July 9 and 31, September 16, and December 11, 2015; January 20, February 19, April 5, June 28, September 13, and December 12 and 22, 2016; January 4 and March 20, 2017.
  4. Sanofi Pasteur. Menomune A/C/Y/W-135 Combined Vaccine. Swiftwater, PA; Sanofi Pasteur; April 2013.
  5. Sanofi Pasteur. Menactra Vaccine. Swiftwater, PA; Sanofi Pasteur; August 2014.
  6. Novartis Vaccines and Diagnostics. Menveo Vaccine. Cambridge, MA; Novartis Vaccines and Diagnostics; August 2013.
  7. GlaxoSmithKline Biologicals. Menhibrix Vaccine. Research Triangle Park, NC; GlaxoSmithKline Biologicals; November 2013.
  8. Pfizer. Trumenba Vaccine. Philadelphia, PA; Pfizer, October 2014.
  9. Novartis Vaccines and Diagnostics. Bexsero Vaccine. Cambridge, MA; Novartis Vaccines and Diagnostics; 2015.
  10. Centers for Disease Control and Prevention. Prevention and Control of Meningococcal Disease, Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR.2013; 62 (2):1-28.
  11. Use of Serogroup B Meningococcal Vaccines in Persons Aged > 10 years at Increased Risk for Serogroup B Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR. 2015; 64(22): 608-12.
  12. ACIP endorses individual choice on meningitis B vaccine. Available at: http://www.cidrap.umn.edu/news-perspective/2015/06/acip-endorses-individual-choice-meningitis-b-vaccine. (Accessed July 9, 2015).
  13. Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, et al. Safety and Immunogenicity of an investigational quadrivalent meningococcal CRM197 conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis 2010; 14:868-75.