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MenB Name Changes

Version 14.19

MenB Name Changes

This page details the name changes for the Meningococcal Group B, Recombinant Vaccine.

Trumenba

  • Trade Name: Trumenba
  • Manufactured By: Pfizer / Wyeth Pharmaceuticals, Inc
  • CPT Code: 90621 (same for 2 or 3 dose schedule)
  • CDC Description: Meningococcal recombinant lipoprotein vaccine, serogroup B, 3 dose schedule, for intramuscular use.
  • CVX Code: 162 (same for 2 or 3 dose schedule)
  • CDC Vaccine Name: meningococcal B, recombinant
  • Note: The two MenB vaccines are not interchangeable; the same vaccine product must be used for all doses in a series.
  • Current OP Vaccine Name: MenB
  • New OP Names:
  • MenB-FHbp_2Dose
  • MenB-FHbp_3Dose
  • MenB-FHbp,NOS (All OP legacy vaccines are renamed and vaccines imported from IMM Regs. use this name.)

Bexsero

  • Trade name: Bexsero
  • Manufactured by: GlaxoSmithKline and Novartis Pharmaceutical Corporation
  • CPT Code: 90620
  • CDC Description: Meningococcal recombinant protein and outer membrane vesicle vaccine, serogroup B (MenB), 2 dose schedule, for intramuscular use
  • CVX code: 163
  • CDC Vaccine Name: meningococcal B, OMV
  • Note:
  • Current OP vaccine name: MenB,OMV
  • New OP name: MenB-4C_2Dose


Reason for Vaccine Name Change in OP
The OP vaccine name for meningococcal Group B vaccine needs to be changed in order for VacLogic to differentiate between the original 3 dose series and the subsequently approved 2 dose series.Each series has its own minimum interval between the first and second dose and therefore each has a different VacLogic forecast. This enables a doctor to order a specific MenB dosing schedule for a patient.


Choice of Dosing Schedule is Risk Dependent
From the Trumenba package insert:
‘...Dose and Schedule
Three-dose schedule: Administer a dose (0.5 mL) at 0, 1--2, and 6 months.’
Two-dose schedule: Administer a dose (0.5 mL) at 0 and 6 months. If the second dose is administered earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose.
The choice of dosing schedule may depend on the risk of exposure and the patient's susceptibility to meningococcal serogroup B disease.”

Based on the statement above, the doctor would determine the patient’s risk of exposure before giving the first MenB-FHbp immunization and then order either a 2 dose or 3 dose series.


Renaming MenB in OP using nomenclature designated in the MMWR

From MMWR May 2017:

‘Two serogroup B meningococcal (MenB) vaccines are currently licensed for use in persons aged 10--25 years in the United States. The two vaccines are MenB-FHbp (Trumenba, Pfizer, Inc.) (1) and MenB-4C Bexsero, GlaxoSmithKline Biologicals, Inc.) (2). ‘


Current OP Name: MenB (Trumenba)
New OP Names: MenB-FHbp_2Dose
MenB-FHbp_3Dose
MenB-FHbp,NOS ( All OP legacy vaccines are renamed and vaccines imported from IMM Regs. use this name).


To avoid user confusion, the OP name of the Bexsero MenB vaccine changes from:
Current OP Name: MenB,OMV
New OP Names: MenB-4C_2Dose


OP User Notes:

  • The CPT and CVX codes are unchanged from prior versions for Trumemba and Bexero dosing series.
  • In OP, both vaccines should point to the same Vaccine Inventory.
  • MenB vaccines already entered in OP are globally updated with the name MenB-FHbp.
  • MenB-FHbp vaccines, brand name Trumenba, imported from an IMM Reg should be imported using the name MenB-FHbp. For historical analysis only, if the spacing between the first and second dose is equal to, or greater than 6 months, the series is marked Complete.


VacLogic Forecast Messages 

  • Patient less than 10 years old: N/A.
  • Patient 10 years or older and have not had any MenB - N/A
  • For high risk patients, MenB-FHbp may be given starting at 10 years through 25 years of age.
  • Patient had 1 dose of -
  • MenB-FHbp_2Dose: “On standard MenB-FHbp 2 dose schedule.”
  • MenB-FHbp_3Dose: “On standard MenB-FHbp 3 dose schedule.”
  • MenB-4C_2Dose: “On standard MenB-4C 2 dose schedule."
  • Patient had 2 doses of -
  • MenB-FHbp_2Dose - the 2nd 6 months after the first:
    “'2 doses of MenB-FHbp vaccine, 6 months apart, is a complete series.”
  • MenB-FHbp_3Dose - the 2nd 1-2 months after the first:
    “On standard MenB_FHbp 3 dose schedule: 3rd dose due 4 months after 2nd, 42 days min. interval, 6 months from 1st) .”
  • MenB-4C_2Dose: "Two doses of MenB-4C_2Dose vaccine is a complete series."
  • 1 dose of MenB-4C and 1 dose of MenB-FHbp: VacLogic shows both MenB series as Due. Either vaccine can be used to complete the MenB series. Minimum intervals apply.
  • Patient had 3 doses of -
  • MenB-FHbp_3Dose: “Compete 3 dose MenB-FHbp series”
  • 1 dose of MenB-4C and 1 dose of MenB-FHbp: Once 2 doses of either MenB-4C or MenB-FHbp is given according to minimum interval rules, that series is declared Complete and the other series is declared N/A.
  • Patient is over 25 years of age, has had 0, 1 MenBs or 2 MenB-FHbp_3Dose -
  • No longer applicable. MenB recommended between the of ages 10 to 25 years, unless warranted by circumstances


Tasks Required to Implement MenB Name Change 

  1. Add names to VACNAMES table in medical.gdb*
  1. Add vaccine name MenB-FHbp_2Dose
  2. Add vaccine name MenB-FHbp_2Dose
  3. Change MenB to MenB-FHbp,NOS
  4. For both of the above vaccines the Vaccine Inventory name is the same. The vaccine inventory name MenB-FHbp has been assigned in the update.
  5. Change MenB, OMV to MenB-4C_2Dose
  1. Run global update to database*
  1. Change MenB to MenB-FHbp,NOS
  1. Update VAC_INVENTORY table in OP 14*
  1. Rename MenB to MenB-FHbp

Note: In the VACNAMES table, all 3 MenB-FHbp vaccines have the same Vaccine Inventory name - ‘MenB-FHbp’. Users need to change the Vaccine Inventory name they currently have to MenB-FHbp before using.

*These tasks are accomplished using a script that runs as part of the OP update package. See script details below.

  1. Update Immunization Order Management form in OP
  1. Add vaccine new names to the tab Men. I have already made these changes.


VacLogic Engine Changes:

Names added to MenB synonym list. MenB rules and logic changed.


(Trumenba) Meningococcal Group B Vaccine Dosing Change

Summary Basis for Regulatory Action Date: April 14, 2016

From: CDR Mike Smith, Ph.D., Chair of the Review Committee BLA/STN#: 125549/17 Applicant Name: Wyeth Pharmaceuticals, Inc. Date of Submission: March 27, 2015 PDUFA Goal Date: April 25, 2016

Proprietary Name/Established Name: Trumenba®/Meningococcal Group B Vaccine

Indication: Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.

Reason for the Submission: Initially to include a change in the dosing regimen from a three dose series administered according to a 0, 2 and 6 month schedule to a two-dose series, with the doses administered at least 1 month apart, followed by an optional booster (3rd) dose that may be administered at least four months after the second dose. Subsequently during the review cycle the Applicant requested the addition of a two-dosing regimen administered according to a 0 and 6 month schedule.

Recommended Action: We recommend approval of Wyeth’s supplement to their biologics license application (sBLA) for Meningococcal Group B Vaccine (Trumenba) to include a two-dose schedule (a dose administered at 0 and 6 months) according to the regulations for accelerated approval, 21 CFR 601.40-46. We also recommend approval of a modification of the three-dose schedule (approved under the original BLA according to the regulations for accelerated approval) from administration at 0, 2, and 6 months to administration at 0, 1-2, and 6 months.

Version 14.10

MenB Name Changes

This page details the name changes for the Meningococcal Group B, Recombinant Vaccine.

Trumenba

  • Trade Name: Trumenba
  • Manufactured By: Pfizer / Wyeth Pharmaceuticals, Inc
  • CPT Code: 90621 (same for 2 or 3 dose schedule)
  • CDC Description: Meningococcal recombinant lipoprotein vaccine, serogroup B, 3 dose schedule, for intramuscular use.
  • CVX Code: 162 (same for 2 or 3 dose schedule)
  • CDC Vaccine Name: meningococcal B, recombinant
  • Note: The two MenB vaccines are not interchangeable; the same vaccine product must be used for all doses in a series.
  • Current OP Vaccine Name: MenB
  • New OP Names:
  • MenB-FHbp_2Dose
  • MenB-FHbp_3Dose
  • MenB-FHbp,NOS (All OP 14 legacy vaccines are renamed and vaccines imported from IMM Regs. use this name.)

Bexsero

  • Trade name: Bexsero
  • Manufactured by: GlaxoSmithKline and Novartis Pharmaceutical Corporation
  • CPT Code: 90620
  • CDC Description: Meningococcal recombinant protein and outer membrane vesicle vaccine, serogroup B (MenB), 2 dose schedule, for intramuscular use
  • CVX code: 163
  • CDC Vaccine Name: meningococcal B, OMV
  • Note:
  • Current OP vaccine name: MenB,OMV
  • New OP name: MenB-4C_2Dose


Reason for Vaccine Name Change in OP 14
The OP vaccine name for meningococcal Group B vaccine needs to be changed in order for VacLogic to differentiate between the original 3 dose series and the subsequently approved 2 dose series.Each series has its own minimum interval between the first and second dose and therefore each has a different VacLogic forecast. This enables a doctor to order a specific MenB dosing schedule for a patient.


Choice of Dosing Schedule is Risk Dependent
From the Trumenba package insert:
‘...Dose and Schedule
Three-dose schedule: Administer a dose (0.5 mL) at 0, 1--2, and 6 months.’
Two-dose schedule: Administer a dose (0.5 mL) at 0 and 6 months. If the second dose is administered earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose.
The choice of dosing schedule may depend on the risk of exposure and the patient's susceptibility to meningococcal serogroup B disease.”

Based on the statement above, the doctor would determine the patient’s risk of exposure before giving the first MenB-FHbp immunization and then order either a 2 dose or 3 dose series.


Renaming MenB in OP 14 using nomenclature designated in the MMWR

From MMWR May 2017:

‘Two serogroup B meningococcal (MenB) vaccines are currently licensed for use in persons aged 10--25 years in the United States. The two vaccines are MenB-FHbp (Trumenba, Pfizer, Inc.) (1) and MenB-4C Bexsero, GlaxoSmithKline Biologicals, Inc.) (2). ‘


Current OP Name: MenB (Trumenba)
New OP Names: MenB-FHbp_2Dose
MenB-FHbp_3Dose
MenB-FHbp,NOS ( All OP legacy vaccines are renamed and vaccines imported from IMM Regs. uses this name).


To avoid user confusion, the OP name of the Bexsero MenB vaccine changes from:
Current OP Name: MenB,OMV
New OP Names: MenB-4C_2Dose


OP User Notes:

  • The CPT and CVX codes are unchanged from prior versions for Trumemba and Bexero dosing series.
  • In OP, both vaccines point to the same Vaccine Inventory.
  • MenB vaccines already entered in OP are globally updated with the name MenB-FHbp.
  • MenB-FHbp vaccines, brand name Trumenba, imported from an IMM Reg should be imported using the name MenB-FHbp. For historical analysis only, if the spacing between the first and second dose is equal to, or greater than 6 months, the series is marked Complete.


VacLogic Forecast Messages 

  • Patient less than 10 years old: N/A.
  • Patient 10 years or older and have not had any MenB - N/A
  • For high risk patients, MenB-FHbp may be given starting at 10 years through 25 years of age.
  • Patient had 1 dose of -
  • MenB-FHbp_2Dose: “On standard MenB-FHbp 2 dose schedule.”
  • MenB-FHbp_3Dose: “On standard MenB-FHbp 3 dose schedule.”
  • MenB-4C_2Dose: “On standard MenB-4C 2 dose schedule."
  • Patient had 2 doses of -
  • MenB-FHbp_2Dose - the 2nd 6 months after the first:
    “'2 doses of MenB-FHbp vaccine, 6 months apart, is a complete series.”
  • MenB-FHbp_3Dose - the 2nd 1-2 months after the first:
    “On standard MenB_FHbp 3 dose schedule: 3rd dose due 4 months after 2nd, 42 days min. interval, 6 months from 1st) .”
  • MenB-4C_2Dose: "Two doses of MenB-4C_2Dose vaccine is a complete series."
  • 1 dose of MenB-4C and 1 dose of MenB-FHbp: VacLogic shows both MenB series as Due. Either vaccine can be used to complete the MenB series. Minimum intervals apply.
  • Patient had 3 doses of -
  • MenB-FHbp_3Dose: “Compete 3 dose MenB-FHbp series”
  • 1 dose of MenB-4C and 1 dose of MenB-FHbp: Once 2 doses of either MenB-4C or MenB-FHbp is given according to minimum interval rules, that series is declared ‘Complete’ and the other series is declared N/A’
  • Patient is over 25 years of age, has had 0, 1 MenBs or 2 MenB-FHbp_3Dose -
  • No longer applicable. MenB recommended between the of ages 10 to 25 years, unless warranted by circumstances


Tasks Required to Implement MenB Name Change 

  1. Add names to VACNAMES table in medical.gdb*
  1. Add vaccine name MenB-FHbp_2Dose
  2. Add vaccine name MenB-FHbp_2Dose
  3. Change MenB to MenB-FHbp,NOS
  4. For both of the above vaccines the Vaccine Inventory name isthe same. The vaccine inventory name MenB-FHbp has been assigned in the update.
  5. Change MenB, OMV to MenB-4C_2Dose
  1. Run global update to database*
  1. Change MenB to MenB-FHbp,NOS
  1. Update VAC_INVENTORY table in OP 14*
  1. Rename MenB to MenB-FHbp

Note: In the VACNAMES table, all 3 MenB-FHbp vaccines have the same Vaccine Inventory name - MenB-FHbp. Users need to change the Vaccine Inventory name they current have to MenB-FHbp before using.

*These tasks are accomplished using a script that runs as part of the OP update package. See script details below.

  1. Update ‘Immunization Order Management’ form in OP 14
  1. Add vaccine new names to the tab Men. I have already made these changes.


VacLogic Engine Changes:

Names added to MenB synonym list. MenB rules and logic changed.


(Trumenba) Meningococcal Group B Vaccine Dosing Change

Summary Basis for Regulatory Action Date: April 14, 2016

From: CDR Mike Smith, Ph.D., Chair of the Review Committee BLA/STN#: 125549/17 Applicant Name: Wyeth Pharmaceuticals, Inc. Date of Submission: March 27, 2015 PDUFA Goal Date: April 25, 2016

Proprietary Name/Established Name: Trumenba®/Meningococcal Group B Vaccine

Indication: Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.

Reason for the Submission: Initially to include a change in the dosing regimen from a three dose series administered according to a 0, 2 and 6 month schedule to a two-dose series, with the doses administered at least 1 month apart, followed by an optional booster (3rd) dose that may be administered at least four months after the second dose. Subsequently during the review cycle the Applicant requested the addition of a two-dosing regimen administered according to a 0 and 6 month schedule.

Recommended Action: We recommend approval of Wyeth’s supplement to their biologics license application (sBLA) for Meningococcal Group B Vaccine (Trumenba) to include a two-dose schedule (a dose administered at 0 and 6 months) according to the regulations for accelerated approval, 21 CFR 601.40-46. We also recommend approval of a modification of the three-dose schedule (approved under the original BLA according to the regulations for accelerated approval) from administration at 0, 2, and 6 months to administration at 0, 1-2, and 6 months.