Summary of EtR and proposed 

recommendations for Pfizer’s MenABCWY

vaccine 

Jennifer Collins MD, MSc

Interim Co-Lead, ACIP Meningococcal Vaccines Work Group

October 25, 2023

National Center for Immunization & Respiratory Diseases
ACIP Recommendations for Meningococcal Vaccines

▪ Routine schedule 

– MenACWY: dose 1 at age 11–12 years, booster dose at age 16 years

– MenB (shared clinical decision-making): two doses at age 16–23 years (preferred age 16–18 years)

▪ Special situations

Indication MenACWY

(age ≥2 months)

MenB

(age ≥10 years)

Medical conditions

Asplenia X X

Complement Deficiency X X

Complement inhibitor use X X

HIV infection X

Other

Some microbiologists X X

Exposure during an outbreak X X

Travel to hyperendemic areas X

First-year college students X

Military recruits X

2
Meningococcal vaccines licensed and 

available in the United States

▪ MenACWY vaccines are interchangeable

▪ MenB vaccines are NOT interchangeable

Vaccine Trade Name Manufacturer Minimum age

MenACWY-CRM Menveo GSK 2 months

MenACWY-TT MenQuadfi Sanofi Pasteur 2 years

3

Vaccine Trade Name Manufacturer Minimum age

MenB-4C Bexsero GSK 10 years

MenB-FHbp Trumenba Pfizer 10 years
Pfizer’s MenABCWY Vaccine

▪ Licensed as a 2-dose series (6-month interval) for individuals aged 10–25 years

▪ Comprised of Trumenba (serogroup B) and Nimenrix (serogroups ACWY)

– Trumenba

• Consists of two purified recombinant lipidated FHbp antigens, one from 

each FHbp subfamily (A and B)

• Currently licensed and available in U.S. (10–25 years)

– Nimenrix

• Meningococcal group A, C, W, and Y polysaccharide tetanus toxoid 

conjugate vaccine

• Not licensed in U.S. but used extensively in Europe and elsewhere for more 

than a decade

4
Policy Questions for 3 PICOs 

▪ Should the pentavalent vaccine be included as an option for 

MenACWY/MenB vaccination in people currently recommended to 

receive both vaccines? 

▪ Should the pentavalent vaccine be included as an option for people 

currently recommended to receive MenACWY only? 

▪ Should the pentavalent vaccine be included as an option for people 

currently recommended to receive MenB only? 

PICO 1

PICO 2

PICO 3

5
GRADE Table 1: Combined Policy Question and PICO

Policy Question Should the pentavalent vaccine be included as an option for people currently recommended to 

receive MenACWY and MenB, MenACWY only, or MenB only?

Population All individuals aged 10 years or older currently recommended to receive MenACWY+MenB, 

MenACWY, or MenB vaccine

Intervention Vaccination with Pfizer’s pentavalent (MenABCWY) vaccine

Comparison Vaccination with currently licensed MenACWY+MenB, MenACWY, or MenB vaccine

Outcomes

• Meningococcal disease caused by serogroups A, B, C, W, and Y (as appropriate by PICO)

• Short-term immunity

• Persistent immunity

• Interference with other recommended vaccines administered concurrently

• Serious adverse events

• Non-serious adverse events

6
How PICOs Translate into Schedule Options for Healthy 

Adolescents – assuming MenB #1 at age 16 years

Legend

Q = MenACWY (quadrivalent)

B = MenB

P = MenABCWY (pentavalent)

Options 11–12 year 

old dose

16 year old

dose #1

16 year old

dose #2

Standard of care (MenACWY only) Q Q –

Standard of care (MenACWY + MenB) Q Q+B B

PICO 1 (MenABCWY as option for MenACWY + MenB) Q P B

PICO 2 (MenABCWY as option for MenACWY) P P ±B

PICO 3 (MenABCWY as option for MenB) Q P P

Combination of all 3 PICOs P P P

7
Schedule options presented in June

Legend

Q = MenACWY (quadrivalent)

B = MenB

P = MenABCWY (pentavalent)

Options 11–12 year 

old dose

16 year old

dose #1

16 year old

dose #2

WG 

Proposal

Standard of care (MenACWY only) Q Q – N/A

Standard of care (MenACWY + MenB) Q Q+B B N/A

PICO 1 (MenABCWY as option for MenACWY + MenB) Q P B

PICO 2 (MenABCWY as option for MenACWY) P P B

PICO 3 (MenABCWY as option for MenB) Q P P

Combination of all 3 PICOs P P P

8
Since June, the WG has refined the EtR and further 

considered possible implications of each PICO 

(especially PICO 3) based on

▪ ACIP members’ concerns raised during the June meeting

– Cost effectiveness 

– Concerns about increasing exposure to B component related to reactogenicity, low 

burden of disease, and limitations to protection

– Optimal timing of B component is often not age 16 years

– Fidelity to clinical trial data and licensure

– Stocking and administration considerations

▪ Cost effectiveness analysis

– Updates to quoted price of the pentavalent vaccine

– Refinements to the CDC model

9
Summary of updated EtR
PUBLIC HEALTH PROBLEM

Is meningococcal disease a problem of public health importance? 

▪ Incidence of meningococcal 

disease is low and decreasing

▪ Causes very severe disease

▪ Poor outcomes even with 

treatment

– Case fatality 10–15% 

– 10–20% of survivors have 

permanent sequelae

11

WG interpretation

PICO 1 

MenABCWY vs. MenACWY + MenB

PICO 2 

MenABCWY vs. MenACWY

PICO 3 

MenABCWY vs. Men B

Yes Yes Yes
BENEFITS & HARMS

▪ Three randomized control trials studied

– MenABCWY 2 doses (0, 6 months and 0, 12 months) vs. MenACWY-CRM 1 dose + MenB-FHbp 2 doses 

(0, 6 months)

– Among ACWY-naïve and ACWY-primed participants

– Available data facilitated assessment of select outcomes through GRADE

• Short-term immunity

• Persistent immunity

• Serious adverse events

• Non-serious adverse events

▪ Other important benefits and harms were not assessed through GRADE but factored into WG 

interpretations

– Increased reactogenicity of MenB relative to MenACWY

– Limitations to B protection

• Low VE expected following a single dose

• Rapidly waning protection following 2-dose series

• Multiple studies demonstrating MenB vaccination has no effect on meningococcal carriage 

12
BENEFITS AND HARMS: Summary of GRADE

Type Outcome Importance Design 

(# studies) Findings

Evidence type*

Healthy Increased risk

Benefits

Meningococcal disease 

caused by serogroups, A, B, 

C, W, and Y

Critical n/a No data available ND ND

Short-term immunity Critical RCT (1)

Serogroup-specific seroresponses one month after 

the first trial dose of ACWY- or B-containing vaccine 

occurred as often or more often in the pentavalent 

group compared with the control group

Moderate Low

Persistent immunity Important RCT (2)

Seroresponse rates by serogroup were similar:

- 48 months after 2 doses pentavalent vs. 54 

months after 1 dose MenACWY-CRM

- 48 months after 2 doses pentavalent vs. 2 doses 

MenB-FHbp

Low─

moderate Low

Harms

Serious adverse events Critical RCT (3)

Significantly more SAEs occurred in the pentavalent 

group vs. comparison group; none were attributed 

to the vaccine

Low Very low

Non-serious adverse 

events

Important RCT (3)

Significantly more non-serious adverse events 

occurred in the pentavalent group vs. comparison 

group

Low Very low

Interference with other 

recommended vaccines 

administered concurrently

Important n/a No data available ND ND

*Downgrades primarily related to indirectness of intervention and comparison groups relative to PICOs, people at increased risk not being included, and wide confidence intervals for adverse events 13
BENEFITS & HARMS – Work Group interpretations

14

Question

PICO 1 

MenABCWY vs. MenACWY + 

MenB

PICO 2 

MenABCWY vs. 

MenACWY

PICO 3 

MenABCWY vs. Men B

How substantial are the 

desirable anticipated 

effects?

Small Minimal, small, or 

moderate Minimal

How substantial are the 

undesirable anticipated 

effects

Small Minimal or small Minimal or small

Do the desirable effects 

outweigh the 

undesirable effects?

Favors intervention Favors intervention, 

comparison, or both

Favors intervention or 

comparison

What is the overall 

certainty? Varies by group Varies by group Varies by group
15

VALUES

▪ Limited data were available 

– Among adolescents during 2021, vaccination coverage of at least 1 dose 

• 89% for MenACWY

• 31% for MenB

– Limited data are available on vaccine uptake in other individuals recommended to receive 

MenACWY or MenB vaccine

▪ Use of combination vaccines can reduce number of injections and is generally preferred over 

separate injections of the equivalent component vaccines1,2

13

1 General Best Practice Guidelines for Immunization. Best Practice Guidance of the ACIP. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf

2 American Academy of Pediatrics. Red Book 2018. Report of the Committee on Infectious Diseases. 31st Ed. https://seciss.facmed.unam.mx/wp-content/uploads/2021/02/Red-Book-31th-Edition.pdf

15

Question PICO 1 

MenABCWY vs. MenACWY + MenB

PICO 2 

MenABCWY vs. MenACWY

PICO 3 

MenABCWY vs. Men B

Does the target population feel 

that desirable effects are large 

relative to undesirable effects?

Probably yes Probably yes Probably yes or don’t 

know

Important uncertainty or 

variability in how much people 

value the main outcomes?

Probably no Probably yes Probably yes 
16

ACCEPTABILITY

Is the intervention acceptable to key stakeholders?

▪ Limited data were available

▪ Acceptability likely depends on PICO and balance of stakeholder values

– Health care providers likely supportive of options that allow stocking fewer vaccines1,2

– Potential to increase vaccination rates against serogroup B disease

– Reduces number of injections from 4 to 3 for some patients

– Potential to incentivize MenB administration at age 16 years with waning immunity by peak risk for some 

patients

• Many vaccine providers prefer waiting until closer to exposure to congregate settings (college/military)

– Concerns about increasing exposure to MenB (which is more reactogenic than MenACWY) when burden of 

MenB disease is already low despite low vaccine coverage

• 31% single dose

• <12% second dose

1 CDC. Timing and Spacing of Immunobiologics: General Best Practice Guidelines for Immunization. ACIP Timing and Spacing Guidelines for Immunization | CDC. 

2 Hall E, Odafe S, Madden J, Schillie S. Qualitative Conceptual Content Analysis of COVID-19 Vaccine Administration Error Inquiries. Vaccines. 2023; 11(2):254.

16

WG interpretation

PICO 1 

MenABCWY vs. MenACWY + MenB

PICO 2 

MenABCWY vs. MenACWY

PICO 3 

MenABCWY vs. Men B

Probably yes or yes Probably yes or yes Don’t know
RESOURCE USE

Is the intervention a reasonable and efficient allocation of resources? 

▪ All proposed meningococcal 

vaccine strategies are 

expensive, including currently 

recommended options for 

adolescents (QQ and QQBB)

▪ With new price estimates, QPP 

is the most cost-effective 

option when MenB protection 

is desired

17

WG interpretation

PICO 1 

MenABCWY vs. MenACWY + MenB

PICO 2 

MenABCWY vs. MenACWY

PICO 3 

MenABCWY vs. Men B

Probably yes or yes Probably no or no Probably yes or yes

Strategy Cost/person

Public sector QQ 241.2

QQBB 554.88

QPB 479.94

QPP 465.6

QQPP 586.2

Private sector QQ 372.0

QQBB 854.64

QPB 707.32

QPP 666.0

QQPP 852.0
EQUITY

What would be the impact on health equity?

▪ Limited data were available 

▪ The pentavalent vaccine is not expected to negatively impact equity

▪ It could potentially reduce disparities among those who might be interested in being 

vaccinated against serogroup B but who might not receive clinical care that includes 

discussion of the MenB vaccine 

▪ Possible risk of clinics not stocking monovalent B vaccines with some policy options, which 

could affect availability for 

– Outbreaks

– People at increased risk recommended to receive 3 doses of MenB-FHbp

18

WG interpretation

PICO 1 

MenABCWY vs. MenACWY + MenB

PICO 2 

MenABCWY vs. MenACWY

PICO 3 

MenABCWY vs. Men B

Probably no impact or varies Probably increased, varies, or 

don’t know Don’t know
FEASIBILITY

Is the intervention feasible to implement?

▪ Challenges with insurance coverage specific to the pentavalent vaccine not expected

▪ Substantial financial burdens for providers or health systems not expected

▪ Pentavalent vaccine would provide additional option in current schedule and may reduce 

number of doses for some people

▪ Administration requires reconstitution, which may lead to administration errors1

▪ Stocking three different meningococcal vaccine types may be prohibitive for some 

providers

▪ Lack of B vaccines interchangeability complicates stocking considerations

19

WG 

interpretation

PICO 1 

MenABCWY vs. MenACWY + MenB

PICO 2 

MenABCWY vs. MenACWY

PICO 3 

MenABCWY vs. Men B

Probably yes or yes Probably yes or yes Probably yes or yes

1https://www.cdc.gov/mmwr/volumes/65/wr/mm6506a4.htm
20

Domain PICO 1 

MenABCWY vs. MenACWY + MenB

PICO 2 

MenABCWY vs. MenACWY

PICO 3 

MenABCWY vs. Men B

Public health problem Yes Yes Yes

Benefits 

&

harms

Desirable anticipated effects Small Minimal, small, or moderate Minimal

Undesirable anticipated 

effects Small Minimal or small Minimal or small

Desirable effects > undesirable 

effects? Favors intervention Favors intervention, comparison, or both Favors intervention or comparison

Overall certainty Varies by group Varies by group Varies by group

Values

Are desirable effects large 

relative to undesirable 

effects?

Probably yes Probably yes Probably yes or don’t know

Important uncertainty or 

variability? Probably no Probably yes Probably yes 

Acceptability Probably yes or yes Probably yes or yes Don’t know

Resource use Probably yes or yes Probably no or no Probably yes or yes

Equity Probably no impact or varies Probably increased, varies, or don’t 

know Don’t know

Feasibility Probably yes or yes Probably yes or yes Probably yes or yes

EtR summary – all 3 PICOs

20 Favorable Somewhat favorable Uncertain Unfavorable
Summary of work group consensus and 

debate

21

▪ Strong consensus in favor of PICO 1: MenABCWY as an option for MenACWY + MenB (QPB)

▪ Strong consensus against PICO 2: MenABCWY as an option for MenACWY only (PPB)

▪ Limited consensus regarding PICO 3: MenABCWY as an option for MenB only

▪ Options debated for PICO 3

Option Preference

A Reject outright

B Accept with limitations (i.e., QPP only)

C Accept fully (i.e., QPP, QQPP, QQPB)
Q

11–12 16 17 18 19 20 21 22 23

Age (years) 

BB

Q

Yes 

(age >16 

years)

22

Existing recommendations for routine schedule 

incorporating SCDM

QBB

Yes 

(age 16 years)

Serogroup B 

vaccine 

desired based 

on shared 

clinical 

decisionmaking?

No

Q
Q

11–12 16 17 18 19 20 21 22 23

Age (years) 

BB

Q

Yes 

(age >16 

years)

23

QBB Yes 

(age 16 years)

Serogroup B 

vaccine 

desired based 

on shared 

clinical 

decisionmaking?

No

Q

PB

P B

Option A adds QPB to the existing options

Lack of data

Neither option is consistent 

with licensure (i.e., 2-dose 

MenABCWY series)
Q

11–12 16 17 18 19 20 21 22 23

Age (years) 

BB

Q

Yes 

(age >16 

years)

24

QBB Yes 

(age 16 years)

Serogroup B 

vaccine 

desired based 

on shared 

clinical 

decisionmaking?

No

Q

PB

P B

Option B adds QPP to Option A

PP
Q

11–12 16 17 18 19 20 21 22 23

Age (years) 

BB

Q

Yes 

(age >16 

years)

25

QBB Yes 

(age 16 years)

Serogroup B 

vaccine 

desired based 

on shared 

clinical 

decisionmaking?

No

Q

PB

P B

Option C adds QQPP and QQPB to option B

PP

Q

Q PP

PB

• Higher cost 

• Lack of data
26

Summary of routine schedule interpretation 

for 3 options 

26

All options would permit current standard of care (i.e., QQ vs. QQBB under SCDM)

Option* Preference for PICO 3 Schedule options incorporating 

SCDM for MenB

A Reject outright QPB

B Accept with limitations QPB + QPP

C Accept fully QPB + QPP + QQPP + QQPB

*All options include a recommendation in favor of PICO 1 and against PICO 2 
27

WG deliberations regarding 3 most favored options

CONSIDERATION Option A

PICO 1 (QPB)

Option B

PICO 1 + PICO 3 (QPP only)

Option C

PICO 1 + PICO 3 (QPP, QQPP, QQPB)

CLINICAL

Alignment with clinical trial data

Not directly assessed; however, 

second pentavalent dose is 

primarily for additional B 

protection

Directly assessed in clinical trial (6-

or 12- month interval between 

pentavalent doses)

Options with additional antigenic 

exposures for which safety and 

immunogenicity have not been assessed 

(QQPP, QQPB)

Alignment with licensure Off-label Yes Yes

Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)

STOCKING AND ADMINISTRATION

Flexibility (especially for underresourced clinics) Least Intermediate Most

Minimum # vaccines to stock if using 

MenABCWY for routine indications* 3 2 2

ECONOMIC

Projected cost effectiveness Unclear cost effectiveness Most cost-effective option based 

on recent price update from Pfizer

Includes more expensive options not 

assessed in CE model (e.g., QQPP)

Potential for insurance reimbursement 

issues Yes No No

Most favorable Somewhat favorable Least favorable

27

*All options would require stocking 3 vaccines for special situations if using MenABCWY. Minimum number of vaccines to stock will remain 2 (MenACWY, MenB) if not using MenABCWY.
28

WG deliberations regarding 3 most favored options

CONSIDERATION Option A

PICO 1 (QPB)

Option B

PICO 1 + PICO 3 (QPP only)

Option C

PICO 1 + PICO 3 (QPP, QQPP, QQPB)

CLINICAL

Alignment with clinical trial data

Not directly assessed; however, 

second pentavalent dose is 

primarily for additional B 

protection

Directly assessed in clinical trial (6-

or 12- month interval between 

pentavalent doses)

Options with additional antigenic 

exposures for which safety and 

immunogenicity have not been assessed 

(QQPP, QQPB)

Alignment with licensure Off-label Yes Yes

Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)

STOCKING AND ADMINISTRATION

Flexibility (especially for underresourced clinics) Least Intermediate Most

Minimum # vaccines to stock if using 

MenABCWY for routine indications* 3 2 2

ECONOMIC

Projected cost effectiveness Unclear cost effectiveness Most cost-effective option based 

on recent price update from Pfizer

Includes more expensive options not 

assessed in CE model (e.g., QQPP)

Potential for insurance reimbursement 

issues Yes No No

Most favorable Somewhat favorable Least favorable

28

*All options would require stocking 3 vaccines for special situations if using MenABCWY. Minimum number of vaccines to stock will remain 2 (MenACWY, MenB) if not using MenABCWY.
29

WG deliberations regarding 3 most favored options

CONSIDERATION Option A

PICO 1 (QPB)

Option B

PICO 1 + PICO 3 (QPP only)

Option C

PICO 1 + PICO 3 (QPP, QQPP, QQPB)

CLINICAL

Alignment with clinical trial data

Not directly assessed; however, 

second pentavalent dose is 

primarily for additional B 

protection

Directly assessed in clinical trial (6-

or 12- month interval between 

pentavalent doses)

Options with additional antigenic 

exposures for which safety and 

immunogenicity have not been assessed 

(QQPP, QQPB)

Alignment with licensure Off-label Yes Yes

Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)

STOCKING AND ADMINISTRATION

Flexibility (especially for underresourced clinics) Least Intermediate Most

Minimum # vaccines to stock if using 

MenABCWY for routine indications* 3 2 2

ECONOMIC

Projected cost effectiveness Unclear cost effectiveness Most cost-effective option based 

on recent price update from Pfizer

Includes more expensive options not 

assessed in CE model (e.g., QQPP)

Potential for insurance reimbursement 

issues Yes No No

Most favorable Somewhat favorable Least favorable

29

*All options would require stocking 3 vaccines for special situations if using MenABCWY. Minimum number of vaccines to stock will remain 2 (MenACWY, MenB) if not using MenABCWY.
30

WG deliberations regarding 3 most favored options

CONSIDERATION Option A

PICO 1 (QPB)

Option B

PICO 1 + PICO 3 (QPP only)

Option C

PICO 1 + PICO 3 (QPP, QQPP, QQPB)

CLINICAL

Alignment with clinical trial data

Not directly assessed; however, 

second pentavalent dose is 

primarily for additional B 

protection

Directly assessed in clinical trial (6-

or 12- month interval between 

pentavalent doses)

Options with additional antigenic 

exposures for which safety and 

immunogenicity have not been assessed 

(QQPP, QQPB)

Alignment with licensure Off-label Yes Yes

Excess doses for ≥1 serogroup No Yes (1 dose) Yes (multiple doses)

STOCKING AND ADMINISTRATION

Flexibility (especially for underresourced clinics) Least Intermediate Most

Minimum # vaccines to stock if using 

MenABCWY for routine indications* 3 2 2

ECONOMIC

Projected cost effectiveness Unclear cost effectiveness Most cost-effective option based 

on recent price update from Pfizer

Includes more expensive options not 

assessed in CE model (e.g., QQPP)

Potential for insurance reimbursement 

issues Yes No No

Most favorable Somewhat favorable Least favorable

30

*All options would require stocking 3 vaccines for special situations if using MenABCWY. Minimum number of vaccines to stock will remain 2 (MenACWY, MenB) if not using MenABCWY.
31

Balance of Consequences — PICO 1 

MenABCWY as an option for MenACWY+MenB

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences in 

most settings 

Undesirable 

consequences 

probably outweigh 

desirable 

consequences in 

most settings

The balance 

between 

desirable and 

undesirable 

consequences is 

closely balanced 

or uncertain

Desirable 

consequences 

probably outweigh 

undesirable 

consequences in 

most settings

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences in 

most settings

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences

31

Majority of WG members think desirable consequences probably

or clearly outweigh undesirable consequences in most settings

Most common 2

nd most common 3rd most common
Most common 2

nd most common 32

Work Group Interpretation — PICO 1

We do not recommend the intervention, but it may be used within FDA licensed indications

We recommend the intervention for individuals based on shared clinical decision-making

We recommend the intervention

Should the pentavalent vaccine be included as an option for 

MenACWY/MenB vaccination in people currently recommended to 

receive both vaccines?

32

Majority of WG members favored recommending the intervention
33

Balance of Consequences — PICO 2 

MenABCWY as an option for MenACWY

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences in 

most settings 

Undesirable 

consequences 

probably outweigh 

desirable 

consequences in 

most settings

The balance 

between 

desirable and 

undesirable 

consequences is 

closely balanced 

or uncertain 

Desirable 

consequences 

probably outweigh 

undesirable 

consequences in 

most settings

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences in 

most settings

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences

Most common 2 33 nd most common 3

rd most common

Majority of WG members think undesirable consequences probably or 

clearly outweigh desirable consequences in most settings
34

Work Group Interpretation — PICO 2

We do not recommend the intervention, but it may be used within FDA licensed indications

We recommend the intervention for individuals based on shared clinical decision-making

We recommend the intervention

Should the pentavalent vaccine be included as an option for 

people currently recommended to receive MenACWY only? 

34

Most common 2

nd most common

Majority of WG members favored not recommending the intervention
Most common 2

nd most common 35

Balance of Consequences — PICO 3 

MenABCWY as an option for MenB

Undesirable 

consequences 

clearly outweigh 

desirable 

consequences in 

most settings 

Undesirable 

consequences 

probably outweigh 

desirable 

consequences in 

most settings

The balance 

between 

desirable and 

undesirable 

consequences is 

closely balanced 

or uncertain 

Desirable 

consequences 

probably outweigh 

undesirable 

consequences in 

most settings 

Desirable 

consequences 

clearly outweigh 

undesirable 

consequences in 

most settings 

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences

35

The WG did not reach a majority consensus on the balance of 

consequences
36

Work Group Interpretation — PICO 3

We do not recommend the intervention, but it may be used within FDA licensed indications

We recommend the intervention for individuals based on shared clinical decision-making

We recommend the intervention but only in certain circumstances (i.e., QPP)

We recommend the intervention in all circumstances

Should the pentavalent vaccine be included as an option for 

people currently recommended to receive MenB only? 

36

Added an additional option because some WG members favored QPP only
37

Work Group Interpretation — PICO 3

We do not recommend the intervention, but it may be used within FDA licensed indications

We recommend the intervention for individuals based on shared clinical decision-making

We recommend the intervention but only in certain circumstances (i.e., QPP)

We recommend the intervention in all circumstances

Should the pentavalent vaccine be included as an option for 

people currently recommended to receive MenB only? 

▪ WG was divided regarding PICO 3

▪ Majority favored PICO 3 in some form

▪ Substantial minority of work group members favored not recommending the intervention

37

Most common 2

nd most common 3rd most common 4th most common
38

38

PICO 1 (QPB)

PICO 2 (PPB)

PICO 3 (QPP only)

Pfizer’s MenABCWY vaccine may be used when both MenACWY and MenB are indicated at the 

same visit.* If MenABCWY is administered in this way, a second dose of MenABCWY may be 

administered 6 months later to complete the series.

*1) Healthy individuals aged 16–23 years (routine schedule) when shared clinical decisionmaking favors administration of MenB vaccination, 2) individuals aged 10 years and older at 

increased risk of meningococcal disease (e.g., due to persistent complement deficiencies, 

complement inhibitor use, or functional or anatomic asplenia) due for both vaccines. 

▪ Remarks:

• for Pfizer’s MenABCWY vaccine, data are not available regarding safety or immunogenicity of dosing intervals exceeding 

12 months

• the licensed B component vaccines are not interchangeable by manufacturer. Administration of a B component vaccine 

(MenB or MenABCWY) requires that subsequent B component vaccine doses be from the same manufacturer

• the minimum interval for Pfizer’s MenABCWY vaccine is 6 months. Individuals at increased risk of meningococcal disease 

who are recommended to receive additional doses of MenACWY and MenB less than 6 months after a dose of 

pentavalent meningococcal vaccine should instead receive separate MenACWY and MenB-FHbp vaccines

Combined draft proposal for option B
39

Rationale in favor of combined draft proposal

▪ Aligns with clinical trial data and licensure

▪ Allows for fewer injections than QQBB

▪ Provides flexibility with vaccine inventory, including for clinics that prefer to stock 

2 vaccines for routine indications

▪ Stocking fewer vaccines may increase equity (e.g., if under-resourced clinics are 

less likely to stock 3 vaccines)

▪ Most cost-effective option based on recent price update from Pfizer

39
40

Rationale against combined draft proposal

▪ Unnecessary ACWY antigen exposure for second pentavalent dose in routine schedule 

(i.e., when only MenB is indicated)

▪ Not as much flexibility for providers as Option 3

General considerations (all options):

▪ Potential to incentivize MenB at age 16 years with waning immunity by peak risk (i.e., 

college/military) for some patients 

▪ Uncertainty regarding cost estimates

▪ If using MenABCWY, it will be necessary to stock 3 vaccines to cover all indications 

(routine schedule + special situations), which may be challenging for some vaccine 

providers 

40
Acknowledgments

▪ ACIP Members on the WG

– Kathy Poehling (Chair)

– Lynn Bahta

– Jamie Loehr

▪ Ex Officio WG Members

– Margaret Bash (FDA)

– Mark Connelly (FDA)

– Francisco Leyva (NIH)

▪ WG Liaisons and Consultants

– Amra Resic (AAFP)

– Samir Shah (AAP) 

– Sharon McMullen (ACHA)

– Cacky Tate / Karyn Lyons (AIM)

– Paul Cieslak (CSTE)

– Kathy Hsu (IDSA)

– Joseline Zafack (NACI)

– Jeff Goad (NFID)

– Jessica Cataldi (PIDS)

– Amy Middleman (SAHM)

– David Stephens (Emory)

▪ CDC Contributors

– Sam Crowe (DBD/NCIRD)

– Lucy McNamara (DBD/NCIRD)

– Ismael Ortega-Sanchez (DVD/NCIRD)

– Andrew Leidner (ISD/NCIRD)

– LeAnne Fox (DBD/NCIRD)

– Susan Hariri (DBD/NCIRD)

– Amy Rubis (DBD/NCIRD)

– Noele Nelson (DBD/NCIRD)

– Alison Albert (DBD/NCIRD)

– Angela Jiles (DBD/NCIRD)

– Jonathan Duffy (DHQP/NCEZID)

– Tanya Myers (DHQP/NCEZID) 

– Liz Velazquez (ISD/NCIRD)

– Jessica MacNeil (ACIP Secretariat)

– Melinda Wharton (ACIP Secretariat)

▪ GRADE/EtR Support

– Doug Campos-Outcalt (Arizona)

– Rebecca Morgan (Case Western Reserve)

41
Thank you! 

Questions?