National Center for Immunization & Respiratory Diseases

Evidence to Recommendations Framework:

Pfizer’s MenABCWY Vaccine

Sam Crowe, PhD, MPH

Meningococcal Vaccines Work Group Lead

June 23, 2023
Outline

▪ Overview of policy questions and PICOs

▪ Evidence to Recommendations framework

▪ Summary of findings

▪ WG proposed options

2
Pfizer MenABCWY Vaccine

▪ 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 US (10–25 years)

– Nimenrix

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

• Not licensed in US but used extensively in Europe and elsewhere for over a decade

▪ Clinical trial data

– Assessed

• Two doses (0,6 m and 0,12 m apart)

– Studied 10 through 25 years of age

– Both MenACWY primed and naïve subjects

– Longer interval studies underway (not available in time for initial product licensure)

3
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? (PICO 1)

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

currently recommended to receive MenACWY only? (PICO 2)

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

currently recommended to receive MenB only? (PICO 3)

4
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 the pentavalent 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

5
Routine Schedule and Increased Risk Populations

▪ Routine schedule 

– One MenACWY dose at 11–12 years and a booster at 16 years

– Two MenB doses at 16–18 years (shared clinical decision-making recommendation)

▪ Increased risk, MenACWY (vaccines are interchangeable)

– Recommended for certain medical conditions

• Asplenia, complement deficiency, complement inhibitor use, and HIV infection

– Some microbiologists

– Exposure during an outbreak

– Travel to hyperendemic areas

– First-year college students

– Military recruits

▪ Increased risk, MenB (vaccines are not interchangeable)

– Recommended for certain medical conditions

• Asplenia, complement deficiency, and complement inhibitor use

– Some microbiologists

– Exposure during an outbreak 6
How PICOs Translate into Schedule Options for 

Healthy Adolescents

Legend

Q = MenACWY (quadrivalent)

B = MenB

P = MenABCWY (pentavalent) 7

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
Public Health Problem

Is meningococcal disease a problem of public health importance? 
9

Meningococcal Disease Incidence —

United States, 1996–2022*

0.00

0.20

0.40

0.60

0.80

1.00

1.20

1.40

1996 2000 2005 2010 2015 2020 2022

Incidence per 100,000

Year

Source : 1996–2022 NNDSS Data. *2021–2022 NNDSS data are preliminary.

0.09 cases/100,000 

population

MenACWY vaccine

1.2 cases/100,000 

population

MenB vaccine
10

Average Annual Meningococcal Disease Incidence by 

Age Group and Serogroup ― United States, 2010–2022*

Source: NNDSS data with additional serogroup data from the Active Bacterial Core Surveillance System and state health departments 

*2022 data are preliminary

0

0.2

0.4

0.6

0.8

1

1.2

<1 year 1 year 2-4

years

5-10

years

11-15

years

16-20

years

21-25

years

26-44

years

45-64

years

65-84

years

85+

years

Incidence per 100,000

Age Group

B ACWY Oth/Unk
Even with treatment, morbidity and mortality are high 

~10–15% 

of cases are fatal

11
10–20% of survivors 

have permanent sequelae

Even with treatment, mortality and morbidity are high 

~10–15% 

of cases are fatal

12
Summary of the Public Health Problem 

▪ Incidence of meningococcal disease

– Low

– Decreasing for some time 

▪ Causes very severe disease

▪ Poor outcomes even with treatment

13
Public Health Problem — Work Group Interpretation

▪ Is meningococcal disease a problem of public health importance? 

No Probably No Probably Yes Yes Varies Don’t Know

14
Benefits and Harms

- How substantial are the desirable anticipated effects?

- How substantial are the undesirable anticipated effects?

- Do the desirable effects outweigh the undesirable effects? 
GRADE Appendix 1: Studies Included in Review of Evidence

Author, Year Study Design Country Age Number of 

Participants 

Number 

Intervention

Number 

Comparison Data Sources

Pfizer (NCT04440163), 

2020 RCT US, Czech R., Denmark, Hungary, Poland

10–25 

years

2412 1763 649 Clinicaltrials.gov, 

Pfizer WG and 

ACIP 

presentations, 

Pfizer 

correspondence, 

Pfizer preliminary 

results 

presentations 

Pfizer (NCT03135834), 

2017 RCT US, Czech R., Finland, Poland

10–25 

years

1600 543 1057

Pfizer (NCT04440176), 

2020 RCT US 11–14 years

294 294 N/A

16
GRADE Table 2: Outcomes and Rankings

Outcome Importance Included in Profile

Meningococcal disease caused by 

serogroups A, B, C, W, and Y Critical No

Short-term immunity Critical Yes

Persistent immunity Important Yes

Interference with other recommended 

vaccines administered concurrently Important No

Serious adverse events Critical Yes

Non-serious adverse events Important Yes

17
Complexity of Review

▪ Four outcomes of interest in evidence profile

– Short-term immunity

– Persistent immunity

– Serious adverse events

– Non-serious adverse events

▪ Three PICO questions

– PICO 1: MenABCWY as an option for MenACWY+MenB

– PICO 2: MenABCWY as an option for MenACWY

– PICO 3: MenABCWY as an option for MenB

▪ Two populations

– Healthy individuals 10 years old or older

– People with medical conditions that put them at increased risk for invasive disease aged 

10 years old or older (i.e., asplenia, complement deficiency, and HIV infection)

18
GRADE Table 4: Short-Term Immunity for Healthy Persons — PICOs 1, 2, and 3

19

Certainty assessment No of patients Effect

Certainty Importance

No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

Short-term immunity for MenACWY (follow-up: 1 month)

1 randomized 

trials

not serious not serious serious1 not serious none In naïve participants, short-term immunity increases slightly for 

serogroups A, C, W, and Y at 1 month after 1 dose of 

MenABCWY versus 1 dose of MenACWY-CRM: 

Serogroup A (n=753), RR of 1.02 (95% CI: 0.99–1.05)

Serogroup C (n=753), RR: 1.20 (95% CI: 1.05–1.38)

Serogroup W (n=736), RR 1.09 (95% CI: 0.99–1.19)

Serogroup Y (n=742), RR 1.16 (95% CI: 1.06–1.27)

In primed participants, little or no difference was observed in 

short-term immunity for serogroups A, C, W, and Y at 1 month 

after 1 dose of MenABCWY versus 1 dose of MenACWY-CRM: 

Serogroup A (n=666), RR of 0.98 (95% CI: 0.95–1.01)

Serogroup C (n=665), RR: 0.99 (95% CI: 0.95–1.03)

Serogroup W (n=650), RR 1.01 (95% CI: 0.98–1.04)

Serogroup Y (n=665), RR 1.01 (95% CI: 0.97–1.05) 

⨁⨁⨁◯

Moderate

CRITICAL

Short-term immunity for MenB (follow-up: 1 month)

1 randomized 

trials

not serious not serious serious1 not serious none 591/755 

(78.3%)2

263/419 

(62.8%)2

RR 1.25

(1.15 to 1.36)

15,692 more 

per 100,000

(from 9,415 

more to 

22,597 more)

⨁⨁⨁◯

Moderate

CRITICAL

1 hSBA titers are the established correlate of protection for serogroup C meningococcal disease. This correlation is assumed to extend to other 

serogroups, but direct evidence for these serogroups is limited. Goldschneider et al. Human immunity to the meningococcus. I. The role of humoral 

antibodies. J Exp Med. 1969;129(6):1307–26. 

2 Calculated based on serogroup B composite data. 
GRADE Table 4: Short-Term Immunity for Persons at Increased Risk — PICOs 1, 2, and 3

20

Certainty assessment No of patients Effect

Certainty Importance

No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

Short-term immunity for MenACWY (follow-up: 1 month)

1 randomized 

trials

not serious not serious very 

serious1,2

not serious none In naïve participants, short-term immunity increases slightly for 

serogroups A, C, W, and Y at 1 month after 1 dose of 

MenABCWY versus 1 dose of MenACWY-CRM: 

Serogroup A (n=753), RR of 1.02 (95% CI: 0.99–1.05)

Serogroup C (n=753), RR: 1.20 (95% CI: 1.05–1.38)

Serogroup W (n=736), RR 1.09 (95% CI: 0.99–1.19)

Serogroup Y (n=742), RR 1.16 (95% CI: 1.06–1.27)

In primed participants, little or no difference was observed in 

short-term immunity for serogroups A, C, W, and Y at 1 month 

after 1 dose of MenABCWY versus 1 dose of MenACWY-CRM: 

Serogroup A (n=666), RR of 0.98 (95% CI: 0.95–1.01)

Serogroup C (n=665), RR: 0.99 (95% CI: 0.95–1.03)

Serogroup W (n=650), RR 1.01 (95% CI: 0.98–1.04)

Serogroup Y (n=665), RR 1.01 (95% CI: 0.97–1.05) 

⨁⨁◯◯

Low

CRITICAL

Short-term immunity for MenB (follow-up: 1 month)

1 randomized 

trials

not serious not serious very 

serious1,2

not serious none 591/755 

(78.3%)3

263/419 

(62.8%)3

RR 1.25

(1.15 to 1.36)

15,692 more 

per 100,000

(from 9,415 

more to 

22,597 more)

⨁⨁◯◯

Low

CRITICAL

1 Clinical trials did not include patients at increased risk for invasive disease.

2 hSBA titers are the established correlate of protection for serogroup C meningococcal disease. This correlation is assumed to extend to other 

serogroups, but direct evidence for these serogroups is limited. Goldschneider et al. Human immunity to the meningococcus. I. The role of humoral 

antibodies. J Exp Med. 1969;129(6):1307–26. 

3 Calculated based on serogroup B composite data. 
GRADE Table 4: Persistent Immunity for Healthy Persons — PICOs 1, 2, and 3

21

Certainty assessment No of patients Effect

Certainty Importance No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

Persistent immunity for MenACWY (follow-up: 48 months)

1 randomized 

trials

not serious not serious very 

serious1,2

not serious none In naïve participants, seroprotection probably increases for 

serogroups A, C, W, and Y at 48 months after 2 doses of 

MenABCWY versus 54 months after 1 dose of MenACWY-CRM: 

Serogroup A (n=112), RR of 1.29 (95% CI: 1.00–1.67)

Serogroup C (n=113), RR: 1.63 (95% CI: 1.06–2.49)

Serogroup W (n=111), RR 1.29 (95% CI: 1.05–1.59)

Serogroup Y (n=113), RR 1.05 (95% CI: 0.98–1.12)

In primed participants, little or no difference was observed in 

seroprotection for serogroups A, C, W, and Y at 48 months after 

2 doses of MenABCWY versus 54 months after 1 dose of 

MenACWY-CRM: 

Serogroup A (n=63), RR of 1.00 (95% CI: 1.00–1.00)

Serogroup C (n=134), RR: 1.10 (95% CI: 1.01–1.21) 

Serogroup W (n=63), RR 1.10 (95% CI: 0.97–1.24)

Serogroup Y (n=62), RR 1.00 (95% CI: 1.00–1.00)

⨁⨁◯◯

Low

IMPORTANT

Persistent immunity for MenB (follow-up: 48 months)

1 randomized 

trials

not serious not serious serious2 not serious none In naïve participants, little or no difference was observed in 

seroprotection for serogroup B at 48 months after 2 doses of 

MenABCWY versus 48 months after 2 doses of MenB-FHbp: 

Serogroup B (A22) (n=233), RR of 0.88 (95% CI: 0.59–1.31)

Serogroup B (A56) (n=243), RR: 1.17 (95% CI: 0.80–1.70)

Serogroup B (B24) (n=243), RR 1.38 (95% CI: 0.93–2.04)

Serogroup B (B44) (n=247), RR 1.13 (95% CI: 0.64–1.98)

⨁⨁⨁◯

Moderate

IMPORTANT

1 Comparisons were between 2 doses of MenABCWY and 1 dose of MenACWY-CRM. Comparisons also were staggered by 6 months.

2 hSBA titers are the established correlate of protection for serogroup C meningococcal disease. This correlation is assumed to extend to other serogroups, but direct 

evidence for these serogroups is limited. Goldschneider et al. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129(6):1307–26. 
GRADE Table 4: Persistent Immunity for Persons at Increased Risk — PICOs 1, 2, and 3

22

Certainty assessment No of patients Effect

Certainty Importance No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

Persistent immunity for MenACWY (follow-up: 48 months)

1 randomized 

trials

not serious not serious very serious1,2,3 not serious none In naïve participants, seroprotection probably increases for 

serogroups A, C, W, and Y at 48 months after 2 doses of 

MenABCWY versus 54 months after 1 dose of MenACWY-CRM: 

Serogroup A (n=112), RR of 1.29 (95% CI: 1.00–1.67)

Serogroup C (n=113), RR: 1.63 (95% CI: 1.06–2.49)

Serogroup W (n=111), RR 1.29 (95% CI: 1.05–1.59)

Serogroup Y (n=113), RR 1.05 (95% CI: 0.98–1.12)

In primed participants, little or no difference was observed in 

seroprotection for serogroups A, C, W, and Y at 48 months after 

2 doses of MenABCWY versus 54 months after 1 dose of 

MenACWY-CRM: 

Serogroup A (n=63), RR of 1.00 (95% CI: 1.00–1.00)

Serogroup C (n=134), RR: 1.10 (95% CI: 1.01–1.21) 

Serogroup W (n=63), RR 1.10 (95% CI: 0.97–1.24)

Serogroup Y (n=62), RR 1.00 (95% CI: 1.00–1.00)

⨁⨁◯◯

Low

IMPORTANT

Persistent immunity for MenB (follow-up: 48 months)

1 randomized 

trials

not serious not serious very serious2,3 not serious none In naïve participants, little or no difference was observed in 

seroprotection for serogroup B at 48 months after 2 doses of 

MenABCWY versus 48 months after 2 doses of MenB-FHbp: 

Serogroup B (A22) (n=233), RR of 0.88 (95% CI: 0.59–1.31)

Serogroup B (A56) (n=243), RR: 1.17 (95% CI: 0.80–1.70)

Serogroup B (B24) (n=243), RR 1.38 (95% CI: 0.93–2.04)

Serogroup B (B44) (n=247), RR 1.13 (95% CI: 0.64–1.98)

⨁⨁◯◯

Low

IMPORTANT

1 Comparisons were between 2 doses of MenABCWY and 1 dose of MenACWY-CRM. Comparisons also were staggered by 6 months.

2 Clinical trials did not include patients at increased risk for invasive disease.

3 hSBA titers are the established correlate of protection for serogroup C meningococcal disease. This correlation is assumed to extend to other serogroups, but direct 

evidence for these serogroups is limited. Goldschneider et al. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129(6):1307–26. 
GRADE Table 4: Serious Adverse Events for Healthy and Increased Risk — PICOs 1, 

2, and 3

23

1 Comparisons were between 2 doses of MenABCWY and 1 dose of MenACWY-CRM plus 2 doses of MenB-FHbp. 

2 Downgraded because relative effect confidence intervals are wide.

3 Clinical trials did not include patients at increased risk for invasive disease. 

Certainty assessment No of patients Effect

Certainty Importance

No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

2 randomized 

trials

not serious not serious serious1serious2 none 13/2306 

(0.6%) 

8/1706 (0.5%) RR 1.94

(0.72 to 5.22)

441 more per 

100,000

(from 131 

fewer to 1979 

more)

⨁⨁◯◯

Low

CRITICAL

Healthy Persons

Persons at Increased Risk

Certainty assessment No of patients Effect

Certainty Importance

No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

2 randomized 

trials

not serious not serious very 

serious1,3

Serious2 none 13/2306 

(0.6%) 

8/1706 (0.5%) RR 1.94

(0.72 to 5.22)

441 more per 

100,000

(from 131 

fewer to 1979 

more)

⨁◯◯◯

Very low

CRITICAL
GRADE Table 4: Non-Serious Adverse Events Healthy and Increased Risk — PICOs 

1, 2, and 3

Healthy Persons

Persons at Increased Risk

24

1 Comparisons were between 2 doses of MenABCWY and 1 dose of MenACWY-CRM plus 2 doses of MenB-FHbp.

2 Downgraded because absolute effect confidence intervals are wide. 

3 Clinical trials did not include patients at increased risk for invasive disease. 

Certainty assessment No of patients Effect

Certainty Importance No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

Non-serious adverse events (assessed with: All adverse events through 1 month after 2nd vaccination)

2 randomized 

trials

not serious not serious serious1serious2 none 581/2306 

(25.2%) 

387/1706 

(22.7%) 

RR 1.31

(1.17 to 1.47)

7,032 more 

per 100,000

(from 3,856 

more to 

10,662 more)

⨁⨁◯◯

Low

IMPORTANT

Certainty assessment No of patients Effect

Certainty Importance No of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other 

considerations

Pfizer 

MenABCWY

MenACWY 

and MenB

Relative

(95% CI)

Absolute

(95% CI)

Non-serious adverse events (assessed with: All adverse events through 1 month after 2nd vaccination)

2 randomized 

trials

not serious not serious Serious1,3 serious2 none 581/2306 

(25.2%) 

387/1706 

(22.7%) 

RR 1.31

(1.17 to 1.47)

7,032 more 

per 100,000

(from 3,856 

more to 

10,662 more)

⨁◯◯◯

Very low

IMPORTANT
25

Benefits and Harms — Work Group Interpretation

▪ How substantial are the desirable anticipated effects?

Minimal Small Moderate Large Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

Minimal Small Moderate Large Varies Don’t Know

Minimal Small Moderate Large Varies Don’t Know
26

Benefits and Harms — Work Group Interpretation

▪ How substantial are the undesirable anticipated effects?

Minimal Small Moderate Large Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

Minimal Small Moderate Large Varies Don’t Know

Minimal Small Moderate Large Varies Don’t Know
27

Benefits and Harms — Work Group Interpretation

▪ Do the desirable effects outweigh the undesirable effects? 

Favors 

intervention

Favors 

comparison Favors both Favors neither Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

Favors 

intervention

Favors 

comparison Favors both Favors neither Varies Don’t Know

Favors 

intervention

Favors 

comparison Favors both Favors neither Varies Don’t Know
Values

- Does the target population feel that the desirable effects are large relative to 

undesirable effects?

- Is there important uncertainty about or variability in how much people value 

the main outcomes? 
Perspective of the Target Population

▪ Limited data are available on values of the target population toward 

inclusion of the pentavalent vaccine

▪ In 2021, vaccination coverage of at least 1 dose was 89% for MenACWY 

and 31% for MenB among adolescents

▪ Limited data are available on vaccine uptake in other individuals 

recommended to receive MenACWY or MenB vaccine

29
Reduced Doses

▪ “Use of combination vaccines can reduce the number of injections patients receive 

and alleviate concern associated with the number of injections... The use of a 

combination vaccine generally is preferred over separate injections of the 

equivalent component vaccines. Considerations should include provider 

assessment, patient preference, and the potential for adverse events.”1

▪ “Combination vaccines represent one solution to the issue of increased numbers 

of injections during single clinic visits and generally are preferred over separate 

injections of equivalent component vaccines.”2

1 General Best Practice Guidelines for Immunization. Best Practice Guidance of the ACIP. https://www.cdc.gov/vaccines/hcp/acip-recs/generalrecs/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/wpcontent/uploads/2021/02/Red-Book-31th-Edition.pdf 30
Values — Work Group Interpretation

▪ Does the target population feel that the desirable effects are large relative to undesirable effects?

No Probably No Probably Yes Yes Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

No Probably No Probably Yes Yes Varies Don’t Know

No Probably No Probably Yes Yes Varies Don’t Know

31
Uncertainty in How People Value the Outcomes

▪ Limited data available on how much people value the main outcomes

▪ Vaccination rates for MenACWY, a routine recommendation, are high 

among the target population

▪ Vaccination rates for MenB are considerably lower, but decisions to 

vaccinate are based on shared clinical decision-making

– Cause for lower rates unclear: lack of interest in vaccination, lack of awareness 

of option? 

32
Values — Work Group Interpretation

▪ Is there important uncertainty about or variability in how much people value the main outcomes? 

Important 

uncertainty or 

variability

Probably important 

uncertainty or 

variability

Probably not 

important 

uncertainty or 

variability

No important 

uncertainty or 

variability

No known 

undesirable 

outcomes

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

Important 

uncertainty or 

variability

Probably important 

uncertainty or 

variability

Probably not 

important 

uncertainty or 

variability

No important 

uncertainty or 

variability

No known 

undesirable 

outcomes

Important 

uncertainty or 

variability

Probably important 

uncertainty or 

variability

Probably not 

important 

uncertainty or 

variability

No important 

uncertainty or 

variability

No known 

undesirable 

outcomes

33
Acceptability

- Is the intervention acceptable to key stakeholders? 
35

Stakeholder Acceptability

▪ Limited data are available on the acceptance among key stakeholders of including MenABCWY 

as an option in the current vaccination schedule

▪ Proponents for increasing MenB vaccination likely would be supportive

– Pentavalent vaccine combines MenB (a shared clinical decision-making recommendation) 

with MenACWY (a standard recommendation)

– Could increase vaccination rates against serogroup B

▪ Patients who seek vaccination against all 5 serogroups also might be supportive due to the 

reduced number of doses needed (4 versus 3)

▪ Health care providers might be supportive, particularly if they could stock fewer vaccines1,2

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.
36

Acceptability — Work Group Interpretation

▪ Is the intervention acceptable to key stakeholders? 

No Probably Probably Yes Yes Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

No Probably No Probably Yes Yes Varies Don’t Know

No Probably No Probably Yes Yes Varies Don’t Know
Resource Use

- Is the intervention a reasonable and efficient allocation of resources? 
38

CDC Cost Effectiveness Model Summary

▪ Weighted cost per dose + administration

– MenACWY: $163 ($128–$191)

– MenB: $210 ($155–$250)

– MenABCWY: $278 ($255–$290)

• Most MenABCWY strategies would save more or the same number of cases as the 

standard of care, but they would do so at a much higher cost per QALY saved

• The exception is the Q-P-B, which could be incrementally cost saving (ICER QALY <0) 

relative to the standard of care
39

Resource Use — Work Group Interpretation

▪ Is the intervention a reasonable and efficient allocation of resources? 

No Probably No Probably Yes Yes Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

No Probably No Probably Yes Yes Varies Don’t Know

No Probably No Probably Yes Yes Varies Don’t Know
Equity

- What would be the impact on health equity? 
41

Equity Considerations

▪ Limited data are available on the impact of the pentavalent vaccine on health 

equity

▪ It is not expected that the vaccine will 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 
42

Equity — Work Group Interpretation

▪ What would be the impact on health equity? 

Reduced Probably 

Reduced

Probably No 

Impact

Probably 

Increased Increased Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

Reduced Probably 

Reduced

Probably No 

Impact

Probably 

Increased Increased Varies Don’t Know

Reduced Probably 

Reduced

Probably No 

Impact

Probably 

Increased Increased Varies Don’t Know
Feasibility

- Is the intervention feasible to implement? 
44

Feasibility Considerations

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

▪ Substantial financial burdens for providers or health systems not expected

▪ Pentavalent vaccine likely would be easily integrated into providers' practices

– Would provide additional option in current schedule

– Administration of the pentavalent vaccine is of equal complexity as currently available vaccines 

– Barriers to stocking the pentavalent vaccine not expected

– Unclear, however, whether providers are willing to stock three different vaccine types

▪ Providers who routinely vaccinate persons aged 16–18 years might have an incentive to stock the 

vaccine to reduce the number of doses given to patients who prefer vaccination against all 5 

serogroups
45

Feasibility — Work Group Interpretation

▪ Is the intervention feasible to implement? 

No Probably No Probably Yes Yes Varies Don’t Know

PICO 1 (MenABCWY as an option for MenACWY+MenB)

PICO 3 (MenABCWY as an option for MenB)

PICO 2 (MenABCWY as an option for MenACWY)

No Probably No Probably Yes Yes Varies Don’t Know

No Probably No Probably Yes Yes Varies Don’t Know
Summary
47

EtR Summary for PICO 1 (MenABCWY as an option for MenACWY+MenB)

Domain Question Work Group Judgment

Public health problem Is meningococcal disease a public health problem? Yes

Benefits and harms

How substantial are the desirable anticipated effects? Small

How substantial are the undesirable anticipated effects? Small

Do the desirable effects outweigh the undesirable effects? Favors intervention

What is the overall certainty of the evidence profile? Varies by group

Values

Does the target population feel the desirable effects are large relative to 

the undesirable effects? Probably yes

Is there important uncertainty about or variability in how much people 

value the main outcomes? 

Probably not important 

uncertainty or variability

Acceptability Is the intervention acceptable to key stakeholders? Probably yes or yes

Resource use Is the intervention a reasonable and efficient allocation of resources? Probably yes or yes

Equity What would be the impact on health equity? Probably no impact or 

varies

Feasibility Is the intervention feasible to implement? Probably yes or yes
48

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

Is there sufficient information to move forward with a recommendation? 

Yes No
49

EtR Summary for PICO 2 (MenABCWY as an option for MenACWY)

Domain Question Work Group Judgment

Public health problem Is meningococcal disease a public health problem? Yes

Benefits and harms

How substantial are the desirable anticipated effects? Minimal, small, or 

moderate

How substantial are the undesirable anticipated effects? Minimal or small

Do the desirable effects outweigh the undesirable effects? Favors intervention, 

comparison, or both

What is the overall certainty of the evidence profile? Varies by group

Values

Does the target population feel the desirable effects are large relative to 

the undesirable effects? Probably yes

Is there important uncertainty about or variability in how much people 

value the main outcomes? 

Probably important 

uncertainty or variability

Acceptability Is the intervention acceptable to key stakeholders? Probably yes or yes

Resource use Is the intervention a reasonable and efficient allocation of resources? Probably no or no

Equity What would be the impact on health equity? Probably increased, varies, 

or don’t know

Feasibility Is the intervention feasible to implement? Probably yes or yes
50

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

Is there sufficient information to move forward with a recommendation? 

Yes No
51

EtR Summary for PICO 3 (MenABCWY as an option for MenB)

Domain Question Work Group Judgment

Public health problem Is meningococcal disease a public health problem? Yes

Benefits and harms

How substantial are the desirable anticipated effects? Minimal

How substantial are the undesirable anticipated effects? Minimal to small

Do the desirable effects outweigh the undesirable effects? Favors intervention or 

comparison

What is the overall certainty of the evidence profile? Varies by group

Values

Does the target population feel the desirable effects are large relative to 

the undesirable effects? Probably yes or don’t know

Is there important uncertainty about or variability in how much people 

value the main outcomes? 

Important or probably 

important

Acceptability Is the intervention acceptable to key stakeholders? Don’t know

Resource use Is the intervention a reasonable and efficient allocation of resources? Probably yes or yes

Equity What would be the impact on health equity? Don’t know

Feasibility Is the intervention feasible to implement? Probably yes or yes
52

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

Is there sufficient information to move forward with a recommendation? 

Yes No
Proposed Options
54

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?
55

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? 
56

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

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

currently recommended to receive MenB only? 

▪ WG was divided on this option, but a small majority were in favor of not 

proposing

▪ WG agreed to have ACIP consider the strengths and weaknesses of this 

option
Schedule Options

Legend

Q = MenACWY (quadrivalent)

B = MenB

P = MenABCWY (pentavalent) 57

Options 11–12 year 

old dose

16 year old 

dose #1

16 year old 

dose #2

WG 

Decision

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
58

Draft Proposal to the ACIP

▪ For individuals aged 10 years or older, Pfizer’s MenABCWY vaccine may be used as an alternative to 

MenACWY and MenB vaccines only when both vaccines are indicated to be given at the same time. 

This proposal applies to healthy individuals (routine schedule) and those at increased risk for 

meningococcal disease.
59

Draft Proposal to the ACIP

▪ For individuals aged 10 years or older, Pfizer’s MenABCWY vaccine may be used as an alternative to 

MenACWY and MenB vaccines only when both vaccines are indicated to be given at the same time. 

This proposal applies to healthy individuals (routine schedule) and those at increased risk for 

meningococcal disease.

– Remarks:

• This proposal is not intended to supersede or negate the shared clinical decision-making 

recommendation for MenB. 

• The licensed MenB vaccines are not interchangeable, so use of the Pfizer pentavalent vaccine for 

the first MenB dose would require subsequent doses to be a Pfizer MenB-FHbp vaccine or 

pentavalent Pfizer MenB-FHbp-containing vaccine. 

• The minimum interval for the Pfizer pentavalent 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.

• The workgroup will review extended interval data when available in anticipation that this may 

provide support for updated schedules that provide protection for all 5 serogroups. 
Strengths and Weaknesses of Q-P-B (PICO 1)

▪ Strengths

– Reduces doses from 4 to 3

– Cost savings 

• ~$95 per person for the routine schedule

• Q-Q-B-B (~$746) vs. Q-P-B (~$651)

– Cost per QALY saved less than standard of care

– Relatively straightforward proposal

▪ Weaknesses

– Does not match dosing used in clinical trials (2 doses at 0,6m) 

– Would require stocking 3 vaccine types (MenACWY, MenABCWY, MenB), which might not be acceptable to some clinicians

– Some clinics might not have funds available to stock multiple formulations, which could increase inequities

– Could be challenging for some recipients to complete MenB series if provider does not carry MenB-FHbp

– If ACIP does not recommend second dose of MenABCWY, insurance companies might not cover it in lieu of MenB

– Potentially could increases risk of provider vaccine administration error1,2

60 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.
Strengths and Weaknesses of Q-P-P (PICO 3)

▪ Strengths

– Reduces doses from 4 to 3

– Small cost savings 

• ~$27 per person for the routine schedule

• Q-Q-B-B (~$746) vs. Q-P-P (~$719)

– Relatively straightforward proposal

– Potentially allows stocking two vaccines for most patients

– Matches dosing used in clinical trials (2 doses at 0,6m) 

▪ Weaknesses

– Persons needing 3 doses of MenB would still need Trumenba because of 6m minimum interval

– Less cost savings than Q-P-B

– Higher cost per QALY saved compared to standard of care

– Concerns from WG that this option could lead to MenB vaccine being discontinued (but need for 

Trumenba for persons at increased risk might reduce likelihood)

61
Comparison of Q-P-B and Q-P-P

Criteria Q-P-B Q-P-P

Number of doses saved 1 1

Cost savings per person compared to standard of care $95 $27

Less cost per QALY saved than standard of care Yes No

Number of vaccine types required for the routine schedule 3 2

Number of vaccines types required for the increased-risk schedule 3 3

Matches dosing used in clinical trials No Yes

Unnecessary doses of one or more serogroups No Yes

62
63

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 (AIM) – Paul Cieslak (CSTE) – Kathy Hsu (IDSA) – Joseline Zafack (NACI) – Jeff Goad (NFID) – Jessica Cataldi (PIDS) – Amy Middleman (SAHM) – David Stephens (Emory)

▪ CDC Contributors – Jenn Collins (DBD/NCIRD) – Lucy McNamara (DBD/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) – Ismael Ortega-Sanchez (DVD/NCIRD) – Liz Velazquez (ISD/NCIRD) – Jessica MacNeil (ACIP Secretariat) ▪ GRADE/EtR Support – Doug Campos-Outcalt (Arizona) – Rebecca Morgan (Case Western Reserve)
Backup Slides
Evidence Retrieval

▪ Systematic review of studies in any language from Medline, Embase, 

Global Health, CINAHL, Cochrane, Scopus, and clinicaltrials.gov databases 

using search string:

– meningococcal pentavalent, pentavalent meningococcal, Pfizer pentavalent meningococcal, 

MenABCWY, Pfizer MenABCWY, pentavalent MenABCWY, 

ABCWY, MenABCWY meningococcal, Neisseria meningitidis group A, B, C, W, and Y, Neisseria 

meningitidis A, B, C, W, and Y, Neisseria meningitidis pentavalent, bivalent RLP2086-containing 

pentavalent, NCT03135834, B1971057, NCT04440163, C3511001, NCT04440176, C3511004, and 

“vaccin*” 

▪ Efforts made to obtain unpublished or other relevant data

▪ Included results that presented primary data on Pfizer’s MenABCWY 

vaccine

65
Evidence Screening Steps

Materials shared by 

Pfizer (n=5)

References identified 

in database search 

(n=43)

Title and abstract 

screening (n=43)

Full-text article or 

public data screening 

(n=14)

Records excluded 

(n=10)

Records excluded 

(n=29)

Data sources included 

in GRADE analysis: 9 

(documenting results 

of 3 clinical trials) 66
GRADE Certainty of Evidence Categories

Evidence 

Type Study Design

High Randomized controlled trials (RCTs) or overwhelming evidence 

from observational studies

Moderate RCTs with important limitations, or exceptionally strong 

evidence from observational studies

Low Observational studies, or RCTs with notable limitations

Very low Clinical experience and observations, observational studies with 

important limitations, or RCTs with several major limitations

67
Short-Term Immunity Key Findings (Table 3a)

Author, 

Pub year Age Serogroup (Test strain)

n/N 

ABCWY

n/N 

comparison

Intervention 

vaccine

Comparator 

vaccine

% (95% CI) for 

intervention

% (95% CI) for 

comparator 

Effect estimate —

RR (95% CI)

Seroresponse based on hSBA titer11 month after 1 intervention dose

Pfizer CT 

(NCT04440163), 

2020

10–25 years; 

ACWY naïve

A 484/499 242/254

MenABCWY (1 

dose)

MenACWYCRM (1 dose) 

+ MenBFHbp (1 

dose) 

97.0% (95.1–98.3) 95.3% (91.9–97.5) 1.02 (0.99–1.05)

C 315/501 132/252 62.9% (58.5–67.1) 52.4% (46.0–58.7) 1.2 (1.05–1.37)

W 390/492 178/244 79.3% (75.4–82.8) 73.0% (66.9–78.4) 1.09 (0.99–1.19)

Y 405/494 175/248 82.0% (78.3–85.3) 70.6% (64.5–76.2) 1.16 (1.06–1.27)

10–25 years; 

ACWY primed

A 416/439 220/227 94.8% (92.2–96.7) 96.9% (93.7–98.8) 0.98 (0.95–1.01)

C 410/439 214/226 93.4% (90.7–95.5) 94.7% (90.9–97.2) 0.99 (0.95–1.03)

W 417/428 214/222 97.4% (95.4–98.7) 96.4% (93.0–98.4) 1.01 (0.98–1.04)

Y 417/442 209/223 94.3% (91.8–96.3) 93.7% (89.7–96.5) 1.01 (0.97–1.05)

Seroresponse based on hSBA titer 1 month after 2 intervention doses

Pfizer CT 

(NCT0444016

3), 2020

10–25 years; 

B naïve2

B (A22) 646/778 313/396

MenABCWY 

(2 doses 6 

months 

apart)

MenACW

Y-CRM (1 

dose) + 

MenBFHbp (2 

doses 6 

months 

apart)

83% (80.2–85.6) 79.0% (74.7–82.9) 1.05 (0.99–1.12)

B (A56) 774/807 378/400 95.9% (94.3–97.2) 94.5% (91.8–96.5) 1.01 (0.99–1.04)

B (B24) 567/833 239/418 68.1% (64.8–71.2) 57.2% (52.3–62.0) 1.19 (1.08–1.31)

B (B44) 731/845 332/419 86.5% (84.0–88.7) 79.2% (75.0–83.0) 1.09 (1.03–1.15)

B (composite) 591/755 263/419 78.3% (75.2–81.2) 68.7% (63.8–73.3) 1.25 (1.15–1.35)

68

1 hSBA = serum bactericidal assay using human complement. For participants with a baseline hSBA titer <1:4, seroresponse is defined as a titer ≥1:16. For those with a baseline hSBA titer ≥1:4 and 

<1:8 (<1:16 for A22), seroresponse is a titer ≥4 times the 1:8 (1:16 for A22). For those with a baseline hSBA titer ≥1:8 (≥1:16 for A22), seroresponse is a titer ≥4 times the baseline titer. 

2 Serogroup B primed not assessed.
Persistent Immunity Key Findings (Table 3b)

Author, pub year Age Serogroup 

(Test strain)

n/N 

MenABCWY

n/N 

comparison

Intervention 

vaccine 

Comparator 

vaccine

% (95% CI) for 

intervention

% (95% CI) for 

comparator 

Effect estimate —

RR (95% CI)

Seroprotection (defined as hSBA titer ≥1:8 for all but A22 which is ≥1:16) at 48 months (54 months for MenACWY-CRM) after last dose

Pfizer CT 

(NCT03135834) 

2017

10–25 years; 

ACWY naïve

A 58/71 26/41

MenABCWY (2 

doses 6 months 

apart)

MenACWYCRM (1 dose) + 

MenB-FHbp (2 

doses 6 months 

apart) 

81.7% (70.7–89.9) 63.4% (46.9–77.9) 1.29 (1.00–1.67)

C 44/71 16/42 62.0% (49.7–73.2) 38.1 % (23.6–54.4) 1.63 (1.06–2.49)

W 64/70 29/41 91.4% (82.3–96.8) 70.7% (54.5–83.9) 1.29 (1.05–1.59)

Y 71/71 40/42 100.0% (94.9–100.0) 95.2% (83.8–99.4) 1.05 (0.98–1.12)

10–25 years; 

B naïve

B (A22) 39/139 30/94 28.1% (20.8–36.3) 31.9% (22.7–42.3) 0.88 (0.59–1.31)

B (A56) 50/145 29/98 34.5% (26.8–42.8) 29.6% (20.8–39.7) 1.17 (0.80–1.70)

B (B24) 53/145 26/98 36.6% (28.7–44.9) 26.5% (18.1–36.4) 1.38 (0.93–2.04)

B (B44) 27/148 16/99 18.2% (12.4–25.4) 16.2% (9.5–24.9) 1.13 (0.64–1.98)

10–25 years; 

ACWY 

primed

A 40/40 23/23 100.0% (91.2–100.0) 100.0% (85.2–100.0) 1.00 (1.00–1.00)

C 75/76 52/58 98.7% (92.9–100.0) 89.7% (78.8–96.1) 1.10 (1.01–1.21)

W 40/40 21/23 100.0% (91.2–100.0) 91.3% (72.0–98.9) 1.10 (0.97–1.24)

Y 40/40 22/22 100.0% (91.2–100.0) 100.0% (84.6–100.0) 1.00 (1.00–1.00)
Persistent Immunity Key Findings, Continued

Author, pub year Age Serogroup n/N 

MenABCWY

n/N

comparison

Intervention 

vaccine 

Comparator 

vaccine

% (95% CI) for 

intervention

% (95% CI) for 

comparator 

Effect estimate — RR (95% CI)

Seroprotection (defined as hSBA titer ≥1:8) at 13 months (12 months for MenACWY-CRM) after last dose

Pfizer CT 

(NCT04440176), 

2020, and Pfizer CT 

(NCT03135834), 2017

11–14 years for 

NCT04440176 

and 10–25 years 

for 

NCT03135834; 

both groups 

ACWY naive

A 102/126 42/59

1 dose of 

MenABCWY

1 dose of 

MenACWY-CRM

81.0% (73.0–87.4) 71.2% (57.9–82.2) 1.14 (0.95–1.37)

C 92/127 32/62 72.4% (63.8–80.0) 51.6% (38.6–64.5) 1.40 (1.08–1.83)

W 125/128 52/62 97.7% (93.3–99.5) 83.9% (72.3–92.0) 1.16 (1.04–1.30)

Y 122/126 61/62 96.8% (92.1–99.1) 98.4% (91.3–

100.0) 0.98 (0.94–1.03)

70
Serious Adverse Event Findings

1 Nine SAEs occurred in 7 patients: Salmonella gastroenteritis (1 patient), depression (1 patient), anxiety (1 patient), suicide attempt (1 patient), 

postural orthostatic tachycardia syndrome (1 patient), dyspnea (1 patient), head injury due to motor vehicle accident (1 patient), traumatic spinal 

cord injury (1 patient), depression with suicidal ideation (1 patient). None of the SAEs were deemed related to the vaccine by the study 

investigators. 

2 Eight SAEs occurred in 6 patients: cyst (1 patient), tendon injury (1 patient), dyskinesia (1 patient), migraine with aura (1 patient), aggression (1 

patient), conversion disorder (1 patient), suicidal ideation (2 patients). None of the SAEs were deemed related to the vaccine by the study 

investigators. 71

1

2
Non-Serious Adverse Event Findings

72

▪ Additional findings related to non-serious adverse events

– NCT04440163: Attention-deficit/hyperactivity disorder (ADHD) was reported by 6 participants in the MenABCWY group 

as newly diagnosed chronic medical conditions (NDCMC). Five had an onset of ADHD-related symptoms that occurred 

prior to study enrollment and the remaining participant had a history of one or more conditions prior to enrollment 

that commonly co-occur with ADHD, including anxiety, depression, and substance use. Overall, none of the NDCMCs 

reported were considered related to vaccine by the investigators.

– No other non-serious adverse events that we are aware of were disproportionately overrepresented in the 

MenABCWY group from any of the trials. 
Nimenrix Background

▪ Nimenrix is not approved in the United States, but has been available in 

other parts of the world for about a decade

▪ The next few slides provide some background on the vaccine’s safety, 

immunogenicity, and potential interference with other routinely 

administered vaccines

73
Nimenrix Safety

▪ First licensed in the European Union in April 2012

▪ Currently licensed in more than 80 countries worldwide

▪ More than 20 thousand people participated in Nimenrix clinical trials

▪ Over a decade of post-marketing safety data available

– More than 30 million doses given worldwide

– Safety consistent between CTs and post-marketing experience

– Most common adverse events — fever, headache, injection site pain, nausea/vomiting, 

fatigue

– Serious adverse events rare relative to doses given

– Safety also consistent with other licensed meningococcal vaccines

1 Serra et al. Clinical trial and postmarketing safety experience with MenACWY-TT, a meningococcal group A, C, W, and Y tetanus conjugate vaccine. 

Vaccine. 2022; 40:7014–7021. 74
Nimenrix Safety, Continued

▪ One clinical trial on MenACWY-TT and asplenia1

– Phase III, non-randomized study

– 1 to 17 year olds with impaired splenic activity with age-matched healthy 

controls

▪ Results

– Both study groups had high and comparable hSBA vaccine response rates 

across serogroups

• First dose: 55.6–77.1% vs. 60.6–76.3% 

• Second dose: 73.0–100% vs. 73.0–85.3% 

– SAEs were comparable (4/43 vs. 1/43) and none were deemed vaccine related

• Cystitis due to Escherichia coli, pneumococcal bacteremia, salmonellosis, and sicklecell anemia with crisis

1 Klein et al. Immunogenicity and safety of the quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in 

splenectomized orhyposplenic children and adolescents: Results of a phase III, open, non-randomized study. Vaccine. 2018. 36;2356–2363. 75
Nimenrix Persistence Compared to Menactra — 5 Years After 

Primary Vaccination in Young Adults Aged 11–25 Years1

1 Pfizer. Nimenrix Product Label. ShowLabeling.aspx (pfizer.com). 

0

50

100

150

200

250

A C W Y

GMT

Serogroup

Nimenrix

Menactra

76
Nimenrix Persistence Compared to MenQuadfi — 3 Years After 

Primary Vaccination in Children Aged 4–5 Years1

1 Sanofi Pasteur. Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children 

Vaccinated 3 Years Earlier as Toddlers. EU Clinical Trials Registry. https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-001993-40/results. 

0

20

40

60

80

100

120

A C W Y

GMT

Serogroup

Nimenrix

MenQuadfi

77
Overall Certainty of Evidence — PICO 1 (Table 5)

Outcome Importance Included in 

Evidence Profile

Certainty for 

Healthy 

Individuals

Certainty for 

Individuals at 

Increased Risk

Meningococcal disease caused by 

serogroups A, B, C, W, and Y Critical No – –

Short-term immunity Critical Yes Moderate Low

Persistent immunity Important Yes Low Low

Interference with other recommended 

vaccines administered concurrently Important No – –

Serious adverse events Critical Yes Low Very low

Non-serious adverse events Important Yes Low Very low

78
Overall Certainty of Evidence — PICO 2 (Table 5)

Outcome Importance Included in 

Evidence Profile

Certainty for 

Healthy 

Individuals

Certainty for 

Individuals at 

Increased Risk

Meningococcal disease caused by 

serogroups A, B, C, W, and Y Critical No – –

Short-term immunity Critical Yes Moderate Low

Persistent immunity Important Yes Low Low

Interference with other recommended 

vaccines administered concurrently Important No – –

Serious adverse events Critical Yes Low Very low

Non-serious adverse events Important Yes Low Very low

79
Overall Certainty of Evidence — PICO 3 (Table 5)

Outcome Importance Included in 

Evidence Profile

Certainty for 

Healthy 

Individuals

Certainty for 

Individuals at 

Increased Risk

Meningococcal disease caused by 

serogroups A, B, C, W, and Y Critical No – –

Short-term immunity Critical Yes Moderate Low

Persistent immunity Important Yes Moderate Low

Interference with other recommended 

vaccines administered concurrently Important No – –

Serious adverse events Critical Yes Low Very low

Non-serious adverse events Important Yes Low Very low

80
Equity Considerations

HISPANIC NON-HISPANIC NON-HISPANIC NON-HISPANIC

WHITE ONLY BLACK ONLY OTHER + 

MULTIPLE

RACE

% 1+ dose MenB 31.83 30.88 39.67 24.73

Among 17yos in NIS-Teen 2021:

81
Equity Considerations, Continued

82
83

Equity Considerations, Continued

▪ Potential equity issues exist involving meningococcal vaccination more generally1

– “Among adolescents aged 17 years, coverage with ≥2 MenACWY doses was 11.8 percentage 

points lower for those living in non-MSAs than for those in MSA principal cities. Disparities 

between non-MSAs and MSA principal cities were statistically significant for adolescents living at 

or above the poverty level, but not for those living below the poverty level.”

– “Hispanic or Latino (Hispanic) adolescents had lower coverage with ≥2 MenACWY doses (−10.8 

percentage points).”

– “Adolescents who were uninsured had lower coverage with ≥1 MenACWY dose.”

1 Pingali et al. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2021. 

MMWR. 2022. 71; 1101–1108. 
84

Demographic Information for NCT04440163
85

Routine and Increased Risk Vaccine Schedules for ≥10 Years Old

▪ Routine

– One MenACWY dose at 11–12 years and a booster at 16 years

– Two MenB doses at 16–18 years

▪ Increased risk, MenACWY (vaccines are interchangeable)

– Recommended for certain medical conditions (asplenia, complement deficiency, complement inhibitor use, and HIV infection), 

some microbiologists, exposure during an outbreak, travel to hyperendemic areas, first-year college students, and military 

recruits

– 2 doses ≥8 weeks apart for primary vaccination (only 1 dose for microbiologists, travelers, military) and single booster dose

every 5 years thereafter for as long as person remains at increased risk

– Only 1 dose during outbreaks if ≥5 years since MenACWY primary vaccination

– Only 1 dose for first year college students within 5 years before starting college 

▪ Increased risk, MenB (vaccines are not interchangeable)

– Recommended for certain medical conditions (asplenia, complement deficiency, and complement inhibitor use), some 

microbiologists, and exposure during an outbreak

– Bexsero: 2 doses ≥1 month apart followed by single dose 1 year later and every 2–3 years thereafter for as long as person 

remains at increased risk

– Trumenba: 3 doses at 0, 1–2, and 6 months followed by single dose 1 year later and every 2–3 years thereafter for period of 

increased risk

– Only 1 dose during outbreaks if ≥1 year after MenB primary series