ACIP Evidence to Recommendations for Use of GSK's Pentavalent Meningococcal Vaccine (MenACWY-CRM/MenB-4C)

Jan. 6, 2026

The Evidence to Recommendations (EtR) frameworks describe information considered in moving from evidence to ACIP vaccine recommendations. Work group judgements are presented for each EtR domains; where differences in judgement among the work group occur for a specific policy question, the full spectrum of judgements is presented.

Summary

Policy Question 1: Should the pentavalent vaccine be included as an option for MenACWY/MenB vaccination in people currently recommended to receive both vaccines?

Policy Question 2: Should the pentavalent vaccine be included as an option for MenACWY vaccination in people currently recommended to receive only MenACWY vaccine?

Policy Question 3: Should the pentavalent vaccine be included as an option for MenB vaccination in people currently recommended to receive only MenB vaccine?

Population: All individuals aged ≥10 years currently recommended to receive MenACWY and MenB vaccines, MenACWY only, or MenB only, depending on the policy question.

Intervention: Vaccination with the pentavalent vaccine.

Comparison(s): Vaccination with currently licensed MenACWY and MenB vaccines, only MenACWY vaccine, or only MenB vaccine, depending on the policy question.

Outcomes: Disease caused by serogroups A, B, C, W, or Y (depending on the policy question); short-term immunity; persistent immunity; interference with other recommended vaccines administered concurrently; serious adverse events; non-serious adverse events

About

Background

Meningococcal disease is a serious bacterial infection caused by Neisseria meningitidis. ACIP recommends quadrivalent (serogroups A, C, W, and Y) meningococcal vaccine (MenACWY) for routine administration as a single dose to persons aged 11–12 years, with a booster dose at age 16 years. ACIP also recommends serogroup B meningococcal vaccine (MenB) as a 2-dose series for persons aged 16–23 years based on shared clinical decision-making, with a preferred age of 16–18 years. Persons at increased risk for meningococcal disease on the basis of certain medical conditions or other exposures are recommended to receive one or both vaccine types, with MenACWY recommended for persons aged ≥2 months and MenB recommended for persons aged ≥10 years.

Previously, ACIP recommended a pentavalent (serogroups A, B, C, W, and Y [MenABCWY]) meningococcal vaccine (MenACWY-TT/MenB-fHbp [Penbraya, Pfizer Inc.]) may be used when both MenACWY and MenB are indicated at the same visit for healthy persons aged 16 – 23 years when shared clinical decision-making favors MenB administration and for persons aged ≥10 years at increased risk for meningococcal disease. GSK developed a second pentavalent vaccine (MenACWY-CRM/MenB-4C [Penmenvy, GSK]) comprised of Menveo (MenACWY) and Bexsero (MenB), both of which are licensed in the United States. The ACIP Meningococcal Vaccines Work Group assessed this pentavalent vaccine using the Evidence to Recommendation (EtR) framework and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.

Public Health Problem

Criteria	Work Group Judgement(s)	Evidence	Additional Information
Is the problem of public health importance?	Policy Questions (PQ) 1, 2, and 3: Yes	Meningococcal disease is rare in the United States, with 503 confirmed and probable cases occurring in 2024 based on preliminary data.1 Approximately 10–15% of infections result in death, and approximately 10–20% of survivors have permanent sequelae that include brain injury, limb amputation, hearing loss, and reduced kidney function.2,3 ACIP has recognized meningococcal disease as a problem of public health importance by recommending MenACWY vaccination for all adolescents and MenB vaccination based on shared clinical decision-making.4	Recently, meningococcal disease incidence has increased in the United States, with this increase mainly attributable to increased serogroup Y.1,5 Persons aged 30–60 years, Black or African American persons, and persons living with HIV have been disproportionately affected by a new serogroup Y strain in the United States.5

Benefits and harms

Criteria	Work Group Judgement(s)	Evidence	Additional Information
How substantial are the desirable anticipated effects?	PQ 1, 2, 3: Small	One month after receipt of 1 dose of ACWY-targeting vaccine, MenACWY-naïve and MenACWY-primed participants in the pentavalent and control groups were similarly likely to have seroprotective* titers against serogroups A, C, W, and Y.** One month after receipt of 2 doses of serogroup B-targeting vaccine administered 6 months apart, participants in the pentavalent and control groups were similarly likely to have seroprotective* titers against 3 of the 4 serogroup B antigens (fHbp, NadA, and NHBA)* contained in MenB-4C; however, participants in the pentavalent group were less likely to have seroprotective titers against the PorA* antigen. Two years after 2 doses of serogroup B-containing vaccine**** participants in the pentavalent and control groups were similarly likely to have seroprotective* titers against all 4 serogroup B antigens.*****	Persons at increased risk were not included in the clinical trials.6,7,8,9,10 The vaccine’s ability to prevent meningococcal disease in healthy persons or persons at increased risk was not directly assessed in trials. Instead, immunogenicity was used as a surrogate measure. No studies were identified for persistent immunity against serogroups A, C, W, and Y.
How substantial are the undesirable anticipated effects?	PQ 1: Minimal PQ 2: Small PQ 3: Minimal	The likelihood of experiencing a serious adverse event possibly related to vaccination^¶ after any vaccine dose was overall very low and comparable between participants in the pentavalent and control (MenACWY and/or MenB) groups. Six events assessed as possibly related to study vaccination occurred across 7 studies, 3 in the pentavalent group (seizure, connective tissue disorder, and neuromyelitis optica^¶¶) and 3 in the control group (syncope, pyrexia^¶¶, and ulcerative colitis^¶¶). Individuals in the pentavalent group were similarly likely to experience non-serious adverse events after 1 or ≥2 doses as individuals in a serogroup B-containing vaccine control group (MenB or MenACWY+MenB). Compared to a single MenACWY dose, individuals in the pentavalent group were significantly more likely to experience non-serious adverse events after either 1 dose or 2 doses administered 6 months apart.	GSK’s clinical trials did not assess interference with other vaccines.6,7,8,9,10,11,12
Do the desirable effects outweigh the undesirable effects?	PQ 1: Favors intervention, favors comparator PQ 2: Favors intervention, favors comparator, favors both PQ 3: Favors intervention, favors comparator, favors both	The pentavalent vaccine would increase the number of vaccines available for providers. For patients looking to be vaccinated against all 5 serogroups, the pentavalent vaccine would reduce the number of doses administered from 2 to 1.	None.
What is the overall certainty of evidence?	PQ 1, 2, 3: Low	There were two critical outcomes (short-term immunity and serious adverse events) and two important outcomes (persistent immunity and non-serious adverse events) with data available. For healthy persons, the certainty of evidence for short-term immunity is moderate because of indirectness. Serologic 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.13 The certainty of evidence for serious adverse events is moderate because of imprecision. The certainty of evidence for persistent immunity against serogroup B is low. Across the different control groups assessed, the certainty of evidence is moderate^§ to high^§§ for non-serious events. For persons at increased risk, the certainty of evidence for all 4 outcomes with data available is additionally downgraded for indirectness, because persons at increased risk were not included in the clinical trials. Therefore, the certainty of evidence is low for short-term immunity, low for serious adverse events, very low for persistent immunity against serogroup B, and low^§ to moderate^§§ for non-serious adverse events.	Because no studies were identified for persistent immunity against serogroups A, C, W, and Y, the evidence certainty could not be assessed. The evidence certainty also could not be assessed for one critical outcome (meningococcal disease caused by serogroups A, B, C, W, and Y) or for one important outcome (interference with other recommended vaccines administered concurrently).

^*Seroprotection was based on serum bactericidal assays using human complement (hSBA) and refers to the proportion of participants with an hSBA titers at or above a certain threshold.

^** Thresholds differed by serogroup and study: ≥1:8–22.7 (serogroup A), ≥1:5.2–8 (serogroup C), ≥1:8–39.6 (serogroup W), and ≥1:8–14.7 (serogroup Y).

^*** Thresholds differed by serogroup B antigen: ≥1:5 (fHbp), ≥1:15 (NadA), ≥1:4 (NHBA), and ≥1:6 (PorA).

^****Pentavalent recipients received two doses 6 months apart, while MenB recipients received two doses 2 months apart. Because the MenB recipients did not receive doses at the currently recommended 6-month interval, this evidence was not weighted as strongly by the work group compared to the evidence for short-term immunity, where both pentavalent and MenB recipients received doses 6 months apart.

^***** Thresholds differed by serogroup B antigen: ≥1:8.0 (fHbp), ≥1:8.6 (NadA), ≥1:8.9 (NHBA), and ≥1:8.2 (PorA).

^¶The relationship of an adverse event to the study vaccine was judged by the study investigator, not the sponsor.

^¶¶ This event was assessed as related to study vaccination by the study investigators; however, it was not considered an adverse drug reaction related to vaccination after both GSK and independent evaluation. This event does not appear in the final package insert approved by FDA on February 14, 2025.

^§Comparisons: 1 dose of pentavalent versus 1 dose of MenACWY+MenB, 1 dose of pentavalent versus 1 dose of MenACWY, ≥2 pentavalent doses versus 1 dose of MenACWY.

^§§Comparisons: 1 dose of pentavalent versus 1 dose of MenB, ≥2 doses of pentavalent versus ≥2 doses of MenB.

Values

Criteria	Work Group Judgement(s)	Evidence	Additional Information
Does the target population feel the desirable effects are large relative to the undesirable effects?	PQ 1: Yes PQ 2: Probably yes PQ 3: Probably yes, yes, don’t know	Limited data are available on the values of the target population regarding inclusion of the pentavalent vaccine. In 2023, vaccination coverage with ≥1 dose among persons aged 13–17 years was 89% for MenACWY and 32% for MenB.14 Limited data are available on vaccine coverage among other individuals recommended to receive MenACWY and/or MenB.	Use of combination vaccines reduces the number of injections and is general preferred over separate injections of equivalent component vaccines; however, administering extra antigens should generally be avoided.15
Is there important variability in how patients value the outcome?	PQ 1: Probably not, no PQ 2: Probably, probably not PQ 3: Probably, probably not	Limited data are available on how much patients value the main outcomes. Vaccination rates for MenACWY, which is routinely recommended, are high among the target population.14 Vaccination rates for MenB are lower, with decisions to vaccination based on shared clinical decision-making.	None.

Acceptability

Criteria	Work Group Judgement(s)	Evidence	Additional Information
Is the intervention acceptable to key stakeholders?	PQ 1: Yes PQ 2: Probably yes PQ 3: Yes, probably yes	Limited data are available on acceptance by key stakeholders for inclusion of MenABCWY as an option in the current vaccine schedule. Acceptability likely depends on the policy question and stakeholder values. Healthcare providers are likely supportive of options that allow stocking fewer vaccines.15,16 Patients may also favor fewer injections. However, MenB components are reactogenic, with 0.88 occurrences of syncope within 15 minutes of MenB administration per 1,000 persons.17	None.

Resource use

Criteria	Work Group Judgement(s)	Evidence	Additional Information
Is the intervention a reasonable and efficient allocation of resources?	PQ 1: Yes PQ 2: Probably no, varies PQ 3: Varies (judgements ranged from no to yes)	Findings from a CDC economic model suggested that MenABCWY would be cost-saving if used to replace 1) a single dose of MenACWY and MenB when both are indicated, or 2) both MenB doses if the first MenB dose was administered at the same time as a MenACWY dose; however, the second option was less cost-saving than the first.18 When MenB vaccination was not indicated, replacing both MenACWY doses with MenABCWY would be incrementally costly.18 Findings from a GSK model, which included several differences in assumptions and inputs, yielded similar conclusions overall to the CDC model.	In the CDC and GSK models, the cost-effectiveness of pentavalent vaccine varied by PQ and number of doses. Both models indicated that MenABCWY would be cost-saving if used to replace 1) a single dose of MenACWY and MenB when both are indicated, or 2) both MenB doses if the first MenB dose was administered at the same time as a MenACWY dose. However, when MenB vaccination was not indicated, the CDC model indicated that replacing both MenACWY doses with MenABCWY would cost $11.3 million per quality-adjusted life year (QALY), while the GSK model indicated a cost of $15.6 million per QALY.19 Replacing both MenB doses with MenABCWY was also incrementally costly compared to administering MenABCWY when both MenACWY and MenB are indicated, with the CDC model indicating a cost of $4.5 million per QALY and the GSK model indicating a cost of $1.5 million per QALY.19

Equity

Criteria	Work Group Judgement(s)	Evidence	Additional Information
What would be the impact of the intervention on health equity?	PQ 1: Probably increased PQ 2: Increased, probably increased PQ 3: Probably increased	Limited data are available for the impact of MenABCWY on health equity. MenABCWY is not expected to negatively impact health equity, and it may reduce disparities among those who might be interested in vaccination against serogroup B who might not receive clinical care that includes discussion of MenB. Because serogroup B-containing vaccine doses from different manufacturers are not interchangeable, the prior recommendation of Penbraya [Pfizer, Inc] created an imbalance in access to pentavalent vaccine. Healthcare providers choosing to stock Pfizer products would be able to offer Penbraya to reduce the number of injections, but healthcare providers choosing to stock GSK products did not previously have a pentavalent vaccine option available. Recommendation of Penmenvy [GSK] would support manufacturer parity.	Patients at increased risk for invasive meningococcal disease, who may also have social and economic challenges, were not included in the vaccine trials. The effect of MenABCWY in these populations is unknown.

Feasibility

Criteria	Work Group Judgement(s)	Evidence	Additional Information
Is the intervention feasible to implement?	PQ 1: Yes PQ 2: Yes, probably yes PQ 3: Yes	Challenges with insurance coverage specific to MenABCWY are not expected, nor are substantial financial burdens for providers and health systems. Penmenvy may reduce the number of injections for some people and create manufacturer parity regarding serogroup B-containing vaccines. However, stocking 3 different meningococcal vaccine types may be prohibitive for some providers. With the availability of multiple serogroup B-containing vaccines, the potential for administration of an incorrect meningococcal vaccine product exists.	None.

Balance of consequences

Policy Question 1: Work group members judged the desirable consequences to probably or clearly outweigh the undesirable consequences in most settings.

Policy Question 2: Work group members were split between judging the desirable consequences to probably outweigh the undesirable consequences, the desirable and undesirable consequences to be closely balanced or of uncertain balance, or the desirable consequences to be clearly outweighed by the undesirable consequences in most settings.

Policy Question 3: Work group members were split between judging the desirable consequences to clearly or probably outweigh the undesirable consequences, the desirable and undesirable consequences to be closely balanced or the balance was uncertain, or the undesirable consequences to probably outweigh the desirable consequences in most settings.

Policy options for ACIP consideration

GSK’s MenABCWY vaccine may be used when both MenACWY and MenB are indicated at the same visit for 1) healthy persons aged 16–23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine and 2) persons aged ≥10 years who are at increased risk of meningococcal disease (e.g., because of persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia).

Final deliberation and decision by the ACIP

Jan. 6, 2026

Sources Print Share

Content Source:

National Center for Immunization and Respiratory Diseases (NCIRD)

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