GSK’s 5-in-1 Meningococcal Vaccine PENMENVY Receives Positive Recommendation from US Advisory Committee on Immunization Practices

Rhea-AI Summary

GSK's PENMENVY, a groundbreaking 5-in-1 meningococcal vaccine, has received a positive recommendation from the US CDC's Advisory Committee on Immunization Practices (ACIP). The vaccine is recommended for persons over 10 years old as an alternative to separate MenACWY and MenB vaccinations.

The vaccine combines components from GSK's existing vaccines BEXSERO and MENVEO, providing protection against serogroups A, B, C, W, and Y of Neisseria meningitidis in a single dose. The FDA approved PENMENVY on February 14, 2025, for individuals aged 10-25 years.

Currently, MenB is the leading cause of invasive meningococcal disease, yet vaccination rates remain low with less than 13% of 17-year-olds completing the recommended two-dose series. GSK manufactures three of every four MenB doses administered in the US. The vaccine will be available for use in the US from Summer 2025.

Positive

• FDA approval received for innovative 5-in-1 vaccine combining protection against all major meningococcal serogroups
• GSK holds 75% market share of MenB doses in the US
• Simplified vaccination schedule could improve immunization rates
• Positive ACIP recommendation strengthens market position

Negative

• Product launch not until Summer 2025
• Current low vaccination rates (13%) indicate potential market adoption challenges

Insights

Vaccine Market Analyst

GSK's 5-in-1 meningococcal vaccine recommendation strengthens market leadership position and expands commercial opportunity in a key therapeutic area.

The ACIP recommendation for PENMENVY represents a significant commercial opportunity for GSK in the US vaccine market. This 5-in-1 vaccine strategically addresses a critical market challenge: the persistently low meningococcal B vaccination rates (<13% completion among 17-year-olds) despite it being the leading cause of invasive meningococcal disease in adolescents.

GSK already holds dominant market position with approximately <percent>75%</percent> of current MenB doses in the US. PENMENVY cleverly leverages this advantage by combining their established BEXSERO and MENVEO products into a single injection, potentially expanding their total addressable market.

The vaccine's value proposition is compelling: fewer injections could substantially improve compliance rates in a demographic historically resistant to completing multi-dose vaccination schedules. From a competitive standpoint, GSK has created a significant market barrier as MenB-containing vaccination schedules must be completed with the same manufacturer's vaccine.

With Summer 2025 availability, PENMENVY positions GSK to potentially capture greater market share through simplified administration (a single injection versus separate shots), which should appeal to providers and patients alike. This recommendation, if formally adopted by the CDC, will establish PENMENVY as standard of care for US adolescent meningococcal vaccination, driving uptake and enhancing GSK's already strong position in this therapeutic area.

Public Health Expert

The ACIP recommendation for GSK's PENMENVY represents a meaningful public health advancement in meningococcal disease prevention. Current vaccination coverage against serogroup B—the leading cause of invasive meningococcal disease among US adolescents—is alarmingly low, with <percent>87%</percent> of 17-year-olds unprotected against this potentially fatal infection.

The pentavalent approach directly addresses a significant public health challenge: vaccination compliance. By reducing required injections, PENMENVY eliminates a major barrier to protection against all five disease-causing meningococcal serogroups. The timing of this recommendation is particularly important, as it targets adolescents and young adults when their risk profile increases due to behavioral and environmental factors including communal living situations.

From an implementation perspective, PENMENVY simplifies the vaccination schedule at age 16, when typically separate MenACWY and MenB vaccines would be administered. This streamlining benefits clinical practice workflow and potentially reduces missed vaccination opportunities.

While any new vaccine must overcome adoption hurdles, PENMENVY's pathway may be smoother since it combines already-established antigens from GSK's existing vaccines. The ACIP recommendation essentially validates this approach as equivalent to the current standard, facilitating integration into vaccination protocols. When available in Summer 2025, this vaccine could significantly improve population-level protection against meningococcal disease through higher completion rates.

• Vaccine recommended to help protect persons over 10 years old in the United States (US) against disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y)
• Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults
• Vaccine doses will be ready for use in the US from Summer 2025

PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) as part of the adolescent meningococcal vaccination schedule. Recommendations made by the ACIP are reviewed and, if adopted, are published as official CDC recommendations.

ACIP voted to recommend that persons over 10 years old receive a single dose of PENMENVY as an alternative to separate administration of meningococcal serogroups A, C, W, and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. This recommendation, if adopted, will allow for vaccination against serogroups A, B, C, W, and Y in fewer doses, could simplify meningococcal vaccination delivery and could improve immunization rates, helping protect more US adolescents against these five disease-causing serogroups for which the US CDC has previously issued recommendations.¹

GSK’s MenABCWY vaccine combines the antigenic components of the Company’s two well-established meningococcal vaccines—BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM₁₉₇ Conjugate Vaccine). On February 14, 2025, the US Food and Drug Administration (FDA) approved GSK’s MenABCWY vaccine for use in individuals aged 10 through 25 years.²

Tony Wood, Chief Scientific Officer at GSK, said: “We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunization rates among adolescents and young adults in the US, who are at an age with increased risk.”

Although MenB is the leading cause of invasive meningococcal disease (IMD) among this population, less than 13% of 17-year-olds received the recommended two-dose vaccination series; around 32% received at least one dose according to 2023 CDC survey data.^3,4 Three of every four MenB doses currently administered in the US are manufactured by GSK,⁵ positioning the company well to lead in the US market as MenB-containing vaccination schedules must be completed with the same manufacturer’s MenB vaccine.⁶

About IMD

IMD is an uncommon but serious illness that can lead to death for up to one in ten of those who contract it in as little as 24 hours from onset, despite treatment.⁷ IMD is easily misdiagnosed, with early symptoms often mistaken for the flu.^7,8 Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems.⁸ Although anyone can get IMD, adolescents and young adults between the ages of 16 and 23 years are one of the groups at highest risk due to common behaviors that help transmit the bacteria that cause IMD, such as living in close quarters like college dormitories, kissing and sharing drinks, utensils, or smoking devices.^9,10

About PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine)

GSK’s MenABCWY vaccine is an injectable suspension for intramuscular use. The vaccine is supplied as one vial of lyophilized MenACWY Component (powder) which is reconstituted at the time of use with the accompanying prefilled syringe of MenB Component (liquid). In the US, PENMENVY is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 through 25 years. The FDA-approved dosing is to administer two doses six months apart. The US Prescribing Information is available here.¹¹

Important Safety Information for PENMENVY in the US

The following is based on the US Prescribing Information for PENMENVY. Please consult the full Prescribing Information for additional safety information.

• Do not administer PENMENVY to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of PENMENVY, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine
• Syncope (fainting) has occurred in association with administration of PENMENVY
• PENMENVY may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains
• Immunocompromised persons, including those receiving immunosuppressive therapy, may have reduced immune responses to PENMENVY
• Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis, including disease caused by serogroups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENMENVY
• Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of a U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENMENVY to persons with a history of GBS should take into account the expected benefits and potential risks
• The most commonly reported solicited adverse reactions in individuals aged 10 through 25 years after Dose 1 and Dose 2: pain at the injection site, fatigue, headache, myalgia, nausea, erythema, and swelling. The most commonly reported solicited adverse reactions in MenACWY conjugate vaccine-experienced individuals aged 15 through 25 years after Dose 1 and Dose 2: pain at the injection site, headache, fatigue, myalgia, and nausea

About BEXSERO (Meningococcal Group B Vaccine)

GSK’s MenB vaccine has received regulatory approval in over 55 countries, including the US, and is used in 18 national immunization programs worldwide for the prevention of IMD caused by Neisseria meningitidis serogroup B. More than 110 million doses have been distributed worldwide since 2015.¹² Clinical data supported its effectiveness in helping to protect adolescents and young adults against diverse disease-causing strains of MenB, with a well-characterized safety profile. In the US, BEXSERO is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years. The US Prescribing Information is available here.¹³

Important Safety Information for BEXSERO in the US

The following is based on the US Prescribing Information for BEXSERO. Please consult the full Prescribing Information for additional safety information.

• Do not administer BEXSERO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of BEXSERO or after a previous dose of BEXSERO
• The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions
• Syncope (fainting) can occur in association with administration of BEXSERO
• BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains
• Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO
• Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroup B even after being vaccinated with BEXSERO
• The most commonly reported solicited adverse reactions: pain at the injection site, fatigue, headache, nausea, erythema, myalgia, and swelling

About MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM₁₉₇ Conjugate Vaccine)

GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, including the US, with more than 80 million doses distributed worldwide since 2010.¹⁴ It offers evidence of immunogenicity with a well-characterized safety profile. In the US, MENVEO is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections. The US Prescribing Information is available here.¹⁵

Important Safety Information for MENVEO in the US

The following is based on the US Prescribing Information for MENVEO. Please consult the full Prescribing Information for additional safety information.

• Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine
• Syncope (fainting) has occurred in association with administration of MENVEO
• Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO
• Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroups A, C, Y, and W, even after being vaccinated with MENVEO
• Guillain-Barré syndrome has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine
• Apnea following intramuscular vaccination has been observed in some infants born prematurely
• Common solicited adverse reactions: at 2 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age - injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Among adolescents and adults aged 11 through 55 years were pain at the injection site, headache, myalgia, malaise, and nausea - similar rates were observed following a booster dose
• In two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation
• Vaccination with MENVEO may not result in protection in all vaccine recipients

About GSK

GSK is a global biopharma Company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024.

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References:

1. Centers for Disease Control and Prevention. About Meningococcal Vaccines. Available at: https://www.cdc.gov/vaccines/vpd/mening/hcp/about-vaccine.html. Accessed April 2025.
2. GSK. Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. Available at: https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/. Accessed April 2025.
3. Cheng WY, et al. Determinants of Meningococcal ACWY vaccination in adolescents in the US: completion and compliance with the CDC recommendations. Hum Vaccin Immunother. 2020;16(1):176-188.
4. Centers for Disease Control and Prevention. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2023. Available at: https://www.cdc.gov/mmwr/volumes/73/wr/mm7333a1.htm#:~:text=Among%20adolescents%20aged%2013%E2%80%9317%20years%20included%20in%20the%202023,view%2Fcdc%2F159388. Accessed April 2025.
5. GSK Data on File Calculation of GSK share in US MenB market January – December 2024. REF-269547. Based on information licensed from IQVIA: IQVIA, DDD, Meningococcal B market all channels, period January – December 2024, reflecting estimates of real-world activity. All rights reserved.
6. Centers for Disease Control and Prevention. Meningococcal Vaccine Recommendations. Available at: https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html. Accessed April 2025.
7. Thompson MJ, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403.
8. Marshall GS, et al. Understanding the Sequelae of Invasive Meningococcal Disease in the United States. Infect Dis Ther. 2024;13(11):2213-2220.
9. European Centers for Disease Control and Prevention. Outbreak of invasive meningococcal disease in the EU associated with a mass gathering event, the 23rd World Scout Jamboree, in Japan. 21 August 2015. Available at: https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/Meningococcal-disease-scouts-EU-August-2015.pdf. Accessed April 2025.
10. Centers for Disease Control and Prevention. Risk Factors for Meningococcal Disease. Available at: https://www.cdc.gov/meningococcal/risk-factors/index.html. Accessed April 2025.
11. GSK. US Prescribing Information for Penmenvy. Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF. Accessed April 2025.
12. GSK Data on File. Number of Bexsero doses shipped from 2015 to November 2023 REF-219766
13. GSK. US Prescribing Information for Bexsero. Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF. Accessed April 2025.
14. GSK Data on File. Menveo Doses Shipped from 2010 to end of 2022 REF-195452.
15. GSK. Prescribing Information for Menveo. Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF. Accessed April 2025.

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FAQ

When will GSK's PENMENVY vaccine be available in the US market?

PENMENVY will be available for use in the US market from Summer 2025.

What age group is GSK's PENMENVY vaccine approved for?

PENMENVY is approved for individuals aged 10 through 25 years.

What is GSK's current market share in the US MenB vaccine market?

GSK manufactures three out of four (75%) MenB doses currently administered in the US.

What is the current vaccination rate for MenB among US teenagers?

Less than 13% of 17-year-olds received the recommended two-dose vaccination series, while around 32% received at least one dose.

How does PENMENVY differ from existing meningococcal vaccines?

PENMENVY combines protection against five serogroups (A, B, C, W, Y) in a single vaccine, reducing the number of required injections compared to separate MenACWY and MenB vaccines.