REG - GSK PLC - GSK 5-in-1 meningitis vaccine recommended in US

GSKAnnouncement

17/04/2025 07:05

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RNS Number : 3687F  GSK PLC  17 April 2025

 

 

Issued: 16 April 2025, London UK

 

GSK's 5-in-1 meningococcal vaccine Penmenvy receives positive recommendation
from US Advisory Committee on Immunization Practices

 

·      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

 

 

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 immunisation 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 CRM(197) Conjugate Vaccine). On 14 February 2025, the US Food and
Drug Administration (FDA) approved
(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/)
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 immunisation 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
six of those who contract it in as little as 24 hours from onset, despite
treatment.(7,8) IMD is easily misdiagnosed, with early symptoms often mistaken
for the flu.(8,9) Approximately one in five survivors may experience long-term
consequences such as brain damage, amputations, hearing loss, and nervous
system problems.(7,9) 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 behaviours 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.(10,11)

 

About Penmenvy

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). It is indicated in the US 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 US
Prescribing Information is available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF)
.(12)

 

About Bexsero

GSK's MenB vaccine has received regulatory approval in over 55 countries,
including the US, and is used in 18 national immunisation programmes worldwide
for the prevention of IMD caused by Neisseria meningitidis serogroup B. More
than 110 million doses have been distributed worldwide since 2015.(13) It is
supported by clinical data supporting its effectiveness in helping to protect
adolescents and young adults against diverse disease-causing strains of MenB,
with a well-characterised safety profile. In the US, this vaccine has received
regulatory approval for active immunisation to prevent invasive disease caused
by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years.
The US Prescribing Information is available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF)
.
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF)
(14)

 

About Menveo

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.(15) It offers evidence of immunogenicity with a well-characterised
safety profile. In the US, this vaccine has received regulatory approval for
active immunisation to prevent IMD caused by Neisseria meningitidis serogroups
A, C, Y, and W in individuals from 2 months through 55 years of age. The US
Prescribing Information is available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)
.
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)
(16)

 

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.

 

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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
(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/
(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
(https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html) .
Accessed April 2025.

7.     World Health Organisation. Meningitis fact sheet. Available at:
https://www.who.int/news-room/fact-sheets/detail/meningitis
(https://www.who.int/news-room/fact-sheets/detail/meningitis) . Accessed April
2025.

8.     Thompson MJ, et al. Clinical recognition of meningococcal disease
in children and adolescents. Lancet. 2006;367(9508):397-403.

9.     Marshall GS, et al. Understanding the Sequelae of Invasive
Meningococcal Disease in the United States. Infect Dis Ther.
2024;13(11):2213-2220.

10.    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
(https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/Meningococcal-disease-scouts-EU-August-2015.pdf)
. Accessed April 2025.

11.    Centers for Disease Control and Prevention. Risk Factors for
Meningococcal Disease. Available at:
https://www.cdc.gov/meningococcal/risk-factors/index.html
(https://www.cdc.gov/meningococcal/risk-factors/index.html) . Accessed April
2025.

12.    GSK. US Prescribing Information for Penmenvy. Available at:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF)
. Accessed April 2025.

13.    GSK Data on File. Number of Bexsero doses shipped from 2015 to
November 2023 REF-219766

14.    GSK. US Prescribing Information for Bexsero. Available at:
gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF)
.
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF)
Accessed April 2025.

15.    GSK Data on File. Menveo Doses Shipped from 2010 to end of 2022
REF-195452

16.    GSK. Prescribing Information for Menveo. Available at:
gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)
.
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)
Accessed April 2025.

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