School Vaccine Mandates

FDA Approves GSK's Pentavalent Meningococcal Vaccine

February 17, 2025

2 min read

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on . Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.Com.

Back to Healio

Key takeaways:

Penmenvy protects against meningococcal serotypes A, B, C, W and Y.

CDC vaccine advisors are set to discuss recommendations for the vaccine on Feb. 26.

The FDA approved GSK's pentavalent meningococcal vaccine to protect children and young adults aged 10 to 25 years against five meningococcal serogroups, the company announced.

The vaccine, branded as Penmenvy, combines components from two of GSK's existing vaccines: Bexsero, which protects against serogroup B; and Menveo, which protects against serogroup A, C, W and Y.

The FDA approved GSK's meningococcal vaccine for children and young adults aged 10 to 25 years, according to a press release. Image: Adobe Stock.

"We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for invasive meningococcal disease caused by serogroup B," Tony Wood, PhD, BSc, GSK's chief scientific officer, said in a press release.

According to the release, serogroup B is the leading cause of invasive meningococcal disease among adolescents and young adults, but only 32% of this population receive their first dose and less than 13% receive both recommended doses.

The approval was based, in part, on data from two phase 3 trials of more than 4,800 participants, which demonstrated a "clinically meaningful immune response" in participants who received two doses 6 months apart, according to a company report.

Adverse events associated with Penmenvy included pain at the injection site, fatigue, headache, myalgia, nausea, erythema and swelling, the company reported.

GSK's vaccine is the second pentavalent vaccine to enter the market. Penmenvy and Pfizer's Penbraya both protect against the five most common serogroups that affect young people.

The CDC's Advisory Committee on Immunization Practices (ACIP) recommended Penbraya for visits where patients are due to get both a Men B and MenACWY vaccine. The committee also unanimously voted to add the vaccine to the Vaccines for Children program, which offers free vaccines to children whose families are unable to pay for them.

The ACIP is scheduled to discuss recommendations for Penmenvy at its Feb. 26 meeting.

References:

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on . Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.Com.

Back to Healio

GSK Gets Ready For Its Next Big Vaccine Launch

News

GSK

Vaccines production line at GSK facility in Wavre, Belgium

GSK has garnered FDA approval for its pentavalent meningococcal vaccine Penmenvy, tipped as one of its major launches for 2025 and a rival to Pfizer's first-to-market Penbraya.

The shot protects against common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y), covering five of the six serogroups that cause most disease worldwide, with the B, C, and Y strains responsible for most cases of invasive meningococcal disease (IMD) encountered in the US.

According to the company, it reduces the number of injections needed and will help "improve vaccination rates and…protect more US adolescents and young adults" from the potentially devastating disease.

Penmenvy is a combination of GSK's already-approved vaccines Bexsero and Menveo, which together brought in more than £1.4 billion (around $1.8 billion) in sales last year with double-digit growth across all regions of the world and Bexsero topping the £1 billion sales threshold for the first time.

Pfizer's Penbraya also combines elements from its older meningococcal vaccines Trumenba (MenACWY) and Nimenrix (MenB), which have trailed behind GSK shots commercially since launch.

The five-in-one vaccine was approved in 2023 but hasn't made a major impact in the market yet, with sales not yet reaching a level to warrant being broken out in Pfizer's financial results, while Trumenba and Nirmenrix collectively contributed $300 million in 2023 but have been in decline.

FDA approval of Penmenvy comes on the back of phase 3 trials, which showed that two doses of the jab given six months apart were at least as effective at stimulating immunity against the target strains as GSK's current vaccines given separately.

While meningococcal vaccine recommendations for all five serogroups have been in place since 2015 in the US, annual immunisation rates for IMD have remained low overall. GSK said that less than 13% of adolescents currently receive the recommended two-dose vaccination series, while around 32% receive at least one dose.

GSK's chief scientific officer Tony Wood said Penmenvy can, in particular, play a role in reducing IMD caused by serogroup B, adding: "We aim to help protect more teens and young adults at a life stage when they are at an increased risk," he noted.

The company has previously said that the vaccine is one of its most important product launches for 2025, with the potential to make $1 billion to $2 billion in sales at its peak.

With FDA approval in hand, all eyes now are on the recommendations on Penmenvy's use from the CDC's Advisory Committee on Immunisation Practices (ACIP), which will determine how it may be used in clinical practice at a meeting scheduled for 26th February.

The MenABCWY shot's importance to GSK's vaccine business has increased since the ACIP changed its stance on respiratory syncytial virus (RSV) jabs – where GSK also competes head-to-head with Pfizer – narrowing its recommendations for both their products.

GSK's 5-in-1 Meningococcal Shot Wins FDA Approval

The Food and Drug Administration on Friday gave a green light to a new meningococcal vaccine from GSK. Dubbed Penmenvy, the "5-in-1" shot is approved for people aged 10 through 25 years old and targets the five most common types of bacteria that cause invasive meningococcal disease, which can lead to life-threatening complications.

Penmenvy combines components of GSK's existing shots Bexsero and Menveo. By simplifying immunization, it could help boost vaccination rates, which have remained low due to a complex vaccine schedule.

"Any new opportunity to increase access to what is just so critical to individual and public health, is a good thing," said Julie Howard, a clinical advisor at the pharmaceutical consulting firm MMIT.

Invasive meningococcal disease is a serious illness involving infection of the spinal cord and brain, which can lead to swelling. Even with treatment, bacterial meningitis can be fatal; about 1 in 6 people who contract invasive meningococcal disease die. The disease can affect people of all ages.

The bacterium called neisseria meningitidis is the leading cause of meningococcal disease. The five strains circulating in the U.S. Are known by their serogroup: A, B, C, W, and Y.

The CDC recommends children aged 11 or 12 receive a "MenACWY" vaccine, followed by a booster dose at age 16. The agency also urges people discuss MenB vaccination with their physician, but recommends vaccination for anyone ages 10 years or older who are at an increased risk of the disease.

In 2023, drugmaker Pfizer received an FDA OK for a shot dubbed Penbraya, which, like Penmenvy, covers five serotypes. However, the CDC says full coverage against MenB must include a dose of Pfizer's other vaccine Trumenba in children aged 16 and older.

The two companies already compete against each other in other markets. Both gained approval in 2023 for RSV vaccines in older adults. GSK has kept majority market share since then, although Pfizer has recently made some headway. But sales of RSV vaccines broadly have dropped after the CDC narrowed its recommendation guidelines.

A key panel advising the CDC on vaccines is set to meet later this month and is scheduled to discuss GSK's shot as well as potential updates to dosing and schedules.

Vaccine schedules — and any changes to them — will be under the microscope now that Robert F. Kennedy Jr., a prominent vaccine critic, is confirmed as head of the Department of Health and Human Services.

Kennedy has for decades promoted vaccine misinformation, claiming they cause more harm than good, and lead to autism in children. He also founded and previously chaired an anti-vaccine group called Children's Health Defense. At the pandemic's height, Kennedy pressed for the FDA to revoke authorization of COVID-19 vaccines.

While he's said he won't take away anyone's vaccines, he will hold substantial influence over their regulation as HHS secretary. For example, he could change the federal Vaccines for Children program, which covers vaccines for children whose families cannot afford them. Vaccines protecting against meningococcal disease, measles and human papillomavirus, among others, are covered by the program. Kennedy has previously criticized meningococcal vaccine requirements.

Correction: A prior version of this story included a line that incorrectly described the dosing regimen required to complete Meningococcal B vaccination.

---