Penmenvy

Penmenvy is a vaccine that helps prevent serious diseases caused by Neisseria meningitidis serogroups A, B, C, W, and Y in children and young adults aged 10 to 25 years.

Penmenvy combines two established meningococcal vaccines made by GSK (Bexsero [MenB vaccine] and Menveo [MenACWY vaccine]) into one vaccine. This provides broad protection against the most common causes of severe meningococcal disease while reducing the number of injections needed.

Penmenvy was approved by the FDA on February 14, 2025.

Clinical trials show that Penmenvy protected against 95% of the meningitis B strains currently found in the US and created immunity against all five major types of meningococcal bacteria (A, B, C, W, and Y) that can cause meningitis and bloodstream infections.

The vaccine was well tolerated with no significant safety issues and was as effective as receiving two separate vaccines (Bexsero and Menveo).

Penmenvy works with your immune system to protect against meningococcal disease (a form of meningitis) in two main ways.

For serogroups A, C, W, and Y:

• The vaccine includes parts of the outer sugar coating from these bacteria.
• Your body sees these parts as foreign and produces protective antibodies against them.
• These antibodies can recognize and help destroy the actual bacteria if you are exposed.

For serogroup B:

• The vaccine contains specific proteins found on the surface of serogroup B bacteria.
• Your body produces antibodies that target these specific proteins.
• These antibodies help your immune system identify and eliminate serogroup B bacteria.

Penmenvy is given as an injection into the muscle (intramuscular, IM) by a healthcare provider.

• 1 dose is injected into the muscle, usually in the deltoid muscle of your upper arm.
• You will need 2 doses in total, with 6 months between each dose.
• It is important that you complete both doses for full protection.

Do not receive Penmenvy if you have had a severe allergic reaction (such as anaphylaxis) to a previous dose of this vaccine, are allergic to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine.

Before you are vaccinated with Penmenvy, tell your healthcare provider if:

• You have any allergies
• You have received any other vaccines recently
• Your immune system function is reduced in any way or you take immunosuppressive medications
• You have a complement deficiency
• You have had Guillain-Barré Syndrome (GBS)
• You take blood thinner medications as this may increase the risk of bleeding from the injection site
• You are pregnant or intending to become pregnant
• You are breastfeeding or intending to breastfeed.

If you are prone to fainting during or soon after vaccine administration, ask your healthcare provider if you can lie down while being administered the vaccine.

Pregnancy

It is unknown if Penmenvy affects an unborn baby. Talk to your healthcare provider before receiving the vaccine if you are pregnant.

Breastfeeding

It is not known if Penmenvy passes into breastmilk.

The most common side effects of Penmenvy are:

• pain at the injection site
• fatigue/tiredness
• headache
• muscle aches and pains
• nausea
• redness and swelling at the injection site.

Fainting has also happened after getting the Penmenvy vaccine.

Serious side effects and warnings

People with weakened immune systems, including those on immunosuppressive therapy, may not respond as well to Penmenvy.

Penmenvy can cause an allergic reaction. Contact your healthcare provider immediately if you notice any of these symptoms during or shortly after vaccination:

• Itching, hives, flushing or swelling of the face
• Breathing issues (shortness of breath, wheezing, cough)
• Confusion, disorientation, dizziness, lightheadedness, weakness, or a fast heart rate
• Nausea, vomiting, stomach cramps, or diarrhea.

Complement Deficiency. Individuals with certain complement deficiencies and those taking specific medications that stop terminal complement activation are at a higher risk for serious disease caused by N. meningitidis, including diseases from serogroups A, B, C, W, and Y, even if they develop antibodies after getting Penmenvy.

Guillain-Barré Syndrome (GBS) has been reported rarely after receiving other meningococcal vaccines. People who have had GBS before should consult their healthcare provider before getting Penmenvy.

In clinical trials of Penmenvy with 3718 participants, there were 2 serious side effects related to the vaccine:

• 1 adolescent developed a connective tissue disorder 44 days after their second dose of Penmenvy
• 1 adult had seizures 9 hours after their first dose of Penmenvy.

Getting vaccinated with Penmenvy may not protect everyone who gets it and may not protect against all meningococcal serogroup B strains.

These are not all the side effects of Penmenvy. Report any suspected side effects to your healthcare provider, GlaxoSmithKline at 1-888-825-5249, or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (or online at www.vaers.hhs.gov).

• Initial Penmenvy dose: 1 dose of 0.5 mL
• 6 months later: 1 dose of 0.5 mL.

Full Name: Meningococcal Groups A, B, C, W, and Y Vaccine.

Administration: Sterile injectable suspension for intramuscular use.

Packaging: Comes as a Lyophilized MenACWY Component vial + prefilled syringe of MenB Component.

Components

Lyophilized MenACWY Component

• Contains N. meningitidis serogroups A, C, W, and Y oligosaccharides.
• Each oligosaccharide is conjugated to Corynebacterium diphtheriae CRM197 protein.
• Appears as a white to off-white lyophilized cake.

MenB Component

• Contains recombinant N. meningitidis proteins: Neisseria adhesin A (NadA) Neisserial Heparin Binding Antigen (NHBA) Factor H binding protein (fHbp) Outer Membrane Vesicles (OMV).
• Appears as a white opalescent suspension.

Production Methods

• MenACWY polysaccharides produced by bacterial fermentation.
• CRM197 protein carrier produced by bacterial fermentation and purification.
• Recombinant proteins individually produced in E. coli.
• OMV component produced by fermentation of N. meningitidis strain NZ98/254.

Final Reconstituted Dose (0.5-mL) Contains

• 10 mcg MenA oligosaccharide
• 5 mcg each of MenC, MenW, and MenY oligosaccharides
• 25.4 to 65.8 mcg CRM197 protein
• 50 mcg each of recombinant proteins (NadA, NHBA, fHbp)
• 25 mcg of OMV
• 1.5 mg aluminum hydroxide (0.5 mg of Al³⁺)
• 3.125 mg sodium chloride
• 0.776 mg histidine
• 22.5 mg sucrose
• ≤0.7 mg potassium phosphate salts
• <0.01 mcg kanamycin
• ≤0.30 mcg residual formaldehyde.

Additional Information

• Appears as a white opalescent suspension after reconstitution.
• Does not contain preservatives.
• Does not contain natural rubber latex in any components.

Penmanvy is manufactured by GlaxoSmithKline (GSK), a global pharmaceutical company headquartered in Brentford, London, UK, with significant operations in Philadelphia, PA and Research Triangle Park, NC. Other notable drugs from GSK include:

• Respiratory products such as Advair/Seretide and Ventolin
• Vaccines such as Shingrix, Engerix-B, and Twinrix
• HIV treatments, such as Tivicay and Triumeq
• Other products such as Augmentin, Paxil, Wellbutrin, Zofran, and Lamictal.