Penbraya
Generic name: Meningococcal Groups A, B, C, W, and Y Vaccine
Dosage form: suspension for intramuscular injection
Drug class: Bacterial vaccines
What is Penbraya?
Penbraya vaccine is used to prevent invasive meningococcal disease (IMD) caused by the most common 5 groups (serotypes) of the Neisseria meningitidis bacteria, which affect adolescents and young adults 10 through 25 years of age. Penbraya helps protect against meningococcal disease as it increases your immunity by creating antibodies that can target and eliminate five different types of Neisseria meningitidis bacteria. Penbraya is the first pentavalent vaccine that protects against the meningococcal groups A, B, C, W, and Y. When Penbraya was in development by Pfizer, it was called the MenABCWY Vaccine.
Penbraya combines the components of the meningococcal vaccine Trumenba® which protects against meningococcal group B, and the meningococcal vaccine Nimenrix® which protects against the 4 meningococcal groups A, C, W-135, and Y. By combining 5 of the most common groups of serogroups into one vaccine may improve meningococcal coverage increase protection among adolescents and young adults.
Penbraya received FDA approval to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y, for use in individuals 10 through 25 years of age. FDA approval was based on positive results from The Phase 3 trial (NCT04440163), which showed it worked similarly (non-inferior) to currently licensed meningococcal vaccines.
What is meningococcal disease?
Meningococcal disease is any illness caused by bacteria called Neisseria meningitidis. These illnesses are rare but are often severe, and can be deadly. The bacterial infection can affect the lining of the brain and spinal cord (meningitis), bloodstream (meningococcal septicemia or meningococcemia), or less commonly can affect the lungs (meningococcal pneumonia). The best protection against meningococcal disease is by vaccination.
There are 6 types (serogroups) of Neisseria meningitidis bacteria that cause most of the disease worldwide, including A, B, C, W, X, and Y. In the United States, the serogroups B, C, and Y cause the most illness.
Penbraya can help prevent invasive meningococcal disease (IMD), but will not treat an active infection.
Penbraya side effects
Common Penbraya side effects after having Dose 1 and Dose 2, respectively were pain at the injection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection site redness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%).
Warning
- You should have a Penbraya vaccination if you have a history of a severe allergic reaction to any component of Penbraya.
- Fainting may happen after getting injectable vaccines, take precautions to avoid falling and injury due to fainting.
- You may have reduced immune responses to Penbraya if you have a weakened immune system (immunocompromised).
- Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination with Penbraya.
- Penbraya may not protect everyone who receives the vaccine against N. meningitidis group A, B, C, W, and Y infections.
- Vaccination with Penbraya does not substitute for vaccination with a tetanus toxoid–containing vaccine to prevent tetanus.
- Guillain-Barré syndrome (GBS) has been reported following administration of other meningococcal vaccines. Ask your healthcare provider about the risks and benefits of this vaccination if you have a history of GBS.
Before taking this medicine
Pregnancy
Tell your healthcare provider if you are pregnant or plan to become pregnant. Ask your healthcare provider about the risks and benefits of Penbraya. Only a healthcare provider can decide if this vaccination is right for you or your child.
There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to Penbraya during pregnancy. Individuals who received this vaccination during pregnancy are encouraged to contact or have their healthcare provider contact, 1-877-390-2953 to enroll in or obtain information about the registry.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as there is no data available to assess the effects of Penbraya on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this vaccination and any potential adverse effects on the breastfed child from Penbraya or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
How is Penbraya given?
Penbraya is given a two-dose series given six months apart.
Penbraya is given as an injection into the muscle, usually the deltoid muscle of the arm, by a healthcare provider.
Penbraya is approved for use in individuals 10 through 25 years of age.
Related/similar drugs
ciprofloxacin, ceftriaxone, Rocephin, rifampin, meningococcal polysaccharide vaccine
Storage
Storage Before Reconstitution
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton.
- During storage, a white deposit and clear supernatant may be observed in the prefilled syringe containing the MenB Component. Store the carton horizontally to minimize the time necessary to resuspend the MenB Component.
- Do not freeze.
- Discard if the carton has been frozen.
Storage After Reconstitution
- After reconstitution, administer immediately or store between 2°C and 30°C (36°F and 86°F) and use within 4 hours.
- Do not freeze.
Ingredients
Active ingredient: N. meningitidis serogroup A, C, W, and Y polysaccharide (5 mcg each; 20 mcg total) conjugated to tetanus toxoid (44 mcg tetanus toxoid). 2 recombinant lipidated factor H binding protein variants from N. meningitidis serogroup B (60 mcg each; total of 120 mcg protein).
Inactive ingredients: L-histidine (0.78 mg) , trometamol (0.097 mg), sucrose (28 mg), aluminum phosphate (0.25 mg aluminum), sodium chloride (4.65 mg), and PS80 80 (0.018 mg) at pH 6.0.
Company
Manufacturer by: Pfizer Ireland Pharmaceuticals, Ringaskiddy, Cork, Ireland.
Distributed by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001.
References
- CDC Centers for Disease Control and Prevention Meningococcal Disease.
- CDC: Meningococcal Disease: Types of Meningococcal Vaccines
- CDC Centers for Disease Control: Meningococcal Vaccination: What Everyone Should Know
- Food and Drug Administration (FDA) Penbraya Product Label
- National Foundation for Infectious Diseases: Meningococcal Disease
More about Penbraya (meningococcal group acwy conjugate-group b vaccine (cvx 316))
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- During pregnancy
- FDA approval history
- Drug class: bacterial vaccines
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.