• PENBRAYA™ provides the broadest serogroup coverage (meningococcal groups A, B, C, W Y) of any meningococcal vaccine available in the U.S. has the potential to help simplify complex vaccination schedule in the U.S.

  • The FDA’s decision is based on data from Phase 2 Phase 3 trials, which demonstrated that PENBRAYA has robust immunogenicity non-inferi to Trumenba® + Menveo® f all serogroups was well-tolerated with a favable safety profile

  • The vaccine further advances Pfizer’s vaccine ptfolio builds on me than 20 years of expertise knowledge in the prevention of meningococcal disease

NEW YK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W Y vaccine), the first only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents young adults 10 through 25 years of age. PENBRAYA combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) Nimenrix® (meningococcal groups A, C, W-135, Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majity of invasive meningococcal disease (IMD) globally.1

“As a pioneer in vaccines, one of our goals is to deliver vaccines that evolve the paradigm help simplify the stard of care in the U.S.,” said Annaliesa erson, Ph.D., Seni Vice President Head, Vaccine Research Development, Pfizer. “Today marks an imptant step fward in the prevention of meningococcal disease in the U.S. In a single vaccine, PENBRAYA has the potential to protect me adolescents young adults from this severe unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours , f survivs, can result in life-altering, significant long-term disabilities.2 PENBRAYA reduces the total number of doses needed f individuals to be fully vaccinated against the five most common serogroups, thereby streamlining the stard of care potentially increasing the number of adolescents young adults vaccinated.3 Accding to the U.S. Centers f Disease Control Prevention (CDC), combining vaccines into fewer shots may mean that me adolescents young adults get their recommended vaccines on time, resulting in fewer delays in protection against serious diseases.4 Routine use of PENBRAYA could also reduce IMD cases associated mtality, the rate of long-term consequences of infection (sequelae) in survivs costs associated with controlling outbreaks.5

“Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups6,” said Jana Shaw, MD, Pediatrics Infectious Disease Specialist, Upstate Golisano Children's Hospital in Syracuse, NY. “F the first time, we have a single vaccine that helps protect against the five most common serogroups has the potential to improve coverage increase protection among adolescents young adults.”

The FDA’s decision is based on the positive results from the Phase 2 Phase 3 trials, including a romized, active-controlled observer-blinded Phase 3 trial assessing the safety, tolerability, immunogenicity of the pentavalent vaccine cidate compared to currently U.S. licensed meningococcal vaccines, with the goal of determining immunologic noninferiity. The Phase 3 trial (NCT04440163) uated me than 2,400 patients from the U.S. Europe.

The CDC Advisy Committee on Immunization Practices (ACIP) will meet on October 25, 2023, to discuss recommendations f the appropriate use of PENBRAYA in adolescents young adults.

About PENBRAYA Regulaty Review

In September 2022, Pfizer announced positive results from a romized, active-controlled observer-blinded Phase 3 trial assessing the safety, tolerability, immunogenicity of the PENBRAYA compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiity. The Phase 3 trial (NCT04440163) uated me than 2,400 patients from the U.S. Europe. This trial was followed by the FDA’s acceptance of PENBRAYA’s Biologics License Application (BLA) in December 2022.

Indication f PENBRAYA

PENBRAYA is indicated f active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, Y. PENBRAYA is approved f use in individuals 10 through 25 years of age.

PENBRAYA is administered as a two-dose series given six months apart.

Imptant Safety Infmation f PENBRAYA

  • PENBRAYA should not be given to anyone with a histy of a severe allergic reaction to any component of PENBRAYA

  • Fainting may happen after getting injectable vaccines, including PENBRAYA. Precautions should be taken to avoid falling injury due to fainting

  • Some individuals with weakened immune system may have reduced immune responses to PENBRAYA

  • Individuals with certain complement deficiencies individuals receiving treatment that inhibits terminal complement activation are at increased risk f invasive disease caused by N. meningitidis groups A, B, C, W, Y, even if they develop antibodies following vaccination with PENBRAYA

  • Vaccination with PENBRAYA may not protect all who receive the vaccine against N. meningitidis group A, B, C, W, Y infections

  • Vaccination with PENBRAYA does not substitute f vaccination with a tetanus toxoid–containing vaccine to prevent tetanus

  • Guillain-Barré syndrome (GBS) has been repted following administration of other meningococcal vaccines. Ask your healthcare provider about the risks benefits of PENBRAYA if you have a histy of GBS

  • The most common adverse reactions were pain at the injection site, fatigue, headache, injection site redness, muscle pain, injection site swelling, joint pain, chills.

  • Tell your healthcare provider if you are pregnant plan to become pregnant

  • Ask your healthcare provider about the risks benefits of PENBRAYA. Only a healthcare provider can decide if PENBRAYA is right f you your child

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U.S. Indication f TRUMENBA® (meningococcal group B vaccine)

TRUMENBA® (meningococcal group B vaccine) is indicated f active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. Approval of TRUMENBA® is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prent strains in the United States. The effectiveness of TRUMENBA® against diverse serogroup B strains has not been confirmed.

Imptant Safety Infmation

  • TRUMENBA® should not be given to anyone with a histy of a severe allergic reaction after a previous dose of TRUMENBA®.

  • Individuals with weakened immune systems may have a reduced immune response.

  • The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, chills.

  • Data are not available on the safety effectiveness of using TRUMENBA®  other meningococcal group B vaccines interchangeably to complete the vaccination series.

  • Tell your healthcare provider if you are pregnant, plan to become pregnant.

  • Ask your healthcare provider about the risks benefits of TRUMENBA®. Only a healthcare provider can decide if TRUMENBA® is right f you your child.

Indication f Nimenrix® in the European Union

Nimenrix® is indicated f active immunization of individuals from the age of six weeks above against invasive meningococcal disease caused by Neisseria meningitidis group A, C, W-135, Y. Nimenrix® is not licensed in the U.S.

Imptant Safety Infmation

Nimenrix® (meningococcal group A, C, W-135, Y conjugate vaccine) should not be given to anyone with a histy of a severe allergic reaction after a previous dose of Nimenrix®.

Individuals with weakened immune systems may have a reduced immune response. The most common adverse reactions were loss of appetite, irritability, drowsiness, pain at the injection site, fatigue, redness at the injection site, swelling at injection site.

Tell your healthcare provider if you are pregnant, plan to become pregnant.

Ask your healthcare provider about the risks benefits of Nimenrix®. Only a healthcare provider can decide if Nimenrix® is right f you your child.