This afternoon, the FDA approved the Pfizer meningococcal vaccine, Penbraya (groups A, B, C, W and Y vaccine). The vaccine is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. Penbraya is approved for use in individuals 10 through 25 years of age.1
“Today marks an important step forward in the prevention of meningococcal disease in the US. In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, PhD, senior vice president and head, Vaccine Research and Development, Pfizer, said in a statement.
Penbraya combines the components from two meningococcal vaccines, Trumenba(meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the 5 most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally.2
According to the Centers for Disease Control and Prevention (CDC), meningococcal bacteria, Neisseria meningitidis, is transmitted by sharing respiratory and throat secretions. About 1 in 10 people are considered carriers.3 The disease is very rare with the CDC reporting there was only about 210 cases in the United States in 2021.
What You Should Know
The FDA has approved the Pfizer meningococcal vaccine, Penbraya, which is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y.
Meningococcal disease, caused by Neisseria meningitidis, is relatively rare. The Centers for Disease Control and Prevention (CDC) reports that there were only about 210 cases in the United States in 2021.
The FDA's decision to approve Penbraya is based on positive results from phase 2 and phase 3 trials, including a phase 3 trial that evaluated the vaccine's safety, tolerability, and immunogenicity.
The FDA’s decision is based on the positive results from the phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently US licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The phase 3 trial evaluated more than 2400 patients from the US and Europe.
What the Data Showed
Back in September 2022, the company reported phase 3 trial data. The pivotal study assessed the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine, which was previously known as MenABCWY in healthy individuals 10 through 25 years of age. Participants in the trial were randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba + one dose of Menveo). Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba and one dose of Menveo.
Additionally, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo. And, in individuals who had not previously received a meningococcal vaccine, the proportion of subjects with ≥4-fold increases in immune responses was observed to be higher following either one or two doses of MenABCWY for serogroups A, C, W and Y compared to one dose of Menveo.
Finally, the proportion of subjects with ≥4-fold increases in immune responses was also observed to be higher against all four serogroup B strains following two doses of MenABCWY compared to two doses of Trumenba. The pentavalent vaccine candidate was well-tolerated, with a safety profile consistent with licensed vaccines.
“We are very pleased with these positive phase 3 data, which are the first for a MenABCWY vaccine candidate,” Pfizer’s Anderson said at the time.
The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 25 to discuss recommendations for the appropriate use of Penbraya in adolescents and young adults.
1. FDA Approves PENBRAYA, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents.Businesswire press release. October 20, 2023. Accessed October 20, 2023.
2. Pardo de Santayana, C. et al. (2023) Epidemiology of invasive meningococcal disease worldwide from 2010-2019: A literature review, Epidemiology and infection. Accessed October 20, 2023.
3. Meningococcal Disease. Causes & How it Spreads. CDC. Accessed October 20, 2023.https://www.cdc.gov/meningococcal/about/causes-transmission.html#:~:text=Six%20serogroups%20(types)%20of%20Neisseria,and%20how%20to%20prevent%20it.