Brian Owens

October 23, 2023

The US Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults.

The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.

This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.

"Today marks an important step forward in the prevention of meningococcal disease in the US," Annaliesa Anderson, PhD, head of vaccine research and development at Pfizer, said in a news release. "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."

One Shot, Five Common Types

Meningococcal disease is rare, but serious. The illness produced by bacteria called Neisseria meningitidis can cause death within 24 hours and can result in significant long-term disabilities in survivors.

"Incomplete protection against invasive meningococcal disease," is common, added Jana Shaw, MD, MPH, a pediatric infectious diseases specialist from Upstate Golisano Children's Hospital in Syracuse, New York. Reducing the number of shots is important because streamlining the vaccination process should help increase the number of young people who get fully vaccinated against meningococcal disease.

Rates are low in the United States, according to the US Centers for Disease Control and Prevention and; in 2021, there were around 210 cases reported. But a statewide outbreak has been going on in Virginia since June 2022, with 29 confirmed cases and 6 deaths.

The FDA's decision is based on the positive results from 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 with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2400 patients from the US and Europe.

The CDC Advisory Committee on Immunization Practices (ACIP) is meeting on Wednesday to discuss recommendations for the appropriate use of Penbraya in young people.