HQ Team
October 21, 2023: The USFDA has approved Pfizer Inc.’s vaccine to treat deadly meningococcal disease in young adults between 10 years and 25 years.
Penbraya is the first and only pentavalent (valency of five) vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults, according to a Pfizer statement.
“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,” said Annaliesa Anderson, PhD, Senior Vice President and Head, Vaccine Research and Development, at Pfizer.
The FDA’s decision was based on the “positive results” from the Phase 2 and Phase 3 trials.
Meningitis
The last-stage trial, which evaluated more than 2,400 patients from the US and Europe, concentrated on the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate.
It was compared to currently US-licensed meningococcal vaccines, with the goal of determining immunologic noninferiority.
Meningococcal disease refers to any illness caused by bacteria called Neisseria meningitidis. These illnesses are often severe, can be deadly, and include infections of the lining of the brain and spinal cord (meningitis) and bloodstream, according to the Centers for Disease Control and Prevention (CDC).
It is an uncommon disease, but when it is severe it can lead to death within 24 hours, and for survivors, can result in life-altering, significant long-term disabilities.
Pfizer’s vaccine reduces the total number of doses needed for individuals to be fully vaccinated against the five most common serogroups, thereby streamlining the standard of care and potentially increasing the number of adolescents and young adults vaccinated, according to the statement.
Single vaccine
According to the CDC, combining vaccines into fewer shots can result in more adolescents and young adults getting their recommended vaccines on time, resulting in fewer delays in protection against serious diseases.
“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, New York.
“For the first time, we have a single vaccine that helps protect against the five most common serogroups and has the potential to improve coverage and increase protection among adolescents and young adults.”
Penbraya is administered as a two-dose series given six months apart.
The CDC Advisory Committee on Immunization Practices will meet on October 25, 2023, to discuss recommendations for the appropriate use of Penbraya in adolescents and young adults.
