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On December 28, Pfizer announced that its Biologics License Application (BLA) for its pentavalent meningococcal vaccine candidate (MenABCWY) has been accepted by the US FDA for the prevention of meningococcal disease
, the most common serogroup in people aged 10 to 25 years.
FDA expects to make a decision
in October 2023.
The pentavalent meningococcal vaccine candidate (MenABCWY) is a combination of Pfizer's two marketed vaccines, Trumenba (meningococcal type B vaccine) and Nimenrix (meningococcal A, C, W-135 and Y conjugated vaccines), which cover five common aggressive meningococcal serogroups (meningococcus A, B, C, W, Y).
Therefore, if approved, it would be the first single vaccine
to cover all common meningococcal serogroups.
Annaliesa, senior vice president and chief scientific officer of Pfizer vaccine research and development
"The FDA's acceptance of our pentavalent meningococcal vaccine candidate is an important step
in helping individuals and communities prevent the most common types of meningococcal disease," Anderson said.
We believe that if our MenABCWY vaccine is approved and recommended, it can help streamline the meningococcal vaccination schedule for adolescents and young adults, thereby increasing vaccination rates and providing a meningococcal vaccine
with the broadest seropopulation coverage.
The pentavalent vaccine candidate is well tolerated in clinical trials and its safety profile is consistent with
currently licensed meningococcal vaccines.
”
with the broadest seropopulation coverage.
In September 2022, Pfizer announced that a pivotal Phase III clinical trial of its MenABCWY vaccine met the primary endpoint
.
This is a randomized, active-controlled, observer-blind, single-blind phase III clinical trial to evaluate the safety, tolerability, and immunogenicity
of MenABCWY in healthy individuals aged 10 to 25 years.
In this trial, participants were randomly assigned to receive 2 doses of MenABCWY vaccine; The control group received a licensed vaccine (2 doses of MenB vaccine Trumenba + 1 dose of MenACWY vaccine Menveo).
.
MenABCWY vaccine phase III results showed that the trial met all primary and secondary endpoints
.
For the five meningococcal serogroups (meningococcus A, B, C, W, Y) that cause most invasive meningococcal diseases, the 2 doses of MenABCWY vaccine showed non-inferiority in immunogenicity compared with licensed vaccines (2 doses of Trumenba + 1 dose of Menveo
).
On meningococcal disease
On meningococcal diseaseMeningococcal disease is a rare but serious disease that usually presents with cold-like symptoms in its early stages, which can lead to death within 24 hours and can lead to severe long-term disability
.
Together, the five serogroups (A, B, C, W, Y) account for 96% of all invasive meningococcal disease cases worldwide, with B serogroup being the deadliest strain, and B serogroup is responsible for most conditions in adolescents and young adults in the United States and Europe
.
Information Reference:
Information Reference:
