U.S. FDA Accepts for Review the BLA for MenABCWY

U.S. FDA Accepts for Review the BLA for MenABCWY

0 0
Read Time:5 Minute, 31 Second

U.S. FDA Accepts for Review the Biologics License Application (BLA) for Pfizer’s Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents 

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine candidate (MenABCWY). Pfizer submitted MenABCWY for the prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age. 

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the pentavalent meningococcal vaccine application is in October 2023. 

Pfizer’s MenABCWY vaccine candidate combines the components of two vaccines into one, helping protect against the meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally. In the U.S., approximately 55 million adolescents and young adults are in the age range for meningococcal vaccination (11-23 years old), according to ACIP recommendations.

“The FDA’s acceptance of our application for the pentavalent meningococcal vaccine candidate is an essential step toward helping protect individuals and communities against the most common types of meningococcal disease,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We believe our investigational MenABCWY vaccine, if approved and recommended, could help simplify the meningococcal vaccination schedule for adolescents and young adults, and in turn improve vaccination rates, and provide the broadest serogroup coverage of any meningococcal vaccine. The pentavalent vaccine candidate was well-tolerated in clinical trials, with a safety profile consistent with currently licensed meningococcal vaccines.” 

The regulatory submission is supported by previously announced positive results from a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe. 

Potential U.S. Public Health Impact of a MenABCWY Vaccine 

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities. Together, the five most common meningococcal serogroups account for 95 percent of all IMD cases worldwide, with serogroup B accounting for the majority of disease in adolescents and young adults in the U.S. and Europe.

In the U.S., the current meningococcal vaccination platform for adolescents and young adults includes a routine recommendation for MenACWY vaccines (two doses) and a separate, shared clinical decision recommendation for MenB-specific vaccines (two doses) in order to achieve the broadest serogroup protection available against meningococcal disease. However, less than a third of U.S. adolescents receive even one dose of a MenB vaccine, and fewer complete the series.4,5 If approved and recommended, Pfizer’s pentavalent vaccine candidate could be another option for the current routine recommendations in place for MenACWY vaccines. Pfizer’s pentavalent vaccine candidate could potentially reduce the total number of doses needed for individuals to be fully vaccinated against the five serogroups, thereby simplifying meningococcal vaccination and increasing the number of adolescents and young adults vaccinated. Routine use of a MenABCWY vaccine could reduce IMD cases and associated mortality, the rate of long-term sequelae in survivors, and costs associated with controlling outbreaks.

About the Pentavalent Meningococcal Vaccine Candidate (MenABCWY) 

Pfizer’s pentavalent meningococcal vaccine candidate combines the components from its two licensed meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine); approvals of Nimenrix® and Trumenba® vary by country. Together, the 5 serogroups included in MenABCWY are responsible for the majority of currently circulating meningococcal disease globally. Top line results from a randomized, active-controlled and observer-blinded Phase 3 trial of Pfizer’s pentavalent meningococcal vaccine candidate (NCT04440163) were previously announced in September 2022. Additional information about the trial and results can be found at www.clinicaltrials.gov. 

INDICATIONS FOR TRUMENBA® IN THE U.S. 

Trumenba® is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidis group B 

IMPORTANT SAFETY INFORMATION 

Trumenba® should not be given to anyone with a history of a severe allergic reaction to any component of Trumenba® 

Some individuals with weakened immune systems may have a reduced immune response 

Persons with certain complement deficiencies and persons receiving treatments such as Soliris® (eculizumab), are at increased risk for invasive disease caused by Neisseria meningitidis group B even with receipt of vaccination with Trumenba® 

Vaccination with Trumenba® may not protect all vaccine recipients against N meningitidis group B infections 

Fainting can occur in association with administration of injectable vaccines, including Trumenba® 

The most common adverse reactions in adolescents and young adults were pain at injection site, fatigue, headache, and muscle pain 

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

Tell your health care provider if you are pregnant, or plan to become pregnant 

Ask your health care provider about the risks and benefits of Trumenba®. Only a health care provider can decide if Trumenba® is right for you or your child 

INDICATION FOR NIMENRIX® IN THE E.U. 

Nimenrix® is a vaccine indicated for individuals six weeks of age and older for active immunization to prevent invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y 

IMPORTANT SAFETY INFORMATION 

Nimenrix® should not be given to anyone with a history of a severe allergic reaction after a previous dose of Nimenrix® 

Some individuals with weakened immune systems may have a reduced immune response 

Persons with certain complement deficiencies and persons receiving treatments such as Soliris® (eculizumab), are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W, and Y, even with receipt of vaccination with Nimenrix® 

As with any vaccine, vaccination with Nimenrix® may not protect all vaccine recipients against N. meningitidis groups A, C, W and Y 

Fainting can occur shortly before or after injecting vaccines, including Nimenrix® 

The most common adverse reactions were loss of appetite, irritability, drowsiness, headache, fatigue, fever, and pain, redness, and swelling at the injection site 

Tell your healthcare provider if you are pregnant, or plan to become pregnant
Ask your healthcare provider about the risks and benefits of Nimenrix®. Only a healthcare provider can decide if Nimenrix® is right for you or your child 

Menveo® and Nimenrix® are trademarks of GlaxoSmithKline Biologicals S.A. 

Soliris® is a trademark of Alexion Pharmaceuticals, Inc. 

Source: Pfizer

Happy
Happy
0 %
Sad
Sad
0 %
Excited
Excited
0 %
Sleepy
Sleepy
0 %
Angry
Angry
0 %
Surprise
Surprise
0 %

Average Rating

5 Star
0%
4 Star
0%
3 Star
0%
2 Star
0%
1 Star
0%

2 thoughts on “U.S. FDA Accepts for Review the BLA for MenABCWY

Comments are closed.