The FINANCIAL — Pfizer Inc. (NYSE: PFE) announced on February 26 that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend serogroup B meningococcal vaccination to help protect individuals at increased risk. Specifically, the ACIP voted to recommend serogroup B meningococcal vaccination for persons aged 10 years and older at increased risk for meningococcal disease, including:
Persons with persistent complement component deficiencies
Persons with anatomic or functional asplenia
Microbiologists routinely exposed to isolates of Neisseria meningitidis
Persons identified to be at increased risk because of a serogroup B meningococcal disease outbreak
In October 2014, Pfizer’s TRUMENBA (Meningococcal Group B Vaccine) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age, according to Pfizer.
“We are encouraged by this initial ACIP recommendation,” said Dr. Laura York, Global Medical Lead for Meningococcal Vaccines, Pfizer Vaccines. “However, we believe public health would be best served by broader routine recommendations for adolescents and young adults who are currently only protected against serogroups A, C, W and Y. We look forward to continued dialogue with the CDC on the most appropriate vaccination strategies towards prevention of serogroup B meningococcal disease in adolescents and young adults.”
The ACIP recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the recommendations are published in the Morbidity and Mortality Weekly Report (MMWR).
TRUMENBA was recently selected for use during large-scale vaccination clinics at Providence College and the University of Oregon, following cases of serogroup B meningococcal disease on both campuses.1,2
“While uncommon, meningitis B cases continue to be reported on college campuses,” said Susan Silbermann, President, Pfizer Vaccines. “We believe a recommendation for adolescents and young adults to be vaccinated against serogroup B meningococcal disease can’t come early enough. Everyone’s goal should be to allow enough time for students to start their vaccination before they return to school next fall.”
U.S. Indication for TRUMENBA (Meningococcal Group B Vaccine)
TRUMENBA (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.
Important Safety Information
TRUMENBA should not be given to anyone with a history of a severe allergic reaction after a previous dose of TRUMENBA.
Individuals with weakened immune systems may have a reduced immune response.
The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills.
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 healthcare provider if you are pregnant, or plan to become pregnant.
Ask your healthcare provider about the risks and benefits of TRUMENBA. Only a healthcare provider can decide if TRUMENBA is right for you or your child.
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