ACIP endorses individual choice on meningitis B vaccine

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The FINANCIAL — Pfizer Inc. announced on June 24 that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that decisions to vaccinate adolescents and young adults 16 through 23 years of age against serogroup B meningococcal disease should be made at the individual level with healthcare providers.

Specifically, the ACIP voted that a serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age, according to Pfizer.

Pfizer’s TRUMENBA (Meningococcal Group B Vaccine) is FDA-approved for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

“Healthcare providers should understand the importance of today’s ACIP recommendation to help protect adolescents and young adults,” said Dr. Laura York, Global Medical Lead for Meningococcal Vaccines, Pfizer Vaccines. “This recommendation is an important step forward that provides guidance that serogroup B meningococcal disease vaccination may be administered between the ages of 16 through 23, with preferred timing for vaccination between ages 16 through 18.”

The ACIP recommendation 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). The Affordable Care Act (ACA) and Vaccines for Children (VFC) program ensure coverage for all vaccines administered in accordance with ACIP recommendations. Healthcare providers should contact their individual plan to determine specific coverage and reimbursement requirements.

“Serogroup B meningococcal disease is an uncommon but serious illness that attacks without warning and may become life-threatening within 24 hours,” said Susan Silbermann, President, Pfizer Vaccines. “Parents and healthcare providers should take action now and consider vaccination particularly for those aged 16 through 23. No one in this age group should lack access to potentially life-saving vaccines.”

This recommendation expands the CDC’s ACIP February 2015 recommendation for serogroup B meningococcal vaccination.

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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