GSK's BEXSERO® included in Category B recommendation by ACIP
GlaxoSmithKline (LSE: GSK) announced today that the U.S. Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) voted for a Category B recommendation for meningococcal group B vaccination, including BEXSERO® (Meningococcal Group B Vaccine), in individuals aged 16 to 23 (with a preferred age of 16-18). This recommendation means that the decision to vaccinate against meningococcal group B will be made by qualified healthcare professionals, based on individual patient risk assessment. BEXSERO® was approved by the U.S. Food and Drug Administration (FDA) in January 2015 through an accelerated approval pathway for use in individuals aged 10 through 25 years and acquired by GSK in March 2015 following the closure of the three-part transaction with Novartis.
"GSK welcomes this vote as an important step forward to help protect against meningococcal disease in the U.S.," said Patrick Desbiens, Senior Vice President, U.S. Vaccines, GSK. "Meningococcal disease is fast-moving, unpredictable and can cause irreversible damage, so vaccination is the best tool to help prevent it. Today's vote is the latest milestone on a 20-year journey to develop a vaccine in order to help protect individuals from this devastating condition."
Meningococcal disease is a rare but serious bacterial infection that can be difficult to diagnose within 24 hours of symptom onset, and can leave those affected with lifelong disability. According to the CDC, each year there are 800-1,200 cases of all serogroups of meningococcal disease across all ages, and with an approximate 12 percent mortality rate. Five serogroups of Neisseria meningitidis [A, B, C, W-135 and Y] cause the majority of cases of meningococcal disease in the U.S. Meningococcal group B is one of the most prevalent serogroups, accounting for 32 percent of all reported U.S. cases in all age groups in 2013.
During today's meeting, the ACIP also voted to include BEXSERO® in the CDC's Vaccines for Children (VFC) program for ages 16 through 18. The ACIP voted in February for the use of meningococcal group B vaccines in people greater than 10 years of age at increased risk for meningococcal group B disease and this was published on June 12, 2015. The recommendation endorsed today by the ACIP will become final upon publication in a future Morbidity and Mortality Weekly Report.
GSK is evaluating the safety and immune response of a pentavalent meningococcal vaccine (A, C, W-135, Y, plus B) which is now in Phase 2 research. GSK plans to continue to invest in vaccines against this disease as a key part of its growth strategy.
BEXSERO® is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO® is approved for use in individuals 10 through 25 years of age. Approval of BEXSERO® is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the U.S. The effectiveness of BEXSERO® against diverse serogroup B strains has not been confirmed.
Outside of the U.S., BEXSERO® is now licensed in 36 countries including the member states of the European Union, Australia and Canada for use in individuals from 2 months of age and older.
BEXSERO® (Meningococcal Group B Vaccine) Important Safety Information
BEXSERO® is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO®.
Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.
The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals.
Syncope (fainting) can occur in association with administration of BEXSERO®. Ensure procedures are in place to avoid injury from falling associated with syncope.
The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%).
Vaccination with BEXSERO® may not provide protection against all meningococcal serogroup B strains.
Vaccination with BEXSERO® may not result in protection in all vaccine recipients.
Please click here for full Prescribing Information.
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