PHILADELPHIA, June 24, 2015 /PRNewswire/ -- 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.
About BEXSERO®
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.
GSK – one of the world's leading research-based
pharmaceutical and healthcare companies – is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com.
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Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking
statements or projections made by GSK, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F for
2014.
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SOURCE GlaxoSmithKline