• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
    • Overview
    • Distribution by PR Newswire
    • Cision Communications Cloud®
    • Cision IR
    • All Products
  • Contact
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases
      • All News Releases
      • All Public Company
      • English-only


      • News Releases Overview
      • Multimedia Gallery
      • All Multimedia
      • All Photos
      • All Videos


      • Multimedia Gallery Overview
      • Trending Topics
      • All Trending Topics


  • Business & Money
      • Auto & Transportation
      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation


      • Auto & Transportation Overview
      • Business Technology
      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors


      • Business Technology Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Financial Services & Investing
      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Stock Offering
      • Stock Split
      • Venture Capital


      • Financial Services & Investing Overview
      • General Business
      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News


      • General Business Overview
  • Science & Tech
      • Consumer Technology
      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications


      • Consumer Technology Overview
      • Energy & Natural Resources
      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities


      • Energy & Natural Resources Overview
      • Environ­ment
      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters


      • Environ­ment Overview
      • Heavy Industry & Manufacturing
      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco


      • Heavy Industry & Manufacturing Overview
      • Telecomm­unications
      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications


      • Telecomm­unications Overview
  • Lifestyle & Health
      • Consumer Products & Retail
      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys


      • Consumer Products & Retail Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Health
      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine


      • Health Overview
      • Sports
      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories


      • Sports Overview
      • Travel
      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry


      • Travel Overview
  • Policy & Public Interest
      • Policy & Public Interest
      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy


      • Policy & Public Interest Overview
  • People & Culture
      • People & Culture
      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women


      • People & Culture Overview
      • In-Language News

      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO

      Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Policy & Public Interest
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • People & Culture
    • People & Culture
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

U.S. CDC committee recommends physicians make individual decisions on the use of meningococcal group B vaccines

- GSK's BEXSERO® included in Category B recommendation by the Advisory Committee on Immunization Practices (ACIP)


News provided by

GlaxoSmithKline

Jun 24, 2015, 01:32 ET

Share this article

Share this article


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.

GSK enquiries:








US Media enquiries:

Sarah Alspach

+1 202 715 1048

(Washington, DC)


Mary Anne Rhyne

+1 919 483 0492

(North Carolina)


Melinda Stubbee

+1 919 483 2510

(North Carolina)


Jenni Ligday

+1 202 715 1049

(Washington, DC)


Karen Hagens

+1 919 483 2863

(North Carolina)


Gwynne Oosterbaan

+1 215 751 7468

(Pennsylvania)


Anna Padula

+1 215 751 4271

(Pennsylvania)





Analyst/Investor enquiries:

Ziba Shamsi

+44 (0) 20 8047 5543

(London)


Tom Curry

+ 1 215 751 5419

(Philadelphia)


Gary Davies

+44 (0) 20 8047 5503

(London)


James Dodwell

+44 (0) 20 8047 2406

(London)


Jeff McLaughlin

+1 215 751 7002

(Philadelphia)

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.

Registered in England & Wales:
No. 3888792

Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS

SOURCE GlaxoSmithKline

Related Links

http://www.gsk.com

Modal title

    Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

    Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

    About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement

    • Asia
    • Brazil
    • Canada
    • Czech
    • Denmark
    • Finland
    • France
    • Germany
    • India
    • Israel
    • Italy
    • Mexico
    • Middle East
    • Netherlands
    • Norway
    • Poland
    • Portugal
    • Russia
    • Slovakia
    • Spain
    • Sweden
    • United Kingdom

    My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision


Products


About


My Services
  • All News Releases
  • Online Member Center
  • ProfNet℠
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2021 Cision US Inc.