All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Sanofi's Six-In-One Pediatric Vaccine Recommended for European Approval

February 26, 2013
By Adeline Siew, PhD
News
Article

The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi's six-in-one pediatric vaccine for marketing authorization.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi's six-in-one pediatric vaccine for marketing authorization. The hexavalent vaccine (DTaP-IPV-Hib-HepB vaccine) was developed by Sanofi Pasteur, the vaccines division of Sanofi. Once approved, the vaccine will be commercialized under two brands names: Hexyon in Western Europe and Hexacima in Eastern Europe. The vaccine will also be available in international markets under the trade name Hexaxim.

Hexyon /Hexacima will be indicated for primary and booster vaccination of infants from six weeks of age in accordance with official recommendations. It is the only fully liquid, ready-to-use, six-in-one vaccine in Europe to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

"Availability of Hexyon/Hexacima ready-to-use, six-in-one pediatric vaccine will raise the standard of care of vaccination for millions of children. It reduces the number of vaccination visits for infants and it is more convenient for parents to complete the recommended vaccination schedule and thus better protect their children against six major childhood diseases," said Olivier Charmeil, president and CEO of Sanofi Pasteur in a press statement. "Upon licensure, we intend to introduce Hexyon/Hexacima vaccine in countries that are looking for improved and effective solutions for public immunization programs."

The formulation does not require reconstitution prior to administration, which makes it convenient for healthcare professionals. It is a fully liquid, ready-to-use vaccine, available in vial and pre-filled syringe presentations. Another key benefit is that the combination of six vaccines into one reduces the number of injections, hence improving comfort and vaccination compliance for infants. Moreover, the use of acP (acellular pertussis) antigens and IPV (inactivated poliovirus vaccine) improves safety and reduces reactogenicity compared with wcP (whole cell pertussis)-containing vaccines and OPV (oral polio vaccine).

The CHMP’s positive opinion is supported by clinical data from multicenter trials involving approximately 5000 infants. Results from Phase III studies comparing Sanofi’s vaccine to licensed combination vaccines demonstrated that Hexyon/Hexacima is safe and induces a robust immune response against all six targeted diseases.

Recent Videos
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content

NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

March 26th 2024
Podcast

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.


Close up the media plate on hand medical technicians working on bacterial culture and drug resistance of pathogens in laboratory. | Image Credit: © analysis121980 - stock.adobe.com

Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics

Patrick Lavery
June 26th 2025
Article

Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.


3D Rendering of CAR - Chimeric Antigen Receptor Between T-Cell and Cancer Cell | Image Credit: © Alpha Tauri 3D - stock.adobe.com

Priothera Awarded €1.7M in Innovation Contest for Hematologic Malignancy Treatments

Patrick Lavery
June 26th 2025
Article

The company’s mocravimod, a novel oral S1P receptor, is being evaluated for its efficacy as an addition to CAR-T cell therapies.

Related Content

NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.


Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.


Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.


Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

March 26th 2024
Podcast

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.


Close up the media plate on hand medical technicians working on bacterial culture and drug resistance of pathogens in laboratory. | Image Credit: © analysis121980 - stock.adobe.com

Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics

Patrick Lavery
June 26th 2025
Article

Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.


3D Rendering of CAR - Chimeric Antigen Receptor Between T-Cell and Cancer Cell | Image Credit: © Alpha Tauri 3D - stock.adobe.com

Priothera Awarded €1.7M in Innovation Contest for Hematologic Malignancy Treatments

Patrick Lavery
June 26th 2025
Article

The company’s mocravimod, a novel oral S1P receptor, is being evaluated for its efficacy as an addition to CAR-T cell therapies.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.