European Commission Grants "2+1 Immunization Schedule" for Hexyon® 6-in-1 Paediatric Vaccine

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Sanofi Pasteur MSD

05 Mar, 2015, 08:00 GMT

- This release is not for French press

LYON, France, March 5, 2015 /PRNewswire/ --

 

This decision opens the way to making Hexyon® available to more infants in European countries  

Sanofi Pasteur MSD announced today that the European Commission has granted a new vaccination schedule of the 6-in-1 paediatric vaccine Hexyon® (DTaP-IPV-HB-Hib vaccine) for a "2+1" schedule of administration, in addition to other possible schedules already approved for this vaccine.

This additional "2+1" schedule is based on a primary immunization with 2 doses followed by 1 booster vaccination around one year of age. This new schedule for Hexyon® comprises a total of 3 doses* and it is simplified compared to the already approved schedules which comprise 4 doses in total (3 doses in primary vaccination and 1 booster dose).

European countries recommending a "2+1" schedule for infant vaccination include France, Italy, Austria, Denmark, Norway and Sweden.

"This approval from the European Commission is another demonstration of Hexyon's good immunogenicity and safety profile", said Dr. Stephen Lockhart, Vice-President Development of Sanofi Pasteur MSD. "We are delighted to be able to offer Hexyon ® with this new schedule, which means that  Hexyon® can be made available to more infants in the European Union", concluded Dr Lockhart.  

The approval of this new schedule for Hexyon® follows the positive opinion from the European Medicines Agency (EMA) granted in February, based on results from a multi-center Phase III clinical trial involving 546 infants, which compared Hexyon® to one licensed hexavalent combination vaccine and that demonstrated that Hexyon® given in a 2+1 immunization schedule is safe and elicits protective immune responses against the 6 targeted diseases.

About Hexyon® 

Hexyon® is a fully liquid, ready-to-use, paediatric hexavalent vaccine.

Hexyon® was granted marketing authorisation from the European Commission in April 2013. It was developed by Sanofi Pasteur® and it is now registered in more than 70 countries worldwide.

Hexyon® is commercialised under three brands names: Hexyon® by Sanofi Pasteur MSD® in Western Europe, Hexacima® by Sanofi Pasteur® in Eastern Europe and Hexaxim® by Sanofi Pasteur® in the rest of the world.

Hexyon® combines protection against six of these major infectious diseases, which are included in the national immunisation calendars of most countries in Europe:

    1. Haemophilius influenza  type b (Hib) disease 

       Hib is a bacterium that can cause severe invasive diseases in infants, such as meningitis[1],[2]

    2. Diphtheria 

       Diphtheria is a highly contagious disease caused by the bacterium Corynebacterium diphtheriae. This germ produces a toxin that can affect the throat and skin, and can cause damage to the heart and other organs[1],[3]

    3. Pertussis (whooping cough) 

       Pertussis is a highly contagious bacterial infection of the upper respiratory tract which can cause serious illness in infants, children and adults[4]

    4. Tetanus 

       Tetanus is a serious disease caused by the bacterium Clostridium tetani, which produces a toxin that causes lockjaw and affects the body's muscles and nerves[5]. Usually the bacterium infects the body through a wound[1],[5]

    5. Poliomyelitis (Polio) 

       Polio is a highly infectious disease caused by the poliovirus, which affects the nerves and can lead to muscle weakness or paralysis[1],[6]

    6. Hepatitis B (Hep B) 

       Hep B is a viral infection that attacks the liver and can cause both acute and chronic disease[7]

Hexyon® provides new levels of efficiency** in the prevention of these six major infectious diseases 

The fully liquid, ready-to-use technology of Hexyon® eliminates the need for reconstitution[8]. By offering high immunogenicity with a good safety profile, while simplifying the vaccination process and reducing the risk of errors or injuries, Hexyon® provides new levels of efficiency for the protection of infants and toddlers against severe diseases.

Hexyon® was approved by the European Commission in April 2013. National recommendations and funding are being progressed in each country.

**New levels of efficiency refers to high immunogenicity, a favourable safety profile, and ready-to-use technology that eliminates the need for reconstitution and reduces preparation time, resulting in fewer handling errors and a lower patient risk.

About Sanofi Pasteur MSD  http://www.spmsd.com

Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the development of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck's research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.

References 

  1. EMA, EPAR summary for the public, EMA/137344/2013, sourced at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002796/WC500145761.pdf , accessed November 2014
  2. NHS. Haemophilus influenzae type b (Hib), sourced at: http://www.nhs.uk/conditions/hib/pages/introduction.aspx , accessed November 2014
  3. WHO. Immunization, Vaccines and Biologicals, sourced at: http://www.who.int/immunization/topics/diphtheria/en/index.html , accessed November 2014
  4. CDC. Whooping Cough (Pertussis) - Fact Sheet for Parents, sourced at: http://www.cdc.gov/vaccines/vpd-vac/pertussis/fs-parents.html , accessed November 2014
  5. WHO, Tetanus, sourced at: http://www.who.int/topics/tetanus/en/ , accessed November 2014
  6. WHO. Poliomyelitis factsheet n°114, sourced at: http://www.who.int/mediacentre/factsheets/fs114/en/ , accessed November 2014
  7. WHO. Hepatitis B, factsheet, sourced at: http://www.who.int/mediacentre/factsheets/fs204/en/index.html , accessed November 2014
  8. Summary of Product Characteristics of Hexyon®, sourced at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002796/human_med_001641.jsp&mid=WC0b01ac058001d124, accessed November 2014