Sanofi Pasteur MSD GmbH

Vaxelis®, New Fully-liquid Paediatric Hexavalent Vaccine Approved in the European Union

Lyon, France (ots/PRNewswire) - This decision opens the way to making Vaxelis® available to infants and toddlers in European countries

Sanofi Pasteur MSD announced today that the European Commission has granted the marketing authorization for Vaxelis®, a new fully-liquid hexavalent vaccine indicated for primary and booster vaccination of infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).

The approval of Vaxelis® follows the positive opinion from the European Medicines Agency (EMA) adopted on December 17, 2015.

"With Vaxelis® Sanofi Pasteur MSD is proud to provide infants and toddlers with a new powerful tool that supports childhood immunization programs", said Dr Stephen Lockhart, Vice-President of Development at Sanofi Pasteur MSD.

The European license application has been supported by the results of extensive clinical development involving over 7500 children across several countries including 6 in Europe. The studies demonstrated that Vaxelis was immunogenic and well tolerated when used according to various European schedules. Vaxelis elicited immune responses to each antigen, which were above predefined thresholds of protection or non-inferior to immune responses of a comparator vaccine after the booster dose.

When launched in Europe, Vaxelis will be the only hexavalent vaccine containing 5 acellular pertussis antigens and Hib antigen conjugated to the Outer membrane protein complex of Neisseria meningitidis (OMPC) carrier. Both components have already been used widely in other combination vaccines and demonstrated significant reduction in pertussis disease as well as an early immune response against Hib during the first year of life.

Moreover, this new vaccine is fully-liquid, avoiding the need for reconstitution prior to administration.

Hexavalent combination vaccines are becoming the cornerstone of infant and toddler immunisation programmes and is key for their success. A fully-liquid presentation also increases vaccination convenience.

Sanofi Pasteur MSD is proud to be able to offer two different fully liquid, ready-to-use hexavalent vaccines to the market: first Hexyon®, and now Vaxelis®. By making both vaccines available, Sanofi Pasteur MSD is demonstrating their understanding and commitment to the needs of paediatricians; thanks to these two hexavalent vaccines, doctors will be able to meet the diverse needs of their patients.

Sanofi Pasteur MSD will continue to market Hexyon®, along with their other pediatric vaccines. With Vaxelis®, Sanofi Pasteur MSD will be the only vaccine company to offer 2 hexavalent ready-to-use vaccines to ensure protection for infants and toddlers against six serious diseases. Bringing this new vaccine to Europe provides an opportunity to secure infant and toddler vaccination programmes.

About Vaxelis[®1]

Vaxelis® is a fully-liquid ready-to-use hexavalent vaccine (DTaP-HB-IPV-Hib) indicated for primary and booster vaccination of infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The primary vaccination schedule consists of two or three doses, with an interval of at least 1 month between doses, and may be given from 6 weeks of age. Vaxelis can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule. After a 2-dose or a 3-dose primary series vaccination with Vaxelis, a booster dose should be given at least 6 months after the last priming dose.

The use of Vaxelis® should be in accordance with official recommendations.

Vaxelis was developed as part of a partnership between Merck & Co. Inc. and Sanofi Pasteur.

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

The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause the following diseases:

1. Diphtheria

Diphtheria is a highly contagious disease caused by the bacterium Corynebacterium diphtheriae, which produces a toxin that can affect the throat and skin, and can cause damage to the heart and other organs and death[2]

2. Tetanus

Tetanus is a serious disease caused by the bacterium Clostridium tetani, which produces a toxin that affects the body's muscles and nerves and can cause death[5]. Usually the bacterium infects the body through a wound[3]

3. Pertussis (whooping cough)

Pertussis is a highly contagious bacterial infection of the upper respiratory tract which can cause serious illness in infants, including death[4] .

4. Hepatitis B (Hep B)

Hep B is a viral infection of the liver and can cause cirrhosis, primary liver cancer and death[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 or death[6]

6. Haemophilus influenza type b (Hib) diseases

Hib is a bacterium that can cause severe invasive diseases in infants, such as meningitis, epiglottitis, with neurologic sequellae and death[7]

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. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_op
   inion_-_Initial_authorisation/human/003982/WC500199007.pdf   
2. WHO. Immunization, Diphtheria, sourced at: 
http://www.who.int/immunization/topics/diphtheria/en/index.html , 
   accessed February 2016.
3. WHO, Tetanus, sourced at: http://www.who.int/topics/tetanus/en/ , 
   accessed November 2014
4. CDC. Whooping Cough and the Vaccine (Shot) to Prevent It - Fact 
   Sheet for Parents, sourced at: 
http://www.cdc.gov/vaccines/vpd-vac/pertussis/fs-parents.html , 
   accessed February 2016.
5. WHO. Hepatitis B, Fact sheet N°204, sourced at: 
http://www.who.int/mediacentre/factsheets/fs204/en/index.html , 
   accessed February 2016.
6. WHO. Poliomyelitis - Fact sheet N°114, sourced at: 
http://www.who.int/mediacentre/factsheets/fs114/en/ , accessed 
   February 2016.
7. NHS. Haemophilus influenzae type b (Hib), sourced at: 
http://www.nhs.uk/conditions/hib/pages/introduction.aspx , 
   accessed February 2016. 

Contact:

Sylvia Martin-Jarrand
Sanofi Pasteur MSD
Tel: +33-4-37-28-40-55
smartin-jarrand@spmsd.com. Loïc Frerejouand
Sanofi Pasteur MSD
lfrerejouand@spmsd.com.
Original-Content von: Sanofi Pasteur MSD GmbH, übermittelt durch news aktuell

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