FDA approves new pediatric hexavalent immunization vaccine by Sanofi

  • The innovative pediatric immunization vaccine is capable of providing children with immunity over six diseases.

  • The company developed the novel vaccine, called the Vaxelis under a partnership deal with Merck.

Sanofi S.A. (Sanofi), a French multinational pharmaceutical firm, has reportedly announced that the United States Food & Drug Administration has approved its new hexavalent pediatric vaccine that could immunize children against six diseases.

Reports cite, the new vaccine, called the Vaxelis has been developed for children aged six weeks to 4-year-old and is specifically designed to safeguard them from tetanus, diphtheria, pertussis, hepatitis B, poliomyelitis as well as invasive disease caused by haemophilus influenza type-B (Hib).

According to a press release by Sanofi S.A., the hexavalent immunization vaccine was developed as part of a partnership agreement between the company and New Jersey-based pharmaceutical company, Merck & Co. (MSD). The two companies are closely working to boost Vaxelis production to facilitate a sustainable supply that would be enough to fulfil anticipated demands in the U.S. market.

The company in the drug’s safety announcement stated that Vaxelis is contraindicated in children that have had severe allergic reaction from a previous dose of the drug or any of the ingredients used in the drug’s development or any other tetanus toxoid, inactivated poliovirus vaccine, hepatitis B vaccine, pertussis-containing vaccine, diphtheria toxoid, or H. influenza type-b vaccine.

The company also reportedly advised that the vaccine should not be administered to anyone with a record of progressive neurologic disorder. The drug could only be administered after a treatment regimen has been set up and the patient’s condition has been stabilized.

The vaccine would reportedly be a three-dose immunization regime where a 0.5 mL dose is given through an intramuscular injection that is administered at two, four & six months of age.

According to reports, the two companies aim to make the vaccine available in the U.S. market by 2020 or later.