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The United States Food and Drug Administration (FDA) has approved the use of Sanofi's Hexavalent Combined Children's Vaccine in children six weeks to five years of age.
The vaccine, called Vaxelis, is indicated for the prevention of diphtheria, tetanus, poliomyelitis, whooping cough, hepatitis B and invasive diseases caused by Haemophilus influenzae type b.
It has been approved for serial use in three doses.
Sanofi has developed Vaxelis in a partnership with MSD, known as Merck in the United States and Canada. Sanofi Pasteur, the vaccines unit of Sanofi, and Merck & Co have been partners since 1991.
Currently, both companies are working on the production of the vaccine to make it available in 2020.
Vaxelis was developed using the expertise of Sanofi and MSD in development and manufacturing. The vaccine contains antigens for diphtheria, tetanus, whooping cough and poliomyelitis of Sanofi, as well as antigens for H. influenzae type b and hepatitis B MSD.
The pediatric vaccine is not indicated for the treatment of children with a history of severe allergic reaction to a previous dose of Vaxelis or any of its components.
It will also be contraindicated in children with a history of encephalopathy such as coma, loss of consciousness, and prolonged seizures.
In addition, it is also advisable not to administer this pediatric vaccine to anyone with a history of progressive neurological disorder.
Earlier this month, Sanofi was commended by the European Commission for its dengue vaccine called Dengvaxia.
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