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news.The US Food and Drug Administration (FDA) has approved Sanofi’s pediatric hexavalent combination vaccine for use in children between six weeks and five years of age.
Sanofi’s pediatric vaccine Vaxelis gets US FDA approval. Photo: The U.S. Food and Drug Administration.
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The vaccine, called Vaxelis, is indicated to prevent diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B and invasive disease due to Haemophilus influenzae type b.
It has been approved for use as a three-dose series.
Sanofi has developed Vaxelis under a joint-partnership with MSD, known as Merck in the US and Canada. Sanofi Pasteur, the vaccines unit of Sanofi, and Merck & Co have been in a partnership since 1991.
Currently, both the companies are working on the production of the vaccine to make it available in 2020.
Vaxelis has been developed utilising the development and manufacturing expertise of Sanofi and MSD. The vaccine features antigens for diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis from Sanofi and antigens for H. influenzae type b and hepatitis B from MSD.
The pediatric vaccine is not indicated for treating children with history of severe allergic reaction to a previous dose of Vaxelis or any ingredient of it.
It will also contraindicated in children with history of encephalopathy such as coma, decreased level of consciousness and prolonged seizures.
Additionally, it is also advised not to administer this pediatric vaccine to anyone with a history of progressive neurologic disorder.
Earlier this month, Sanofi received the European Commission nod for its dengue vaccine called Dengvaxia.
