Sanofi has announced that the FDA has approved Vaxelis, a full-liquid ready-to-use hexavalent combination vaccine for infants from 6 weeks old to 4 years old (before the 5th birthday). The vaccine is part of a strategic partnership between Sanofi and Merck who are currently working to maximize Vaxelis production to achieve a sustainable vaccine supply that meets the expected market demand.
According to a statement issued by Sanofi, Vaxelis will not be fully commercialized in the US market until 2020. In the European Union, Vaxelis was approved in May 2016 for infants and young children older than 6 weeks to prevent 6 different diseases.
Introduction to Vaxelis
Vaxelis contains active ingredients of diphtheria, tetanus, pertussis and Haemophilus influenzae type B, hepatitis B virus and inactivated poliovirus, which is an active immunization vaccine for infants from 6 weeks to 4 years of age to prevent diphtheria, tetanus, pertussis, polio, hepatitis B and invasive diseases caused by Haemophilus influenzae type B. Vaxelis used a 3-dose immunization series consisting of a 0.5 mL intramuscular injection administered at 2, 4, and 6 months of age.
Mechanism of action of Vaxelis
Vaxelis fights disease by guiding the immune system (the body’s natural defense system) and contains small amounts of substances from viruses and bacteria. By vaccination, the immune system identifies substances in bacteria and viruses as foreign substances and produces antibodies against them. When the human body is naturally exposed to bacteria or viruses, the immune system will be able to produce antibodies quickly, helping prevent diseases caused by these bacteria and viruses.
It is worth noting that Vaxelis is banned from children who has a history of severe allergic reactions to pre-immunized Vaxelis, any component of Vaxelis or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated polio vaccine, hepatitis B vaccine or influenza B. The vaccine cannot be used 7 days after vaccination with a history of encephalopathy (such as coma, low level of consciousness, long-term seizures) or pertussis. In addition, Vaxelis is forbidden for children with a history of progressive neurological disorders until the treatment regimen is determined.
Vaxelis origins from a partnership between Merck and Sanofi Pasteur in the United States in 1991, drawing on experiences of the development, manufacturing and sales of single and combined vaccines in both companies. The vaccine includes antigens of polio, pertussis and tetanus from Sanofi, as well as antigens of influenza B and hepatitis B from Merck.