BRIEF—FDA approves Vaxelis, Sanofi and MSD's pediatric hexavalent combo vaccine

The US Food and Drug Administration has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th birthday).

Vaxelis was developed as part of a joint-partnership between French pharma major Sanofi and US giant Merck & Co, known as MSD outside of the USA and Canada.

The combination vaccine was approved by the European Commission in February 2016.

Sanofi and MSD are working to maximize production of Vaxelis to allow for a sustainable supply to meet anticipated US demand. Commercial supply will not be available in the USA prior to 2020, the companies noted.