Hexavalent vaccine


A hexavalent vaccine, or 6-in-1 vaccine, is a combination vaccine with six individual vaccines conjugated into one, intended to protect people from multiple diseases. The principal example is a pediatric vaccine, used in more than 90 countries around the world including in Europe, Canada, Australia, and New Zealand that protects against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus B, and hepatitis B.

Formulations

The generic vaccine is known as diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine. The liquid vaccine is also known in abbreviated form as DTaP-HepB-IPV-Hib or DTPa-HepB-IPV-Hib. Branded formulations include Hexavac, Hexaxim, Hexyon, and Vaxelis manufactured by Sanofi Pasteur.
There is a two-part formulation known in abbreviated form as DTaP-IPV-HepB/Hib or DTPa-HBV-IPV/Hib. It consists of a suspension of diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliomyelitis vaccine that is used to reconstitute a lyophilised Haemophilus influenzae type B powder. A branded formulation with a 3-antigen pertussis component, Infanrix hexa, is manufactured by GlaxoSmithKline.

EU approval

On 23 October 2000, the European Commission issued marketing approval for Hexavac and for Infanrix hexa.
Marketing approval for Hexavac was suspended in November 2005, on the advice of the agency's Committee for Medicinal Products for Human Use in view of the variability of its long-term protection against hepatitis B. In April 2012, the manufacturer Sanofi Pasteur voluntarily withdrew the product from the market. The European Commission formally withdrew marketing permission on 28 June 2012.
On 21 June 2012, the European Medicines Agency issued a positive scientific opinion on Hexaxim for use outside the EU, in cooperation with the World Health Organization.
On 17 April 2013, marketing approval in the EU was granted to Hexyon.
On 15 February 2016, marketing approval in the EU was granted to Vaxelis.

USA approval

On 21 December 2018 the U.S. Food and Drug Administration licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus influenzae type b conjugate and hepatitis B vaccine, DTaP-IPV-Hib-HepB, for use as a 3-dose series in infants at ages two, four, and six months. On 26 June 2019, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted to include DTaP-IPV-Hib-HepB in the federal Vaccines for Children Program.