Hexavalent vaccine

Hexavalent vaccine
Combination of
DTaP vaccine Vaccine
Hepatitis B vaccine Vaccine
Polio vaccine Vaccine
Haemophilus vaccine Vaccine
Clinical data
Trade names Infanrix hexa, Hexyon, Vaxelis, Hexaxim, EasySix
Routes of
administration		 Intramuscular injection
ATC code
Identifiers
ChemSpider
  • none

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[1][2] that protects against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus B, and hepatitis B.

Formulations

The generic vaccine is known as diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and haemophilus influenzae type B conjugate vaccine. The liquid vaccine is also known in abbreviated form as DTaP-HepB-IPV-Hib or DTPa-HepB-IPV-Hib. Branded formulations have included Hexavac[3], Hexaxim[4], Hexyon,[5] and Vaxelis[6] manufactured by Sanofi Pasteur, and EasySix manufactured by Panacea Biotec.

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 (DTaP-IPV-HepB or DTPa-HBV-IPV) vaccine that is used to reconstitute a lyophilised (freeze-dried) Haemophilus influenzae type B (Hib) powder. A branded formulation with a 3-antigen pertussis component, Infanrix hexa,[7] is manufactured by GlaxoSmithKline.

EU approval

On 23 October 2000, the European Commission issued marketing approval for Hexavac[8] and Infanrix hexa[9] in the EU.

Marketing approval for Hexavac was suspended in November 2005 on the advice of the agency's Committee for Medicinal Products for Human Use (CHMP) in view of the variability of its long-term protection against hepatitis B.[10] 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.[8]

On 21 June 2012, the EMA issued a positive scientific opinion on Hexaxim for use outside the EU, in cooperation with the WHO.[11]

On 17 April 2013, marketing approval in the EU was granted to Hexyon.[12]

On 15 February 2016, marketing approval in the EU was granted to Vaxelis.[13]

USA approval

No hexavalent vaccines currently have marketing approval in the USA.[14]

References

  1. ↑ Obando-Pacheco, Pablo; et al. (2017). "New perspectives for hexavalent vaccines". Vaccine. doi:10.1016/j.vaccine.2017.06.063.
  2. ↑ "6-in-1 Vaccine". Vaccine Knowledge Group. 29 June 2018. Retrieved 3 July 2018.
  3. ↑ "Hexavac". European Medicines Agency. Retrieved 28 June 2018.
  4. ↑ "Hexaxim H-W-2495". European Medicines Agency. Retrieved 28 June 2018.
  5. ↑ "Hexyon". European Medicines Agency. Retrieved 28 June 2018.
  6. ↑ "Vaxelis". European Medicines Agency. Retrieved 28 June 2018.
  7. ↑ "Infanrix hexa". European Medicines Agency. Retrieved 28 June 2018.
  8. 1 2 "Public statement on Hexavac. Withdrawal of marketing authorisation in the European Union" (PDF). European Medicines Agency. 24 July 2012. Retrieved 28 June 2018.
  9. ↑ "EPAR summary for the public: Infanrix hexa" (PDF). European Medicines Agency. 29 November 2017. Retrieved 28 June 2018.
  10. ↑ "Scientific conclusions and grounds for the suspension of the marketing authorisation of Hexavac presented by the EMEA" (PDF). European Medicines Agency. 16 August 2012. Retrieved 28 June 2018.
  11. ↑ "EPAR summary for the public: Hexaxim" (PDF). European Medicines Agency. 14 June 2016. Retrieved 28 June 2018.
  12. ↑ "EPAR summary for the public: Hexyon" (PDF). European Medicines Agency. 6 July 2017. Retrieved 28 June 2018.
  13. ↑ "EPAR summary for the public: Vaxelis" (PDF). European Medicines Agency. 26 February 2016. Retrieved 28 June 2018.
  14. ↑ "Vaccines Licensed for Use in the United States". U.S. Food and Drug Administration. Retrieved 28 June 2018.
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