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.[1] The principal example is a pediatric vaccine, used in more than 90 countries around the world including in Europe, Canada, Australia, and New Zealand[2][3] that protects against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus B, and hepatitis B.[1]

Hexavalent vaccine
Combination of
DTaP vaccineVaccine
Hepatitis B vaccineVaccine
Polio vaccineVaccine
Haemophilus vaccineVaccine
Clinical data
Trade namesInfanrix hexa, Hexyon, Vaxelis, others
AHFS/Drugs.comProfessional Drug Facts
License data
Routes of
administration		Intramuscular injection
ATC code
Legal status
Legal status
  • US: ℞-only
  • In general: ℞ (Prescription only)
Identifiers
ChemSpider
  • none

Formulations

The generic vaccine is known as diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine.[4] The liquid vaccine is also known in abbreviated form as DTaP-HepB-IPV-Hib or DTPa-HepB-IPV-Hib. Branded formulations include Hexavac[5], Hexaxim[6], Hexyon,[7] and Vaxelis[8] 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 (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,[9] is manufactured by GlaxoSmithKline.

EU approval

On 23 October 2000, the European Commission issued marketing approval for Hexavac[10] and for Infanrix hexa.[9]

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.[11] 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.[10]

On 21 June 2012, the European Medicines Agency (EMA) issued a positive scientific opinion on Hexaxim for use outside the EU, in cooperation with the World Health Organization (WHO).[12]

On 17 April 2013, marketing approval in the EU was granted to Hexyon.[13]

On 15 February 2016, marketing approval in the EU was granted to Vaxelis.[14][15]

USA approval

Vaxelis was approved by the U.S. Food and Drug Administration (FDA) on 21 December 2018.[16]

References
  1. Orsi A, Azzari C, Bozzola E, Chiamenti G, Chirico G, Esposito S, Francia F, Lopalco P, Prato R, Russo R, Villani A, Franco E (June 2018). "Hexavalent vaccines: characteristics of available products and practical considerations from a panel of Italian experts". J Prev Med Hyg. 59 (2): E107–E119. PMC 6069402. PMID 30083617.
  2. Obando-Pacheco, Pablo; et al. (2017). "New perspectives for hexavalent vaccines". Vaccine. doi:10.1016/j.vaccine.2017.06.063.
  3. "6-in-1 Vaccine". Vaccine Knowledge Group. 29 June 2018. Retrieved 3 July 2018.
  4. "Vaxelis Approval History". Drugs.com. 30 December 2018. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  5. "Hexavac". European Medicines Agency (EMA). Retrieved 28 June 2018.
  6. "Hexaxim H-W-2495". European Medicines Agency (EMA). Retrieved 28 June 2018.
  7. "Hexyon". European Medicines Agency (EMA). Retrieved 28 June 2018.
  8. "Vaxelis". European Medicines Agency (EMA). Retrieved 28 June 2018.
  9. "Infanrix Hexa". European Medicines Agency (EMA). 27 March 2019. Retrieved 16 October 2019.
  10. "Hexavac". European Medicines Agency (EMA). 16 August 2012. Retrieved 16 October 2019.
  11. "European Medicines Agency recommends suspension of Hexavac". European Medicines Agency (EMA) (Press release). 20 September 2005. Retrieved 16 October 2019.
  12. "European Medicines Agency gives first opinion for a vaccine for use outside the EU". European Medicines Agency (EMA) (Press release). 22 June 2012. Retrieved 16 October 2019.
  13. "Hexyon". European Medicines Agency (EMA). 3 June 2019. Retrieved 16 October 2019.
  14. "Vaxelis". European Medicines Agency (EMA). 19 February 2019. Retrieved 16 October 2019.
  15. Syed YY (February 2017). "DTaP5-HB-IPV-Hib Vaccine (Vaxelis®): A Review of its Use in Primary and Booster Vaccination". Paediatr Drugs. 19 (1): 69–80. doi:10.1007/s40272-016-0208-y. PMID 28035545.
  16. "Vaxelis". U.S. Food and Drug Administration (FDA). 17 October 2019. STN 125563. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
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