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][2] The term usually refers to the children's vaccine that protects against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus B, and hepatitis B,[1][2] which is used in more than 90 countries around the world including in Europe, Canada, Australia, and New Zealand.[1][3]

Hexavalent vaccine
Infanrix hexa vaccine (brand name of the 6-in-1 vaccine used in the UK)[1]
Combination of
Diphtheria vaccineVaccine
Pertussis vaccineVaccine
Tetanus vaccineVaccine
Hepatitis B vaccineVaccine
Polio vaccineVaccine
Clinical data
Trade namesInfanrix hexa, Hexyon, Vaxelis, Hexacima, others
AHFS/Drugs.comProfessional Drug Facts
License data
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
  • US: ℞-only
  • EU: Rx-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[5] 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.[10] In April 2012, the manufacturer Sanofi Pasteur voluntarily withdrew the product from the market.[11] The European Commission formally withdrew marketing permission on 28 June 2012.[11][5]

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[7] and to Hexacima.[13]

On 15 February 2016, marketing approval in the EU was granted to Vaxelis.[8][14]

US approval

On 21 December 2018, the U.S. Food and Drug Administration (FDA) licensed a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib) conjugate (meningococcal protein conjugate) and hepatitis B (HepB) (recombinant) vaccine, DTaP-IPV-Hib-HepB (Vaxelis), for use as a three-dose series in infants at ages two, four, and six months.[15][16] On 26 June 2019, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to include DTaP-IPV-Hib-HepB in the federal Vaccines for Children Program (VFC).[16]

References
  1. "6-in-1 Vaccine". Vaccine Knowledge Group. 29 June 2018. Retrieved 3 July 2018.
  2. Orsi A, Azzari C, Bozzola E, Chiamenti G, Chirico G, Esposito S, et al. (June 2018). "Hexavalent vaccines: characteristics of available products and practical considerations from a panel of Italian experts". Journal of Preventive Medicine and Hygiene. 59 (2): E107–E119. PMC 6069402. PMID 30083617.
  3. Obando-Pacheco P, Rivero-Calle I, Gómez-Rial J, Rodríguez-Tenreiro Sánchez C, Martinón-Torres F (August 2018). "New perspectives for hexavalent vaccines". Vaccine. 36 (36): 5485–5494. doi:10.1016/j.vaccine.2017.06.063. PMID 28676382.
  4. "Vaxelis Approval History". Drugs.com. 30 December 2018. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  5. "Hexavac EPAR". European Medicines Agency (EMA). 16 August 2012. Retrieved 16 October 2019.
  6. "Hexaxim H-W-2495". European Medicines Agency (EMA). Retrieved 28 June 2018.
  7. "Hexyon EPAR". European Medicines Agency (EMA). Retrieved 28 June 2018.
  8. "Vaxelis EPAR". European Medicines Agency (EMA). 19 February 2019. Retrieved 16 October 2019.
  9. "Infanrix Hexa EPAR". European Medicines Agency (EMA). 27 March 2019. Retrieved 16 October 2019.
  10. "European Medicines Agency recommends suspension of Hexavac". European Medicines Agency (EMA) (Press release). 20 September 2005. Retrieved 16 October 2019.
  11. "Public statement on Hexavac [diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis b (recombinant) and haemophilus influenzae type b conjugate vaccine, adjuvanted] Withdrawal of marketing authorisation in the European Union" (PDF). European Medicines Agency (EMA). 24 July 2012.
  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. "Hexacima EPAR". European Medicines Agency (EMA). Retrieved 30 September 2020.
  14. 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. S2CID 25164446.
  15. "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. This article incorporates text from this source, which is in the public domain.
  16. Oliver SE, Moore KL (6 February 2020). "Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants" (PDF). MMWR. Morbidity and Mortality Weekly Report. 69 (5): 136–9. doi:10.15585/mmwr.mm6905a5. ISSN 0149-2195. PMC 7004397. PMID 32027629. This article incorporates text from this source, which is in the public domain.
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