|Hepatitis B vaccine||Vaccine|
|Trade names||Infanrix hexa, Hexyon, Vaxelis, others|
|AHFS/Drugs.com||Professional Drug Facts|
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.
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. 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 (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, is manufactured by GlaxoSmithKline.
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. 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 17 April 2013, marketing approval in the EU was granted to Hexyon.
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 3-dose series in infants at ages two, four, and six months. 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).
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- "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.
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- "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.
- 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. This article incorporates text from this source, which is in the public domain.
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