 Infanrix hexa vaccine (one of two brands of the 6-in-1 vaccine used in the UK)[1] | |
| Combination of | |
|---|---|
| Diphtheria vaccine | Vaccine |
| Pertussis vaccine | Vaccine |
| Tetanus vaccine | Vaccine |
| Hepatitis B vaccine | Vaccine |
| Polio vaccine | Vaccine |
| Haemophilus vaccine | Vaccine |
| Clinical data | |
| Trade names | Infanrix hexa, Hexyon, Vaxelis, others |
| AHFS/Drugs.com | Professional Drug Facts |
| License data | |
| Pregnancy category | |
| Routes of administration | Intramuscular |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| ChemSpider |
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Ahexavalent vaccine, or6-in-1 vaccine, is acombination vaccine with six individual vaccines conjugated into one, intended to protect people from multiple diseases.[1][9] The term usually refers to the children's vaccine that protects againstdiphtheria,tetanus,pertussis,poliomyelitis,haemophilus B, andhepatitis B,[1][9] which is used in more than 90 countries around the world including in Europe, Canada, Australia, Jordan, and New Zealand.[1][10]
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.[11] The liquid vaccine is also known in abbreviated form as DTaP-HepB-IPV-Hib or DTPa-HepB-IPV-Hib. Branded formulations include Hexavac,[4] Hexaxim,[12] Hexyon,[5] and Vaxelis[6] manufactured bySanofi 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,[8] is manufactured byGlaxoSmithKline.
In October 2000, theEuropean Commission issued marketing approval for Hexavac[4] and for Infanrix hexa.[8]
Marketing approval for Hexavac was suspended in November 2005, on the advice of the agency'sCommittee for Medicinal Products for Human Use (CHMP) in view of the variability of its long-term protection against hepatitis B.[13] In April 2012, the manufacturer Sanofi Pasteur voluntarily withdrew the product from the market.[14] The European Commission formally withdrew marketing permission in June 2012.[14][4]
In June 2012, theEuropean Medicines Agency (EMA) issued a positive first opinion on Hexaxim for use outside the EU, in cooperation with theWorld Health Organization (WHO),[15] but later withdrew the opinion.[16]
In April 2013, marketing approval in the EU was granted to Hexyon[5] and to Hexacima.[7]
In February 2016, marketing approval in the EU was granted to Vaxelis.[6][17]
In December 2018, the USFood 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.[18][19] In June 2019, theCenters for Disease Control and Prevention (CDC)Advisory Committee on Immunization Practices (ACIP) voted to include DTaP-IPV-Hib-HepB in the federalVaccines for Children Program (VFC).[19]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
