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 term usually refers to the children's vaccine that protects against

diphtheria Diphtheria is an infection caused by the bacterium '' Corynebacterium diphtheriae''. Most infections are asymptomatic or have a mild clinical course, but in some outbreaks more than 10% of those diagnosed with the disease may die. Signs and s ...

tetanus Tetanus, also known as lockjaw, is a bacterial infection caused by ''Clostridium tetani'', and is characterized by muscle spasms. In the most common type, the spasms begin in the jaw and then progress to the rest of the body. Each spasm usually ...

pertussis Whooping cough, also known as pertussis or the 100-day cough, is a highly contagious bacterial disease. Initial symptoms are usually similar to those of the common cold with a runny nose, fever, and mild cough, but these are followed by two or t ...

, poliomyelitis,

haemophilus B ''Haemophilus influenzae'' (formerly called Pfeiffer's bacillus or ''Bacillus influenzae'') is a Gram-negative, Motility, non-motile, Coccobacillus, coccobacillary, facultative anaerobic organism, facultatively anaerobic, Capnophile, capnophili ...

, and

hepatitis B Hepatitis B is an infectious disease caused by the '' Hepatitis B virus'' (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection. Many people have no symptoms during an initial infection. ...

, which is used in more than 90 countries around the world including in Europe, Canada, Australia, and New Zealand.

Formulations

The generic vaccine is known as diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate eningococcal protein conjugateand hepatitis b ecombinantvaccine. 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 Sanofi Pasteur is the vaccines division of the French multinational pharmaceutical company Sanofi. Sanofi Pasteur is the largest company in the world devoted entirely to vaccines. It is one of four global producers of the yellow fever vaccine. ...

. 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.

EU approval

On 23 October 2000, the

European Commission The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...

issued marketing approval for Hexavac and for Infanrix hexa. Marketing approval for Hexavac was suspended in November 2005, on the advice of the agency's

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regardin ...

(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 21 June 2012, the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

(EMA) issued a positive first opinion on Hexaxim for use outside the EU, in cooperation with the

World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...

(WHO), but later withdrew the opinion. On 17 April 2013, marketing approval in the EU was granted to Hexyon and to Hexacima. On 15 February 2016, marketing approval in the EU was granted to Vaxelis.

US approval

On 21 December 2018, the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(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. On 26 June 2019, the

Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...

(CDC)

Advisory Committee on Immunization Practices The Advisory Committee on Immunization Practices (ACIP) is a committee within the United States Centers for Disease Control and Prevention (CDC) that provides advice and guidance on effective control of vaccine-preventable diseases in the U.S. c ...

(ACIP) voted to include DTaP-IPV-Hib-HepB in the federal

Vaccines for Children Program The Vaccines for Children Program (VFC) is a federally funded program in the United States providing no-cost vaccines to children who lack health insurance or who otherwise cannot afford the cost of the vaccination. The VFC program was created b ...

(VFC).

References

{{DEFAULTSORT:Hexavalent Vaccine Combination vaccines Diphtheria Haemophilus Hepatitis B Polio Tetanus Vaccines Whooping cough