Hexavalent vaccine

{{Short description|Single vaccine protecting against six individual diseases}}

{{Infobox drug

| type = combo

| image = Infanrix hexa vaccine.jpg

| caption = Infanrix hexa vaccine (one of two brands of the 6-in-1 vaccine used in the UK){{cite web|url=http://vk.ovg.ox.ac.uk/6-in-1-vaccine|access-date=3 July 2018|date=29 June 2018|title=6-in-1 Vaccine|website=Vaccine Knowledge Group|archive-date=3 July 2018|archive-url=https://web.archive.org/web/20180703163800/http://vk.ovg.ox.ac.uk/6-in-1-vaccine|url-status=live}}

| component1 = Diphtheria vaccine

| class1 = Vaccine

| component2 = Pertussis vaccine

| class2 = Vaccine

| component3 = Tetanus vaccine

| class3 = Vaccine

| component4 = Hepatitis B vaccine

| class4 = Vaccine

| component5 = Polio vaccine

| class5 = Vaccine

| component6 = Haemophilus vaccine

| class6 = Vaccine

| tradename = Infanrix hexa, Hexyon, Vaxelis, others

| Drugs.com = {{drugs.com|ppa|diphtheria-and-tetanus-toxoids-acellular-pertussis-hepatitis-b-recombinant-poliovirus-inactivated-and-haemophilus-influenzae-b-conjugate-adsorbed-vaccine}}

| MedlinePlus =

| DailyMedID = Vaxelis

| pregnancy_AU = B2

| pregnancy_AU_comment =

| pregnancy_category=

| routes_of_administration = Intramuscular

| ATC_prefix = J07

| ATC_suffix = CA09

| ATC_supplemental =

| legal_AU = S4

| legal_AU_comment = {{cite web | title=Vaxelis APMDS | website=Therapeutic Goods Administration (TGA) | date=6 April 2022 | url=https://www.tga.gov.au/resources/auspmd/vaxelis | access-date=24 April 2022}}{{cite web | title=Prescription medicines: registration of new chemical entities in Australia, 2014 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 | access-date=10 April 2023 | archive-date=10 April 2023 | archive-url=https://web.archive.org/web/20230410065838/https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 | url-status=live }}

| legal_BR =

| legal_BR_comment =

| legal_CA =

| legal_CA_comment =

| legal_DE =

| legal_DE_comment =

| legal_NZ =

| legal_NZ_comment =

| legal_UK =

| legal_UK_comment =

| legal_US = Rx-only

| legal_US_comment =

| legal_EU = Rx-only

| legal_EU_comment =

| legal_UN =

| legal_UN_comment =

| legal_status = Rx-only

| CAS_number = 756896-32-9

| CAS_supplemental =

| PubChem =

| PubChemSubstance =

| IUPHAR_ligand =

| DrugBank =

| ChemSpiderID = none

| UNII =

| KEGG =

| ChEBI =

| ChEMBL =

| synonyms =

}}

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.{{cite journal | vauthors = Orsi A, Azzari C, Bozzola E, Chiamenti G, Chirico G, Esposito S, Francia F, Lopalco P, Prato R, Russo R, Villani A, Franco E | title = Hexavalent vaccines: characteristics of available products and practical considerations from a panel of Italian experts | journal = Journal of Preventive Medicine and Hygiene | volume = 59 | issue = 2 | pages = E107–E119 | date = June 2018 | pmid = 30083617 | pmc = 6069402 }} The term usually refers to the children's vaccine that protects against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus B, and hepatitis B, which is used in more than 90 countries around the world including in Europe, Canada, Australia, Jordan, and New Zealand.{{cite journal | vauthors = Obando-Pacheco P, Rivero-Calle I, Gómez-Rial J, Rodríguez-Tenreiro Sánchez C, Martinón-Torres F | title = New perspectives for hexavalent vaccines | journal = Vaccine | volume = 36 | issue = 36 | pages = 5485–5494 | date = August 2018 | pmid = 28676382 | doi = 10.1016/j.vaccine.2017.06.063 | s2cid = 4384043 }}

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.{{cite web | title=Vaxelis Approval History | website=Drugs.com | date=30 December 2018 | url=https://www.drugs.com/history/vaxelis.html | access-date=16 October 2019 | archive-url=https://web.archive.org/web/20191017052525/https://www.drugs.com/history/vaxelis.html | archive-date=17 October 2019 | url-status=live }} The liquid vaccine is also known in abbreviated form as DTaP-HepB-IPV-Hib or DTPa-HepB-IPV-Hib. Branded formulations include Hexavac, Hexaxim,{{cite web|url=https://www.ema.europa.eu/en/hexaxim-h-w-2495|title=Hexaxim H-W-2495|access-date=28 June 2018|website=European Medicines Agency (EMA)|archive-date=2 October 2018|archive-url=https://web.archive.org/web/20181002181211/https://www.ema.europa.eu/en/hexaxim-h-w-2495|url-status=live}} Hexyon,{{cite web|url=https://www.ema.europa.eu/en/medicines/human/EPAR/hexyon|title=Hexyon EPAR|access-date=28 June 2018|website=European Medicines Agency (EMA)|date=12 July 2013 |archive-date=25 June 2019|archive-url=https://web.archive.org/web/20190625104554/https://www.ema.europa.eu/en/medicines/human/EPAR/hexyon|url-status=live}} and Vaxelis{{cite web|url=https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis|title=Vaxelis EPAR|access-date=16 October 2019|date=19 February 2019|website=European Medicines Agency (EMA)|archive-date=17 October 2019|archive-url=https://web.archive.org/web/20191017045354/https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis|url-status=live}} 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,{{cite web|url=https://www.ema.europa.eu/en/medicines/human/EPAR/infanrix-hexa|title=Infanrix Hexa EPAR|website=European Medicines Agency (EMA)|access-date=16 October 2019|date=27 March 2019|archive-date=25 June 2019|archive-url=https://web.archive.org/web/20190625092519/https://www.ema.europa.eu/en/medicines/human/EPAR/infanrix-hexa|url-status=live}} is manufactured by GlaxoSmithKline.

Society and culture

= Legal status =

In October 2000, the European Commission issued marketing approval for Hexavac{{cite web | title=Hexavac EPAR | website=European Medicines Agency (EMA) | date=16 August 2012 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hexavac | access-date=16 October 2019 | archive-date=17 October 2019 | archive-url=https://web.archive.org/web/20191017053939/https://www.ema.europa.eu/en/medicines/human/EPAR/hexavac | url-status=live }} 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 (CHMP) in view of the variability of its long-term protection against hepatitis B.{{cite press release | title=European Medicines Agency recommends suspension of Hexavac | website=European Medicines Agency (EMA) | date=20 September 2005 | url=https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-hexavac | access-date=16 October 2019 | archive-date=17 October 2019 | archive-url=https://web.archive.org/web/20191017055027/https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-hexavac | url-status=live }} In April 2012, the manufacturer Sanofi Pasteur voluntarily withdrew the product from the market.{{cite web | url=https://www.ema.europa.eu/en/documents/public-statement/public-statement-hexavac-withdrawal-marketing-authorisation-european-union_en.pdf | title=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 | website=European Medicines Agency (EMA) | date=24 July 2012 | access-date=30 September 2022 | archive-date=21 December 2021 | archive-url=https://web.archive.org/web/20211221174116/https://www.ema.europa.eu/en/documents/public-statement/public-statement-hexavac-withdrawal-marketing-authorisation-european-union_en.pdf | url-status=live }} The European Commission formally withdrew marketing permission in June 2012.

In June 2012, the European Medicines Agency (EMA) issued a positive first opinion on Hexaxim for use outside the EU, in cooperation with the World Health Organization (WHO),{{cite press release|url=https://www.ema.europa.eu/en/news/european-medicines-agency-gives-first-opinion-vaccine-use-outside-eu|website=European Medicines Agency (EMA)|access-date=16 October 2019|date=22 June 2012|title=European Medicines Agency gives first opinion for a vaccine for use outside the EU|archive-date=17 October 2019|archive-url=https://web.archive.org/web/20191017050451/https://www.ema.europa.eu/en/news/european-medicines-agency-gives-first-opinion-vaccine-use-outside-eu|url-status=live}} but later withdrew the opinion.{{Cite web |last=European Medicines Agency |date=14 June 2016 |title=Hexaxim: Opinion on medicine for use outside EU |url=https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/hexaxim |archive-date=3 August 2022 |website=European Medicines Agency |access-date=30 September 2022 |archive-url=https://web.archive.org/web/20220803091635/https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/hexaxim |url-status=live }}

In April 2013, marketing approval in the EU was granted to Hexyon and to Hexacima.{{cite web | title=Hexacima EPAR | website=European Medicines Agency (EMA) | date=12 July 2013 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hexacima | access-date=30 September 2020 | archive-date=11 November 2020 | archive-url=https://web.archive.org/web/20201111235841/https://www.ema.europa.eu/en/medicines/human/EPAR/hexacima | url-status=live }}

In February 2016, marketing approval in the EU was granted to Vaxelis.{{cite journal |vauthors=Syed YY |title=DTaP5-HB-IPV-Hib Vaccine (Vaxelis): A Review of its Use in Primary and Booster Vaccination |journal=Paediatr Drugs |volume=19 |issue=1 |pages=69–80 |date=February 2017 |pmid=28035545 |doi=10.1007/s40272-016-0208-y |s2cid=25164446 }}

In December 2018, the US 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.{{cite web | title=Vaxelis | website=U.S. Food and Drug Administration (FDA) | date=17 October 2019 | url=https://www.fda.gov/vaccines-blood-biologics/vaxelis | archive-url=https://web.archive.org/web/20191017044241/https://www.fda.gov/vaccines-blood-biologics/vaxelis | archive-date=17 October 2019 | url-status=live | access-date=16 October 2019 |id=STN 125563}} {{PD-notice}}{{cite journal | vauthors=Oliver SE, Moore KL | title=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 | journal=MMWR. Morbidity and Mortality Weekly Report | volume=69 | issue=5 | date=6 February 2020 | issn=0149-2195 | doi=10.15585/mmwr.mm6905a5 | pages=136–9 | pmid=32027629 | pmc=7004397 | url=https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6905a5-H.pdf | access-date=30 September 2022 | archive-date=7 May 2020 | archive-url=https://web.archive.org/web/20200507204934/https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6905a5-H.pdf | url-status=live }} {{PD-notice}} In 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).

References

Category:Combination vaccines

Category:Whooping cough