Hexavalent vaccine

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Hexavalent vaccine
Infanrix hexa vaccine.jpg
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, Hexacima, others
AHFS/Drugs.com Professional Drug Facts
License data
Pregnancy
category
Routes of
administration 		Intramuscular
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [2] [3]
  • US: ℞-only
  • EU:Rx-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none

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] [4] The term usually refers to the children's vaccine that protects against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus B, and hepatitis B, [1] [4] which is used in more than 90 countries around the world including in Europe, Canada, Australia, Jordan, and New Zealand. [1] [5]

Contents

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. [6] The liquid vaccine is also known in abbreviated form as DTaP-HepB-IPV-Hib or DTPa-HepB-IPV-Hib. Branded formulations include Hexavac, [7] Hexaxim, [8] Hexyon, [9] and Vaxelis [10] 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, [11] is manufactured by GlaxoSmithKline.

Society and culture

In October 2000, the European Commission issued marketing approval for Hexavac [7] and for Infanrix hexa. [11]

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. [12] In April 2012, the manufacturer Sanofi Pasteur voluntarily withdrew the product from the market. [13] The European Commission formally withdrew marketing permission on 28 June 2012. [13] [7]

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), [14] but later withdrew the opinion. [15]

In April 2013, marketing approval in the EU was granted to Hexyon [9] and to Hexacima. [16]

In February 2016, marketing approval in the EU was granted to Vaxelis. [10] [17]

In 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. [18] [19] 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). [19]

Related Research Articles

ATC code J07Vaccines is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products. Subgroup J07 is part of the anatomical group J Antiinfectives for systemic use.

<span class="mw-page-title-main">DPT vaccine</span> Class of combination vaccines

The DPT vaccine or DTP vaccine is a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis, and tetanus. The vaccine components include diphtheria and tetanus toxoids and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either "DTwP" or "DTaP", where the lower-case "w" indicates whole-cell inactivated pertussis and the lower-case "a" stands for "acellular". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain the pathogen itself, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest. However, booster doses are recommended every ten years to maintain immune protection against these pathogens.

<i>Haemophilus influenzae</i> Species of bacterium

Haemophilus influenzae is a Gram-negative, non-motile, coccobacillary, facultatively anaerobic, capnophilic pathogenic bacterium of the family Pasteurellaceae. The bacteria are mesophilic and grow best at temperatures between 35 and 37 °C.

<span class="mw-page-title-main">Childhood immunizations in the United States</span>

The schedule for childhood immunizations in the United States is published by the Centers for Disease Control and Prevention (CDC). The vaccination schedule is broken down by age: birth to six years of age, seven to eighteen, and adults nineteen and older. Childhood immunizations are key in preventing diseases with epidemic potential.

<span class="mw-page-title-main">Hepatitis B vaccine</span> Vaccine against hepatitis B

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected.

<span class="mw-page-title-main">Hib vaccine</span> Haemophilus influenzae type B vaccine

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

<span class="mw-page-title-main">Diphtheria vaccine</span> Vaccine against diphtheria

Diphtheria vaccine is a toxoid vaccine against diphtheria, an illness caused by Corynebacterium diphtheriae. Its use has resulted in a more than 90% decrease in number of cases globally between 1980 and 2000. The first dose is recommended at six weeks of age with two additional doses four weeks apart, after which it is about 95% effective during childhood. Three further doses are recommended during childhood. It is unclear if further doses later in life are needed.

<span class="mw-page-title-main">Pertussis vaccine</span> Vaccine protecting against whooping cough

Pertussis vaccine is a vaccine that protects against whooping cough (pertussis). There are two main types: whole-cell vaccines and acellular vaccines. The whole-cell vaccine is about 78% effective while the acellular vaccine is 71–85% effective. The effectiveness of the vaccines appears to decrease by between 2 and 10% per year after vaccination with a more rapid decrease with the acellular vaccines. The vaccine is only available in combination with tetanus and diphtheria vaccines. Pertussis vaccine is estimated to have saved over 500,000 lives in 2002.

Panacea Biotec is an Indian multinational global generic and specialty pharmaceutical and vaccine maker. It has principal offices in New Delhi, Mumbai, and Lalru. It has business interests in research, development, manufacturing and marketing of pharmaceutical formulations, vaccines, biosimilars, and natural products.

A Vaccine Information Statement (VIS) is a document designed by the Centers for Disease Control and Prevention (CDC) to provide information to a patient receiving a vaccine in the United States. The National Childhood Vaccine Injury Act requires that medical professionals provide a VIS to patients before receiving certain vaccinations. The VIS includes information about the vaccine's benefits and risks, a description of the vaccine, indications and contraindications, instructions for patients experiencing an adverse reaction, and additional resources.

<span class="mw-page-title-main">Tetanus vaccine</span> Vaccines used to prevent tetanus

Tetanus vaccine, also known as tetanus toxoid (TT), is a toxoid vaccine used to prevent tetanus. During childhood, five doses are recommended, with a sixth given during adolescence.

A pentavalent vaccine, also known as a 5-in-1 vaccine, is a combination vaccine with five individual vaccines conjugated into one.

<span class="mw-page-title-main">DTaP-IPV vaccine</span> Vaccine against diphtheria, tetanus, whooping cough and polio

DTaP-IPV vaccine is a combination vaccine whose full generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (IPV).

DTaP-IPV/Hib vaccine is a 5-in-1 combination vaccine that protects against diphtheria, tetanus, whooping cough, polio, and Haemophilus influenzae type B.

DTaP-IPV-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated polio vaccine or DTaP-IPV-Hep B. It protects against the infectious diseases diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B.

DPT-Hib vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and whole-cell pertussis vaccine adsorbed with Hib conjugate vaccine, sometimes abbreviated to DPT-Hib. It protects against the infectious diseases diphtheria, tetanus, pertussis, and Haemophilus influenzae type B.

DTaP-Hib vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed with Haemophilus B conjugate vaccine, sometimes abbreviated to DTaP-Hib. It protects against the infectious diseases diphtheria, tetanus, pertussis, and Haemophilus influenzae type B.

DTP-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and whole-cell pertussis and hepatitis B (recombinant) vaccine (adsorbed) or DTP-Hep B. It protects against the infectious diseases diphtheria, tetanus, pertussis, and hepatitis B.

Trudy Virginia Noller Murphy is an American pediatric infectious diseases physician, public health epidemiologist and vaccinologist. During the 1980s and 1990s, she conducted research at Southwestern Medical School in Dallas, Texas on three bacterial pathogens: Haemophilus influenzae type b (Hib), Streptococcus pneumoniae (pneumococcus), and methicillin-resistant Staphylococcus aureus (MRSA). Murphy's studies advanced understanding of how these organisms spread within communities, particularly among children attending day care centers. Her seminal work on Hib vaccines elucidated the effects of introduction of new Hib vaccines on both bacterial carriage and control of invasive Hib disease. Murphy subsequently joined the National Immunization Program at the Centers for Disease Control and Prevention (CDC). where she led multi-disciplinary teams in the Divisions of Epidemiology and Surveillance and The Viral Hepatitis Division. Among her most influential work at CDC was on Rotashield™, which was a newly licensed vaccine designed to prevent severe diarrheal disease caused by rotavirus. Murphy and her colleagues uncovered that the vaccine increased the risk of acute bowel obstruction (intussusception). This finding prompted suspension of the national recommendation to vaccinate children with Rotashield, and led the manufacturer to withdraw the vaccine from the market. For this work Murphy received the United States Department of Health and Human Services Secretary's Award for Distinguished Service in 2000, and the publication describing this work was recognized in 2002 by the Charles C. Shepard Science Award from the Centers for Disease Control and Prevention.

References

  1. 1 2 3 4 "6-in-1 Vaccine". Vaccine Knowledge Group. 29 June 2018. Archived from the original on 3 July 2018. Retrieved 3 July 2018.
  2. 1 2 "Vaxelis APMDS". Therapeutic Goods Administration (TGA). 6 April 2022. Retrieved 24 April 2022.
  3. ↑ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  4. 1 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.
  5. ↑ 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. S2CID   4384043.
  6. ↑ "Vaxelis Approval History". Drugs.com. 30 December 2018. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  7. 1 2 3 "Hexavac EPAR". European Medicines Agency (EMA). 16 August 2012. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  8. ↑ "Hexaxim H-W-2495". European Medicines Agency (EMA). Archived from the original on 2 October 2018. Retrieved 28 June 2018.
  9. 1 2 "Hexyon EPAR". European Medicines Agency (EMA). Archived from the original on 25 June 2019. Retrieved 28 June 2018.
  10. 1 2 "Vaxelis EPAR". European Medicines Agency (EMA). 19 February 2019. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  11. 1 2 "Infanrix Hexa EPAR". European Medicines Agency (EMA). 27 March 2019. Archived from the original on 25 June 2019. Retrieved 16 October 2019.
  12. ↑ "European Medicines Agency recommends suspension of Hexavac". European Medicines Agency (EMA) (Press release). 20 September 2005. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  13. 1 2 "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. Archived (PDF) from the original on 21 December 2021. Retrieved 30 September 2022.
  14. ↑ "European Medicines Agency gives first opinion for a vaccine for use outside the EU". European Medicines Agency (EMA) (Press release). 22 June 2012. Archived from the original on 17 October 2019. Retrieved 16 October 2019.
  15. ↑ European Medicines Agency (14 June 2016). "Hexaxim: Opinion on medicine for use outside EU". European Medicines Agency. Archived from the original on 3 August 2022. Retrieved 30 September 2022.
  16. ↑ "Hexacima EPAR". European Medicines Agency (EMA). Archived from the original on 11 November 2020. Retrieved 30 September 2020.
  17. ↑ 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.
  18. ↑ "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  19. 1 2 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. Archived (PDF) from the original on 7 May 2020. Retrieved 30 September 2022.PD-icon.svg This article incorporates text from this source, which is in the public domain .
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