DTwP-HepB-Hib vaccine

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DTwP-HepB-Hib vaccine
Combination of
DTP vaccine Vaccine
Hepatitis B vaccine Vaccine
Haemophilus vaccine Vaccine
Clinical data
Trade names Quintavax, Pentavac, Pentacel, others
Routes of
administration 		Intramuscular injection
ATC code
Identifiers
CAS Number

DTwP-HepB-Hib vaccine is a 5-in-1 combination vaccine with five individual vaccines conjugated into one. [1] It protects against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type B, [1] which is generally used in middle- and low-income countries, where polio vaccine is given separately. [2] [3]

Contents

By 2013, pentavalent vaccines accounted for 100% of the DTP-containing vaccines procured by UNICEF, which supplies vaccines to a large proportion of the world's children. [4]

Safety

During studies and tests, the conjugated liquid DTPw-HepB-Hib vaccine was found to have positive safety when given as a booster to young children who have been given a vaccination course with another pentavalent booster that requires a change in constitution and was also found to be adequately immunogenic. [5]

History

In October 2004, the European Medicines Agency granted marketing approval to the pentavalent vaccine Quintanrix, manufactured by GlaxoSmithKline. [6] Quintanrix was voluntarily withdrawn by the manufacturer in 2008. [7] [8]

In September 2006, the first pentavalent vaccine formulation received pre-qualification approval from the World Health Organization. [9]

In 2012, UNICEF and the World Health Organization issued and recommended a joint statement to the Immunization Division, Ministry of Health and Family Welfare, Government of India and other developing nations in separate documents about the use of pentavalent vaccines to protect against five of the leading causes of vaccine-preventable death in children. [10]

By 2013, pentavalent vaccines accounted for 100% of the DTP-containing vaccines procured by UNICEF, which supplies vaccines to a large proportion of the world's children. [4]

In 2014, South Sudan became the last of the 73 GAVI-supported countries to introduce the five-in-one vaccine. [11]

Society and culture

In May 2010, Crucell N.V. announced a US$110 million award from UNICEF to supply its pentavalent pediatric vaccine Quinvaxem to the developing world. [12]

In November 2010, the public-private consortium GAVI announced that the cost of the pentavalent vaccine for emerging-market countries had dropped below US$3.00 per dose. [13]

High-income countries tend to use alternative formulations using acellular pertussis (Pa), which has a more favourable profile of side-effects, rather than whole-cell pertussis components. [14] [1] In Europe, hexavalent vaccines that also contain inactivated polio vaccine (IPV) are in wide use. [15]

India

In 2013, it was found that Pentavac PFS vaccines were being supplied with two different sets of packaging: One set with manufacturing and expiry dates was being provided to private hospitals, whereas the other set without manufacturing and expiry dates was being distributed to government hospitals. [17] It was later clarified that the undated vaccines were supplied by UNICEF and complied with Indian Law.[ citation needed ]

Sri Lanka

Sri Lanka introduced Quinvaxem in January 2008. Within three months, four reports of deaths and 24 reports of suspected hypotonic-hyporesponsive episodes prompted regulatory attention and precautionary suspension of the initial vaccine lot. A subsequent death that occurred with the next lot in April 2009 led the authorities to suspend pentavalent vaccine use and resume DTwP and hepatitis B vaccination. Following an investigation by independent national and international experts, the vaccine was reintroduced in 2010. [18]

Bhutan

Bhutan introduced Easyfive-TT in September 2009. The identification of five cases with encephalopathy and/or meningoencephalitis shortly after pentavalent vaccination prompted the authorities to suspend vaccination on 23 October 2009. Subsequently, four additional serious cases related to vaccine administered prior to suspension were identified and investigated. After a comprehensive review by independent national and international experts, the vaccine was reintroduced in 2011. [18]

Vietnam

Between December 2012 and March 2013 nine deaths were reported in Viet Nam of children who had recently received injections of the pentavalent vaccine Quinvaxem. [19] On 4 May 2013, the Ministry of Health of Viet Nam announced that use of Quinvaxem was suspended. [20]

After a review of the cases conducted by national experts together with staff from WHO and UNICEF and an independent clinician, no link with vaccination could be identified. [19] The fatalities reported in Viet Nam were attributed to coincidental health problems related in time but not related to the use of Quinvaxem, or cases for which the information available did not allow for a definite conclusion but there were no clinical signs that were consistent with the use of the vaccine. The WHO report emphasized that more than 400 million doses of Quinvaxem had been administered and that no fatal adverse event had ever been associated with Quinvaxem or similar vaccines. [20]

Following additional reports from India, Sri Lanka, and Bhutan of a small number of serious adverse events following immunization with pentavalent vaccines, the WHO asked a global panel of independent experts to review the safety of the vaccine. This review took place 12–13 June 2013 and concluded that no unusual reaction could be attributed to pentavalent vaccines. [21] On 20 June 2013, the Ministry of Health announced that Viet Nam would resume use of Quinvaxem. [18]

The reported events in these Asian nations caused public uncertainty regarding the use of pentavalent vaccines to spread to other developing nations. [22] In response to this, and a corresponding spread of inaccurate information about vaccine safety, the Indian Academy of Pediatrics released a statement in support of pentavalent vaccines. [23]

Formulations

Common versions of pentavalent vaccines include Quinvaxem, Pentavac PFS, Easyfive TT, ComBE Five, Shan5, and Pentabio. [24] [25]

Vaccine Manufacturer Date pre-qualified by WHO [9]
Quinvaxem Crucell [a] 26 September 2006
Pentavac PFS Serum Institute of India 23 June 2010
Easyfive TT Panacea Biotec 2 October 2013 [b]
ComBE Five Biological E. Limited 1 September 2011
Shan5 Shantha Biotechnics 29 April 2014
Pentabio Bio Farma 19 December 2014

Notes

  1. ↑ The vaccine was developed and manufactured by Crucell in Korea and co-produced by Chiron Corporation (later purchased by Novartis International AG on April 20, 2006), which provides four out of the five vaccine elements in bulk. [26] [27]
  2. ↑ Easyfive was removed from the WHO's list of pre-approved and prequalified vaccines in mid-2011. [28] It was re-approved by WHO on 2 October 2013. [9]

Related Research Articles

<span class="mw-page-title-main">Vaccination</span> Administration of a vaccine to protect against disease

Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating the body's adaptive immunity, they help prevent sickness from an infectious disease. When a sufficiently large percentage of a population has been vaccinated, herd immunity results. Herd immunity protects those who may be immunocompromised and cannot get a vaccine because even a weakened version would harm them. The effectiveness of vaccination has been widely studied and verified. Vaccination is the most effective method of preventing infectious diseases; widespread immunity due to vaccination is largely responsible for the worldwide eradication of smallpox and the elimination of diseases such as polio and tetanus from much of the world. However, some diseases, such as measles outbreaks in America, have seen rising cases due to relatively low vaccination rates in the 2010s – attributed, in part, to vaccine hesitancy. According to the World Health Organization, vaccination prevents 3.5–5 million deaths per year.

<span class="mw-page-title-main">DPT vaccine</span> Combination vaccine

The DPT vaccine or DTP vaccine is a class of combination vaccines to protect against three infectious diseases in humans: diphtheria, pertussis, and tetanus (lockjaw). 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 any live pathogen, 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.

<span class="mw-page-title-main">Vaccination schedule</span> Series of vaccinations

A vaccination schedule is a series of vaccinations, including the timing of all doses, which may be either recommended or compulsory, depending on the country of residence. A vaccine is an antigenic preparation used to produce active immunity to a disease, in order to prevent or reduce the effects of infection by any natural or "wild" pathogen. Vaccines go through multiple phases of trials to ensure safety and effectiveness.

<span class="mw-page-title-main">Pneumococcal vaccine</span> Vaccine to prevent infection by the bacteria Stretococcus pneumoniae

Pneumococcal vaccines are vaccines against the bacterium Streptococcus pneumoniae. Their use can prevent some cases of pneumonia, meningitis, and sepsis. There are two types of pneumococcal vaccines: conjugate vaccines and polysaccharide vaccines. They are given by injection either into a muscle or just under the skin.

<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.

The rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children. The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of the risk of death among young children due to severe diarrhea. Immunizing babies decreases rates of disease among older people and those who have not been immunized.

<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.

<span class="mw-page-title-main">Panacea Biotec</span> Indian pharmaceutical company

Panacea Biotec is a 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.

<span class="mw-page-title-main">GAVI</span> Global health organization

GAVI, officially Gavi, the Vaccine Alliance is a public–private global health partnership with the goal of increasing access to immunization in poor countries. In 2016, Gavi channeled more than half of total donor assistance for health, and most donor assistance for immunization, by monetary measure.

<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.

<span class="mw-page-title-main">Hexavalent vaccine</span> Single vaccine protecting against six individual diseases

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, 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.

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.

<span class="mw-page-title-main">Vaccination in Brazil</span>

Vaccination in Brazil includes all the practice and social issues related to vaccines in Brazil.

A pentavalent vaccine combines five vaccines into one dose. Pentavalent vaccines include:

References

  1. 1 2 3 "5-in-1 Vaccine (also called Pentavalent Vaccine)". Vaccine Knowledge Project. 22 March 2018. Retrieved 3 July 2018.
  2. ↑ World Health Organization, World Health Organization Department of Immunization, Vaccines and Biologicals (2004). Immunization in Practice: A Practical Guide for Health Staff. World Health Organization. p. 20. ISBN   9789241546515 . Retrieved 15 July 2018.
  3. ↑ Malhame M, Baker E, Gandhi G, Jones A, Kalpaxis P, Iqbal R, et al. (August 2019). "Shaping markets to benefit global health - A 15-year history and lessons learned from the pentavalent vaccine market". Vaccine. 2: 100033. doi:10.1016/j.jvacx.2019.100033. PMC   6668221 . PMID   31384748.
  4. 1 2 "Diphtheria Tetanus and Pertussis Vaccine Supply Update" (PDF). UNICEF. October 2016. Archived from the original (PDF) on 29 June 2018. Retrieved 28 June 2018.
  5. ↑ Suárez E, Asturias EJ, Hilbert AK, Herzog C, Aeberhard U, Spyr C (February 2010). "A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador". Revista Panamericana de Salud Pública. 27 (2): 117–24. doi: 10.1590/S1020-49892010000200005 (inactive 14 November 2024). PMID   20339615.{{cite journal}}: CS1 maint: DOI inactive as of November 2024 (link)
  6. ↑ "Quintanrix : EPAR - Summary for the public" (PDF). European Medicines Agency. Archived from the original (PDF) on 15 July 2018. Retrieved 15 July 2018.
  7. ↑ "Public statement on Quintanrix: Withdrawal of the marketing authorisation in the European Union". European Medicines Agency. 29 August 2008. Archived from the original on 15 July 2018. Retrieved 15 July 2018.
  8. ↑ "Quintanrix EPAR". European Medicines Agency. 25 September 2018. Retrieved 13 October 2023.
  9. 1 2 3 "WHO Prequalified Vaccines". World Health Organization . Retrieved 29 June 2018.
  10. ↑ "Pentavalent Vaccine" (PDF). World Health Organization .
  11. ↑ "With GAVI support, pentavalent vaccine is available in the 73 poorest countries". GAVI Alliance . Archived from the original on 18 July 2014. Retrieved 7 December 2015.
  12. ↑ "Crucell Announces New Award of $110 Million..." PRNewswire (Press release).
  13. ↑ "Price of life-saving vaccine expected to drop significantly in 2011". GAVI. 26 November 2010. Retrieved 3 July 2018.
  14. ↑ "Vaccine Market". World Health Organization. Archived from the original on 11 February 2015. Retrieved 28 June 2018.
  15. ↑ 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.
  16. 1 2 Malhame M, Baker E, Gandhi G, Jones A, Kalpaxis P, Iqbal R, et al. (August 2019). "Shaping markets to benefit global health - A 15-year history and lessons learned from the pentavalent vaccine market". Vaccine. 2: 100033. doi:10.1016/j.jvacx.2019.100033. PMC   6668221 . PMID   31384748.
  17. ↑ Rajiv G (13 December 2013). "Pentavalent vaccine maker claims Unicef exemption on manufacturing dates". Times Of India . Retrieved 3 July 2018.
  18. 1 2 3 "Update on quality and safety of Quinvaxem (DTwP-HepB-Hib) pentavalent vaccine". World Health Organization . 5 July 2013. Archived from the original on 30 August 2014. Retrieved 3 July 2018.
  19. 1 2 "Frequently Asked Questions (FAQs) Quinvaxem vaccine" (PDF). World Health Organization . Retrieved 30 June 2018.
  20. 1 2 "Safety of Quinvaxem (DTwP-HepB-Hib) pentavalent vaccine". World Health Organization . 10 May 2013. Archived from the original on 11 November 2013. Retrieved 30 June 2018.
  21. ↑ "Global Advisory Committee on Vaccine Safety, report of meeting held 12-13 June 2013". World Health Organization . 19 July 2013. Archived from the original on 22 December 2013. Retrieved 3 July 2018.
  22. ↑ Datta PT (22 September 2013). "Infant deaths cast shadow on scale-up of pentavalent vaccine use". The Hindu Business Line . Retrieved 3 July 2018.
  23. ↑ "Pentavalent vaccine is safe, assures IAP". The Indian Express . Express News Service. 13 September 2013. Retrieved 3 July 2018.
  24. ↑ "Products". Vaccine World. Archived from the original on 6 April 2016. Retrieved 17 September 2014.
  25. ↑ "'Shan5' vaccine gets WHO nod". Business Standard . 5 May 2014.
  26. ↑ "Crucell's Quinvaxem gets WHO prequalification". The Pharma Letter .
  27. ↑ "Crucell Announces Product Approval in Korea for Quinvaxem Vaccine". Marketwired . Archived from the original on 29 June 2018. Retrieved 17 September 2014.
  28. ↑ "Pentavalent vaccine, Easyfive, removed from WHO list of prequalified vaccines". WHO . Archived from the original on 12 August 2013.

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