Hexavalent vaccines | NITAG RESOURCE CENTER

Burden & epidemiology

Number of new cases per year (last 3-5 years)

NOT RELEVANT FOR CURRENT DECISIONS - PLEASE CONSULT THE RELEVANT WHO POSITION PAPERS. ^{Go to footnote 11, Go to footnote 22, Go to footnote 33, Go to footnote 44, Go to footnote 55, Go to footnote 66, Go to footnote 77, Go to footnote 88} For disease burden for relevant diseases (at least D,T,P) countries can consult the WHO JRF data for their country, or subregion per WHO JRF. ^{Go to footnote 99}

Proportion of the population affected by the disease or infected with the antigen

NOT RELEVANT FOR CURRENT DECISIONS - PLEASE CONSULT THE RELEVANT WHO POSITION PAPERS. ^{Go to footnote 11, Go to footnote 22, Go to footnote 33, Go to footnote 44, Go to footnote 55, Go to footnote 66} For disease burden for relevant diseases (at least D,T,P) countries can consult the WHO JRF data for their country, or subregion per WHO JRF. ^{Go to footnote 1010}

Serogroup or serotype distribution (for serogroup- or serotype-specific vaccines)

NOT RELEVANT FOR CURRENT DECISIONS - PLEASE CONSULT THE RELEVANT WHO POSITION PAPERS ^{Go to footnote 11, Go to footnote 22, Go to footnote 33, Go to footnote 44, Go to footnote 55, Go to footnote 66, Go to footnote 77, Go to footnote 88}

Number of deaths from the disease per year

Case Fatality ratio (number of deaths / number of new cases, in %)

NOT RELEVANT FOR CURRENT DECISIONS - PLEASE CONSULT THE RELEVANT WHO POSITION PAPERS

Outbreak, epidemic or pandemic risk

Diphtheria, though largely controlled in many regions thanks to vaccination, outbreaks are still reported today, especially in populations with low immunization coverage, high mobility, or poor living conditions. ^{Go to footnote 1111} Diphtheria outbreaks have been reported in various settings, including refugee camps in Asia, and among asylum seekers in Europe. ^{Go to footnote 1212, Go to footnote 1313}
Tetanus is generally rare in areas with high vaccination coverage, and since it is acquired from environmental sources, it does pose a risk for outbreaks. ^{Go to footnote 1414}
Pertussis has a well-documented history of causing outbreaks, even in populations with high vaccination coverage. Recent trends show that pertussis continues to have significant outbreak potential worldwide, affecting both children and adults, and posing particular risks to infants. ^{Go to footnote 1515, Go to footnote 1616}
Hepatitis B has significant potential for outbreaks, especially in settings with poor infection control or low vaccination coverage. Outbreaks of hepatitis B have been documented in both healthcare and community settings, and the virus remains a persistent public health threat in many regions. ^{Go to footnote 1717, Go to footnote 1818}
Prior to widespread vaccination, small outbreaks or clusters of cases of Hib disease have been noted in day-care centres and there were reports of nosocomial transmission in hospitals. The risk of Hib disease was also higher in larger families. ^{Go to footnote 1919}
The risk of poliovirus outbreaks and localised epidemics remains significant in areas with low vaccination coverage, fragile health systems, or gaps in immunization campaigns, particularly in regions experiencing conflict or displacement. Wild poliovirus (WPV) is endemic to Afghanistan and Pakistan, while vaccine-derived poliovirus (cVDPV) outbreaks have been reported in 20 countries in 2024. There is a rising risk of outbreaks of cVDPV2 since the global switch to bivalent oral poliovirus vaccine (bOPV). Although the global pandemic potential is low due to widespread immunity and effective vaccines, lapses in immunization and surveillance have led to the detection of poliovirus in environmental samples in previously polio-free countries. ^{Go to footnote 66, Go to footnote 77, Go to footnote 88, Go to footnote 2020}

Contribution of the vaccine to achievement of the national, regional or global disease goals

There are no established global elimination goals for Diphtheria or Pertussis (some countries have defined control goals for Diphtheria)

The Maternal and Neonatal Tetanus Elimination (MNTE) initiative, launched by the World Health Organization (WHO) in 1989, initially aimed to eliminate neonatal tetanus by 1995. As of June 2024, 47 out of 59 priority countries have achieved MNTE status, significantly reducing neonatal tetanus cases by 89% and deaths by 84% since 2000. Vaccination is the cornerstone of the strategy. Immunizing women of reproductive age with tetanus toxoid-containing vaccines (TTCVs) has been the primary driver of this reduction. ^{Go to footnote 2121, Go to footnote 2222}

There is a clear and internationally recognized goal to eliminate hepatitis B as a public health threat. The World Health Organization (WHO) has set a target to achieve hepatitis B elimination by 2030, aiming for a 90% reduction in new infections and a 65% reduction in deaths. Vaccination is the single most important tool in the global effort to eliminate Hepatitis B. Widespread and timely hepatitis B vaccination, especially starting at birth, dramatically reduces new infections, chronic disease, and deaths from liver complications. The prevalence of hepatitis B surface antigen (HBsAg) in children under 5 dropped from 4.7% before vaccination to 1.3% by 2015, thanks to universal vaccination programs in 189 countries. ^{Go to footnote 2323, Go to footnote 2424, Go to footnote 2525}

While no formal global Hib elimination goal is set by WHO, elimination of invasive Hib disease is considered biologically and programmatically possible, and has been achieved in some countries through high vaccination coverage. After the introduction of Hib conjugate vaccines, countries like the US, UK, and Canada saw a reduction in Hib disease incidence by over 95%, with some regions achieving near elimination of invasive Hib disease in children under five years old. More than 90% of countries have included Hib vaccines in their national immunization programs, resulting in significant global decreases in Hib disease, though complete eradication has not yet been achieved. ^{Go to footnote 2626, Go to footnote 2727}

Polio vaccination has reduced poliomyelitis cases by over 99.9% globally since the launch of the Global Polio Eradication Initiative in 1988. Coordinated immunization campaigns have led to the certification of polio-free status in the Americas (1994), the Western Pacific (2000), Europe (2002), and Africa (2020). Globally, the vaccines (Polio mono and multivalent and IPV-containing combination vaccines) have brought the world closer to eradicating wild poliovirus, which is now confined to Afghanistan and Pakistan. In addition, they play a critical role in controlling outbreaks of vaccine-derived poliovirus (cVDPV). ^{Go to footnote 2828, Go to footnote 2929, Go to footnote 3030, Go to footnote 3131, Go to footnote 3232}

Sources

Go back to footnote reference 1a Go back to footnote reference 1b Go back to footnote reference 1c Go back to footnote reference 1d
Diphtheria vaccine: WHO position paper, August 2017. Weekly Epidemiological Record. 2017; 92(31): 417–435.
Go back to footnote reference 2a Go back to footnote reference 2b Go back to footnote reference 2c Go back to footnote reference 2d
Tetanus vaccine: WHO position paper, February 2017. Weekly Epidemiological Record. 2017; 92(6): 53–76.
Go back to footnote reference 3a Go back to footnote reference 3b Go back to footnote reference 3c Go back to footnote reference 3d
Pertussis vaccine: WHO position paper, August 2015. Weekly Epidemiological Record. 2015; 90(35): 433–460.
Go back to footnote reference 4a Go back to footnote reference 4b Go back to footnote reference 4c Go back to footnote reference 4d
Hepatitis B vaccines: WHO position paper, July 2017. Weekly Epidemiological Record. 2017; 92(27): 369–392.
Go back to footnote reference 5a Go back to footnote reference 5b Go back to footnote reference 5c Go back to footnote reference 5d
Haemophilus influenzae type b (Hib) vaccine: WHO position paper, July 2013. Weekly Epidemiological Record. 2013; 88(39): 413–426.
Go back to footnote reference 6a Go back to footnote reference 6b Go back to footnote reference 6c Go back to footnote reference 6d Go back to footnote reference 6e
Polio vaccines: WHO position paper, June 2022. Weekly Epidemiological Record. 2022; 97(25): 277–296.7.
Go back to footnote reference 7a Go back to footnote reference 7b Go back to footnote reference 7c
Wild poliovirus count. In: Global Polio Eradication Initiative [website]. Geneva: Global Polio Eradication Initiative; 2025 (https://polioeradication.org/wild-poliovirus-count/, accessed 24 June 2025).
Go back to footnote reference 8a Go back to footnote reference 8b Go back to footnote reference 8c
Circulating vaccine-derived poliovirus count. In: Global Polio Eradication Initiative [website]. Geneva: Global Polio Eradication Initiative; 2025 (https://polioeradication.org/circulating-vaccine-derived-poliovirus-count/, accessed 24 June 2025).
Go back to footnote reference 9
Global immunization data. In: World Health Organization [website]. Geneva: World Health Organization; n.d. (https://immunizationdata.who.int/global?topic=Reported-cases-and-incidence&location=, accessed 11 July 2025).
Go back to footnote reference 10
Global immunization data. In: World Health Organization [website]. Geneva: World Health Organization; n.d. (https://immunizationdata.who.int/global?topic=&location=, accessed 11 July 2025).
Go back to footnote reference 11
Centers for Disease Control and Prevention (no date). Diphtheria: Chapter 1. In: Surveillance Manual. Atlanta: CDC. Available at: https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-1-diphtheria.html (accessed 1 July 2025).
Go back to footnote reference 12
Fatihatun R, Adnan N, Laila N (2024). Diphtheria outbreak in Serang City, Banten, Indonesia, 2024: epidemiological investigation and response. J Teknol Kesehat Borneo. doi:10.30602/jtkb.v5i2.354.
Go back to footnote reference 13
Brockhaus L, Urwyler P, Leutwyler U, Würfel E, Vasconcelos M, Goldenberger D et al. (2024). Diphtheria in a Swiss asylum seeker reception centre: outbreak investigation and evaluation of testing and vaccination strategies. Int J Public Health. doi:10.3389/ijph.2024.1606791.
Go back to footnote reference 14
Finkelstein P, Teisch L, Allen C, Ruiz G (2017). Tetanus: a potential public health threat in times of disaster. Prehosp Disaster Med. 32:339–342. doi:10.1017/S1049023X17000012.
Go back to footnote reference 15
Khalil A, Samara A, Campbell H, Ladhani SN, Amirthalingam G (2024). Recent increase in infant pertussis cases in Europe and the critical importance of antenatal immunizations: we must do better…now. Int J Infect Dis. 146:107148. doi:10.1016/j.ijid.2024.107148.
Go back to footnote reference 16
Bricks LF, Vargas-Zambrano JC, Macina D (2024). Epidemiology of pertussis after the COVID-19 pandemic: analysis of the factors involved in the resurgence of the disease in high-, middle-, and low-income countries. Vaccines (Basel). 12(12):1346. doi:10.3390/vaccines12121346.
Go back to footnote reference 17
Lanini S, Puro V, Lauria F, Fusco F, Nisii C, Ippolito G (2009). Patient to patient transmission of hepatitis B virus: a systematic review of reports on outbreaks between 1992 and 2007. BMC Med. 7:15. doi:10.1186/1741-7015-7-15.
Go back to footnote reference 18
Lee C, Emeto T, Walsh N (2022). Prevalence of hepatitis B virus amongst refugees, asylum seekers and internally displaced persons in low‐ and middle‐income countries: a systematic review. J Viral Hepat. 30:4–18. doi:10.1111/jvh.13770.
Go back to footnote reference 19
Shane AL, Pickering LK (2012). Infections associated with group childcare. In: Cherry JD, Demmler-Harrison GJ, Kaplan SL, Steinbach WJ, Hotez PJ, editors. Principles and practice of pediatric infectious diseases. 4th ed. Philadelphia: Elsevier Saunders; 2012:24–32.e6. doi:10.1016/B978-1-4377-2702-9.00102-1.
Go back to footnote reference 20
Namageyo-Funa A, Greene SA, Henderson E, et al. (2024). Update on Vaccine-Derived Poliovirus Outbreaks — Worldwide, January 2023–June 2024. MMWR Morb Mortal Wkly Rep. 2024;73:909–916. DOI: http://dx.doi.org/10.15585/mmwr.mm7341a1
Go back to footnote reference 21
Maternal and neonatal tetanus elimination (MNTE). In: World Health Organization [website]. Geneva: World Health Organization; no date (https://www.who.int/initiatives/maternal-and-neonatal-tetanus-elimination-%28mnte%29, accessed 24 June 2025).
Go back to footnote reference 22
Jones CE, Yusuf N, Ahmed B, Kassogue M, Wasley A, Kanu FA (2024). Progress toward achieving and sustaining maternal and neonatal tetanus elimination — worldwide, 2000–2022. MMWR Morb Mortal Wkly Rep. 73:614–621. DOI: http://dx.doi.org/10.15585/mmwr.mm7328a1.
Go back to footnote reference 23
Chen D (2009). Hepatitis B vaccination: the key towards elimination and eradication of hepatitis B. J Hepatol. 50(4):805–816. https://doi.org/10.1016/j.jhep.2009.01.002.
Go back to footnote reference 24
Al-Busafi S, Alwassief A (2024). Global perspectives on the hepatitis B vaccination: challenges, achievements, and the road to elimination by 2030. Vaccines. 12. https://doi.org/10.3390/vaccines12030288.
Go back to footnote reference 25
Zhao H, Zhou X, Zhou Y (2020). Hepatitis B vaccine development and implementation. Hum Vaccin Immunother. 16:1533–1544. https://doi.org/10.1080/21645515.2020.1732166.
Go back to footnote reference 26
Slack M, Esposito S, Haas H, Mihályi A, Nissen M, Mukherjee P, Harrington L (2020). Haemophilus influenzae type b disease in the era of conjugate vaccines: critical factors for successful eradication. Expert Rev Vaccines. 19:903–917. https://doi.org/10.1080/14760584.2020.1825948.
Go back to footnote reference 27
Gilsdorf J (2021). Hib vaccines: their impact on Haemophilus influenzae type b disease. J Infect Dis. 224:S321–S330. https://doi.org/10.1093/infdis/jiaa537.
Go back to footnote reference 28
Frequently asked questions and considerations for the introduction of hexavalent vaccine DTwP-HepB-Hib-IPV in routine immunization programmes. In: World Health Organization [website]. Geneva: World Health Organization; 2024 (https://www.technet-21.org/en/resources/guidance/frequently-asked-questions-and-considerations-for-the-introduction-of-hexavalent-vaccine-dtwp-hepb-hib-ipv-in-routine-immunization-programmes-june-2024, accessed 24 June 2025).
Go back to footnote reference 29
World Health Organization (2022). Polio vaccines: WHO position paper – June 2022. Wkly Epidemiol Rec. 97(25):277–296. Available at: https://www.who.int/publications/m/item/polio-vaccines-who-position-paper-june-2022 (accessed 24 June 2025).
Go back to footnote reference 30
Global Polio Eradication Initiative website. In: Global Polio Eradication Initiative [website]. Geneva: Global Polio Eradication Initiative; no date (https://polioeradication.org/, accessed 24 June 2025).
Go back to footnote reference 31
Poliomyelitis: Fact sheet. In: World Health Organization [website]. Geneva: World Health Organization; no date (https://www.who.int/news-room/fact-sheets/detail/poliomyelitis, accessed 24 June 2025).
Go back to footnote reference 32
Poliomyelitis overview. In: Centers for Disease Control and Prevention [website]. Atlanta: CDC; no date (https://www.cdc.gov/polio/index.html, accessed 24 June 2025).