Our vaccine solution

Combination vaccines are increasingly a cornerstone of infant immunization programs.

MCM partnership objective

Was to leverage the extensive expertise of MSD and Sanofi Pasteur Inc. to develop a combination vaccine that uses antigens from both companies^(1-2).

MCM Vaccine has developed a 6-in-1 vaccine indicated for the primary and booster vaccinations from the age of six weeks, against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and diseases caused by Haemophilus type b (Hib)⁽³⁾.

The European Medicines Agency granted marketing authorization for this vaccine, under the brand name of Vaxelis® - diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine (adsorbed) - in February 2016⁽⁴⁾.

Please read the full information about the product posted here.

US FDA granted marketing authorization for this vaccine, under the brand name of Vaxelis®, in December 2018⁽⁵⁾.

Swissmedic granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in August 2019⁽⁶⁾. The MAH in Switzerland is FutureHealth Pharma GmbH.

Australian TGA granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in March 2022⁽⁷⁾.

For United Kingdom, the EU/EEA marketing authorisation of Vaxelis has been converted into an United Kingdom marketing authorisation effective in Great Britain since 1 January 2021⁽⁸⁾.

For additional information, please consult your health care provider.

Diphtheria

Diphtheria is a highly contagious disease caused by the bacterium Corynebacterium diphtheria, which produces a toxin that can affect the throat and skin, and can cause damage to the heart and other organs and death⁽⁹⁾.

TETANUS

Tetanus is a serious disease caused by the bacterium Clostridium tetani, which produces a toxin that affects the body's muscles and nerves and can cause death. Usually the bacterium infects the body through a wound⁽¹⁰⁾.

Pertussis (whooping cough)

Pertussis is a highly contagious bacterial infection of the respiratory tract which can cause serious illness in infants, including death⁽¹¹⁾.

Hepatitis B (Hep B)

Hep B is a viral infection of the liver and can cause cirrhosis, primary liver cancer and death⁽¹²⁾.

Poliomyelitis (Polio)

Polio is a highly infectious disease caused by the poliovirus, which affects the nerves and can lead to muscle weakness or paralysis or death^(13-14).

Haemophilus type b (Hib) diseases

Hib is a bacterium that can cause severe invasive diseases in infants, such as meningitis, with neurologic sequelae and death⁽¹⁵⁾.

MCM partnership objective

Was to leverage the extensive expertise of MSD and Sanofi Pasteur Inc. to develop a combination vaccine that uses antigens from both companies^(1-2).

Please read the full information about the product posted here.

US FDA granted marketing authorization for this vaccine, under the brand name of Vaxelis®, in December 2018⁽⁵⁾.

Swissmedic granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in August 2019⁽⁶⁾. The MAH in Switzerland is FutureHealth Pharma GmbH.

Australian TGA granted marketing authorization for this vaccine, also under the brand name of Vaxelis®, in March 2022⁽⁷⁾.

For United Kingdom, the EU/EEA marketing authorisation of Vaxelis has been converted into an United Kingdom marketing authorisation effective in Great Britain since 1 January 2021⁽⁸⁾.

For additional information, please consult your health care provider.

(1) European Medicines Agency (EMA): Assessment report VAXELIS. https://www.ema.europa.eu/en/documents/assessment-report/vaxelis-epar-public-assessment-report_en.pdf Last accessed December 2023).

(2) Andrew W. Lee, Emilia Jordanov, Florence Boisnard & Gary S. Marshall (2017) DTaP5-IPV-Hib-HepB, a hexavalent vaccine for infants and toddlers, Expert Review of Vaccines, 16:2, 85-92, DOI: 10.1080/14760584.2017.1268920.

(3) VAXELIS SmPC. European Medicines Agency [EMA]. https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis#ema-inpage-item-product-details (Last accessed December 2023).

(4) European Medicines Agency (EMA). EPAR summary for the public. Vaxelis. 2016. Sourcedat: https://www.ema.europa.eu/en/medicines/human/EPAR/vaxelis#ema-inpage-item-product-details (Last accessed December 2023).

(5) U.S Food & Drug Administration (FDA). Approval Letter – VAXELIS. 2018. Sourced at https://www.fda.gov/media/119466/download (Last accessed December 2023).

(6) Swissmedic. Vaxelis®, Injektionssuspension in einer Fertigspritze. Availableat: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines/vaxelis_injektionssuspension_fertigspritze.html (Last accessed December 2023).

(7) Australian Government, Department of Health and Aged Care, Therapeutic Goods Administration (TGA). Australianprescription medicine decision summaries – VAXELIS. 2022. Sourced at https://www.tga.gov.au/apm-summary/vaxelis (Last accessed December 2023).

(8) GOV.UK. Marketing authorisations, variations and licensing guidance. 2020. Sourced at https://www.gov.uk/guidance/converting-centrally-authorised-products-caps-to-uk-marketing-authorisations-mas-grandfathering-and-managing-lifecycle-changes (Last accessed December 2023).

(9) Centers for Disease Control and Prevention (CDC). Epidemiology and Prevention of Vaccine-Preventable Disease. Diphtheria. Hamborsky J, Kroger A, Wolfe C, eds. 13th ed. Washington, DC. Public Health Foundation. 2015;107-118. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/dip.pdf (Last accessed December 2023).

(10) CDC. Epidemiology and Prevention of Vaccine-Preventable Disease. Tetanus. Hamborsky J, Kroger A, Wolfe C, eds. 13th ed. Washington, DC. Public Health Foundation. 2015;341–351 https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/tetanus.pdf (Last accessed December 2023).

(11) CDC. Pertussis (Whooping cough). https://www.cdc.gov/pertussis/about/causes-transmission.html (Last accessed December 2023).

(12) WHO. Hepatitis B vaccines. WHO position paper. Wkly Epidemiol Rec. 2009;84(40):405–420.

(13) WHO. Polio vaccines: WHO position paper, March 2016. Weekly epidemiologcal record (WER), 2016; 91:145-168.

(14) WHO. Poliomyelitis - Fact sheet N°114, sourced at: http://www.who.int/mediacentre/factsheets/fs114/en/, (Last accessed December 2023).

(15) Natonal Health Service (UK). Haemophilus influenzae type b (Hib), sourcedat: http://www.nhs.uk/conditions/hib/pages/introduction.aspx, (Last accessed December 2023).