Sanofi Pasteur

French vaccines manufacturing division of Sanofi

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45°43′37″N 4°50′37″E﻿ / ﻿45.727°N 4.8437°E﻿ / 45.727; 4.8437

Sanofi PasteurCompany type| Division

|

Founded| August 2004; 19 years ago (2004-08) by merger
Headquarters| 14 Espace Henry Vallée,

Lyon

France

Key people

| David Loew Executive Vice President, Vaccines[1]
Revenue| €4.74 billion (2015)

Number of employees

| 15,000
Parent| Sanofi

Sanofi Pasteur is the vaccines division of the French multinational pharmaceutical company Sanofi. Sanofi Pasteur is the largest company in the world devoted entirely to vaccines. It is one of four global producers of the yellow fever vaccine.[2]

## History[edit]

Main article: Sanofi Biogenius Canada

Since 1992, Sanofi Pasteur has sponsored Sanofi Biogenius Canada (SBC), a national, biotechnology-focused science competition for Canadian high school and CEGEP students. Those selected for the SBC work with local mentors, giving students hands-on research experience in a professional lab setting. Participants compile their results and present their findings at regional competitions. Cash prizes are awarded and regional winners advance to the National stage, where they vie for the top spot and the chance to compete in the International BioGENEius Challenge, held at the prestigious BIO International Convention – the largest biotechnology event in the world.

In 2004, Aventis merged with and into Sanofi. The new Sanofi-Aventis Group became the world's 3rd largest pharmaceutical company. Aventis Pasteur, the vaccine division of Sanofi-Aventis Group,[3][4] changed its name to Sanofi Pasteur.[5] In 2014, Sanofi Pasteur stopped producing its effective Fav-Afrique antivenom because competition from cheaper though less powerful competitors made it unprofitable.[6] Doctors Without Borders said that it would take two years to develop a similar antivenom, and that existing stocks would run out in June 2016.[6]

Further information: BCG vaccine § Supply shortage

In the fall of 2011 the Sanofi Pasteur plant flooded, causing problems with mold.[7] The facility, located in Toronto, Ontario, Canada, produced BCG vaccine products made with the Glaxo 1077 strain,[8] such as a tuberculosis vaccine and ImmuCYST, a BCG immunotherapeutic and bladder cancer drug. By April 2012 the FDA had found dozens of documented problems with sterility at the plant including mold, nesting birds and rusted electrical conduits, as well as numerous procedural safety issues and violations.[7] The resulting closure of the plant for over two years resulted in shortages of bladder cancer and tuberculosis vaccines.[9] On October 29, 2014 Health Canada gave the permission for Sanofi to resume production of BCG.[10]

Main article: Dengvaxia controversy

The Philippine Department of Health began in 2016 a programme in three regions to vaccinate schoolchildren against dengue fever, using Dengvaxia supplied by Sanofi Pasteur. On 29 November 2017, Sanofi issued a caution stating that new analysis had shown that those vaccinated who had not previously been infected with dengue ran a greater risk of infection causing severe symptoms. On 1 December 2017, the Philippine DOH placed the programme on hold, pending review. Over 700,000 people had received at least one vaccination at that point.[11][12] Since the announcement by Sanofi, at least 62 children have died, allegedly after receiving a vaccination. The victims' parents blamed the dengue vaccine for the deaths of their children.[13]

In July 2020, Sanofi Pasteur announced that it would begin phase three testing of a COVID-19 vaccine in several countries, including Mexico, and that the cost would be US $7 to $10 per dose.[14] If data are positive, a global phase 3 study could start in Q2 2021. If the vaccine meets clinical requirements on safety and effectiveness, approved by regulatory authorities, a vaccine can expected in the fourth quarter of 2021.[15] One of the vaccines ordered by the Netherlands for the mass anti-coronavirus vaccination programme in 2021 seems not to work well in elderly people and the development of the vaccine will face delays.[16]

In 2021, Sanofi Toronto announced it was seeking to start a new Biosafety level 3 laboratory.[17]

### Key dates[edit]

* 1897: Marcel Mérieux creates the Mérieux Biological Institute in Lyon. Richard Slee creates the Pocono Biological Laboratories, in Swiftwater, Pennsylvania in the U.S.[18][19]
* 1914: John G. FitzGerald creates Connaught Laboratories,[20] part of the University of Toronto.
* 1968: Rhône-Poulenc acquires 51% of the capital of the Institut Mérieux.
* 1974: Pasteur Institute creates Pasteur Production, a subsidiary specializing in manufacturing vaccines.
* 1978: Connaught Laboratories in Canada acquires the vaccine manufacturing facility (Merrell-National Laboratories) at Swiftwater, Pennsylvania, U.S.
* 1985: Pasteur Production is acquired by the Mérieux Institute, and Pasteur Vaccins is created.
* 1989: The Mérieux Institute acquires the Connaught Laboratories in Canada and its subsidiaries and becomes a world leader in human biology.
* 1990: Creation of Pasteur Mérieux Serums & Vaccins.
* 1994: Pasteur Mérieux Sérums & Vaccins becomes a wholly owned subsidiary of Rhône-Poulenc.
* 1996: Pasteur Mérieux Connaught is the new name of Pasteur Mérieux Serums et Vaccins.
* 1999: Rhône-Poulenc and Hoechst unite their Life Sciences activities in a single company, which takes on the name Aventis. Within this group, Pasteur Mérieux Connaught changes its name to Aventis Pasteur.
* 2004: merger of Aventis with and into Sanofi. The new Sanofi-Aventis Group becomes the world's 3rd largest pharmaceutical company, behind Pfizer and GlaxoSmithKline. Aventis Pasteur, the vaccine division of the Sanofi-Aventis Group, changes its name to Sanofi Pasteur.
* 2008: Sanofi Pasteur acquires Acambis plc, a biotech company.
* 2009: Sanofi Pasteur acquires major stake in Hyderabad-based Shantha Biotechnics.[21]
* 2020: Sanofi Pasteur and GlaxoSmithKline have said they are starting clinical trials of their coronavirus vaccine. They hope to have the first results of the trial by December and if it is successful they will move on to further trials by the end of the year.[22]

## Key facts & figures in 2012[edit]

Sanofi Pasteur

* 2012 net sales: €3,897 million (+5.7% over 2011)
* Staff: nearly 13,000 employees worldwide
* More than 1 billion doses of vaccines produced yearly to immunize more than 500 million people in the world
* Largest product range available, against 20 infectious diseases
* More than €1 million invested every day in R&D
* Nearly €2 billion invested in the last 5 years in production infrastructures.
* Headquarters: Lyon, France
* 14 production and/or R&D sites located in:
* Marcy-l'Étoile and Val-de-Reuil, France
* Swiftwater, Pennsylvania (Sanofi Pasteur's United States headquarters),[23] Cambridge, Massachusetts and Canton, Massachusetts, Orlando, Florida and Rockville, Maryland, United States
* Toronto, Ontario, Canada
* Pilar, Buenos Aires Province, Argentina
* Shenzhen, China
* Hyderabad, India
* Ocoyoacac, Mexico
* Chachoengsao, Thailand
* Neuville-sur-Saône, France[24]

## Vaccines[edit]

This list is for vaccines with trade names; Sanofi Pasteur also produces many generic vaccines which do not have trade names[25]

* Cancer vaccines
* bladder cancer: TheraCys[26]
* Coronavirus vaccines
* A COVID-19 vaccine is under development by the French pharmaceutical and the British pharmaceutical company GlaxoSmithKline.[27] Advanced clinical trials of the vaccine were delayed in December 2020 after it failed to produce a strong immune response in people over the age of 50, most likely due to an insufficient antigen concentration in the vaccine, delaying the launch of the vaccine to late 2021.[28]
* Dengue vaccines
* Dengvaxia, approved in 18 countries[29][30]
* DPT vaccines[25][31]
* Adacel
* Daptacel
* Tripedia (Trepedia), discontinued, last shipped in 2012[32]
* Haemophilus influenzae type b vaccines
* ActHIB[25][31][33]
* Hepatitis A vaccines
* Avaxim 160 U[33] (or just Avaxim)[34]
* Hepatitis B vaccines[33]
* Genhevac B Pasteur
* Hbvaxpro (5, 10 and 40 μg)
* Influenza vaccines
* Addigrip[34]
* Flublok Quadrivalent
* Fluzone High-Dose
* Fluzone[31] (standard-dose; without preservatives; pediatric dose without preservatives)[34]
* Sandovac[34]
* Vaxigrip[33][34]
* Japanese encephalitis virus vaccines
* JE-VAX[26] (inactivated)
* IMOJEV (live, attenuated)[35]
* Measles vaccines
* Rouvax[33]
* Meningococcal vaccines
* Menactra, the first meningococcal vaccine approved for use in infants[26][31][36]
* Menomune-A/C/Y/W-135[26]
* Vaccin Meningococcique A+C[33]
* MMR vaccines
* M-M-RVaxPro[33]
* Pneumonia vaccines
* Pneumo 23[33][34]
* Polio vaccines
* Imovax Polio[33]
* Ipol[31]
* Polio Salk[34]
* Rabies vaccines
* Imovax Rabies[26] (Imovax)[31]
* Imogam Rabies-HT, rabies immune globulin[26]
* Vaccin Rabique Pasteur[33]
* Rubella vaccines
* Rudivax[33]
* Smallpox vaccines
* ACAM 2000[31]
* Tetanus vaccines
* Vaccin Tetanique Pasteur[33]
* Tuberculosis vaccines
* Mycobax[31]
* Tubersol[26]
* Vaccin Bcg Ssi[33]
* Typhoid fever vaccines
* Typhim Vi[25][33][31]
* Yellow fever vaccines
* Stamaril[33][34]
* YF-VAX[25][31][34]
* Diphtheria and tetanus combined vaccines
* DECAVAC[31]
* dT reduct[34]
* D. T. Vax[33]
* Diphtheria, tetanus and polio combined vaccines
* Revaxis[33]
* DPT, haemophilus combined vaccines
* TriHIBit, a booster vaccine, with DPT and haemophilus influenzae type b vaccines[26]
* DPT, polio combined vaccines
* Repevax[33][34]
* DPT, haemophilus, polio combined vaccines
* Pentacel[25][31]
* Pentavac[33]
* DPT, haemophilus, polio, hepatitis B combined vaccines
* Hexavac[34]
* Hepatitis A, typhoid fever combined vaccines
* Tyavax[33]

## References[edit]

1. ^ "Sanofi Announces Changes to Executive Committee Aligned to its Strategic Roadmap 2020" (Press release). Sanofi. 23 May 2016. Archived from the original on 3 June 2018. Retrieved 17 March 2017.[self-published source]
2. ^ "Yellow plague". The Economist. 14 May 2016. ISSN 0013-0613. Retrieved 19 May 2016.
3. ^ "Sanofi Pasteur VaccineHub". Sanofi Pasteur. Retrieved 1 March 2014.[self-published source]
4. ^ "Home - Sanofi".
5. ^ "Aventis Pasteur, the vaccine division of the Sanofi-aventis Group, changes its name to sanofi pasteur" (Press release). Sanofi-Aventis. 10 January 2005. Archived from the original on 25 May 2007. Retrieved 4 November 2007.[self-published source]
6. ^ a b "Snakebite anti-venom running out worldwide, MSF says". CBC News. Associated Press. 7 September 2015. Retrieved 8 September 2015.
7. ^ a b "April 2012 Inspectional Observations (form 483)", Vaccines, Blood & Biologics, U.S. Food and Drug Administration, April 2012, FEI No. 3002888623, archived from the original on 6 February 2016, retrieved 29 January 2016
8. ^ Fine, Paul E. M.; Carneiro, Ilona A. M.; Milstien, Julie B.; Clements, C. John (2004). Issues relating to the use of BCG in immunization programmes: A discussion document, WHO/V&B/99.23 (PDF). Geneva: WHO. p. 8\. Archived from the original (PDF) on 21 October 2012.
9. ^ Palmer, Eric (10 September 2014), "Merck again shipping BCG cancer treatment but Sanofi still is not: Shortages of bladder cancer and tuberculosis treatment have persisted for two years", FiercePharma, retrieved 29 January 2016
10. ^ Palmer, Eric (31 March 2015), "Sanofi Canada vax plant again producing ImmuCyst bladder cancer drug", FiercePharma, retrieved 29 January 2016
11. ^ Santos, Tina G (30 November 2017). "Pharma firm issues caution on use of anti-dengue vaccine". Inquirer.net. Retrieved 2 April 2018.
12. ^ "DOH suspends dengue immunization program over potential health risk". The Philippine Star. 1 December 2017. Retrieved 2 April 2017.
13. ^ "Anak namin namatay sa Dengvaxia" (in Tagalog). Archived from the original. Pilipino Star Ngayon. Retrieved December 20, 2017.
14. ^ "Sanofi-Pasteur probará en México su vacuna contra el coronavirus: esto es lo que se sabe". MARCA Claro México (in Mexican Spanish). 31 July 2020. Retrieved August 1, 2020.
15. ^ "Sanofi's Commitment to Fighting COVID-19".
16. ^ "Dutch coronavirus vaccination programme hit as Sanofi GSK vaccine faces delays". 11 December 2020.
17. ^ "Biosafety Officer Assistant". Alten Canada.
18. ^ "Why vaccinate?". Vaccine Hub. Sanofi Pasteur. Retrieved 1 March 2014.[self-published source]
19. ^ "Home - Sanofi". sanofipasteur.us. Sanofi Pasteur. Retrieved 19 February 2018.[self-published source]
20. ^ Rutty, Christopher J. (June 1966). "Connaught and the Canadian Polio Vaccine Story". CONNTACT (Employee News of Connaught Laboratories Limited). 9 (3). Retrieved 11 December 2012 - via Health Heritage Research Services.
21. ^ Mulugu, Somashekar (13 June 2011). "Top level changes at Shantha Biotechnics". The Hindu Business Line. Archived from the original on 21 October 2011.
22. ^ "Drugmakers Sanofi and GSK launch human trials for COVID-19 vaccine". Business Insider.
23. ^ "SanofiPasteur.us". Sanofi Pasteur. Retrieved 2 February 2018.[self-published source]
24. ^ "Sanofi en France" [Sanofi in France] (in French). Archived from the original on 8 July 2013.[self-published source]
25. ^ a b c d e f Meunier, Yann A. (2013). Tropical Diseases: A Practical Guide for Medical Practitioners and Students. Oxford University Press. List of FDA-Approved Vaccines. ISBN 9780199997923 - via Google Books (preview).
26. ^ a b c d e f g h "Sanofi Pasteur US Products". Sanofi Pasteur. Archived from the original on 14 January 2008. Retrieved 4 December 2007.[self-published source]
27. ^ "Coronavirus vaccine trial begun by drug firms GSK and Sanofi". BBC News. 3 September 2020.
28. ^ Taylor, Nick Paul (December 11, 2020). "Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine". Fierce Biotech. Retrieved January 25, 2021.
29. ^ "Philippines: 3 Deaths May be Linked to Dengue Vaccinations". Drug Discovery & Development Magazine. Associated Press. 2 February 2018. Retrieved 2 February 2018.
30. ^ "Dengue Vaccine Registered in 18 Countries". dengue.info. Sanofi Pasteur. Retrieved 2 February 2018.[self-published source]
31. ^ a b c d e f g h i j k l Turgeon, Mary Louise (2014). Immunology & Serology in Laboratory Medicine (5th ed.). St. Louis: Elsevier. pp. 215–6. ISBN 9780323085182. OCLC 814440874 - via Google Books (preview).
32. ^ "FDA Did Not Issue New Statement on Vaccines and Autism". Drug Discovery & Development. Business Advantage Media. Associated Press. 8 March 2018. Retrieved 8 March 2018.
33. ^ a b c d e f g h i j k l m n o p q r s t Meunier, Yann A. (2013). Tropical Diseases: A Practical Guide for Medical Practitioners and Students. Oxford University Press. List of Vaccines Available in France. ISBN 9780199997923 - via Google Books (preview).
34. ^ a b c d e f g h i j k l Pawelec, Graham (2008). Immunosenescence. Medical Intelligence Unit. New York: Springer. p. 110\. ISBN 9780387768427. OCLC 938883046 - via Google Books (preview).
35. ^ "IMOJEV MD". WHO \- Prequalification of Medical Products. Archived from the original on 29 March 2023.
36. ^ "FDA Grants Licensure To Expand Indication For Sanofi Pasteur's Menactra". RTTNews. 25 April 2011. Retrieved 26 April 2011.

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