Asia Pacific Biotech News

Sanofi Pasteur’s tetravalent dengue vaccine, Dengvaxia^{^®}, was approved for use in individuals 9-45 years of age for the prevention of dengue fever caused by all four serotypes on 22nd December 2015 in the Philippines. It is the first vaccine licensed for the prevention of dengue in the world. The vaccine is produced in a dedicated production site in France with planned full-scale production capacity of 100 million vaccine doses annually.

Dengvaxia^{^®} was made available for private sector vaccination in the Philippines in February 2016. Doses have been shipped and received in the Philippines to support both private and public sector access to dengue vaccination.

Dengvaxia^{^®} has also been registered in Mexico, Brazil and El Salvador to date. Regulatory review for Dengvaxia^{^®} is continuing in other countries where dengue is a public health priority.

Sanofi Pasteur’s vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study programme (phase I, II and III. Large-scale safety and efficacy studies of Dengvaxia^{^®} were successfully completed in 2014 [5, 6]. The Philippines participated in all three phases of the clinical development of Dengvaxia^{^®}.

Pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were published in ^{The New England Journal of Medicine}

on 27th July 2015 documenting the vaccine’s consistent efficacy and longer-term safety profile in study population 9-16 years of age. In the pooled efficacy analysis in this age group, Dengvaxia^{^®} was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalisations and up to 93% of severe dengue cases, including dengue hemorrhagic fever that can be deadly. [7]

Additional information about Sanofi Pasteur’s dengue vaccine is available at www.dengue.info.

Asia currently bears 70% of the world’s dengue burden [1]; in the Philippines alone 200,000 cases of dengue were reported in 2013. [2] A new analysis published in the ^{New England Journal of Medicine}

on 24th March 2016 reports that the Philippines had the highest incidence of confirmed dengue in the 10 endemic countries that participated in the clinical efficacy studies for Dengvaxia^{^®}. The analysis also reported that as much as 15% of febrile disease leading to healthcare utilization in children 9 years and older in the Philippines is due to dengue. [3]

Sanofi Pasteur is committed to working closely with the Philippines government to facilitate successful introduction of the dengue vaccine, as well as monitor the impact of dengue vaccination in the country with an extensive post-marketing communication and surveillance plan, consistent with the recent Call to Action on countries issued by the Asian Dengue Vaccination Advocacy (ADVA) at the Asia Dengue Summit in February. [4]

About the Interviewee

Dr. Guillaume Leroy, Vice
President of Dengue Vaccine Company, Sanofi Pasteur

Dr. Guillaume Leroy has over 20 years of experience in the health industry from five countries, managing large multinational teams and working collaboratively with national and international health authorities.

Since 2011, Dr. Leroy has been Vice President of Dengue Vaccine at Sanofi Pasteur, driving the project's progression from clinical development through to regulatory filing and towards first licensure and introduction in public immunisation programs. In this position, Dr. Leroy manages an international, cross-disciplinary team of over 500 employees dedicated to the development and introduction of the world's leading dengue vaccine first in countries where dengue continues to represent a major public health priority.

The dengue vaccine is the culmination of 20 years of Sanofi Pasteur's commitment to discover and develop a vaccine against dengue for priority introduction in Latin American and Asian countries where dengue is a major public health priority. Dr. Leroy's leadership role in dengue vaccine is founded on his extensive 15-year experience living and working in Latin America for Sanofi Pasteur. In particular, during his 9-year tenure as General Manager of Mexico and, subsequently, the Latin American region, Dr. Leroy was able to build a number of public/private partnerships to advance the country and region's public health agenda. For instance, he was instrumental in introducing the Mexican Immunisation Programme for an acP-IPV combination vaccine in 2005; the first such programme in Latin America. He also played a pivotal role in securing the national recommendation and introduction of influenza vaccine for children and adults, as well as in the introduction of the 23-valent pneumococcal vaccine for adults.

In addition to his native French, Dr. Leroy is also fluent in English, Spanish and Portuguese. He holds a PhD in Pharmacy from the University of Rouen, France, as well as an MBA from the ESCP European Business School in Paris and has completed executive programmes in business and finance at Wharton School, University of Pennsylvania, USA and INSEAD, Fontainebleau, France. He is currently based at Sanofi Pasteur headquarters in Lyon, France, where he lives with his wife and two children.

1. What are your thoughts about the launch of the public immunisation programme in the Philippines?

The launch of the public immunisation programme is certainly a historic milestone in public health globally and a clear indication of the leadership role that the Philippines is taking in dengue prevention. The introduction of the vaccine is part of the Philippines’ integrated management strategy for tackling dengue, which includes other key activities such as disease surveillance, vector control, and community mobilisation efforts. It is consistent with the recommendations of the WHO SAGE group and the launch is an important step towards achieving the WHO country objectives to reduce dengue mortality by 50% and morbidity by 25% by 2020.

2. Would you mind sharing the developmental journey of the dengue vaccine, Dengvaxia^® by Sanofi Pasteur?

Dengvaxia^® is the culmination of 20 years of research and development, and close collaboration with the global dengue scientific and public health communities involving over 100 collaborations. It was a complex vaccine to develop and manufacture as it needs to be clinical effective against all four serotypes of dengue circulating in the world today.

The development of Dengvaxia^® represents a novel model for both innovative vaccine development and introduction. Sanofi Pasteur has a long-standing commitment to develop, seek approval and introduce the first dengue vaccine with priority in countries where dengue is a major public health priority and where the vaccine can have the biggest disease reduction impact on dengue burden globally. Our extensive research and clinical programme for Dengvaxia^® involved 40,000 children, adolescents and adults from diverse ethnics, cultural and geographic settings in 25 studies conducted in 15 countries.

3. Will patients who have had dengue or are currently infected by the dengue virus be good candidates for this vaccination? Will Dengvaxia^® be effective for these groups of people?

Pooled efficacy data in individuals 9 to 16 years of age shows that the vaccine protects both those who had been exposed to dengue before (81.9 per cent) and those naïve to dengue (52.5 per cent) prior to vaccination during up to 25 months of follow-up.

4. Do you have plans of manufacturing Dengvaxia^® locally in the Philippines?

No, we are producing the vaccine at a dedicated production facility near Lyon, France, that was built in 2009. Construction is also underway at Sanofi Pasteur’s Swiftwater site in Pennsylvania, United States, for a new facility to manufacture the vaccine upon licensure in the United States. This site will offer additional manufacturing capacity complementing the site in France. Completion is anticipated in 2017.

5. What will be the important impacts of the Philippines’ public dengue immunisation programme in the field of dengue vaccinology?

The public immunisation programme in the Philippines is a milestone in the history of vaccinology. The Philippines’ experience with the programme will become an important reference point for other dengue-endemic countries looking to effectively manage their dengue burden by successfully integrating the dengue vaccine alongside vector control, surveillance and community mobilisation efforts targeting this disease.

2. Department of Health National Epidemiology Center Public Helath Surveillance and Informatics Division Disease surveillance report Morbidity week 46 November 10 – 16, 2013. Nec.doh.gov. or ph. 02 651 7800 2930)

5. Capeding M.R. et.al, Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial ; Volume 384, Issue 9951, 11–17 October 2014, Pages 1358–1365.

6. Villar L, Dayan GH, Arredondo-Garcia JL, Rivera DM, Cunha R, Deseda C et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med. 2015.

7. Hadinegoro, Sri Rezeki S., et al. Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease Integrated Analysis of Efficacy and Interim Long-Term Safety Data for a Dengue Vaccine in Endemic Regions. July 27, 2015DOI: 10.1056/NEJMoa1506223.