As Senior Medical Director, Dengue Medical Affairs, Dr. Muruga Vadivale reinforces Sanofi Pasteur’s commitment to dengue vaccine research and creates awareness for one of the top public health issues in Asia Pacific. Dr. Vadivale is responsible to ensure the introduction of the vaccine and ensure its safety in the population. He will be responsible for all studies after launch to support the vaccine in terms of evaluating effectiveness, long term safety and co-administrative studies. He also plays a key role in facilitating the exchange of best practices latest updates on the vaccine between key health administrators.
Dr. Vadivale has more than 23 years pharmaceutical industry experience having managed Malaysia, Singapore, Brunei, Indonesia, Sri Lanka, Nepal, India and South Korea before taking on his current regional role. He started his career in Ministry of Health Malaysia in 1982, and during his career was Chief Medical Officer, Kuala Pilah District Hospital and later as a Distinct Health Officer for Kuala Pilaj/Jempol before embarking his career in Pharma. He did his medical in University of Mysore (1982, KMC Manipal), India and his Master’s in Occupational Medicine in national University of Singapore (1990). He had received a Scholarship from ASEAN Foundation in Singapore to pursue his Masters.
1. Dengvaxia® is the first dengue vaccine licensed for dengue prevention in Asia. What are the hurdles before getting Dengvaxia® into market?
Specifically, the first Asian country to license Dengvaxia® for dengue prevention is the Philippines. The regulatory review process is ongoing in other endemic countries within Asia.
Before we even talk about the vaccine, we have to address the public perception of dengue. According to the World Health Organisation, while the incidence of dengue has increased 30-fold over the last 50 years, it is still classified as a neglected tropical disease, reflecting the public attitude towards this disease.
Another hurdle to overcome is the other extreme, whereby the public views the vaccine as a cure-all. We must remember that vaccination forms part of the solution only. Vector control to curb the Aedes mosquito, which hosts the virus, as well as a robust public education program must work in conjunction with vaccination programs to effectively combat dengue.
2. What are the next regions/countries you are planning to get approval of this vaccine?
The regulatory review process is ongoing in endemic countries. By end of 2015, the vaccine’s regulatory file will have been submitted in about 20 countries, mainly in Asia and Latin America, reflecting the global burden of dengue and the countries that participated in our clinical development program for Dengvaxia®. This regulatory filing strategy is consistent with our commitment to introduce the vaccine first in countries where dengue is endemic, so that Dengvaxia® can have the greatest impact on the worldwide dengue disease burden.
3. How the dengue virus infection occurs?
Dengue is transmitted through the bite of an Aedes mosquito infected with one of the four dengue virus serotypes.
4. What are the other traditional ways used by people who are living developing countries to prevent getting dengue?
Traditionally, before the advent of the dengue vaccine, prevention of dengue was and continues to be done through the control of and protection from the bites of infected mosquitos. Vector control programs help to eliminate the habitats of the mosquitoes through the spraying of biological control agents. In addition, community engagement is also a key in combating this disease.
5. How can Dengvaxia® be used to prevent dengue fever? Can it be used to target other diseases as well?
Dengvaxia® is a live, attenuated tetravalent vaccine that can be used in the prevention of dengue disease caused by all four dengue virus serotypes in individuals 9 to 45 years of age living in endemic areas. It cannot be used to target other diseases.
Again, what is important to note is that vaccination should form part of the overall solution. A comprehensive vector control program, along with a robust public education campaign should work hand in hand with vaccination programs in our fight against dengue.
Based in Singapore, Dr. Alain Bouckenooghe currently oversees the regional R&D management of Sanofi Pasteur’s licensed vaccines portfolio. In this position, he is also in charge of directing Sanofi Pasteur’s new vaccine developments in the Asia Pacific region. This includes the establishment of a regional R&D platform as well as strategic regional input to all aspects of new vaccine development within the region with regards to regulatory strategy, business affairs, medical affairs and public policy. Prior to joining Sanofi Pasteur USA in December 2006, Dr. Bouckenooghe led the rotavirus vaccine clinical development program at GlaxoSmithLine Biologicals. He has also previously held the position of Director, Regulatory Affairs with MSD Europe as well as worked for several years as the General and Distinct Medical Officer at the Ministry of Health in Zambia. He obtained his MD at the Catholic University of Leuven, Belgium.
1. How long (months or years) is needed for Dengvaxia® to be approved in a country?
Acceptability of a license application follows local regulation and is based on the vaccine benefit-risk assessment carried out by each national regulatory agency, given the unmet medical need and the vaccine public health impacts. Therefore the duration of the approval process varies from country to country.
Sanofi Pasteur provides all the scientific evidence supporting the fact our dengue vaccine is of the highest pharmaceutical quality, is safe, and is effective for the intended populations who will be eligible to receive it.
2. What are the challenges for the regulatory pathway of this dengue vaccine Dengvaxia®?
Unlike vaccines for many other diseases, Dengvaxia is the first of its kind for the prevention of disease against dengue. Each national regulatory agency will follow its own regulation and pathway towards regulatory approval once our dossier has been submitted. The dossier includes the data generated from our extensive research and clinical program involving 40,000 children, adolescents and adults in 25 studies conducted in 15 countries .
3. When will Dengvaxia® be introduced in Singapore?
The timing and availability of Dengvaxia in various countries will depend on the duration of the regulatory approval process, which differs from country to country. What we can confirm is that Sanofi Pasteur has flipped the conventional model of vaccine introduction by providing highly dengue-endemic countries with access to the vaccine before developed countries. This ensures the vaccine can have the greatest impact on disease burden.
4. With the marketing approval of Dengvaxia®, how can it benefit the people in Philippines (direct and indirect)?
Asia currently bears 70 per cent of the world’s dengue burden and in the Philippines alone, on average over 110,000 people are reported to get sick by dengue every year . The introduction of the first vaccine against dengue will be a critical addition to the country’s dengue prevention efforts and help them to achieve the WHO objectives to reduce their dengue mortality by 50 per cent and morbidity by 25 per cent by 2020.
As an example, disease modelling studies with Dengvaxia indicate that vaccination could lead to a 50 per cent reduction in disease burden in the 10 countries that participated in the Phase III studies of the vaccine (including the Philippines), once 20 per cent of the at-risk population has been vaccinated. The high impact of the vaccine is due in part to indirect protection for unvaccinated individuals once enough people are protected and hence reduces the dengue infection rate. This shrinks the pool of infected people which reduces the potential for further transmission.
Is there other potential vaccine development by Sanofi Pasteur in Asia Pacific for other infectious diseases?
Sanofi Pasteur is the vaccine division of Sanofi and it is entirely focused on the development, improvement and large scale production of safe and effective vaccines against infectious diseases. This includes new and improved versions of important pediatric infectious disease vaccines in various combinations, covering diphtheria, tetanus, pertussis, polio, hepatitis B, HiB, measles, mumps, rubella, as well as vaccines against influenza, travelers/endemic diseases such as typhoid, hepatitis A, rabies, JE, yellow fever, etc. The company is working on innovative vaccines against clostridium difficile toxins, tuberculosis, HIV, RSV just to name a few, there are many programs in different stages of development. Sanofi Pasteur also partners and collaborates with many entities working on new vaccine constructs.
- World Health Organization. Dengue and severe dengue. Factsheet No 117, updated May 2015. Available at: https://www.who.int/mediacentre/factsheets/fs117/en/
- Shepard D et al. Am. J. Trop. Med. Hyg., 92(2), 2015, pp. 360–366