First laboratory to develop a vaccine against dengue, the French company Sanofi Pasteur wants to enjoy the experience to come out ahead in the development process of a product against zika virus. Head of the research and development program of the company's dengue vaccine, Nicholas Jackson was recently in Brazil to define details on the process. In an exclusive interview, he revealed that animal testing should begin by June.
In February, Sanofi Pasteur announced that it will begin research for a vaccine against zika. How is this process?
We have the experience of three flavivirus vaccines: yellow fever, Japanese encephalitis, and now dengue. We can use the strength, experience and accumulated infrastructure also against zika and put us in a position that would enable a very fast forward. About zika, we are probably looking at the tip of the iceberg. There is a potential that it causes same consequences in children without symptoms. Microcephaly is very easy to see, but there is a concern that children who seem healthy develop neurological problems because of zika. There is a need to carefully investigate this disease.
And when testing the vaccine should be started?
We are in a very early stage of research and the next step would be to have the appropriate studies for animals, to ensure product safety. We expect to begin animal studies in the spring (in the Northern Hemisphere, which runs from March to June).
They intend to skip some stages of the process because of this expertise in other vaccines?
We have to follow all the steps, but we can work in parallel. We can use the ChimeriVax technology (Japanese encephalitis vaccine) to work on a vaccine zika.
How will the way for the development of the vaccine?
We define a plan that needs to be evaluated by regulatory agencies because, for fast advance, it needs to be aggressive. Looking at the pre-clinical safety studies, will be a substantial effort with animal models and we need the involvement of regulatory agencies and experts to make sure that our plan is robust and will allow us to go reliably for clinical trials (in humans ). Whereas ChimeriVax was tested in 15,000 individuals and Dengvaxia (dengue vaccine) in 45000, we have 60 thousand people in which this technology has been certified safe, this is very important. The vaccine zika will use the same technology ChimeriVax.
How long we could have a vaccine zika?
It's too early to give specific dates. What I can say is that we should be able to cut years of a normal process. The development of a vaccine may take ten years, but this period is too long for the zika virus in an emergency context. The potential of this disease devastate families and communities is very real.
Anvisa has record for Dengvaxia in Brazil but experts criticize the fact she did not have high efficacy against all types of dengue virus ...
When there is no specific treatment for the disease, when there are difficulties to control the mosquito and the absence of any vaccine, the index we have, 66% efficiency, meets a great need for health. We have evidence that the vaccine can prevent 80% of hospitalizations. So I do not agree that this vaccine has no potential to meet medical needs. In São Paulo, where you had a major outbreak of dengue fever, the authorities had to use tents to meet people. If you can prevent 80% of cases of hospitalization, it is a huge win for public health.
Nenhum comentário:
Postar um comentário