1. Drug Discovery on Chemistry of
Medicinal Drug
Presented by:
LORRAINE S. RIVERA
MSPharm (Student)
2. wwwwww
Dengue vaccine research
Dengue is a mosquito-borne flavivirus
disease that has spread to most tropical and
many subtropical areas.
The disease is caused by four closely related
viruses, the Dengue viruses 1-4.
3. Dengue Vaccine
Research
There are no specific dengue
therapeutics and prevention is currently
limited to vector control measures.
A dengue vaccine would therefore
represent a major advance in the control
of the disease.
4. Status of Vaccine Development
The first dengue vaccine, Dengvaxia
(CYD-TDV) by Sanofi Pasteur, was first
registered in Mexico in December, 2015.
5. Status of Vaccine Development
CYD-TDV is a live recombinant
tetravalent dengue vaccine that has been
evaluated as a 3-dose series on a 0/6/12
month schedule in Phase III clinical
studies.
It has been registered for use in
individuals 9-45 years of age living in
endemic areas.
6. Current Status of Dengue
Vaccine Development
One dengue vaccine has been licensed,
Dengvaxia® (CYD-TDV), developed by
Sanofi Pasteur.
Approximately five additional dengue
vaccine candidates are in clinical
development, with two candidates
(developed by Butantan and Takeda)
expected to begin Phase III trials in early
2016.
7. WHO’s Recommendations
Related to CYD-TDV
The WHO Strategic Advisory Group of
Experts (SAGE) on Immunization is
currently reviewing the evidence and will
advise WHO (likely in April 2016) on
recommended use of a dengue vaccine.
8. WHO’s Recommendations
Related to CYD-TDV
Main considerations include vaccine
safety, vaccine efficacy, disease burden,
programmatic suitability, including dose
scheduling, and cost-effectiveness
9. WHO’s Recommendations
Related to CYD-TDV
WHO guidance on public health use will
only be issued following licensure of the
vaccine by a functional NRA meeting
certain criteria as assessed by WHO and
the SAGE assessment.
Sanofi Pasteur = the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines.
Sanofi = a French multinational pharmaceutical company headquartered in Gentilly, France
Butantan =is a Brazilian biomedical research center affiliated to the São Paulo State Secretary of Health. Considered one of the major scientific centers in the world,[largest immunobiologicals and biopharmaceuticals producer in Latin America (and one of the largest of the world).
Takeda =largest pharmaceutical company in Japan and Asia and a top 15 pharmaceutical company.
NRA (National Regulatory Authorities Equivalent to FDA
NRA (National Regulatory Authorities Equivalent to FDA
NRA (National Regulatory Authorities Equivalent to FDA
NRA (National Regulatory Authorities Equivalent to FDA