Dengvaxia, Sanofi Pasteur's Dengue Vaccine
Dengvaxia, Sanofi Pasteur's Dengue Vaccine
Dengvaxia, the world’s first dengue vaccine, was rolled out, there have been mixed reactions as
to its efficacy.
Dengue is a mosquito-borne viral disease that has spread to most tropical and many subtropical
areas. The disease is caused by four closely-related viruses, the dengue virus types 1-4. There are
no specific treatments for dengue, and until the Sanofi Pasteur dengue vaccine, prevention was
primarily limited to vector control measures. The vaccine is designed to induce an immune
response against each of the four dengue viruses, but not to cause disease. The immune response
results in antibodies capable of fighting dengue infections.
Until the development of the Sanofi Pasteur vaccine, there was no vaccine or clinical preventive
measure against dengue available to healthcare professionals. Currently, there remains no
specific medical treatment for the disease. Traditional means of controlling outbreaks of the
disease have been through elimination of breeding areas, fogging operations with anti-mosquito
spray and increased inspections of potential breedin grounds by organizations. With the Aedes
mosquito preferring to breed in clean, stagnant water, about two thirds of breeding sites are
found in homes. As the government continues to conduct its dengue prevention measures in the
community, the new vaccine could provide an additional means for individuals to supplement
their efforts to avoid dengue infection. In other dengue endemic countries where the dengue
burden, routine and catch-up mass vaccination programs could help achieve a greater impact in
terms of more rapidly reducing the disease burden.
Sanofi Pasteur built a dedicated production facility for the dengue vaccine in order to secure
adequate supply of quality product in a timely manner to countries upon approval. According to
the what I have learned in the internet, this facility has a production capacity of 100 million
doses per year; this means one billion doses in ten years. Deliveries to meet orders for both
public programs in the Philippines and Brazil and demand from private patients in other endemic
countries where the vaccine has been registered have proceeded smoothly, and as anticipated.
Sanofi Pasteur is committed to offering a fair and equitable price for the vaccine that
is sustainable for both the company and the governments where the vaccine is approved. Price
for the vaccine in public programs will be determined once agreement has been reached on the
nature of the dengue immunization program needed in the country to address its dengue burden.
To date, in all the countries where we have conducted cost-effectiveness analyses, Dengvaxia
has been shown to be cost effective or even cost-saving, based on the WHO criteria as I have
searched again in the internet, for cost-effectiveness which accounts for GDP of the country and,
hence, affordability. These analyses incorporate current country-specific burden of disease,
dengue epidemiology and overall cost burden of dengue, as well as the documented clinical
profile of the vaccine.
The Philippines Department of Health has confirmed the Dengue School-Based Immunization
program being implemented in the National Capital Region, Central Luzon, and Calabarzon will
continue and not stop as claimed by some groups. According to what I have searched in the
internet, no safety concerns related to vaccination were observed after analyzing data from over
20,000 clinical trial participants from 9-60 years of age who had received the vaccine. The most
common side effects were headache, muscle ache, injection site pain, tiredness, feeling unwell
and fever. These effects were mild to moderate in severity, lasted up to three days, and resolved
on their own. The side effects described by participants who received the vaccine were generally
comparable with those described by study participants who had received placebo control. Taken
at a dengue vaccination center in the Philippines.
As dengue is a complex disease, the virus interacts in different ways with the human immune
system, and different serotypes can co-circulate or change in prominence from year to year in
dengue-endemic countries. The combined data from Asia and Latin America studies in the 9-16
year old age group showed that approximately two out of three vaccines were protected against
dengue of any severity caused by any of the four serotypes. Furthermore, efficacy was significant
for each serotype with higher protection against serotypes 3 and 4 seen compared with serotypes
1 and 2. Importantly, vaccine efficacy against all four serotypes also contributes to the ability of
the vaccine to prevent eight out of ten dengue hospitalizations and nine out of ten severe dengue
cases in the first 25 months following the first dose. Some efficacy was observed in clinical
study participants below nine years of age. However, until more data is gathered as part of long-
term evaluations, the overall benefit of vaccinating children under nine against dengue remains
to be determined. As the nine and above age group represents the majority of dengue cases
worldwide as identified by national surveillance systems in several dengue-endemic countries,
and up to 90 percent of dengue cases in some endemic areas, a vaccine indicated for a targeted
population of nine years and older has the potential to significantly impact dengue disease in
high-burden countries.
New findings indicate that vaccination could lead to more severe disease in people who have
never had a prior dengue infection.
Dengxavia, the world's first approved dengue vaccine, has been rolled out in parts of Asia and
South America— but doubts over its efficacy and potential for causing side effects remain.
The world's first dengue vaccine is good news, but not a perfect solution.