TO allay the fears of the public, Sanofi Pasteur recently released a new supplementary exploratory analysis of the long-term follow-up of its dengue vaccine.
This is part of the company’s ongoing commitment to evaluate the long-term impact of the dengue vaccine and is also consistent with the recommendation put forward in the World Health Organization’s (WHO) position on the vaccine.
These new findings demonstrate a different profile of the dengue vaccine for those with or without a previous dengue infection. For individuals who have been previously infected by dengue virus, there is a clear and sustained benefit of being vaccinated with the dengue vaccine up to six years following the first injection. For individuals who have not been previously infected by dengue virus, there is an increased risk of hospitalization for dengue and severe dengue, predominantly Grade 1 or 2 Dengue Hemorrhagic Fever (DHF).
Severe dengue can be categorized from milder to more severe forms as DHF 1, 2, 3 and 4 according to WHO. DHF IV was not seen in those vaccinated. “We have shared this new data in full transparency with the Philippine Food and Drug Administration [FDA] and the Department of Health [DOH]. Furthermore, the severe dengue observed in vaccinated individuals was not clinically different from that reported in unvaccinated people in the studies. “All study participants who got severe dengue, whether vaccinated or not, have fully recovered,” Sanofi Pasteur said in a statement.
“Consequently, we are proposing an update to the current vaccine label to ensure that physicians can make appropriate vaccination decisions with their patients to enhance the impact of the vaccine in the Philippines, where the majority have been infected by dengue by the time they reach adolescence,” the statement said.
The company has also started to inform the new label proposal with private health-care professionals to help them in the assessment of the benefits and/or risks of vaccination o their patients. Dengue is highly endemic in the Philippines, and since 2010 there has been a reported average of over 160,000 cases every year, mostly in children and teenagers.
Studies have shown that in individuals aged 9 to 14 years old, nine out of 10 of them would have already been infected by the dengue virus. However, not all people who have been infected by the dengue virus are aware, because around 75 percent of them do not have any symptoms.
The dengue vaccine does not contain viruses that can make people ill with dengue or severe dengue. Severe dengue infections are uncommon complications of dengue disease, occurring in an estimated 0.5 percent of cases manifesting symptoms of dengue annually.
Sanofi Pasteur’s dengue vaccine has been clearly proven to be safe and effective in the prevention of dengue in people 9 years of age and older living in endemic settings. Phase 3 clinical studies conducted in over 30,000 study participants from 10 countries in Latin America and Asia show a pooled efficacy of 65.6 percent against all four serotypes of dengue; 80-percent efficacy against hospitalizations due to dengue and 93-percent efficacy against severe disease in the study population nine years of age and older over the 25 month follow-up period of the study program.
The continuing long-term safety evaluation of the vaccine shows significantly fewer hospitalizations due to dengue in vaccinated vs. unvaccinated participants 9 years and older.
More than 700,000 children all over the country got the vaccination since the program was implemented.
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