The World Health Organization (WHO) on Thursday announced that Sanofi’s vaccine against dengue, Dengvaxia, should be used only after testing on individuals to assess whether they have ever been exposed to the infection.
The WHO announcement prompted the Department of Health (DOH) to declare that it would not be using the dengue vaccine for at least two years.
The WHO findings “strengthens our position to stop the vaccination and that Dengvaxia should not be included in the mass immunization program,” Health Undersecretary Rolando Enrique Domingo said in a press briefing on Friday.
Experts’ findings
“I don’t think it will change in one to two years. There will be no immunization with Dengvaxia possibly in the next two years,” he added.
After a two-day meeting in Geneva, WHO experts recommended extra safety measures for Dengvaxia.
“We have now clear information that the vaccine needs to be dealt with in a much safer way,” said Alejandro Cravioto, chair of WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization.
Cravioto said there was no system yet for the tests but that one could be developed “in the next years.”
Domingo had the same information. “It will take another one to two years before a validated test for screening is produced since there are no commercially available tests right now,” he said.
Severe dengue
Sanofi, in a statement, continued to defend Dengvaxia’s “safety and its proven potential to reduce dengue disease burden in endemic countries.”
In November, Sanofi warned that Dengvaxia, the world’s sole licensed vaccine against dengue and first approved in late 2015, could increase the risk of severe dengue in people who had not been previously exposed to the disease.
Joachim Hombach, executive secretary of SAGE, defended WHO’s initial recommendation that Dengvaxia could be used in children aged 9 and older in places where 70 percent of the population had previously been exposed to the virus.
$1B-a-year product
Dengvaxia had been approved and registered in 19 other countries.
Initially seen as a potential $1-billion-a-year product, Dengvaxia’s net sales stood at $3.71 million in 2017 as Sanofi was forced to buy back unused doses, including those in the Philippines.
At least 837,000 school children had been vaccinated with Dengvaxia in the Philippines, prompting a health scare after it was found that the vaccine could be deadly for those who have had no dengue before vaccination.
Sanofi Pasteur denied any wrongdoing. —JULIE M. AURELIO