THE Health department said Friday it has suspended use of a landmark vaccine for the potentially deadly dengue virus after its manufacturer warned it could worsen the disease in some cases.
French pharmaceutical giant Sanofi announced Wednesday that its world-first dengue vaccine could lead to more severe symptoms for people who had not previously been infected.
The Philippines has vaccinated more than 700,000 children with Dengvaxia since 2016 when it became the first country to start using it on a mass scale.
But it said Friday the program had been suspended.
“In the light of this new analysis, the DoH [Department of Health] will place the dengue vaccination program on hold while review and consultation is ongoing with experts, key stakeholders, and the WHO [World Health Organization],” a government statement said.
Sanofi had initially said its Dengvaxia vaccine was “critical” in the fight against dengue, the world’s most common mosquito-borne virus.
It said Wednesday that a new study has confirmed Dengvaxia’s benefits for “those who had prior infection.”
“For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” Sanofi said.
The government said it had not yet received reports of any problems with Dengvaxia.
“Currently, there is no reported case of severe dengue infection among those who received the vaccine,” its statement said.
More than 1,000 people in the Philippines died from dengue last year, out of 211,000 suspected cases, according to the government.
Senator Nancy Binay called on the DoH and Sanofi to launch a nationwide medical advisory and information drive to reach out to parents whose children have taken the vaccine.
“The latest medical report issued by Sanofi Pasteur is deeply shocking and disturbing, especially to any parent whose children have received the vaccine,” she said.
Binay said the public–particularly the parents–need to know the circumstances surrounding the vaccine, what symptoms should be monitored, precautions, indications, contra-indications, side effects and possible adverse effects.
In 2016, the DoH launched the dengue vaccination initiative in three highly endemic regions (Regions III, IV-A and NCR) with over 700,000 individuals receiving at least one dose of the vaccine.
This immunization program is in line with the recommendation of the WHO for mass vaccination in highly endemic countries.
Dengue fever and dengue hemorrhagic fever are acute viral infections that affect infants, young children, and adults. It is transmitted by a bite of an Aedes aegypti mosquito infected with any one of the four dengue serotypes: Den-1, Den-2, Den-3 and Den-4.
An average of 200,000 cases of Dengue are reported every year.
Senator Richard J. Gordon, chairman of the Senate Blue Ribbon committee, expressed alarm over Sanofi’s announcement.
He said an official of the WHO had warned that the vaccine had not been given pre-qualification approval as it had not yet been tested on at least 200 children first, at the time it was procured by the administration of then President Benigno Aquino III.
“This admission by Sanofi that the Dengvaxia poses risks shows that when the Aquino administration procured it and the DoH proceeded to inoculate 280,000 children initially, the vaccine was not yet ready for distribution. Now we have the evidence on that,” the senator said.
“Before we conducted an investigation on the anomalous procurement of this vaccine, we talked to several health experts and they told us that they had already warned government long before about the possible adverse effect of the new drug on individuals with no prior history of dengue. With this admission by Sanofi, they have been proven right. The safety of the children vaccinated is paramount here,” he added.
After delivering a privilege speech last year condemning what said was a midnight deal, Gordon filed a resolution calling for an inquiry into the procurement of the vaccine.
Gordon pointed out that while there was no question on the need to take preventive measures against dengue, there was a need to question the apparent railroading in the procurement process and why the DoH immediately started inoculating schoolchildren even before the issuance by the WHO of the pre-qualification guidelines.
