Philippine authorities Tuesday ordered French pharmaceutical giant Sanofi to stop selling and marketing its anti-dengue vaccine as well as recall stocks of the drug circulating nationwide, following the firm’s recent admission of “potential risks” to those taking it.
The move by the Philippine Food and Drug Administration (FDA) followed a decision last week by the country’s health department to suspend a public school-based immunization program using the Dengvaxia vaccine, which was given to more than 740,000 children in and around Manila. The department halted the drive soon after Sanofi warned that people with no history of dengue infection could be exposed to health risks if given Dengvaxia.
“In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA,” the FDA said in an advisory.
Food and drug officials also ordered Sanofi to launch a campaign to disseminate information about its flagship anti-dengue drug. They noted that the FDA was in close touch with the health department for “any adverse events/reactions that may be reported” by any of the schoolchildren who had been vaccinated since last year.
The Philippines was the first country in Asia to roll out the vaccine in a push to inoculate children against mosquito-borne dengue.
“All drug establishments, including consumers and-non consumer users… are enjoined to take part in the post marketing surveillance of Dengvaxia,” the FDA said in its advisory, as it called on everyone to report any case in which the drug caused or contributed to death, serious injury or illness.
In a statement, Sanofi said it was notified of the government’s directive, but insisted that the drug did not “contain any viruses that can make people ill with dengue or severe dengue.”
The firm said it had proposed a “label update” to Philippine regulators based on the new findings about the drug.
“The proposed label update suggested to include the new data findings and instructions to ensure that physicians can make appropriate vaccination decisions with their patients,” Sanofi said, adding it was ready to work with the FDA on the issue.
“If you have had no previous dengue infection before vaccination, the vaccine does not give you dengue,” Sanofi said. “It is estimated that only one in 800 of all dengue infections – including symptomless infections – could lead to a severe infection.”
Investigation under way
On Tuesday, Philippine presidential spokesman Harry Roque said the Justice Department had opened an investigation into the government’s purchase of Dengvaxia, which had been introduced earlier in Brazil, another country where dengue was endemic.
“I think the investigation will benefit everyone including those that made the decision to purchase the medicine. If there are any irregularities, we will find out,” Roque said, as he called on the public to remain calm.
Meanwhile, a group of demonstrators protested outside the Health Department, calling for a thorough investigation.
Lyndon Lee Suy, a spokesman for the department who is an expert on infectious disease, sought to assure the public that the probe would be transparent.
“We have on hand right now, in our regional offices, all of the addresses of the children who were recipients of this vaccine. We’re going to monitor them,” Suy said.
Dengue fever and dengue hemorrhagic fever are acute viral infections known to 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 strains.
The disease infects about 200,000 Filipinos every year.