MANILA (Reuters) – The Philippines on Monday ordered an investigation into the vaccination of more than 730,000 children with a vaccine for dengue that has been suspended following an announcement by the French pharmaceutical company Sanofi ( SASY.PA ) that could worsen the disease in some cases.
A non-governmental organization in the Philippines said that he had received information that three children who were vaccinated with Dengvaxia in April 2016 had died, but Sanofi said no deaths had been reported as a result of the program.
"As far as we know, as far as we know, there are no reports of deaths related to dengue vaccination," said Ruby Dizon, medical director of Sanofi Pasteur Philippines, at a press conference in Manila.
Last week, the Philippine Health Department stopped using Dengvaxia after Sanofi said it should be strictly limited due to evidence that it may worsen the disease in people who were not previously exposed to the infection.
In a statement issued in the Philippines, Sanofi explained the "new findings," but said the long-term safety badessment of the vaccines showed significantly fewer hospitalizations for dengue in vaccinated people older than 9 years compared to those who did not. had been vaccinated
Nearly 734,000 9-year-old children in the Philippines have received a dose of the vaccine as part of a program that cost 3.5 billion pesos ($ 69.54 million).
The Department of Justice ordered the National Bureau of Investigation (NBI) on Monday to examine "the alleged danger to public health … and if the evidence justifies it, submit the corresponding charges."
There was no indication that health officials in the Philippines knew of any risk when administering the vaccine.
However, the World Health Organization said in a July 2016 document that "vaccination may be ineffective or theoretically may even increase the future risk of severe or hospitalized dengue disease in those who are seronegative at the time of the first vaccination regardless of age. " "
The Health Sciences Authority of Singapore said last week that it marked the risks when the vaccine was approved there in October 2016, and was working with Sanofi to reinforce the risk warnings on the medicine's packaging.  According to Sanofi in Manila, 19 licenses were granted for Dengvaxia, and it was launched in 11 countries, of which only two, the Philippines and Brazil, had public programs to administer the vaccine.
"A DISAPPEARED SCAM"
A spokesman for the president of the Philippines, Rodrigo Duterte, said on Sunday that the government would hold accountable those responsible for a program that has put at risk thousands of lives.
"We will not leave stone in hand to make those responsible for this shameless public health scam that puts at risk hundreds of thousands of young people at risk, "said spokesman Harry Roque in a statement.
Roque said no case of" infection "had been reported. No severe dengue "since the vaccine was administered and asked the public" not to disclose information that could cause undue alarm. "
However, Volunteers Against Crime and Corruption said it was reviewing a report that three children on the northern island of Luzon had died since they were vaccinated in April 2016 and described the situation as a disaster.
"We have received information from our coordinator in the center of Luzón that three children have died," the group's president, Dante Jiménez, told reporters.
"I'm still getting verified, the names, if they've ever been buried … we ask the NBI to do an exhumation, this is really serious."
Dengue is a tropical disease transmitted by mosquitoes. Although not as serious as malaria, it is spreading rapidly in many parts of the world, killing about 20,000 people a year and infecting hundreds of millions.
While Sanofi Dengvaxia is the first approved vaccine for dengue, scientists have already recognized that it was not perfect and that it did not protect equally against the four different types of the virus in clinical trials.
A new badysis of six years of clinical data demonstrated that the Dengvaxia vaccine provides a persistent protective benefit against dengue in those who had a previous infection.
But for those who had not previously been infected by the virus, more cases of severe disease could occur in the long term after vaccination after a dengue infection, Sanofi said.
Additional reporting by Karen Lema in MANILA and by John Geddie in SINGAPORE; Written by John Chalmers; Edition of Raju Gopalakrishnan