Deaths of 14 Dengvaxiavaccinated kids probed by UP-PGH experts

The deaths of 14 children, who had been administered with the controversial anti-dengue vaccine, are now under investigation by

a panel of medical experts from the University of the Philippines-Philippine General Hospital (UP-PGH).

“We have submitted 14 cases with complete case records to the expert panel of PGH for review,” Department of Health (DOH) Enrique Domingo said yesterday, on the sidelines of a forum at the Manila Hotel.

“’Yung (These) 14 cases are deaths. These are Dengvaxia recipients starting from 2016, (they have) been monitored, and have died for one reason or another,” said Domingo.

“We asked them the question na, number 1, what they think is the cause of death? And then, second, do they think it is related to the vaccination or associated with the vaccination? And if the answer is yes, what is the association is? These are the questions the questions that we asked after giving them the cases,” Domingo added.

The children, aged nine to 11 years old, came from Central Luzon, Southern Luzon, and Metro Manila, he disclosed.

Out of the 14 cases, four listed dengue as the cause of death in their death certificates. Others had listed heart ailments, leukemia, and lupus. One case in Bataan reported severe dengue as the cause of death. The most recent death was in December 2017.

The panel Earlier, the DOH tapped the UP-PGH to provide an independent review and assessment on the probable cause of deaths among children who were vaccinated with the controversial dengue vaccine Dengvaxia.

“We are being transparent to erase doubts of some sectors and the public that the DOH is allegedly concealing material information resulting from Dengvaxia vaccination. The UP-PGH, as the national university hospital, is the most credible third party institution to conduct this review for the DOH as it has the clinical and research expertise as well as mandate to provide assistance on matters of important health concern. UP-PGH will be providing an independent review and assessment on the probable cause of deaths submitted by the DOH through an expert group of pediatric infectious disease experts together with some forensic pathologists and other specialists with no financial and intellectual ties with Sanofi Pasteur,” Health Secretary Francisco Duque III said in a press conference last December.

The expert panel will be headed by Dr. Juliet Aguilar, the head of its Department of Pediatrics.

”Any reports of deaths or disease of these children will be referred to the PGH for review to see if there’s any relationship between the fatality and the vaccine,” Domingo said yesterday.

Vaccine controversy On November 29, 2017, Sanofi Pasteur announced a “new finding” on its vaccine Dengvaxia, which was used in the government’s mass immunization program involving around 830,000 children.

“The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in 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 in a previous statement.

On December 1, 2017, Duque put on hold the government vaccination drive.

The government has fined Sanofi $2,000 (roughly 1100,000) and suspended the clearance of the French drug maker’s controversial dengue vaccine Dengvaxia, citing violations on product registration and marketing.

Duque said Sanofi had been ordered to stop the sale, distribution and marketing of Dengvaxia after the company last month warned the vaccine could worsen the disease in some cases.

Sanofi Pasteur has vowed to cooperate with the Food and Drug Administration (FDA) and comply with Philippine laws.

“As part of our standard company practices, Sanofi routinely conducts postapproval commitments to continuously evaluate the safety and effectiveness of our vaccines in the countries where they are in use, and we have done so in the Philippines with Dengvaxia. Sanofi Pasteur confirms that in accordance with international and local laws, regulations and company standards, post-approval commitments for Dengvaxia, as described in the pharmacovigilance plan submitted to the Philippines FDA and other national regulatory authorities, have been – and will continue to be – fulfilled. Sanofi Pasteur will continue to cooperate in full transparency with the Philippines FDA and is committed to comply with the Philippines laws and regulations,” it said in a statement.