Sanofi Pasteur: No Dengvaxia-related death has been reported to us

MANILA - The Department of Health (DOH) on Friday said 2 of the three reported deaths of children vaccinated with Dengvaxia could be attributed to vaccine failure.

"Tatlong kaso ay nakitaan ng causal association. Sila ay namatay sa dengue kahit sila ay nagbigyan ng Dengvaxia. Dalawa sa kanila ay maaaring dulot ng vaccine failure," said Health Undersectary Enrique Domingo.

Vaccine failure, according to the fact sheet provided by the DOH, "refers to the development of the specific disease being prevented by the vaccine in a person who is appropriately and fully vaccinated, taking into account the incubation period of the disease and the normal delay for the protection to be acquired as a result of immunization."

Domingo clarified that vaccine failure was not seen in all the 830,000 children vaccinated with Dengvaxia.

"Three cases out of of 830,000 is a very small number. The vaccine failure is for particular cases," he said.

Dr. Juliet Sio-Aguilar, professor and chair of Pediatrics of the Philippine General Hospital said all three cases are confirmed as dengue shock syndrome.

Aguilar said they found out that two patients who completed the three doses of the dengue vaccine still died.

"Yung unang kaso, na-receive niya 3 doses of the dengue vaccine. After one and a half months after the 3rd dose, nagkaroon siya ng dengue-like symptoms. Lumala ang condition niya. Namatay siya sa shock 5 days after nagsimula ang sakit niya," Aguilar said.

When the blood sample was checked, the doctor who attended to the patient found out that the NS1, the test to check if the patient has dengue infection, turned out positive. However, the antibodies for both IgG and IgM were negative.

"Bakit nabigyan na ng bakuna, wala pa palang antibodies? IgG usually is positive, the antibodies' response to an active infection. Yung IgM naman pwede dun sa infection o pwede sa bakuna," Aguilar explained.

The other case experienced the typical signs of dengue, one month after the 3rd dose was administered.

"Namatay siya on the 6th day from the time na nagkaroon ng infection," she said.

"Ito very interesting, iba ang pattern. NS1 positive siya, nagkaroon siya ng infection dahil nakagat siya ng lamok. Ang antibody to IGG is positive. Usually when the antibody is positive, dapat protective yun. Bakit hindi siya naprotektahan? Namatay pa rin siya?"

"Is it because of the vaccine failure? Pero may antibody siya or is it something else?" she said.

The third case involved a patient who had dengue shock syndrome four days after the first dose.

"Ang tingin namin ang bilis-bilis ng kanyang course pati yung kanyang atay apektado. Namatay siya after 5 days," she said.

Although the NS1 test came out positive, the patient had no antibodies against dengue.

"May kutob kami na baka nagi-incubate na siya ng infection bago pa siya naturukan," she said.

In all these three cases, Aguilar said they recommend tissue evaluation so they can do more tests.

During the presentation of the findings of the UP-Philippine General Hospital Dengue Investigative Task Force (DITF) on the deaths of 14 children given from one to three doses of Dengvaxia, it was found out that aside from the 3 cases of dengue deaths, 3 others had nothing to do with Dengvaxia.

"Nagkataon lang na ang nabakunahan ay nagkaroon ng ibang malubhang sakit na hindi dulot ng bakuna," Domingo said.

Six cases are still indeterminate; and 2 unclassifiable due to inadequate information available.

"Dalawang kaso ay hindi matiyak dahil kulang impormasyong nakolekta. Anim na kaso ng mga batang namatay sa ibang sakit, ngunit nagkasakit at namatay sa loob ng 30-araw matapos maturukan. Ang ikinamatay nila ay hindi dengue at walang tiyak na ebidensiya na ito ay konektado sa Dengvaxia," he added.

In a statement, Dengvaxia maker Sanofi Pasteur said it "sympathizes" with the families of the children who allegedly died due to severe dengue, but maintained that Dengvaxia did not cause the deaths.

"In Dengvaxia clinical trials conducted over more than a decade, and the over one million doses of the vaccine administered, no deaths related to the vaccine have been reported to us," Sanofi said.

Sanofi said it would continue to work with the Philippine government "to address this urgent public health challenge."

Several government agencies are investigating the use of Dengvaxia after the French drug maker admitted in November that it might cause more severe symptoms if given to those who have not had dengue.

• DOH on alert as Sanofi admits dengue vaccine poses risks

The drug was given to about 830,000 children in Metro Manila, Southern Luzon, Central Luzon and Central Visayas under the state's dengue immunization program before it was shut down late last year over the Sanofi warning.

"These findings strengthen the decision made by the Secretary to stop the vaccinations. We feel that Dengvaxia is not ready for mass immunization," Domingo said.

The DOH will forward the results to the Department of Justice to help in building a case against those responsible for the controversial dengue immunization program.