Experts warned Garin vs. Dengvaxia ‘side effects’ before vaccination project roll-out —letter

A letter obtained by a government agency shows at least nine academics, scientists, clinicians, and concerned citizens had reached out to former Health Secretary Janette Garin to raise concerns over the Dengvaxia vaccine before it was rolled out to hundreds of thousands of school children in 2016.

The four-page letter dated March 27, 2016, secured by the Public Attorney's Office (PAO) and shown to reporters on Thursday, reveals Garin was warned of a "real" "possibility of harm" and an uncertain duration of protection brought about by the anti-dengue vaccine.

It also raised concerns over the cost of the dengue immunization project -- P3.5 billion -- and the supposed insufficiency of the number of trained health workers to administer the vaccine thrice "and manage the systemic side effects."

"The studies show systemic side effects in up to 57% of patients (Capeding et al, Lancet 2014). This may cause a public furor, especially if any children die," the letter said.

It was signed by Antonio L. Dans, Minerva Calimag, Benjamin Co, Leonila F. Dans, Mercy Fabros, Mary Ann Lansang, Ana Maria R. Nemenzo, Maria Asuncion Silvestre, and Madeleine de Rosas Valera, who hail from different health institutions including the Philippine Medical Association and the UP College of Medicine.

Five other names were written as signatories but were not accompanied by signatures in the copy of the letter shown by PAO.

Eighty-seven of the close to 900,000 school children who received at least one shot of the anti-dengue vaccine since the immunization program kicked off in April 2016 have died of dengue and of other illnesses, according to the latest count by the Department of Health (DOH).

It is not yet certain if these deaths are directly related to Dengvaxia.

PAO legally represents nine families whose children's deaths are alleged to be linked to the effects of the controversial drug. They have filed complaints before the Department of Justice (DOJ) against Garin and several former and incumbent DOH officials.

The rising number of criminal and civil complaints in connection with the vaccine follows the announcement of Dengvaxia's manufacturer, Sanofi Pasteur, that the drug may worsen a subsequent dengue infection among people who have never contracted the mosquito-borne disease prior to vaccination.

The experts' letter also suggested waiting for a "new generation vaccine" that was, at that time, already being tested and may have "better efficacy, needs only 1 dose, and may overcome the possible harm and numerous adverse effects (Rothman JID 2016)."

It also sounded the need for an independent cost-effectiveness study, as the one used by the DOH was supposedly commissioned by Sanofi Pasteur "and has not been published."

PAO chief Persida Rueda-Acosta was set to submit the letter to the DOJ panel in charge of the nine criminal complaints, but said after the Thursday hearing that they were no longer required to do so.

She said the panel may still take judicial notice of the letter, which she claimed was also submitted to the Senate for its probe into the government's now-suspended dengue immunization program.

Also forming part of the complaints was an identification by Sanofi Pasteur of "risks" connected to the vaccine: "allergic/anaphylactic reaction, viscerotropism and neurotropism, increase in severity of dengue disease from the start of vaccination and waning protection against dengue disease over time."

Sought for comment, Garin said meetings had been "specially convened" by virtue of the March 2016 letter, but said "mainstream science still has to prevail."

She also pointed to former Health secretary Paulyn Ubial, who she said allowed the dengue immunization program to continue during her incumbency.

"As the legal process moves forward and scientific facts [are] determined, the truth will come out. Of the 20 countries in the world using Dengvaxia, only in the Philippines are we allowing alarmists to exaggerate things and sow fear in [the] public," she said in a text message to reporters.

"We listen to all but decide as an institution following experts who have debated and analyzed data for decades," she added.

Garin and other Health officials, including current Health chief Francisco Duque III, have been required to personally appear at the DOJ panel's next hearing on June 25 to subscribe to their respective counter-affidavits. — MDM/KBK, GMA News