FORMER officials of the Department of Health (DOH) and Food and Drug Administration (FDA) were aware of the adverse effects of Dengvaxia vaccine because its manufacturer, Sanofi Pasteur Inc., disclosed these to them prior to the mass vaccination in 2016, documents show.
An FDA document, a certified true copy of which was obtained by The Manila Times, indicates that as early as December 2015, the vaccine maker submitted its disclosure (Responses to Question) to DOH and FDA, citing the vaccine’s potential risks in particular.
During the initial hearings of the first batch of eight Dengvaxia cases that were later dismissed by Quezon City-Regional Trial Court Branch 228 Judge Cleto Villacorta III, one of the medical experts, Dr. Clarito Cairo, attested to Sanofi’s disclosures.
Unfortunately, the presiding judge at the time, Lily Ann Marcos-Padaen of Branch 13, disallowed Cairo, who used to be DOH’s Disease Control and Prevention Bureau project manager, to fully present his affidavit in open court.
In his affidavit, Cairo said that the concerned DOH officials during the time of ex-DOH secretary and now Iloilo Rep. Janette Garin withheld from them Dengvaxia’s four fatal serious adverse effects — neurotropism, viscerotropism, severe dengue and anaphylaxis.
To address the risk and ensure appropriate post-marketing surveillance in the Philippines, Sanofi said “Pharmacovigilance Plan deployed in the Philippines will consist of passive or routine surveillance and active surveillance” that involves post-authorization safety studies, post-authorization effectiveness studies and clinical studies.
Sanofi, in an official statement issued in November 2017, said: “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.”
The parents of the eight school children whose deaths were linked to the controversial anti-dengue shot had filed administrative complaints before the Supreme Court’s Office of the Court Administrator for “being biased and partial” against Marcos-Padaen, who eventually inhibited herself from handling the case.
Interviewed by this newspaper on Monday, Cairo confirmed what he said in his affidavits when he testified as one of the prosecution witnesses.
“When I handled the dengue program of the DOH and helped in the orientation and training of personnel from various local government units about Dengvaxia, they (Garin and other DOH officials) never disclosed to us these four potential risks,” Cairo said.
“As a result, all of us including the trainers and vaccinators were unaware about these fatal risks from Dengvaxia,” he added.
Had the potential risks of the vaccine been disclosed to them prior to the personnel orientation and training for the planned mass vaccination that began in 2016 with the P3.5-billion Dengvaxia purchase, Cairo said “more lives would have been spared and saved.”
Meanwhile, independent health reform advocate and prosecution witness Dr. Tony Leachon, a former DOH official and Covid-19 task force consultant, said that he would not stop from exposing the truth amid smear campaigns against him.
“This is the fight I have taken up not because it is easy but because it is necessary,” Leachon told this writer.
“The question we need to ask right now is: Why are they so intent on silencing those who speak the truth, why are they so afraid of accountability,” he added.
Leachon maintained that he would not be moved and affected.
“You can attack me, deploy your trolls and flood social media with lies but you cannot drown out the truth. I will not stop fighting for the millions of Filipinos who deserve better,” he said.
More than 1 million Filipinos, mostly children, were reportedly the recipients of Dengvaxia vaccines.
Garin and co-respondents — seven of them doctors — and executives from Sanofi and vaccine distributor Zuellig Pharma, are facing reckless imprudence resulting in homicide, among others.
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