PH Department of Justice Dismissed 98 Dengvaxia Cases Against Garin et. al. on 10 January 2025. Justice or Injustice for 98 Children? Parents are Furious. PAO Files Motion for Reconsideration.

DOJ rejects child deaths 8+ days post-jab as not causally linked, rejects witness experts for not being expert-enough, self-serving & unreliable, rejects autopsy findings as dengvaxia death evidence.

The Philippines Dengvaxia case has hit another milestone with the DOJ Dismissal of 98 Criminal Cases Against former DOH Secretary Garin and 2 others on 10th January 2025. The Philippines Attorneys Office (PAO), which brought the cases, filed a motion for consideration against the dismissal on 24 January 2025.

This article sets out the history of Dengvaxia in Philippines, summarizes the DOJ dismissal and PAO’s response, and provides some selected news clippings.

It would be welcome if there were any international experts willing to publicly comment on this case and its current status. If there has been failure of the justice system over Dengvaxia, it should be spotlighted in international news!

Dr. Garin’s statement after the 10 January 2025 dismissal shows that her science might be The Science (aka of the Anthony Fauci vested interest and cherry-picked type), considering that it is in her interest that the case be dismissed without being heard.

Maybe she is thinking of some other vaccine… Dengvaxia doesn’t match her claims: -

Never mind that Dengvaxia is not in widespread use and is not recommended for anyone who has not had confirmed prior dengue infection due to concerns with antibody dependent disease enhancement (ADE), as last updated by the WHO on 10 May 2024. About 10% of the vaccinated Filipino children are estimated to not have had prior dengue infection, placing an estimated 83,000 children at possibly lifetime risk of ADE in the dengue endemic Philippines.

The Philippines Dengvaxia Saga - History

In 2016 the Philippines Government rolled out Dengvaxia to some 830,000 school children. The rollout was mired in controversy with talk of undue haste surrounding the PHP3.5 billion Vaccination Program which then took a much darker turn when some of the vaccinated children became severely ill and died gruesomely with multi-organ failure and bleeding. Key dates are set out: -

• April 17, 2015: Sanofi Pasteur, Inc. (SPI) submitted a Risk Management Plant to the Philippines FDA as part of application for initial registration of Dengvaxia.

• May 2015: Janette Garin meets with officials of French drug maker Sanofi Pasteur in Paris in 2015 to discuss the dengue vaccine.

• December 22, 2015: the Philippines’ FDA approved Dengvaxia¹, a tetravalent dengue vaccine for individuals aged from 9-45 years of age living in endemic areas, making it the first vaccine to be licensed for the prevention of dengue in Asia. Note that Phase 3 Clinical Trials had not been completed at the time that Dengvaxia was registered with the Philippines FDA for use in the Philippines.

• 13 January 2016: SPI submitted a Specific Pharmacovigilance Plan to the Philippines FDA. This plan identified 4 important risks for post-marketing surveillance; 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.

• 4 April 2016: the Philippines DOH commenced a nationwide government-sponsored immunization campaign against dengue targeting Grade 4 students in selected regions with high dengue prevalence. The vaccine was to be administered as a 3-dose series, with dosing at 6-month intervals. Around 830,000 children aged 9 - 10 received at least 1 of the 3 recommended doses through the school program. The vaccine was also available privately for people who wanted the vaccine outside of the DOH program. The Government paid PHP3.5 Billion for Dengvaxia vaccines.

• 29 November 2017: SPI updated its product information to advise again its use in persons not previously having confirmed infection.

• The DOH responded by immediately implementing a temporary suspension of the Dengvaxia Program.

• 12 December 2017: DOJ orders PAO to provide free legal assistance to Dengvaxia victims in civil, criminal and administrative cases under Department Order No. 792.

• 29 December 2017: FDA Ordered suspension of the Dengvaxia Certificates of Product Registration (CPRs) and fined SPI PHP100,000.00.

• 21 December 2018: FDA permanently revoked the Dengvaxia CPRs. SPI appealed the decision but was unsuccessful.

• Cases were filed by PAO on behalf of 170 dengvaxia victims; 198 Dead, and 2 Survivors. Victims died as early as 7 days and up to several months after their last dose of Dengvaxia. Forensic examination² on deceased recipients found enlargement of and extensive bleeding in various organs.

• 14 January 2021: Government officials claimed that the filing of charges over Dengvaxia were malicious and filed counter claims against Public Attorney's Office (PAO) chief, Persida Rueda-Acosta and forensic medico-legal expert Dr. Erwin Erfe.

  The Ombudsman dismissed these claims finding that “there is no probable cause for malversation of public funds or property and illegal use of public funds or property” against Acosta and Erfe.

• 10 January 2025: DOJ dismisses 98 of the 100 Batch 6 Cases.

• 24 January 2025: PAO files Motion for Reconsideration on the dismissed cases.

• 6 February 2025: Dr. Leachon one of PAO’s experts, alleges that the DOJ has conflict of interest in the dismissal of the 98 cases due to DOJ USec Jesse Andrews, responsible for control and supervision of the agency’s prosecution service, being a former personal lawyer of Garin who is the principal accused.

"Poor victims' parents and relatives, too. The DOJ is sabotaging justice in Dengvaxia cases."

• This possible conflict was already raised by parents of victims in December 2022, but was dismissed by the DOJ which claimed that Andrews was a professional.

Update on the Cases of the 170 Dengvaxia Victims

Criminal Cases filed with DOJ: 167 Dead for Reckless Imprudence Resulting into Homicide, 2 Survivor Victims for Reckless Imprudence Resulting into Serious Physical Injuries. Note the family of 1 victim did not proceed with filing.

• Batch 1: 8 cases, dismissed by RTC Branch 229, subject for Review on Certiorari.

• Batches 2 - 5: 35 cases re-raffled and pending before RTC Branch 102 following inhibition of presiding judges.

• Batch 6: 100 cases; 82 resolved for filing and 18 dismissed. The dismissed cases were subjected to petitions for review which remain pending. These are the 98 cases dismissed on 10th January 2025 (also includes the 18 previously dismissed cases).

• 11 additional criminal complaints have since been filed with DOJ.

The criminal graft and illegal use of public funds case initiated by the National Bureau of Investigation (NBI) and being prosecuted by the Office of the Ombudsman is pending trial at the Sandiganbayan³. Motion to Quash filed by former Department of Health (DOH) Secretary and current Iloilo 1st District Rep. Janette Garin was denied, as were similar motions by co-accused former DOH undersecretaries Bayugo, Hartigan-Go and OIC Ducusin and former Philippine Children’s Medical Center Executive Director Lecciones.

Counterpart Civil Cases have been filed for 158 of the 169 criminal cases. These were consolidated and are pending before the RTC Branch 226 with service of summons are being undertaken. The Defendants Sanofi and Zuellig Pharma questioned the consolidation of the cases before the Court of Appeals, with the Presiding Judge upholding the consolidation. Zuellig filed its Motion for Reconsideration.

It is nearly 9 years since the Government Dengvaxia program rolled out and just over 7 years since the program was suspended. The wheels of justice turn very slowly indeed.

Basis for the 10 January DOJ Dismissal and PAO’s Motion for Reconsideration Counter Argument

I referred the PAO Motion for Reconsideration dated 10 January 2025 to set out the basis for the DOJ dismissal ruling and to provide selected items from PAO’s MR.

The DOJ basis for dismissal was: -

1. There is no causal link between Dengvaxia vaccination and the deaths of the victims because the scientific studies of the World Health Organization (WHO) and other respected experts point to a contrary conclusion. (Resolution, page 74) Specifically, DOJ required that vaccine-related viscerotropic or neurotropic disease should manifest within eight (8) days from vaccination (Ref. SAGE 2016 Background Paper on Dengue vaccine and WHO documentation from 2018). (Resolution, page 75)

2. Dr. Scott Halstead statement to the Senate Blue Ribbon Committee that the diagnosis of Dengvaxia cannot be based on autopsy. (Resolution, page 75)

3. Dr. Raymundo W. Lo statement that viscerotropism and neurotropism are terms that cannot be attributed to a deceased person, but only to a live human subject because the effects to be observed can only be seen in living persons. (Resolution, page 76)

4. The Philippine General Hospital Dengue Investigative Task Force (PGH-DITF) recommendation for further investigations including determination of the presence of dengue vaccine particles in tissue samples through the use of histopathological examination. (Resolution, page 76)

5. That Complaints were based on self-serving hearsay and unreliable evidence – the statements made during the joint hearings of the Senate Blue Ribbon Committee, the Committee on Health and Demography and Finance. (Resolution, page 77)

6. The PAO reports and forensic examination reports are self-serving, as the same people who prepared the reports are representing the Complainants as counsels. The witnesses do not have personal knowledge of facts and circumstances relevant to the case. (Resolution, page 77)

7. Dr. Erfe and Dr. Leachon cannot be considered experts because they have never conducted an independent and rigorous study of the Dengvaxia vaccine nor have they published any works in a reputable medical journal concerning the vaccine. (Resolution, page 80)

In response PAO argued that the decision of the DOJ is premature, and that case should go to full-blown trial on the merits to allow a full and exhaustive display of evidence, and justice and due process to be served. Selected points include: -

1. The resolution ignored that The victims died simultaneously after vaccination, although living in different places, but all clearly manifested common patterns of clinical manifestations, post-mortem (autopsy) findings: brain and multi-organ bleeding, organ enlargement and edema, and with no history of said concomitant indications.

2. Prior to vaccination these were healthy children who had not been hospitalized for any illness and had no family history of such illness. The only common substance given was the Dengvaxia vaccine. They present that the vaccine is most likely the valid and indisputable explanation for the serious illness and deaths of the children.

3. Being a new vaccine, there is as yet no “expert” in Dengvaxia vaccine. There is as yet no specific parameters in determining causality in Dengvaxia vaccination.

4. To counter DOJ’s claim their experts were not expert enough, PAO pointed out that focusing an argument on expertise cannot absolve criminal acts and negligence, particularly considering that the adverse events were fatal.

   PAO also set out the expertise of their experts Dr. Erfe and the PAO forensic team, which extensively studied, analyzed and correlated the adverse events of the victims, and Dr. Leachon who is an experienced cardiologist and internist who works as a public health advocate and has expertise in public health.

5. DOJ ignored that there is not just 1, but rather there are 4 important adverse outcomes for consideration. These were documented by SANOFI to the Philippines FDA on 22 December 2015 BEFORE the rollout of the pediatric vaccination program;

   1. Allergic/Anaphylactic - typically an acute reaction,

   2. Viscerotropic/Neurotropic - expected risk but characteristics of presentation for the new Dengvaxia product have not been adequately defined (how could these be limited to only 8 days),

   3. Antibody Dependent Enhancement (ADE) of Disease resulting in severe dengue - can present at any time throughout the life of a recipient when they become infected with Dengue, and

   4. waning vaccine protection over time.

6. The DOH and the FDA knew of these important adverse outcomes and did not disclose them to the public.

7. The presentation and deaths of many victims is consistent with ADE where they presented with viscerotropic-like (multiorgan failure / sepsis) and neurotropic-like (severe neurological symptoms) disease.

8. DOJ only focused their argument and causality on viscerotropic and neurotropic disease. The Viscerotropic and neurotropic disease definitions relied on the Brighton Collaboration Criteria associated with Yellow Fever Vaccine, not the new Dengvaxia vaccine, which needs to have its own Dengvaxia-associated viscerotropism characterized and defined.

9. PAO emphasizes that for the Filipino Population, there is NO established criteria for viscerotropic-like and neuro-tropic-like disease. Foreign literature cannot be referenced because the Filipino population has never been exposed to yellow fever or yellow fever vaccines.

10. That the quoted remark from Dr. Halstead about Dengvaxia not being diagnosable from autopsy, was taken out of context, as he was specifically referring just to ADE. Even while PGH-DITF recommendation included autopsy as a scientific method of determining Dengvaxia causality.

    Dr. Halstead had been alarmed and upset over the mass immunization with Dengvaxia having said “If you’re seronegative… and you get vaccinated, your first infection may put you in the hospital, and may be worse.” and “if you’ve been vaccinated and then you’re hospitalized, something is wrong with the vaccine.”

Selected Historical and New Media Report Clippings

1 December 2017: Researchers at University of Minnesota raised the specter of ADE when they first became aware of the proposed Dengvaxia rollout in the Philippines. Their concerns were initially dismissed and only recognized 2 years later when the vaccination program was suspended.

4 December 2017: Sanofi denies that Filipinos are part of any clinical trial because the vaccination program is conducted the Philippines DOH, not by Sanofi. Also claimed there are no vaccine-related deaths.

7 December 2017: Dr. Garin’s activities in Paris in May 2015, just months before she championed Dengvaxia under question.

19 December 2017: PAO was ordered to represent Dengvaxia Victims by the Philippines Department of Justice.

26 January 2018: CHR called for monitoring of Dengvaxia-vaccinated children and ensuring they would be assisted in case of they develop severe dengue. The suspected Dengvaxia-linked deaths of 14 children were reported as being under investigation.

18 January 2021: If the message is unpleasant, prosecute the messenger. There were repeated efforts to smear PAO personnel charged with filing Dengvaxia cases. Charges brought against PAO, Rueda-Accost and Erfe did not prosper.

14 Dec 2023: PAO set to autopsy another person who has died with history of Dengvaxia injection.

28 January 2025: Dr. Garin celebrating justice and a win for science following the January 2025 DOJ dismissal of 98 criminal complaint cases against her and 2 others. The science appears to be The Science aka. Anthony Fauci’s science that has been coopted and twisted to fit certain vested narratives.

29 January 2025: PAO’s filing of a Motion for Reconsideration is reported.

Dr. Leachon has alleged conflict of interest in the DOJ case dismissal, claiming that USec Jesse Andrews, responsible for control and supervision of the agency’s prosecution service, was a former personal lawyer of Garin who is the principal accused. If these claims are proven, the DOJ decision needs to be looked at in a new light.

In Conclusion - Have Lessons Been Learned?

The Philippines government has a love affair with vaccines, perhaps seeing them as a short-cut to public health. What happens when the reality of a product doesn’t match the hopes or promises with which it was sold? The Dengvaxia saga should have taught the Philippines vital lessons about rushing products, about product review and safety, about informed consent, about detecting and acting on adverse events, about assisting victims.

Should have!

It is likely that Dengvaxia mistakes will be doubled down upon with the Covid-19 vaccines. To date there is not even any official acknowledgement of a problem related to Covid-19 vaccination, other than allegations of corruption. This time there are at least 78 million people affected, not yet counting the (surviving) babies being born to vaccinated parents.

The song and imagery are of war and the need to learn from it. Exactly where we are today!

1. Approval under CPR No.s BR-1128 and BR-1129 valid to December 2020 with conditions which included no change in formulation, compliance with all relevant doses and FDA circulars. In the post-approval commitment letter dated 22 Dec 2015 SPI was required to comply with its provided Risk Management Plan and monitoring.

2. PAO conducted forensic examinations using external Forensic pathologists from UERM and Ospital ng Maynia. Dr. Erfe, the team’s forensic and medico-legal expert, conducted forensic autopsies of the dengvaxia victims, assisted by medical internist, pathologists, forensic examiners, etc.

3. Special court established under Presidential Decree No. 1606 having jurisdiction over criminal and civil cases involving graft and corrupt practice and other offences committed by public officers and employees. Equivalent to the Court of Appeals and sits in five divisions of 3 justices each.