Dengvaxia controversy

The Dengvaxia controversy, Dengvaxia issue, or Dengvaxia mess[5] is an ongoing controversy about the use of anti-dengue vaccine Dengvaxia in the Philippines. In late November 2017 the Philippine Department of Health (DOH) suspended a school-based vaccination program[6] utilizing French drug-based vaccine maker Sanofi Pasteur's Dengvaxia vaccine (Tagalog pronunciation: [dɛŋˈvakʃa]) because reports circulated that several children died from various complications allegedly attributed to the dengue vaccine.[7] Shortly after, the company made a statement that its product poses higher risks to people without prior dengue infection.[8]

Dengvaxia controversy
LocationPhilippines
Cause
ParticipantsPublic Attorney's Office
Department of Health
Casualties
3,281 hospitalized after receiving Dengvaxia (1,967 with dengue indication)[1]
Deaths±600 people (as of October 2, 2019)[note 1][3][4]

As of August 2019, over 600 people who have received the vaccine, mostly children, have died[4] (though not necessarily caused by the vaccine itself) and the DOH has banned the vaccine's sale or use in the country.[9] The scare caused by the controversy may be a factor in the country's loss of confidence in vaccines and low immunization rates, [10] resulting in an infectious disease crisis in the Philippines in 2019,[11] including the 2019 Philippines measles outbreak.

Background
President Aquino converses with Sanofi Pasteur CEO Olivier Charmeil during a courtesy call on December 1, 2015 in Paris, France.

On December 1, 2015, former President Benigno Aquino III met with executives of Sanofi Pasteur in a courtesy call in Paris, making the Philippines the first Asian country to approve the commercial sale of Dengvaxia.[12]

President Benigno Aquino III at the launching of the dengue vaccine school-based immunization program.

In April 2016, the Department of Health (DOH), launched the dengue vaccination campaign in regions Central Luzon, Calabarzon and Metro Manila, where about 700,000 individuals received at least one dose of the vaccine.[13] The government paid P3.5-billion for the vaccine.[12]

Events

On November 29, 2017, French drugmaker Sanofi Pasteur released a statement stating that their Dengue vaccine, Dengvaxia, posed risk to individuals vaccinated without having a prior dengue infection.[8][14] This came some time after reports circulated of children dying allegedly from complications associated with the vaccine.[7] Soon after, the Philippine Department of Health (DOH) suspended the vaccination on FCS program based in schools owing to the said concern,[15] with DOH Secretary Francisco Duque saying "In the light of this new analysis, the DOH will place the dengue vaccination on hold while review and consultation is ongoing with experts, key stakeholders and the World Health Organization."[13] On December 2, 2017, the government of Makati immediately suspended its anti-dengue vaccination drive following its statement.[16]

In its statement, pharmaceutical company Sanofi Pasteur reported concerns that Filipinos, mostly schoolchildren, could potentially be at risk of a more severe disease, where the recipient of the vaccine had not had a previous dengue infection; however, a medical director of Sanofi said that the dengue vaccination would not cause "severe dengue".[17] On December 4, 2017, Sanofi also denied that they made Filipinos into “guinea pigs”, explaining that the vaccine program was conducted by the DOH and not them.[18][19] Senator JV Ejercito, chair of the Senate Committee on Health and Demography, sought to identify by January 2018 whether there was an irregularity in the procurement of the vaccine,[20] while Senator Risa Hontiveros urged the government to address the health threats posed by the vaccine.[21] The Food and Drug Administration of the Philippines ordered Sanofi to stop distributing of Dengvaxia into the country.[22][23] Former Health Secretary Janette Garin said she welcomed the investigation which will be conducted by the Philippine Department of Justice.[24] Presidential spokesperson Harry Roque told the media that 10 percent of the 733,000 schoolchildren[note 2] were at risk of dengue infection.[27] Since then, the Philippine Department of Education has closely monitored the students who have been injected by the vaccine.[28] Hontiveros said that Sanofi should take liability for the medical expenses of those who contracted severe dengue fever after receiving doses of the vaccine.[29]

Sanofi representative Thomas Triomphe "was forced to apologize" during the House of Representatives hearing on the Dengvaxia dengue vaccine.[30] Former President Benigno Aquino III, who approved the vaccination program in 2016, expressed interest on attending the Senate hearing.[31] On December 16, Aquino told reporters that "With the announcement of Sanofi and the reactions to it, there has been a lot of tension building up and I think it is incumbent upon me even as a citizen to try and allay certain fears, to put it in the proper perspective, to put it on the proper level".[32]

Secretary Duque reminded the public, especially parents, that "the vaccine is not a 'standalone' preventive measure against dengue."[33] On December 15, 2017, former Education and Skills Development chief Augusto Syjuco Jr filed "mass murder and plunder" complaints against Aquino and former health secretary Janette Garin over the controversial vaccination program.[34] Former health secretary Enrique Ona blamed his successor Janette Garin, who advised former president Benigno Aquino lll to purchase the Dengvaxia.[35]

On February 2, 2018, the University of the Philippines-Philippine General Hospital (UP-PGH) issued a report stating that three out of 14 children who died after receiving Dengvaxia had an indication of dengue despite immunization.[36] On February 3, a group of doctors, including former health secretary Esperanza Cabral, urged the Public Attorney's Office (PAO) to stop conducting autopsies.[37]

On February 5, 2018 during a probe at the House of Representatives, mothers of children who took part in a mass vaccination program confronted Garin, screaming at her and accusing her of killing their children. The women would later admit to media that none of their children died after vaccination. [38]

On February 21, 2018 Senator Richard Gordon said that the DOH must be liable for the controversy.[39] On March 13, Senator Gordon formally terminated the investigation of the controversy.[40]

On February 26, 2018 Aquino appeared for the first time at House inquiry about the controversy; he said that the controversy has been "politicized",[41] but the Malacañang Palace distanced itself from Aquino's allegations.[42]

On February 27, 2018 the opposition Representatives such as Gary Alejano of Magdalo and Edcel Lagman of Albay urged President Rodrigo Duterte to intervene about the dispute between the PAO and DOH.[43] On March 3, about 200 families of Dengvaxia vacinees joined the advocacy run held in Quezon Memorial Circle.[44]

Sanofi stated that they will make a decision on seeking regulatory approval for dengue vaccine Dengvaxia in the United States, despite the health scare in the country, after they have had a meeting with the US Food and Drug Administration.[45] Sanofi received approval for Dengvaxia sale in Europe.[46]

Charges

On April 5, Public Attorney’s Office filed the criminal charges (reckless imprudence resulting in homicide under Article 365 of the Revised Penal Code and violation of Republic Act No. 9745 (Anti-Torture Act) and torture) against the Former Health Secretary Janette Garin and other former officials.[47][48] However, Garin said that the charges have no basis and vowed to file a counter-charge against PAO.[49] The families of four children — Aejay Bautista (11), Lenard Baldonado (10), Zandro Colite (11), and Angelica Pestilos (10), whose deaths had been linked to Dengvaxia — also filed the charges.[50]

On April 19, PAO filed criminal complaints before the Department of Justice (DOJ), including the incumbent Health Secretary Francisco Duque III, following the death of the 13-year-old girl after receiving Dengvaxia on November 17, 2017.[51] Duque fires back by describing the charges against him as "malicious and oppressive" and he also said that he has nothing to do with the implementation of the dengue immunization program since he was seated as the secretary last October 2017.[52]

Gordon's draft report

On April 11, Gordon released his draft report, stating that Aquino is guilty of "malfeasance, misfeasance and nonfeasance" in connection to that controversy despite comments from known health experts showing the contrary.

On April 15, Gordon said he expected at least 10 senators to sign his report holding former President Benigno Aquino III and other officials liable.[53] Senator Panfilo Lacson will not sign the report due to "unreasonable comments" about him.[54] On April 17, Aside from Gordon, who already signed the report, Senators Ralph Recto, Manny Pacquiao, Win Gatchalian, Tito Sotto, Gregorio Honasan, Juan Miguel Zubiri, JV Ejercito, Nancy Binay, and Grace Poe have signed.[55] On April 20, Senator Sonny Angara also signed.[56]

Casualties and consequences

Over 600 people reportedly died from the vaccine[4], but since the announcement by Sanofi, no deaths have been scientifically confirmed. However, many of the victims' parents nonetheless blamed the dengue vaccine for the deaths of their children;[57] Some of them even had no prior knowledge of their children being injected.[58] One victim's parent considered to file charges against the doctors who allegedly mishandle the autopsy to the victim's body for "medical malpractice" and caused Persida Acosta to express anger.[59]

Most of the deaths were caused by internal bleedings in heart, lungs, and brain based on the autopsy conducted by PAO.[60][61][7] Duque angrily confronted the summoned hospital officials after he learned that four hospitals in Cavite allegedly refused to admit the Dengvaxia vaccinees because "there is no room for the patient".[62]

According to DOH, 729,105 Grade 4 students from selected regions have received the first dose of the vaccine. Of these, 534,303 students had approved parental consent but only 491,990 students received the first dose of the vaccine.[63]

Reactions

Citizens, as well as Senator Ejercito, expressed frustration on February 5, 2018 blaming the PAO for panic in dengue vaccination.[64] Attorney Persida Acosta of the PAO said that the PAO should not be blamed for that panic but Sanofi Pasteur itself.[64]

Allegations of Corruption

Employees of the Public Attorneys Office have asked the Office of the Ombudsman to issue a preventive suspension order against PAO chief Persida Acosta and her forensics chief Dr. Erwin Erfe for alleged corruption in the agency. It was alleged that Acosta has two “loyal” certified public accountants named Lira Hosea Suangco and Maveric Sales who are tasked to maintain office supplies such as bond paper to be used for the Dengvaxia cases. The funds however were used for other purposes. It was also alleged that Acosta and Erfe are using PAO funds to purchase tarpaulins, t-shirts and coffins to be used in rallies.[65]

See also

Notes
  1. Four with dengue indication.[2]
  2. Some sources say 700,000[25] or 830,000.[26]

References
  1. "DOH: Over 3,000 students hospitalized after Dengvaxia shot". Rappler.
  2. "PAO sees 'pattern' in deaths of 4 Dengvaxia recipients". ABS-CBN News. 2018-01-10.
  3. "DOH says 62 kids may have died after receiving Dengvaxia". Philippine Daily Inquirer.
  4. Isoux, Carol (21 April 2019). "Are Philippine children's deaths linked to dengue vaccine?". South China Morning Post. Retrieved 28 September 2019.
  5. "DOJ compels VACC, Vanguard to submit evidence on Dengvaxia complaint". ABS-CBN News. 23 March 2018.
  6. Cepeda, Mara (1 December 2017). "DOH suspends dengue vaccination program". Rappler. Manila, Philippines. Retrieved 28 September 2019.
  7. "TV Patrol: Nasuri ng PAO na naturukan umano ng Dengvaxia, umabot na sa 41". ABS-CBN News – via YouTube.
  8. Santos, Tina G. (30 November 2017). "Pharma firm issues caution on use of anti-dengue vaccine". Philippine Daily Inquirer. Retrieved 28 September 2019.
  9. Paris, Janella (22 August 2019). "DOH upholds permanent ban of Dengvaxia". Rappler. Manila, Philippines. Retrieved 28 September 2019.
  10. Tomacruz, Sofia (27 September 2018). "Parents still scared of govt's free vaccines a year after Dengvaxia scare". Rappler. Ilocos Sur, Philippines. Retrieved 28 September 2019.
  11. Editorial (2019-12-01). "Disease Burden of Dengue Fever and Dengue Hemorrhagic Fever". Lancet Infectious Diseases. Berlin/Heidelberg: Springer-Verlag.
  12. "Senate invites Aquino to vaccine probe". The Philippine Star. 2017-12-13.
  13. "DOH suspends dengue immunization program over potential health risk". The Philippine Star. 2017-12-17.
  14. "Sanofi updates information on dengue vaccine". Sanofi Pasteur. November 29, 2017.
  15. "Suspended dengue vaccine was given to 730,000 children, Philippines says". The Guardian. 5 December 2017.
  16. "Makati suspends anti-dengue vaccination program". Philippine Canadian Inquirer. 2 December 2017.
  17. "Ex-DOH chief ready to face probe over Dengvaxia mess". ABS-CBN News. 5 December 2017.
  18. "Sanofi, DOH allay dengue vaccine fears". The Philippine Star. 4 December 2017.
  19. "Sanofi denies Pinoys became 'guinea pigs,' says no reported Dengvaxia deaths in PH". News5.
  20. "Senate to probe dengue vaccine in January". The Philippine Star. 2 December 2017.
  21. "Risa says Sanofi must pay over Dengvaxia mess; DOJ orders probe of PNoy gov't's P3.5-B vaccination drive". News5.
  22. "PH gov't orders Sanofi to stop sale, distribution of Dengvaxia". News5.
  23. "FDA Advisory No. 2017-318 || Suspension of Sale/Marketing/Distribution of Sanofi Pasteur, Inc.’s Tetravalent Vaccine (Live, Attenuated)(Dengvaxia)". Archived from the original. Food and Drug Administration.
  24. "Garin ready to face govt's Dengvaxia probe". News5.
  25. "LIVE: Senate hearing on Dengvaxia". Rappler.
  26. "DOJ wants right expert to look into alleged Dengvaxia deaths". ABS-CBN News. 8 February 2018.
  27. "Filipinos not made guinea pigs – Sanofi". Philippine Daily Inquirer.
  28. "DepEd monitors students administered with Dengvaxia". Manila Bulletin. 2 December 2017.
  29. "Hontiveros: Sanofi should take on medical expenses of those who were vaccinated". Manila Bulletin.
  30. "Sanofi exec forced to apologize during Dengvaxia inquiry". Philippine Daily Inquirer.
  31. "Aquino ready to face Dengvaxia probe at Senate".
  32. "Aquino: It's my duty to explain". Philippine Daily Inquirer .
  33. "Duque to public: Don't rely too much on vaccination to fight dengue". GMA News.
  34. "Aquino, Garin face mass murder, plunder raps over dengvaxia controversy". Philippine Canadian Inquirer. December 15, 2017.
  35. "Dengue vaccine fiasco: Enrique Ona blames Janette Garin". 19 December 2017.
  36. "3 out of 14 kids died of dengue after Dengvaxia shot – UP-PGH panel". Rappler. 3 February 2018.
  37. "'Stop PAO autopsies on suspected Dengvaxia victims'". Rappler.
  38. "Mothers of Dengvaxia kids confront Garin after House probe". Rappler.
  39. "Gordon says DOH 'liable' over Dengvaxia mess". Rappler.
  40. "Gordon vows 'hard-hitting' report as Senate ends Dengvaxia probe". Rappler.
  41. "Aquino hits 'loud' forensic expert on Dengvaxia mess". Philippine Daily Inquirer.
  42. "Dengvaxia mess 'politicized'? Certainly not because of Duterte, says Palace". Philippine Daily Inquirer.
  43. "Bandila: Ilang mambabatas, hinamon si Duterte ukol sa Dengvaxia".
  44. "Mga pamilya ng naturukan ng Dengvaxia, nagsagawa ng 'advocacy run'". ABS-CBN News.
  45. "Sanofi may seek U.S. approval for Dengvaxia despite Philippines outrage". Reuters.
  46. "Dengvaxia sale approved for dengue-endemic areas in Europe".
  47. "Garin, other Health execs charged over 'Dengvaxia deaths'". The Manila Times.
  48. "Garin: Raps filed by parents of alleged Dengvaxia victims 'have no scientific basis'". Philippine Daily Inquirer.
  49. "Raps filed vs. Garin, 34 others over alleged Dengvaxia deaths". GMA News.
  50. "Dengvaxia victims' kin file complaint vs DOH, Sanofi, Zuellig execs". Rappler.
  51. "Duque, other DOH officials face criminal raps over Dengvaxia mess". ABS-CBN News.
  52. "Duque blasts PAO chief for 'malicious' Dengvaxia rap". ABS-CBN News.
  53. "Gordon: 10 senators to sign committee report on Dengvaxia probe". Philippine Daily Inquirer.
  54. "Lacson won't sign Dengvaxia report due to Gordon's 'unreasonable' remark". Philippine Daily Inquirer.
  55. "9 senators have signed report seeking charges vs former President Aquino". Philippine Daily Inquirer.
  56. "Angara signs blue ribbon Dengvaxia report with 'reservations', too". Philippine Daily Inquirer.
  57. "Anak namin namatay sa Dengvaxia" (in Tagalog). Archived from the original. Pilipino Star Ngayon. 5 December 2017
  58. See the interviews:
    Victim's parent: (Crying) Malaki po talaga hinanakit ko. Bago man sana sila... turok sa bata, tinanong nila kung alam ang magulang. Mayron talaga magulang yung mga estudyante, bakit nila tinurukan. Parang-awa niyo na.("TV Patrol: 2 pang batang naturukan ng Dengvaxia, namatay noong Enero")
  59. "DOH, gumastos na ng P22 milyon para sa mga 'dumadaing' sa Dengvaxia" (in Tagalog). ABS-CBN News – via YouTube.
  60. "Bakit namamaga ang internal organs ng mga namatay umano sa Dengvaxia?". ABS-CBN News (in Tagalog). 11 January 2018.
  61. "TV Patrol: Bangkay ng binatilyong 3 beses tinurukan ng Dengvaxia, sinuri" ABS-CBN News – via YouTube.
  62. "TV Patrol: Duque, sinugod ang mga ospital na 'tumanggi' sa naturukan ng Dengvaxia" ABS-CBN News – via YouTube.
    (1:41-1:47) ...Hindi naman pala puno ang hospital pero wala lang daw bakanteng kwarto noon para sa kaso ng bata.
  63. "Failon Ngayon: Dengvaxia". ABS-CBN News and Current Affairs – via YouTube. Note: Pause at 2:48.
  64. "Bandila: PAO, binabatikos dahil sa 'panic' sa Dengvaxia" (in Tagalog). ABS-CBN News — via YouTube.
  65. ABS News, Adrian Ayalin and Mike Navallo, ABS-CBN. "Acosta accused of using Dengvaxia issue for corruption in PAO". 2019-08-15. Retrieved 2019-12-02.https://news.abs-cbn.com/news/08/15/19/acosta-accused-of-using-dengvaxia-issue-for-corruption-in-pao
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