Dengvaxia controversy

Dengvaxia controversy
Location Philippines
Cause
Participants Public Attorney's Office
Department of Health
Casualties
3,281 hospitalized after receiving Dengvaxia (1,967 with dengue indication)[1]
Deaths 62 children (as of April 7, 2018)[note 1][3]

The Philippine Department of Health (DOH), on late November 2017, temporarily suspended a school-based dengue vaccination (also known as "Dengvaxia", Tagalog pronunciation: [dɛŋˈvakʃa]) program after French drug based vaccine maker Sanofi Pasteur made a statement that its product poses higher risks to people without prior dengue infection.[4][5] As a result, the Dengvaxia controversy, or Dengvaxia mess,[6] began to emerge following the reports of several children dying from various complications allegedly attributed to the dengue vaccine.[7]

Background

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.[8] The government paid P3.5-billion for the vaccine.[9] 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.

Events

Following the attempt by the dengue vaccination maker Sanofi Pasteur on November 29, 2017,[10] the Philippine Department of Health (DOH) suspended the vaccination program based in schools owing to the concern that it worsens the disease in some cases where the recipient had no previous exposure.[11] DOH Secretary Francisco Duque III said "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."[8] On December 2, 2017, the government of Makati immediately suspended its anti-dengue vaccination drive following its statement.[12]

In its statement, pharmaceutical company Sanofi Pasteur reported concerns that Filipinos, mostly schoolchildren, could be potentially be at risk of a more severe disease, where the recipient of the vaccine had not had a previous dengue infection. On December 4, 2017, Sanofi denied that they made Filipinos into “guinea pigs”, explaining that the vaccine program was conducted by the DOH, not Sanofi.[13][14] Dr Ruby Dizon, a medical director of Sanofi, said that the dengue vaccination would not cause "severe dengue".[15] Senator JV Ejercito, chair of the Senate Committee on Health and Demography, is seeking to identify by January 2018 whether there was an irregularity in the procurement of the vaccine.[16] Senator Risa Hontiveros urged the government to address the health threats posed by the vaccine.[17] The Food and Drug Administration of the Philippines ordered Sanofi to stop distributing of Dengvaxia into the country.[18][19] Former Health Secretary Janette Garin said she welcomed the investigation which will be conducted by the Philippine Department of Justice.[20] Presidential spokesperson Harry Roque told the media that 10 percent of the 733,000 schoolchildren[note 2] were at risk of dengue infection.[23] Since then, the Philippine Department of Education has closely monitored the students who have been injected by the vaccine.[24] Hontiveros said that Sanofi should take liability for the medical expenses of those who contracted severe dengue fever after receiving doses of the vaccine.[25]

Sanofi representative Thomas Triomphe "was forced to apologize" during the House of Representatives hearing on the Dengvaxia dengue vaccine.[26] Former President Benigno Aquino III, who approved the vaccination program in 2016, expressed interest on attending the Senate hearing.[27] 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".[28]

Secretary Duque reminded the public, especially parents, that "the vaccine is not a 'standalone' preventive measure against dengue."[29] 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.[30] Former health secretary Enrique Ona blamed his successor Janette Garin, who advised former president Benigno Aquino lll to purchase the Dengvaxia.[31]

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.[32] On February 3, a group of doctors, including former health secretary Esperanza Cabral, urged the Public Attorney's Office (PAO) to stop conducting autopsies.[33] On February 21, Senator Richard Gordon said that the DOH must be liable for the controversy.[34] On March 13, Senator Gordon formally terminated the investigation of the controversy.[35] On February 26, Aquino appeared for the first time at House inquiry about the controversy; he said that the controversy has been "politicized",[36] but the Malacañang Palace distanced itself from Aquino's allegations.[37] On February 27, 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.[38] On March 3, about 200 families of Dengvaxia vacinees joined the advocacy run held in Quezon Memorial Circle.[39]

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.[40]

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.[41][42] However, Garin said that the charges have no basis and vowed to file a counter-charge against PAO.[43] 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.[44]

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.[45] 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.[46]

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.[47] The blue ribbon committee also told Aquino for "simply not caring" because the lives of Filipino children in grave danger.[47] Gordon said that Aquino, former Budget Secretary Florencio Abad, Garin and other conspirators must be prosecuted for the Dengvaxia mess.[47][48] Gordon slammed Aquino by saying that "he's insensitive and lacks compassion."[49] However, left-wing figures called Gordon’s report “one-sided,”[50] and Senator Antonio Trillanes IV defends Aquino by saying that Gordon's report was "black propaganda".[51] Aquino reacted by saying, “What should we expect from the Dick Gordon show?”.[52] Also, Senator Ejercito said that while Aquino is "guilty of negligence", Garin and Abad are the ones who should be held liable.[50]

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, Sherwin 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

Since the announcement by Sanofi, at least 65 children have died as of early July 2018, allegedly after receiving a vaccination. The victims' parents blamed the dengue vaccine for the deaths of their children.[57] Most of the deaths are caused by internal bleedings in heart, lungs, and brain based on the autopsy conducted by PAO.[58][59][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".[60]

As of October 11, 2018, there has been 93 deaths reported.

Reactions

Netizens, as well as Senator Ejercito, expressed frustration on February 5, blaming the PAO for panic in dengue vaccination.[61] Attorney Persida Acosta of the PAO said that the PAO should not be blamed for that panic but Sanofi Pasteur itself.[61]

Notes

  1. ↑ Four with dengue indication.[2]
  2. ↑ Some sources say 700,000[21] or 830,000[22]

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.
  3. ↑ "DOH says 62 kids may have died after receiving Dengvaxia". Philippine Daily Inquirer.
  4. ↑ "DOH suspends dengue vaccination program". Rappler.
  5. ↑ "Pharma firm issues caution on use of anti-dengue vaccine".
  6. ↑ "DOJ compels VACC, Vanguard to submit evidence on Dengvaxia complaint". ABS-CBN News.
  7. 1 2 "TV Patrol: Nasuri ng PAO na naturukan umano ng Dengvaxia, umabot na sa 41". ABS-CBN News – via YouTube.
  8. 1 2 "DOH suspends dengue immunization program over potential health risk". The Philippine Star.
  9. ↑ "Senate invites Aquino to vaccine probe".
  10. ↑ "Sanofi updates information on dengue vaccine". Sanofi Pasteur. November 29, 2017.
  11. ↑ "Suspended dengue vaccine was given to 730,000 children, Philippines says". The Guardian.
  12. ↑ "Makati suspends anti-dengue vaccination program". Philippine Canadian Inquirer.
  13. ↑ "Sanofi, DOH allay dengue vaccine fears". The Philippine Star.
  14. ↑ "Sanofi denies Pinoys became 'guinea pigs,' says no reported Dengvaxia deaths in PH". News5.
  15. ↑ "Ex-DOH chief ready to face probe over Dengvaxia mess". ABS-CBN News.
  16. ↑ "Senate to probe dengue vaccine in January". The Philippine Star.
  17. ↑ "Risa says Sanofi must pay over Dengvaxia mess; DOJ orders probe of PNoy gov't's P3.5-B vaccination drive". News5.
  18. ↑ "PH gov't orders Sanofi to stop sale, distribution of Dengvaxia". News5.
  19. ↑ "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.
  20. ↑ "WATCH | Garin ready to face govt's Dengvaxia probe". News5.
  21. ↑ "LIVE: Senate hearing on Dengvaxia". Rappler.
  22. ↑ "DOJ wants right expert to look into alleged Dengvaxia deaths". ABS-CBN News.
  23. ↑ "Filipinos not made guinea pigs – Sanofi". Philippine Daily Inquirer.
  24. ↑ "DepEd monitors students administered with Dengvaxia". Manila Bulletin.
  25. ↑ "Hontiveros: Sanofi should take on medical expenses of those who were vaccinated". Manila Bulletin.
  26. ↑ "Sanofi exec forced to apologize during Dengvaxia inquiry". Philippine Daily Inquirer.
  27. ↑ "Aquino ready to face Dengvaxia probe at Senate".
  28. ↑ "Aquino: It's my duty to explain". Philippine Daily Inquirer .
  29. ↑ "Duque to public: Don't rely too much on vaccination to fight dengue". GMA News.
  30. ↑ "Aquino, Garin face mass murder, plunder raps over dengvaxia controversy". Philippine Canadian Inquirer. December 15, 2017.
  31. ↑ "Dengue vaccine fiasco: Enrique Ona blames Janette Garin".
  32. ↑ "3 out of 14 kids died of dengue after Dengvaxia shot – UP-PGH panel". Rappler.
  33. ↑ "'Stop PAO autopsies on suspected Dengvaxia victims'". Rappler.
  34. ↑ "Gordon says DOH 'liable' over Dengvaxia mess". Rappler.
  35. ↑ "Gordon vows 'hard-hitting' report as Senate ends Dengvaxia probe". Rappler.
  36. ↑ "Aquino hits 'loud' forensic expert on Dengvaxia mess". Philippine Daily Inquirer.
  37. ↑ "Dengvaxia mess 'politicized'? Certainly not because of Duterte, says Palace". Philippine Daily Inquirer.
  38. ↑ "Bandila: Ilang mambabatas, hinamon si Duterte ukol sa Dengvaxia".
  39. ↑ "Mga pamilya ng naturukan ng Dengvaxia, nagsagawa ng 'advocacy run'". ABS-CBN News.
  40. ↑ "Sanofi may seek U.S. approval for Dengvaxia despite Philippines outrage". Reuters.
  41. ↑ "Garin, other Health execs charged over 'Dengvaxia deaths'". The Manila Times.
  42. ↑ "Garin: Raps filed by parents of alleged Dengvaxia victims 'have no scientific basis'". Philippine Daily Inquirer.
  43. ↑ "Raps filed vs. Garin, 34 others over alleged Dengvaxia deaths". GMA News.
  44. ↑ "Dengvaxia victims' kin file complaint vs DOH, Sanofi, Zuellig execs". Rappler.
  45. ↑ "Duque, other DOH officials face criminal raps over Dengvaxia mess". ABS-CBN News.
  46. ↑ "Duque blasts PAO chief for 'malicious' Dengvaxia rap". ABS-CBN News.
  47. 1 2 3 "Senate blue ribbon on Dengvaxia mess: Aquino simply did not care". The Philippine Star.
  48. ↑ "Aquino, Abad, Garin 'caused' Dengvaxia 'tragedy' – draft report". Philippine Daily Inquirer.
  49. ↑ "Former President Aquino is responsible because he caused the purchase of Dengvaxia and in the process caused irreversible damage, possibly death, to children, [and] anxiety, sleepless nights, unnecessary expense on the part of the parents and guardians. The greatest sin and transgression of Aquino was to put the lives of Filipino children in grave peril. He simply did not care. Manhid siya at walang malasakit (He's insensitive and lacks compassion)."" ("Gordon report: File criminal charges vs Aquino, Garin, Abad over Dengvaxia mess") — Rappler
  50. 1 2 "Senators cool to Gordon report on Dengvaxia". The Philippine Star.
  51. ↑ "Gordon draft report 'black propaganda', won't pass Senate scrutiny - Trillanes". ABS-CBN News.
  52. ↑ "Clearly it's 'Dick Gordon show,' says Aquino on Dengvaxia draft report". Philippine Daily Inquirer.
  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. Retrieved December 20, 2017.
  58. ↑ "Bakit namamaga ang internal organs ng mga namatay umano sa Dengvaxia?". ABS-CBN News (in Tagalog).
  59. ↑ "TV Patrol: Bangkay ng binatilyong 3 beses tinurukan ng Dengvaxia, sinuri" ABS-CBN News – via YouTube.
  60. ↑ "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.
  61. 1 2 "Bandila: PAO, binabatikos dahil sa 'panic' sa Dengvaxia" (in Tagalog). ABS-CBN News — via YouTube.
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