Dengvaxia controversy
The Dengvaxia controversy, also known as the Dengvaxia issue and Dengvaxia mess, was a controversy in the Philippines about the use of Dengvaxia, a dengue vaccine produced by French drug-based vaccine maker Sanofi Pasteur. In late November 2017, the Department of Health suspended the school-based vaccination program that utilized the dengue vaccine after the reports circulated that several children have died from various complications which were allegedly attributed to the vaccine. Shortly after, the company made a statement that its product poses higher risks to people without prior dengue infection.
As of August 2019, over 600 people that have received at least a single dose of the vaccine have died, though not necessarily caused by the vaccine itself. The DOH has since banned the vaccine's use and sale in the Philippines. The scare caused by the controversy may be a factor in the country's loss of confidence in vaccines and low immunization rates, resulting in an infectious disease crisis in the country in 2019, including a measles outbreak.
Background
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.at the launching of the dengue vaccine school-based immunization program.
In April 2016, the Department of Health, 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. The government paid P3.5-billion for the vaccine.
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. This came some time after reports circulated of children dying allegedly from complications associated with the vaccine. Soon after, the Philippine Department of Health suspended the vaccination on FCS program based in schools owing to the said concern, 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." On December 2, 2017, the government of Makati immediately suspended its anti-dengue vaccination drive following its statement.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". 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. 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, while Senator Risa Hontiveros urged the government to address the health threats posed by the vaccine. The Food and Drug Administration of the Philippines ordered Sanofi to stop distributing of Dengvaxia into the country. Former Health Secretary Janette Garin said she welcomed the investigation which will be conducted by the Philippine Department of Justice. Presidential spokesperson Harry Roque told the media that 10 percent of the 733,000 schoolchildren were at risk of dengue infection. Since then, the Philippine Department of Education has closely monitored the students who have been injected by the vaccine. Hontiveros said that Sanofi should take liability for the medical expenses of those who contracted severe dengue fever after receiving doses of the vaccine.
Sanofi representative Thomas Triomphe "was forced to apologize" during the House of Representatives hearing on the Dengvaxia dengue vaccine. Former President Benigno Aquino III, who approved the vaccination program in 2016, expressed interest on attending the Senate hearing. 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".
Secretary Duque reminded the public, especially parents, that "the vaccine is not a 'standalone' preventive measure against dengue." 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. Former health secretary Enrique Ona blamed his successor Janette Garin, who advised former president Benigno Aquino lll to purchase the Dengvaxia.
On February 2, 2018, the University of the Philippines-Philippine General Hospital issued a report stating that three out of 14 children who died after receiving Dengvaxia had an indication of dengue despite immunization. On February 3, a group of doctors, including former health secretary Esperanza Cabral, urged the Public Attorney's Office to stop conducting autopsies.
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.
On February 21, 2018 Senator Richard Gordon said that the DOH must be liable for the controversy. On March 13, Senator Gordon formally terminated the investigation of the controversy.
On February 26, 2018 Aquino appeared for the first time at House inquiry about the controversy; he said that the controversy has been "politicized", but the Malacañang Palace distanced itself from Aquino's allegations.
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. On March 3, about 200 families of Dengvaxia vacinees joined the advocacy run held in Quezon Memorial Circle.
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. Sanofi received approval for Dengvaxia sale in Europe.
Charges
On April 5, Public Attorney's Office filed the criminal charges against the Former Health Secretary Janette Garin and other former officials. However, Garin said that the charges have no basis and vowed to file a counter-charge against PAO. The families of four children — Aejay Bautista, Lenard Baldonado, Zandro Colite, and Angelica Pestilos, whose deaths had been linked to Dengvaxia — also filed the charges.On April 19, PAO filed criminal complaints before the Department of Justice, including the incumbent Health Secretary Francisco Duque III, following the death of the 13-year-old girl after receiving Dengvaxia on November 17, 2017. 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.
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. Senator Panfilo Lacson will not sign the report due to "unreasonable comments" about him. 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. On April 20, Senator Sonny Angara also signed.
Casualties and consequences
No one reportedly died from the vaccine, 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; Some of them even had no prior knowledge of their children being injected. 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.Most of the deaths were caused by internal bleedings in heart, lungs, and brain based on the autopsy conducted by PAO. 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".
According to the 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.