Dengvaxia controversy

Dengvaxia controversy

Cause	Dengue vaccine (primary allegation) Internal bleeding (autopsy conducted by PAO)
Deaths	41 children (as of March 28, 2018)

The Philippine Department of Health (DOH), on late November 2017, temporarily suspended a school-based dengue vaccination (also known as "Dengvaxia") program after French drug based vaccine maker Sanofi Pasteur made a statement that its product poses higher risks to people without prior dengue infection. As a result, the dengue vaccination controversy began to emerged following the reports of almost 40 children died from various complications after allegedly receiving dengue vaccine (some even without parents' knowledge).

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. The government paid P3.5-billion for the vaccine. 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 statement by the dengue vaccination maker Sanofi Pasteur on November 29, 2017, 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. 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." 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 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. Dr Ruby Dizon, a medical director of Sanofi, said that the dengue vaccination would not cause "severe dengue". 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. Senator Risa Hontiveros urged the government to address the health threats posed by the vaccine. The Food and Drug Administration of the Phillipines 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 "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 3, 2018, a group of doctors, including former health secretary Esperanza Cabral, urged the Public Attorney's Office (PAO) to stop conducting autopsies. Netizens, as well as Senator Ejercito, expressed frustration on February 5, blaming the PAO for panic in dengue vaccination. Attorney Persida Acosta of the PAO said that the PAO should not be blamed for that but Sanofi Pasteur itself. On February 21, Senator Richard Gordon said that the DOH must be liable for the controversy.

Sanofi stated that they will make a decision on seeking regulatory approval for dengue vaccine Dengvaxia in the United States, despite the Philippines health scare, after they have had a meeting with the US Food and Drug Administration.

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. 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 (11), Lenard Baldonado (10), Zandro Colite (11), and Angelica Pestilos (10), whose deaths had been linked to Dengvaxia — also filed the charges.

Casualties

Since the announcement by Sanofi, at least 36 children have died as of late March 2018, allegedly after receiving a vaccination. The victims' parents blamed the dengue vaccine for the deaths of their children.

Reported casualties

Name, age	Origin	Notes	Ref.
Anjielica Pestilos	Quezon City	Pestilos died mainly due to lupus.
Michael Tablate, 11	Subic, Zambales	Tablate died on October 31, 2017. According to the death certificate, his caused of death are cardiopulmonary arrest, acute respiratory failure, and status asthmaticus. Three months after he was injected, he suffered fever in a week and eventually died in the hospital. According to Dr. Edwin Erfe of PAO Forensic, he had the severe bleedings in heart and lungs.
Leonard Baldonado, 10	San Pablo, Laguna	The body of Baldonado, who injected by dengue vaccine on November 9, 2017, was examined by forensics. Initial findings stated that he had an internal bleedings in the liver, lungs, heart, and brain.
Zandro Colite, 11	Imus, Cavite	Colite died on December 27, 2017. According to the death certificate, his cause of death are "Sepsis 2, intra-abdominal infection and acute ruptured appendicitis".
Crezel Ann Joy Viaros, 10	Sariaya, Quezon	Viaros died on January 16, 2018 due to alleged respiratory failure but the victim's parents disputed this. After her body was examined, the experts found no problems in the lungs. She died probably in brain hemorrhage.
Marc Axl Eboña, 13	Muntinlupa	Eboña brought to the hospital on January 29, 2018 and died shortly. His cause of death are hypovolemic shock, massive gastointestine bleeding and typhoid fever.
Rei Jazztine Alimagno, 13		Alimagno died on January 3, 2018 due to alleged "dengue shock syndrome". According to victim's father, he saw the blood coming out from his son's nose and mouth.
John Marky Ferrer, 11	Tarlac City	Ferrer experienced back and forth fever until his leg paralyzed after he is injected three times of vaccine. He is confined four days in ICU and eventually died on March 16, 2018. Based on death certificate, his cause of death are acute respiratory failure and pneumonia.
unnamed, 11	Tanay, Rizal	The PAO examined the 11-year-old, who died on November 2017. According to the result of the findings, he had the enlarged spleen, and internal bleedings in heart, lungs, and whole parts of brain.