DENGVAXIA

The Philippine Department of Health (DOH), in late November 2017, temporarily suspended a school-
based dengue vaccination (also known as "Dengvaxia"). 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 Dengvaxia controversy, or Dengvaxia mess, began to emerge following the reports of several children
dying from various complications allegedly attributed to the dengue 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. 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. The government paid P3.5-billion for the vaccine.
Following the press release 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 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 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".

JOHN CHRISTOPHER A. LOPEZ, RN

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 (UP-PGH) 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 (PAO) to stop conducting autopsies. On February 21, 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, 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, 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.[40] Sanofi has received approval for Dengvaxia sale in Europe.

JOHN CHRISTOPHER A. LOPEZ, RN