MANILA, Philippines (2nd UPDATE) – The moment the Department of Health (DOH) announced it would be bringing the world’s first-ever dengue vaccine to the Philippines, health experts raised the alarm. 

They argued that launching a school-based immunization program in April 2016 was just too soon, since it was a mere 4 months after the Philippines approved the sale of Sanofi Pasteur’s Dengvaxia vaccine.

Issues over the vaccine’s safety and efficacy, cost-effectiveness given its P3.5-billion budget, and alleged anomalies in its procurement process have cropped up in the past year.

The immunization program received a big blow on Wednesday, November 29, when Sanofi itself issued a warning against its own vaccine.  

New analysis of 6 years’ worth of clinical data showed “more cases of severe disease” could be experienced by people who received the vaccine but had not been previously infected by the virus.

The warning comes as the Philippines is already more than a year into implementing its school-based dengue immunization program for 9-year-old public school students in the National Capital Region (NCR), Central Luzon, and Calabarzon.

Several health experts want to take legal action, because thousands of young Filipinos are now at risk of getting severe dengue.

Health Secretary Francisco Duque III said their technical assistance office is meeting with independent medical experts to determine the proper course of action to take following Sanofi’s advisory. He added that the safety of children is “paramount.” 

He already suspended the program.

Look back at the events surrounding Dengvaxia – from its approval for commercial sale in the Philippine market in 2015 to Sanofi’s warning on the safety of the vaccine in 2017:

November 9, 2014 – Presidenit Benigno Aquino III meets Jean-Luc Lowinski, Sanofi’s senior vice president in Asia, at the Philippine Embassy in Beijing, China.

January 21, 2015 – Sanofi’s submits initial requirements to obtain a certificate of productio registration from the Food and Drug Administration (FDA).

February and May 2015 – Sanofi completes its requirements for the FDA.

May 15, 2015 – Then-DOH chief Janette Garin is invited by Sanofi to visit their dengue vaccine facility in Lyons, France. Garin was in Europe to ask help from experts regarding another disease in Central Luzon at the time.

December 1, 2015 – Aquino receives executives from the company in a courtesy call in Paris, France. 

December 10, 2015 – Garin submits to the Department of Budget and Management (DBM) a proposal to allocate budget from the Health Facilities Enhancement Program for the procurement of 3 million doses of the dengue vaccine.

December 11, 2015 – Dr Mariano Baquilod submits the justification to procure the dengue vaccine under the National Dengue Prevention and Control Program.

Decmber 22, 2015 – The Philippines becomes the first Asian country to approve commercial sale of the world’s first dengue vaccine, Dengvaxia. The FDA issues its certificate product registration for the vaccine. 

December 23, 2015 – Then-DBM chief Florencio Abad issues a memorandum on funding various projects through the savings from the Miscellaneous Personnel Benefits Fund (MPBF) and the Pension Gratuity Fund  so they can be disbursed before December 31, 2015.

Among the projects identified to by funded through the MPBF is the dengue vaccination program in NCR, Central Luzon, and Calabarzon worth P3,556,155,900.

December 28, 2015 – The DBM asks the Enhanced Program on Immunization to prepare procurement documents for Dengvaxia.

December 29, 2015 – The DBM releases the Special Allotment Release Order to the DOH for the dengue vaccination program.

First week of January 2016 – Farin tells Philippine Children’s Medical Center (PCMC) Executive Director Julius Lecciones about the plan to implement the dengue vaccination program. PCMC will be signing the procurement documents, not DOH.

January 5, 2016 – Garin says then-president Benigno Aquino III approved the administration of the dengue vaccine to 1,077,623 9-year-old public school students in NCR, Central Luzon, and Calabarzon. 

A whopping P3.5 billion will be sourced from sin tax revenues to fund the immunization purchase.  

January 7, 2016 – The Formulary Executive Council (FEC) meets to discuss the safety, efficacy, and cost-efficacy of Dengvaxia.

January 21, 2016 – PCMC files a purchase order for the dengue vaccine to Dengvaxia’s distributor, Zuellig Pharma, without the FEC’s recommendations.

January 25, 2016 – FEC holds its second meeting on the dengue vaccine. 

February 1, 2016 – The FEC recommends to the DOH an exemption for Dengvaxia dengue vaccine for only a year, with certain conditions. A phased implementation and staged procurement are recommended.

February 2, 2016 – DOH issues a Certificate of Fund availability to PCMC.

February 3, 2016 – Garin issues the Certificate of Exemption for Dengvaxia.

February 11, 2016 – Doses of Dengvaxia arrive in the Philippines.

February 19, 2016 – The memorandu of agreement between the PCMC and the DOH Disease Prevention and Control Bureau on the dengue vaccination program’s implementation is finalized and notarized.

March 8, 2016 – A total of P3 billion is transferred to PCMC’s funds to purchase the dengue vaccine. 

March 15, 2016 – Around 200,000 multi-dose vials of the dengue vaccine is delivered to the warehouse of the Research Institute for Tropical Medicine. 

March 28, 2016 – Garin says in a press conference that the dengue vaccine has undergone extensive clinical trials, was vetted by international experts, and earned approval from the World Health Organization (WHO).  

This follows reports that the vaccine was not safe, and that 4 participants in a clinical trial had died as a result of the vaccine.

April 4, 2016 – The DOH launches the school-based dengue vaccination program for more than one million 9-year-old public school students in NCR, Central Luzon, and Calabarzon.

But health experts question the “rushed” implementation of the mass vaccination program, arguing that it could pose risks to Filipinos since studies on its safety were still being conducted at the time. 

April 11, 2016 – An 11-year-old boy who had congenital heart disease dies after receiving a dengue shot on March 31. The DOH denies Dengvaxia was to blame for his death.  

April 18, 2016 – The WHO recommends the administration of Dengvaxia “in populations where the disease incidence in the population is at least 50%.”  

The vaccine is not recommended for children below 9 years old, and should be given in 3 doses at a 6-month interval.

July 18, 2016 –  Dr Paulyn Ubial is now DOH chief under President Rodrigo Duterte. She signs a resolution recommending the deferment of the program, saying the vaccine is not proven safe. 

July 29, 2016 – The WHO publishes its first position paper on the dengue vaccine. It said countries should consider the introduction of the dengue vaccine “only in geographic settings (national or subnational) where epidemiological data indicate a high burden of disease.” It also did not recommend the use of the vaccine for children under 9 years of age. 

September 28, 2016 – But two months later, Ubial issues a Certificate of Exemption for Dengvaxia so it could still be used despite her earlier flagging of certain issues.

October 5, 2016 – Quezon 4th District Representative Angelina Tan files House Resolution No. 444 calling for a probe into the DOH’s school-based immunization program for the dengue vaccine. Tan is chairperson of the House committee on health. 

DOH officials tell lawmakers during the plenary deliberations for the 2017 budget that they plan to expand the vaccination program to Central Visayas.

October 17, 2016 – Nueva Ecija 1st District Representative Estrellita Suansing files House Resolution No. 480 seeking an inquiry into the P3.5-billion contract to purchase Dengvaxia from Sanofi as well as the safety and efficacy of the vaccine. 

November 21, 2016 – The House health committee holds its first hearing on the dengue immunization program, but it is cut short after lawmakers question why Garin was not invited to speak.

Though she is not on the list of resource persons for the hearing, the ex-health chief is still present to tell the health committee that she was supposed to go abroad from this week until Christmas. Because the hearing was canceled, Garin said she is willing to fly back to attend the next hearing.

December 6, 2016 – The House health committee continues its probe. Dr Anthony Leachon, a member of the dengue experts panel of the DOH tasked to evaluate Dengvaxia, says they had recommended in July to temporarily halt the program. He says this was so the DOH could properly validate reports that two people allegedly died due to the vaccine.

Tan says the House health committee had recommended to the good government and public accountability panel that there should be “proper social preparation and precautionary/screening test should be done prior [to] vaccination.”

The Senate blue ribbon panel also probes the P3.5-billion purchase of Dengvaxia during the Aquino administration. Senator Richard Gordon criticizes health workers’ “obvious” lack of training in administering the dengue vaccine.

February 21, 2017 – The House committees on health and public accountability hold a joint hearing into the dengue vaccination program. 

The hearing is based on Oriental Mindoro 1st District Representative Doy Leachon’s privilege speech, where he questioned why the P3.5-billion budget for the program was still issued a Special Allotment Release Order by the budget department even if the funds were not included in the 2015 and 2016 national budgets.

The lawmaker also questions why the DOH allotted P3.5 billion for one vaccine alone, when its budgets for 2015 and 2016 were at P3.3 billion and P3.9 billion, respectively.

Leachon is the brother of Dr Anthony Leachon, who is also an independent director at the Philippine Health Insurance Corporation.

July 26, 2017 – Garin faces the House panels once again. Lawmakers ask her why the DOH sought an exemption from the Formulary Executive Council (FEC) for the procurement of the dengue vaccine. Garin says the exemption was needed because the FEC has backlogs in pending applications. 

The ex-Aquino Cabinet official also denies the dengue immunization program was launched in anticipation of the 2016 polls.

October 24, 2017 – The FDA penalizes Sanofi and pharmacy Watsons for illegally promoting and advertising Dengvaxia, a violation of the Food and Drug Act of 2009 and Administrative Order No. 65. Both companies are slapped with a P5,000 fine each.

November 7, 2017 – Health Assistant Secretary Lyndon Lee Suy says that despite the controversies hounding the immunization program, it is not ethically right to abruptly stop the vaccination process without completing all 3 doses. “There will be more problems if you don’t complete the 3 doses,” he says.

November 29, 2017 – Sanofi issues a warning against its own vaccine. New analysis of 6 years’ worth of clinical data reveals Dengvaxia could lead to “more cases of severe disease” when administered to a person who has never been infected by dengue.

November 30, 2017 – Health advocates once again express outrage over the DOH’s dengue immunization program. Dr Anthony Leachon says vaccinated Filipino children now have to live with the possibility of getting severe dengue “for the rest of their lives.”

December 1, 2017 – Duque suspends the dengue vaccination program and says the DOH will closely monitor the health of all vaccinated children in the next 5 years.

December 11, 2017 – The Senate blue ribbon committee and panels on health and demography, and finace reopen its probe into the dengue vaccine controversy. – Rappler.com