Mass use of dengue vaccine had no backing of DOH medical experts
MANILA, Philippines – The move to include dengue vaccine Dengvaxia in the national vaccination program did not have the imprimatur of the panel of medical experts that was tasked to review its safety, effectiveness, and even its cost-effectiveness.
Minutes of a January 25, 2016 meeting of that panel, called the Formulary Executive Council (FEC), said, “Since the safety and efficacy of the vaccine are not yet well-established, the Council suggested a small scale pilot testing of the vaccine through phased implementation rather than vaccinating the target children in the 3 regions all at once.” (READ: W.H.O. didn't recommend Dengvaxia for PH vaccination program)
The 3 regions referred to were the National Capital Region, Central Luzon, and Calabarzon (Cavite, Laguna, Batangas, Rizal, Quezon).
The FEC, according to Executive Order No. 49, is the body mandated to determine which drugs should be part of the National Formulary, a list of drugs that the government can buy and use. Any drug not listed in the formulary cannot be purchased by government.
Given this restriction, the FEC recommended to the DOH an exemption for Sanofi Pasteur’s Dengvaxia dengue vaccine for only a year, with certain conditions. Any purchases beyond that period were supposed to be subject to another study, according to minutes of meetings obtained by Rappler.
Under that one-year purchasing period, the FEC also recommended a “staged procurement” of the vaccine.
All these indicate that then-DOH chief Janette Garin had decided to forego the FEC’s recommendations when she launched the school-based dengue vaccination program in the 3 regions on April 4, 2016. (READ: TIMELINE: Dengue immunization program for public school students)
Less than two years after, Sanofi said new analysis of 6 years’ worth of clinical data showed its vaccine could lead to “more severe” cases of dengue when administered on a persons who have not been previously infected by the virus.
Current DOH Secretary Francisco Duque III already suspended the program, but not before 830,000 Filipino children received the vaccine in school. (READ: Duque confirms vaccinated 12-year-old in Tarlac later got severe dengue)
Another 15,000 cops, their dependents, and walk-in civilians got the vaccine from an immunization drive in Quezon City.
The FEC is composed of experts in the fields of pharmacology, toxicology, clinical epidemiology, pharmacy, clinical medicine, public health, health economics, health social science, and law and medicine.
The FEC members who tackled the dengue vaccine were:
- Lawyer Froilan Bagabaldo
- Dr Cleotilde How
- Dr Cecilia Jimeno
- Dr Hilton Lam
- Dr Cecile Maramba-Lazarte
- Dr Paul Matthew Pasco
- Dr Imelda Peña
- Dr John Wong
Throughout their 3 meetings – on January 7 and 25, 2016 and February 1, 2016 – a majority of the FEC members argued there weren’t enough clinical studies at the time to guarantee that Dengvaxia was safe to use, effective in preventing dengue, and cost-effective enough for the government to buy for mass consumption.
But in a way, they were working under a “deadline.”
Even before the FEC’s first meeting, Garin publicly said then president Benigno Aquino III already approved the allotment of P3.5 billion in sin tax revenues to administer the vaccine to more than a million kids in the 3 regions.
The February 1, 2016 minutes also quoted ex-DOH undersecretary Kenneth Hartigan Go as saying it was “not yet imperative” to include Dengvaxia in the National Formulary, but a “political decision to allot the budget from the national agencies’ savings was already made by a higher Committee.”
He did not specify which committee he was exactly referring to.
Not illegal, but was it right?
To be clear, it was not illegal for Garin to ignore the FEC regarding Dengvaxia, as it is merely a recommendatory body. But former DOH undersecretary Susan Pineda Mercado explained that the FEC’s recommendations are usually the basis of the DOH chief’s key policy decisions.
“Because if you have a number of experts who studied the issue and put their approval behind it, then the secretary of health can say, ‘Well, the leading scientists have already said that this is ok,’” said Pineda.
“In fact, the recommendation of the FEC is what secretaries of health usually use as their basis for making a decision. It is not some external body, some international expert,” she added.
Public health experts have renewed outrage over the dengue immunization program now that Sanofi issued its new advisory against its vaccine.
Duque plans to go after Sanofi, eyeing to demand a refund and making the French pharmaceutical giant set up an indemnity fund for vaccinated Filipino kids who will later be hospitalized due to dengue.
Garin speaks up
Others pin the blame on Garin for the “rushed” implementation of the vaccination program. But she stands by her decision, arguing it was above-board.
“Hindi po totoo ‘yon na maraming nag-object at pinilit ko… Lahat sila ngayon nagke-claim na eksperto sila eh. Pero sino ba ang talagang totoong eksperto? The DOH is on top of the situation. The DOH has the authority to say kung ano ang gagawin, ano ang nangyayari, at sila dapat ang pinakikinggan natin,” Garin told ABS-CBN.
(It’s not true that there were many objections but I forced to implement the program… They’re now all claiming to be experts. But who are the real experts? The DOH is on top of the situation. The DOH has the authority to say what should be done, what is happening, and they should be the only ones we should listen to.)
She said she was saddened that the dengue vaccine controversy is being used as a “vehicle to confuse the people.”
“I understand the concern. At kailangan na itong tutukan kasi maski kami, galit na galit [sa] announcement ng Sanofi, lalo na no’ng makita mo severe dengue. Nanay din ako. Anak ko nabakunahan din. Ako nabakunahan din. So ang tinitingnan ko, bakit ganito?” said Garin.
(I understand the concern. We need to closely look into this because even we are also very angry over Sanofi’s announcement, especially when I saw it involved severe dengue. I am a mother, too. My child was vaccinated as well. I was vaccinated also. So why did this happen?)
It’s the same question lawmakers want to find answers to next week, when congressional investigations on Dengvaxia will be reopened.
The Senate blue ribbon committee will probe into the dengue vaccination program on Monday, December 11, while the House panels on health and good government and public accountability will hold a joint hearing on Wednesday, December 13.
Read copies of the minutes of the FEC's meetings on January 7 and 25, 2016 and February 1, 2016 below:
– with a report from Sofia Tomacruz/Rappler.com