‘Miscommunication’ over Sanofi definition of severe dengue blamed for panic over Dengvaxia —experts

Infectious disease specialists blamed "miscommunication" for the widespread panic over the dengue vaccine Dengvaxia by vaccine manufacturer Sanofi Pasteur.

Philippine Foundation for Vaccination (PFV) founder Dr. Lulu Bravo said at a forum organized by the Philippine College of Physicians (PCP) that she had no idea that Sanofi Pasteur's "scientific" report could cause such a reaction.

"Miscommunication... Kagaya nga ng mga tanong ninyo, hindi namin naisip na ganito pala ang mangyayari. Yung Sanofi, nung nilabas nila yung report nila, nireport nila on a scientific basis," Bravo said on Wednesday.

"Sinabi nila, severe dengue — ano po ba yung severe dengue? Eh yun po, sa atin, sa totoo lang, ay lagnat, baba ang platelet, nagkaroon ng sakit ng ulo," she continued.

Dr. Mario Panaligan of the Philippine Society for Microbiology and Infectious Diseases (PSMID) said in a text message to GMA News Online that the term "severe dengue" should be blamed for the panic.

"With this, it caused panic among many Filipinos, particularly the parents of children who got vaccinated; they had this misconception that because those who did not have dengue before, and got vaccinated, may develop severe dengue — with the perception that they would have higher danger for bleeding," he said.

Panaligan added that Sanofi Pasteur used an "operational definition" for severe dengue characterized by the symptoms described by Bravo.

Pediatric Infectious Disease Society of the Philippines (PIDSP) board member Dr. Fatima Gimenez said at the same forum that most parents mistook the severe dengue reported as dengue shock syndrome (DSS).

Gimenez and Panaligan said Sanofi Pasteur never observed DSS in their clinical trials.

"You can range from asymptomatic to severe. Ito nga, sa clinical trials, dengue 1 and 2 ang nakita nila. Nobody went into shock or death," she said.

"This is different from the dengue definition that they used for the clinical trial. Kasi yung sa clinical trial, nakita rin nila yung dengue, grade 1 and 2 lang. Wala silang nakita namang resulting into death," Gimenez later added.

Panaligan on Wednesday reiterated the distinction between the WHO and Sanofi Pasteur's use of "severe dengue" in their clinical trial, in which children were closely monitored for Dengvaxia's effects.

"Dahil may pagbabantay, nung nakita nilang bumababa yung platelets, ah, ospital, severe dengue. So yun ang classification nila sa clinical trial. Pero hindi ganun eh, yung kadalasang nakamamatay," he said.

‘Severe dengue’ definiton

Sanofi Pasteur in November said "more cases of severe disease could occur following vaccination upon a subsequent dengue infection" for individuals not previously infected by dengue prior to vaccination.

"There are many factors that can lead to severe dengue infection. However, the highest risk of getting more severe disease has been observed in people infected for the second time by a different dengue virus," the company said.

After the panic caused by the statement, Sanofi Pasteur clarified that the definition they used for severe dengue "was a wider definition than the definition in countries that follow the WHO’s 2009 criteria."

WHO guidelines in 2009 grouped symptomatic dengue into three categories: undifferentiated fever, DF, DHF, and DSS

"DHF was further classified into four severity grades, with grades III and IV being defined as dengue shock syndrome (DSS)," the guidelines said.

Symptoms of DF under WHO guidelines differentiate depending on the patient's age, but includes high fever, "severe headache, pain behind the eyes, muscle and bone or joint pains, nausea and vomiting, and rash."

Four major clinical manifestations characterize typical DHF cases: high fever, haemorrhagic phenomena, hepatomegaly or enlarged liver, and circulatory failure.

Patients who progress to DSS deteriorates after a fever of two to seven days. They experience a rapid, weak pulse or hypotension, acute abdominal pain, lethargy, then restlessness before experiencing shock.

Sanofi Pasture noted that every individual who contracted severe dengue, as they have defined, in their clinical studies have "fully recovered."

Dr. Joselito Sta. Ana, regional director of Sanofi, said among the symptoms of a severe dengue were fever lasting more than two days, low platelet count, nosebleeding, and hematoma or bruising.

The vaccine itself, Sanofi Pasteur medical director Dr. Ruby Dizon also assured, will not cause severe dengue.

Bring kids to doctors

Other physicians have since then said that not every individual injected with Dengvaxia will develop severe dengue.

However, parents were still urged to bring their children to the nearest health facility if they develop a fever that lasts for two days or more to avoid possible complications.

"Being a clinician, anong nakikita ko from those who progress into those who have shock and later death? Late consult. The kids are brought to you at the time when they are already shocky," Gimenez said Tuesday.

"What I'm seeing from all the children we have seen with dengue is they were brought to you late. Kaya anong gagawin natin? Anong kailangan nating gawin? Pag may sakit ang anak, pakonsulta na agad 'cause that could be life-saving," she added. — MDM, GMA News