Sanofi clarifies Dengvaxia does not cause ‘severe dengue’

French-based pharmaceutical company Sanofi Pasteur Philippines on Monday clarified that the dengue vaccine Dengvaxia does not cause "severe dengue."

"I'd like to address the little misinformation, hindi nakukuha yung severe dengue from the vaccine so hindi dahil nabakunahan ka nagka-severe dengue ka, hindi siya ganon. Nakukuha mo siya dahil you had a subsequent exposure to the virus so hindi dahil binigyan ka ng bakuna, magkakasevere dengue ka," Dr. Ruby Dizon, medical director of Sanofi Pasteur said at a press conference in Taguig City.

Last week, Sanofi has advised against prescribing the dengue vaccine Dengvaxia to patients who have not been infected by the virus in the past, since it was found that it may cause severe diseases in the long run.

The Department of Health (DOH) has put on hold the government's dengue vaccination program after Sanofi raised health concerns on the vaccine.

DOH said that more than 733,000 children — aged 9 and above — from public schools in Metro Manila, Central Luzon, and Calabarzon have already received at least the first three doses of the vaccine.

After their "supplementary exploratory analysis" of the long-term follow-up on the dengue vaccine, Sanofi said they found that "there is a clear and sustained benefit of being vaccinated with the dengue vaccine up to 6 years following the first injection" for those individuals who were previously infected by dengue virus.

"In individuals who have not been previously infected by dengue virus, there is an increased risk of hospitalization for dengue and severe dengue, predominantly Grade I or II Dengue Hemorrhagic Fever (DHF)," Sanofi said in a statement.

Sanofi citing data from the World Health Organization said that "severe dengue" can be categorized from "milder to more severe forms as DHF I, II, III, and IV."

It said that the DHF IV was not seen for individuals who were vaccinated, noting that they have shared their new data in "full transparency" with the Philippine Food and Drug Administration (FDA) and the DOH.

"Furthermore, the severe dengue observed in vaccinated individuals was not clinically different from that reported in unvaccinated people in the studies. All study participants who got severe dengue, whether vaccinated or not, have fully recovered," Sanofi said.

Despite this, Dr. Ng Su Peing, global medical head of Sanofi Pasteur said that they "would not recommend vaccination" for those who have not experienced dengue.

Dr. Ng Su Peing (Global Medical Head, Sanofi Pasteur) explains “severe dengue” pic.twitter.com/2ammlG8MRl

— Marlly (@marllybondoc) December 4, 2017

Dr. Joselito Sta. Ana, regional director of Sanofi Pasteur, meanwhile, explained that the potential "severe dengue" would not be fatal as perceived by the public.

"Let us put it in the proper context, ano ba itong severe? Ang iniisip kasi natin na 'pag severe ito na yung dengue shock na mamatay, hindi," Sta. Ana said.

"Severe could only be yung lagnat ng dalawang araw, at kapag may suspect na case ng dengue, yung platelet count, puwedeng bumaba puwede rin kapag nabunggo ka, magkakahematoma ka or makakapasa ka at puwede ring 'pag nainitan ka, mababalinguyngoy ka," he added.

Sanofi said dengue is highly endemic in the Philippines and an average of over 160,000 cases, mostly in children and teenagers were reported since 2010.

"Studies have shown that in individuals aged 9 to 14 years old, 9 out of 10 of them would have already been infected by the dengue virus. However, not all people who have been infected by the dengue virus are aware, because around 75% of them do not have any symptoms," Sanofi said.

"The dengue vaccine does not contain viruses that can make people ill with dengue or severe dengue. Severe dengue infections are uncommon complications of dengue disease, occurring in an estimated 0.5% of cases manifesting symptoms of dengue annually," it added.

DOH reacts

Health Secretary Francisco Duque III on Tuesday said what Sanofi Pasteur said regarding Dengvaxia not causing severe dengue that could be fatal is "under controlled circumstances."

"'Yung sinasabi ng Sanofi (na severe na hindi aabot sa mamamatay), under controlled circumstances. In other words, binabantayan na nila. Eh paano 'yung andun sa on the ground, 'yung reyalidad na nasa malayong barangay, nasa malayong lalawigan na hindi mo binabantayan? Eh papano, 'di mo naman matutukan lahat," Duque said in an interview on Dobol B sa News TV.

Duque said he has asked for the master list of all those who received the vaccine so they can be profiled, their medical history taken, and should they be hospitalized, be monitored closely. —RSJ/KG, GMA News