Sanofi Pasteur Vows to Cooperate on ‘Dengvaxia’ Review

Sanofi Pasteur on Monday assured its full support to the progress of the review that will be done by experts and the Department of Health (DOH) on Dengvaxia and in the delivery of proper information campaign on dengue vaccine especially in areas where the vaccination was carried out.

“Sa ngayon (As of now), nagco-collaborate kami ng (we are collaborating with) FDA (Food and Drug Administration) and DOH on the on-going review. And we don’t want to pre-empt it,” said Ching Santos, general manager of Sanofi Pasteur in a press briefing held at F1 Hotel in Bonifacio Global City, in Taguig City.

Santos added they will join the DOH in conducting an awareness campaign which includes dissemination of proper information on the matter to help allay the fear of parents of vaccinated children.

She added that part of their actions is to go to regions and cities wherein the vaccine was provided as part of the school-based immunization program in partnership with the Department of Education (DepEd) in line with the government’s anti-dengue campaign.

A person can acquire dengue up to four times in a lifetime.

Earlier, Health Secretary Francisco Duque III has suspended the vaccination program pending the recommendations from World Health Organization (WHO) panel of experts on the matter which is set to come out in two weeks.

The move was in response to Sanofi’s statement issued on November 29, citing latest findings that severe dengue may possibly occur to those vaccinated but not had any previous exposure to dengue illness before.

In the same statement, however, the company also cited the effectiveness and protection that the vaccine can give for those who have previous exposure to dengue in endemic countries such as the Philippines.

Meanwhile, Sanofi Pasteur global medical head Dr. Ng Su Peing said that all study participants who got severe dengue, whether vaccinated or not, have fully recovered.

“Furthermore, the severe dengue observed in vaccinated individuals was not clinically different from that reported in unvaccinated people in the studies,” added Ng.

Under the said findings, Ng said they also noted that 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 1 or II Dengue Hemorrhagic Fever (DHF).

Severe dengue can be categorized from milder to more severe forms of DHF I, II, III and IV according to WHO.

Ng, however, emphasized that DHF IV was not seen in those vaccinated.

She also said that there are actually a lot of factors that drives people to develop severe dengue while others are not.

“What is important to note however is that it depends on which country you might be in. It is sometimes not easy to really identify. As I’ve said before that among those who has had previous infection, we saw three out four can have no symptoms. So given that, you have to look at the local data, you have to look at the epidemiology of the burden of the disease of the country to make an assessment of the sero prevalence,” she added.

Dr. Joselito Sta. Ana, Sanofi Pasteur regional director also urged the public to have greater understanding of what severe dengue can be.

“Let us put into proper context, ano ba itong severe — ang iniisip kasi natin kapag severe ito na yung “dengue shock na nakamamatay”. Hindi. Ipinapakita sa analysis na piniresent ni Dr. Su, it could only be lagnat na dalawang araw, at kapag may suspected case ng dengue, yung platelet count pwedeng bumaba, pwede ring kapag nabunggo ka magkaka-hematoma ka or magkakapasa ka at pwede ring pag nainitan, magkakabalinguyngoy ka (What is this severe — what we are thinking when we say severe is the deadly dengue. No. What was shown in Dr. Su’s analysis could only be fever for two days and if there is a suspected case of dengue, platelet count could drop. It’s like you can have hematoma once you are hit or you can get bruises. Also, if you are exposed to heat, you can have nosebleed),” Sta. Ana explained.

Sta. Ana said that the undue fear for the dengue vaccine on the concept of “severity” of the illness should not out-weight in any way the benefits that can be derived from vaccine-preventable illnesses.

“Kasi ang nangyayari ngayon ang mga magulang natatakot di lang sa dengue vaccination at posible sa lahat ng pagbabakuna natatakot sila. And this is very bad kasi alam natin na ang bakuna ay isa sa mga public health tools na nagliligtas ng mga tao sa vaccine-preventable diseases,” he added.

Sanofi Pasteur also reiterated that it remains committed in following the guidance of WHO for the dengue vaccine.

The vaccine was launched in 11 countries and obtained 19 licenses from different dengue endemic countries.

The country being involved in the more than 20 years clinical trial was the second country who approved a license of it through the FDA in December, 2015.

The trials were all conducted in compliance to the country’s FDA and US FDA.

Being part of the trial, the participation was actually a way to demonstrate the impact being one of the highly endemic countries wherein high cases of dengue were noted in line with the guidelines of WHO.

At present there were two public health programs that were initiated using Dengvaxia — one in Brazil and the other one is in the country through the school-based immunization which was launched in April, 2016.

More than 700,000 Grade 4 pupils in public schools ages 9 years old and above became recipients of the program in Regions III, 4A, and NCR.

The program was also expanded to same age of students in selected cities in Quezon City, Manila, Makati, Caloocan City in Metro Manila and in some areas in Cebu using vaccines that were left usused for the three target regions. (PNA)