Dengvaxia Update

We continue to monitor developments associated with Dengvaxia. We did not identify any new press releases or statements on the Sanofi website.
‘Stop PAO autopsies on suspected Dengvaxia victims’
Ex-DOH chief Esperanza Cabral and other doctors urge the DOJ to stop PAO’s autopsies on 14 children who supposedly died due to Dengvaxia
February 03, 2018
By Michael Bueza
MANILA, Philippines – A group of doctors, including former health secretary Esperanza Cabral, urged the Department of Justice (DOJ) to stop the Public Attorney’s Office (PAO) from conducting autopsies on 14 children who supposedly died due to the controversial dengue vaccine Dengvaxia.
In a statement Saturday, February 3, the group Doctors for Public Welfare said it makes “no sense for any more families to be subjected to the torture of having a loved one exhumed and cut up, only to find out that no useful information was derived from the cruel act.”
“We urge the Department of Justice to order the PAO to stop performing autopsies on these children, and to leave the matter of determining the cause of death to competent forensic pathologists,” the doctors said.
The group issued the statement after forensic pathologists from the University of the Philippines-Philippine General Hospital (UP-PGH) presented their diagnosis on these deaths on Friday, February 2…

Kids’ vaccination rate down to 60% after Dengvaxia scare – DOH
Health Undersecretary Enrique Domingo appeals to parents to continue getting ‘tried and tested’ vaccines for their children to avoid diseases like polio, diphtheria, measles, and tetanus
February 02, 2018
By Mara Cepeda
MANILA, Philippines – The Department of Health (DOH) is alarmed as more and more parents are refusing to avail of the government’s various vaccination programs following the Dengvaxia mess.
Health Undersecretary Enrique Domingo said on Friday, February 2, that only about 60% of Filipino children are getting their scheduled vaccines, when the DOH’s annual vaccination rate target is around 85%.
“I think we are down to 60% coverage, kasi dati gusto natin diyan mga 85% (because we usually want the figure at 85%). I don’t know exactly the exact figures but siguro (maybe) by the end of the year, we’ll get a more exact figure. But the local experience right now is the uptake of our vaccination programs is really going down,” Domingo in a press conference on Friday.
The health official made the statement on the same day that the DOH and the experts panel from the University of the Philippines-Philippine General Hospital bared the results of the analysis of 14 cases of children who died after getting vaccinated with Sanofi Pasteur’s Dengvaxia dengue vaccine.
Three vaccinated children developed and died of dengue, 9 died due to various diseases they got after their vaccination, while the cause of death of the last two cases remain unknown.
Domingo explained that parents have become so scared after Sanofi announced Dengvaxia may lead a person to develop severe dengue if he or she had not been infected by the virus prior to immunization. (READ: TIMELINE: Dengue immunization program for public school students)
The parents are now refusing to avail of free government vaccines that could prevent their kids from getting other preventable diseases like polio and measles.
Domingo said this explains the recent measles outbreak in Davao. He added parents are even avoiding deworming initiatives from the DOH.
   “We really just like to implore all of our parents na kung nagkaroon po tayo ng duda, kung nagkaroon po talaga tayo ng problema dito sa bakunang [Dengvaxia na] ito, hindi po dapat madamay ‘yong ibang bakuna (We really just like to implore all of our parents that if you have doubts, if you had problems with the Dengvaxia vaccine, don’t let other vaccines be affected by it),” said Domingo.
   “[Ito ay] dahil napakarami nating bakuna na magpoprotekta sa anak ninyo, sa polio, sa diphtheria, sa tigdas, sa tetanus. Mga tried and tested po ito at kailangan maibigay ito sa ating mga anak,” he added. (This is because we have countless other vaccines that can protect your child from polio, diphtheria, measles, and tetanus. They are tried and tested, and it is vital that your children get them.)
Health Secretary Francisco Duque III made the same appeal to parents as soon as he suspended the dengue vaccination program in December 2017…

Philippines: 3 Deaths May Be Linked to Dengue Vaccinations
New York Times | 2 February 2018
MANILA, Philippines — Philippine health officials said Friday that the deaths of three children injected with a Sanofi Pasteur dengue vaccine may have “causal association” to the inoculation, including two who may have died because the vaccine failed.
The Philippine government halted its massive immunization drive last year after Sanofi said a study showed the vaccine may increase the risks of dengue in people vaccinated prior to infection. More than 830,000 children were injected with the Dengvaxia vaccine, health officials said.
“This issue continues to sow fear and confusion, especially to the parents of children who have been injected with Dengvaxia,” Health Secretary Francisco Duque III’s office said in a statement. “We aim to give clarity on the issues with an honest and objective reporting of the evidence and science.”
Duque said further study was needed on the vaccine. Investigators found no evidence the rest of the 14 reported child deaths were related to the vaccine.
Dr. Juliet Sio-Aguilar, who led the investigation, told a news conference that only one of the three dead children had developed dengue antibodies, which would have served as a protection against an infection, but still died.
“We really want to know what happened,” she said.
Sanofi Pasteur officials did not immediately issue any comment.

Secretary Duque issues directives to regions and hospitals to prioritize the needs of vaccinated children
Republic of the Philippines – Department of Health
Press Release/ January 30, 2018
[text bolding from original]
To formulate policy and set guidelines on addressing the issues surrounding the rollout of Dengvaxia vaccine, the Department of Health under the leadership of Secretary Francisco T. Duque III held a command conference bringing together the Department’s Executive Committee, Regional Directors, Hospital Chiefs and program managers, experts from the Research Institute for Tropical Medicine and the Food and Drug Administration, members of the Expert Panel on Dengvaxia, and the World Health Organization Representative Office in the Philippines.

Chaired by DOH Chief-of-Staff Undersecretary Mario Villaverde, the high-level conference provided a valuable opportunity for the top DOH officials from all over the country to update themselves on the issues and concerns associated with Dengvaxia, share the best practices and challenges faced by affected regions, and discuss guidelines prepared by the Task Force convened by the Secretary of Health in December of last year.

Secretary Duque closed the conference by issuing a set of directives to be immediately pursued and enforced by the entire DOH which will be subject to amendments as the need arises during their implementation.

“Considering all the discussions, resolutions, and other outputs of this Joint Executive Committee Meeting and Command Conference on Dengvaxia, I, the Secretary of Health, hereby direct the following:
The Dengue Task Force:
(a) has approved in principle three interim guidelines to address the issues and concerns as a result of the Dengue vaccination initiative subject to the final review of the Expert Panel:
[i] Surveillance – instituting a mechanism of enhanced surveillance over the next five years initially covering admitted cases following immunization, and then expanding to a reporting system covering outpatient settings through health centers, clinics, LGUs, and regional offices.
[ii] Dengue case management and patient referral – emphasizing on the early diagnosis and proper case management of Dengue; and, establishing a network of both public and private hospitals which can provide services to patients.
[iii] Risk communication – giving correct information to allay unfounded fears based on misconceptions; provide basic information on Dengue and the 4S approach to prevent infection; constantly updating the public on DOH’s efforts in addressing the concerns of vaccinees; and, designating public health advocates at the regional offices and hospitals who can help patients navigate through the health system so that their health needs are adequately and expeditiously addressed.
These interim guidelines are immediately effective once approved subject to specific period of implementation and revisions as we learn more from our experience.

(b) shall review the policy and processes on the introduction of new antigens in our national immunization program;

(c) shall study other proposed guidelines to enhance the delivery of public health vaccination programs;
[i] Financing and reimbursement of hospitalized cases of adverse events following immunization using PhilHealth, the Medical Assistance Program, and other possible financing sources. For the regional offices to negotiate with private providers not to charge beyond the PhilHealth case rates.
[ii] Vaccine Injury Compensation;
[iii] Autopsy of alleged deaths following Dengvaxia immunization; and,
[iv] Laboratory diagnosis and confirmatory test.

(d) shall pursue possible legislative reforms that emerged from this issue by:
[i] Strengthening the mandate of RITM to be an independent research arm on infectious diseases, not influenced by the industry; and,
[ii] Strengthening the independence of FDA in exercising its mandate to protect the public in regulating health products.

(e) shall be constantly vigilant about possible/emerging concerns that may arise from this issue.
In relation to this, I would also like to reiterate my request to the Expert Panel to give guidance to the DOH on determining the causality of adverse events specifically following Dengue vaccine immunization.

The Regional Directors are to do the following:
(a) give a human face to the efforts of the DOH by reaching out to the parents and patients, and to show compassion particularly to the bereaved parents and relatives;
(b) document, sustain, and institutionalize best practices that have been developed in the course of addressing the crisis in their respective areas; and,
(c) lead the operationalization of policies in their covered provinces/cities and provide feedback.

The Concerned DOH Hospitals are to:
[a] extend their utmost service to appropriately manage the health and psychosocial concerns of Dengvaxia vaccinees;
[b] raise the level of scientific and administrative discussion among personnel and officials to further enhance the capabilities of their respective units in dealing with such crisis.

For the future directions of the Department on public health programs:
[a] The design and implementation of public health programs should consider the universal principles of respect for persons, beneficence, nonmaleficence, and justice.
[b] Exercise of prudence in introducing new health technologies, noting that they should be based on rigorous scientific and economic evaluation, considering other factors when implementing the program in the real world.

I would like to extend my heartfelt gratitude to everyone present today. Your participation and cooperation are vital in addressing these issues on Dengvaxia. I anticipate with optimism the same degree of participation and cooperation in operationalizing these directives in the days to come. With this, I give my full trust and confidence in the decisions you will make as well as the execution of such directives in your own respective offices.”