Cruz, Justine S

4 BAC

Facts about Dengvaxia

A vaccine aimed at protecting hundreds of thousands of school children from dengue may have put their lives at
risk.

Around 10 percent of over 800,000 students who were immunized with Dengvaxia, but did not have a prior
dengue infection, now face contracting a "severe disease," according to the vaccine's manufacturer Sanofi
Pasteur.

Following the announcement, the Department of Health (DOH) halted its nationwide dengue immunization
program and has demanded billions in pesos as a refund for the vaccines.

Meanwhile, both Congress and the Justice Department are digging deeper into the controversy, with officials
from the current and previous administrations pointing fingers at each other.

Here's how it happened:

2014
Dengvaxia successfully completes its two parallel Phase 3 clinical studies, which compare the safety and
effectiveness of the new treatment.

The Philippines was among the 10 countries that took part in the study.

November 9, 2014
Then-President Benigno Aquino III meets Sanofi Senior Vice President in Asia Region Jean-Luc Lowinski at the
Philippine Embassy in Beijing, China.

October 29, 2015

Sanofi Pasteur applies at the DOH for Dengvaxia to be included in the Philippine National Formulary, a list of
drugs that all pharmacies in the Philippines must carry, pending approval by the Food and Drug Administration
(FDA).

December 10, 2015

Garin submits a proposal to the Budget Department to buy three million doses of Dengvaxia.

December 22, 2015

The Philippines grants marketing approval to Dengvaxia, making it the first vaccine to be licensed for the
prevention of dengue in Asia.

The Food and Drug Administration (FDA) approves the drug for the prevention of disease caused by all four
dengue types in individuals from nine to 45 years old living in high-risk areas.

December 29, 2015

The Budget Department issues a ₱3.5-billion Special Allotment Release Order to Garin's office to purchase the
vaccines.
January 21, 2016
The Philippine Children's Medical Center (PCMC) makes a ₱3-billion purchase order for the vaccines without
approval from the FEC.

February 3, 2016
Garin issues a Certificate of Exemption for Dengvaxia vaccines to be utilized in the pilot implementation in the
National Capital Region, Region III, and Region IV-A.

February 11, 2016

The Philippines, under Health Secretary Janette Garin, hosts the worldwide launch of Dengvaxia.

March 2016
The World Health Organization (WHO) releases a paper saying Dengvaxia "may be ineffective or may even
increase that risk in those who are seronegative at the time of first vaccination."

Seronegative pertains to people who have not yet had dengue.

March 9, 2016
The PCMC issues its purchase order to Zuellig Pharma, the distributor of Dengvaxia.

April 4, 2016
The government kicks off its ₱3.5-billion, school-based dengue immunization program. The health department
says students would be given three doses, which would be administered every six months.

July 2016
The WHO releases another paper, saying Dengvaxia "may act as a silent natural infection that primes
seronegative vaccinees to experience a secondary-like infection upon their first exposure to dengue virus."

In other words, the body says the vaccine "may be ineffective or may theoretically even increase the future risk of
hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination regardless of
age."

That same month, former Health Secretary Paulyn Ubial issues a Resolution temporarily suspending the school-
based dengue immunization program.

Only the 489,003 pupils who received the first dose would take the second and third doses.

September 2016
The health department moves to continue the vaccination program.

That same month, the Medical Research Council Center FOR Outbreak Analysis and Modelling at Imperial College
London releases a study saying Dengvaxia could lead to an increase in the number of cases of the disease if not
implemented correctly.

"Unlike most diseases, the second time you get dengue, it's much more likely to be severe than the first time you
get it," said the center's director Neil Ferguson.
November 2016
The House of Representatives probes the allegedly anomalous purchase of the Dengvaxia vaccines.

Its draft report of the Committee on Health, the DOH reported there were 30 cases from March 18 to August 20,
2016 that were "considered as serious cases that needed hospitalization."

Of the three deaths it monitored, two were not related to the immunization program.

December 2016
The Senate launches its own investigation into the vaccines, saying the project cost was too big and was approved
without congressional approval.

November 29, 2017

Sanofi Pasteur announces the results of new clinical data analysis, which found that Dengvaxia is more risky for
people not previously infected by the virus.

"For individuals who have not been previously infected by dengue virus, vaccination should not be
recommended," it added.

December 1, 2017
Following Sanofi Pasteur's announcement, Health Secretary Francisco Duque III orders the temporary suspension
of the dengue vaccination program.

Duque says 733,713 children from Central Luzon, the region of Cavite, Laguna, Batangas, Rizal, and Quezon, and
Metro Manila were administered Dengvaxia. Eight to 10 percent or about 70,000 children have not had dengue
yet, the DOH added.

December 5, 2017
The FDA suspends the sale and distribution of Dengvaxia.

The WHO says it never recommended to countries the use Dengvaxia in their national immunization programs.

December 6, 2017
It is now monitoring 40 cases of children who fell seriously ill, up from 30 in 2016, and nine deaths.

December 7, 2017
The Health Department says it will return around 800,000 leftover Dengvaxia vaccines, worth P1.4-billion, to
Sanofi.

December 8, 2017
The health department calls for a refund of the P3.5 billion it paid for the vaccines, adding it has created a task
force to look into the program.

December 14, 2017

Aquino, under whose administration the deal was approved, attends the Senate hearing on the vaccine program.
Meanwhile, Ubial reveals that Garin's husband, Rep. Oscar Garin Jr., pressured her to continue the roll out of the
vaccine program.

January 4, 2018
Sanofi Pasteur says it has complied with international and local laws and regulations when it launched Dengvaxia,
saying it will continue to cooperate with the country's FDA.

January 10, 2018

The Public Attorney's Office (PAO) conducts an autopsy on five vaccinated children who died.

January 10, 2018

A former DOH official claims 19 officials, including former Health Secretary Garin, were part of a "mafia" in the
department. The "mafia" allegedly benefited from the Dengvaxia purchase, saying that 90 percent of the funds
goes back to the DOH, while 10 percent is given to a supposed "financier."

Garin denies the allegations.

January 19, 2018

At an event in San Fernando, Pampanga, Health Secretary Francisco Duque III confirms Sanofi Pasteur has
refunded P1.16 billion worth of unused Dengvaxia vaccines.

However, Duque clarifies the reimbursement does not put the French pharmaceutical company off the hook,
adding the investigation continues whether Sanofi withheld significant information on possible risks.

January 26, 2018

Duque reveals health officials did not wait for the results of clinical trials of the Research Institute for Tropical
Medicine (RITM) on Dengvaxia to know its risks before launching the nationwide immunization program.

He also suggests Executive Order 674, which establishes the RITM, should be reviewed to include possible
conflicts of interest in its research activities in partnership with pharmaceutical companies.

The Health Chief also sends a letter to Sanofi Pasteur formally requesting for a full refund of all the used and
unused vaccines.

January 31, 2018

Some parents in Zamboanga refuse the DOH's deworming program due to the Dengvaxia scare.

Health officials add the unused budget for the dengue vaccination program, worth P556 million, is still with the
PCMC.

February 2, 2018
The University of the Philippines - Philippine General Hospital (UP-PGH) experts' panel reports that out of 14
autopsies they conducted, three died due to complications of dengue. Two of those three dengue deaths could
possibly be related to Dengvaxia failure, they say.

A group of doctors from the East Avenue Medical Center also points out a decline in children's vaccinations
against other diseases such as flu, polio, and measles.
The doctors attribute this decline to the Dengvaxia scare, but they maintain other vaccines are safe.

February 5, 2018
Sanofi Pasteur turned down the Health Department's demand to refund used dengue vaccine vials. It said
agreeing to the demand will mean Dengvaxia does not work. The Dengvaxia maker also rejected the Department
of Health's request to financially support hospitalized vaccinated children.

PAO's findings state the deaths showed "strong links" to Dengvaxia, although it added the results are
inconclusive. Meanwhile, the findings by the UP-PGH found no direct link between the deaths and the vaccine.

The PAO also files a civil case against Garin, former Undersecretary Kenneth Uy, and other health officials of
implementing the program in undue haste even if "the product has no proven safety and efficacy."

Also included in the case are Sanofi and distributor Zuellig Pharma Philippines for failing to inform the public of
the vaccine's risks. All in all, the PAO is seeking at least P4 million in damages.