Timeline of Dengue Vaccine Procurement and Vaccination Implementation Presented by Senator Richard Gordon

COMMITTEE
ON
ACCOUNTABILITY OF
PUBLIC OFFICERS
AND INVESTIGATIONS
joint with
HEALTH AND DEMOGRAPHY;
and FINANCE
11 December 2017
COMMITTEE ON
ACCOUNTABILITY OF
PUBLIC OFFICERS AND
INVESTIGATIONS
Senator Richard J. Gordon
Chairperson
TIMELINE OF DENGUE VACCINE PROCUREMENT
AND VACCINATION IMPLEMENTATION
DATE EVENT
November President Benigno S. Aquino III

9, 2014 met with Jean-Luc Lowinski,
Senior Vice President in Asia
Region of Sanofi at the Philippine
Embassy in Beijing, Peoples
Republic of China.
President Aquino met with Sanofi officials to discuss the availability
of a dengue vaccine in 2015 and also the dengue situation in the
Philippines while he was in the APEC Leaders Meeting in China.
DATE EVENT
January 21, Initial submission of

2015 documents to FDA
DATE EVENT
Sanofi Pasteur completed its dossier,
February and
submitted to the FDA.
May 2015
DATE EVENT
Sec. Janet Garin went to Paris, France and met
May 14, 2015 with Sanofi Pasteur Officials.
During their dinner, the cost of vaccines were
discussed.
Sec Garin visited the Sanofi Pasteur Neuville
May 15, 2015 Dengue Vaccine Facility
DATE EVENT
June 9, 2015 Sec. Janet Garin negotiated

with Sanofi to reduce the cost
of the vaccines.
Source: CHRONOLOGY OF EVENTS submitted by DOH Sec.
Ubial, 2016 Senate Budget Hearings
DATE EVENT
October Sanofi Pasteur submitted to PD the

application to include dengue vaccine in
29, 2015
the Philippine National Formulary (PNF)
pending the Certificate of Product
Registration (CPR) issuance of FDA as
the vaccine is prioritized by the current
administration
DATE EVENT
December 1, President Benigno S. Aquino III
2015 together with DOH Secretary Janet
Garin went to Paris for the UN
Conference on Climate Change.
During this visit, President Aquino
received Sanofi Pasteur officials at the
Hotel Scribe, Paris
Source: CHRONOLOGY OF EVENTS submitted by DOH Sec. Ubial,
2016 Senate Budget Hearings
SUPPLY DRIVEN
DATE EVENT
Top Sanofi officials paid a courtesy call to
December
PNoy, along with DOH Sec. Garin and Finance
1, 2015 Sec. Cesar Purisima, when he visited Paris for
the UN Conference on Climate Change.
Finance Sec. Purisima
DOH Sec. Garin
DATE EVENT
At 11:10 a.m., the President received Sanofi
December
Pasteur officials, as requested by Ms. Conchita
1, 2015 Santos, Country Manager of Sanofi Pasteur
(Philippines) at the Hotel Scribe Paris
DATE EVENT
December Sec. Garin submitted a proposal
10, 2015 to DBM for Health Facilities
Enhancement Program (HFEP)
Funding and Procurement of 3
million doses of dengue vaccine.
Source: CHRONOLOGY OF EVENTS submitted by DOH Sec. Ubial, 2016
Senate Budget Hearings
DATE EVENT
December Dr. Mariano Baquilod submitted

11, 2015 the justification for the
procurement of dengue vaccine
under National Dengue
Prevention and Control Program
DATE EVENT
December Meeting regarding declaration of
21, 2015 savings to augment items of
appropriations for various
urgent projects
Source: Memo for the President by Secretary Abad dated December 23,
2015
DATE EVENT
December The Food and Drug Administration
22, 2015 (FDA) approved the marketing of the
Dengue Tetravalent Vaccine
(Dengvaxia). FDA issued Certificate of
Product Registration.
DATE EVENT
December Memorandum for President issued by Secretary
Abad recommending:
23, 2015
1. Funding of projects from FY2015 savings
from the Miscellaneous Personnel Benetis
Fund (MPBF) and Pension Gratuity Fund
(PGF) so they can be obligated and/or
disbursed before the end of 31 December
2015;
DATE EVENT
December Memorandum for President issued by
Secretary Abad recommending:
23, 2015
NOTE: Among the projects identified to be
funded by FY 2015 MPBF Savings is the
Dengue Vaccine (NCR, III, IV-A) under
Expanded Program for Immunization at the
amount of P3,556,155,900.00
Source: Memo for the President by Secretary Abad dated December 23, 2015
DATE EVENT
December DBM asked the EPI to prepare

procurement documents for dengue
28, 2015 vaccine
The DOH Family Health Office
submitted a request to Sec. Garin for
Philippine National Drug Formulary
(PNDF) exemption per EO No. 49
s.1993 for Dengvaxia.
DATE EVENT
December Special Allotment Release Order (SARO) was
issued by DBM to DOH-Office of the
29, 2015 Secretary.
Funding Source: Regular Agency Fund, FY
2015 GAA, RA 10651 amounting to
P3,556,155,900.00 to cover the procurement
of dengue vaccine
The allotment herein released shall be valid
for obligation until December 31, 2015
2015 Expanded Immunization Program Budget vs. Dengvaxia Budget
Dengvaxia Procurement (SARO):

P3.556B
2015 Expanded Immunization

Program (GAA):
P3.336B
Special Allotment Release Order (SARO)
Notes:
The allotment herein released shall be valid
for obligation until December 31, 2015
*PURCHASE ORDER BEFORE BID
DATE EVENT
First Week DOH Sec. Garin informed Dr.

of January Julius Lecciones, Executive
2016 Director of the Philippine
Childrens Medical Center
(PCMC) about the plan to
implement dengue vaccination
and request for PCMC to procure
the vaccine
*PURCHASE ORDER BEFORE BID
DATE EVENT
January 4, DOH Sec Janette Garin

2016 announced that over a million
public school students will be
selected to have three doses of
dengue vaccines.
DATE EVENT
January 7, 1st FEC Meeting for 2016, members agreed

that the FEC will follow standard
2016 procedure and to defer any
recommendation regarding exemption of
dengue vaccine until a formal request is
submitted by the concerned DOH
program. The application for the PNF
inclusion shall likewise undergo the
standard process.
DATE EVENT
Second Submission and review of draft

Memorandum of Agreement (MOA)
Week of
between DOH-Disease Prevention and
January Control Bureau (DPCB) and PCMC for
2016 the transfer of funds and procurement
of vaccine. The said MOA was finalized
and then notarized on 19 February
2016
DATE EVENT
January Philippine Childrens Medical Center

made a purchase order for dengue
21, 2016
vaccine to Zuellig Pharma (the sole
distributor of Dengvaxia in the
Philippines), without approval from
Formulary Executive Committee (FEC).
DATE EVENT
In the 2nd meeting of the FEC, Usec. Hartigan-Go
January said that the recommendation on the inclusion of
21, 2016 the vaccine in the Philippine National Formulary
(PNF) is not yet imperative at the moment. He
explained that dengue vaccine procurement was
indeed not planned in 2015 and 2016 as part of a
DOH project, however, a political decision to
allot the budget from the national agencies
savings was already made by a higher
Committee.
TIMELINE OF DENGUE VACCINE PROCUREMENT AND VACCINATION
IMPLEMENTATION
DATE EVENT
2nd FEC Meeting for 2016 agreed:
January To defer recommendation until additional
25, 2016 requirements are provided:
Formal Phase IV study protocol and risk
management plan by Sanofi
Protocol for staggered implementation with
target population and pilot schools
Operational guidelines for the use and
administration of the vaccine
Baseline profiling and serial antibody monitoring
Operational research protocol
Source: CHRONOLOGY OF EVENTS submitted by DOH Sec. Ubial, 2016 Senate
Budget Hearings
DATE EVENT
February DOH issued Certificate of Fund

2, 2016 availability to PCMC
Budget Hearings
DATE EVENT
February Sec. Garin issued Certification for the

Exemption of Dengue tetravalent vaccine to
3, 2016 be utilized for the pilot implementation in
three regions NCR, Region III and Region
IV-A.
Meeting of the FEC with Sec. Garin, PCMC,
FEC, WHO, DPCB, RITM, FDA, FHO regarding
dengue vaccine
Budget Hearings
DATE EVENT
February Doses of Dengvaxia arrive in the

11, 2016 Philippines.
Source: Rappler Worlds first dengue vaccine now available in PH
<https://www.rappler.com/science-nature/life-health/122061-dengue-
vaccine-available-philippines>
DATE EVENT
February Memorandum of Agreement

19, 2016 (MOA) between DOH-Disease
Prevention and Control Bureau
(DPCB) and PCMC for the transfer
of funds and procurement of
vaccine.
DATE EVENT
March Health Secretary Janette Garin

2016 said that DOH would start the
vaccination program starting in
March.
DATE EVENT
March 2, Notice of Cash Allocation was

2016 issued by DBM to DOH
amounting to P4,513,000,000.00
DATE EVENT
March 8, Fund transferred to PCMC total

2016 amount of Php 3 billion
Disbursement Voucher was
issued for transferring of funds to
PCMC
DATE EVENT
March 9, Purchase Order was issued by

2016 PCMC to Zuellig Pharma
DATE EVENT
March 15, Delivery of 200,000 multi-dose

2016 vials (1st dose supply) to
Research Institute for Tropical
Medicine (RITM) Warehouse
DATE EVENT
March An 11-year old boy, John Paul Rafael, was

vaccinated, he was screened and assessed
31, 2016
by a health doctor.
3rd NAEFIC Meeting
Presentation of baseline survey results to
the NAEFIC
Source: CHRONOLOGY OF EVENTS submitted by DOH Sec. Ubial, 2016 Senate Budget
Hearings
DATE EVENT
April 4, Launching of Dengue Vaccination

2016 in Parang Elementary School,
Marikina City. DOH, DepEd and
DILG collaborated in the major
launch of the vaccine in Metro
Manila.
Hearings
DATE EVENT
April 5, Launching of Dengue Vaccine in

2016 Iba, Zambales
Hearings
DATE EVENT
April 11, 11-yr old John Paul Rafael dies after

suffering cardiac arrest.
2016
The case was presented to the DOH
National Adverse Event Following
Immunization Committee (NAEFIC) for
review, after which the committee said
that it is coincidental that the boy had
cardiac arrest after immunization.
Hearings
DATE EVENT
April 18, The WHO recommends the

administration of Dengvaxia "in
2016
populations where the disease incidence
in the population is at least 50%." The
vaccine is not recommended for children
below 9 years old, and should be given in
3 doses at a 6-month interval.
Source: PH vaccine safe, effective WHO <https://www.rappler.com/science-nature/life-
health/129954-ph-dengue-vaccine-safe-effective-who>
DATE EVENT
July 18, Dr. Paulyn Ubial, now DOH Chief,

2016 signs a resolution recommending
the deferment of the program,
saying the vaccine is not proven
safe.
Source: Rappler <https://www.rappler.com/science-nature/life-health/190022-timeline-
dengue-immunization-program-doh-philippines-dengvaxia-vaccine>
DATE EVENT
September Sec. Ubial issue a Certificate of

28, 2016 Exemption for Dengvaxia so it
could still be used despite earlier
flagging of certain issues.
Source: Rappler <https://www.rappler.com/science-nature/life-health/190022-
timeline-dengue-immunization-program-doh-philippines-dengvaxia-vaccine>
DATE EVENT
May 5, Per Secretary Ubial, DOH will halt

2017 the dengue vaccination program
after completing the third and final
round of injections for Grade 4
students from April to July.
Source: GMA News Online
<http://www.gmanetwork.com/news/lifestyle/healthandwellness/609622/dengue-vaccine-
program-to-temporarily-end-after-3rd-round-of-pilot/story/>
DATE EVENT
TED Failon Interview on DENGVAXIA, with the following points:
June 23,
I. INTERVIEW OF ROBERT MENDOZA (Alliance of
2017 Health Workers, President):
The issue was about the stocked dengue vaccines,
having expiration dates of August 2018. Mendoza
mentioned that the budget of the maintenance and
operations of the hospitals were reduced. But,
according to Mendoza, Sec. Ubial plans to buy new
dengue vaccines, as well. (DENIED BY SEC. UBIAL)
DATE EVENT
October The Food and Drug Administration

penalizes Sanofi and pharmacy Watsons
24, 2017
for illegally promoting and advertising
Dengvaxia, a violation of the Food and
Drug Act of 2009 and Administrative
Order No. 65. Both companies are slapped
with a P5,000 fine each.
Source: Rappler <https://www.rappler.com/science-nature/life-health/190022-timeline-
dengue-immunization-program-doh-philippines-dengvaxia-vaccine>
DATE EVENT
November DOH Assistant Secretary Lyndon See Luy

says that despite the controversies
7, 2017
hounding the immunization program, it
is not ethically right to abruptly stop the
vaccination process without completing
all 3 doses.
Source: GMA News Online
<http://www.gmanetwork.com/news/news/nation/632218/doh-ethically-bound-
dengue-vaccine-program/story/>
DATE EVENT
Sanofi updates information on dengue vaccine
November
Based on up to six years of clinical data, the new
29, 2017 analysis evaluated long-term safety and efficacy of
Dengvaxia in people who had been infected with
dengue prior to vaccination and those who had not.
The analysis confirmed that Dengvaxia provides
persistent protective benefit against dengue fever in
those who had prior infection. For those not
previously infected by dengue virus, however, the
analysis found that in the longer term, more cases of
severe disease could occur following vaccination
upon a subsequent dengue infection.
DATE EVENT
November Vaccination should only be recommended

when the potential benefits outweigh the
29, 2017 potential risks (in countries with high
burden of dengue disease). For individuals
who have not been previously infected by
dengue virus, vaccination should not be
recommended.
Source: Sanofi Media Release <http://mediaroom.sanofi.com/sanofi-updates-
information-on-dengue-vaccine/>

Timeline of Dengue Vaccine Procurement and Vaccination Implementation Presented by Senator Richard Gordon

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COMMITTEE

November President Benigno S. Aquino III

January 21, Initial submission of

June 9, 2015 Sec. Janet Garin negotiated

October Sanofi Pasteur submitted to PD the

DOH Sec. Garin

December Dr. Mariano Baquilod submitted

December DBM asked the EPI to prepare

Dengvaxia Procurement (SARO):

2015 Expanded Immunization

First Week DOH Sec. Garin informed Dr.

January 4, DOH Sec Janette Garin

January 7, 1st FEC Meeting for 2016, members agreed

Second Submission and review of draft

January Philippine Childrens Medical Center

February DOH issued Certificate of Fund

February Sec. Garin issued Certification for the

February Doses of Dengvaxia arrive in the

February Memorandum of Agreement

March Health Secretary Janette Garin

March 2, Notice of Cash Allocation was

March 8, Fund transferred to PCMC total

March 9, Purchase Order was issued by

March 15, Delivery of 200,000 multi-dose

March An 11-year old boy, John Paul Rafael, was

April 4, Launching of Dengue Vaccination

April 5, Launching of Dengue Vaccine in

April 11, 11-yr old John Paul Rafael dies after

April 18, The WHO recommends the

July 18, Dr. Paulyn Ubial, now DOH Chief,

September Sec. Ubial issue a Certificate of

May 5, Per Secretary Ubial, DOH will halt

October The Food and Drug Administration

November DOH Assistant Secretary Lyndon See Luy

November Vaccination should only be recommended

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