Bacungan, V. J., de Guzman, C. & Hermonio, E. (2018).

Timeline: The dengvaxia

controversy. CNN Philippines. Retrieved on May 15, 2018 at
http://cnnphilippines.com/news/2017/12/09/The-Dengvaxia-controversy.html

Cepeda, M. (2018a). Sanofi knew Dengvaxia risks in 2015 but didn’t tell PH – FDA,
physician. https://www.rappler.com/nation/196915-sanofi-knew-dengvaxia-risks-2015-
did-not-tell-philippines.

Cepeda, M. (2018b). Sanofi denies concealing Dengvaxia risks from Philippines.

Retrieved on May 12m, 2018 at https://www.rappler.com/nation/196915-sanofi-knew-
dengvaxia-risks-2015-did-not-tell-philippines

Demetillo-Mendoza, D. (2017). World's first dengue vaccine launched in the Philippines.

The Asian Parent Philippines. Retrieved on May 12, 2018 at
https://ph.theasianparent.com/first-dengue-vaccine-launched-in-the-philippines

France-Presse, A. (2018). Dengue vaccine row wreaks havoc on Philippine war on

disease. ABS-CBN News. Retrieved on May 12, 2018 at http://news.abs-
cbn.com/news/02/02/18/dengue-vaccine-row-wreaks-havoc-on-philippine-war-on-
disease

Geronimo, J. Y. (2018). DOH: Over 3,000 students hospitalized after Dengvaxia shot
The health department reveals that 1,967 out of the 3,281 patients 'were found to have
contracted dengue, as confirmed through clinical and serological tests'. Retrieved on May
13, 2018 at https://www.rappler.com/nation/200187-doh-students-hospitalized-
dengvaxia.

Jaymalin, M. (2018). Suspected Dengvaxia deaths climb to 26. The Philippine Star.
Retrieved on May 12, 2017 at
https://www.philstar.com/headlines/2018/01/26/1781519/suspected-dengvaxia-deaths-
climb-26#lJs1oFE4Zs8cA0b4.99

Mogato, M. (2018). Philippines says anti-dengue vaccine may be connected to three

deaths. Reuters. https://www.reuters.com/article/us-sanofi-dengue-
philippines/philippines-says-anti-dengue-vaccine-may-be-connected-to-three-deaths-
idUSKBN1FM0SP

Santos, A. (2018). Dengue vaccine controversy sparks panic in Philippines. Deutsche

Welle. https://www.dw.com/en/dengue-vaccine-controversy-sparks-panic-in-
philippines/a-42711828
 Chapter VI

REVIEW OF RELATED LITERATURE AND STUDIES

The following literatures are gathered after data analysis to support the thematic

presentations of the study.

The Dengvaxia Vaccine

The world’s first dengue vaccine is now available in private clinics in the

Philippines. The vaccine, which is aptly called Dengvaxia, was launched in Manila on

February 12. According to a fact sheet by the Department of Health (DOH), the vaccine

was developed over a period of 20 years. The fact that the three phases of the clinical trial

has been concluded in the Philippines is a reflection of the efficiency and capability of

Filipino researchers. This shows that the world recognizes Philippine expertise in the area

of research,” said Health Secretary Janette P. Loreto-Garin in the factsheet. It was further

revealed by Dr. Maria Rose Capeding of the Department of Microbiology Research

Institute for Tropical Medicine that the country is the only country where all three stages

of clinical trials were completed. Clinical trials showed a 65.6 percent reduction in

symptomatic dengue, 93 percent reduction in severe disease, and 80.8 percent reduction

in hospitalized dengue. The vaccine, which was developed by Sanofi Pasteur, is

recommended for people between the ages of 9 and 45 and is effective against all four

strains of dengue. According to the World Health Organization (WHO), dengue is the

fastest growing mosquito-borne disease in the world, causing some 400 million infections

annually. In the last 50 years, incidence has increased 30-fold. An estimated 2.5 billion

people live in over 100 endemic countries and areas where dengue viruses can be

transmitted. Up to 50 million infections occur annually with 500 000 cases of dengue
haemorrhagic fever and 22,000 deaths mainly among children, the WHO said. Also

according to WHO, some 500,000 people are hospitalized per year for severe dengue, a

majority of whom are children. In the Philippines, the DOH reports that approximately

220 Filipinos a day can be infected with dengue, with each patient spending as much as

PhP 18,000 in medical bills. With the launch of the vaccine, however, the health sector

hopes dengue cases in the country will be reduced by as much as 24 percent within a

period of 5 years. This means there will be 775,053 less cases of dengue; 502,000

avoided hospitalizations; 22,010 avoided deaths; and close to 21 billion reduction in

medical costs. In a report, Cable New Network (CNN) said the Philippine government

currently has Php 3.5 billion allotted for dengue immunization, and that the DOH is

working for the approval for continuous funding. In a recent interview on ABS-CBN

News Channel (ANC), Garin revealed that the DOH expects to acquire the vaccine at a

discounted price by March, and will initially target a total of 1,077,623 poor children

aged 9 in the public school system. The government’s dengue immunization efforts will

concentrate on NCR, Region III and Region IV-A, where dengue is most prevalent. In St.

Luke's Quezon City, the vaccine can cost up to Php 5,000 per shot, with each patient

receiving 3 shots 6 months apart (Demetillo-Mendoza, 2017).

Timeline of Dengvaxia Vaccine

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. In 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. In 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. In June 9, 2015, then-

Health Secretary Janette Garin negotiates with Sanofi to reduce the cost of buying the

vaccines. In 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).

In December 1, 2015, Aquino and Garin meet Sanofi officials during the UN Conference

on Climate Change in Paris, France. In December 10, 2015, Garin submits a proposal to

the Budget Department to buy three million doses of Dengvaxia. In 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. In December 28, 2015,

The DOH-Family Health Office submits a request to Garin to exempt Dengvaxia from

being included in the Philippine National Formulary. This excludes it from review by the

Formulary Executive Council (FEC), which determines what drugs are included on the

list. In December 29, 2015, The Budget Department issues a Php 3.5-billion Special
Allotment Release Order to Garin's office to purchase the vaccines (Bacungan, de

Guzman & Hermonio, 2018).

In January 21, 2016, The Philippine Children's Medical Center (PCMC) makes a

Php 3-billion purchase order for the vaccines without approval from the FEC. In 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. In

February 11, 2016, The Philippines, under Health Secretary Janette Garin, hosts the

nationwide launch of Dengvaxia. In 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. The WHO calls for more studies into the vaccine.

In March 8, 2016, Garin issues a Php 3-billion disbursement voucher to the PCMC to

fund the purchase of the vaccines. In March 9, 2016, the PCMC issues its purchase order

to Zuellig Pharma, the distributor of Dengvaxia. In April 4, 2016, the government kicks

off its Php 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. In 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. In 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. In

October 2016, the Singapore Health Sciences Authority flags "postulated risk" of

Dengvaxia. "As the vaccine is more effective in those who had previous dengue

infection, and that there is a postulated risk of severe dengue in those who do not have

past dengue infections when they become infected," it said. In 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. The panel directed the DOH to check the medical records of

Christine de Guzman who died months after taking the vaccine. It also recommended that

the DOH temporarily suspend the expansion of the vaccination program, pending

completion of data collection, evaluation, and analyses on "adverse effects." In December

2016, the Senate launches its own investigation into the vaccines, saying the project cost

was too big and was approved without congressional approval (Bacungan, de Guzman &

Hermonio, 2018).
 In 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 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," it said. "For individuals who have not been

previously infected by dengue virus, vaccination should not be recommended," it added.

In 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 (Bacungan,

de Guzman & Hermonio, 2018).

In December 4, 2017, the Justice Department orders the National Bureau of

Investigation to look into the dengue vaccination program. In 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. In

December 6, 2017, the health department says more than 800,000 students received the

vaccine, up from the 733,713 figure mentioned by Duque. It is now monitoring 40 cases

of children who fell seriously ill, up from 30 in 2016, and nine deaths. In December 7,

2017, the Health Department says it will return around 800,000 leftover Dengvaxia

vaccines, worth P1.4-billion, to Sanofi. In 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. That same day, the House and the Senate announce they will
again investigate the dengue vaccination program. It begins on Monday, December 11. In

December 11, 2017, the Senate starts its probe into the Dengvaxia issue. Former Health

Secretaries Janette Garin and Paulyn Ubial, as well as Health Secretary Francisco Duque

III and Sanofi officials, are among those present. Before the start of the hearing, former

Health Secretary Enrique said Garin, his successor, was "solely responsible" for the

Dengvaxia issue. Meanwhile, Garin says the purchase of the vaccines was "above board."

In December 14, 2017, Aquino, under whose administration the deal was approved,

attends the Senate hearing on the vaccine program. Aquino claims no one advised him

against procuring Dengvaxia, with health reform advocate Dr. Anthony Leachon saying

that the former President cannot be faulted if he was given "misleading" information on

Dengvaxia. Presidential Spokesperson Harry Roque says that President Rodrigo Duterte

believes the program was done "in good faith," adding that Duterte would have done the

same. Meanwhile, Ubial reveals that Garin's husband, Rep. Oscar Garin Jr., pressured her

to continue the roll out of the vaccine program. In January 19, 2018, at an event in San

Fernando, Pampanga, Health Secretary Francisco Duque III confirmed Sanofi Pasteur has

refunded P1.16 billion worth of unused Dengvaxia vaccines. However, Duque clarified

the reimbursement does not put the French pharmaceutical company off the hook, adding

the investigation continues on whether Sanofi withheld significant information on

possible risks (Bacungan, de Guzman & Hermonio, 2018).

In 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. In January 10, 2018, The Public Attorney's Office

(PAO) conducts an autopsy on five vaccinated children who died. Dr. Erwin Erfe,
director of the PAO Forensic Laboratory, says while the findings are inconclusive, signs

and symptoms - as well as the death - occurred within six months after the last Dengvaxia

injection. In 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. In January 19, 2018, at an event in San Fernando, Pampanga, Health

Secretary Francisco Duque III confirms Sanofi Pasteur has refunded Php 1.16 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 (Bacungan,

de Guzman & Hermonio, 2018).

In 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. In January 31, 2018, some parents in

Zamboanga refuse the DOH's deworming program due to the Dengvaxia scare. During

Duque's confirmation hearing before the Commission on Appointments, committee

members question him over the existence of the DOH "mafia." Duque denies the claims,

along with two other health officials who were supposedly involved. Health officials add
the unused budget for the dengue vaccination program, worth Php 556 million, is still

with the PCMC. In 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. However, the panel members

suggest to have more tissue analyses on the bodies to come up with conclusive findings.

They also call on parents of dengue victims to have the remains of their children to be

examined only by legitimate forensic pathologists. 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. In 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. Meanwhile, Duque tells lawmakers that it will up to the Justice

Department to consolidate and reconcile the findings of the Public Attorney's Office

(PAO) and University of the Philippines-Philippine General Hospital's (UP-PGH) panel

of experts. 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. In February 6, 2018, Senate Blue Ribbon committee chair Richard Gordon

says he may recommend the filing of charges against Aquino, Garin and other former

officials over the Dengvaxia controversy (Bacungan, de Guzman & Hermonio, 2018).

Dengvaxia Linked to Deaths

Philippines said on Friday the anti-dengue vaccine Dengvaxia may be connected

to three deaths in the country, according to a government-ordered inquiry, and that the

drug is not ready for mass immunization. Dr. Rolando Enrique Domingo (R),

Undersecretary of the Department of Health (DOH), with Dr. Gerardo Legaspi, Director

of the Philippine General Hospital (PGH), answer questions during a news conference at

the DOH headquarter in metro Manila, Philippines. Sanofi revealed in November that

Dengvaxia - the world’s first dengue vaccine - might increase the risk of severe disease in

people who had never been exposed to the virus. The news prompted an uproar in the

Philippines, where more than 800,000 school-age children had been vaccinated in 2016.

The Philippine Health Ministry halted Dengvaxia immunizations in November. It formed

a 10-member panel of experts to determine if the drug was directly connected to the

deaths of 14 children after they were given the vaccine. It found it may have been

connected to the deaths of three. The findings strengthen the decision of the Department

of Health to stop the vaccine. It has failed in some children. Dengvaxia is not ready for

mass vaccinations and it would need three to five more years to watch and monitor if

there would be other adverse reactions from the vaccine. Mosquito-borne dengue is the

world’s fastest-growing infectious disease, afflicting up to 100 million people worldwide,

causing half a million life-threatening infections and killing about 20,000 people, mostly
children, each year. Domingo said the panel’s findings would be shared with the justice

department, which is considering cases against those responsible for the mass

immunisation programme. Paediatrician and panel member Juliet Sio-Aguilar, from the

University of the Philippines-Philippine General Hospital (UP-PGH), said the team was

recommending further studies as it was difficult to directly connect the three deaths to

Dengvaxia. No vaccine has a 100 percent success rate, as said. The dengue death rate in

the Philippines was 60 times higher than global rate according to Sio-Aguilar. Sanofi said

on Saturday the UP-PGH’s findings confirmed there is currently no evidence directly

linking the Dengvaxia vaccine to any of the 14 deaths. In Dengvaxia clinical trials

conducted over more than a decade and the over one million doses of the vaccine

administered, no deaths related to the vaccine have been reported, the company said in a

statement. The Philippines spent 3.5 billion pesos (USD 68 million) on the Dengvaxia

programme to reduce the 200,000 dengue cases reported every year. Sanofi said clinical

evidence confirms dengue vaccination in the Philippines will provide a net reduction in

dengue disease, including severe dengue. The Philippines has already fined Sanofi a

symbolic USD 2,000, citing violations in product registration and marketing (Mogato,

2018).

Five more children vaccinated with Dengvaxia died, bringing the death toll

believed to be related to the controversial anti-dengue vaccine to 26, the Department of

Health (DOH) reported yesterday. Health Secretary Francisco Duque III, however,

maintained that experts could not yet determine whether the deaths were indeed caused

by the dengue vaccine. In a press conference, DOH Undersecretary Maria Francia

Laxamana said the department has already recorded a total of 26 deaths among children
vaccinated with Dengvaxia from March 2016 to January 2018. As of January 24 there

were 725 admitted cases and out of that, there are 26 deaths from March 2016. Of the 725

so-called adverse effects following immunization cases, Laxamana said only 412 were

confirmed to be dengue while the rest tested negative for the mosquito-borne infection.

Duque, however, stressed that there have been dengue mortality even before the

Dengvaxia immunization campaign of the government. Even without Dengvaxia, there is

a case fatality ratio and in dengue, the case fatality ratio is still below one percent as

explained by Duque. But Duque said the previous administration could have exercised

prudence and should have waited for the completion of the clinical trial before embarking

on dengue immunization drive. The clinic trial started sometime June 2011 and

that’s supposed to be a six-year study for the Phase 3 clinical trial period. They started

giving the Dengvaxia as early as 2016, while the findings on the severe dengue came out

after they concluded the Phase 3 in September of 2017 as explained by Duque. Based on

the records they have gathered, Duque said, it appeared that Dengvaxia manufacturer

Sanofi Pasteur did not disclose vital information that could have prevented health

authorities from launching the dengue immunization program. The panel of experts from

the Philippine General Hospital (PGH) is set to convene and come out with the results of

their audit on the medical records of the children who allegedly died after dengue

vaccination. He said the DOH is also inviting the forensic to harmonize their findings

(Jaymalin, 2018).

The Dengvaxia Phenomenon

Widespread fears over a controversial dengue vaccine that some blame for child

deaths are wreaking havoc on the Philippines' war on preventable diseases, with many
parents refusing to get their children immunized, a senior health official said Friday.

Immunization rates for polio, chicken pox, tetanus and other diseases are significantly

down from previous years since the government suspended the sale and distribution of

the Dengvaxia vaccine in December. The government is also investigating Dengvaxia's

alleged role in the deaths of at least 14 children who were among the 830,000 who got the

vaccine as part of the world's first public dengue immunization programme in 2016-2017.

Immunization rates for some diseases are down to 60 percent, significantly lower than in

recent years and below the target of 85 percent. The Philippine government is concerned

about the potential for epidemics because of lower immunization rates, he said. Dengue --

a mosquito-borne disease -- infects 400 million people each year and kills 9,000 globally,

the health department said, citing World Health Organization data. The Philippines has

one of the highest dengue fatality rates in the world, with 732 deaths last year, it added.

Dengvaxia's manufacturer Sanofi disclosed in December, two months after the

vaccination campaign was completed, that it could worsen symptoms for people who had

not previously been infected with the virus. The disclosure sparked nationwide panic,

with some parents alleging the vaccine caused the deaths of their children. The

communities, all the pediatricians are really heartbroken because all the patients -- the

parents (and) the children -- feel that they are going to die. Sanofi says no one has been

proven to have died from the vaccine, but last month the French pharmaceutical giant

agreed to reimburse the Philippine government for leftover doses. The health department

said Friday an inquiry into the deaths of 14 children injected with Dengvaxia found no

direct proof it had caused any of the fatalities. Three children died from dengue even

though they were given Dengvaxia -- vaccine failure was the possible cause in two of
them. Nine others died of reasons unrelated to dengue, while the cause of two other

deaths could not be determined. Asked if the vaccine itself caused the three deaths, Juliet

Sio-Aguilar, the head of the inquiry, told reporters on Friday that while it could be

possible it cannot be categorically said. Further studies on tissue samples are needed, she

added (France-Presse, 2018).

Health experts fear that a drop in immunization rates amid an ongoing dengue

vaccine controversy could jeopardize other government vaccination programs and trigger

epidemics in the Philippines. Rolando Enrique Domingo, the Philippines' Health

Undersecretary, confirmed to DW that there has been a decline in immunization rates in

the country. Only 60 percent of children are getting their scheduled vaccines. The health

department's annual vaccination target is around 85 percent, Domingo said. In 2016, the

Philippines became one of the first Asian countries to use Dengvaxia, the first-ever

dengue vaccine. More than 800,000 Filipinos, mostly school children, were inoculated as

part of the government's nationwide dengue immunization campaign. But in November

last year, French pharmaceutical company Sanofi Pasteur, manufacturer of Dengvaxia,

announced that Dengvaxia may cause a person to develop a more severe type of dengue

if they had never contracted the mosquito-borne disease prior to immunization. Health

officials say the panic over Dengvaxia has 'contributed' to the outbreak of other diseases.

Following the announcement, the health ministry halted its dengue vaccination program

in December 2017 (Santos, 2018).

Diminishing public trust? The news caused panic and outrage among parents, who

even began to reject immunization programs for diseases like polio and measles. The

health department admits that its programs like deworming and innocuous procedures
like vision testing have also been adversely affected due to the dengue vaccine

controversy. The controversy has greatly diminished public trust in immunization,

Esperanza Cabral, former health secretary and member of the advocacy group Doctors

for Public Welfare. The Philippines is witnessing a fall in immunization rates and an

increase in outbreaks of diseases such as measles. The situation could worsen if public

trust in the immunization programs is not restored soon, Cabral added (Santos, 2018).

Fear-mongering. The health ministry has set up a task force to monitor the health

of those who were given the Dengvaxia vaccine over a five-year period. Reported deaths

of children as a result of the vaccine are currently under investigation. Dengvaxia itself is

not causing the dengue infection but may be making those who have not been exposed to

the virus more susceptible to developing dengue when they get infected later. The link

between severe or fatal dengue and Dengvaxia is related to the vaccine's impact on the

person's immune system, Dr Gundo Aurel Weiler, World Health Organization's country

director in the Philippines. Vaccines are among the most powerful public health

interventions that have saved the lives of millions globally. We will have to observe if the

drop in immunizations is a sustained decline, said Weiler (Santos, 2018).

Dengvaxia Risks

Both the current Food and Drug Administration (FDA) chief and a physician said

Sanofi Pasteur was well-aware of the risks of its Dengvaxia vaccine in 2015 but did not

inform the Philippine government. FDA director-general Nela Charade Puno and

physician Anthony Leachon both presented documents to prove their accusations against

the French pharmaceutical giant as the House resumed its probe into the now-suspended

dengue immunization program on Monday, February 26. Both the current Food and Drug
Administration (FDA) chief and a physician said Sanofi Pasteur was well-aware of the

risks of its Dengvaxia vaccine in 2015 but did not inform the Philippine government.

FDA director-general Nela Charade Puno and physician Anthony Leachon both presented

documents to prove their accusations against the French pharmaceutical giant as the

House resumed its probe into the now-suspended dengue immunization program on

Monday, February 26. Puno said the FDA’s special task force on Dengvaxia reviewed the

papers Sanofi had submitted to Singapore, which allowed the commercial sale of the

dengue vaccine in their country in October 2016. The FDA chief said Sanofi already

informed Singapore at the time that Dengvaxia will lead a person to develop severe

dengue if he or she had not been infected the virus prior vaccination. December 22, 2015

was the day when FDA allowed Sanofi to commercially sell Dengvaxia in the country.

Sanofi only publicly issued the warning on their vaccine in November 29, 2017, more

than a year after ex-health chief Janette Garin approved the use of Dengvaxia in the

school-based dengue immunization program in 3 regions starting April 2016. Last

December, FDA already suspended Dengvaxia’s sale for a year and fined Sanofi with

P100,000 for failing to comply with post-marketing authorization requirements. Under

the post-marketing authorization stage, a company is required to submit several

documents to ensure the product is still safe to use even after its release in the market.

Puno said Sanofi has not complied with this (Cepeda, 2018a).

4 more risks of Dengvaxia. Apart from Puno’s findings, Leachon pointed to a

document Sanofi submitted to FDA in December 2015, which shows the company

already identified 4 risks of Dengvaxia. These risks, however, were not indicated on the

vaccine’s package insert nor the consent form parents must sign before their children
were given Dengvaxia in school. In this document, Dengvaxia was still referred to by

Sanofi as CYD-TDV. Four important identified risks have been established for CYD

dengue vaccine: allergy/anaphylactic reaction, viscerotropism and neurotropism, increase

in severity of dengue disease from the start of vaccination, and warning protection against

dengue disease over time, said Sanofi. But the company also noted there were “with

respect to claimed population (from 9 through 45 years old in endemic areas) no

important identified risks have been established.” And what is very repulsive is that they

actually concealed the 4 identified risks. It should be written in the informed consent so

that the mothers, the victims are aware of the risks,” said Leachon. “You have

concealment of data and safety, which is supposedly for public safety…. And to me, this

is a great sin to the Filipino nation considering this was a program of the government,” he

added. Sanofi Asia Pacific head Thomas Triomphe, however, said it is "factually wrong"

to claim they withheld information regarding Dengvaxia. He explained the risks Sanofi

was referring to 2015 document were potential risks to look for. "What was

communicated before – and I think that’s important because there is a misunderstanding

about this – the [information] identified before referring to 2015 and 2016 are talking

about potential risks to look for or are talking about theoretical risks to look for," said

Triomphe. He also said Sanofi immediately warned the public about Dengvaxia's effects

on a person who had not develop dengue prior immunization as soon as the information

was available to them. "Let me just mention here that what was mentioned here was

factually wrong. So there was no informed data before November 2017 when the findings

were discovered and were immediately communicated," said Triomphe (Cepeda, 2018a).
 The dengue vaccine maker says it immediately issued the warning against

Dengvaxia when it found out about the risks in November 2017. French pharmaceutical

giant Sanofi Pasteur denied accusations it concealed risks of its Dengvaxia dengue

vaccine from the Philippine government in 2015. The company's defense: In a statement

on Wednesday, February 28, Sanofi said it was only in November 2017 when it

discovered Dengvaxia could lead a person to develop severe dengue if he or she had not

been infected by the virus before vaccination. Sanofi said it immediately announced its

findings – which were based on 6-year analysis of clinical data – on November 29, 2017.

French pharmaceutical giant Sanofi Pasteur denied accusations it concealed risks of its

Dengvaxia dengue vaccine from the Philippine government in 2015. The company's

defense: In a statement on Wednesday, February 28, Sanofi said it was only in November

2017 when it discovered Dengvaxia could lead a person to develop severe dengue if he or

she had not been infected by the virus before vaccination. Sanofi said it immediately

announced its findings – which were based on 6-year analysis of clinical data – on

November 29, 2017. "For the dengue vaccine, from the time of the sale, until November

2017, we had no information or data with regards to the serostatus of the vaccinees

showing a different product profile in the population of 9 years old and above," said

Sanofi. Serostatus indicates if a person had already been infected by a virus (seropositive)

or not (seronegative). "We learnt of the different product profile of the dengue vaccine

for those with or without a previous dengue infection in November 2017 and Sanofi

Pasteur has shared the new data in full transparency with national health authorities in

countries where the vaccine is approved or where it is being considered for regulatory

approval," Sanofi added. Why the company is defending itself: In a congressional hearing
two days before, Food and Drug Administration (FDA) Director-General Nela Charade

Puno said Sanofi was already aware of Dengvaxia's possible effect on seronegative

patients as early as 2015. The FDA's special task force on Dengvaxia reviewed the papers

Sanofi had submitted to Singapore, which allowed the commercial sale of the dengue

vaccine there in October 2016. Puno said Sanofi already informed Singapore at the time

that Dengvaxia is risky for seronegative people. Why it matters: Dengvaxia was the

vaccine used when ex-Department of Health (DOH) chief Janette Garin launched the

school-based dengue vaccination program in 3 regions in April 2016. Public experts had

claimed the program was "rushed" because the clinical trial on the vaccine's safety had

not been completed at the time. When Sanofi issued the warning against Dengvaxia less

than two years later, current Health Secretary Francisco Duque III immediately

suspended the program. But more than 837,000 kids had already gotten the vaccine.

While experts have not yet established clear evidence that Dengvaxia caused the deaths

of several children, 3 out of 14 were found to have died of dengue despite getting at least

one shot of Dengvaxia (Cepeda, 2018b).

Effects of Dengvaxia: Dengue

The Department of Health (DOH) on Friday, April 13 said that over 3,200

students who received the dengue vaccine Dengvaxia as part of government's school-

based immunization program were hospitalized following their vaccination. The DOH

said in a statement Friday that from March 2016 to March 2018, a total of 3,281 students

were hospitalized in different public and private hospitals for "various illnesses." The

DOH shouldered the cost of their treatment through PhilHealth. The remaining expenses

were paid through the DOH's Medical Assistance for Indigent Program as explained by
Health Undersecretary Rolando Enrique Domingo said in the statement. The health

department also revealed that 1,967 out of the 3,281 patients were found to have

contracted dengue as confirmed through clinical and serological tests. 65 deaths were

also reported which are now under investigation, the DOH added. It later noted that over

98 percent of those hospitalized were eventually sent home. Hence, the DOH reiterates

the importance of seeking early consultation as soon as signs and symptoms are noted in

order to prevent more severe and even fatal complications. The Senate and the House of

Representatives conducted investigations into the school-based dengue immunization

program after Sanofi Pasteur issued an advisory in November 2017 that Dengvaxia could

cause more severe cases of dengue if administered to a person who had not been

previously infected by the virus. The DOH has since suspended the program, and tapped

experts from the University of the Philippines-Philippine General Hospital to validate

alleged deaths due to Dengvaxia. According to the experts, 3 out of the 14 cases showed

indications that the deaths were related to dengue despite them getting the vaccine, but

said further tests had to be conducted. The Public Attorney's Office is also exhuming

bodies and conducting forensic examinations of other vaccinated children, but its findings

have been questioned by both public health experts and lawmakers. Meanwhile, Senate

blue ribbon committee chairman Richard Gordon recommended this week in his draft

report the filing of corruption charges against former president Benigno Aquino III,

former health secretary Janette Garin, and former budget secretary Florencio Abad, citing

alleged haste in the purchase of the dengue vaccine. Php 20 million - DOH's allocation to

4 regions covered by the school-based dengue immunization program as initial financial

augmentation to the regional offices' Dengue Assistance Program. Php 17 million - As of

April 5, this is the estimated amount of financial assistance that has been given to patients

who got sick and were admitted to hospitals in the 4 regions, namely, Metro Manila,

Central Luzon, Calabarzon, and Cebu. Php 1.16 billion - The refunded amount from

Sanofi for the unused dengue vaccines. DOH is waiting Congress' approval to use this

amount to implement the Dengvaxia Assistance Program. This amount expanded the

assistance being given by the DOH to the children vaccinated with Dengvaxia and will

cover the medical assistance program for hospitalization, outpatient health care services

for Dengvaxia recipients, deployment of nurses to monitor vaccine recipients in schools

and communities and dengue prevention kits," the health department said, referring to the

Php 1.16 billion (Geronimo, 2018).