TIMELINE: The Dengvaxia controversy

Published Dec 9, 2017, 9:28:48 AM

Updated Feb 26, 2018, 3:57:00 PM

Metro Manila (CNN Philippines) — 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.

June 9, 2015

Then-Health Secretary Janette Garin negotiates with Sanofi to reduce the cost of buying the vaccines.

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 1, 2015

Aquino and Garin meet Sanofi officials during the UN Conference on Climate Change in Paris, France.

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 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.

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 nationwide launch of Dengvaxia.

Read: World's first dengue vaccine now available in PH

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.

March 8, 2016

Garin issues a ₱3-billion disbursement voucher to the PCMC to fund the purchase of the vaccines.

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.

Read: DOH starts dengue vaccination program

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.

Read: New dengue vaccine could instead cause more cases, experts warn

"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.

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.

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."

December 2016

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

Read: Senate probes dengue vaccine program

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.

Read: Drug firm warns of 'severe disease' from dengue vaccine for people with no 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," it said.

"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.

Read: Gov't halts dengue vaccination program due to health risk

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 4, 2017

The Justice Department orders the National Bureau of Investigation to look into the dengue vaccination program.

Read: DOJ orders probe of dengue vaccine program

December 5, 2017

The FDA suspends the sale and distribution of Dengvaxia.

Read: FDA suspends sale, distribution of dengue vaccine Dengvaxia

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

Read: WHO denies recommending Dengvaxia for nat'l immunization programs

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.

Read: DOH: More than 800,000 children vaccinated with Dengvaxia

December 7, 2017

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

Read: Health Department to return ₱1.4 billion worth of Dengvaxia vaccines

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.

Read: DOH to demand from Sanofi full refund of P3.5 billion spent on Dengvaxia

That same day, the House and the Senate announce they will again investigate the dengue vaccination program. It begins on Monday, December 11.

Read: Senate to open probe on dengue vaccine scare

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.

Read: Ex-DOH Sec. Ona: Garin solely responsible for Dengvaxia 'nightmare'

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

Read: Ex-DOH Secretary Garin: No corruption in Dengvaxia purchase

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.

Read: Ex-President Aquino: No one advised me against 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.

Read: Duterte thinks Dengvaxia purchase done in 'good faith' - Roque

Meanwhile, Ubial reveals that Garin's husband, Rep. Oscar Garin Jr., pressured her to continue the roll out of the vaccine program.

Read: Ex-DOH Sec. Ubial: Janette Garin's husband asked me to buy more Dengvaxia

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.

READ: Sanofi refunds P1.16-B for unused Dengvaxia vaccines

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.

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.

READ: PAO forensic consultant finds pattern in 5 severe dengue deaths

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."

READ: Ex-Health Dept. consultant bares 'mafia' operating in DOH

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.

READ: Sanofi refunds P1.16-B for unused Dengvaxia vaccines

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.

READ: Duque: DOH formally demands full refund of Dengvaxia vaccines

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 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.

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.

READ: Doctors: Parents refusing vaccines due to Dengvaxia scare

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.

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.

Read: DOJ to consolidate PAO, experts' Dengvaxia findings - DOH

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.

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.

Read: Gordon: Aquino, Garin may face charges over Dengvaxia mess

"Ang linaw ng paper trail and there is a direct causal connection," Gordon said in an interview following the panel's Tuesday hearing.

[Translation: The paper trail is clear and there is a direct causal connection.]

Gordon noted the haste in the purchase of the dengue vaccine Dengvaxia, which the government used for the ?3.5-billion dengue vaccination program it kicked off in April 2016.

"Yung lumalabas talaga, tuwing lalakad sa abroad, bumibilis yung papeles," Gordon said. "Nagmamadali dun sa pagkuha ng FDA (Food and Drug Administration) permit. Pati yung (Philippine National) Formulary, ini-influence."

[Translation: What's really emerging is that when there are trips abroad, the papers move faster. There is a rush to get the FDA permit. And even the Formulary is being influenced.]

For questions or concerns regarding the Dengvaxia program, you may call the DOH at 711-1001 or 711-1002.

This is a developing story. Please refresh the page for updates.

CNN Philippines digital producers VJ Bacungan, Chad de Guzman and Senior Researcher Ella Hermonio contributed to this report.

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