TIMELINE: the Dengvaxia Controversy
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BREAKING NEWS Customs fixer Mark Taguba surrenders to NBI over drug charges filed by DOJ Search CNN Philippines Advertisement (http://cnnphilippines.com/) FRONT PAGE (HTTP://CNNPHILIPPINES.COM/) / NEWS (HTTP://CNNPHILIPPINES.COM/NEWS/) TIMELINE: The Dengvaxia controversy By CNN Philippines Sta Updated 19:25 PM PHT Sun, January 21, 2018 Like Share 2.2M people like this. Sign Up to see what your friends like. 1.7K 171 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, n ow 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 ocials from the current and previous administrations pointing fingers at each other. Here's how it happened: BREAKING NEWS Cu2s0to1m4 s fixer Mark Taguba surrenders to NBI over drug charges filed by DOJ Dengvaxia successfully completes its two parallel Phase 3 clinical studies, which compare the safety and eectiveness 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 ocials 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 Oce 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 oce 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. BREAKING NEWS CRuesatodm: Ws ofirxlde'rs M fiarsrtk dTeangguubea v saucrcreinned neorsw t oav NaBilaI bolvee irn d PrHug (h cthtpa:r/g/censn fiplheidli pbpyi nDeOs.Jcom/news/2016/02/11/dengue-vaccine- Dengvaxia-Philippines.html) March 2016 The World Health Organization (WHO) releases a paper saying Dengvaxia "may be ineective 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 o 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 (http://cnnphilippines.com/news/2016/04/04/doh-starts-dengue- vaccination-program.html) 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 ineective 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 (http://cnnphilippines.com/news/2016/09/02/Dengue-vaccine-Dengvaxia.html) " 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 eective in those who had previous dengue infection, and that there is a postulated risk of severe BREAKING NEWS dengue in those who do not have past dengue infections when they become infected," it said. Customs fixer Mark Taguba surrenders to NBI over drug charges filed by DOJ 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 eects." Related: House body resumes probe of school-based dengue vaccine program (http://cnnphilippines.com/news/2016/12/12/house-committee-resumes-probe-into-school-based-dengue-vaccine- program.html) 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 (http://cnnphilippines.com/news/2016/12/07/senate-probes-dengue- vaccine-program.html) 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 (http://cnnphilippines.com/news/2017/11/30/dengue-department-of-health-vaccine.html) "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 (http://cnnphilippines.com/news/2017/12/01/Dengue- vaccine-Dengvaxia.html) 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 (http://cnnphilippines.com/news/2017/12/04/Dengue-vaccine- Dengvaxia-investigation.html) BRDEeAcKeINmGb NeEr W5S, 2017 CTuhset oFmDAs sfiuxsepr eMndasrk t hTea gsauleb aa nsdu rdriesntrdibeurtsio tno o Nf BDeI nogvevar xdiaru. g charges filed by DOJ Read: FDA suspends sale, distribution of dengue vaccine Dengvaxia (http://cnnphilippines.com/news/2017/12/05/fda- suspend-sale-dengue-vaccine-dengvaxia.html) 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 (http://cnnphilippines.com/news/2017/12/06/WHO-denies-recommending-Dengvaxia-for-natl-immunization- programs.html) 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