French pharmaceutical company Sanofi Pasteur Philippines on Monday denied that Filipinos have been used as "guinea pigs" for the first licensed dengue vaccine.
Dr. Joselito Sta. Ana, regional director of Sanofi Pasteur clarified that dengue vaccine Dengvaxia was not a "clinical trial" and is rather a public program of the Department of Health.
"Para mas malinaw, yung programa ng DOH ay hindi clinical trial, ito'y isang public program so I think 'yun yung parang kalituhan ng ibang mga nagsasabi na ginawang guinea pigs ang mga Filipino," Sta. Ana said in a press conference in Taguig City.
Sanofi Pasteur's general manager Ching Santos, meanwhile, expressed disappointment over such comments that Filipinos were turned into "guinea pigs," saying that the product has been developed for over 20 years and has gone through "vigorous tests."
"Syempre masakit 'yun na we are being accused 'cause kung meron man tao that actually will decide to protect my Filipino colleagues ay ako because even my children were vaccinated, just to let you know and naniniwala ako na you know at this point in time ay halos lahat ng tao talaga ay exposed," Santos said.
"Sa ganyang mga comments, of course nakakafeel ka rin ng lungkot kaya ang gusto talaga namin ay ipahatid sa lahat kung ano yung tama talaga not based sa data para lahat tayo ay magkaroon ng unified information...right understanding of the data at para hindi magkaron ng ganyang accusations or belief or mindset na tayo ay ginagawang test," she added.
Justice Secretary Vitaliano Aguirre II earlier issued Department Order No. 763, tasking the National Bureau of Investigation to investigate and build a case against those responsible for supposedly placing public health in danger.
The NBI will determine whether Sanofi has communicated with the DOH the proper warning that the vaccine should not be given to somebody who has not contracted dengue before.
Last week, Sanofi Pasteur has advised against prescribing the dengue vaccine Dengvaxia to patients who have not been infected by the virus in the past, since it was found that it may cause severe diseases in the long run.
However, it clarified on Monday that Dengvaxia does not cause "severe dengue," saying that "there is a clear and sustained benefit of being vaccinated with the dengue vaccine up to 6 years following the first injection" for those individuals who were previously infected by dengue virus.
"In individuals who have not been previously infected by dengue virus, there is an increased risk of hospitalization for dengue and severe dengue, predominantly Grade I or II Dengue Hemorrhagic Fever (DHF)," Sanofi said in a statement.
Sanofi citing data from the World Health Organization said that "severe dengue" can be categorized from "milder to more severe forms as DHF I, II, III, and IV."
It said that the DHF IV was not seen for individuals who were vaccinated, noting that they have shared their new data in "full transparency" with the Philippine Food and Drug Administration (FDA) and the DOH.
DOH, meanwhile, has put on hold the government's dengue vaccination program after Sanofi raised health concerns on the vaccine.
It said that more than 733,000 children aged 9 and above from public schools in Metro Manila, Central Luzon, and Calabarzon have already received at least the first three doses of the vaccine.
Justice Secretary Vitaliano Aguirre II ordered the National Bureau of Investigation (NBI) on Monday to investigate the P3.5-billion dengue vaccination program of the Department of Health (DOH) that put the lives of more than 733,000 public school children at risk.
Aguirre issued Department Order No. 763, tasking the NBI to investigate and build a case against those responsible for supposedly placing public health in danger.
The dengue vaccination program began during the term of then-Health Secretary Janette Garin in April 2016.
"Tama ba ang pag-order kaagad ng ganito karaming vaccine na worth P3.5 billion? Na naturukan agad ang 733,000 children, tama ba ito, kahit apat buwan pa lang nama-manufacture ito?" Aguirre said in a press conference.
The NBI will determine whether Sanofi has communicated with the DOH the proper warning that the vaccine should not be given to somebody who has not contracted dengue before.
At a press conference, Sanofi said it will cooperate with the NBI on its probe.
"In line with that, well of course kami naman is a very responsible company, transparent kami," Ching Santos, Sanofi Pasteur's general manager said.
"If we will be invited, kung ano man ang data that we have presented to the stakeholders, to FDA (Food and Drug Administration), to DOH ay 'yan din ang ipe-present namin sa ano mang ahensiya ang magtatawag sa amin para magbigay ng information. Of course we will cooperate," Santos added.
Three deaths
The Volunteers Against Crime and Corruption, which requested for an NBI probe, said it has documented three deaths in Central Luzon allegedly as a result of the dengue vaccination.
"Nagkaroon ng parang warning 'yung Sanofi Pasteur, 'yung manufacturer, sa government officials. Kaya ang susunod na tanong ay nasunod ba? O naiparating ba ito sa karamihan ng nasa DOH kung itong warning ng Sanofi ay talagang naibigay? At kung naibigay, ito ba ay talagang naipatupad ng ating DOH officials?" Aguirre said.
Aguirre urged parents whose children may have suffered adverse effects of the vaccine to help in the investigation.
"To help this investigation, nananawagan po kami sa mga na-injection nitong Dengvaxia na ito na mayroong adverse effect sa inyong mga anak, come forward to us, give your information to the NBI, help the NBI para matukoy po natin at matulungan ang ating gobyerno ng kanilang gagawin sapagkat dapat malaman ng gobyerno kung ano ang nangyari lalong lalo na iyong may adverse effect dito sa mga batang naturukan ng vaccine na ito," he said.
Health Secretary Francisco Duque III earlier said they have not yet received any reports of individuals experiencing a "severe case" of the disease.
On Friday, the Health Department stopped the use of Dengvaxia—the vaccine used in the program—after French manufacturer Sanofi Pasteur issued a statement setting limits to the use and application of Dengvaxia as results of a recent study showed it can actually put at risk people who have not been previously exposed to the disease.
According to the DOH, more than 733,000 children, 9 years old and above, from public schools in Metro Manila, Central Luzon, and Calabarzon were given the first three doses of Dengvaxia since it was launched.
The DOH said it would evaluate the program in close coordination with the Department of Education to monitor the condition of students who have been given Dengvaxia, the world’s first dengue vaccine.
On Friday, the Health Department stopped the use of Dengvaxia—the vaccine used in the program—after French manufacturer Sanofi Pasteur issued a statement setting limits to the use and application of Dengvaxia as results of a recent study showed it can actually put at risk people who have not been previously exposed to the disease.
According to the DOH, more than 733,000 children, 9 years old and above, from public schools in Metro Manila, Central Luzon, and Calabarzon were given the first three doses of Dengvaxia since it was launched.
The DOH said it would evaluate the program in close coordination with the Department of Education to monitor the condition of students who have been given Dengvaxia, the world’s first dengue vaccine.
Source: NB, GMA News
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