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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 12:07 am 
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Dengvaxia not registered with EU drug authority: Sanofi

http://news.abs-cbn.com/news/02/05/18/dengvaxia-not-registered-with-eu-drug-authority-sanofi

MANILA - The controversial dengue vaccine Dengvaxia was not yet registered with the European Union drug authority when it was used to vaccinate kids in the Philippines, French drug-maker Sanofi Pasteur admitted Monday.

Thomas Triomphe, Asia-Pacific head of Sanofi Pasteur, explained that Dengvaxia, which was produced for countries with high cases of dengue, was not a priority in Europe.

"Every single national regulatory agency decides on its own when to license another product. We have nothing to do in its process... Looking at the geographic situation of France and the borders of France it is not a priority by the European Union," he said in a hearing by a House of Representatives committee.

Dengvaxia is still in the process of certification, said Triomphe. He stressed that its safety and efficacy has been demonstrated sans registration with the European Medicines Agency, the EU's equivalent to the Philippines' Food and Drug Administration.

Iloilo Rep. Ferjenel Biron said the Philippines should not have accepted Dengvaxia as it has not even been approved by the European FDA.

"We're talking of a product, a biological product which safety and efficacy has not been established even from the country of origin... Kung hindi siya rehistrado sa Europe what business do we have importing this product here?" he pointed out.

Why PH should closely monitor Dengvaxia kids
The FDA said the agency approves a lot of vaccines and medicines that have not been registered with the country of origin, as long as they pass certain standards and requirements.

"Not only vaccines but medicine in general that we approved if there is proof of Good Manufacturing Practice compliance and are freely zoned," said FDA's Melody Samudio.

"Other than these administrative documents, we have more requirements like requirements of quality, safety, and efficacy, and these have been satisfied."


hindi pa kasi tapos ang clinical trial sa Pinas kaya di pa approve.

:lol: :lol: :lol:

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 11:12 am 
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kamusta na ang findings ni Dra. Acosta ng PAO? taliwas pa rin sa sinasabi ng mga experts? :banghead:

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 11:55 am 
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Garin, others criminally liable after Sanofi admission — PAO
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hihihihih wrote:
The admission of the manufacturer of Dengvaxia that it was still in clinical trial when the previous Aquino administration approved a P3.5-billion dengue vaccination program is enough to hold dozens of individuals criminally liable, according to the Public Attorney’s Office (PAO).

PAO chief Persida Rueda Acosta on Wednesday assured the parents and other relatives of grade school students who allegedly died after being inoculated with Dengvaxia that the complaints they filed against former Health Secretary Janette Garin and 36 others were strong.

Clinical trial

At the resumption of the preliminary hearing of the complaints in the Department of Justice (DOJ), Acosta pointed out that French pharmaceutical giant Sanofi Pasteur had disclosed on Dec. 22, 2015, that a vaccine it developed to combat the mosquito-borne disease was still undergoing clinical trial.

Just a week later, she claimed the Department of Budget and Management issued a special allotment release order for the purchase of P3.5 billion worth of Dengvaxia vaccines.

“That’s where the problem started. Dengvaxia was just an experimental vaccine under clinical trial then. Why did they use nearly 1 million Filipinos as guinea pigs?” Acosta told reporters.

‘Disrespect for life’

“It’s a grave sin and a disrespect for human life when they implemented the vaccination without the informed consent of the victims,” she added.

Acosta expressed confidence that the “medical evidence and literature” they presented to the DOJ panel of prosecutors were enough to convict the respondents for violation of the antitorture law and for reckless imprudence resulting in multiple homicide.

The DOJ directed Garin and her fellow accused to file their rejoinder-affidavits on Aug. 30 before wrapping up the preliminary investigation.

Meanwhile, PAO brought a 12th criminal complaint against Garin and the others for the death of 11-year-old John Paul Rafael, who allegedly died in April 2016 after he was inoculated with Dengvaxia.

Go PAO hihihih :lol: :lol: :lol:

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 11:58 am 
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So ano ngayon if hindi approved sa Europe ang Dengvaxia?
Mali ba kung mag clinical trial sa Pilipinas at may mga collateral damage?
Ilan lang naman ang namatay...
Let's sa 100 lang...
What's 100 compared to 800k na nabakunahan...
That's just 0.125%...
So nasa 99.9875% pa rin ang success rate...

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 11:59 am 
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tsk tsk tsk :?
Another child dies: PAO records 74th alleged victim of Dengvaxia

Quote:
The death toll potentially related to the controversial Dengvaxia mess rose to 74 as of Wednesday night, Public Attorney’s Office (PAO) Chief Persida Acosta revealed.

Acosta said the latest death was recorded in Malolos, Bulacan, after PAO’s forensic team found in the child’s case the supposed pattern of deaths in other alleged victims of the vaccine.

Acosta lamented that the alleged number of fatalities could soon reach 75 if proven that the case of another deceased child in Muntinlupa shows the same pattern.
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“Hanggang may namamatay ay sisigaw ng katarungan yung mga biktima at mga magulang,” she said over radio dzMM on Thursday.

(As long as the children die, victims and parents will continue to shout for justice.)

PAO’s forensic team found in the 74th victim the same complications in reported victims of Dengvaxia, including a bleeding brain and enlarged internal organs, Acosta said.

According to Acosta, these are similar to the potential effects that pharmaceutical company Sanofi, developer of Dengvaxia, warned about before the Department of Health purchased the vaccine.

Meanwhile, PAO on Wednesday also filed another criminal complaint against former Health Secretary Janette Garin and 36 others before the Department of Justice over the death of an 11-year old boy who received the vaccine.

READ: New complaint filed vs Garin, 36 others over Dengvaxia death

A total of 12 Dengvaxia-related cases have been filed as of posting but Acosta said they are preparing to file seven more from families in Cebu City.

She also disclosed that some “spearheaders” of the vaccine have allegedly tried to stop the PAO from further conducting autopsies on alleged victims.
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“Pinipigilan tayo ng ibang spearheaders ng bakunang ito na mag-autopsy dahil lalong tumitibay at kumikinang ang paghingi ng hustisya ng mga bangkay ng mga batang ito na walang kamalay-malay nabakunahan,” she said.

(Some spearheaders try to stop us from doing autopsies because these further strengthen the demand for justice for the children who were vaccinated without knowing the vaccine’s effects.)

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 1:08 pm 
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JABEZJ wrote:
So ano ngayon if hindi approved sa Europe ang Dengvaxia?
Mali ba kung mag clinical trial sa Pilipinas at may mga collateral damage?
Ilan lang naman ang namatay...
Let's sa 100 lang...
What's 100 compared to 800k na nabakunahan...
That's just 0.125%...
So nasa 99.9875% pa rin ang success rate...



tama nga naman... ano ba nman ang 100 na katao na collateral damage...

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 1:37 pm 
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pubringjuandelacruz wrote:
JABEZJ wrote:
So ano ngayon if hindi approved sa Europe ang Dengvaxia?
Mali ba kung mag clinical trial sa Pilipinas at may mga collateral damage?
Ilan lang naman ang namatay...
Let's sa 100 lang...
What's 100 compared to 800k na nabakunahan...
That's just 0.125%...
So nasa 99.9875% pa rin ang success rate...



tama nga naman... ano ba nman ang 100 na katao na collateral damage...


Proven na ba na dengvaxia ang cause of death?
Hindi naman ah..
That means successful ang program...
Worth it ang 3B plus na ginastos para sa mass clinical trial...

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A GIFT…THAT’S WHY IT IS CALLED THE PRESENT “.


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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 1:55 pm 
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at saka wala naman anomaly sa pagprocure niyan

walang nakinabang

walang tumiba ng salaping bayan


malinis yan deal na yan :)










hihihihih :lol:

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 2:32 pm 
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JABEZJ wrote:
pubringjuandelacruz wrote:
JABEZJ wrote:
So ano ngayon if hindi approved sa Europe ang Dengvaxia?
Mali ba kung mag clinical trial sa Pilipinas at may mga collateral damage?
Ilan lang naman ang namatay...
Let's sa 100 lang...
What's 100 compared to 800k na nabakunahan...
That's just 0.125%...
So nasa 99.9875% pa rin ang success rate...



tama nga naman... ano ba nman ang 100 na katao na collateral damage...


Proven na ba na dengvaxia ang cause of death?
Hindi naman ah..
That means successful ang program...
Worth it ang 3B plus na ginastos para sa mass clinical trial...


sana nga turukan lahat wag lang mga bata, para ma test talaga ng mabuti ang gamot :lol: :lol:
sayang kasi accomplishment pa naman ni pnoy to 8)

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 3:12 pm 
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JABEZJ wrote:
pubringjuandelacruz wrote:
JABEZJ wrote:
So ano ngayon if hindi approved sa Europe ang Dengvaxia?
Mali ba kung mag clinical trial sa Pilipinas at may mga collateral damage?
Ilan lang naman ang namatay...
Let's sa 100 lang...
What's 100 compared to 800k na nabakunahan...
That's just 0.125%...
So nasa 99.9875% pa rin ang success rate...



tama nga naman... ano ba nman ang 100 na katao na collateral damage...


Proven na ba na dengvaxia ang cause of death?
Hindi naman ah..
That means successful ang program...
Worth it ang 3B plus na ginastos para sa mass clinical trial...
bigatooth wrote:

sana nga turukan lahat wag lang mga bata, para ma test talaga ng mabuti ang gamot :lol: :lol:
sayang kasi accomplishment pa naman ni pnoy to 8)


OK lang if sa mga bata ginawa ang clinical trial..
hindi pa naman working age bracket ang mga yan..
hindi sayang kung maging collateral damage man..

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 4:09 pm 
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:shock: :lol: :lol:

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 6:31 pm 
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Musta na kaya ung mga pulis na naturukan sa QC...


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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 7:47 pm 
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musta na si kitty at ang mga apo ni tatay digong? :biglaugh:

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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 7:52 pm 
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:cry: :whistle:


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 Post subject: Re: DENGAVAXIA
PostPosted: Mon Aug 13, 2018 8:40 pm 
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