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 Post subject: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 10:15 am 
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Napapanahon itong topic na to. Dito po natin ipost ang lahat ng mga article at opinyon sa isyu na to. ICB pakilipat mga link mo dito. :D

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 10:21 am 
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Pa vaccine ka gudz... :lol:

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 10:35 am 
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JABEZJ wrote:
Pa vaccine ka gudz... :lol:

Hoist! Manahimik ka. Seryoso tong topic na to. Mas malala pa to sa MRT. :D

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 10:40 am 
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Sanofi updates information on dengue vaccine


New analysis of long-term Dengvaxia® data found differences in vaccine performance based on prior dengue infection
Company will ask regulators to update product label to reflect new information

PARIS, FRANCE – November 29, 2017 – Sanofi will ask health authorities to update information provided to physicians and patients on its dengue vaccine Dengvaxia® in countries where it is approved. The request is based on a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection.

Based on up to six years of clinical data, the new analysis evaluated long-term safety and efficacy of Dengvaxia in people who had been infected with dengue prior to vaccination and those who had not. The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had 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.

“These findings highlight the complex nature of dengue infection. We are working with health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries,” said Dr. Su-Peing Ng, Global Medical Head, Sanofi Pasteur.

About half of the world’s population lives in countries where four serotypes of dengue virus are in circulation. Every year an estimated 390 million dengue infections are reported. People can be infected with dengue up to four times in their lifetime and they can get severely ill after any of these infections. Surveillance data from some endemic countries indicate that between 70 and 90 percent of people will have been exposed to dengue at least once by the time they reach adolescence. There are many factors that can lead to severe dengue infection. However, the highest risk of getting more severe disease has been observed in people infected for the second time by a different dengue virus.

Dengvaxia is currently indicated in most of the countries for individuals 9 years of age and older living in a dengue-endemic area. In this indicated population, Dengvaxia has been shown to prevent 93 percent of severe disease and 80 percent of hospitalizations due to dengue over the 25 month phase of the large-scale clinical studies conducted in 10 countries in Latin America and Asia where dengue is widespread.

Proposed Label Update

Based on the new analysis, Sanofi will propose that national regulatory agencies update the prescribing information, known as the label in many countries, requesting that healthcare professionals assess the likelihood of prior dengue infection in an individual before vaccinating. Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease). For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.

The Sanofi label proposal will be reviewed by national regulatory agencies in each of the countries where the vaccine is registered or under registration. Following their review, each agency might amend the company proposed label.

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 10:45 am 
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Gov't halts dengue vaccination program due to health risk

By Lara Tan, CNN Philippines

Updated 10:20 AM PHT Sat, December 2, 2017


Metro Manila (CNN Philippines, December 1) — The Department of Health (DOH) temporarily halted its dengue vaccination program after a new study that shows the vaccine poses a risk for those not previously infected by the mosquito-borne virus.

Those at risk are some 70,000 children who were vaccinated under a Health Department program since 2016.

"In the light of this new analysis, the DOH will place the dengue vaccination program on hold while review and consultation are ongoing with experts and key stakeholders and the WHO (World Health Organization), Health Secretary Francisco Duque III said in a media briefing on Friday.

Duque said 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.

Pharmaceutical company Sanofi on Wednesday said new clinical data analysis showed those not previously infected with dengue and got vaccinated with Dengvaxia could contract "severe disease".

"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.

Sanofi maintained that it provided protection against dengue fever to those who had been infected before.

According to Sanofi's study, Duque said the vaccine will prevent severe illness for at least 30 months, regardless if a person contracted the infection or not. But in the long term, "severe cases may occur" for those who never were infected by the mosquito-borne virus.

The World Health Organization recommended the use of Dengvaxia in 2016 in areas where dengue is highly endemic based on information available from Sanofi that time.

The Food and Drug Administration (FDA) said Dengvaxia underwent clinical trials to ensure safety and efficacy.

"It will not get an FDA approval if the documents are not complete," FDA Director Dr. Benjamin Co said.

He said there were no reported cases yet of severe illnesses from those who received the vaccination.

Health officials said they will profile those who got the vaccine and impose a five-year post-vaccination surveillance.

"Although sinabi nating 30 months ang protection, we will heighten our surveillance activities," Duque said.

Duque said they have fully paid Sanofi for the vaccines. The Health Department spent P3.5 billion for the immunization program, a move questioned by some doctors as Dengvaxia was not yet been approved by the World Health Organization.

To date, there are still almost 800,000 doses that have not been used, amounting to almost 800 million pesos, most of which will expire in August 2018.
Lawmakers alarmed over vaccine health risk


Senator Richard Gordon raised the issue that the vaccine was not tested on a small group.

"WHO has warned that the vaccine had not been given pre-qualification approval as it had not yet been tested on at least 200 children first, at the time it was procured by the administration of then President Benigno Aquino III... The vaccine was not yet ready for distribution. Now we have the evidence on that," he said in a statement.

Senator Nancy Binay called on DOH and Sanofi Pasteur to launch a nationwide medical advisory and information drive to reach out to parents whose children have had the vaccine.

"It is sad that the DOH ignored the warning about the issue of patient safety and research integrity of Dengvaxia. Safety should always be the paramount concern when it comes to any immunization program," she said in a statement.

The Health Department under then-Secretary Janette Garin launched Asia's first public dengue vaccine program in April 2016.

Health authorities earlier warned the vaccine would have side effects, including fever, headache, muscle pain, weakness, redness, and swelling.


The program was halted in mid-2016 by former Health Secretary Paulyn Ubial pending results of the pilot program, saying the vaccine was not proven safe.

Three children allegedly died in 2016 after the administration of the vaccine, but health officials and pharmaceutical officials denied the claim.


House and Senate committees have conducted hearings to look into the contract to purchase Dengvaxia from Sanofi.

Gordon, chairman of the Senate Blue Ribbon Committee, launched an investigation in December 2016, questioning the haste in buying dengue vaccines towards the end of the Aquino administration.

"The investigation is still ongoing," he said on Friday.

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 10:49 am 
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go PNoy kailangan ulit ng Powerpoint mo dito :lol:

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 10:50 am 
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Parang mali yung 8 to 10% or approximately 70,000 of the 700,000 vaccinated na affected ng negative side effect na data ng DOH. It is the other way around. I have not heard that there was an epidemic where 80 to 90 % of the people in an area were all affected by Dengue. It is more likely that 90% of those vaccinated or 630,000 of the 700,000 have never had dengue and that is the number that is affected by the side effects of Dengavaxia.

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 Post subject: Re: DENGVAXIA
PostPosted: Sat Dec 02, 2017 11:13 am 
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rudge wrote:
Napapanahon itong topic na to. Dito po natin ipost ang lahat ng mga article at opinyon sa isyu na to. ICB pakilipat mga link mo dito. :D

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 11:41 am 
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DOH on alert as Sanofi admits dengue vaccine poses risks

http://news.abs-cbn.com/news/11/30/17/d ... oses-risks

:shock:

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 11:42 am 
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Ex-DOH chief Garin says dengue vaccine program meets WHO standards

http://www.gmanetwork.com/news/news/nat ... rds/story/


:shock:

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 11:49 am 
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hind imo kailangan ng ano mang vaccine gudz. kelangan mo utak... :banghead:

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 11:57 am 
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DENGVAXIA BACKLASH | Experts had told PNoy govt of risks from dengue vaccine – Gordon
By
News5 | InterAksyon
| December 2, 2017, 12:42 AM

Concerned over the health of close to some 500,000 schoolchildren administered with the vaccine Dengvaxia, Senator Richard J. Gordon has expressed alarm over reports that the manufacturer Sanofi has acknowledged its dengue vaccine poses risks to certain recipients.

In what many described as a major Aha! Moment, Sanofi disclosed Thursday that, “for individuals who have not been previously infected by dengue virus, vaccination should not be recommended.”


The situation poses a big and deep quandary, especially for those responsible in the formulation and execution of this mass dengue vaccination program intended to cover one million children nine years old and up.

Click and watch a related video report from News5 below:


Early warning
Critics have noted the apparent haste that accompanied the Dengvaxia program’s rollout. Senator Gordon, chairman of the Senate Committee on Accountability of Officers and Investigations, or Blue Ribbon, said an official of the World Health Organization (WHO) had earlier warned that, at the time it was procured by the administration of then President Benigno Aquino III, the vaccine had not received pre-qualification approval.

This means the vaccine was not yet ready for distribution, explained Senator Gordon. “Now we have the evidence on that.”

Haphazard
For his part, Senator Joel Villanueva called for accountability from Sanofi as well as Department of Health officials responsible “for haphazardly allowing the vaccine to be administered without extensive due diligence on the effects and without waiting for the results of comprehensive clinical trial.”

The senator also expressed his disappointment that Sanofi had only recently revealed the result of their clinical study, after the DOH had already spent more than PhP3 billion for the program.

Senator Gordon elaborated: “Before we conducted an investigation on the anomalous procurement of this vaccine, we talked to several health experts and they told us that they had already warned government long before about the possible adverse effect of the new drug on individuals with no prior history of dengue. With this admission by Sanofi, they have been proven right.”

Sanofi acknowledgment
Sanofi acknowledged in the recent disclosure that the drug may be harmful when administered to individuals not previously infected with dengue, citing a new analysis of long-term clinical trial data that indicated that “for those not previously infected by dengue virus, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.”


In effect, what Sanofi is now saying is its dengue vaccine mostly helps people who’d been previously infected by the virus.

Sanofi urged regulators to update the vaccine’s label so doctors can be guided in screening out patients who have never suffered dengue.

3 doses six months apart
Known in the technical nomenclature as CYD-TDV, Dengvaxia is what’s called a “tetravalent, live attenuated, chimeric dengue vaccine in a yellow fever 17D backbone developed by Sanofi Pasteur.” The schedule that has been evaluated in Phase III clinical trials includes 3 doses of vaccine (at 0, 6 and 12 months).

See also:
DOH to spend P3,000 per child on dengue vaccine

Total bill: PhP3.5B
In January 2016, then Health Secretary Dr. Janette Garin told the Philippine Star that DOH was spending a total of P3.5 billion for the vaccination program for public school students in areas with high incidence of the potentially fatal disease. The initial beneficiaries of the free dengue vaccine were nine-year-old children enrolled in government schools at the National Capital Region, Central Luzon, and Calabarzon.

Garin said DOH bought the Food and Drug Administration-licensed Dengvaxia, at PhP1,000 per dose. This amount included syringes, vaccine carriers, surveillance and monitoring, and implementation costs.

Three doses were procured for one million children, each successive dose to be given every six months. The school-based dengue immunization was launched in April last year.

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 12:00 pm 
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don robert wrote:
hind imo kailangan ng ano mang vaccine gudz. kelangan mo utak... :banghead:



masisira na naman monitor ni dr.
:lol: :lol: :lol:

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 12:00 pm 
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Ehem minadali na naman ba yan? :roll:



:biglaugh:

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 Post subject: Re: DENGAVAXIA
PostPosted: Sat Dec 02, 2017 12:06 pm 
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:biglaugh:

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