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Tsikoteer
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July 17th, 2019 11:03 AM #31
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Tsikoteer
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July 17th, 2019 11:07 AM #32i always tell my students,
"even if historical statistics are favorable, the same statistics are not acceptable, if it was your kid suffering from its ill-effects".
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July 17th, 2019 11:07 AM #33
FDA approves the first vaccine for dengue fever, but with major restrictions
The Food and Drug Administration on Wednesday approved the first vaccine against dengue fever, one that protects against a common disease but has generated significant controversy due to evidence it can increase the risk of severe infection in some people.
The agency ruled that Dengvaxia, manufactured by Sanofi Pasteur, can only be used in individuals aged 9 to 16 living in parts of the United States where the dengue virus is endemic — in other words, where it circulates on an ongoing basis. Dengue is found only in Puerto Rico and a few other U.S. offshore territories and protectorates.
Furthermore, the vaccine can only be given to children and teens who have had one previous laboratory-confirmed case of dengue.
Regulators have sought to restrict access to Dengvaxia following post-marketing research by Sanofi that showed that, while the vaccine offers protection for people who have already had at least one bout of dengue, it increases the risk of severe infection in children who were dengue-naïve — that is, never infected — when they were vaccinated.
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July 17th, 2019 11:08 AM #34
EVEN SANOFI admits di pwede ang dengvaxia sa dengue-naive
ginawa lang nilang malaking clinical trial ang Pinas
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July 17th, 2019 11:09 AM #35
pero syempre para sa mga hardened anti-du30, this issue is pure politics
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Tsikoteer
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July 17th, 2019 11:12 AM #36
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July 17th, 2019 11:12 AM #37WHO | WHO advises Dengvaxia be used only in people previously infected with dengue
The WHO Global Advisory Committee on Vaccine Safety considered the company’s new results from clinical trial data analyses. Those studies indicate that increased risk of severe dengue disease in people who have never been infected affects about 15% of the vaccinated individuals. The magnitude of risk is in the order of about 4 out of every 1000 seronegative patients vaccinated who developed severe dengue disease during five years of observation. The risk of developing severe dengue disease in non-vaccinated individuals has been calculated as 1.7 per 1000 over the same period of observation. By contrast, for the 85% who have had dengue disease before immunization, there is a reduction of 4 cases of severe dengue per 1 000 who are vaccinated.
2nd infection and so on - severe dengue can happen. That's what the vaccine is supposed to prevent.
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Verified Tsikot Member
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July 17th, 2019 11:16 AM #38
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July 17th, 2019 11:20 AM #39were these conditions already being mulled by the manufacturer and/or the researchers, even before the DOH approved its seeming-lightning-fast program?
or was it kept hush-hush, back then?
there were warnings already over ADE (antibody-dependent enhancement) but Sanofi played it down
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Tsikoteer
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July 17th, 2019 11:20 AM #40
Be careful with channels like "China Observer" on YouTube. There is a clear bias in their posts and...
Xiaomi E-Car