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Old 18-05-2018, 02:09 PM   #11
st jimmy
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Sanofi’s dengue vaccine

In the Philippines, a major controversy has erupted over drug giant Sanofi’s Dengvaxia vaccine, for dengue fever.
Philippines suspended it, after growing public anger over its use in 830,000 schoolchildren. Filipino health secretary Francisco T. Duque III said the government is demanding a refund from Sanofi for the about $69 million it spent.

Dengvaxia was first approved in 2015. It’s approved in 19 countries and is the first vaccine for dengue.
Brazil and the Philippines initiated government-sponsored vaccination campaigns. Brazil’s government said it would continue vaccination, but avoid vaccinating people who have never had dengue.

It was already known in 2015, that children younger than 9, poisoned with Dengvaxia, suffer more hospitalisations in 3 years. They approved the vaccine anyway; with Sanofi’s advice to restrict Dengvaxia to children 9 and older (this advice was followed by the Philippines).
Brazil decided to limit the vaccination program to people over age 15.

The explanation is almost as bizarre as for Zika.
According to Dr. Scott B. Halstead, and the medical establishment, the second time somebody is infected with dengue is the worst. So they claim that the vaccine before somebody suffered dengue fever makes the second (worst) infection happen sooner.

Only at the end of November 2017, Sanofi changed its advice to not recommend vaccination for people who have never had dengue. But that only adds to the confusion, because there is no useable test. Current tests take too much time (money), and are unreliable as there’s trouble distinguishing dengue from Zika (supposedly both spread by the miraculous Aedes aegypti mosquitoes).
Sanofi stated in its official statement:
Quote:
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.
Vaccination should only be recommended when the potential benefits outweigh the potential risks.
For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.
Sanofi has recorded 22 million Euros ($26 million) in sales of Dengvaxia in the first 3 quarters of 2017.
The similar Takeda vaccine and another by the US National Institutes of Health, mainly sold by Merck, are expected to be approved soon.

Dengue infects about 400 million people, puts 500,000 people in the hospital yearly and kills 25,000, mostly in Latin America and South Asia.
For some reason, the dengue fever is rapidly progressing. According to the state media this is caused by global climate change: https://www.nytimes.com/2017/12/17/h...ilippines.html
(archived here: http://archive.is/3XYDW)


Of course the fast increasing reported cases of dengue fever could also be explained with: changes in reporting, higher vaccination rates or that spraying more pesticides, against “mosquitoes”, causes illness...


It sounds almost like Sanofi timely announced that no people should be poisoned with the Dengvaxia vaccine that had not suffered from dengue fever before...

In July 2016, the WHO (besides not recommending the vaccine for children younger than 9) already advised that the vaccine only should be given where more than 70% of the population (age group) has suffered from dengue before:
Quote:
This variability in efficacy likely reflects at least in part the baseline seropositivity and circulating serotypes, both of which affect the performance of the vaccine.
In defining populations to be targeted for vaccination, prior infection with dengue virus of any serotype, as measured by seroprevalence, should be approximately 70% or greater in the age group targeted for vaccination in order to maximize public health impact and cost-effectiveness. Vaccination of populations with seroprevalence between 50% and 70% is acceptable but the impact of the vaccination programme may be lower.
The vaccine is not recommended when seroprevalence is below 50% in the age group targeted for vaccination.
The number of dengue cases reported annually to WHO has increased from 0.4 million in 1996 to 1.3 million in 2005, 2.2 million in 2010 and 3.2 million in 2015 (an 8-fold increase in 20 years).
The WHO simply also claims that there’s “substantial under-reporting”, without “evidence”. It is acknowledged that dengue fever isn’t understood completely. How could they know that the mosquitoes cause it...

Vaccine trials showed a highly unpredictable “efficacy”: only 31.3% in Mexico, but 79.0% in Malaysia.

It’s even bizarre that only children of 9 years and over are targeted with the vaccine (including older than 16), as:
Quote:
NRAs have approved the use of the product in individuals over 16 years of age, although vaccine efficacy data were available only up to 16 years of age. Safety and immunogenicity studies were undertaken in 294 individuals aged 18–45 years in endemic settings.
http://www.who.int/wer/2016/wer9130.pdf?ua=1


Here’s the 2015 report that showed that more children younger than 9 years are hospitalised in the third year because of the vaccine - Sri Rezeki Hadinegoro et al; Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease: https://www.nejm.org/doi/10.1056/NEJ...i.nlm.nih.gov&

This “study” was really, really “independent”, funded by Sanofi Pasteur...
Quote:
Dr. Chotpitayasunondh reports receiving lecture fees from Sanofi Pasteur; Dr. Reynales, participating in recruiting participants for clinical trials in multiple therapeutic areas for Merck, GlaxoSmtihKline, Novartis, Sanofi, Janssen, AstraZeneca, Amgen, and Takeda; Drs. Bouckenooghe, Chansinghakul, Cortés, Forrat, Frago, Gailhardou, Jackson, Noriega, Plennevaux, Wartel, Zambrano, and Saville, being employees of Sanofi Pasteur; Drs. Chansinghakul, Cortés, Forrat, Frago, Gailhardou, Jackson, Noriega, Plennevaux, Wartel, Zambrano, and Saville, having an equity interest in Sanofi Pasteur; and Ms. Fanouillere, being employed by Sanofi R&D.
The dengue vaccine was assessed in 3 trials involving more than 35,000 children between ages 2 and 16 years in Asian–Pacific and Latin American countries.
During year 3, in the 3 trials combined, hospitalisation for virologically confirmed dengue occurred in 65 of 22,177 participants in the vaccine group and 39 of 11,089 participants in the control group. Hospitalisation for severe dengue occurred in 18 of 22,177 participants in the vaccine group and 6 of 11,089 participants in the control group.
Table 1. Annual Incidence of Hospitalization for Virologically Confirmed Dengue.


Efficacy rates for symptomatic dengue during the first 25 months were estimated at: 65.6% for those 9 years or older; 44.6% for those younger than 9 years; and 60.3% for all ages.

For some reason (the text of) the document, doesn’t present that the higher hospitalisation occurred mainly in the children younger than 9 that were poisoned with the vaccine...
Among subjects younger than 9 years of age: 8 of 19 participants in the vaccine group and none of 6 participants in the placebo group were hospitalised for severe dengue.
In the CYD14 trial, there were 12 cases of severe dengue in the vaccine group and none in the placebo group.
--------------------------------------------

The obvious conflicts of interest in the previous study are worrisome, but it’s not completely useless as there was an actual placebo (control) group.
My main problem is that overall health effects aren’t reported, but only dengue. This is all the more a problem as dengue fever isn’t even properly understood...


The following 2016 paper, is a completely ridiculous modelling exercise, where first a model is fitted to the results, and then that model is used to make predictions...
Neil M. Ferguson et al – Benefits and risks of the Sanofi-Pasteur dengue vaccine: Modeling optimal deployment: http://science.sciencemag.org/conten...6303/1033.full

It gives some information on the previous study.
Fig. 1, shows that the model was fit to the Asian phase 3 clinical trial (but this doesn’t “prove” that the model is good...).
Strangely it’s claimed that while at the same time a lot less children poisoned with vaccine are reported to suffer from dengue, in age group 2-5 years, much more children on vaccines end up in hospital...


This report claims that vaccination of subjects with one prior dengue infection results in a boosting of immunity to levels comparable with someone who has had 2 natural infections.
If this is the case one could argue that people with 2 prior dengue infections shouldn’t be targeted, but I guess there is no test for that. If there is no test to establish this, they couldn’t even know that the second infection is the worst. Like so often stories on vaccines, don’t bear a critical review...
The vaccine protection in seronegative recipients (who never had dengue) decays rapidly, with a mean duration of 7 months. They claim not to know how “transient” the supposed “protection” is in seropositive recipients (who have had dengue before).

They predict tremendous positive results from the Dengvaxia vaccine in 30 years, based on their worthless model...

This worthless “study” was also really, really “independent”...
Quote:
The authors acknowledge research funding from the UK Medical Research Council, the UK National Institute of Health Research under the Health Protection Research Unit initiative, National Institute of Allergy and Infectious Diseases and National Institute of General Medical Sciences (NIH) under the MIDAS initiative, and the Bill and Melinda Gates Foundation. Views expressed do not necessarily represent those of the funders. N.M.F., I.R.-B., and D.A.T.C. have advised Sanofi Pasteur Ltd., without payment, on the implications that this work has on the use of their vaccine. We thank N. Grassly for comments on the manuscript and N. Jackson and L. Coudeville at Sanofi Pasteur for useful discussions.
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Last edited by st jimmy; 19-05-2018 at 02:01 PM.
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