Dengue Vaccine On the Way!

AlterEgo

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Google babble translated, see link for charts, etc.:

Approved the first vaccine against dengue

About 40% of the world's population is at risk of contracting dengue

DENGUE| 09 DIC 2015 1:58 PM |EFE

MEXICO. Health authorities in Mexico today authorized the first vaccine against dengue in the world after evidence of their quality, safety and therapeutic efficacy in a global protocol in which more than 40,000 patients participated.

The Health Ministry said in a statement that the vaccine was approved after a process of analysis of more than two years contemplated an exchange of information with leading experts in the field at national and international level.

The vaccine, developed by Sanofi Pasteur and whose approval by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) makes Mexico "to regulatory vanguard" is indicated for people aged 9 to 45 who live in areas where Dengue is endemic.

It works for all four serotypes of the virus causing the disease "has an average efficiency of 60.5% for the prevention of dengue and 93.2% for the prevention of severe dengue".

According to the World Health Organization (WHO), about 40% of the world's population is at risk of contracting dengue, which equals 3,900 million.

"An estimated 400 million are infected each year in more than 128 countries around the world." In Mexico, last year 32,100 cases were registered, of which 23,432 correspond to non-severe dengue and 8,668 to severe dengue, "explained the Ministry of Health.

The social cost associated with dengue, he said, exceeded 3,200 million pesos (about 188 million dollars) in 2014, equivalent to 2.5% of the budget allocated to the whole health sector in Mexico for 2016.

The vaccine can you prevent more than 8,000 hospitalizations in Mexico, 104 deaths annually and generate savings to public finances by 1,100 million pesos (65 million dollars) a year by the reduction in costs associated with medical care, estimated.

"An estimated 400 million are infected each year in more than 128 countries around the world." In Mexico, last year 32,100 cases were registered, of which 23,432 correspond to non-severe dengue and 8,668 to severe dengue, "explained the Ministry of Health.

Cofepris asked the French drug plan risk management designed especially for Mexico, including an electronic record of the vaccinated population and reporting of adverse reactions "through medical centers sentries located in endemic populations in which it is applied ".

"Historic milestone"

The CEO of Sanofi Pasteur, Olivier Brandicourt, held the first authorization of the vaccine, calling it a "historic milestone" for the company, the public health "and more importantly, for half the world's population living at risk of suffering from dengue. "

The approval comes after an extensive clinical development program in which more than 40,000 people from 15 countries participated, including several in Latin America.

Mexico is with the Philippines the only nation in the world that participated in the three stages of clinical trials of a decade that began in 2004.

The company announced in a statement that production of the vaccine against dengue already begun in France, so the first doses are available.

He noted that the regulatory review process for the vaccine against dengue continues in other endemic countries and reiterated its commitment to launch the first vaccine in those countries where dengue is a major public health priority.

The dengue virus is transmitted by the mosquito "Aedes aegypti" and symptoms of the disease include high fever, headache, muscle and joint pain, vomiting, sore eyes and a characteristic rash.

People infected annually, two million, mostly children, develop the hemorrhagic variety, which can be fatal.

It occurs mostly in tropical and subtropical climates of the planet, both in urban and suburban areas, and the direct and indirect cost estimate is 9,000 dengue billion a year globally.

http://www.diariolibre.com/noticias/salud/aprueban-la-primera-vacuna-contra-el-dengue-KF2124509
 

CristoRey

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Have had dengue twice since living down here. I know, my luck... Sure some of you would say
I probably deserved it.
I am happy to hear Mexico has developed a vaccine to help prevent/ fight it.
 

AlterEgo

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I just re-read the OP. The vaccine is for ages 9 to 45. What??????????

The young children and older folks get hit the hardest, I wonder why they're not included? Maybe didn't work for those demographics?? :(
 

william webster

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Have had dengue twice since living down here. I know, my luck... Sure some of you would say
I probably deserved it.
I am happy to hear Mexico has developed a vaccine to help prevent/ fight it.
2x in less than 3yrs ... not counting the first attack

3x in 6yrs..... experto, yo
 

melphis

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I just re-read the OP. The vaccine is for ages 9 to 45. What??????????

The young children and older folks get hit the hardest, I wonder why they're not included? Maybe didn't work for those demographics?? :(
This is understandable if it's still in the trial stage. The test age group has healthy auto immune systems. Any younger or older could be a death sentence as their body's can't deal with the vaccine.
I sure hope it works. Stage 2 of testing will probably include up to mid 50's. Then I am in.
 

AlterEgo

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This is understandable if it's still in the trial stage. The test age group has healthy auto immune systems. Any younger or older could be a death sentence as their body's can't deal with the vaccine.
I sure hope it works. Stage 2 of testing will probably include up to mid 50's. Then I am in.
Thank you, makes sense.
 

CristoRey

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2x in less than 3yrs ... not counting the first attack

3x in 6yrs..... experto, yo
First time in my life I have ever been sick to the point where I thought I could really die from something like this.
Had it once in mosquito infested rice patty town south of Nagua in 2012. Second time was in Sosua 2013 almost
a year later to the same week. If given the opportunity I would try the vaccine.
 

william webster

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Just my head takes a beating Cristo..... but it's a real battering
As I said, can't touch my skull w/o pain for 36 hrs after.

It's my liver I worry about... the horse sized acetaminophen pills chew it up.

The report indicates that I am too old to be a vaccine candidate

Pardon me while i go iron my long sleeved shirt and long pants....:glasses:
 

AlterEgo

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My husband has been terribly sick with dengue. Started with the high fever (even hallucinations) then the awful headache that WW described. No joint pain for him but severe fatigue. Small hospital out here diagnosed it from plummeting plaquettas and set him up with an IV drip of B-complex. They put him in a dengue ward for the day. When he was discharged they told him to drink guava juice and a juice made from red bell peppers, so I blended the guava with three large peppers and some ice in the blender. I'm told it helps the blood counts and next day his platelets rose 30 points so it worked, as odd as it sounds.

He's one of those guys who's been healthy as a horse his whole life, and to see him this sick is scary. On Monday we're going to SD to see an infectologist because he has an UTI - which guys only get if there is an infection in kidneys or prostate (so I'm told). Apparently dengue can affect kidneys, liver, etc.

I pray I never get dengue, I don't have the immune system or strength that he has.
 

william webster

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AE, sorry to hear this.... yes, the liver takes a beating.

Pedialyte.... coconut juice... both help the electrolytes rebound.
That juice cocktail is a local thing.... some debunk it.... Clinica Abreu did .

Water and lime juice... lots of it

I had no hospital or IV this last time.... just fluids and pain pills.....
No Tylenol or blood thinners.

Depends how many days.... 6 -10 .... dependente

Bed rest... I was sleeping 15-16 hours / day

Plaquette count needs monitoring.....no alcohol.

read this...http://loveyourliver.com.au/diet/

Call me if you have questions

WW - MD, Dengue Specialista y Survivor x3
MD = multiple dengues
 

mart1n

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Yes don’t talk prevention just roll up your sleeves and get your dos of mercury and formaldehyde and all the other things that are dangerous with no long term testing.
The system love vaccine because they are not responsible for the damage they do and the companies that make them cannot be sued.
 

AlterEgo

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FDA approves dengue vaccine

(Apparently only for kids!!)

FDA approves the first vaccine for dengue fever, but with major restrictions

By HELEN BRANSWELL @HelenBranswell

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.

The various restrictions mean the U.S. market for the vaccine is smaller still than the already modest market Sanofi had sought. Still, the company said it was pleased by the FDA’s decision.

“Today’s FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue, particularly among children, in U.S. dengue-endemic areas,” Dr. David Greenberg, Sanofi’s regional medical head for North America, said in a statement.

Late last year, the European Commission approved the vaccine for use in dengue endemic parts of Europe — mainly offshore territories, such as the Caribbean islands of Martinique and Guadeloupe. The approval allows for use of the vaccine in people ages 9 to 45 who have previously had at least one dengue infection.

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.

There are four serotypes of dengue viruses, numbered 1 through 4. Infection with one virus does not protect against the others and actually appears, for a time, to increase the risk that another dengue infection will trigger a severe form of the disease that can be life threatening. That phenomenon is called antibody-dependent enhancement, or ADE.

After Sanofi announced its findings, the Philippines — the only country to have used the vaccine broadly to date — suspended use of Dengvaxia and ultimately revoked its license. Prosecutors have charged Sanofi, a half-dozen of its employees, and several current and former Philippines health officials over a series of deaths it alleges are linked to use of the vaccine.

Based on the company’s findings, experts who advise the World Health Organization on vaccine policy recommended that Dengvaxia only be given to people who are known to have had a previous infection.

Identifying those people is currently a challenge. Many dengue infections are mild and go undiagnosed, so lack of a confirmed dengue case on a child’s medical record cannot be taken as proof the child was never infected. Testing is needed — but at present there is no rapid point-of-care test to administer.

Sanofi officials have said they hope to have such a test ready to submit for approval to the FDA by late 2020.

Dengvaxia is licensed for use in 19 countries, plus the eligible parts of the European Union. Sanofi said the vaccine is currently available in 10 countries in Latin America and Asia.

Despite the restrictions placed on the vaccine by the FDA, by bringing to market a product to protect against dengue fever, Sanofi will earn a priority review voucher — an incentive created to encourage pharmaceutical companies to develop drugs and vaccines that can treat or protect against diseases for which market forces alone don’t spur development.

A company can use a voucher to expedite the review of another product it hopes to bring to market or it can sell it to another pharmaceutical firm. Since the priority review voucher program was initiated about a decade ago, roughly two dozen vouchers have been issued; vouchers that have been sold recently earned prices of between $80 million to $130 million.

About the Author

Helen Branswell
Senior Writer, Infectious Disease

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development.

helen.branswell@statnews.com
@HelenBranswell

https://www.statnews.com/2019/05/01/fda-dengue-vaccine-restrictions/
 

william webster

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There is something about Dengue and the 1st - then ensuing - cases

For instance... the serious version - hemorrhagic - can only be contracted after an initial case has been experienced