Dengue vaccine launched in Phuket

[webfact]

Dengue vaccine launched in Phuket

Tanyaluk Sakoot

 

The dengue vaccine Dengvaxia was launched to the public at Phuket International Hospital last week.v

 

PHUKET: -- The long-awaited dengue vaccine Dengvaxia, developed by Sanofi Pasteur over 20 years at a cost of US$1.6 billion (B56.4bn), arrived in Phuket last week, but doctors at public hospitals are hoping the Health Ministry will make the vaccine freely – or at least cheaply – available to the public.

 

The Phuket launch of Dengvaxia was held at Phuket International Hospital last Wednesday (Jan 11), where the vaccine – administered by three injections six months apart – is available for B9,990.

 

Phuket Public Health Office (PPHO) Chief Dr Jirapan Taepan welcomed the arrival of the vaccine, whether through a private hospital or not.

 

“Whether to make this vaccine available at public hospitals is still being considered by the Health Ministry. I have no idea at what stage this issue is at now,” he said.

 

Already in the first three weeks of this year, eight confirmed cases of 69 suspected infections had been diagnosed at hospitals in Phuket.

 

Full story: http://www.thephuketnews.com/dengue-vaccine-launched-in-phuket-60690.php

 

-- © Copyright Phuket News 2017-01-20

[sawadee1947]

...so the poor can still enjoy the fever?

[carstenp]

Good news, so i hope i Can get it up here in isaan. anyone  knows if there is any side effects 

[lungnorm]

1 hour ago, carstenp said:

Good news, so i hope i Can get it up here in isaan. anyone  knows if there is any side effects 

There is plenty of information online and lots of video's on you tube that should dissuade anyone from ever getting any vaccine. There has never been a successful vaccine just a lot of misinformation put out. Its a billion dollar industry and its going to take a lot of dismantling. However President Trump has done one good deed so far, he has appointed Robert F Kennedy Jr to head up a commission to get to the bottom of the whole vaccine mess. 

[stevenl]

There is plenty of information online and lots of video's on you tube that should dissuade anyone from ever getting any vaccine. There has never been a successful vaccine just a lot of misinformation put out. Its a billion dollar industry and its going to take a lot of dismantling. However President Trump has done one good deed so far, he has appointed Robert F Kennedy Jr to head up a commission to get to the bottom of the whole vaccine mess. 

Total nonsense, and extremely dangerous post.

Sent from my ROBBY using Thaivisa Connect mobile app

[carstenp]

This will help many people down here. but of cause expensive 2 adults and 2 kids is around 40000. Hope the price will go down

 

Side effects

Quote

Most of the reported side effects occurred within 3 days after the injection of the vaccine: Very Common (may affect more than 1 user in 10): Headache, muscle pain (myalgia), generally feeling unwell (malaise), feeling of weakness (asthenia), injection site pain, fever.

 

Vaccine Efficacy

Quote

Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series (per protocol analysis). During this initial time period, pooled vaccine efficacy against severe dengue was 79.1%. Efficacy varied by serotype: vaccine efficacy was higher against serotypes 3 and 4 (71.6% and 76.9%, respectively) than for serotypes 1 and 2 (54.7% and 43.0%). Vaccine efficacy also varied by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).

More info here http://www.who.int/immunization/research/development/dengue_q_and_a/en/

[scubascuba3]

3 hours ago, carstenp said:

Good news, so i hope i Can get it up here in isaan. anyone  knows if there is any side effects 

Yes, an empty wallet

[lungnorm]

14 hours ago, stevenl said:

Total nonsense, and extremely dangerous post.

Sent from my ROBBY using Thaivisa Connect mobile app
 

It is not nonsense. Its actually very true and the only damaging part of my post is idiots that think its not true. The evidence is out there online. I suggest you learn how to google info and find things on you tube. Grrr

[Old Croc]

15 hours ago, stevenl said:

Total nonsense, and extremely dangerous post.

Sent from my ROBBY using Thaivisa Connect mobile app
 

This guy is a typical conspiracy theorist.

Will quote idiotic, radical, internet theory, posted by nutjobs, as fact, while ignoring overwhelming, and tested, scientific evidence to the contrary.  He's popped up before in similar threads. Best ignored. 

[partington]

1 hour ago, lungnorm said:

It is not nonsense. Its actually very true and the only damaging part of my post is idiots that think its not true. The evidence is out there online. I suggest you learn how to google info and find things on you tube. Grrr

 

What is really difficult to understand is why people like you think You Tube videos are reliable evidence of anything. Surely common knowledge tells you that any idiot can post anything they like on YouTube and there is no reason why anything posted should be true.You must be aware that there is something called "Fake News"? No-one checks, no-one validates and there is simply no guard at all against lies. Yet you somehow imagine that looking on YouTube provides "evidence".

 

 The simple truth is that scientific research on vaccines is carried out by people who have spent 7+ years training in the scientific method, have documented expertise in clinical  immunology, and before publication is permitted have to have years of experimental results evaluated and criticised by anonymous peer experts, usually being refused publication in the scientific journals until further evidence has been asked for and acquired. 

 

Clearly this is infinitely more reliable than a YouTube video.

 

You are the one in need of more education, and simply put, more bloody common sense!

[lungnorm]

21 minutes ago, partington said:

 

What is really difficult to understand is why people like you think You Tube videos are reliable evidence of anything. Surely common knowledge tells you that any idiot can post anything they like on YouTube and there is no reason why anything posted should be true.You must be aware that there is something called "Fake News"? No-one checks, no-one validates and there is simply no guard at all against lies. Yet you somehow imagine that looking on YouTube provides "evidence".

 

 The simple truth is that scientific research on vaccines is carried out by people who have spent 7+ years training in the scientific method, have documented expertise in clinical  immunology, and before publication is permitted have to have years of experimental results evaluated and criticised by anonymous peer experts, usually being refused publication in the scientific journals until further evidence has been asked for and acquired. 

 

Clearly this is infinitely more reliable than a YouTube video.

 

You are the one in need of more education, and simply put, more bloody common sense!

All the video's on you tube are Medical Doctors most of which have vaccine damaged children prompting them to speak out. If you want a reliable look up the Cochrane institute who only publish facts that are not paid for by the vaccine manufacturers and the CDC trying to cover their asses by telling outright lies.

[chiang mai]

6 minutes ago, lungnorm said:

All the video's on you tube are Medical Doctors most of which have vaccine damaged children prompting them to speak out. If you want a reliable look up the Cochrane institute who only publish facts that are not paid for by the vaccine manufacturers and the CDC trying to cover their asses by telling outright lies.

 

Cochrane has nothing to say about the Dengue vaccine.

 

[lungnorm]

1 hour ago, partington said:

 

What is really difficult to understand is why people like you think You Tube videos are reliable evidence of anything. Surely common knowledge tells you that any idiot can post anything they like on YouTube and there is no reason why anything posted should be true.You must be aware that there is something called "Fake News"? No-one checks, no-one validates and there is simply no guard at all against lies. Yet you somehow imagine that looking on YouTube provides "evidence".

 

 The simple truth is that scientific research on vaccines is carried out by people who have spent 7+ years training in the scientific method, have documented expertise in clinical  immunology, and before publication is permitted have to have years of experimental results evaluated and criticised by anonymous peer experts, usually being refused publication in the scientific journals until further evidence has been asked for and acquired. 

 

Clearly this is infinitely more reliable than a YouTube video.

 

You are the one in need of more education, and simply put, more bloody common sense!

Coming from you that's a compliment. I never take advice from 3rd graders. I put you in the know all Fxxx all catagory. You just don't get it, the vaccine makers determining what gets published.

 

Edited January 21, 2017 by lungnorm

[CALSinCM]

I understand the controversy regarding vaccination and I believe that the medical community and drug companies are pushing an agenda to over-vaccinate the population.  There are risks associate with vaccines which I will not debate in this thread. <sorry pro-vaccination proponents>
With that said, each person needs to weight the risks with the benefits.  For example, I'm around numerous feral animals in the village, I've been bitten more than once and I keep my rabies vaccinations up to date. <sorry anti-vaccination opponents>
I've also had Dengue.  If I contract it again, it could be a death sentence as the second time around can be serious if not fatal.  So at this point a Dengue vaccination is something I'll look into. This has a higher benefit to risk ratio for me personally.  But at the moment I want a lot more information regarding studies and side-effects of this particular vaccine.  If anyone has links to Dengue vaccination studies, I'd love to read them.  Thanks for this link, it's a good starting point.
http://www.who.int/immunization/research/development/dengue_q_and_a/en/

Edited January 21, 2017 by CALSinCM

[Tredz]

just one question made by  Sanofi Pasteur  but not avaible in France...........

 

[Jimi007]

1 hour ago, Tredz said:

just one question made by  Sanofi Pasteur  but not avaible in France...........

 

 

Is there much dengue in France?

[lungnorm]

19 hours ago, lungnorm said:

Coming from you that's a compliment. I never take advice from 3rd graders. I put you in the know all Fxxx all catagory. You just don't get it, the vaccine makers determining what gets published.

 

Examining RFK Jr.'s claim that the CDC “Owns over 20 vaccine patents.”

Mr. Kennedy is in very safe territory by reporting that the CDC has over 20 patents that create vast, undisclosed conflicts of interests in vaccine safety.

This past week, President-Elect Trump invited Robert F. Kennedy Jr. to discuss Mr. Kennedy leading a vaccine safety commission.  The mainstream media coverage of the meeting was widespread and furious. 

The vaccine industry and its media lap dogs do not want their corruption exposed in any official forum, and they have pointed their fury at Mr. Trump and Mr. Kennedy. 

We have seen a great deal of media on Kennedy and his vaccine safety and corruption claims in the last week.  The nice thing about that is this - because he has been in the mercury fight for so long, and started investigating the claims of moms of vaccine injured children more than a decade ago, his coverage has returned  the spotlight to the corruption that was uncovered in the early days of the realization that the vaccine program was hurting our kids.

One of these old pieces of information that has made its way back into the discussion because of Mr. Kennedy's media attention is the claim that, “The CDC owns over 20 vaccines patents.”

My vaccine safety and corruption research began shortly after my son was vaccine injured in 2003, and I have heard this claim circulated since I began advocacy in this arena, but I have never seen any evidence for this claim.

In 2003, UPI reporter Mark Benjamin wrote an in depth piece on the conflicts of interest (COI) in vaccine safety entitled, “UPI Investigates: The vaccine conflict.”  We have Mr. Benjamin to thank for bringing the patents and COIs held by the members of the CDC Advisory Committee on Immunization Practices, including Dr. Paul Offit, to the public's attention, and for documenting the early years of Offit's increasingly absurd claims.  In this article, Offit asserts that holding vaccine patents, being funded by Merck and having Merck buy and distribute, to physicians, his book extolling the virtues of vaccines, does not compromise his objectivity as a member of the committee that determines what is and is not sound vaccine practice:

Follow this up if you wish to know all the truth!!!

[lungnorm]

20 hours ago, partington said:

 

What is really difficult to understand is why people like you think You Tube videos are reliable evidence of anything. Surely common knowledge tells you that any idiot can post anything they like on YouTube and there is no reason why anything posted should be true.You must be aware that there is something called "Fake News"? No-one checks, no-one validates and there is simply no guard at all against lies. Yet you somehow imagine that looking on YouTube provides "evidence".

 

 The simple truth is that scientific research on vaccines is carried out by people who have spent 7+ years training in the scientific method, have documented expertise in clinical  immunology, and before publication is permitted have to have years of experimental results evaluated and criticised by anonymous peer experts, usually being refused publication in the scientific journals until further evidence has been asked for and acquired. 

 

Clearly this is infinitely more reliable than a YouTube video.

 

You are the one in need of more education, and simply put, more bloody common sense!

Examining RFK Jr.'s claim that the CDC “Owns over 20 vaccine patents.”

Mr. Kennedy is in very safe territory by reporting that the CDC has over 20 patents that create vast, undisclosed conflicts of interests in vaccine safety.

This past week, President-Elect Trump invited Robert F. Kennedy Jr. to discuss Mr. Kennedy leading a vaccine safety commission.  The mainstream media coverage of the meeting was widespread and furious. 

The vaccine industry and its media lap dogs do not want their corruption exposed in any official forum, and they have pointed their fury at Mr. Trump and Mr. Kennedy. 

We have seen a great deal of media on Kennedy and his vaccine safety and corruption claims in the last week.  The nice thing about that is this - because he has been in the mercury fight for so long, and started investigating the claims of moms of vaccine injured children more than a decade ago, his coverage has returned  the spotlight to the corruption that was uncovered in the early days of the realization that the vaccine program was hurting our kids.

One of these old pieces of information that has made its way back into the discussion because of Mr. Kennedy's media attention is the claim that, “The CDC owns over 20 vaccines patents.”

My vaccine safety and corruption research began shortly after my son was vaccine injured in 2003, and I have heard this claim circulated since I began advocacy in this arena, but I have never seen any evidence for this claim.

In 2003, UPI reporter Mark Benjamin wrote an in depth piece on the conflicts of interest (COI) in vaccine safety entitled, “UPI Investigates: The vaccine conflict.”  We have Mr. Benjamin to thank for bringing the patents and COIs held by the members of the CDC Advisory Committee on Immunization Practices, including Dr. Paul Offit, to the public's attention, and for documenting the early years of Offit's increasingly absurd claims.  In this article, Offit asserts that holding vaccine patents, being funded by Merck and having Merck buy and distribute, to physicians, his book extolling the virtues of vaccines, does not compromise his objectivity as a member of the committee that determines what is and is not sound vaccine practice:

Follow this info up if you want to find the truth about Vaccines!!!!

[stevenl]

35 minutes ago, lungnorm said:

Examining RFK Jr.'s claim that the CDC “Owns over 20 vaccine patents.”

Mr. Kennedy is in very safe territory by reporting that the CDC has over 20 patents that create vast, undisclosed conflicts of interests in vaccine safety.

This past week, President-Elect Trump invited Robert F. Kennedy Jr. to discuss Mr. Kennedy leading a vaccine safety commission.  The mainstream media coverage of the meeting was widespread and furious. 

The vaccine industry and its media lap dogs do not want their corruption exposed in any official forum, and they have pointed their fury at Mr. Trump and Mr. Kennedy. 

We have seen a great deal of media on Kennedy and his vaccine safety and corruption claims in the last week.  The nice thing about that is this - because he has been in the mercury fight for so long, and started investigating the claims of moms of vaccine injured children more than a decade ago, his coverage has returned  the spotlight to the corruption that was uncovered in the early days of the realization that the vaccine program was hurting our kids.

One of these old pieces of information that has made its way back into the discussion because of Mr. Kennedy's media attention is the claim that, “The CDC owns over 20 vaccines patents.”

My vaccine safety and corruption research began shortly after my son was vaccine injured in 2003, and I have heard this claim circulated since I began advocacy in this arena, but I have never seen any evidence for this claim.

In 2003, UPI reporter Mark Benjamin wrote an in depth piece on the conflicts of interest (COI) in vaccine safety entitled, “UPI Investigates: The vaccine conflict.”  We have Mr. Benjamin to thank for bringing the patents and COIs held by the members of the CDC Advisory Committee on Immunization Practices, including Dr. Paul Offit, to the public's attention, and for documenting the early years of Offit's increasingly absurd claims.  In this article, Offit asserts that holding vaccine patents, being funded by Merck and having Merck buy and distribute, to physicians, his book extolling the virtues of vaccines, does not compromise his objectivity as a member of the committee that determines what is and is not sound vaccine practice:

Follow this info up if you want to find the truth about Vaccines!!!!

That is twice the same quote without any source.

[lungnorm]

14 minutes ago, stevenl said:

That is twice the same quote without any source.

Not hard to find the source, its even been on the news. www.greenmedinfo.com

 

Edited January 22, 2017 by lungnorm

[stevenl]

Not hard to find the source, its even been on the news. www.greenmedinfo.com

 

Now that's not so difficult, is it, and good webpractise: quote a site, mention the source. But I understand why you didn't do that here.

Wiki has some things to say about that site, e.g.: the truest statement on the website is the disclaimer.

That site should imo be classed as fake news.

Sent from my ROBBY using Thaivisa Connect mobile app

[lungnorm]

16 minutes ago, stevenl said:

Now that's not so difficult, is it, and good webpractise: quote a site, mention the source. But I understand why you didn't do that here.

Wiki has some things to say about that site, e.g.: the truest statement on the website is the disclaimer.

That site should imo be classed as fake news.

Sent from my ROBBY using Thaivisa Connect mobile app

You cannot go through life not trusting anybody. 

[Old Croc]

Some people go through life trusting every liar, fraudster, cult leader and sociopath who comes along.

They soak up, and believe, every twisted theory, lie and promise these flawed individuals serve up to them despite there being massive weight of evidence against their perverted views of the world.

Without these weak minded followers, blindly accepting everything they represent, there would be no dictators, nor the likes of Jim Jones, David Koresh, L. Ron Hubbard, Charles Manson or Sayer Ji.

 

The latter ,with his hatred of modern medicine, including vaccinations, is particularly dangerous because he targets the idiot parents of vulnerable children.   

[lungnorm]

2 hours ago, stevenl said:

Now that's not so difficult, is it, and good webpractise: quote a site, mention the source. But I understand why you didn't do that here.

Wiki has some things to say about that site, e.g.: the truest statement on the website is the disclaimer.

That site should imo be classed as fake news.

Sent from my ROBBY using Thaivisa Connect mobile app

I learned a very long time ago Wiki cannot be trusted either.

[lungnorm]

1 hour ago, Old Croc said:

Some people go through life trusting every liar, fraudster, cult leader and sociopath who comes along.

They soak up, and believe, every twisted theory, lie and promise these flawed individuals serve up to them despite there being massive weight of evidence against their perverted views of the world.

Without these weak minded followers, blindly accepting everything they represent, there would be no dictators, nor the likes of Jim Jones, David Koresh, L. Ron Hubbard, Charles Manson or Sayer Ji.

 

The latter ,with his hatred of modern medicine, including vaccinations, is particularly dangerous because he targets the idiot parents of vulnerable children.   

If you think Sayer Ji is in the same class as Charles Manson, You must be in the same class as Noddy.

[stevenl]

2 hours ago, lungnorm said:

You cannot go through life not trusting anybody. 

Agree, I trust many people. But those behind that website and believers are not among them regarding this subject.

[stevenl]

42 minutes ago, lungnorm said:

I learned a very long time ago Wiki cannot be trusted either.

Not 100%, agree again. But it can make one think, which is not positive for the site you're referring to.

[ezrider62]

On 1/20/2017 at 5:51 PM, sawadee1947 said:

...so the poor can still enjoy the fever?

 

This is the funniest thing I've heard all day! Thank you!

[Felt 35]

The first dengue vaccine, Dengvaxia (CYD-TDV) by Sanofi Pasteur, was first licensed in December, 2015, in Mexico. It has been registered for use in individuals 9-45 years of age living in endemic areas. CYD-TDV is a live recombinant tetravalent vaccine based on the yellow fever 17d backbone and is registered as a 3-dose vaccine given on a 0/6/12 month schedule. Several other vaccine candidates are in clinical or pre-clinical development.

WHO recommends prevention of dengue through vector control methods such as mosquito habitat removal and use of insecticides. WHO recommends that countries should consider introduction of the dengue vaccine CYD-TDV only in geographic settings (national or subnational) where epidemiological data indicate a high burden of disease.

The development of a safe and effective dengue vaccine is a high priority and WHO supports this effort through technical guidance and advice

 

http://www.who.int/immunization/diseases/dengue/en/

 

http://www.who.int/immunization/research/development/dengue_q_and_a/en/

 

Questions and Answers on Dengue Vaccines

What is the current status of dengue vaccine development?

There is a growing public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. A safe, effective and affordable dengue vaccine against the four strains would represent a major advance for the control of the disease and could be an important tool for reaching the WHO goal of reducing dengue morbidity by at least 25% and mortality by at least 50% by 2020. One dengue vaccine has been licensed, Dengvaxia® (CYD-TDV), developed by Sanofi Pasteur. Approximately five additional dengue vaccine candidates are in clinical development, with two candidates (developed by Butantan and Takeda) expected to begin Phase III trials in early 2016.

What is Dengvaxia® (CYD-TDV)?

CYD-TDV is the first dengue vaccine to be licensed. It was first licensed in Mexico in December 2015 for use in individuals 9-45 years of age living in endemic areas. CYD-TDV is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur (CYD-TDV), given as a 3-dose series on a 0/6/12 month schedule.

What are the results from the Phase 3 trials?

CYD-TDV has been evaluated in two Phase 3 clinical trials (CYD14 in five countries in Asia and CYD15 in five countries in Latin America). Together, these trials included over 35,000 participants aged 2 to 16 years: ages at first vaccination were 2 to 14 years in CYD14, 9 to 16 years in CYD15. In each of these trials, participants were randomized to vaccine and placebo in a 2:1 ratio. The study protocols included an active phase of follow-up for one year after the last dose of vaccine in the series (25 months from dose 1) and include a hospital-based follow-up period of four additional years, which is ongoing.

Results have been published for each trial separately, as well as pooled. Trial results include children aged <9 years old, which is an age group that is not included in the current indication. This is due to results that were observed during the Phase 3 trials in the youngest age group in the CYD14 Phase 3 trial.

Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series (per protocol analysis). During this initial time period, pooled vaccine efficacy against severe dengue was 79.1%. Efficacy varied by serotype: vaccine efficacy was higher against serotypes 3 and 4 (71.6% and 76.9%, respectively) than for serotypes 1 and 2 (54.7% and 43.0%). Vaccine efficacy also varied by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).

When limited to older age groups (ages included in the current licensure), pooled vaccine efficacy amongst all participants aged 9 years or over was 65.6%, and in participants aged <9 years it was 44%.

Within the randomized subset of participants for whom pre-vaccination blood samples were collected, pooled vaccine efficacy against VCD in those seropositive for a prior exposure to dengue virus was 78.2%, while in those seronegative at baseline it was 38.1% (not statistically significant). In a post-hoc analysis in those ≥9 years of age, vaccine efficacy in those seronegative at baseline was 52.5% (95% CI 5.9%, 76.1%).

While efficacy was reported against hospitalized and severe dengue in Years 1 and 2 post-dose 1, an excess of cases of hospitalized and severe dengue cases in those receiving CYD-TDV was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. The excess was mostly observed in those vaccinated aged 2-5 years in CYD14 in Asia, for which the relative risk of hospitalized dengue in vaccinees was 7.45 (95% CI 1.15, 313.80) in Year 3, based on 15 cases in the CYD-TDV group and 1 case in the control group. This younger age group has not been included in the age indication of the vaccine. No safety signals were reported in the older age groups.

What are WHO’s recommendations related to CYD-TDV?

WHO recommends that countries should consider introduction of the dengue vaccine CYD-TDV only in geographic settings (national or subnational) where epidemiological data indicate a high burden of disease. Complete recommendations may be found in the WHO position paper on dengue vaccines.

WHO position paper on dengue vaccines
pdf, 437kb

Has the vaccine been prequalified by WHO?

CYD-TDV is currently not prequalified. Prequalification requires an NRA of record, which is typically the NRA in the manufacturing country (in this case, EMA). WHO is awaiting a submission of an application from the manufacturer for prequalification of this vaccine.

[lungnorm]

8 minutes ago, Felt 35 said:

The first dengue vaccine, Dengvaxia (CYD-TDV) by Sanofi Pasteur, was first licensed in December, 2015, in Mexico. It has been registered for use in individuals 9-45 years of age living in endemic areas. CYD-TDV is a live recombinant tetravalent vaccine based on the yellow fever 17d backbone and is registered as a 3-dose vaccine given on a 0/6/12 month schedule. Several other vaccine candidates are in clinical or pre-clinical development.

WHO recommends prevention of dengue through vector control methods such as mosquito habitat removal and use of insecticides. WHO recommends that countries should consider introduction of the dengue vaccine CYD-TDV only in geographic settings (national or subnational) where epidemiological data indicate a high burden of disease.

The development of a safe and effective dengue vaccine is a high priority and WHO supports this effort through technical guidance and advice

 

http://www.who.int/immunization/diseases/dengue/en/

 

http://www.who.int/immunization/research/development/dengue_q_and_a/en/

 

Questions and Answers on Dengue Vaccines

What is the current status of dengue vaccine development?

There is a growing public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. A safe, effective and affordable dengue vaccine against the four strains would represent a major advance for the control of the disease and could be an important tool for reaching the WHO goal of reducing dengue morbidity by at least 25% and mortality by at least 50% by 2020. One dengue vaccine has been licensed, Dengvaxia® (CYD-TDV), developed by Sanofi Pasteur. Approximately five additional dengue vaccine candidates are in clinical development, with two candidates (developed by Butantan and Takeda) expected to begin Phase III trials in early 2016.

What is Dengvaxia® (CYD-TDV)?

CYD-TDV is the first dengue vaccine to be licensed. It was first licensed in Mexico in December 2015 for use in individuals 9-45 years of age living in endemic areas. CYD-TDV is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur (CYD-TDV), given as a 3-dose series on a 0/6/12 month schedule.

What are the results from the Phase 3 trials?

CYD-TDV has been evaluated in two Phase 3 clinical trials (CYD14 in five countries in Asia and CYD15 in five countries in Latin America). Together, these trials included over 35,000 participants aged 2 to 16 years: ages at first vaccination were 2 to 14 years in CYD14, 9 to 16 years in CYD15. In each of these trials, participants were randomized to vaccine and placebo in a 2:1 ratio. The study protocols included an active phase of follow-up for one year after the last dose of vaccine in the series (25 months from dose 1) and include a hospital-based follow-up period of four additional years, which is ongoing.

Results have been published for each trial separately, as well as pooled. Trial results include children aged <9 years old, which is an age group that is not included in the current indication. This is due to results that were observed during the Phase 3 trials in the youngest age group in the CYD14 Phase 3 trial.

Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series (per protocol analysis). During this initial time period, pooled vaccine efficacy against severe dengue was 79.1%. Efficacy varied by serotype: vaccine efficacy was higher against serotypes 3 and 4 (71.6% and 76.9%, respectively) than for serotypes 1 and 2 (54.7% and 43.0%). Vaccine efficacy also varied by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).

When limited to older age groups (ages included in the current licensure), pooled vaccine efficacy amongst all participants aged 9 years or over was 65.6%, and in participants aged <9 years it was 44%.

Within the randomized subset of participants for whom pre-vaccination blood samples were collected, pooled vaccine efficacy against VCD in those seropositive for a prior exposure to dengue virus was 78.2%, while in those seronegative at baseline it was 38.1% (not statistically significant). In a post-hoc analysis in those ≥9 years of age, vaccine efficacy in those seronegative at baseline was 52.5% (95% CI 5.9%, 76.1%).

While efficacy was reported against hospitalized and severe dengue in Years 1 and 2 post-dose 1, an excess of cases of hospitalized and severe dengue cases in those receiving CYD-TDV was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. The excess was mostly observed in those vaccinated aged 2-5 years in CYD14 in Asia, for which the relative risk of hospitalized dengue in vaccinees was 7.45 (95% CI 1.15, 313.80) in Year 3, based on 15 cases in the CYD-TDV group and 1 case in the control group. This younger age group has not been included in the age indication of the vaccine. No safety signals were reported in the older age groups.

What are WHO’s recommendations related to CYD-TDV?

WHO recommends that countries should consider introduction of the dengue vaccine CYD-TDV only in geographic settings (national or subnational) where epidemiological data indicate a high burden of disease. Complete recommendations may be found in the WHO position paper on dengue vaccines.

WHO position paper on dengue vaccines
pdf, 437kb

Has the vaccine been prequalified by WHO?

CYD-TDV is currently not prequalified. Prequalification requires an NRA of record, which is typically the NRA in the manufacturing country (in this case, EMA). WHO is awaiting a submission of an application from the manufacturer for prequalification of this vaccine.

Typical of all vaccines. Being released before they are proven effective and safe.