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Showing posts with label DEPARTMENT OF HEALTH. Show all posts
Showing posts with label DEPARTMENT OF HEALTH. Show all posts

Thursday, October 07, 2021

Bakunado kana ba laban sa Covid-19? Sumali sa Bakunado Panalo Raffle ng DOH at Manalo ng P1M!




MANILA, Philippines — UPANG mahikayat ang karamihan na magpabakuna laban sa coronavirus disease o Covid-19, hindi ngayon nagpahuli ang Department of Health o DOH sa mga pakulo gaya ng ginagawa ng ibang bansa.

Sa post ng DOH sa Facebook page nito, nakalagay na may tsansang manalo ang bakunadong individual mula P100,000 hanggang P1 million na cash sa “Resbakuna Bakunado Panalo” program.

Isang daang winner ang pipilin mula Oktubre hanggang Disyembre habang P1 million naman ang cash prize sa grand draw na gagawin bago matapos ang taon.
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Narito ang guidelines ng nabanggit na raffle:

Ano ang bakunado plano?
  • Ang Bakunado Panalo ay isang raffle na bukas sa mga Pilipinos nagpabakuna kontra-COVID-19.
Sinu-sinu ang pwedeng sumali at manalo?
  • Isa itong nationwide raffle. Lahat nang nabakunahan na 18 na taon pataas ay maaring sumali. Ang mga sumusunod ay hindi maaaring sumali sa raffle:

  • Kamag-anak ng mga tauhang kabilang sa nag-organisa ng raffle;

  • Mga opisyal ng gobyerno, mula nasyonal hanggan sa nibel ng barangay;
Paano sumali? Hanggang kailan pwedeng sumali?
  • Para makasali sa raffle, kailangan niyo munang mag-register. I-text ang RESBAKUNAREG <space> NAME/AGE/ADDRESS to 8933 para mag-register. (Hal. RESBAKUNAREG Juan Dela Cruz/45/Blk 6 Lot 18 Golden Subd. Pasig City)

  • Pagkatapos mag-register, pwede kayong kumuha ng raffle entry sa pamamagitan ng pagtetext ng RESBAKUNA <space> 1st letter ng vax brand/pang-ilang dose/LGU/date ng bakuna to 8933. (Hal. RESBAKUNA M/2/Pasig City/March 5, 2021)

  • Pwedeng sumali mula October 4, 2021 hanggang December 15, 2021. Magpabakuna para dumami ang pagkakataong manalo!
May bayad po ba para sumali sa raffle?
  • Ang bawat entry sa e-raffle ay PHP 1.00 ng cellphone load lamang.
Ilang raffle entry ang matatanggap ko kapag nagpabakuna?
  • Makakatanggap ng 1 raffle entry ang lahat ng may isang dose, at 3 entry kung fully vaccinated na ang isang indibidwal.

  • Para sa seniors, doble ang matatanggap na raffle entry sa kanilang pagpapabakuna.

  • Makakatanggap ng 1 raffle entry ang lahat ng may isang dose, at 3 entry kung fully vaccinated na ang isang indibidwal.

  • Para sa seniors, doble ang matatanggap na raffle entry sa kanilang pagpapabakuna.
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Dapat ba nakakumpleto na ng bakuna para makasali? Pwede bang sumali kahit nakaka-isang dole pa lamang ng bakuna?
  • Maaaring sumali kahit isang dose pa lamang ang iyong bakuna. Siguraduhing kumpletuhin mo ang iyong ikalawang dose para mas maraming pagkakataong manalo!
Ilang tao ang pwedeng gumamit ng iisang cellphone number?
  • Isang pangalan lang po ang pwedeng nakarehistro kada-cellphone number o SIM card.
Pwede bang sumali ang mga senior citizen sa raffle?
  • Pwede sumali ang mga senior sa raffle. Ang mga Senior ay makakakuha ng dobleng entry sa kanilang pagsali.
Anu ano ang mga premyo na pwedeng mapanalunan?
  • Para sa buwan ng Oktubre and Nobyembre, mayroong 50 na mananalo ng PHP 5,000.
  • Sa grand draw sa Disyembre:
10 ang mananalo ng PHP 100,000,
1 ang mananalo ng PHP 500,000,
1 ang mananalo ng PHP 1,000,000

Paao pipilian ang mga mananalo?
  • Gagamit ng isang e-raffle system kung saan isasalang ang bawat raffle entry.
Kailan magaganap ang bawat draw sa e-raffle?
  • Ang resulta ng bawat raffle draw ay ilalabas sa katapusan ng bawat buwan.
Paano ko malalaman kung ako ang nanalo?
  • Hintayin ang tawag mula sa 8933 para malaman kung nanalo ka!

  • Maliban sa tawag, ipopost din ang pangalan mo sa DOH website (doh.gov.ph/vaccine) at sa lahat ng DOH platforms.
Paano ko makukuha ang aking premyo?
  • Ang premyo ay ipamimigay sa pamamagitan ng mga e-wallet.
Paano ko mapapatunayan na ako ay bakunado?
  • Kapag mananalo, kayo ay aming tatawagan. Kailangan lamang i-submit ang mga sumusunod:
Valid ID
Vaccination card
SIM card na ginamit sa pag-submit ng raffle entry

Paano iaannounce ang mga mananalo?
  • Maliban sa text, ipopost din ang pangalan mo sa DOH website (doh.gov.ph/vaccine) at sa lahat ng DOH platforms.
Paano ko malalaman kung ilang raffle entry ang meron ako?
  • I-text lamang ang RESBAKUNA<space>CHECK sa 8933.
Paano kung may katanungan pa ako tungkol sa raffle?
  • I-text lamang ang RESBAKUNA<space>HELP sa 8933.



©2020 THOUGHTSKOTO

Friday, January 15, 2021

Mga tatanggi sa Covid-19 vaccine na ibibigay ng gobyerno, ilalagay sa ‘bottom list’ ayon sa DOH





MANILA — KINUMPERMA ngayon ng Department of Health o DOH na ilalagay sa pinaka-huling listahan ng mga recipients ang sinomang Pinoy na tatanggi sa bakuna laban sa Covid-19 na ibibigay ng gobyerno.

Ayon kay Health Undersecretary Maria Rosario Vergeire, malayang pumili ang mga Pinoy ng brand ng Covid-19 vaccines na gusto ng mga ito, ngunit paalala niya, nasa state of public health emergency pa rin ang bansa.

“Ang napag-usapan, kung kayo po ay tatanggi, we will have to put you at the bottom of the list and we will give it to the next person in line as part of our priority. Hindi po natin ipipilit, very simple consent actually kaya nga lang po, mawawala ang chance niyo,” 

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“You would go to the bottom of the line and the next time na puwede na kayo uli magpabakuna ay yan po kapag pagdating ng susunod ng delivery at kapag tapos na po ang sektor na kabilang po kayo,” ang bahagi ng pahayag ni Vergeire.

Nilinaw ni Vergeire na naiintindihan ng DOH ang mga rason kung bakit gusto ng mga Pinoy na pumili ng kanilang bakuna.

Sinabi din ng opisyal na hindi rin maaaring mag-demand ang sinomang Pinoy na unang tumanggi sa bakuna na mailagay ito sa priority list sa susunod na batch ng mga bakuna na ipapadala sa bansa.

“Kaya lang hindi po namin kayo puwede ilagay na… dumating yung another vaccine, kayo na ang priority, hindi po, hindi po ganun ang mangyayari. Uunahin natin yung iba pa pong priority population natin,” 

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Town Hall on COVID - 19 Vaccine Deployment Plan

ATM: DOH spearheads Town Hall on COVID - 19 Vaccine Deployment Plan for MDs and Allied Healthcare Professionals #BeatCOVID19 #BIDASolusyon #ExplainExplainExplain #COVID19Vaccines #COVID19PH #WeHealAsOne

Posted by Department of Health (Philippines) on Wednesday, January 13, 2021

 

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“Hindi namin sinasabi na diretsahan na hindi ka puwede mamili kasi may informed consent naman po kayo, you will have to give us the consent kung gusto niyo yung bakuna or hindi.” dagdag na pahayag ni Vergeire.

Sa survery na isinagawa ng Pulse Asia noong 2020, 47 porsyento sa mga Filipinos ang nagpahayag na hindi sila magpapabakuna laban sa Covid-19 dahil sa safety concerns.

Nasa 25 million dose na ng bakuna laban sa Covid-19 ang na-secure ng Pilipinas mula sa Sinovac Biotech ng China habang 30 million dose naman sa Serum Institute ng India.

Sinabi din ng Malacanang na posibleng makatanggap din ng paunang batch ng bakuna mula sa SU-based Pfizer at Russia's Gamaleya Institute sa Pebrero ang Pilipinas.

©2020 THOUGHTSKOTO

Saturday, September 12, 2020

Paalala ng DOH: 'Wag Pigiling Lumabas ng Ospital ang mga Pasyenteng 'Di Makakabayad ng Bill




DAHIL sa krisis dulot ng coronavirus 2019 o Covid-19, mas nagiging mahirap ang buhay ng mga tao, lalo na ng mga mahihirap. Dahil dito, muling pina-alalahanan ngayon ng Department of Health o DOH ang mga ospital sa buong bansa na hindi nila maaring pigilin ang paglabas ng isang pasyente na kulang ang pambayad o wala pang maipambayad sa kanilang hospital bills.

Sa isang panayam, inihayag ni Health Undersecretary Maria Rosario Vergeire na bawal ang hospital dentention sa ilalim ng Republic Act 9439 o Anti-Hospital Detention Act.


Sa ilalim ng Republic Act 9349, maaring pagmultahin ng hanggang P50, o kaya ay makulong ng hanggang anim na buwan ang sinumang opisyal o empleyado ng isang medical facility na mapapatunayang nanggipit ng isang pasyenteng hindi kayang barayan ang hospital bill. 

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Una rito nakatanggap ang DOH ng mga impormasyon ukol sa isang pribadong ospital na nag-detain ng isang pasyente na walang maibayad sa kanyang hospital bill.

Sa kabila nito, nilinaw ni Vergeire na obligado pa rin ang pasyenteng magbayad ng kanilang bill kung kaya't kinakailangan nitong mag-iwan ng dokumento o identification card sa ospital upang matiyak na hindi nila tatakbuhan ang kanilang obligasyon.


“Bawal po tayo mag-detain ng ating pasyente because they cannot pay as of this time. Alam niyo naman ang mga ospital ay entities din po ang mga ito na gumagastos and they need din po na mabayaran sila,” ang pahayag ni Vergeire.

“Although hindi tamang nagde-detain ng pasyente pero kailangan ang pasyente o ang pamilya ay makapag-iwan ng katunayan na babalik ka,” dagdag pa niya.
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Ang maaari aniyang gawin ng pasyente ay gumawa ng sulat o promissory note para sa pagsasa-ayos ng bayarin. “They can leave a promissory note with the promise of course that they can pay in installment kung kailangan,” ani Vergeire.

Hindi rin umano maaring i-refer ang isang pasyente o kaanak nito sa isang lending facility para makakuha ng loan na pambayad sa ospital.
“It is also not a good practice that hospitals will be directing patients to lending facilities and all. Ang kailangan lang po that is acceptable, humihinigi lang po sila ng ID na iiwanan nila or something than can be tracked pa rin ang pasyente,” dagdag pa niya.


Paalala rin ng DOH na dapat maayos ang usapan at walang magigipit sa ganitong sitwasyon.

“It is an internal arrangement between the hospitals and patients. Una, kailangan din natin intindihin ang side ng hospital mayroon kasing naiwan na pera na hindi mababayaran,” ani Vergeire.

Kung nakaranas ng panggigipit sa mga ospital, maaaring maghain ng reklamo sa Health Facilities and Services Regulatory Bureau ng DOH upang maimbestigahan ang isyu.


Nangyayari ang hospital detention sa mga sumusunod na sitwasyon:

  • The patient who is partially or fully recovered has expressed his/ her intention to leave the hospital or medical clinic, or the attending physician has issued a discharge order
  • The patient is not confined in a private room and is financially incapable to settle in part or in full the corresponding hospital bills or medical expenses/ hospitalization expenses
  • Patient has executed a promissory note covering the unpaid hospital bills or medical expenses/ hospitalization expenses
  • The officer or employee of the hospital or medical clinic responsible for releasing the patient has restrained him from leaving the hospital premises.
Ano ang penalty sa mga lalabag?

Mapaparusahan ng multang hindi bababa sa P20,000 ngunit hindi naman hihigit sa P50,000 ang sinomang opisyal o empleyado ng ospital o medical clinic na responsable sa pagpapalabas ng mga pasyente sakaling mapatunayang nilabag nito ang Republic Act No. 9439.
Maliban sa multa, maari din itong makulong mula isa hanggang anim na buwan.


©2020 THOUGHTSKOTO

Sunday, February 02, 2020

Breaking: DOH confirms first nCoV death in PH

The Department of Health (DOH) reported on Sunday, February 2, the death of the first novel coronavirus (nCoV) patient in the country.
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In a press conference, health officials confirmed that the 44-year-old male died on Saturday, February 1, 2020, saying that he developed severe pneumonia aver the course of his admission. While the patient was stable and showed signs of improvement in his last few days, his condition deteriorated within his last 24 hours resulting in his demise.

It was disclosed that the country recorded two confirmed cases in the Philippines: a 38-year-old Chinese female and her companion, a 44-year-old Chinese male. Both patients are from Wuhan, China and arrived in the Philippines via Hong Kong last January 21. They were both admitted for isolation and supportive treatment at the San Lazaro Hospital in Sta. Cruz, Manila.
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“We are currently working with the Chinese Embassy to ensure the dignified management of the remains according to national and international standards to contain the disease,” Health Secretary Francisco Duque III assured, telling the public that all measures needed to contain the spread of the virus is being strictly implemented and followed. 

Moreover, San Lazaro Hospital has implemented rigorous infection control protocols while caring for these patients. Both patients were isolated following strict isolation standards, and all health personnel who came in contact with them practiced stringent infection control measures and wore appropriate personal protective equipment, it was noted.

Meanwhile, the DOH's Epidemiology Bureau (EB) is urrently conducting contact tracing of passengers aboard the flights of the two positive cases. EB has secured the manifestos of the flights and is in close coordination with the concerned airlines. Contact tracing activities are ongoing in Cebu and Dumaguete, and in other places where the patients stayed and traveled to.

“The Philippine Government has already implemented a temporary travel ban for travelers coming from China, Macao, and Hong Kong. DOH is monitoring every development on the 2019-nCoV very closely and is taking proactive measures to contain the spread of this virus in our country. This health event is fast-evolving and fluid. We are continuously recalibrating our plans and efforts as the situation develops,” Duque said.

“We are providing the public with constant updates and advisories as frequently as possible, so all I ask from the public now is to heed the advisories from official DOH channels and to refrain from sharing unverified and unvalidated information. I assure the public that we will keep you abreast of any information that we have,” he added.
Related news:


©2019 THOUGHTSKOTO

Saturday, December 02, 2017

Did Your Child Had A Shot? WHO and DOH Answers Questions Regarding The Controversial Vaccine

In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur.  What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization.  What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).  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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings.  What is WHO’s current position on the use of Dengvaxia®?  Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients.  Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus.  What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data?  WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;  WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.  Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.  What do these data mean for other dengue vaccines in clinical development?  A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More:  ©2017 THOUGHTSKOTO

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In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worries, the World Health Organization releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur.

 What is Dengvaxia®?
There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization.
In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur. What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization. What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination). 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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings. What is WHO’s current position on the use of Dengvaxia®? Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients. Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus. What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data? WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied; WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®. Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination. What do these data mean for other dengue vaccines in clinical development? A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More: ©2017 THOUGHTSKOTO
What was previously known about the licensed dengue vaccine, Dengvaxia®?
Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).

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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings.

What is WHO’s current position on the use of Dengvaxia®?

Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients.

Sponsored Links
What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®?
Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus.
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.
What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination?
While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination.
What is WHO’s interim interpretation of the data?

WHO’s interim interpretation of data is that:
—The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied;
—The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;

WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.

Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.

What do these data mean for other dengue vaccines in clinical development?

A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects.
Source: World Health Organization

Meanwhile, the Department of Health releases an infographics of the most frequently asked questions about the vaccine. The DOH assures every Filipinos that the situation is being closely monitored.

In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur.  What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization.  What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).  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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings.  What is WHO’s current position on the use of Dengvaxia®?  Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients.  Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus.  What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data?  WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;  WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.  Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.  What do these data mean for other dengue vaccines in clinical development?  A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More:  ©2017 THOUGHTSKOTO

In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur.  What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization.  What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).  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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings.  What is WHO’s current position on the use of Dengvaxia®?  Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients.  Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus.  What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data?  WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;  WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.  Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.  What do these data mean for other dengue vaccines in clinical development?  A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More:  ©2017 THOUGHTSKOTO

In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur.  What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization.  What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).  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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings.  What is WHO’s current position on the use of Dengvaxia®?  Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients.  Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus.  What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data?  WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;  WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.  Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.  What do these data mean for other dengue vaccines in clinical development?  A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More:  ©2017 THOUGHTSKOTO

In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur.  What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization.  What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).  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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings.  What is WHO’s current position on the use of Dengvaxia®?  Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients.  Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus.  What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data?  WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;  WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.  Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.  What do these data mean for other dengue vaccines in clinical development?  A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More:  ©2017 THOUGHTSKOTO

In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur.  What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization.  What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination).  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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings.  What is WHO’s current position on the use of Dengvaxia®?  Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients.  Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus.  What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data?  WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied;  WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®.  Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination.  What do these data mean for other dengue vaccines in clinical development?  A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More:  ©2017 THOUGHTSKOTO


In the midst of Filipino parents with kids already vaccinated with the controversial anti-dengue shots worry, the World Health Organization Releases their stand and answers questions about Dengvaxia. Over 7000,000 had been vaccinated since the nationwide vaccination commenced and the Department of Health that about 10% of them were not infected by the virus prior to the vaccination putting them at risk of having "severe diseases" as to the statement of the vaccine manufacturer Sanofi Pasteur. What is Dengvaxia®? There continues to be a strong public health need for effective preventive interventions against dengue, a disease caused by four viruses, termed serotypes 1-4. One dengue vaccine has been licensed, Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur. Dengvaxia® is a live recombinant tetravalent dengue vaccine developed by Sanofi Pasteur, given as a 3-dose series on a 0/6/12 month schedule. Dengvaxia® is the first dengue vaccine to be licensed and has now been approved by 19 regulatory authorities for use in endemic areas in persons typically ranging from 9-45 (in some countries 9-60) years of age. It has been introduced in two subnational programs in the Philippines and Brazil targeting about one million individuals. It is otherwise available on the private market in countries where there is a marketing authorization. What was previously known about the licensed dengue vaccine, Dengvaxia®? Dengvaxia® has been evaluated in two Phase 3 clinical trials (CYD14 trial in five countries in Asia and CYD15 trial in five countries in Latin America). Together, these trials included over 30,000 participants aged 2 to 16 years. Vaccine efficacy against confirmed dengue pooled across both trials was 59.2% in the year following the primary series, and 79.1% against severe dengue. Efficacy varied by serotype, by age at vaccination and serostatus at baseline (i.e., previous exposure to dengue prior to vaccination). 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 Dengvaxia® was seen in Year 3 in some subgroups, although it is based on relatively small numbers of cases. Whether the increased risk was due to age or serostatus at baseline, which is highly correlated with age, could not be fully clarified with the available data at the time. For subjects aged 9 and above, in the first 25 months of the phase 3 trials, there was a reduction in severe dengue by 93% and a reduction in hospitalizations by 81%. Owing to the higher efficacy among participants vaccinated at age ≥9 years, as well as an elevated risk of hospitalized dengue in the 2–5-year age group, licensure was obtained in several countries to date for those aged 9–45 or 9–60 years living in dengue-endemic settings. What is WHO’s current position on the use of Dengvaxia®? Following recommendations made by the Strategic Advisory Group of Experts (SAGE) on immunization, WHO’s advisory body on vaccination, a position paper was published in July 2016 based on the data available at that time. The position paper makes a conditional recommendation on the use of the vaccine for highly endemic areas. Based on considerations of superior efficacy and, possibly, safety and duration of protection in seropositive individuals, SAGE recommended seroprevalence thresholds as the best population-level strategy. Based on mathematical modeling, an optimal seroprevalence in the age group targeted for vaccination was defined in the range of ≥70%. At that time theoretical elevated risk of dengue in vaccinated seronegative subjects was noted, and research into this was considered high priority. WHO thus called on Sanofi Pasteur to provide more data on efficacy and safety in baseline seronegative vaccine recipients. Sponsored Links What are the additional analyses on efficacy and safety in baseline seronegative persons who received Dengvaxia®? Because the Phase 3 trials did not collect blood samples from all participants to be able to determine serostatus at baseline, the company performed additional testing to infer serostatus at the time of vaccination. However, samples were available for all trial participants at month 13, one month after the 3rd dose was administered. These samples were tested using an assay that identifies antibodies against the dengue non-structural protein 1 (NS1) based on the fact that the Dengvaxia® non-structural proteins code for Yellow Fever vaccine proteins, rather than for dengue. This allows differentiation between previous natural exposure to dengue and vaccination. Based on this test, Sanofi Pasteur reanalyzed the trial data stratified by seronegative and seropositive subjects to estimate the safety and efficacy of the vaccine by baseline serostatus. What are the preliminary results from the recent analysis of vaccine safety in persons seronegative to dengue prior to vaccination? While vaccinated trial participants overall had a reduced risk of virologically-confirmed severe dengue and hospitalizations due to dengue, the subset of trial participants who had not been exposed to dengue virus infection prior to vaccination had a higher risk of more severe dengue and hospitalizations due to dengue compared to unvaccinated participants, regardless of age. This increased risk was observed after an initial protective period and persisted over the observation period of up to 66 months post primary vaccination. What is WHO’s interim interpretation of the data? WHO’s interim interpretation of data is that: —The vaccine significantly protects against hospitalized and severe dengue in subjects seropositive for dengue at time of first vaccination in all age groups studied; —The risk of hospitalized and severe dengue is significantly increased among vaccinated subjects who were seronegative for dengue at the time of first vaccination in all age groups studied; WHO will conduct a full review of the data through the Global Advisory Committee on Vaccine Safety and SAGE, for revised guidance of the use of Dengvaxia®. Pending the full review of the data, as a precautionary and interim measure, WHO recommends that Dengvaxia® is only administered to subjects that are known to have been infected with dengue prior to vaccination. What do these data mean for other dengue vaccines in clinical development? A more detailed analysis of the data is needed to answer this question. The two candidate vaccines in phase 3 clinical development differ significantly from Dengvaxia®, so that no conclusions on the safety and efficacy profile of these candidates should yet be drawn. However, it will be necessary to carefully monitor vaccine performance over time in both seronegative and seropositive subjects. Source: World Health Organization Advertisement Read More: ©2017 THOUGHTSKOTO

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