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Showing posts with label vaccination. Show all posts
Showing posts with label vaccination. Show all posts

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.

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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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Friday, December 01, 2017

About 10% Out Of Over 700,000 Filipino Youth At Risk Due To Anti-dengue Vaccine?

About 700,000 youth is now at risk after the manufacturer of an anti-dengue vaccine said that using the medicine with people who did not previously infected with the virus could cause severe diseases. Sanofi, the manufacturer of the anti-dengue vaccine Dengvaxia which was first approved in the Philippines disclosed the result of their research that the vaccine is only effective with people who were previously infected by the deadly virus. However , using it with those who were not infected by the disease could seriously harm them. Sponsored Links The vaccination program was facilitated by then Department Of Health head Janette Garin using the P3.8B budget allocated by the administration of former president Benigno Aquino, III. The program was continued by Health Secretary Pauleen Ubial. Recently, after the statement from Sanofi, Health Secretary Francisco Duque halted the vaccination until further recommendation by the World Health Organization which is expected to come out by the second week of December. Advertisement However, the vaccine was approved by the World Health Organization before it was implemented by DOH in the Philippines. Former Health Secretary Garin said that the implementation of the vaccine is also based on WHO recommendation and this has been followed in other countries who are using the same vaccine against the deadly dengue virus. The dengue vaccine experiment was completed after 3 years of intensive tests. The Department of Health was among those which secured the vaccines which needed three consecutive shots for full immunization. Meanwhile, Senator richard Gordon said that the Senate Blue Ribbon Committee will revive the investigation regarding the DOH purchase of the controversial vaccine after its manufacturer disclosed about the possible health risk of Dengvaxia to those who had received the vaccine without being infected before by the virus. In September 2016, the committee conducted a hearing about the alleged "midnight deal" involving the purchase of the medicine during the Aquino administration in spite that the vaccine is still undergoing tests and yet to be guaranteed to be safe. Gordon warned the agency but the former administration still pushed on experimenting and gave the vaccine to initially 280,000 children. According to Senator Gordon's timeline, it is pointed out that: —On November 14, the DOH considered the national vaccination program followed by a documentation on July 2015. —December 2, 2015, former President Aquino had a meeting with Sanofi while he attended the Climate Change Summit in France followed by the approval for the vaccine by the Bureau of Food and Drugs (BFAD)on December 2015. — December 29, 2015, the Department of Budget and Management has released a sum of P3.5 billion from the government savings, hence, it doesn't went through the Congress. Gordon said that the government indeed swiftly acted to prevent Filipino children from being affected by the deadly dengue but it should also carefully consider that hastening the administering of the vaccine, which at that time lacks the assurance of its safety, could put their health at risk. Sanofi studies revealed that the vaccine is only effective to those who were already infected by dengue before being injected with the vaccine, otherwise, it could cause severe diseases. Read More: ©2017 THOUGHTSKOTO

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About 10% of the 700,000 Filipino youth is now at risk after the manufacturer of an anti-dengue vaccine said that using the medicine with people who did not previously infected with the virus could cause severe diseases.
Sanofi, the manufacturer of the anti-dengue vaccine Dengvaxia which was first approved in the Philippines disclosed the result of their research that the vaccine is only effective with people who were previously infected by the deadly virus. However , using it with those who were not infected by the disease could seriously harm them.
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The vaccination program was facilitated by then Department Of Health head Janette Garin using the P3.8B  budget allocated by the administration of former president Benigno Aquino, III. The program was continued by Health Secretary Pauleen Ubial. Recently, after the statement from Sanofi, Health Secretary Francisco Duque halted the vaccination until further recommendation by the World Health Organization which is expected to come out by the second week of December.





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However, the vaccine was approved by the World Health Organization before it was implemented by DOH in the Philippines. Former Health Secretary Garin said that the implementation of the vaccine is also based on WHO recommendation and this has been followed in other countries who are using the same vaccine against the deadly dengue virus.
The dengue vaccine experiment was completed after 3 years of intensive tests. The Department of Health was among those which secured the vaccines which needed three consecutive shots for full immunization.

Meanwhile, Senator richard Gordon said that the Senate Blue Ribbon Committee will revive the investigation regarding the DOH purchase of the controversial vaccine after its manufacturer disclosed about the possible health risk of Dengvaxia to those who had received the vaccine without being infected before by the virus.

In September 2016, the committee conducted a hearing about the alleged "midnight deal" involving the purchase of the medicine during the  Aquino administration in spite that the vaccine is still undergoing tests and yet to be guaranteed to be safe.
Gordon warned the agency but the former administration still pushed on experimenting and gave the vaccine to initially 280,000 children.
According to Senator Gordon's timeline, it is pointed out that:
 —On November 14, the DOH considered the national vaccination program followed by a documentation on July 2015.

—December 2, 2015, former President Aquino had a meeting with Sanofi while he attended  the Climate Change Summit in France followed by the approval for the vaccine by the Bureau of Food and Drugs (BFAD) on December 2015.
— December 29, 2015, the Department of Budget and Management has released a sum of P3.5 billion from the government savings, hence, it doesn't went through the Congress.
Gordon said that the government indeed swiftly acted to prevent Filipino children from being affected by the deadly dengue but it should also carefully consider that hastening the administering of the vaccine, which at that time lacks the assurance of its safety, could put their health at risk.
Sanofi studies revealed that the vaccine is only effective to those who were already infected by dengue before being injected with the vaccine, otherwise, it could cause severe diseases.

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.
Update*
 According to Health Secretary Duque, the extent of the possible damage among those who had the anti-dengue vaccine Dengvaxia is about 10% translated to about 70,000 children out of the total 733,713 from different parts of the country.
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