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Marie-paule Kieny - One of the best experts on this subject based on the ideXlab platform.

  • global production capacity of seasonal Influenza Vaccine in 2011
    Vaccine, 2013
    Co-Authors: Jeffrey Partridge, Marie-paule Kieny
    Abstract:

    The effectiveness of Vaccines to mitigate the impact of annual seasonal Influenza epidemics and Influenza pandemics has been well documented. However, the steady increase in global capacity to produce annual seasonal Influenza Vaccine has not been matched with increased demand, and thus actual Vaccine production. Currently, without a significant increase in demand for seasonal Influenza Vaccine, global capacity will be far from able to meet even the essential needs for a monovalent Vaccine in the event of a severe Influenza pandemic. Global commitment to the development of Influenza Vaccine production capacity was renewed at a consultation leading to the Second Global Action Plan on Influenza Vaccines (GAP) in July 2011. To monitor progress on the GAP, the World Health Organization has carried out periodic surveys of Influenza Vaccine manufacturers. This latest survey compares current maximum global capacity and actual production of seasonal Influenza Vaccine in 2011 with data from surveys carried out in 2009 and 2010; analyses global Influenza production capacity in the context of sustainability; and discusses options to increase demand, based on strong evidence of public health benefit.

  • Technology transfer hub for pandemic Influenza Vaccine.
    Vaccine, 2008
    Co-Authors: Martin Friede, I. Serdobova, Laszlo Palkonyay, Marie-paule Kieny
    Abstract:

    Abstract Increase of Influenza Vaccine production capacity in developing countries has been identified as an important element of global pandemic preparedness. Nevertheless, technology transfer for Influenza Vaccine production to developing country Vaccine manufacturers has proven difficult because of lack of interested technology providers. As an alternative to an individual provider–recipient relationship, a technology and training platform (a “hub”) for a generic non-proprietary process was established at a public sector European manufacturer's site. The conditions for setting up such a platform and the potential applicability of this model to other biologicals are discussed.

Emmanuel B Walter - One of the best experts on this subject based on the ideXlab platform.

  • immunogenicity safety and consistency of new trivalent inactivated Influenza Vaccine
    Vaccine, 2008
    Co-Authors: Keipp H Talbot, Wendy A Keitel, Thomas R Cate, John J Treanor, James D Campbell, Rebecca C Brady, Irene Graham, Cornelia L Dekker, Patricia L Winokur, Emmanuel B Walter
    Abstract:

    To augment the available Influenza Vaccine supply, a phase III study was conducted to evaluate the immunogenicity, safety, and consistency of a new trivalent inactivated Influenza Vaccine manufactured by CSL Limited. Healthy adults (ages 18-64) were randomized to receive either a single dose of TIV from multi-dose vials with thimerosal, TIV from pre-filled syringes without thimerosal, or placebo. Of the TIV recipients, 97.8% achieved a post-vaccination titer > or =40 against H1N1, 99.9% against H3N2 component, and 94.2% against Influenza B. Few local or systemic adverse events were noted after vaccination with either TIV presentation. TIV was well tolerated and immunogenic.

  • immunization with trivalent inactivated Influenza Vaccine in partially immunized toddlers
    Pediatrics, 2006
    Co-Authors: Janet A Englund, Emmanuel B Walter, Adepeju Gbadebo, Arnold S Monto, Yuwei Zhu, Kathleen M Neuzil
    Abstract:

    OBJECTIVE. Children ≥6 months of age who have previously received 1 dose of trivalent inactivated Influenza Vaccine are recommended to be given an additional single trivalent inactivated Influenza Vaccine dose the following fall. Limited data exist documenting the immunogenicity of 2 doses of Influenza Vaccine given in separate years to young children, and it is not known if the antigen content of each of the 2 doses of Vaccine must be identical or similar to optimally immunize children in this age group. In 2004, the A/H3N2 and B antigens contained in trivalent inactivated Influenza Vaccine were changed from those in the 2003–2004 Influenza Vaccine, providing the opportunity to assess the effect of such a change on the single-dose recommendation in trivalent inactivated Influenza Vaccine-experienced toddlers. PATIENTS AND METHODS. We conducted an observational, nonrandomized, open-label study comparing immunogenicity and reactogenicity of 2 doses of trivalent inactivated Influenza Vaccine in 2 groups of healthy children aged 6 to 23 months. Children who had received 1 dose of 2003 trivalent inactivated Influenza Vaccine the previous season received 1 dose of 2004 trivalent inactivated Influenza Vaccine according to current guidelines (group 1). Trivalent inactivated Influenza Vaccine-naive toddlers received the standard 2 doses of 2004 trivalent inactivated Influenza Vaccine 1 month apart (group 2). Blood was obtained 4 weeks after the second dose of trivalent inactivated Influenza Vaccine. The primary outcome measure was antibody response to the 3 Vaccine antigens in the 2004 trivalent inactivated Influenza Vaccine after 2 doses of Vaccine, as determined by hemagglutination-inhibition antibody titers. Noninferiority of the antibody response was based on the proportion of subjects in each group achieving a titer of ≥1:32 postvaccination to antigens (H1N1, H3N2, and B) contained in the 2004–2005 Vaccine. For each antigen, the antibody response was proposed to be noninferior if the upper bound of the 95% confidence interval of the difference between the proportion of children in the 2 groups with postvaccination titers ≥1:32 was RESULTS. Fifty six of 58 previously immunized children (group 1) and 63 of 64 Vaccine-naive children (group 2) completed the study. The groups were similar, except group 1 was older at receipt of the second trivalent inactivated Influenza Vaccine. Reactogenicity did not differ by age or time between doses. Antibody responses to the unchanged Influenza A/H1N1 antigen at 4 weeks after the second trivalent inactivated Influenza Vaccine dose were similar in both groups, with good responses as measured by geometric mean titer (75.2 vs 69.1) and percentage with antibody titers ≥1:32 (82.1% group 1 vs 85.7% group 2). For the A/H3N2 antigen, which changed between 2003 and 2004, there was a significantly higher geometric mean titer in group 1 compared with group 2 (156 vs 53.7), but both groups had very high rates of seroconversion that were not statistically different (91% vs 84%). The antibody response to Influenza B was significantly lower in group 1 recipients, who received only a single dose of 2005 Vaccine, as measured by both geometric mean titer and percentage with antibody ≥1:32. The group 1 geometric mean titer was 13.8, and the group 2 geometric mean titer was 49.1. Only 27% of children in group 1 achieved antibody levels ≥1:32 to Influenza B compared with 86% in group 2. Using logistic regression, we also determined that older children had less potentially seroprotective levels to Influenza B. Overall, noninferiority of the antibody response for group 1 compared with group 2 was confirmed for Influenza A/H3N2, was marginally significant for A/H1N1, and was not confirmed for Influenza B. CONCLUSIONS. The assessment of immune responses in children after changes in Vaccine composition is important, because Influenza Vaccines change frequently, affecting not only antibody responses in partially immunized toddlers, but potentially immune responses in more fully immunized individuals. In this study, a change in 2 different Vaccine antigens enabled us to assess and compare the impact of the original priming antigens after relatively minor changes in 1 antigen (A/H3N2) or after considerable antigenic changes in another Vaccine antigen (B). Our subjects demonstrated relatively good responses to the Vaccine antigen change characterized by relatively minor changes (A/H3N2). Circulating virus may have primed infants in both groups to antigen more closely related to the 2004 Influenza A/H3N2 strain. The high A/H3N2 antibody response to the second dose of trivalent inactivated Influenza Vaccine in children who were immunized the previous fall with a different Vaccine is consistent with the fact that more children in group 1 were alive during this epidemic and, therefore, were more likely to have experienced priming with natural infection. In contrast, a decreased antibody response to the Influenza B antigen was seen in children primed with the earlier 2003 Vaccine, suggesting that the major change in B virus lineage in the 2004 Vaccine reduced the priming benefit of previous vaccination. Our findings are reminiscent of antibody responses in children seen after immunization with different but novel Influenza antigens, such as swine flu Vaccine (Influenza A/swine/1976/37-like virus). Our results should be taken into account when evaluating new Vaccines in young children for novel viruses, such as new pandemic strains of Influenza. The need for multiple doses of Vaccine to produce potentially protective antibody levels in children needs to be considered, even when Vaccine is in short supply.

Arnold S Monto - One of the best experts on this subject based on the ideXlab platform.

  • Influenza Vaccine effectiveness in the united states during the 2015 2016 season
    The New England Journal of Medicine, 2017
    Co-Authors: Michael L Jackson, Arnold S Monto, Jessie R Chung, Lisa A Jackson, Hallie C Phillips, Joyce Benoit, Emily T Martin, Edward A Belongia, Huong Q Mclean, Manjusha Gaglani
    Abstract:

    BackgroundThe A(H1N1)pdm09 virus strain used in the live attenuated Influenza Vaccine was changed for the 2015–2016 Influenza season because of its lack of effectiveness in young children in 2013–2014. The Influenza Vaccine Effectiveness Network evaluated the effect of this change as part of its estimates of Influenza Vaccine effectiveness in 2015–2016. MethodsWe enrolled patients 6 months of age or older who presented with acute respiratory illness at ambulatory care clinics in geographically diverse U.S. sites. Using a test-negative design, we estimated Vaccine effectiveness as (1−OR)×100, in which OR is the odds ratio for testing positive for Influenza virus among vaccinated versus unvaccinated participants. Separate estimates were calculated for the inactivated Vaccines and the live attenuated Vaccine. ResultsAmong 6879 eligible participants, 1309 (19%) tested positive for Influenza virus, predominantly for A(H1N1)pdm09 (11%) and Influenza B (7%). The effectiveness of the Influenza Vaccine against any...

  • early estimates of seasonal Influenza Vaccine effectiveness united states january 2015
    Morbidity and Mortality Weekly Report, 2015
    Co-Authors: Brendan Flannery, Richard K. Zimmerman, Arnold S Monto, Michael L Jackson, Lisa A Jackson, Huong Q Mclean, Joshua G Petrie, Jessie Clippard, Mary Patricia Nowalk, Edward A Belongia
    Abstract:

    In the United States, annual vaccination against seasonal Influenza is recommended for all persons aged ≥6 months. Each season since 2004-05, CDC has estimated the effectiveness of seasonal Influenza Vaccine in preventing medically attended acute respiratory illness (ARI) associated with laboratory-confirmed Influenza. This season, early estimates of Influenza Vaccine effectiveness are possible because of widespread, early circulation of Influenza viruses. By January 3, 2015, 46 states were experiencing widespread flu activity, with predominance of Influenza A (H3N2) viruses. This report presents an initial estimate of seasonal Influenza Vaccine effectiveness at preventing laboratory-confirmed Influenza virus infection associated with medically attended ARI based on data from 2,321 children and adults enrolled in the U.S. Influenza Vaccine Effectiveness Network (Flu VE) during November 10, 2014-January 2, 2015. During this period, overall Vaccine effectiveness (VE) (adjusted for study site, age, sex, race/ethnicity, self-rated health, and days from illness onset to enrollment) against laboratory-confirmed Influenza associated with medically attended ARI was 23% (95% confidence interval [CI] = 8%-36%). Most Influenza infections were due to A (H3N2) viruses. This interim VE estimate is relatively low compared with previous seasons when circulating viruses and Vaccine viruses were well-matched and likely reflects the fact that more than two-thirds of circulating A (H3N2) viruses are antigenically and genetically different (drifted) from the A (H3N2) Vaccine component of 2014-15 Northern Hemisphere seasonal Influenza Vaccines. These early, low VE estimates underscore the need for ongoing Influenza prevention and treatment measures. CDC continues to recommend Influenza vaccination because the Vaccine can still prevent some infections with the currently circulating A (H3N2) viruses as well as other viruses that might circulate later in the season, including Influenza B viruses. Even when VE is reduced, vaccination still prevents some illness and serious Influenza-related complications, including thousands of hospitalizations and deaths. Persons aged ≥6 months who have not yet been vaccinated this season should be vaccinated, including persons who might already have been ill with Influenza this season.

  • immunization with trivalent inactivated Influenza Vaccine in partially immunized toddlers
    Pediatrics, 2006
    Co-Authors: Janet A Englund, Emmanuel B Walter, Adepeju Gbadebo, Arnold S Monto, Yuwei Zhu, Kathleen M Neuzil
    Abstract:

    OBJECTIVE. Children ≥6 months of age who have previously received 1 dose of trivalent inactivated Influenza Vaccine are recommended to be given an additional single trivalent inactivated Influenza Vaccine dose the following fall. Limited data exist documenting the immunogenicity of 2 doses of Influenza Vaccine given in separate years to young children, and it is not known if the antigen content of each of the 2 doses of Vaccine must be identical or similar to optimally immunize children in this age group. In 2004, the A/H3N2 and B antigens contained in trivalent inactivated Influenza Vaccine were changed from those in the 2003–2004 Influenza Vaccine, providing the opportunity to assess the effect of such a change on the single-dose recommendation in trivalent inactivated Influenza Vaccine-experienced toddlers. PATIENTS AND METHODS. We conducted an observational, nonrandomized, open-label study comparing immunogenicity and reactogenicity of 2 doses of trivalent inactivated Influenza Vaccine in 2 groups of healthy children aged 6 to 23 months. Children who had received 1 dose of 2003 trivalent inactivated Influenza Vaccine the previous season received 1 dose of 2004 trivalent inactivated Influenza Vaccine according to current guidelines (group 1). Trivalent inactivated Influenza Vaccine-naive toddlers received the standard 2 doses of 2004 trivalent inactivated Influenza Vaccine 1 month apart (group 2). Blood was obtained 4 weeks after the second dose of trivalent inactivated Influenza Vaccine. The primary outcome measure was antibody response to the 3 Vaccine antigens in the 2004 trivalent inactivated Influenza Vaccine after 2 doses of Vaccine, as determined by hemagglutination-inhibition antibody titers. Noninferiority of the antibody response was based on the proportion of subjects in each group achieving a titer of ≥1:32 postvaccination to antigens (H1N1, H3N2, and B) contained in the 2004–2005 Vaccine. For each antigen, the antibody response was proposed to be noninferior if the upper bound of the 95% confidence interval of the difference between the proportion of children in the 2 groups with postvaccination titers ≥1:32 was RESULTS. Fifty six of 58 previously immunized children (group 1) and 63 of 64 Vaccine-naive children (group 2) completed the study. The groups were similar, except group 1 was older at receipt of the second trivalent inactivated Influenza Vaccine. Reactogenicity did not differ by age or time between doses. Antibody responses to the unchanged Influenza A/H1N1 antigen at 4 weeks after the second trivalent inactivated Influenza Vaccine dose were similar in both groups, with good responses as measured by geometric mean titer (75.2 vs 69.1) and percentage with antibody titers ≥1:32 (82.1% group 1 vs 85.7% group 2). For the A/H3N2 antigen, which changed between 2003 and 2004, there was a significantly higher geometric mean titer in group 1 compared with group 2 (156 vs 53.7), but both groups had very high rates of seroconversion that were not statistically different (91% vs 84%). The antibody response to Influenza B was significantly lower in group 1 recipients, who received only a single dose of 2005 Vaccine, as measured by both geometric mean titer and percentage with antibody ≥1:32. The group 1 geometric mean titer was 13.8, and the group 2 geometric mean titer was 49.1. Only 27% of children in group 1 achieved antibody levels ≥1:32 to Influenza B compared with 86% in group 2. Using logistic regression, we also determined that older children had less potentially seroprotective levels to Influenza B. Overall, noninferiority of the antibody response for group 1 compared with group 2 was confirmed for Influenza A/H3N2, was marginally significant for A/H1N1, and was not confirmed for Influenza B. CONCLUSIONS. The assessment of immune responses in children after changes in Vaccine composition is important, because Influenza Vaccines change frequently, affecting not only antibody responses in partially immunized toddlers, but potentially immune responses in more fully immunized individuals. In this study, a change in 2 different Vaccine antigens enabled us to assess and compare the impact of the original priming antigens after relatively minor changes in 1 antigen (A/H3N2) or after considerable antigenic changes in another Vaccine antigen (B). Our subjects demonstrated relatively good responses to the Vaccine antigen change characterized by relatively minor changes (A/H3N2). Circulating virus may have primed infants in both groups to antigen more closely related to the 2004 Influenza A/H3N2 strain. The high A/H3N2 antibody response to the second dose of trivalent inactivated Influenza Vaccine in children who were immunized the previous fall with a different Vaccine is consistent with the fact that more children in group 1 were alive during this epidemic and, therefore, were more likely to have experienced priming with natural infection. In contrast, a decreased antibody response to the Influenza B antigen was seen in children primed with the earlier 2003 Vaccine, suggesting that the major change in B virus lineage in the 2004 Vaccine reduced the priming benefit of previous vaccination. Our findings are reminiscent of antibody responses in children seen after immunization with different but novel Influenza antigens, such as swine flu Vaccine (Influenza A/swine/1976/37-like virus). Our results should be taken into account when evaluating new Vaccines in young children for novel viruses, such as new pandemic strains of Influenza. The need for multiple doses of Vaccine to produce potentially protective antibody levels in children needs to be considered, even when Vaccine is in short supply.

David Baltimore - One of the best experts on this subject based on the ideXlab platform.

  • the pathway to a universal Influenza Vaccine
    Immunity, 2017
    Co-Authors: Catharine I Paules, Hilary D. Marston, Robert W Eisinger, David Baltimore
    Abstract:

    Development of a universal Influenza Vaccine is a research priority for the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health. To facilitate this goal, we convened a workshop in Rockville, Maryland to identify knowledge gaps in Influenza research and develop strategies to fill them.

Avalow Olsen - One of the best experts on this subject based on the ideXlab platform.