Dr. Rappuoli said Novartis has been working on pandemic influenza since 1999. The company plans to begin trials of an H1N1 vaccine with and without adjuvant in late July or early August. Studies will include about 4,000 children and adults ranging in age from six months to over 65 years. Data analysis should be completed by October or November, but preliminary data may be available sooner. Data from influenza cell culture trials in Europe may be available in September.
Novartis’ adjuvant, Mf59, has been licensed for use in Europe since 1997 as part of a seasonal influenza vaccine, and 45 million commercial doses have been distributed. It provides protection against drifted strains. Data comes from 120 studies involving more than 200,000 subjects, including a database of pediatric patients.
After one dose, Mf59 stimulates strong response from helper B cells and T cells. Boosting with Mf59 induces a protective immune response against all H5N1 isolates in seven days.
H5N1-plus-Mf59 prepandemic vaccine increases antibody production when compared to unadjuvanted vaccine and so reduces the amount of antigen needed. It also demonstrates cross-reactivity against most H5N1 subclades that have caused human disease, and Novartis has seen cross-coverage when Mf59 is combined with seasonal influenza vaccine. After a primary vaccine is administered, a booster dose can be given 6-8 years later and demonstrate protection in 7 days. The prepandemic vaccine has a favorable safety profile and a growing clinical database that includes children as young as six months.
The combined safety data for Mf59 provided to FDA include 25,000 cases compared with normal influenza vaccine. Adverse events are all local reactions that resolve quickly. Novartis is currently conducting a 3-year trial in Italy of 150,000 elderly people. The pharmacovigilance database from that study includes spontaneous reports after 40 million doses and has revealed no safety signals for selected adverse events.
Novartis is producing a cell-culture based H1N1 vaccine at its facility in Germany and is working with HHS to build a plant in North Carolina. With the addition of the North Carolina plant, Novartis will have the capacity to produce 150 million doses. Novartis is planning to have commercial production of prepandemic vaccine, adjuvant, and seasonal influenza vaccine in 2012.
Novartis’ influenza cell culture (Optaflu) demonstrated efficacy of 84% against vaccine-like virus strains when compared with placebo. Adjuvanted influenza cell culture H5N1 vaccine is both antigen- and adjuvant-dose-sparing. Novartis has limited capacity to produce this product, but it can still be available quickly.
Dr. Rappuoli concluded that Novartis has had an ongoing partnership with HHS to develop an H5N1 vaccine. It is working to develop a novel H1N1 vaccine for current pandemic in adjuvanted and unadjuvanted formulations, with potential use of Mf59 potential for dose sparing and cross-protection.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf
Novartis’ adjuvant, Mf59, has been licensed for use in Europe since 1997 as part of a seasonal influenza vaccine, and 45 million commercial doses have been distributed. It provides protection against drifted strains. Data comes from 120 studies involving more than 200,000 subjects, including a database of pediatric patients.
After one dose, Mf59 stimulates strong response from helper B cells and T cells. Boosting with Mf59 induces a protective immune response against all H5N1 isolates in seven days.
H5N1-plus-Mf59 prepandemic vaccine increases antibody production when compared to unadjuvanted vaccine and so reduces the amount of antigen needed. It also demonstrates cross-reactivity against most H5N1 subclades that have caused human disease, and Novartis has seen cross-coverage when Mf59 is combined with seasonal influenza vaccine. After a primary vaccine is administered, a booster dose can be given 6-8 years later and demonstrate protection in 7 days. The prepandemic vaccine has a favorable safety profile and a growing clinical database that includes children as young as six months.
The combined safety data for Mf59 provided to FDA include 25,000 cases compared with normal influenza vaccine. Adverse events are all local reactions that resolve quickly. Novartis is currently conducting a 3-year trial in Italy of 150,000 elderly people. The pharmacovigilance database from that study includes spontaneous reports after 40 million doses and has revealed no safety signals for selected adverse events.
Novartis is producing a cell-culture based H1N1 vaccine at its facility in Germany and is working with HHS to build a plant in North Carolina. With the addition of the North Carolina plant, Novartis will have the capacity to produce 150 million doses. Novartis is planning to have commercial production of prepandemic vaccine, adjuvant, and seasonal influenza vaccine in 2012.
Novartis’ influenza cell culture (Optaflu) demonstrated efficacy of 84% against vaccine-like virus strains when compared with placebo. Adjuvanted influenza cell culture H5N1 vaccine is both antigen- and adjuvant-dose-sparing. Novartis has limited capacity to produce this product, but it can still be available quickly.
Dr. Rappuoli concluded that Novartis has had an ongoing partnership with HHS to develop an H5N1 vaccine. It is working to develop a novel H1N1 vaccine for current pandemic in adjuvanted and unadjuvanted formulations, with potential use of Mf59 potential for dose sparing and cross-protection.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf