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news.Results revealed that MedImmune's H1N1 vaccine has similar safety profile as seasonal vaccine in eligible children and adults
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MedImmune has reported interim data from human studies of its nasal spray vaccine for the 2009 novel Influenza A (H1N1) virus. It demonstrated a similar clinical profile in children and adults 2 to 49 years of age as previously studied seasonal formulations of the vaccine. The live attenuated influenza vaccine (LAIV) for the 2009 novel Influenza A (H1N1) virus received approval from the FDA on September 15, 2009.
Reportedly, two randomised, double-blind, placebo-controlled trials are ongoing in children (2-17 years) and adults (18-49 years) to evaluate the safety, tolerability, and immunogenicity of vaccine. A total of 326 children and 300 adults were randomly assigned to receive 2 doses of 2009 H1N1 LAIV or placebo 28 days apart. Both clinical trials are collecting data following a second dose of the vaccine.
The company said that LAIV, for 2009 H1N1, is made using the same process as LAIV for seasonal influenza. The safety of the 2009 H1N1 vaccine was evaluated in the same way that the safety of new seasonal LAIV strains is assessed every year. The H1N1 vaccine was also evaluated in children to further establish its safety profile.
LAIV initiates the immune response in the nose, where the virus enters the body and replicates, and is the key to establishing a vaccine response that will help prevent disease if the person later encounters a circulating H1N1 virus. In response to the vaccine, the body develops mucosal immunoglobulin A (IgA), serum immunoglobulin G (IgG), and cellular immunity to help protect the individual from infection from an influenza virus.
Study results have been submitted to and reviewed by authorities at the FDA, the US Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the US Department of Health and Human Services (HHS).
Filip Dubovsky, vice president of clinical development and vaccines at MedImmune, said: “MedImmune is pleased to report these findings that demonstrate that the safety profile and immunogenicity of our nasal spray vaccine for the 2009 H1N1 virus is, as expected, similar to our seasonal influenza vaccine. It is rewarding for all of us at MedImmune to see the vaccine being used to help protect the US population from this novel strain of influenza.”