Interim Clinical Trial Results Show MedImmune's H1N1 Vaccine Has Similar Safety Profile as Seasonal Vaccine in Eligible Children and Adults H1N1 Immunogenicity Profile Also Consistent with Seasonal Vaccine Formulations
GAITHERSBURG, Md., Oct. 22 /PRNewswire/ -- MedImmune announced today that interim data from human studies of its nasal spray vaccine for the 2009 novel Influenza A (H1N1) virus demonstrate 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 U.S. Food and Drug Administration (FDA) on September 15, 2009.
"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," said Filip Dubovsky, M.D., vice president, clinical development, vaccines. "It is rewarding for all of us at MedImmune to see the vaccine being used to help protect the U.S. population from this novel strain of influenza."
Two randomized, 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.
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.
In children, the most common side effects following the first dose of vaccine included headache, runny/stuffy nose, and cough. In adults, the most common side effects were headache, runny nose and decreased activity. Symptoms after the second dose were similar but generally occurred at lower rates in both children and adults. No vaccine-related serious adverse events have been reported in children or adults. The local and systemic symptoms observed are consistent with intranasal vaccine virus replication and are similar to those observed with seasonal LAIV. Serum antibody responses to the vaccine in addition to pre-clinical characterization data are also consistent with previously studied formulations of seasonal LAIV, which has been shown in multiple studies to be safe and effective in eligible children and adults 2 to 49 years of age.
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 U.S. Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the U.S. Department of Health and Human Services (HHS).
About LAIV
LAIV is different from the injectable influenza vaccine ("flu shot") in that it contains live vaccine virus strains that are specifically designed to prompt the body to begin mounting a protective response, but weakened so as not to cause the flu. It is delivered into the nose, where the influenza virus usually enters the body, rather than by injection. MedImmune's seasonal influenza vaccine is currently licensed in the United States, South Korea, and Hong Kong and MedImmune's H1N1 influenza vaccine is currently licensed in the United States; both are approved for eligible individuals 2 through 49 years of age.
Important Safety and Eligibility Information for Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
Who may be eligible for Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal?
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is a vaccine approved for the prevention of influenza disease caused by pandemic (H1N1) 2009 virus in children, adolescents and adults, from 2-49 years of age. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal may not protect everyone who gets it. This vaccine is for intranasal administration only. Children 2 through 9 years of age are recommended to receive 2 doses of vaccine approximately 1 month apart; individuals 10 years of age and older are recommended to receive a single dose of vaccine.
Who may not be able to get Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal?
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not right for everyone. This vaccine must not be given to: people with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine; people with life-threatening reactions to previous influenza vaccinations; and children and adolescents receiving aspirin or aspirin-containing therapy. Children less than 24 months of age are not eligible for this vaccine.
The following people may not be able to get Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or may be able to get it only in certain situations: people with asthma or active wheezing, or children less than 5 years of age with recurrent wheezing; people with a history of Guillain-Barre syndrome; people with a weakened immune system; people with long-term medical conditions including heart disease, kidney disease, and metabolic diseases, such as diabetes; and pregnant women.
If a patient falls into one of these groups, a health care provider will decide if Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is right for them.
For Complete Product Information please visit: http://www.medimmune.com/pdf/products/h1n1_pi.pdf
About MedImmune
MedImmune, the worldwide biologics business for AstraZeneca PLC , has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune's website at www.medimmune.com.
The Novel Influenza A (H1N1) project has been funded in whole or in part with the Federal funds from HHS/ASPR, under Contract No. HHSO100200900002I. The opinions expressed herein do not represent opinions or statements made or expressed by the U.S. Department of Health and Human Services.
SOURCE MedImmune
CONTACT: Karen Lancaster, +1-301-398-5864, lancasterk@medimmune.com or Tor
Constantino, +1-301-398-5801, constantinos@medimmune.com
Web site: http://www.medimmune.com/