GAITHERSBURG, Md., Sept. 21 /PRNewswire/ -- MedImmune announced today that the U.S. Department of Health and Human Services (HHS) has placed an order for an additional 29 million doses of its live attenuated influenza vaccine (LAIV) against the 2009 H1N1 influenza virus. This brings HHS orders to date to more than 40 million vaccine doses, with a total cumulative contract value of approximately $453 million. Previous HHS orders for approximately 13 million doses of LAIV for the 2009 H1N1 strain were placed in May and July.
The vaccine received approval from the U.S. Food and Drug Administration (FDA) on Sept. 15 and is indicated for the active immunization of individuals 2-49 years of age against influenza caused by pandemic (H1N1) 2009 virus.
MedImmune's development of LAIV for this strain of H1N1 began at the end of April, when the company received the novel virus from the U.S. Centers for Disease Control and Prevention (CDC). Enough bulk vaccine to fill all orders placed by HHS has already been manufactured and about 3.4 million doses have been released by the FDA. Distribution will occur at the direction of public health authorities.
"At MedImmune, our mission is to develop and deliver medicines that change lives, and we are proud that our innovative LAIV technology may help protect the public from the threat of 2009 H1N1 influenza," said Tony Zook, president of MedImmune. "We will continue to work collaboratively with the U.S. government and public health authorities to contribute to the response to this unpredictable infectious disease."
LAIV is different from the injectable influenza vaccine ("flu shot") in that it contains live vaccine virus strains that are 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. LAIV prompts the body to begin mounting an immune response after the first dose. MedImmune's influenza vaccines are currently only licensed in the United States.
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 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.
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.
What are the most common side effects of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
Most common side effects are based on studies conducted with seasonal trivalent Influenza Vaccine Live, Intranasal manufactured by MedImmune and include runny nose or nasal congestion, sore throat, and fever. For a full list of side effects, please see section 6.1 in the following product information.
For Complete Product Information please visit: http://www.medimmune.com/pdf/products/h1n1_pi.pdf
MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 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.
Karen Lancaster, +1-301-398-5864, firstname.lastname@example.org, or Tor Constantino, +1-301-398-5801, both for MedImmune