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.”

About LAIV

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-Barré 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

About MedImmune

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.

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ATTENTION BROADCASTERS:  B-ROLL AVAILABLE

GAITHERSBURG, Md., June 1 /PRNewswire/ — MedImmune announced today that the U.S. Department of Health and Human Services (HHS) has awarded the company a contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders. This project has been funded in whole or in part with the Federal funds from HHS/ASPR/BARDA, under Contract No. HHSO100200900002I.

MedImmune scientists have identified several promising vaccine candidates against the Novel Influenza A (H1N1) strain, and are currently evaluating their growth properties and antigenicity (i.e., their ability to stimulate antibodies) for mass production as part of the vaccine manufacturing process.

“MedImmune is pleased to be able to contribute our scientific expertise in influenza vaccine development and manufacturing to help combat this unpredictable public health threat,” said Ben Machielse, Drs., executive vice president of operations, MedImmune. “We are confident that our vaccine technology has several attributes that may be useful in protecting people with limited exposure to influenza against the Novel Influenza A (H1N1) strain.”

MedImmune’s live attenuated influenza vaccine (LAIV) technology may be particularly well-suited for vaccinating against emerging influenza strains. LAIV is different from the injectable influenza vaccine (“flu shot”) in that it is a gentle mist sprayed into the nose, where the influenza virus usually enters the body. It contains live vaccine virus strains that are weakened so as not to cause the flu, but prompt the body to mount an immune response after the first dose. Because it is live and stimulates a broad range of immune responses, LAIV may offer some cross-protection against circulating flu strains that are “drifted” – meaning they are very closely-related but not perfectly matched to the flu strains in the vaccine.

As a needle-free nasal spray, LAIV is well suited to facilitate mass vaccination, and has been widely used for school-based vaccinations and to help protect active-duty military personnel.

While MedImmune is committed to supporting global efforts to help protect individuals against the Novel Influenza A (H1N1) virus, its vaccine technology is currently only licensed in the United States. MedImmune is willing to make additional vaccine available to other governments if any capacity remains after fulfilling obligations to the U.S. government, assuming that necessary regulatory approval can be obtained.

Seasonal FluMist(R) on Track to Begin Shipping in August

MedImmune believes that the best way to help protect all eligible age groups against seasonal influenza is to vaccinate prior to and during the back-to-school period. The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccination for all age groups as soon as seasonal vaccine is available each year. MedImmune plans to begin shipping the first of approximately 10 million doses of seasonal FluMist(R) (Influenza Virus Vaccine Live, Intranasal) to health care providers in August. This early availability of vaccine significantly widens the window of opportunity to vaccinate more eligible individuals and improve seasonal influenza vaccination rates, as patients seeing their providers for routine office visits can be vaccinated without waiting for the rush of fall vaccination clinics.

About Seasonal FluMist

FluMist(R) (Influenza Virus Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune

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 opinions expressed herein do not represent opinions or statements made or expressed by the U.S. Department of Health and Human Services.

http://www.medimmune.com

SOURCE MedImmune

CONTACT: Karen Lancaster of MedImmune, +1-301-398-5864

NIJMEGEN, The Netherlands, January 6, 2009 — MedImmune, the global biologics unit of AstraZeneca, announced today that it has submitted a Marketing Authorisation Application (MAA) for its nasal spray live attenuated influenza vaccine (LAIV), which is now being reviewed by the European Medicines Agency (EMEA). The proposed indication in the MAA is for prevention of seasonal influenza.

The MAA submission for LAIV is based on data from 73 global clinical and U.S. post-marketing studies of more than 141,000 subjects ranging in age from 7 weeks to 97 years and conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

Influenza creates a heavy medical and economic burden on Europe and throughout the world, and we are hopeful that the future availability and product characteristics of this novel nasal spray influenza vaccine will contribute to an increase in vaccination rates and reduce the spread of influenza around the world, said Alex Zukiwski, M.D., executive vice president, clinical affairs and chief medical officer. MedImmune is pleased to submit this application for approval of our nasal spray influenza vaccine in Europe.

About LAIV
Each dose of LAIV is formulated to contain three live attenuated influenza virus strains, which are weakened as to not cause illness: Two Type A influenza strains (A/H1N1 and A/H3N2) and one Type B strain. The vaccine strains are selected annually by the World Health Organization (WHO) based on anticipated circulating influenza strains for the upcoming season. The vaccine is sprayed into the nose, rather than by injection as with other licensed influenza vaccines, where it induces protective immunity.

In the U.S., LAIV is marketed under the trade name FluMist® (Influenza Virus Vaccine Live, Intranasal). It was approved by the U.S. Food and Drug Administration in 2003. The vaccine included in the MAA has not been registered in the European Union (EU) and is not available outside of the United States.

About Influenza
Influenza is the most common vaccine-preventable disease in the developed world. According to WHO estimates, seasonal influenza results in three to five million cases of severe illness and up to half a million deaths globally each year, primarily among the elderly. Rates of infection are highest among children, with school-aged children significantly contributing to spread of disease to their families, communities and high-risk individuals.

Influenza also has socioeconomic consequences related to both direct and indirect health care costs, including hospitalizations, work absence and loss of work productivity when either a caregiver or child is sick with influenza.

In the EU, current guidelines recommend annual influenza vaccination for the elderly as well as those with underlying medical conditions such as chronic heart or lung disease. However, vaccination rates in the recommended groups throughout Europe are estimated to be only 35 percent (Ryan, Vaccine, August 2006).

To date, six EU countries (Finland, Austria, Estonia, Latvia, Slovakia and Slovenia) recommend routinely vaccinating young children against influenza with varying age limits. EU and Member State policymakers continue to evaluate data on the impact of influenza in children to best inform the potential expansion of recommendations.

About MedImmune
MedImmune is a leading innovation-focused biotechnology company whose mission is to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide and is the wholly owned biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune’s website at http://www.medimmune.com.

Contacts
Media:
Chris Sampson, +44 (0)207 304 5130 (AstraZeneca)
Sarah Lindgreen, +44 (0)207 304 5033 (AstraZeneca)
Karen Lancaster, +1-301-398-5864 (MedImmune)