of Annual Flu Vaccination and Knowing Vaccine Options

GAITHERSBURG, MD (Oct. 13, 2011) – Families are busy enough during the back-to-school season – new class schedules, countless extracurricular activities, and daily homework assignments – without having to worry about the flu. To help raise awareness about the importance of annual influenza vaccination as the recommended best defense against the disease, MedImmune, along with soccer legend and mom Brandi Chastain, today launched the second year of “When Will You Pick?,” a national education campaign that encourages all eligible family members this flu season to “Don’t Wait to Vaccinate!”

“My goal every year is to not to wait to vaccinate. As a mom, keeping my family healthy and active is at the top of my to-do list, so we make sure to get our flu vaccine as soon as possible every year,” Chastain said. “Make an appointment today with your doctor to help keep yourself and your eligible family members protected. Also, if your children’s school offers an in-school vaccination program, be sure to fill out and return consent forms so they can get vaccinated at school.” 

The U.S. Centers for Disease Control and Prevention (CDC) recommends that all eligible Americans 6 months and older receive the flu vaccine, beginning as soon as the vaccine is available each year. Even though the 2011-2012 flu vaccine contains the same three strains as last year, the CDC encourages people to get vaccinated each year, regardless of whether the viruses in the vaccine have changed or not since the previous season because immunity can wane over time.

Seasonal flu vaccines, including the nasal spray FluMist^® (Influenza Vaccine Live, Intranasal), started shipping in August of this year. MedImmune expects to provide approximately 15 to 16 million doses of FluMist for the 2011-2012 influenza season.

FluMist is a nasal spray flu vaccine for eligible kids and adults 2- 49 years old. It starts fighting the flu where it usually starts — the nose. The most common side effects of FluMist are runny or stuffy nose, sore throat, and fever over 100°F.

Parents and families can learn more about the importance of flu vaccination by visiting the campaign’s Facebook page at www.facebook.com/dontwaitvaccinate, which offers tips to help stay healthy throughout the flu season, a quiz to test influenza knowledge, and one-of-a-kind campaign photos and videos featuring Chastain. Additionally, for everyone who “likes” the page, $1 (up to $50,000) will be donated by MedImmune to help support the nationwide flu vaccination education efforts of the non-profit organization, Families Fighting Flu. The campaign will also reach families through local events at school-located vaccination clinics across the country throughout the season, including Atlanta, Minneapolis, and Houston.

“Vaccination is the best defense we have against influenza. Families should make vaccination a priority every year,” said Dr. Anat Feingold, M.D., a pediatric infectious disease expert and mother of three. “Individuals should also take everyday steps to help prevent the spread of germs, such as washing their hands and covering their coughs, but vaccination is the most important protection step one can take.” 

An average of 5-20 percent of the U.S.population becomes ill with the flu each year, which can result in significant complications. Children between the ages of 2 to 17 are twice as likely to get the flu as adults and can spread the flu to family members. Not every flu vaccine option is right for everyone, so parents are recommended to talk to their doctor about which option is best for each eligible family member.

“MedImmune is committed to supporting the annual U.S. influenza vaccination campaign, starting as early as possible each year,” said Chris Ambrose, M.D., Senior Director of Medical & Scientific Affairs. “We are also thrilled to team-up with Brandi Chastain again this year to help share important messages about flu prevention with families across the country.”

Important Safety and Eligibility Information 

What is FluMist® (Influenza Vaccine Live, Intranasal)?

FluMist is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49. FluMist may not prevent influenza in everyone who gets vaccinated.

Who should not get FluMist?

You should not get FluMist if you: are allergic to eggs, gentamicin, gelatin, or arginine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin–children or adolescents should not be given aspirin for 4 weeks after getting FluMist unless your healthcare provider tells you otherwise. 

Children under 2 years old should not get FluMist because there is a chance they may wheeze (have difficulty with breathing) after getting FluMist.

Who may not be able to get FluMist?

 Tell your healthcare provider if you: are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking Tamiflu®, Relenza®, amantadine, or rimantadine.

They will decide if FluMist is right for you.

What are the most common side effects of FluMist?

The most common side effects of FluMist are runny or stuffy nose; sore throat; and fever over 100 degrees F.

Please see accompanying complete Product Information, including patient information at www.medimmune.com. 

For more information, please visit www.FluMist.com.

About MedImmune

MedImmune, the global biologics arm for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com. 

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“We are delighted that FLUENZ has received regulatory approval in Europe since influenza creates a significant medical and economic burden there and throughout the world. We hope that the availability of this nasal spray influenza vaccine with its novel mechanism of action will help reduce the spread of influenza,” said Alex Zukiwski, M.D., executive vice president and chief medical officer of MedImmune, the biologics unit of AstraZeneca.

It is expected that the FLUENZ vaccine will be initially available in select European markets for the 2012-13 influenza season.

The EC decision and CHMP positive opinion were reached after a review of data from 73 global clinical studies and US post-marketing studies of more than 141,000 subjects conducted in 38 countries. Study objectives included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

- ENDS -

NOTES TO EDITORS

About LAIV
Each dose of FLUENZ is formulated to contain three live attenuated influenza virus strains, which are weakened so as to not cause illness. 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 administered by spraying into the nose where it induces protective immunity. In several clinical studies it has demonstrated superior efficacy in children 24 months to less than 18 years of age compared to traditional inactivated influenza vaccines that are injected. The most common adverse events for LAIV include runny nose or nasal congestion. The live influenza virus strains used in LAIV are cold-adapted, temperature sensitive and attenuated.

In the US, FLUENZ is marketed by MedImmune under the trade name FluMist (Influenza Vaccine Live, Intranasal). FluMist was approved by the US Food and Drug Administration in 2003. The seasonal vaccine is currently approved in five countries including the US and Canada.

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.

Studies in several European countries have demonstrated that hospitalization rates associated with influenza are highest in young children including those without underlying medical problems (Weigl et al, 2002; Pitman et al, 2007; Gasparini et al, 2007; Lenglet et al, 2007; Jansen et al, 2007). Based on these accumulated data, many experts include young children among those at high risk for severe influenza disease and influenza-related complications (Heikkinen et al, 2006). 

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

To date, seven EU countries (Finland, Austria, Estonia, Latvia, the state of Saxony in Germany, 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, the worldwide biologics unit for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $33.3 billion in 2010.  For more information please visit: www.astrazeneca.com.                           

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The Committee’s positive opinion is now referred for a final decision by the European Commission (EC).  The EC, which makes the decision whether to approve a new drug candidate for use in the European Union, typically decides within a few months of the CHMP issuing its opinion. 

“Influenza creates a significant 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 reduce the spread of influenza around the globe,” said Alex Zukiwski, M.D., MedImmune’s executive vice president and chief medical officer.

The positive opinion was reached after the CHMP reviewed data from 73 global clinical studies and US post-marketing studies of more than 141,000 subjects conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

NOTES TO EDITORS

 About LAIV
Each dose of Fluenz is formulated to contain three live attenuated influenza virus strains, which are weakened so as to not cause illness. 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 administered by spraying into the nose where it induces protective immunity. In several clinical studies it has demonstrated superior efficacy in children 24 months to less than 18 years of age compared to traditional inactivated influenza vaccines that are injected. The most common adverse events for LAIV are nasal congestion/rhinorrea, decreased appetite, headache, malaise and fever. The live influenza virus strains used in LAIV are cold-adapted, temperature sensitive and attenuated.

In the US, Fluenz is marketed by MedImmune under the trade name FluMist (Influenza Vaccine Live, Intranasal). FluMist was approved by the US Food and Drug Administration in 2003. The seasonal vaccine is currently approved in a further six countries including Canada.

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.

Studies in several European countries have demonstrated that hospitalisation rates associated with influenza are highest in young children including those without underlying medical problems (Weigl et al, 2002; Pitman et al, 2007; Gasparini et al, 2007; Lenglet et al, 2007; Jansen et al, 2007). Based on these accumulated data, many experts include young children among those at high risk for severe influenza disease and influenza-related complications (Heikkinen et al, 2006). 

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

To date, seven EU countries (Finland, Austria, Estonia, Latvia, the state of Saxony in Germany, 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, the worldwide biologics unit for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.  For more information please visit: www.astrazeneca.com

 GAITHERSBURG, MD, July 23, 2010 – MedImmune announced today that it has begun shipping FluMist^® (Influenza Vaccine Live, Intranasal) to influenza vaccine distributors who service health care providers throughout the United States. 

MedImmune expects to provide approximately 15 million doses of its trivalent (three-strain) nasal spray flu vaccine for the 2010-2011 influenza season through a variety of private health care practices, public health departments, school-located vaccination programs, military bases, and other venues. 

 Earlier this year, the Advisory Committee on Immunization Practices (ACIP), a panel of immunization experts advising the U.S. Centers for Disease Control and Prevention (CDC) expanded the recommendations for annual influenza vaccination to include all people aged six months and older. Please refer to the specific prescribing information for each manufacturers’ influenza vaccines as not all vaccines are indicated for all ages.

 The CDC also recommends that flu vaccine be administered to eligible recipients every year as soon as the vaccine becomes available.  A MedImmune analysis looking at pediatric populations suggests that starting influenza vaccination in August and September — months earlier than the typical influenza vaccination season — may help reach an additional 10.5 million children at already-scheduled healthcare provider visits.

 Global public health authorities have determined that this season’s vaccine will include the 2009 H1N1 pandemic strain among the three vaccine strains. Additionally, the ACIP voted in June 2010 to recommend that children younger than nine years who did not receive at least one dose of the H1N1 monovalent vaccine in the 2009-2010 season should receive two doses of the 2010-2011 trivalent seasonal vaccine. 

 “MedImmune is committed to supporting public health efforts to initiate seasonal influenza vaccination as early as possible each year, greatly widening the window of opportunity for vaccination,” said Alex Zukiwski, MD, MedImmune’s Executive Vice President, Clinical Research & Chief Medical Officer. “The public can be reassured that influenza vaccination with FluMist in the late summer helps protect against influenza throughout the influenza season, even into the late spring.”

 FluMist is available in every state, except South Dakota, through the federally funded Vaccines for Children (VFC) program, which provides vaccines at no cost to eligible children.  Based on a nationally-representative sample of private insurance claims from approximately 50 percent of US patients, FluMist accounted for 34 percent of seasonal influenza vaccinations given to children two through 18 years of age during the 2009-2010 season. FluMist is covered by approximately 99 percent of private health plans which offer immunization benefits.

 FluMist is now available on the Vaccine for Adults contract allowing state and local immunization programs to access the vaccine at the public-sector price for community vaccination programs focused on young adults and immunization of first-responders and healthcare workers.

Important Safety and Eligibility Information for FluMist

 Who may be eligible for FluMist^® (Influenza Vaccine Live, Intranasal)?

FluMist is a vaccine approved for the prevention of certain types of influenza disease in children, adolescents and adults 2-49 years of age. FluMist may not protect everyone who gets it. FluMist is for intranasal administration only.

 Who may not be able to get FluMist?

FluMist is not right for everyone. FluMist 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 FluMist.

 The following people may not be able to get FluMist or may be able to get it only in certain situations: people with asthma or active wheezing, or children less than five 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 you or your child falls into one of these groups, their healthcare provider will decide if FluMist is right for you or your child.

 What are the most common side effects of FluMist?

Most common side effects included 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.

Please see the complete product information, including patient information at www.medimmune.com.

 For more information, please visit www.FluMist.com.

 About MedImmune

MedImmune, the worldwide biologics unit for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

“With the growing importance of influenza prevention, it is essential to better understand the current data on influenza vaccines as well as how best to provide them to children and adults in the United States,” said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. “The data being presented at the conference build on our extensive foundation of research and help advance innovative solutions for preventing illnesses that negatively impact the health of the U.S. population.”

 MedImmune abstracts to be presented at NIC on influenza include:

• “Parent’s Decision-Making for Immunizing Children Against Seasonal Influenza.” Flood, E.M., et al. Workshop in the Regency Ballroom VI: April 21, 2010 Time: 11:20AM.

• “Pediatric Office Characteristics and Activities Associated with Increased Influenza Vaccine Delivery.” Bhatt, P., et al. Workshop in the Centennial Ballroom I: April 22, 2010 Time: 9:20AM.

• “Relative Efficacy of Live Attenuated and Inactivated Influenza Vaccine in Children as a Function of Time Post Vaccination.” Belshe, R.B., et al. Poster Session in the Grand Hall: April 20-21, 2010 Time: 10 AM – 4 PM.

• “Preferences for Influenza Vaccines for Children: Do Children and Parents Agree?” Rousculp, M.D., et al. Poster Session in the Grand Hall: April 20-21, 2010 Time: 10AM – 4 PM.

• “High Inter-Office Variability in Pediatric Influenza Vaccination.”  Block, S.L., et al.  Poster Session in the Grand Hall: April 20-21, 2010 Time: 10AM – 4 PM.

•  “Case Reports on Maternal and Fetal Outcomes After Exposure to LAIV During Pregnancy.” Toback, S.L., et al.  Poster Session in the Grand Hall: April 20-21, 2010 Time: 10AM – 4 PM.

• “Elementary School-Based Influenza Vaccination Programs: Findings to Inform Pandemic Vaccination Campaigns.” Rousculp, M.D., et al.  Poster Session in the Grand Hall: April 20-21, 2010 Time: 10AM – 4 PM.

•  “What do Children Know About Influenza and Influenza Vaccines?”  Ryan, K.J., et al. Poster Session in the Grand Hall: April 20-21, 2010 Time: 10AM – 4 PM.

• “Real-Time Assessment of 2009-2010 Influenza Vaccine Utilization Among Practicing Pediatricians.” Carr, W., et al.  Poster Session in the Grand Hall: April 20-21, 2010 Time: 10AM – 4 PM.

•  “Live Attenuated Influenza Vaccine and Reduction in Influenza-Associated Acute Otitis Media in Children 24-83 Months.” Block, S.L., et al.  Poster Session in the Grand Hall: April 20-21, 2010 Time: 10AM – 4 PM.

 Additional information about the 44^th National Immunization Conference can be found at http://www.cdc.gov/vaccines/events/nic/default.htm

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com