Influenza A (H1N1) Information


Overview
 As an influenza vaccine manufacturer under contract with the U.S. government to produce a vaccine for the novel Influenza A (H1N1) strain, MedImmune takes its responsibility very seriously in helping protect the population against this unpredictable health threat. We are also very committed both as an employer and a corporate citizen to support the public health authorities as they confront the first influenza pandemic in decades.

On June 11, the World Health Organization (WHO) raised its pandemic alert to Phase 6, which indicates that a Novel Influenza A (H1N1) pandemic is underway based on surveillance of sustained community-level outbreaks in multiple WHO regions. The Phase 6 declaration is not indicative of the severity of the outbreak, but its spread among humans.

Non-Safety Related Voluntary Recall of Specific Lots of Influneza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
MedImmune’s top priority is the health and safety of the patients who receive our products. As such, through consultation with public health authorities, on December 22, 2009 MedImmune announced that it is voluntarily recalling unused doses of 13 specific lots of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal due to a slight decrease in potency. There is no safety concern with the lots that are being recalled.  

The slight decrease in vaccine potency is expected to have little, if any, impact on the response to vaccination. Revaccination is not recommended because the vaccine in the affected lots is still expected to be effective in stimulating a protective immune response. These doses were well within potency specifications at the time they were distributed, and in fact, some of the doses being recalled are actually still within required potency limits. In exercising the most conservative approach, MedImmune is recommending that all lots marked with an expiration date of between January 19 and January 26,2010 not be used.

For questions and answers about this voluntary recall, click here. For specific information for healthcare providers on action to be taken, click here.

MedImmune’s Nasal Spray Vaccine for Novel H1N1 Influenza
 On Sept. 15, 2009, MedImmune received approval from the U.S. Food and Drug Administration (FDA) for its live attenuated influenza vaccine (LAIV) against the novel H1N1 influenza virus. The vaccine is indicated for the active immunization of individuals 2-49 years of age against influenza caused by pandemic (H1N1) 2009 virus.

HHS orders for approximately 40 million doses of LAIV for the H1N1 strain have been placed to date.

MedImmune’s development of LAIV for this strain of H1N1 began at the end of April, when the company received the new viral strain from the U.S. Centers for Disease Control and Prevention (CDC). Enough bulk vaccine to fill all orders placed by HHS has been manufactured. Delivery of the product is subject to the direction of public health authorities. Vaccine cannot be purchased directly from MedImmune. Healthcare providers can obtain information on ordering H1N1 vaccine by visiting http://www.cdc.gov/h1n1flu/vaccination/statecontacts.htm

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 currently holds a license for its seasonal and H1N1 LAIV products 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 2-49 years of age, and public health authorities may have additional recommendations for use. 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. In addition, public health authorities may establish prioritization for certain groups to obtain the vaccine.

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

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.

For the most current information about seasonal and Influenza A (H1N1) 2009 visit www.flu.gov.

 

About the Flu
Influenza, commonly referred to as "the flu", is a contagious disease caused by the influenza virus.1 Each year, up to 60 million Americans get the flu. Resulting complications cause more than 200,000 hospitalizations and about 36,000 deaths in the U.S. each year, primarily among the elderly.2

The flu, much like the common cold, is airborne and can be easily transmitted from person to person.1 Cold and flu are often confused for one another because both are respiratory illnesses.3 Flu symptoms are often much worse and can include fever, headache, extreme fatigue, and body aches.1 The most notable difference is that the flu can result in serious complications such as pneumonia and bacterial infections.3 Also, unlike symptoms of the common cold, the fatigue and weakness caused by the flu can last more than two weeks–lingering long after other symptoms subside.4

Tips to Stay Healthy
The CDC recommends several common sense actions to stay healthy: 5

  • Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.
  • Avoid touching your eyes, nose or mouth. Germs spread that way.
  • Try to avoid close contact with sick people.
  • Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people.
  • If you get sick, CDC (and MedImmune) recommends that you stay home from work or school and limit contact with others to keep from infecting them.  

 

The opinions expressed herein do not necessarily represent opinions or statements made or expressed by the U.S. Department of Health and Human Services.
  1. Centers for Disease Control and Prevention (CDC). Key Facts about Seasonal Influenza. Available at http://www.cdc.gov/flu/keyfacts.htm. Accessed July 30, 2008.
  2. Thompson, W, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003;289:179-186.
  3. Centers for Disease Control and Prevention (CDC). Questions & Answers: Cold Versus Flu. Available at http://www.cdc.gov/flu/about/qa/coldflu.htm. Accessed June 23, 2008.
  4. U.S. Food and Drug Administration (FDA). Colds and Flu: Time Only Sure Cure. Available at http://www.fda.gov/fdac/features/896_flu.html.
  5. Centers for Disease Control and Prevention (CDC). What You Can Do to Stay Healthy. Available at http://www.cdc.gov/swineflu/. Accessed April 28, 2009.