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FDA approves New Influenza Vaccine for Older People

By Assam News on December 24, 2009 at 1:28 am

Sanofi Pasteur announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental biologics license application (sBLA) for licensure of Fluzone® High-Dose (Influenza Virus Vaccine). Fluzone High-Dose vaccine was specifically designed to generate a more robust immune response in people 65 years of age and older. This age group typically does not respond as well to the standard dose of influenza virus vaccines as younger individuals because they have weakened immune systems. The new vaccine, for adults 65 years of age and older, will be available to health-care providers for immunizations administered this fall in preparation for the upcoming 2010-2011 influenza season.

Fluzone High-Dose vaccine Influenza vaccines have been shown to offer public health benefits in reducing influenza-related morbidity and mortality in older adults. However, as people age, research has shown that the immune system weakens. Older adults are not only more susceptible to infections, but also less responsive to vaccination. When infected with the influenza virus, they are less able to mount an effective immune response to neutralize the attack. Compared to younger adults, people 65 years of age and older suffer disproportionately from seasonal influenza and its complications, including severe illness leading to hospitalization and death. Although this group comprises only 15 percent of the U.S. population, it accounts for 65 percent of the estimated 226,000 hospitalizations and 90 percent of the 36,000 deaths attributed to seasonal influenza and its complications on average each year.

Fluzone High-Dose vaccine is an inactivated influenza virus vaccine indicated for active immunization of people 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. This indication is based on the immune response elicited by Fluzone High-Dose vaccine and there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine.

Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin per strain of influenza virus in the vaccine as compared to 15 mcg of influenza virus hemagglutinin per strain of influenza virus in standard-dose Fluzone vaccine. Fluzone High-Dose vaccine is produced in the same production facility as Fluzone vaccine. Fluzone High-Dose vaccine is supplied as a single-dose, no preservative, prefilled syringe.

In a clinical study of 3,876 adults 65 years of age and older, Fluzone High-Dose vaccine was compared with the standard-dose Fluzone vaccine. The key finding was that the new high-dose vaccine induced statistically significant increases in immune responses compared to standard-dose Fluzone vaccine in the study population. After 28 days following immunization, investigators assessed serum hemagglutination inhibition (HAI) titers in study participants, a standard measurement of the immune response to influenza vaccination. Higher HAI titers were reported in those who received the high-dose vaccine compared with those who received the standard-dose vaccine. Immunogenicity results met pre-defined criteria for superiority of the high-dose vaccine. The primary endpoint of the study was the statistical superiority of immune responses to at least two of the strains contained in the vaccines when comparing Fluzone High-Dose vaccine to standard-dose Fluzone vaccine. Pre-defined criteria for overall superiority in the Phase III study were based on geometric mean titers (GMT) and seroconversion, which is defined as either a rise in HAI titer from <1:10 to ≥1:40 post-vaccination or a ≥4-fold increase in HAI titer post-vaccination from a pre-vaccination titer ≥1:10. There are no data demonstrating clinically relevant prevention of culture confirmed influenza or its complications after vaccination with Fluzone High-Dose vaccine compared to standard-dose Fluzone in adults 65 years of age and older.

In the clinical trial, Fluzone High-Dose vaccine was shown to have a clinically comparable safety profile to Fluzone vaccine. Rates of unsolicited and serious adverse events were similar between those who received Fluzone High-Dose vaccine and those who received Fluzone vaccine. Solicited local (injection site) adverse events and solicited systemic adverse events were more frequent after vaccination with Fluzone High-Dose vaccine compared to standard-dose Fluzone vaccine. More frequent mild to moderate local reactions were observed at the injection site as would be expected with increased antigen. The most common injection site reactions (≥10 percent) were injection site pain and redness. The most common systemic adverse events (≥10 percent) were malaise (feeling unwell), headache and myalgia (body aches).

Side effects to Fluzone vaccines are soreness, pain and swelling at the injection site; fever, fatigue, headache and muscular pain. Other side effects may occur. Fluzone vaccines should not be administered to anyone with a history of serious allergic reaction to any vaccine component, including eggs, egg products, or thimerosal (the only Fluzone vaccine product containing thimerosal is the multi-dose vial), or to persons who have been previously diagnosed with Guillain-Barré syndrome (GBS). If you notice any other problems or symptoms following vaccination, please contact your health-care professional immediately. Vaccination with Fluzone vaccine or Fluzone High-Dose vaccine may not protect all individuals.

Sanofi Pasteur is the vaccines division of the sanofi-aventis Group. Before administering Fluzone High-Dose vaccine or Fluzone vaccine, please see full Prescribing Information at www.vaccineplace.com/products .



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