High-dose flu vaccine Fluzone for elderly approved by US FDA: Sanofi Pasteur

Fluzone high-dose influenza virus vaccine for adults 65 years of age and older has been approved for use in US.

Fluzone high-dose influenza virus vaccine will be available to health-care providers for immunizations administered this fall in preparation for the upcoming 2010-2011 influenza season, Sanofi Pasteur announced in a press release.

US Food and Drug Administration has approved the company’s supplemental biologics license application (sBLA) for licensure of Fluzone high-dose influenza virus vaccine.

People 65 years of age and older typically does not respond as well to the standard dose of influenza virus vaccines as younger individuals because they have weakened immune systems.

Fluzone high-dose vaccine was specifically designed to generate a more robust immune response in people 65 years of age and older, the release said.

Influenza-related morbidity and mortality in older adults. 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.

Elderly people are less able to mount an effective immune response to neutralize the attack, when infected with the influenza virus.

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.

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 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.

In the clinical trial, Fluzone high-dose vaccine was shown to have a clinically comparable safety profile to Fluzone vaccine.

Serious adverse events were similar between those who received Fluzone high-dose vaccine and those who received Fluzone vaccine.

“In 2011 the first baby boomers will turn 65 and, by the year 2030, the number of adults over age 65 is anticipated to double and surpass 70 million people, or 20 percent of the U.S. population,” stated Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur.

Sanofi Pasteur is the vaccine division of sanofi-aventis. Sanofi Pasteur provided more than 1.6 billion doses of vaccine in 2008. A world leader in the vaccine industry, Sanofi Pasteur offers a range of vaccines protecting against 20 infectious diseases.