FDA Approves High-Dose Seasonal Flu Vaccine for Seniors
FDA Approves High-Dose Seasonal Flu Vaccine for Seniors
December 28, 2009 — The US Food and Drug Administration (FDA) has granted accelerated approval for a high-dose seasonal influenza vaccine (Fluzone High-Dose, Sanofi Pasteur, Inc) to prevent disease caused by influenza virus subtypes A and B in people aged 65 years and older.
Seniors who contract seasonal influenza are most susceptible to complications that can lead to hospitalization and death. The new vaccine, which contains 180 μg of influenza virus hemagglutinin (HA), rather than the standard 45-μg dose, has been shown to produce an enhanced immune response in this population.
"As people grow older, their immune systems typically become weaker," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, in an agency news release. "This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza."
The FDA also warned that the high HA content has been linked to an increased rate of "non-serious" adverse events compared with the company's standard influenza vaccine (Fluzone). Injection site pain, erythema, and swelling, as well as headache, muscle aches, fever, and malaise, were the most commonly reported adverse events. Because it contains egg protein, the vaccine should not be used in people who are allergic to eggs or egg products.
December 28, 2009 — The US Food and Drug Administration (FDA) has granted accelerated approval for a high-dose seasonal influenza vaccine (Fluzone High-Dose, Sanofi Pasteur, Inc) to prevent disease caused by influenza virus subtypes A and B in people aged 65 years and older.
Seniors who contract seasonal influenza are most susceptible to complications that can lead to hospitalization and death. The new vaccine, which contains 180 μg of influenza virus hemagglutinin (HA), rather than the standard 45-μg dose, has been shown to produce an enhanced immune response in this population.
"As people grow older, their immune systems typically become weaker," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research, in an agency news release. "This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza."
The FDA also warned that the high HA content has been linked to an increased rate of "non-serious" adverse events compared with the company's standard influenza vaccine (Fluzone). Injection site pain, erythema, and swelling, as well as headache, muscle aches, fever, and malaise, were the most commonly reported adverse events. Because it contains egg protein, the vaccine should not be used in people who are allergic to eggs or egg products.