FDA Press Release: New Seasonal Vax Approved for People Over Age 65

[indigo girl]

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195483.htm

This is a very good thing. It has long been known that the elderly have a less than optimal immune response to influenza vaccines yet they are the group that is most severely impacted by seasonal flu. Now before anyone starts getting alarmed about

the accelerated approval process being used, consider this. It would appear that the

only thing different about this vaccine for the elders is the increased amounts of

antigen needed to generate that better immune response for this age group. Because more antigen is being used, there may be more "non serious adverse effects" and

they go on to list what they have been seeing thus far. These possible side effects

of the higher dose injection have been compared to those of the current dose being used by the same manufacturer, and thus far does not sound so very bad, and if it can prevent hospitalization and the death of our elders, it seems well worth it to me.

And, there is a thimerosal free version as well.

Accelerated approval process used in vaccine approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

“As people grow older, their immune systems typically become weaker,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “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.”

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

(hat tip pfi/Mn Eagle)