Nasal flu vaccine developed at ''U'' not endorsed by FDA panel

BY DAVID BAYBIK
Daily Staff Reporter
Published August 12, 2001

Although the U.S. Food and Drug Administration"s Vaccines and Related Biological Products Advisory Committee declared the effectiveness of FluMist, the new influenza vaccine developed by University Prof. Hunein "John" Maassab, the committee determined July 27 there is insufficient data to affirm its safety.

For that reason the VRBPAC has decided to postpone a decision to commercially license the drug.

The adequate safety of the attenuating vaccine is one piece of the puzzle that remains to be put in place.

FluMist, developed at the School of Public Health"s Department of Epidemiology, facilitates the prevention of influenza in both children and adults from the ages of one to 64.

Sprayed into the nasal passages as a mist, the vaccine is intended to stop a flu virus even before it enters the lungs, where it may thrive.

"The vaccine thinks about the flu as an airborne flu if you can generate an immune response to stop the wild virus dead in its tracks, it can"t get into the lungs where it causes disease," said Assistant Epidemiology Prof. Rosemary Rochford. "(FluMist is) a substitute to the traditional flu shot."

If the FDA finds that FluMist is indeed a safe solution and decides to license it, the vaccine will be the first of its kind to be commercially available in mist form.

Faculty and staff at the School of Public Health remain confident that FluMist will soon hit the market and become a successful and useful vaccine.

"FluMist already missed the 2001 to 2002 winter season, but we are hopeful that it will be available for the 2003-2004 winter season," Rochford said. "(Maassab) has been working on this for a long time, (waiting) one more year is part of the process."

If licensed, Aviron and Wyeth Lederle Vaccines, a division of American Home Products, would market the vaccine.

Statistics show influenza infects 35 to 50 million people each year in the U.S. alone. This results in 20,000 deaths and as much as $12 billion in direct and indirect costs for Americans.