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Helen Branswell of the Canadian Press brings us an in depth look tonight at some of the testing hurdles that the various competing pandemic vaccines must negotiate (or potentially, skip) in order for vaccinations to be offered this fall.
Vaccine manufacturers will conduct the normal safety and efficacy trials that are usually associated with each year’s vaccine, but a variety of government agencies in the United States and Canada are going to be looking at other issues.
There are serious questions regarding the co-administration of seasonal flu vaccines at the same time as the H1N1 vaccine. Probably not a problem . . . but it’s never been done before.
There will be trials to determine the usefulness, and safety, of adjuvants added to vaccines to boost the recipient's immune response. These aren’t licensed here in the US, but could conceivably be used under an Emergency Use Authorization.
And since most vaccines are still manufactured using eggs, people with egg-allergies have traditionally been told not to get the flu shot. There will be testing to try to determine how dangerous these vaccines really are for people with these allegeries.
Helen Branswell brings us greater detail in her story. Follow the link to read it in its entirety.
Studies aim to answer key questions as world readies for swine flu vaccination
Provided by: Canadian Press
Written by: Helen Branswell, THE CANADIAN PRESS
Jul. 19, 2009
A research scientist works in the vaccine research lab at the British Columbia Centre for Disease Control in this file photo.
THE CANADIAN PRESS/Darryl Dyck
TORONTO - A flurry of innovative vaccine trials is in the offing as governments and regulatory agencies prepare for the probable launch of mass swine flu vaccination programs in the fall.
The results of the trials could determine whether people with egg allergies can be offered pandemic (and regular) flu vaccine, whether pandemic and seasonal flu shots could be given at the same time and whether one company's vaccine can be given with another's adjuvant, a compound that boosts its potency.
Vaccine manufacturers are either unable or unlikely to undertake the complicated studies required to answer these questions. Governments will fund the work instead.
Infectious diseases expert Dr. Anthony Fauci says the goal here for organizations like the U.S. National Institute of Allergy and Infectious Diseases - which he heads - is to fill key knowledge gaps for vaccine regulators.
"What are they going to need that somebody else can't do?" Fauci explains.
Some of those priorities will be aired Thursday in Washington when the U.S. Food and Drug Administration's vaccine and related biological products advisory committee meets in a session on clinical trials for pandemic vaccines.
