U.S. agency hopes secret recipes won?t hurt public health

[Snowy Owl]

Ways to stretch influenza vaccine supplies studied
U.S. agency hopes secret recipes won?t hurt public health
By HELEN BRANSWELL The Canadian Press

http://thechronicleherald.ca/Canada/564974.html
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No one would dream of asking Mr. Christie to share his cookie recipes with the Keebler elves.

But when it comes to pandemic influenza vaccine, secret recipes may get in the way of global public health needs.

With that in mind, U.S. government researchers are interested in conducting some unusual clinical trials, mixing the pandemic flu vaccine of some companies with proprietary boosting compounds called adjuvants made by their competitors.

The aim is to see whether, in the face of a serious pandemic, the best of these secret weapons could be used to improve the products of both their owners and their rivals, thereby increasing many fold the amount of influenza vaccine that can be made worldwide.

The director of the U.S. National Institutes of Allergy and Infectious Diseases suggested his researchers are eager to do the work.

"Certainly ? if the companies are . . . willing to partner with and utilize what we can bring to table, which is a clinical trial network and people who have expertise in clinical trials," Dr. Anthony Fauci said in an interview Thursday.

"The fundamental principle is something that we clearly are interested in."

But Fauci said there are technical issues that need to be addressed, including finding out from companies what goes into their adjuvants, because "when we mix it up with a particular antigen and inject it into somebody, we don?t want to do that blindly."

In fact, pandemic vaccine research contracts issued by the U.S. department of Health and Human Services earlier this year stipulated that the three recipients ? GlaxoSmithKline, Novartis Vaccines and Iomai Corp. ? must provide their proprietary adjuvants for government-sponsored studies to evaluate their effectiveness with vaccine made by other companies.

And at a hearing of a Food and Drug Administration advisory panel on pandemic vaccine late last month, a Health and Human Services vaccine specialist asked the gathered experts for guidance on how to design clinical trials to test this mix-and-match approach.

Whether vaccine manufacturers are quite as enthused hasn?t been entirely clear, though earlier this week there was a sign from GSK ? the world?s No. 2 flu vaccine maker ? that it will entertain the idea of licensing its proprietary adjuvant, called AS03, to other vaccine producers.

David Stout, GSK?s chief operating officer, told the Bloomberg financial news service that the U.S. government may buy GSK?s adjuvant to mix with H5N1 avian flu vaccine in the American national stockpile.

The stockpiled vaccine, made by Sanofi Pasteur, does not contain an adjuvant and must be used in extraordinarily high doses to be protective.

The Sanofi vaccine requires two doses of 90 micrograms apiece, which is 12 times more antigen than used in seasonal flu shots.

In contrast, GSK?s H5N1 vaccine, mixed with AS03, is effective at two doses of 3.75 micrograms.

If the world?s combined flu vaccine production capacity could be formulated in two doses of 3.75 micrograms, there could be enough vaccine to vaccinate nearly two billion people in the first year of a pandemic.

At two doses of 90 micrograms, however, that figure falls to 75 million people.

Asked to clarify how willing it is to share, GlaxoSmithKline said this Thursday:
"GSK is currently investigating how best, in the midst of a pandemic, to provide its adjuvant system to other organizations within regulatory and clinical guidelines," it said in a statement.

"We are always open to discussing with governments ? or other companies ? options that would help them prepare for a pandemic.
"This could include solely providing them adjuvant for use with (another company?s) antigen for making pandemic vaccine."

Other companies are working with proprietary adjuvants of their own to try to meet or best GSK?s results.

For instance, Sanofi has already started a clinical trial with an unnamed proprietary adjuvant and hopes to have results later this year. But it too said Thursday it is open to exploring all options.

"Sanofi Pasteur is committed to supporting government initiatives and to producing as much pandemic vaccine as possible ? as quickly as possible ? of the most advanced vaccine candidate at the time of a pandemic declaration.

"To that end, we are willing to explore any opportunities the government proposes if those efforts will lead to improved supply," the company said in a written statement.

Fauci cautioned, though, that it remains to be seen whether one company?s adjuvant will work as well with another company?s vaccine.
"Whenever you assume generalizability (of results), there are always things that come up that are unexpected," he said.

"But you need to pursue if it is generalizable and that?s where we come in to try to see if we can bridge that gap of knowledge."