Stretching the H1N1 vaccine may stretch the limits of safety

Secret Sauce

If FDA officials are nervous about approving a drug for widespread use, then count me in — I’m nervous too. You just know something is not quite right if this drug-happy agency is treading with caution.

But this time it’s not a drug. It’s a potentially dangerous component of a drug. And that drug is the H1N1 vaccine.

Rats and guinea pigs

You’ve probably heard the word “adjuvant” tossed around in reports about H1N1 vaccine availability. It sounds harmless enough. An adjuvant is something added to a medical treatment to enhance effectiveness.

Easy, right? But this is kind of a big deal with the H1N1 shot because supplies of the vaccine have been arriving slowly.

That’s why FDA Commissioner Margaret Hamburg felt some pressure recently. “Expert” armchair quarterbacks second- guessed her decision to NOT stretch H1N1 vaccine supplies with adjuvant.

Hamburg hung in there, though, telling Reuters that the agency didn’t want to “risk using them.”

Some scientists believe that the adjuvant over-hypes the immune system. Sure, it produces an immune effect. But it’s too much. It’s out of balance with the natural defense a healthy body mounts on its own. (Key word: “healthy.” The U.S. population, as a whole, is exhausted, stressed out, and overfed with bad food.)

Some European countries have already distributed H1N1 vaccines with adjuvant. But Hamburg pointed out that the pumped-up shots were mostly used in the elderly. Responses in children and pregnant women are still largely unknown.

Another cautious FDA official put it this way. She told Bloomberg that it’s a bad idea to give the altered vaccine to humans until research shows it won’t harm rats or guinea pigs.

All this caution! What the heck has gotten into the FDA?

Rest assured they’re not soft-pedaling this issue over at the CDC. Officials there have already agreed to pay two drug companies more than $400 million to produce an adjuvant. (When it comes to H1N1 vaccine program payouts to drug companies, taxpayer dollars flow like green beer on St. Patrick’s Day.)

On a CDC website that features a Q&A about the H1N1 vaccine, the CDC asks itself: “Will the 2009 H1N1 vaccines that are currently recommended contain adjuvants?”

Answer: “No.”

But that unqualified “No” is followed by two paragraphs of hazy bureaucratic double talk. Translation: “No plans to use it right now, but, you know, stuff happens.” Sometimes “No” doesn’t mean “No.”

Meanwhile, Canadian health officials have embraced the adjuvant-spiked H1N1 vaccine. They’ve already distributed more than eight million doses. But they also purchased non- adjuvant vaccines for infants, pregnant women, and one other group: stubborn hosers who would rather not play the role of guinea pigs in a national safety experiment.

To Your Good Health,

Jenny Thompson

Sources:
“FDA Chief Defends H1N1 Vaccine Supply” Susan Heavey, Reuters, 11/12/09, reuters.com
“Swine Flu Shot May Rely on Emergency Use of Additives” Tom Randall and Gary Matsumoto, Bloomberg, 7/29/09, Bloomberg.com
“Adverse Effects of Adjuvants in Vaccines” Viera Scheibner, Ph.D., Nexus, Vol. 8, No. 2, February 2001, nexusmagazine.com
“General Questions and Answers on 2009 H1N1 Influenza Vaccine Safety” Centers for Disease Control and Prevention, 11/3/09, cdc.gov