Why You Can't Get the Swine Flu Vaccine

[Guest guest]

Why You Can't Get the Swine Flu Vaccine By SCOTT GOTTLIEB

Though the swine flu is widespread in 46 states many Americans are still waiting

to get their vaccines. The Obama administration blames the shortage on

manufacturing delays at the five firms making these products. But production

issues only explain part of the shortfall. Also to blame are a series of policy

decisions that reflect our extreme caution when it comes to these products.

From a regulatory standpoint, vaccines are unique in many ways. Since we

distribute them widely to otherwise healthy people, they deserve careful

oversight. But right now we are shunning new, superior vaccine science by being

overly cautious.

On Saturday, when President Obama declared the outbreak a national emergency, he

enabled the suspension of federal rules in order to speed the distribution of

treatments. Yet less than half the projected vaccine has been actually shipped.

Supply is far below the government's estimate of 40 million ready vaccines by

November.

The first fateful policy decision, made last spring, was to forgo vaccine

additives—called adjuvants—that activate the immune system and make shots more

potent. Adjuvants allow a smaller supply of vaccine stock to be stretched across

more doses. These adjuvants are included in H1N1 vaccines world-wide, but not in

the U.S.

Why do adjuvants matter? An adjuvanted H1N1 vaccine being used in Europe

contains 3.75 micrograms of vaccine stock. The same vaccine in the U.S., without

the adjuvant, requires 15 micrograms of vaccine for equal potency. If we used

adjuvants, we could have had four times the number of shots with the same raw

material.

The second cautious decision was to require that the H1N1 vaccine be a single

shot. The government demanded single-dose syringes because they contain smaller

amounts of thimerosal than multi-dose vials. This mercury-containing vaccine

preservative continues to stir concern it can trigger childhood autism, even

though this has been firmly disproven.

The third policy decision was to stick for too long with a proven, but slow

process for making flu shots that uses chicken eggs to grow the raw vaccine

material. Shots can be made much faster using mammalian cells to grow vaccine,

and this process is already being used in Europe. The cell-based vaccines are

unlikely to be approved in the U.S. Our precaution when it comes to vaccines

means we don't easily embrace novel technologies, even if the Europeans would

part with some of their limited supply.

How can we improve our regulatory process to prevent such shortages? First, the

Food and Drug Administration (FDA) needs to create a review pathway for

adjuvants that can become components of multiple vaccines. One, called

monophosphoryl lipid A, was recently the first modern adjuvant to be approved in

the U.S.—in this case as part of a vaccine for cervical cancer. We've been slow

to integrate vaccine additives, bowing to imprudent activism and litigation. The

European strategy of having adjuvants preapproved, as part of mock up pandemic

vaccines, was smart. We should adopt it.

Second, the FDA requires vaccines to sit for weeks after they come off the

manufacturing line to make sure they haven't grown bacterial impurities. This is

why most of the H1N1 vaccine supply is released in waves and won't be ready

until later this winter. The FDA can work with manufacturers to develop better

standardized tools, called assays, to quickly assess new vaccine.

Finally, we need to invest in more modern facilities for manufacturing flu

vaccine, particularly cell-based facilities. These plants can be scaled more

quickly, enabling rapid production. A certain amount of these facilities should

be built here at home. In a full-blown pandemic, with a very deadly strain of

flu, it's hard to imagine that foreign nations would allow limited supplies of

vaccine to be shipped outside their borders.

The Obama team deserves credit for ordering vaccines early last spring when H1N1

first emerged. They contracted properly for the shots and negotiated a fair

price. But passing all the blame for our current vaccine shortage onto

manufacturers is unfair. The administration needs to take responsibility for

improving our current system.

—Dr. Gottlieb, a practicing physician and resident fellow at the American

Enterprise Institute, was deputy commissioner of the FDA from 2005-2007. He is

partner to a firm that invests in health-care companies. Printed in The Wall

Street Journal, page A21

http://online.wsj.com/article/SB20001424052748704335904574497324151841690.html