Why You Can't Get the Swine Flu Vaccine
U.S. regulations are too cautious. Europe has adopted a more sensible approach.
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.
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.
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....
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....
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