October 28, 2009

How Europe Made Better H1N1 Vaccine Choices than the USA

The Wall Street Journal describes how Europe made better choices than the USA in regards to H1N1 vaccines

* Europe choose to use adjuvants

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


* Use Mammalian cells instead of chicken eggs to grow vaccine

Shots can be made much faster using mammalian cells to grow vaccine, and this process is already being used in Europe




* Preapprive adjuvants that can be used in multiple vaccines

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.


* Use assays to quickly assess vaccines instead of waiting weeks

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.


* invest in more modern facilities for manufacturing flu vaccine, particularly cell-based facilities.

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