H1N1 COUNTERMEASURES STRATEGY AND ... - PHE Home

NBSB Pandemic Influenza Working Group
Detailed Report
easier. Using products that are not currently approved or not well understood, like a
new adjuvanted vaccine, is more problematic and we have to balance the risks and
benefits. The CDC and NIH are also play a part in the EUA oversight and approval
process. The agency can look at conditions it thinks are needed to make the product
more safe and efficacious. We have required safety sheets in some cases.
Dr. Rappuoli: We can make some decisions earlier, like formulations. We may not
need to wait for the second-dose data to do the analysis. We could produce lots of
vaccine earlier if we use adjuvants. Regarding strain drift, we don’t know if it will
happen or how much adjuvant will do if it does. With H5N1 and seasonal vaccine, we
know we could cover multiple clades with adjuvant.
We do know that there is little effect of adjuvant in seasonal vaccine on older people, but
there is an effect for younger people. Adjuvant increases immune response after one
dose, possibly providing earlier protection. Unpublished data have been submitted to
FDA on the quality of the immune response. Adjuvant increases recognized epitopes, so
the quality of the immune response is different (better). With adjuvant, you get a good
response in one dose.
Stephen Redd, M.D.: There is a plan for community engagement and recent experience
at CDC. We did a public engagement process for community mitigation guidance and
prioritization for vaccination. Those were intensive engagements. The scenarios
discussed were related to more severe H5N1. In this case, we have real-life scenarios and
public perception is likely to evolve over time.
Dr. Quinlisk: From a State health department perspective, we may be giving seasonal
influenza vaccine, the first dose of H1N1 vaccine, and a second dose of H1N1 vaccine,
treating people sick with H1N1, and tracking adverse events. We can’t handle that with
our current capacity, but, if this treatment plan is supposed to work, we need to do all of
that.
Dr. Pavia: To sum up, we’ve heard about the advantages of adjuvants for priming, mass
vaccination, and broader immune response as well as the potential liabilities that come
from paperwork, uncertainty, and political fallout. We need to think about how we can
make the decision-making process easier when the decision has to be made.
HHS Decision Planning—Bruce Gellin, M.D., M.P.H., NVPO
Dr. Gellin said decision planning is all about setting expectations. We need to think what
data elements will go into decision-making. No single group is responsible for making
these decisions and we need to think about the roles of other Federal advisory bodies in
advising on these issues, especially adjuvant. Every government is wrestling with the
question of what to do once a vaccine is available.
Decision Process—George Korch Jr., Ph.D., ASPR
Dr. Korch stressed the importance of having a strong decision-making process and the
difficulty of balancing multiple factors in making decisions about complex public health
concerns. In 1978, Neustadt and Feinburg said the failures with the 1976 swine influenza
vaccine stemmed from:
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