Report to the President on U.S. Preparations for 2009 H1N1-Influenza

[HonestRN]

Here is a link to the full 86 page report to the White House concerning H1N1 preparations for 2009.

http://www.whitehouse.gov/assets/documents/PCAST_H1N1_Report.pdf

[HonestRN]

Indicators of substantially increased severity that might justify changes in plans for antiviral use, vaccine formulation (adjuvant use), or community mitigation.

••observations of novel symptomatology in the Southern Hemisphere or in isolated Northern Hemisphere groups during summer, especially if combined with evidence of viral changes associated

with this symptomatology;

••increased ratios of ICU admissions to overall hospitalizations for influenza-like illnesses (ILI) (probably

not observable unless very large changes occur);

••early evidence of intense burdens on health care providers without evidence that the infection is peaking; changes in risk groups to include more healthy adults or children among severe cases.

In addition, concentrations of unusually severe cases could occur in a population subgroup defined by geography/ethnicity (e.g., a remote Native American population), by underlying medical condition (e.g., pregnancy or a novel risk factor), or by place of residence (e.g., nursing home, prison). In such cases it will be urgent to provide adequate treatment for affected persons, consider accelerating vaccine delivery to similar groups, and ascertain reasons for this increased severity, distinguishing viral changes from infectious cofactors, host factors, or other reasons.

page 19 of report.

pages 36 & 38 deal with the possible use of adjuvants under the Emergengy Use Authorization by the FDA

[indigo girl]

http://www.whitehouse.gov/assets/documents/PCAST_H1N1_Report.pdf

Trigger for using adjuvant.

The effectiveness of vaccines can often be increased by co-administration with adjuvants, substances that can amplify an immune response when mixed with an appropriate antigen, allowing the dosage of antigen to be decreased. Thus a given amount of antigen can be used to immunize more individuals. This strategy may be important if a vaccine is poorly immunogenic (and

thus requires a large quantity of antigen) or if vaccine supplies are insufficient to fill an urgent national need. A supply of one adjuvant (MF59) has been ordered and stockpiled for possible use with the 2009- H1N1 vaccine.

Adjuvants are not currently approved for use with influenza vaccines in the United States, although they have been approved and are being used with influenza vaccines in Europe. Accordingly, the use of adjuvants would require an EUA by the FDA. Given these circumstances, there is reluctance to use adjuvants unless they are clearly necessary to extend the vaccine supply. The Working Group encourages DHHS to develop quantitative criteria (vaccine efficacy, severity of epidemic) that would trigger a decision to use adjuvants and to ensure that sufficient data are available for the FDA to grant an EUA.

From Page 38

[HonestRN]

Although clinical trials of 2009-H1N1 vaccines with adjuvants are planned for the coming months, it will not be feasible to obtain standard FDA approval in time for use this fall. Nonetheless, it would be desirable to achieve licensure of the currently available adjuvants for use in the near future. Beyond existing adjuvants, recent advances in immunology point the way to powerful new types of adjuvants, the pursuit of which may ultimately enhance the efficacy and lower the costs of influenza vaccines.

page 64

[indigo girl]

Well there you have it. No adjuvants this fall. Thank you!

[HonestRN]

Well there you have it. No adjuvants this fall. Thank you!

I'm thinking that is correct however I do think if things get dire that they may use the EUA for adjuvants.

[indigo girl]

There is that possibility. They don't want to use them, but they might have to.

It's part of the backup plan.