CREW: U.S. Department of Health and Human Services: Regarding Distribution of The H1N1 Vaccine: ASPR Records Redacted - (Released Pages) 1st Partial

Chief of Staff
H1N1 Update
Agenda
July 31, 2009
12:30 p.m. – 1:15 p.m.
Room 638 G
(ASPR Main Conference RM 638G)
1. New item:
a. NVAC and ACIP Summary and Reflections (Gellin / Schuchat)
i. NVAC Financing Recommendations are included at the end of these

meeting minutes.
ii. NVAC Safety Recommendations can be found here:

http://www.hhs.gov/nvpo/nvac/Draft2009H1N1VaccineSafetyMonitor
ing.html
Related: CDC is planning an adverse events drill, the need for which
was reinforced by the White House earlier this week. FDA reinforced
that many vital questions including what systems will be leveraged and
who is leading, co-leading, and/or supporting safety monitoring need
to be answered BEFORE the drill to bolster the usefulness of the
exercise. NVPO will ensure relevant DOD and VA representatives are
involved given their participation in a related ASH-led federal task
force on vaccine safety.
Action: CDC, FDA/CBER and NVPO will coordinate on planning
and execution of the CDC-sponsored adverse events drill.
iii. ACIP Recommendations can be found here:

http://www.cdc.gov/media/pressrel/2009/r090729b.htm
The HHS Secretary may add target groups consistent with the low
severity tier 2 groups identified in the 2008 pandemic vaccine
allocation guidance. The COS and NVPO (Gellin) are leading
discussions with DHS staff on this issue. The COS requested further
conversation on the ACIP recommendation related to the 65+ group.
b. Other
i. Antiviral use guidance
CDC mentioned that work on antiviral use guidance is ongoing and it

is likely to support post exposure prophylaxis of high risk groups in
addition to treatment for those with ILI. A number of questions were
raised about state and local readiness to dispense antiviral drugs
quickly and effectively, the challenges of recommending prophylaxis
in the context of potentially limited marketplace supply and public
stockpile use policies that aim antiviral drugs for treatment only.
Action: CDC will prepare draft guidance and brief this group next
week on the guidance and plans to engage S/L governments on
best practices (Note: the National Framework requires this
guidance by 1 August).
ii. Outreach to provider groups
Conversations with providers need to be ratcheted up and cover a

multitude of issues and concerns including use of antiviral drugs and
identifying and managing high risk population groups including
pregnant women and asthmatics. CDC sponsors COCA calls but there
may be audience gaps. Also, HRSA and IHS need to be involved in
outreach to these communities.
Action: ASPR (G. Michael) will reach out to the COCA lead to
identify any gaps in outreach.
Action: ASPR (Helminiak) will form a working group on outreach
to medical groups. Please contact Clare if you would like to take
part in this working group.
2. Update/Follow-up:
a. Continuing Discussion of School Guidance (Redd )
The latest draft of the school guidance has been sent to key interagency staff
for review; it is also being reviewed by senior staff in OS and comments will
be sent to CDC by the end of the day. The COS is (b)(5)
(b)(5)
(b)(5)
(b)(5) with
conver (b)(6)
mentioned that the webinar may be pushed up but the date remai n.
Both Secretarys Duncan and Sebelius are available on Monday 10 August
(Secretary Napolitano is not available that day but the webinar may go one
without her).
Action: HHS Senior leadership will forward comments to CDC NLT
COB today.
Action: CDC will develop a one to two page executive summary of the
school guidance document NLT COB Monday.
Action: ASPA will update this group next week on roll out plans.
3. Action items:
a. Comprehensive Vaccine Safety presentation to Dr. Lurie
b. Tribal Access to State Planning Funds (Lurie)

For Official Use Only
Chief of Staff
H1N1 Update
Meeting Minutes
August 4, 2009
12:30 p.m. – 1:15 p.m.
Room 638 G
1. New item:
a. H1N1 Vaccine: Fill and Finish Decision Making (Robinson)
ASPR / BARDA presented three options on the timing of the 2009-H1N1

vaccination program: to have vaccine available in September, October, or
November. The fill and finish process needs to start about 4 weeks before vaccine
is needed. The varying amounts of vaccine that are expected to be available in
each option were discussed. Based on the characteristics of 2009-H1N1 flu seen
thus far, the group leaned towards starting a vaccination campaign with the 36 -
40 M doses of vaccine that should be available in late September, although no
decision was made. That would require manufacturers to begin to fill and finish
very soon. Discussion is to continue Wednesday. (b)(5)
(b)(5)
i. Action: ASPR / BARDA will circulate a table displaying week by

week vaccine availability for discussion by Wednesday
ii. Action: By the end of this week, HHS needs to make a decision on
the start date of a vaccination program, so ASPR / BARDA can
communicate with the manufacturers regarding when fill and
finish needs to begin.
(b)(5)
b.
(Helminiak/Schuchat)
(b)(5)
(b)(5)
Thursday. Since similar questions were asked to DHS, a call has been set up to
coordinate responses between the two Departments.
(b)(5)
(b)(5) which are due at
to discuss
For Official Use Only
outstanding concerns at Wednesday’s COS meeting, and brief the

Secretary.
a. School Preparedness Guidance

i. Status of guidance + executive summary (Redd)
ii. Roll-out strategy (Backus)
Not discussed. On agenda for Wednesday’s meeting.

Chief of Staff
H1N1 Update
Minutes
August 7, 2009
12:30 p.m. – 1:15 p.m.
Room 638 G
1. Pillar updates (10 minutes)
a. Surveillance
Yesterday’s MPHISE meeting went well. The SORT tool, otherwise

affectionately referred to as “Am_I_sick.gov” was well received and a
working group will be formed to manage dissemination/implementation
challenges. ASPA relayed that the White House is interested in designing
flu.gov around this new tool. There is a meeting scheduled for Monday that
will engage on the legal issues related to hosting this tool on the HHS web.
b. Mitigation Measures
i. Medical Surge
A test of the HAVEBED System is being planned; the target date for
reporting should be NLT 1 September. Also, a meeting with CMS will
take place next week to discuss coordination of data collection efforts.
ii. Community Mitigation
The School Preparedness Guidance and Tool Kit were well received
(many kudos to CDC and others who contributed!). USDA and ED
Secretaries will publish a letter related to resources for continuing
school based lunch programs in the context of school closures.
iii. Medical Countermeasures
N/A
c. Immunization
It continues to be difficult to learn how States are progressing with their

planning for a campaign. Also, CDC has established a robust logistics
planning group; this group will need to be tapped to help answer a number of
questions the Secretary has about how doses will be moving and allocated
within States. Action: Elin Gursky will be coordinating efforts to draft
summary statements on these issues.
d. Communications
ASPA, ASPR and CDC communications staffs are drafting a list of key
populations group for outreach. Also, DHS is leading the drafting of a
business outreach plan that includes guidance for the private sector. CDC and
ASPR are supporting t
(b)(5)
(b)(5)
SPA before it goes to the White House.
e. HHS Workforce
A memo on antiviral and PPE purchase in support of HHS workforce

protection is being finalized. This memo will pave the way for procurement.
(b)(5)
(b)(5)
further distribution to Federal
employees, the first of which is not on message. Action: CDC will identify a
POC to work with Ilka Chavez and ASPA on this and related OPM
messaging issues.
2. New Items:
a. Overview o (b)(5) briefing (Lurie/Petrou)
(b)(5)
However, the meeting confirmed that HHS needs a better way to

communicate about vaccine supply.
b. Update on funding/spend plan development (ASRT)
Primarily tabled for Monday but ASRT did summarize that a package was
being drafted for both additional antiviral purchases and vaccine distribution
(e.g. McKesson) but ASRT is waiting for final paperwork on Pneumococcal
vaccine. RADM Redd also expressed concern that the timetable for another
ask out of the contingency emergency appropriation may result in HHS
having vaccine available but no funding to support administration. This
discussion will continue on Monday.
The Fill and Finish memo will go to the Secretary today for signature with the
goal of communicating with the manufacturers before the end of the business
day.
c. Other
i. As Gretchen briefed, there is an ongoing interdepartmental effort to
draft guidance for businesses/private sector and DHS would like the
guidance ready for roll out the week of 17 August if possible. The
COS suggested the following roll out activities: 1) Meeting between
the President and business leaders and 2) a letter from the Secretaries
of DHS, HHS, LABOR, and perhaps other Departments.
ii. Action for CDC: The timetable for the HHS/CDC early childhood
guidance needs to be accelerated.
iii. Action: Gretchen Michael will forward the latest guidance release
schedule to the COS.
iv. PCAST is briefing the President today and may be releasing the report
to the public on Tuesday.
v. The COS illustrated how complicated it will be to communicate with
the public about who should be receiving which vaccine and when and
suggested a table or graphic to help communicate these concepts. She
also suggested meetings with families to gain a better sense of their
level of knowledge. Next week CDC will brief this group on the
vaccine communications plan which accounts for her concerns.
N/A
4. Outstanding Issues
a. Purchasing of IV antiviral drugs (scheduled for discussion on Monday)

b. Pneumococcal Vaccine Purchase Strategy (Robinson / Schuchat / Redd)
c. Status of Vaccine Priority Group recommendations (Schuchat / Redd)
5. Due Dates for Documents
N/A
Chief of Staff
H1N1 Update
Minutes
August 11, 2009
12:30 p.m. – 1:15 p.m.
Room 638 G
1. Pillar Updates (10 minutes)

a. Surveillance – N/A
b. Mitigation Measures – N/A
i. Medical Surge
ii. Community Mitigation
iii. Medical Countermeasures
c. Immunization – N/A
d. Communications – N/A
e. HHS Workforce – N/A
2. New Items
a. Pneumococcal Vaccine Communications Plan (Redd)
Communications Plan Goal: Reinforce ACIP recommendations for use of

Pneumococcal vaccine but with an emphasis on the younger age group (25 to 64
year olds with underlying conditions); Audience: providers; Timing: As soon as
possible
To promote increased and available supply of vaccine, ASPR and CDC proposed
purchasing 250,000 doses, via the VA schedule. These doses will be vendor
managed and there will be options available for additional purchase if necessary.
NIH, FDA and OPHS concurred with the recommendation. CDC confirmed there
was no existing stockpile of this vaccine.
Action: ASPR/BARDA and CDC will draft a paper, to include budget
implications, for formal signoff
b. H1N1 Vaccine Communications Plan (Butler)

A completed communications plan for the H1N1 vaccine should be available by
the end of next week however the major goals will be the following:
Strategic Goal: provide critical information to partners and guide expectations;
Audience: Providers, media, and high risk populations (pregnant women will be
the most difficult to reach due to the dynamics of the vaccine itself and the
relative inexperience of OB/GYNs; CDC is having discussions with ACOG and
this provider group can share information on where pregnant women can most
easily access vaccine if not provided in their providers office).
Sub Goals: coordinate H1N1 vaccine messages with community mitigation,
seasonal flu and Pneumococcal messages; provide situational awareness on
campaign progress; enlist public and private organizations as part of the solution
To assist with planning and implementation, CDC is hosting a journalist
workshop 24-25 August.
Action: This communications plan will need to be shared with the White
House before finalized.
3. Update/Follow-up
a. Other
Estimates of vaccine production will be provided every Friday at the COS

Update meetings.
a. Purchasing of IV Antiviral Drugs (scheduled for discussion week of August

10-BARDA)
N/A
b. Pneumococcal Vaccine Purchase Strategy (Robinson / Schuchat / Redd)
Complete.
c. Status of Vaccine Priority Group Recommendations (Schuchat / Redd)
The CDC reported that the ACIP Statement is going through clearance
without a footnote allowing Federal government discretion to support
homeland and national security missions and additional critical infrastructure
groups. The COS will follow up with CDC leadership on whether clearance
should continue to be pursued.
5. Due Dates for Documents

Chief of Staff
H1N1 Update
Minutes
August 14, 2009

12:30 p.m. – 1:15 p.m.
Room 638 G
1. Pillar updates (10 minutes)

a. Surveillance – N/A
b. Mitigation Measures – N/A
i. Medical Surge – N/A
ii. Community Mitigation – N/A
iii. Medical Countermeasures – N/A
c. Immunization – N/A
d. Communications – N/A
e. HHS Workforce – N/A
2. New Items:
a. Vaccine Production Timetable (Lurie/Robinson)
The National Biodefense Science Board (NBSB) is meeting today and HHS will
discuss the latest information on vaccine production timelines. We are expecting 40
to 54 million doses will be ready for distribution by Oct 12 with additional doses
coming on line every week afterwards. Reasons for the reduced amount of vaccine
available by this date include issues related to yield, reagents, filling lines and
contractual arrangements between one of the manufacturers and the country in which
they reside.
b. Other
i. Dr. Lurie expects a copy of the PCAST report to be shared shortly. An

advance copy of their recommendations and a tracking table has been
disseminated to principals within the Department for the purpose of tracking
progress on these recommendations. Dr. Lurie would like relevant operating
and staff divisions to populate the table of recommendations with status
updates by Monday morning 8/17. ACTION: Please forward status updates
on the PCAST recommendations, in the table provided, to Michala Koch
by Monday morning.
ii. The ASH requested a master summary of advisory committee

recommendations. ACTION: If a master summary already exists, please
forward it to Casey Wright by COB Monday 8/17.
iii. Drs Lurie, Parker and Robinson held a series of productive calls with the
manufacturers this week. The CEOs expressed great appreciation for FDA’s
efforts to expedite fill line inspection and the working relationship they have
with both FDA and ASPR/BARDA.
iv. The White House, DHS and HHS are collaborating with other interagency
partners to support the deployment of State Assessment Teams to assess
H1N1 planning progress, determine common barriers and assess where
additional Federal support would be beneficial. These teams will be led by
the Regional Health Administrators who will be coordinating with HHS assets
in the regions including CMS, CDC and ASPR, and interagency assets
including Education and Veteran’s Affairs partners. Elin Gursky is
coordinating this effort from HHS Headquarters and she is developing the
common tool for information gathering.
v. The OMB Office of Information and Regulatory Affairs (OIRA) will be

reviewing all significant HHS guidance. They require 3-4 days to conduct
their review but are willing to review near-final drafts. The COS will be
responsible for transmitting the guidance to OIRA for review; the DHS/HHS
business guidance will need to be sent to OIRA by close of business today or
soon after to meet release timeline. ACTION: CDC, please forward the
latest draft of the business guidance to the COS as soon as possible.
vi. CMS reported they are answering questions related to vaccine reimbursement,
including drafting a policy paper related to vaccines used under EUA.
N/A
a. Status of Vaccine Priority Group Recommendations (Schuchat / Redd)
CDC is evaluating the impact of the recent vaccine production numbers to determine
if the ~40 million ACIP priority groups should be targeted vs. the ~160M target
groups. The challenge is balancing the number of available doses and the capability
of the delivery system/operational feasibility.
The final statement on priority groups should be ready by Tuesday of next week. The
statement will be accompanied by a state planners guide (although simultaneous
release is not likely) and that guide will need to be coordinated with the State
Assessment Team questionnaire and assessment process.
b. Purchasing of IV Antiviral Drugs (scheduled for discussion week of August 10-
BARDA)
The final memo has been prepared after incorporating review from relevant agencies;
it is with the ASPR Exec Sec group awaiting signature.
5. Outstanding Deliverables
a. Pneumococcal Vaccine Implementation Paper (Robinson/Butler)
Will be discussed in further detail next week
b. Vaccine Communications Plan (Seasonal, Pneumococcal and H1N1) (Butler)
Dr. Koh requested dialogue on plans to accelerate the launch of a seasonal influenza
vaccine campaign and the communications role out. This will be discussed next week
in the context of the CDC vaccine communications plan.
Chief of Staff
H1N1 Update
Meeting Minutes
August 17, 2009
12:30 p.m. – 1:15 p.m.
1. New Items:
a. This Week: Guidance Release Dates and Communications Strategy (Michael)
i. The Updated Interim Guidance for Businesses and Employers to Plan and
Respond to 2009 H1N1 Influenza will be released on Wednesday baring any
last minute challenges. Roll out activities include stakeholder calls on
Tuesday 18 August, a Cabinet level press conference hosted at the Department
of Commerce on Wednesday 19 Aug and a sub-Cabinet level web cast on
Thursday 20 Aug.
ii. Post-secondary education guidance is nearing completion with release planned

late this week or early next. The roll out strategy is still under development
but Education Secretary Duncan is anxious for this guidance to be published
and he could be available as soon as Thursday for release activities.
iii. The HHS Secretary will be in Ohio later this week hosting an H1N1 back to
school event with parents and teachers.
iv. The ACIP Statement, via MMWR, is ready for release except for a pending
question related to 2nd dose of vaccine for people over 9 years old and the
need for an EUA. Depending on this answer, the ACIP Statement may need
to be revised thus publication is on hold until resolution.
When the ACIP Statement is released, our response to questions related to

sub-prioritization will need to be clearly outlined. As of today, there are no
plans to support sub-prioritization and who will receive early vaccine will be
left to State and local governments.
CDC is drafting materials to facilitate State and local planning for

vaccination; this planning tool will be posted on flu.gov and introduced during
weekly calls held with ASTHO and NACCHO. This planning tool will relay
our best information on what will arrive when and how it will be allocated.
Action: Elin Gursky/team will present a proposed roll-out strategy for

reviewing clinical trails data. Additionally, a suggested flow chart for
staged distribution of vaccine to high-risk groups will be presented.
1
a. Purchasing of IV Antiviral Drugs (Petrou/Lurie)
There should be a Secretarial decision by tomorrow on the purchase of IV antiviral drugs.
N/A
a. Pneumococcal Vaccine Implementation Paper (Butler/Robinson) - N/A
b. Vaccine Communications Plan (Seasonal, Pneumococcal and H1N1) (Butler) – N/A
5. Other
a. State Assessment Teams
These teams, who will be leading rapid field assessments of State vaccination
strategies and readiness, will be led by the 10 RHAs. Each will be responsible for
information gathering (including a team-sponsored half day meeting), analyzing level
of preparedness, and providing comprehensive reports (10 regional reports later
synthesized down to one final report). The teams should be in the field by next week
and they will be visiting those States and Territories identified by CDC as having the
least developed vaccination plans based on previous evaluation efforts.
Challenges related to the coordination of these teams with the DHS Regional
Coordination Teams highlight the need to define this as a “one government” and ESF
8 mission that will set the stage for any necessary longer term support throughout the
H1N1 outbreak.
Action: IGA, OPHS, CDC and ASPR will coordinate on strategies to engage
with the US Virgin Islands and Pacific Territories.
2
Chief of Staff
H1N1 Update
MEETING MINUTES
August 21, 2009

12:30 p.m. – 1:15 p.m.
1. New Items:
N/A
a. Spend Plan Update (Turman)
ASRT is working closely with OMB to free up funding for both antigen/adjuvant
purchases and vaccine distribution. It was hoped we could start the clock today by
notifying Congress of our intent but this looks unlikely. ASRT will keep this group
posted on the status of this issue.
b. Final ACIP Statement (Redd/Schuchat)
The final ACIP statement will be released today (8/21) followed by online postings of the
following: Video with Dr. Schuchat, information sheets, Q&A, models and tools to
estimate staffing, guides for parents, guides for persons with certain medical conditions,
vaccine information statements, school clinics, safety and monitoring, etc.
c. Purchasing of IV Antiviral Drugs (Petrou/Lurie)
Secretary Sebelius has approved the purchase of IV Antiviral Drugs. ASPR/BARDA is

now in negotiation with the manufacturers about purchase.
d. Other
a. CMS Open Forum
CMS held an open forum yesterday in coordination with CDC, HRSA, and
ASPR. The advance collection of questions allowed for a substantive dialog on
H1N1 with the 2200 people who attended the session. Despite extensive
guidance, the HHS staff fielded numerous basic questions about H1N1. An
additional 250 emails with more questions were received after the call. A
continuation of this forum will convene on September 14.
A meeting today with AHA had similar results; HHS staff fielded a number of
basic level questions about H1N1.
ACTION: Sally Phillips will work with CDC, CMS, ASPA, and ASPR to
discuss options to improve healthcare-related strategic communications.
b. Update on yesterday’s Deputies Committee
(b)(5)
ASRT notified the group that OMB will host a meeting on Monday (8/24) to
discuss funding of international vaccine assistance. Richard and Laura will
discuss offline appropriate HHS representation. The question was raised if
appropriated funds can be used for international vaccine assistance.
(b)(5)
ACTION:
(b)(5)
c. Labor Day activities
Labor Day is an excellent opportunity to highlight publicly what H1N1 means for
workers.
ACTION: Ilka Chavez will follow up with DOL and ASPA on any planned
activities.
d. CMS issues
CMS reminded the group that providers are allowed to bill now for seasonal flu
vaccine.
CMS is also in the process of simplifying its website and making it easier to find
information on what Medicare and Medicaid will pay for.
Dr. Lurie relayed that AHA has asked for a summary of all new guidance and
major decisions that related to the provision of healthcare for H1N1 and the
development of such a summary should be considered.
N/A
a. Vaccine (Seasonal, Pneumococcal and H1N1) Communications Plan

(Butler/Sheedy/Nowak) – Scheduled for COS discussion Monday 24 August
b. H1N1 Vaccine Distribution to High Risk Groups (Redd/Butler) – Scheduled for COS
discussion Tuesday 25 August
c. Modeling Scenarios (Meltzer, Phillips, Olsen and Korch) – Tentatively Scheduled for
COS discussion Thursday 27 August
d. Pneumococcal Vaccine Implementation Paper (Butler/Robinson)
e. Q&A on Clinical Trial Results Scenarios (Backus/Michael)
Chief of Staff
H1N1 Update

MEETING MINUTES
August 27, 2009

12:30 p.m. – 1:15 p.m.
1. New Items:
a. Primary Care Physician Meeting (Levy)
CDC held a meeting over three calendar days in the week of August 24th to help
physicians and their practices deal with an increase of patients, and help relieve
the burden from hospital emergency rooms. Attendees included primary care
physicians, OB/ GYNs, pediatricians, their office managers and administrators,
representatives from relevant professional societies, local public health, ASTHO /
NACCHO, and federal partners from DHS/ OHS, AHRQ, ASPR, and IHS.
A draft template for an office plan was shared with attendees, and a draft flu
organizer will be shared in September. Attendees were very enthusiastic, and
several volunteered to review the draft organizer.
ACTION: BARDA will provide CDC with pictures of the vaccine / ancillary
supply kits that physicians will receive to help create an information sheet for
physicians.
ACTION: Deborah Levy will share the presentation on vaccine given at this
meeting.
b. Vaccine Shipment Start Date (Gellin)
Approximately 15M doses of vaccine will be available at the end of September,

but no decision has been made yet as to how these initial doses will be used.
Clarity is needed as to when vaccine shipping, and thus immunizations, will start,
and how that vaccine will be for. States need a concrete date and adequate notice
to plan appropriately. There has been much confusion after release of the PCAST
report if the immunization campaign will start before October 15 or not. There are
many possible ways to use the first 15M doses that need to be weighted against
programmatic constraints and considerations.
ACTION: A small group discussion will occur on Monday at 12:30 PM in
place of the regular COS meeting to determine how to target the initial 15M
doses of vaccine.
N/A
N/A
a. Modeling Scenarios (Meltzer, Phillips, Olsen and Korch) – Tentatively

Scheduled for COS discussion Tuesday September 1
b. Pneumococcal Vaccine Implementation Paper (Butler/Robinson)
c. Q&A on Clinical Trial Results Scenarios (Backus/Michael)

Chief of Staff
H1N1 Update
MEETING MINUTES
September 8, 2009
3:30 p.m. – 4:15 p.m.
1. New Items:
a. Modeling: Summary of Efforts and Scenarios (Korch)
The Modeling Summary of Efforts and Scenarios summarized federally funded 2009-
H1N1 modeling efforts in the following categories: vaccination, antiviral drugs,
laboratory support, community mitigation, epidemiology, and additional identified needs.
These efforts range in complexity from simple to complex, and are in various states of
competition (functional, in development, planned, ongoing, or concept). Although this
summary is not intended to be shared with the public, a shorter, reader-friendly version
will be developed and shared at a later date. The summary of these efforts is available on
the H1N1 knowledgebase site.
a. Update on Federal H1N1 Vaccine Use Policy Statement (Petrou)
The policy statement that immunization of civilian federal employees with 2009-H1N1
vaccine will follow ACIP guidelines has been shared with the White House, and was
presented to chiefs of staff from other federal departments and agencies at the USG-wide
Chief of Staff weekly lunch. A key message in this statement is that only healthcare
workers, EMS, and some day care providers will be targeted for early vaccine based on
occupational status, not other CI/KR groups included in the published 2008 Guidance for
Allocating and Targeting Pandemic Influenza Vaccine. Federal agencies were asked to
create demand for 2009-H1N1 vaccine among employees who fall into the ACIP target
groups. Furthermore, the decision to provide H1N1 vaccine to federal agencies for their
occupational clinics directly from CDC (instead of through states) has not yet been made,
but is likely to happen.
a. Respiratory Device Guidance (Redd)
a. Pneumococcal Vaccine Implementation Paper (Butler/Robinson)

b. Q&A on Clinical Trial Results Scenarios (Backus/Michael)
5. Other
a. Vaccine for private occupational health clinics
Large employers who operate across state lines also want to receive vaccine for their
occupational health clinics directly from CDC, instead of having to order from state
health departments in each state in which they have a business presence. This is not
logistically possible, but a standard response is needed for those who receive this frequent
question.
ACTION: ASPR (N. Natarajan) and CDC (J. Butler) will develop Q&As on this
issue and the question of how large employers could access SNS supplies distributed
to states.
b. Upcoming guidance documents
CDC guidance documents currently in clearance include guidance for 1) pregnant women
2) children with special health care needs and 3) revised guidance for clinicians. There
was consensus that the revised guidance for clinicians should explain the more limited
circumstances in which testing for H1N1 is now recommended.
ACTION: CDC will share with this group a summary of guidance documents under
development. This should include target dates to provide each document to OS for
HHS clearance, and estimated publication dates.
c. IOM recommendations on PPE use for health care workers
CDC is working on guidance for the use of N95 respirators that will balance the IOM’s
recommendations with an understanding of N95 respirator availability and need so the
guidance can be actually implemented. Product availability is the most difficult to
determine, but CDC is working to obtain a better estimate of product need. The document
will articulate how available N95 respirators should be prioritized within the health care
setting.
There is a meeting with unions on Wednesday, September 9th, a meeting with federal
unions on Friday, September 11, and a meeting with hospital groups later this week to
obtain input into the guidance.
d. Communications and Outreach
ACTION: CDC will add pharmacists to its clinicians and provider calls, if they are
not included already.
ACTION: Key messages, such as when sick individuals should see a doctor, that
managers should not require doctors notes for employees to return to work, etc,
need to be repeated consistently by spokespersons, so the public and other intended
audiences hears them and acts upon them,
e. PREP Act and H1N1 testing
f. Countermeasure Injury Compensation Program (CICP)
ACTION: HRSA and OGC will share the Q&A they are developing to explain why
liability protection for 2009-H1N1 vaccine is different than seasonal flu.
Handouts were used for this meeting:
Associated documents can be found within the “Relevant_ MEETING MATERIALS” folder, filed under the equivalent date.
Chief of Staff
H1N1 Update
MEETING MINUTES

September 11, 2009
12:30 p.m. – 1:15 p.m.
1. New Items:
N/A
a. Vaccine Production Update (Dr. Robinson)
Before clinical trial data indicated that one dose of vaccine should be sufficient in adults,
manufacturers had already printed package inserts saying that two doses of vaccine were needed.
The current projection of doses that should be available on September 30 is now 12 M (estimated
at 15 M last week).The lengthy process of the manufacturers to manually change the package
inserts contributes to this decrease in doses estimated to be ready by September 30. 28 M
cumulative doses of H1N1 vaccine should be available by mid October. By the end of 2009, 173-
194 M doses should be available. Additional details are available on the H1N1 restricted
knowledgebase website.
Ancillary supply kits should be available by September 22. The kitting will be done by a separate
contractor, and then shipped to McKesson for synchronized delivery.
b. Q/A on Clinical Trial Results Scenarios (Backus)
N/A
a. Process for Providing Vaccine to Federal Employees (Petrou)
The plan to provide vaccine to federal agencies through CDC is back on track. The policy
statement has changed into a letter from Secretary Sebelius and John Berry, the director of OPM,
and is currently at the White House, which wanted more specifics information added. The letter
1
should be finalized soon (hopefully Friday), and sent then to all Departments and Agencies early
in the week of September 14th.
The legislative branch has been looped into the implementation process through the Office of the
Attending Physician for Capitol Hill.
Action: ASAM will seek OPM’s assistance in connecting CDC with the judicial branch of
the USG.
Action: CDC will draft guidance for departments and agencies to order vaccine
a. Pneumococcal Vaccine Implementation Paper (Butler/Robinson)
b. Respiratory Device Guidance (Redd)
5. Other
a. Vaccine for DOD
Misinformation is circulating from OSD/ Health Affairs staff that OSD will vaccinate DOD
dependants.
ACTION: Dr. Parker will contact OSD/ Health Affairs to see if their leadership can correct
the misinformation being reported by their staff.
b. Federal Workforce Guidance
ASAM is working to modify CDC’s guidance for businesses and employers for the federal
government, which OPM will send out. It must be tailored to incorporate federal human
resources considerations.
c. Start date of Vaccination Campaign
If all goes well, vaccine produced by one company should arrive at McKesson to begin
distribution on September 23rd. When it’s available, CDC would like to do a dry run with a
limited amount of initial vaccine in four states (~ 300 doses).
There is a need to tell states when to expect vaccine, and when they should be ready to start their
immunization campaigns. From a logistical standpoint, it is unknown what the earliest possible
date is to first put vaccine into arms and noses. However, October 5th is the latest date when the
campaign could start, and still be considered “early.”
ACTION: By Monday, September 14, CDC should be able to tell States the immunization
campaigns start date, with a range of doses they should be prepared to receive. Deleted: campaign’s
2
ACTION: CDC will provide a briefing on vaccine distribution dress rehearsals.
ACTION: CDC to provide a briefing on the timeline and process for vaccine distribution
on Monday, September 14.
3
Page 1 of 1
Daley, Garfield (HHS/ASPA)
From: Wright, Casey (HHS/ASPR/OPSP)

Sent: Thursday, August 20, 2009 4:38 PM
To: Lurie, Nicole (HHS/ASPR/IO)
Cc: Gellin, Bruce (HHS/OPHS); Chavez, Ilka (HHS/ASPR/OPSP); Gursky, Elin (HHS/OS) (CTR)
Subject: Federal use of H1N1 vaccine
Dr. Lurie,
CDC is hosting a meeting next Thursday in DC to share with the Federal interagency details on the general
strategy for H1N1 vaccine distribution but specifically the procedures and protocols for vaccination of the federal
workforce. Before this meeting takes place, I think it will be important to have informed or have a plan to inform
interagency leadership what the final ACIP recommendations mean for federal workforce vaccination.
In 2008, the previous President approved a plan for vaccinating US residents; this guidance included a “less
severe” scenario. The ACIP recommendations leave out a number of categories of Federal personnel accounted
for in the less severe scenario including deployed and mission critical non-DOD personnel (e.g. overseas DOS
employees), domestic national security personnel (personnel in federal/state/local agencies deemed essential or
mission critical to sustainment of day-to-day or emergency operations), intelligence services, border protection
personnel, national guard personnel and manufacturers of vaccines and antiviral drugs (plus McKessen has
recently requested vaccine for 4,000 of their staff).
Based on a number of conversations at the sub-IPC level, interagency pandemic planners and their executive
leadership expect HHS to follow the 2008 guidance. Interagency staff are questioning why HHS would make the
unilateral decision to accept the ACIP recommendations without considering the impact on the Federal workforce.
I think we face a number of challenges: Should we give doses to Federal Departments for the purpose of
vaccinating employees who do not meet ACIP criteria, particularly in the first weeks of a national vaccination
campaign? If so, do we do this for all Departments or a subset (I am thinking here about any arrangements we
may have made with DHS)? Are we concerned that this sets a poor example for States and the general public?
Or is this consistent with ACIP concerns that we not turn anyone away?
Given the meeting next Thursday plus the release of the ACIP statement tomorrow, is this conversation
appropriate for the COS meeting tomorrow? Or should this be discussed separately? Or is this something
someone else has under control and I should stop fretting? Please advise.
R/Casey
3/25/2010
Page 1 of 5
From: Shimabukuro, Tom (CDC/CCID/NCIRD)

Sent: Friday, September 18, 2009 1:39 PM
To: Barnes, Bethanne (HHS/ASPR/RPE); Helminiak, Clare (HHS/ASPR/OPEO)
Cc: Goldhaber, Benjamin (HHS/ASPR/RPE); Chavez, Ilka (HHS/ASPR/OPSP); Smith, Amanda
(HHS/ASPR/OPSP); Pereira, Esmeralda (HHS/ASPR/RPE)
Subject: RE: Federal Workforce Vaccine - OMB Questions
Bethanne,
It looks good to me. Thanks for pulling this together.
Tom
Tom T. Shimabukuro, MD, MPH, MBA

CDR, U.S. Public Health Service
Pandemic Influenza Vaccine Coordinator
Health Services Research and Evaluation Branch
Immunization Services Division
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention (CDC)
Phone: 404-639-8542
Fax: 404-639-8614
Email: TShimabukuro@cdc.gov
Regular mail: 1600 Clifton Road, MS E-52, Atlanta, GA 30333
Express mail: 12 Corporate Square Blvd, Room 4324, Atlanta, GA 30329
From: Barnes, Bethanne (HHS/ASPR/RPE)

To: Shimabukuro, Tom (CDC/CCID/NCIRD); Helminiak, Clare (HHS/ASPR/OPEO)
Cc: Goldhaber, Benjamin (HHS/ASPR/RPE); Chavez, Ilka (HHS/ASPR/OPSP); Smith, Amanda (HHS/ASPR/OPSP);
Pereira, Esmeralda (HHS/ASPR/RPE)
Hello,
I have put together a consolidated set of answers to OMB based on the input that you have provided (below).
Can you please review these before we send them on?
1. Since federal agencies will be able to order vaccine directly, will other large companies? If not, why?
Corporations may not receive medical countermeasures (including vaccines and antivirals) directly from
the federal government. The CDC is using the same process to ship H1N1 vaccines to immunization
providers as is used for the childhood immunization program. Vaccine is allocated to states on a pro rata
basis for distribution and dispensing according to state influenza plans. Vaccine will be shipped to clinics,
offices, health departments, and other project area-designated sites which may include a mix of public
health and private sector sites via centralized distribution.
States working with the stakeholders in their jurisdictions determine the appropriate strategies for
3/25/2010
Page 2 of 5
distribution and dispensing of medical countermeasures. Businesses with occupational health clinics that
wish to provide vaccine for their workers have the option to register with the state health department and
request vaccine like other vaccine providers in a state. CDC has encouraged state and local health
departments to work with large employers and incorporate them into their planning. Additionally, state or
local government agencies may also order vaccine for and conduct vaccination clinics for their workforce.
2. Does the federal government have the data to centrally determine the number of workers in the priority
populations at each agency? Who has this data?
The CDC assumes that ACIP target groups (except healthcare workers) are evenly distributed across
agencies, such that a pro rata calculation should be sufficient. CDC is primarily concerned with
quantifying the number of healthcare workers and emergency medical services personnel in agencies
where providing direct patient care is a large part of their day-to-day operations. Adjustments in the initial
shipments to these agencies will be made to account for the high number of HCW/EMS. This really
involves VA, IHS, NIH, DOD, BOP, FOH and maybe a few others.
3. Otherwise, will agencies be asked to come up with these estimates on their own? How will they know?
The CDC will distribute vaccine on a pro rata or modified pro rata basis, based on dept/agency size with
some initial modification for agencies with high
numbers of HCW/EMS. Implementing the vaccination will be the responsibility of the dept/agency.
4. How will the allocations to federal agencies be factored into the State’s allocations, since federal workers
are located across the country. Also, will these allocations particularly skew vaccines needed in
DC/MD/VA?
The vaccine for the 3M Feds was taken out of the total vaccine order for the country. The federal
workforce is ~0.96% of the total U.S. population. The federal allocation reduces state pro rata allocations
by a fractions of a percent when factored in to the overall pro ratas, so in the grand scheme the federal
allocation in negligible.
Thanks,
Bethanne Barnes
Presidential Management Fellow
Program Analyst
HHS/ASPR/RPE
Phone: 202.205.2843
From: Shimabukuro, Tom (CDC/CCID/NCIRD)

Sent: Wednesday, September 16, 2009 5:41 PM
To: Helminiak, Clare (HHS/ASPR/OPEO); Barnes, Bethanne (HHS/ASPR/RPE)
Cc: Goldhaber, Benjamin (HHS/ASPR/RPE); Chavez, Ilka (HHS/ASPR/OPSP); Smith, Amanda (HHS/ASPR/OPSP)
Just some comments to go along with Clare's responses.
No, the private sector orders thru the State Depts of Public Health which control vaccine flow to the
States. Vaccine will be shipped to clinics, offices, health departments, and other project area-designated
sites which may include a mix of public health and private sector sites via centralized distribution. This is
the same process that is used to ship vaccines for the childhood immunization program to immunization
providers. CDC's centralized distribution mechanism will be substantially enhanced to provide capacity for
this activity in addition to shipping of other vaccines. Vaccine is allocated to states on a pro rata basis for
distribution and dispensing according to state influenza plans. Corporations may not receive medical
countermeasures (including vaccines and antivirals) directly from the federal government. Medical
countermeasures are provided to the states and are subsequently dispensed according to existing state
plans. States working with the stakeholders in their jurisdictions determine the appropriate strategies for
3/25/2010
Page 3 of 5
distribution and dispensing of medical countermeasures.
TTS: Businesses withoccupational health clinics that wish to provide vaccine for their workers have the
option to register with the state health department and request vaccine like other vaccine providers in a
state. CDC has encouraged state and local health departments to work with large employers and
incorporate them into their planning. Additionally, state or local government agencies may also order
vaccine for and conduct vaccination clinics for their workforce.
No. Each Dept put in a request and we will have to have CDC responds as to how they calculated the
pro rata allocation to each Dept.
TTS: CDC is primarily concerned with quantifying the number of healthcare workers and emergency
medical services personnel in depts/agencies where providing direct patient care is a large part of their
day-to-day operations. Adjustments in the initial shipments to these depts/agencies will be made to
account for the high number of HCW/EMS. This really involves VA, IHS, NIH, DOD, BOP, FOH and
maybe a few others. We assume other ACIP target groups are evenly distributed across agencies so pro
rata should be sufficient.
In HHS each agency had to determine their own tiered numbers.
TTS: CDC will distribute vaccine on a pro rata or modified pro rata basis based on dept/agency size with
some initial modification for depts/agencies with high
numbers of HCW/EMS. Implementing vaccination will be the responsibility of the dept/agency.
DC/MD/VA?
The vaccine for the 3M Feds was taken out of the total vaccine order for the country. Each dept is
working with CDC as to how to get their vaccine. If a dept uses FOH they can get the vx thru that, or deal
directly with Perry Point, or work with their private occupational health clinics. CDC is working with one
POC for each Fed dept.
TTS: The federal workforce is ~0.96% of the total U.S. population. When factored in to the overall pro
ratas, that reduces grantee pro rata allocations by a fractions of a percent, so in the grand scheme the
federal allocation in negligible.
From: Helminiak, Clare (HHS/ASPR/OPEO)

To: Barnes, Bethanne (HHS/ASPR/RPE)
Cc: Goldhaber, Benjamin (HHS/ASPR/RPE); Chavez, Ilka (HHS/ASPR/OPSP); Smith, Amanda (HHS/ASPR/OPSP);
Shimabukuro, Tom (CDC/CCID/NCIRD)
Importance: High
Bethanne here is a rough response. Amanda is sending a one pager and Tom S. at CDC will have to review for a
truly fulsome response on this.
OMB Questions:
No, the private sector orders thru the State Depts of Public Health which control vaccine flow to the States.
3/25/2010
Page 4 of 5
Vaccine will be shipped to clinics, offices, health departments, and other project area-designated sites which may
include a mix of public health and private sector sites via centralized distribution. This is the same process that is
used to ship vaccines for the childhood immunization program to immunization providers. CDC's centralized
distribution mechanism will be substantially enhanced to provide capacity for this activity in addition to shipping of
other vaccines. Vaccine is allocated to states on a pro rata basis for distribution and dispensing according to state
influenza plans. Corporations may not receive medical countermeasures (including vaccines and antivirals)
directly from the federal government. Medical countermeasures are provided to the states and are subsequently
dispensed according to existing state plans. States working with the stakeholders in their jurisdictions determine
the appropriate strategies for distribution and dispensing of medical countermeasures.
No. Each Dept put in a request and we will have to have CDC responds as to how they calculated the pro rata
allocation to each Dept.
In HHS each agency had to determine their own tiered numbers.
DC/MD/VA?
The vaccine for the 3M Feds was taken out of the total vaccine order for the country. Each dept is working with
CDC as to how to get their vaccine. If a dept uses FOH they can get the vx thru that, or deal directly with Perry
Point, or work with their private occupational health clinics. CDC is working with one POC for each Fed dept.
From: Barnes, Bethanne (HHS/ASPR/RPE)

To: Helminiak, Clare (HHS/ASPR/OPEO)
Cc: Goldhaber, Benjamin (HHS/ASPR/RPE)
Subject: Fw: Federal Workforce Vaccine - OMB Questions
Importance: High
Dr. Helminiak,
Here are the questions that OMB are currently bringing up. Can you help to answer these, or point us in the
direction of someone who can help?
Thanks,
Bethanne
From: Norton, Bonnie (HHS/ASRT)

To: Barnes, Bethanne (HHS/ASPR/RPE)
Sent: Wed Sep 16 12:01:55 2009
Subject: Federal Workforce Vaccine - OMB Questions
Bethanne,
OMB has several questions/concerns related to the federal workforce vaccine. I am hoping to answer some of
these at the staff level before it becomes a bigger issue. I have included their concerns. Please send me
responses today if possible, since this policy is now being discussed with federal agencies. Thank you!
Bonnie
OMB Questions:
3/25/2010
Page 5 of 5
DC/MD/VA?
Bonnie L. Norton
Presidential Management Fellow
Office of the Secretary / ASRT / Budget Office
U.S. Department of Health and Human Services
200 Independence Ave, S.W.
Washington, D.C. 20201
(202) 690-5419
3/25/2010
Page 1 of 1
From: Helminiak, Clare (HHS/ASPR/OPEO)

Sent: Thursday, October 29, 2009 1:27 PM
To: 'COMMCORPS_MEDOFFCRS@LIST.NIH.GOV'
Cc: Barror, Richard F. (FDA); Clark, Edith (IHS/PHX); Halliday, Christopher (IHS/HQ); Harlan,
David M (NIH/NIDDK) [E]; Helminiak, Clare (HHS/ASPR/OPEO); Mainzer, Hugh
(CDC/CCEHIP/NCEH); Milner, Michael R (HHS/OPHS); Nesseler, Kerry (HRSA); Pittman,
Robert E. (IHS/HQ); Rodenbeck, Sven (ATSDR/DHAC/CAPEB); Romano, Carol
(HHS/OPHS); Shepherd, Craig (CDC/OPHPR/DSLR); Siegel, Karen (AHRQ/COE); Welch,
Michael (IHS/PHX); Williams-Fleetwood, Sharon O. (ATSDR/DHAC/OD); Siegel, Karen
(AHRQ/COE); Williams, Robert C (HHS/OPHS); Bardack, Stephanie (HHS/ASPR/OPSP);
Smith, Amanda (HHS/ASPR/OPSP)
Subject: H1N1 Vaccine for Commissioned Corps officers
Importance: High
Attachments: Vaccine for Commissioned Corps Officers.pdf
Keeping the Corps deployment ready is of utmost important to all of us.

In HHS and in other departments in the Federal Interagency there may be Commissioned Corps officers that may
not have ready access, or any access, to employee H1N1 vaccination programs in a timely manner. This may
negatively impact deployability. This number of officers is difficult to quantify.
Please review the attached information and algorithm, and feel free to contact me if you, or officers in your duty
station, identify vaccine access issues.
3/25/2010
MEMORANDUM FOR HEADS OFI~TlV~"''{MENTS AND AGENCIES
FROM: KATHLEEN SEBELIUS

SECRETARY
~ ~
U.s. DEPARTMENT OF HEALTH AND HUMAN SERVICES
~ ~
JOHNBERR
DIRECfOR
U.s.OFFlC OF ERSONNEL A EMENT
Subject: Immunization of Federal Workers with 2009 HINt and Seasonal

Flu Vaccines
Date: September 30, 2009
Keeping the Federal workforcehealthy is ~top priority for President Obama during the upcoming
flu season. As the lead officials for the Governmentagenciesresponsiblefor human resources
policies affecting Federal employeesand for protecting the health of all Americans, we arejoined in
an all-out effort to reduce the spread of the 2009 HINI influenza viI11S.
On September IS, the U.S. Food and Drug Administrationlicensedthe 2009 HINI influenza
vaccine, which will be available starting next week. The 2009 HIN I vaccine is not intended to
replace the seasonal flu vaccine - it is intended to be used alongside seasonal flu vaccine.
Vaccination is the best way to prevent influenza infection and its complications. For this reason, we
are encouragingFederal agenciesto provide vaccine and intensivelypromote vaccination against the
2009 HINI flu as well as seasonal flu.
The Federal Government will offerthe 2009 HINI vaccine to its employeesand will follow national
guidelines for prioritization of the 2009 HINI vaccine, as outlinedbelow. All Federal employees,
except those with a severe allergy to eggs, are encouragedto get vaccinatedagainst the 2009 HINI
flu. In the initial 2 or 3 weeks of the 2009 HINI vaccinationprogram, limited vaccine may be
available nationwide, and specific target groups and high-risk subgroupshave been prioritized to
receive the first available doses. Thereafter, the 2009 HINl vaccine will be produced on a continual
basis and be available to all.
Target groups. The Advisory Committeeon hnmunization Practices (ACIP)provides

recommendationsto the U.S. Departmentof Health and Hwnan Services' (HHS) Centers for Disease
Control and Prevention (CDC) for the prevention and control of vaccine-preventablediseases in the U.S.
civilian population. ACIP recommendedthat specific groups receive the earliest doses of2009 HINI
vaccine. In making these recommendations,ACIP members consideredthe evolvingburden of illness
caused by the virust the age and risk groups most affected,anticipatedvaccine supply, critical
infrastructure and security needs, and vaccination strategies. ACIP's deliberationswere also infonned
by consultation with other Federal agencies and a review of vaccine allocationguidance developed as
part of pre-pandemic influenza planning during 2007-2008.
The ACIP guidelines recommend ~ as vaccinebecomesavailabl~vaccinationprogramsand

providers target vaccine first to the followingfive priority groups because they are at highest risk for
disease or complicationsrelated to the 2009 HINt virus:
. Pregnant women
. Persons who live with or provide care for infants less than 6 months old
. Health care and emergencymedical servicespersonnel
. Persons aged 6 months to 24 years
. Persons aged 2S to 64 years who have medical conditionsthat put them at higher risk for
influenza-relatedcomplications.
Further, ACIP recommendedthat if vaccine is initially availablein limited quantities, the following
subgroups (listed in no particular order) receive vaccine before others:
. Pregnant women
. Persons who live with or provide care for infants less than 6 months old
. Health care and emergencymedical servicespersonnel with direct patient contact
. Persons aged 6 months to 4 years
. Persons aged 5-18 years who have medical conditions that put them at higher risk for influenza-
related complications.
Change from 2005-2008 pandemic planning. This policy is based on the fact ~ unlikepandemic
influenza scenariosthe Federal Governmenthad previously planned for, the 2009 HINt virus is not
expected to threaten the continuity of Governmentor cause severe economic or social disruption. This
targeting strategy will be used nationwide and is based on health risk. Except for health care workers,
emergency medical personne~ and some day care providers,these recommendationsdo not target
specific occupational groups either within or outside the Federal workforce.
Timing. Overall, the initial target groups encompassabout 160million people - approximatelyhalf the
U.S. population - and the highest-risk subgroupsencompassabout 42 million people. Although all
persons over 6 months old, except those with a severe allergy to eggs, are encouragedto get vaccinated
against the new HINt flu in 2009t people in the priority groups are encouragedto get vaccine as soon as
it becomes available. The 2009 HINI vaccine will become available starting the week of October 5. In
the initial 2 or 3 weeks of the HINI vaccinationprogram, limited vaccine will be available,and
vaccinators should target the subgroups for whom the risk of HI NI influenza-relatedcomplications is
greatest. Thereafter, vaccine will be produced on a continual basis and be availableto anyone who
wants and needs it.
Federal Employees 2009 HINt Vacdnation. The Federal civilian workforcewill not receive any
special priority or preferential treatment. Like the generalpopulation, Federal workers in the target
groups are encouraged to get vaccinated as soon as vaccine is available.
Along with other major employers and good partners, many Federal departments and agencies will offer
voluntary vaccination for Federal employees,followingthe ACIP recommendationsbeing used
nationally, and covering the remaining employeepopulation thereafter. Federal vaccination sites can
help alleviate the anticipatedburden on State and local health departments,especially in areas with large
concentrations of Federal employees. Some Federal employeesmay choose to receive the HINI
vaccine through their personal health care provider or other private mechanism, as they can for seasonal
flu vaccine, depending on States' distributionplans. Any vaccine not used by Feder~ agencies will be
made available to the States.
Federal departments and agencies may register with CDC to receivevaccine and become a vaccine
provider for employees. Alternatively,they may use existing or new agreementswith Federal
Occupational Health or HHS's Supply ServiceCenter at Perry Point, MD, which are both coordinating
with CDC to receive vaccine for existing or new customers. In addition,the Departmentof Veterans
Affairs (VA) will vaccinate Federal health care and emergencymedical servicespersonnel at VA
medical centers across the Nation. To avoid double countingof Federal employeesand to ensure
equitable distributio~ vaccine provided to Federal agencies will be deducted trom the relevant States'
shares.
Vaccine shipments will be phased to ensure that Federal employeesare offered vaccine in the same
manner as the civilian population. The initial shipmentsof vaccine to the Federal Governmentshould
be targeted to health care and emergencymedical servicespersonnel and others in the highest-risk
subgroups. As more vaccine becomes available,other employeesin the original ACIP target groups -
and, ultimately, all employees - should be encouragedto get vaccinated.
We are committed to ensuring the Federal workforce has access to both seasonal and HINI vaccines as
recommended by the ACIP, and ask that we all do our part to followthese recommendationslaid out as
the best strategy for the Nation. Departmentsand agencieswill receive details on vaccinationordering
procedures separately.
Seasonal Ou. Seasonal flu vaccine is available now, and the Centers for Disease Control and Prevention
recommends that all persons over 6 months old, except those with a severe allergy to eggs, get their
seasonal flu vaccine as soon as possible.
Page 1 of 1
From: Smith, Amanda (HHS/ASPR/OPSP)

To: Bardack, Stephanie (HHS/ASPR/OPSP); Chavez, Ilka (HHS/ASPR/OPSP); Fernandez, Jose
(HHS/ASPR/OMSPH); Finne, Kristen (HHS/ASPR/RPE); Gill, Sara (HHS/ASPR/IO); Gursky,
Elin (HHS/OS) (CTR); Helminiak, Clare (HHS/ASPR/OPEO); Lawlor, Matthew
(HHS/ASPR/BARDA); Marinissen, Maria Julia (HHS/ASPR/OMSPH); Michael, Gretchen
(HHS/ASPR/OPSP); Natarajan, Nitin (HHS/ASPR/OPEO); OS ASPR ERCCR; Phillips, Sally
(HHS/ASPR/IO); Ray, Jennifer (HHS/OGC); Schafer, Julie (HHS/ASPR/BARDA); Shapiro,
Jonathan (HHS/ASPR/IO); Sherman, Susan (HHS/OGC); Smith, Amanda
(HHS/ASPR/OPSP); Tappero, Jordan (CDC/OID/NCHHSTP); Tytel, Jessica
(HHS/ASPR/OPSP); Wright, Casey (HHS/ASPR/OPSP)
Subject: FW: HHS-OPM Memo: Immunization of Federal Workers with 2009 H1N1 and Seasonal Flu
Vaccines
Attachments: HHs-OPM flu memo 09-30-09 final.pdf
For all who may be interested, the long anticipated memo HHS-OPM memo on immunization of federal workers
was sent out today.
Amanda M. Smith, MPH

Policy Analyst
Office of Policy, Strategic Planning and Communications
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
Pho
BB: (b)(6)
Em
3/25/2010
Policy of Immunization of Federal Workers with 2009 H1N1 Vaccine
The Advisory Committee on Immunization Practices (ACIP) provides recommendations to the

U.S. Department of Health and Human Services' Centers for Disease Control and Prevention for
the prevention and control of vaccine-preventable diseases in the U.S. civilian population. ACIP
recommended that specific groups receive the earliest doses of 2009 H1N1 vaccine. In making
these recommendations, ACIP members considered the evolving burden of illness caused by the
virus, the age and risk groups most affected, anticipated vaccine supply, critical infrastructure
and security needs, and vaccination strategies. ACIP's deliberations were also informed by
consultation with other federal agencies and a review of vaccine allocation guidance developed
as part of pre-pandemic influenza planning during 2007-2008.
Target groups. The ACIP guidelines recommend that, as vaccine becomes available,
vaccination programs and providers target vaccine first to the following five priority groups
because they are at highest risk for disease or complications related to the 2009 H1N1 virus:
• Pregnant women
• Persons who live with or provide care for infants less than 6 months old
• Health care and emergency medical services personnel
• Persons aged 6 months to 24 years
• Persons aged 25 to 64 years who have medical conditions that put them at higher risk for
influenza-related complications.
Further, ACIP recommended that if vaccine is initially available in limited quantities, the
following subgroups (listed in no particular order) receive vaccine before others:
• Pregnant women
• Health care and emergency medical services personnel with direct patient contact
• Persons aged 5-18 years who have medical conditions that put them at higher risk for
Change from 2008 pandemic planning. This policy is based on the fact that, unlike pandemic
influenza scenarios the federal government had previously planned for, the 2009 H1N1 virus is
not expected to threaten the continuity of government or cause severe economic or social
disruption. This targeting strategy will be used nationwide and is based on health risk. Except
for health care workers, emergency medical personnel, and some day care providers, these
recommendations do not target specific occupational groups either within or outside the federal
workforce.
Timing. Overall, the initial target groups encompass about 160 million people – approximately
half the U.S. population – and the highest-risk subgroups encompass about 42 million people.
Although all persons over 6 months old, except those allergic to eggs, are encouraged to get
vaccinated against the new H1N1 flu in 2009, people in the priority groups are encouraged to get
vaccine as soon as it becomes available. Based on current projections, 2009 H1N1 vaccine will
become available starting in October. In the initial two or three weeks of the H1N1 vaccination
program, limited vaccine will be available, and vaccinators should target the subgroups for
whom the risk of H1N1 influenza-related complications is greatest. Thereafter, vaccine will be
produced on a continual basis and be available to anyone who wants and needs it.
Federal workers. The federal civilian workforce will not receive any special priority or
preferential treatment. However, federal workers in the target groups are encouraged to get
vaccinated as soon as vaccine is available.
As major employers and good partners, many federal departments and agencies will offer
voluntary vaccination for federal employees, following the ACIP recommendations being used
nationally, and covering the remaining employee population thereafter. Federal vaccination sites
can help alleviate the anticipated burden on state and local health departments, especially in
areas with large concentrations of federal employees, and can facilitate access to vaccination for
federal employees.
We are committed to ensuring the federal workforce has access to both seasonal and H1N1
vaccines as recommended by the ACIP and ask that we all do our part to follow these
recommendations laid out as the best strategy for the nation.
Seasonal flu. Seasonal flu vaccine is available now, and the Centers for Disease Control and
Prevention recommends that all persons over 6 months old, except those allergic to eggs, get
their seasonal flu vaccine as soon as possible.

U.S. Department of Health and Human Services' Centers for Disease Control and Prevention for
the prevention and control of vaccine-preventable diseases in the U.S. civilian population. ACIP
recommended targeting specific groups to receive the earliest doses of 2009 H1N1 vaccine. Its
guidance was based on their best informed scientific and medical judgments.
ACIP members considered the evolving burden of illness caused by the virus, the age and risk
groups most affected, anticipated vaccine supply, critical infrastructure and security needs, and
vaccination strategies. ACIP's deliberations were also informed by consultation with other
federal agencies and a review of vaccine allocation guidance developed as part of influenza pre-
pandemic planning during 2007-2008.
The ACIP guidelines recommend that, as vaccine becomes available, vaccination programs and
providers target vaccine first to the following five priority groups for whom the novel H1N1
virus poses the greatest health risk:
• Pregnant women
This targeting strategy will be used nationwide, and is based on health risk. Except for health
care workers, emergency medical personnel, and some day care providers, these
recommendations do not target specific occupational groups. Overall, the initial target groups
encompass about 160 million people – approximately half the U.S. population. Although
everyone is encouraged to get vaccinated for seasonal and H1N1 flu in 2009, people in the
priority groups are encouraged to get vaccinated as soon as vaccine becomes available. Based on
current projections, vaccine will become available starting in October. Because vaccine will be
produced on a continual basis throughout the flu season, vaccine will be available to anyone who
wants and needs it.
The Federal civilian workforce will follow the ACIP recommendations, and will not receive any
special priority. Federal workers who are in the priority groups are encouraged to get vaccinated
as soon as the vaccine is available. This policy is based on the fact that, unlike pandemic
influenza scenarios the federal government had previously planned for, the 2009 H1N1 virus is
not expected to cause severe economic or social disruption or a degradation of the federal
infrastructure.
As a major employer and a good partner, Federal Departments/Agencies will provide vaccination
sites to offer voluntary vaccination for Federal employees, following the immunization practices
being used nationally that start with the ACIP recommended groups, and covering the remaining
employee population thereafter. These sites can help alleviate the burden anticipated on State
resources, especially in areas with large concentrations of Federal employees, and can facilitate
access to vaccination for Federal employees.
We are committed to ensuring that the Federal workforce has access to these vaccines as
recommended by the ACIP, and ask that we all do our part to follow the recommendations laid
out as the best strategy for the Nation.

U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention
(CDC) for the prevention and control of vaccine-preventable diseases in the U.S. civilian
population. ACIP recommended that specific groups receive the earliest doses of 2009 H1N1
vaccine. In making these recommendations, ACIP members considered the evolving burden of
illness caused by the virus, the age and risk groups most affected, anticipated vaccine supply,
critical infrastructure and security needs, and vaccination strategies. ACIP’s deliberations were
also informed by consultation with other federal agencies and a review of vaccine allocation
guidance developed as part of pre-pandemic influenza planning during 2007-2008.
Target groups. The ACIP guidelines recommend that, as vaccine becomes available,
vaccination programs and providers target vaccine first to the following five priority groups
because they are at highest risk for disease or complications related to the 2009 H1N1 virus:
• Pregnant women
Further, ACIP recommended that if vaccine is initially available in limited quantities, the
following subgroups (listed in no particular order) receive vaccine before others:
• Pregnant women
• Health care and emergency medical services personnel with direct patient contact
• Persons aged 5-18 years who have medical conditions that put them at higher risk for
Change from 2005-2008 pandemic planning. This policy is based on the fact that, unlike
pandemic influenza scenarios the federal government had previously planned for, the 2009
H1N1 virus is not expected to threaten the continuity of government or cause severe economic or
social disruption. This targeting strategy will be used nationwide and is based on health risk.
Except for health care workers, emergency medical personnel, and some day care providers,
these recommendations do not target specific occupational groups either within or outside the
federal workforce.
Timing. Overall, the initial target groups encompass about 160 million people – approximately
half the U.S. population – and the highest-risk subgroups encompass about 42 million people.
Although all persons over 6 months old, except those with a severe allergy to eggs, are
encouraged to get vaccinated against the new H1N1 flu in 2009, people in the priority groups are
encouraged to get vaccine as soon as it becomes available. Based on current projections, 2009
H1N1 vaccine will become available starting in October. In the initial two or three weeks of the
H1N1 vaccination program, limited vaccine will be available, and vaccinators should target the
subgroups for whom the risk of H1N1 influenza-related complications is greatest. Thereafter,
vaccine will be produced on a continual basis and be available to anyone who wants and needs it.
Federal workers. The federal civilian workforce will not receive any special priority or
preferential treatment. Like the general population, federal workers in the target groups are
encouraged to get vaccinated as soon as vaccine is available.
Along with other major employers and good partners, many federal departments and agencies
will offer voluntary vaccination for federal employees, following the ACIP recommendations
being used nationally, and covering the remaining employee population thereafter. Federal
vaccination sites can help alleviate the anticipated burden on state and local health departments,
especially in areas with large concentrations of federal employees. Some federal employees may
choose to receive the H1N1 vaccine through their personal health care provider or other private
mechanism, as they can for seasonal flu vaccine, depending on states’ distribution plans. Any
vaccine not used by federal agencies will be made available to the states.
Federal departments and agencies may register with CDC to receive vaccine and become a
vaccine provider for employees. Alternatively, they may use existing or new agreements with
Federal Occupational Health or HHS’s Supply Service Center at Perry Point, MD, which are
both coordinating with CDC to receive vaccine for existing or new customers. In addition, the
Department of Veterans Affairs has offered to vaccinate federal health care and emergency
medical services personnel at selected VA medical centers. To avoid double counting of federal
employees and to ensure equitable distribution, vaccine provided to federal agencies will be
deducted from the relevant states’ shares.
Vaccine shipments will be phased to ensure that federal employees are offered vaccine in the
same manner as the civilian population. The initial shipments of vaccine to the federal
government should be targeted to health care and emergency medical services personnel and
others in the highest-risk subgroups. Consistent with guidance to state health departments,
federal departments and agencies that choose to participate in a vaccination program for
employees in federal occupational settings should consider maintaining a small reserve to be
used at the discretion of the department or agency head to ensure access to early vaccine for
particularly high-risk/high-priority individuals as defined by ACIP, and who may not present
immediately when vaccine is first available. As more vaccine becomes available, other
employees in the original ACIP target groups – and, ultimately, all employees – should be
encouraged to get vaccinated.
We are committed to ensuring the federal workforce has access to both seasonal and H1N1
vaccines as recommended by the ACIP, and ask that we all do our part to follow these
recommendations laid out as the best strategy for the Nation. Department/agency human
resources officers will receive details on vaccination ordering procedures shortly. The CDC e-
mail address for questions on these procedures is: H1N1FedAgency@cdc.gov.
Seasonal flu. Seasonal flu vaccine is available now, and the Centers for Disease Control and
Prevention recommends that all persons over 6 months old, except those with a severe allergy to
eggs, get their seasonal flu vaccine as soon as possible.
VERY HOT! Federal Workforce Toolkit and White House Counsel Comments Page 1 of 3
From: Chavez, Ilka (HHS/ASPR/OPSP)

Sent: Wednesday, September 23, 2009 7:18 AM
To: Trent, Brian (HHS/ASPR/IO)
Cc: Smith, Amanda (HHS/ASPR/OPSP)
Subject: Fw: Immunization of Federal Workers
Attachments: Policy of Immunization of Federal Workers with 2009 H1N1 Vaccine V10 9-22-09.docx
FYI, it seems this is moving so no need to bring it up at the COS H1N1 meetings.
Thank you for your assistance.
Ilka
From: Novy, Steve (HHS/ASAM)

To: Petrou, Laura (HHS/OS)
Cc: Holland, Ned (HHS/ASAM); Pereira, Segundo (HHS/ASAM); Gillham, Kristin (HHS/ASAM); Sanders, Martin L.
(CDC/OCOO/OHS); Helminiak, Clare (HHS/ASPR/OPEO); Chavez, Ilka (HHS/ASPR/OPSP); Smith, Amanda
(HHS/ASPR/OPSP)
Sent: Tue Sep 22 18:14:11 2009
Subject: RE: Immunization of Federal Workers
Laura,
As you mentioned below, as soon as we receive John Berry’s cover memo the attached
Immunization of Federal Workers Policy will be ready to go.
Steve
From: Petrou, Laura (HHS/OS)

Sent: Tuesday, September 22, 2009 5:10 PM
To: Novy, Steve (HHS/ASAM)
(CDC/OCOO/OHS)
Subject: Immunization of Federal Workers
(b)(5)
Can you send me the version you send to Jennifer? Or is CDC working on this?

(b)(5)

don’t, but I haven’t seen it yet. Anyway, if we assume
recommend” that people go home when they’re sick. (b)(5)
(b)(5) Anyway, Jennifer is preparing a cover note to go with the immunization policy statement (final
version attached) so we could send both things out tomorrow from Berry and KGS.

3/25/2010

(CDC/OCOO/OHS)
Subject: FW: VERY HOT! Federal Workforce Toolkit and White House Counsel Comments
Laura,
Please see Jen’s email below. Jen says she will see you at the 12:30 meeting.
First read from CDC is no problem the recommended changes. With all that is going on CDC
says it will probably be tomorrow before they will get the document completed.
Steve
From: Mason, Jennifer I. [mailto:Jennifer.Mason@opm.gov]

To: Novy, Steve (HHS/ASAM); Sanders, Martin L. (CDC/OCOO/OHS)
Cc: Holland, Ned (HHS/ASAM); Pereira, Segundo (HHS/ASAM); Mikowicz, Jerry; Carmichael, J. Michael; Moore,
Kimberly; Harris, Antonia T (HHS/ASAM); Lewis, Kimberly (HHS/ASAM); Gillham, Kristin (HHS/ASAM)
Subject: Re: VERY HOT! Federal Workforce Toolkit and White House Counsel Comments
Steve we are reviewing it now. I'm sure it is fine. I will see Laura at the 12:30 meeting and speak with her.
Thanks
Jen

To: Mason, Jennifer I.; Sanders, Martin L. (CDC/OCOO/OHS)
Cc: Holland, Ned (HHS/ASAM) ; Pereira, Segundo (HHS/ASAM) ; Mikowicz, Jerry; Carmichael, J. Michael; Moore,
Kimberly; Harris, Antonia; Lewis, Kimberly (HHS/ASAM) ; Gillham, Kristin (HHS/ASAM)
Sent: Tue Sep 22 11:49:13 2009
Subject: VERY HOT! Federal Workforce Toolkit and White House Counsel Comments
Jen and Martin,
Please see the two attachments.
(b)(5)
(b)(5)
conversations we have had, i don not presume
to answer for OPM or CDC.
(b)(5)
Thanks Steve
<<Federal workforce H1N1 guidance DRAFT 09-18-09.doc>> <<WH Comments Reply.docx>>
3/25/2010
Steven D. Novy
Director, Business Continuity Project Office
Program Support Center
Offic
Cell: (b)(6)
Fax: (301) 480-9959
E-mail: steve.novy@hhs.gov
3/25/2010
To: 'Mason, Jennifer I.'; Parker, Gerald (HHS/ASPR/IO)
Cc: Holland, Ned (HHS/ASA); Pereira, Segundo (HHS/ASAM); Gillham, Kristin (HHS/ASA);
Koenig, Lillian (PSC); Helminiak, Clare (HHS/ASPR/OPEO); Chavez, Ilka
(HHS/ASPR/OPSP); Smith, Amanda (HHS/ASPR/OPSP); 'Carmichael, J. Michael';
'Mikowicz, Jerry'; 'Moore, Kimberly'
Subject: FW: Policy Statement on 2009 H1N1 Vaccine Availability for Federal Workforce
Attachments: Policy of Immunization of Federal Workers with 2009 H1N1 Vaccine (sm edits) V4 1.doc
Policy of
mmunization of Fed.
Hi Jen,
Thank you for your comments and very fast turn around. I will pass them up the line.
Have a great weekend. Steve
Gerry,
The OPM Deputy Chief of Staff Jennifer Mason had her flu team review the vaccine
prioritization policy letter and attached are OPM's comments. Overall the policy is fine
with OPM. Jen's email is below.
Thanks Steve
----------------------------------
-----Original Message-----
From: Mason, Jennifer I. [mailto:Jennifer.Mason@opm.gov]
To: Novy, Steve (HHS/ASAM)
Subject: RE: Policy Statement on 2009 H1N1 Vaccine Availability for Federal Workforce
Hi Steve. Our Flu team has had a chance to review and attached are our only comments.
Overall its fine with us.
Thanks
-Jen
From: Novy, Steve (HHS/ASAM) [mailto:Steve.Novy@hhs.gov]
Sent: Thursday, September 03, 2009 5:27 PM
To: Mason, Jennifer I.
Cc: Holland, Ned (HHS/ASAM); Pereira, Segundo (HHS/ASAM); Parker, Gerald (HHS/ASPR/IO);
Gillham, Kristin (HHS/ASAM); Helminiak, Clare (HHS/ASPR/OPEO); Carmichael, J. Michael;
Chavez, Ilka (HHS/ASPR/OPSP); Smith, Amanda (HHS/ASPR/OPSP); Mikowicz, Jerry; Moore,
Kimberly
Subject: Policy Statement on 2009 H1N1 Vaccine Availability for Federal Workforce
Jen,
Attached is the HHS draft policy letter for Federal workers. Please note we have not
talked with our COS on this version and this version has not gone to the White House. That
said, we decided it was best to get you the draft policy as soon as possible. I also
1
understand our COS will reach out to OPM for coordination.
I know the issue of contractor's was brought up in today's Sub-IPC meeting. This policy
letter is directed at the Federal workforce.
For obvious reasons, please provide your comments as soon as possible.
Thanks Steve
2
To: Smith, Amanda (HHS/ASPR/OPSP); Wright, Casey (HHS/ASPR/OPSP)
Attachments: Policy of Immunization of Federal Workers with 2009 H1N1 Vaccine (sm edits) V4 .doc
Policy of
mmunization of Fed.
Ilka
From: Parker, Gerald (HHS/ASPR/IO)
To: Petrou, Laura (HHS/OS); Lurie, Nicole (HHS/ASPR/IO); Mitchell, Samuel (HHS/IOS)
Cc: Chavez, Ilka (HHS/ASPR/OPSP); Korch, George (HHS/ASPR/IO); Helminiak, Clare
(HHS/ASPR/OPEO); Holland, Ned (HHS/ASAM); Pereira, Segundo (HHS/ASAM); Novy, Steve
(HHS/ASAM)
Laura - Policy Statement on Federal Workforce Immunization. It was reviewed by CDC, ASAM,
IOS, and ASPR.
OPM is eager to work with us and help work on next level of guidance.
For example, I understand many Departments/Agencies will have some difficulty estimating
how many of their employees fit into one of the ACIP guidelines, and presumably OPM can
help with that.
Also, John Brennan is concerned that until we have some of those details better defined,
it is premature for CDC to request from Departments/Agencies their vaccine requirements -
particularly by Sept 4. In case CDC was requesting that by tomorrow, I went ahead and
asked Steve Redd to push the PAUSE button on that tactical level until the policy and OPM
guidance could catch up; and to mitigate further information gaps, or mis-information from
taking a life of its own.
From: Korch, George (HHS/ASPR/IO)
To: Parker, Gerald (HHS/ASPR/IO); Chavez, Ilka (HHS/ASPR/OPSP)
Gerry:
This version represents the final from the staffing within HHS. ASAM/CDC/ASPR/IOS and
some feedback from COS's staff are included.
Yours to now transmit as you see fit.
George
George W. Korch Jr., Ph.D.

Senior Science Advisor
Principal Deputy Assistant Secretary for Preparedness & Response Department of Health and
1
Human Services Washington, D.C.
202-690-5760
202-690-7412 (FAX)
Disclaimer:
This message is intended for the exclusive use of the recipients named above. It may
contain information that is PROTECTED, PRIVILEDGED, and/or CONFIDENTIAL, and it should not
be disseminated, distributed, or copied to persons not authorized to receive such
information. All sensitive documents must be properly labeled before dissemination via
email. If you are not the intended recipient, any dissemination, distribution, or copying
is strictly prohibited. If you have received this communication in error, please erase
all copies of the message and its attachments and notify us immediately.
To: Korch, George (HHS/ASPR/IO)
Cc: Smith, Amanda (HHS/ASPR/OPSP)
Is this with the COS's office yet?
Ilka
To: Parker, Gerald (HHS/ASPR/IO)
Cc: Pereira, Segundo (HHS/ASAM); Gillham, Kristin (HHS/ASAM); Koenig, Lillian (PSC);
Chavez, Ilka (HHS/ASPR/OPSP); Helminiak, Clare (HHS/ASPR/OPEO); Smith, Amanda
(HHS/ASPR/OPSP); Wright, Casey (HHS/ASPR/OPSP); Payne, Matthew (OS/ASPR/OPSP)
Subject: RE: Policy Statement on 2009 H1N1 Vaccine Availability for Federal Workforce
Gerry,
Gerry,
Ned has reviewed the document and says it is good to go. As soon as possible please
provide me the "final" copy I can share with the OPM DCOS Jennifer Mason. I believe
Jennifer will be very helpful as we move forward and getting her and OPM in the mix as
early as possible will be value added.
Thanks Steve
2
Options for Commissioned Corps Officers to Receive 2009 H1N1 Vaccine
In the upcoming weeks and months, along with other major employers and good partners, many
Federal departments and agencies will offer voluntary vaccination for Federal employees, following
the ACIP recommendations being used nationally, and covering the remaining employee population
thereafter. Vaccine will be provided in accordance with Advisory Committee on Immunization
Practices (ACIP) national guidelines for prioritization of the 2009 H1N1 vaccine, which
recommend that, as vaccine becomes available, vaccination programs and providers target vaccine
first to the following five priority groups because they are at highest risk for disease or
complications related to the 2009 H1N1 virus:
• Pregnant women
influenza-related complications
The initial shipments of vaccine to the Federal Government should be targeted to health care and
emergency medical services personnel and others in the highest-risk subgroups. Some Federal
employees may choose to receive the H1N1 vaccine through their personal health care provider or
other private mechanism, as they can for seasonal flu vaccine, depending on States’ distribution
plans. Any vaccine not used by Federal agencies will be made available to the States.
There are several mechanisms through which Commissioned Corps Officers should be able to
receive vaccine. The figure on the following page walks you through available options. If you have
any questions, please contact the HHS H1N1 taskforce workforce lead, Amanda Smith at 202-205-
8077, or Amanda.Smith@hhs.gov
Page 52 redacted for the following reason:
---------------------
Entire page withheld under (b)(5).
Page 1 of 1

Sent: Tuesday, September 08, 2009 11:40 AM
To: Wright, Casey (HHS/ASPR/OPSP)
Cc: Smith, Amanda (HHS/ASPR/OPSP); Korch, George (HHS/ASPR/IO)
Subject: FW: Vaccine Policy Statement for Feds
Attachments: Policy of Immunization of Federal Workers with 2009 H1N1 Vaccine (lp edits) V5 DRAFT.doc
For the COS of staff. Laura worked on the document and indicated that this could be discussed at the meeting
this afternoon.
Ilka

Sent: Tuesday, September 08, 2009 11:33 AM
To: Chavez, Ilka (HHS/ASPR/OPSP)
Subject: FW: Vaccine Policy Statement for Feds
Please add draft. Thanks.

(b)(6)
From: Laura Petrou [mailto:
Sent: Monday, September 0
Subject: Vaccine Policy Statement for Feds
3/25/2010
Page 1 of 2
From: Schafer, Julie (HHS/OS)

Sent: Monday, May 18, 2009 7:40 PM
To: Wright, Casey (HHS/ASPR/OPSP)
Subject: FW: Follow up documents for review from the 6:30 call: Summary funding table and
appropriations language
Attachments: DRAFT APPROPRIATIONS LANGUAGE FOR A CONTINGENT APPROPRIATION.DOC;
Vax_Costs_v5.xls; White paper on private v public ; H1N1 Vaccine prod estimates 05-17-09
v5 RR.PDF; Summary table with all vaccine related costs for OMB.XLSX
From: Goldhaber, Benjamin (HHS/ASPR/RPE)

Sent: Mon 5/18/2009 7:27 PM
To: Kosinski, Mary (HHS/ASPR/IO); Schafer, Julie (HHS/OS)
Subject: FW: Follow up documents for review from the 6:30 call: Summary funding table and appropriations
language
From: Cochran, Norris (HHS/ASRT)

To: Petrou, Laura (HHS/OS); Robinson, Robin ((HHS/ASPR/BARDA); Turman, Richard (HHS/ASRT)
Cc: DeVoss, Liz (HHS/ASRT); Gellin, Bruce (HHS/OPHS); Monahan, John (HHS/OS); Corr, Bill (HHS/IOS);
Hughes, Dora (HHS/IOS); Vanderwagen, William C. (HHS/ASPR/IO); Cade, David (HHS/OGC); Kamoie, Brian
(HHS/ASPR); Parker, Gerald (HHS/ASPR/IO); Schuchat, Anne MD (CDC/CCID/NCIRD); Shimabukuro, Tom
(CDC/CCID/NCIRD); Petillo, Jay (HHS/ASPR/RPE); Nichols, Bill (CDC/OCOO)
Sent: Mon May 18 09:51:00 2009
Subject: RE: Follow up documents for review from the 6:30 call: Summary funding table and appropriations
language
The set of materials that went to OMB and HSC leadership late last night is attached. It includes:
z Draft appropriations language

z Summary cost estimate table
z ASPR draft table of current estimates of vaccine production costs
z CDC table estimating vaccine distribution costs
z Paper describing reasoning for public vaccine administration
Thanks all!
From: Cochran, Norris (HHS/ASRT)

Sent: Sunday, May 17, 2009 10:31 PM
To: Petrou, Laura (HHS/OS); Robinson, Robin ((HHS/ASPR/BARDA); Turman, Richard (HHS/ASRT)
(CDC/CCID/NCIRD); Petillo, Jay (HHS/ASPR/RPE); Nichols, Bill (CDC/OCOO)
Subject: Follow up documents for review from the 6:30 call: Summary funding table and appropriations
language
I am using the conference call invite list for this distribution, please forward to your respective colleagues as
3/24/2010
Page 2 of 2
necessary. Attached are two documents. The first is the appropriations language to create a contingent
appropriation, which reflects edits through 9p tonight. The second is an excel table Liz created. A short summary
of the approach on the table is below.
Description of the table:

1. Includes FY 2009 and FY 2010 costs
2. Option A (Vaccine): shows the full cost of vaccine activities in both columns, including the FY 2009 cost of
adjuvants to Option A based on the plan described on the call that we were going to buy adjuvants at least
through September under both scenarios until we had the science to decide whether to use them or not.
3. Option B (Vaccine): shows the full cost of vaccine activities in both columns, except adjuvants.
4. Vaccine campaign: using the CDC table, reflecting FY 2009 obligations in the FY 2009 column (consistent
with Anne's direction) and the range of full cost in the total cost column.
5. Compensation: includes the estimate of $16 million for FY 2009 ($6 million for operations and $10 million for
claims) and the range for the total cost
6. Offset: it subtracts out the $800 million we are covering with balances now, with the bulk to be replenished
with the $1.5B.

Sent: Sun 5/17/2009 2:32 PM
To: Robinson, Robin ((HHS/ASPR/BARDA); Cochran, Norris (HHS/ASRT); Turman, Richard (HHS/ASRT)
(CDC/CCID/NCIRD)
Subject: Another Call at 6:30 PM
In case some of you missed the very end of the call, we agreed to have a follow‐up call at 6:30 pm
tonight (instead of 8 pm). Same call‐in information:
(b)(2)High
Thanks,
3/24/2010
From: Schuchat, Anne MD (CDC/CCID/NCIRD)
Sent: Friday, June 12, 2009 9:23 AM
To: Chavez, Ilka (HHS/ASPR/OPSP)
Cc: Wright, Casey (HHS/ASPR/OPSP); Schuchat, Anne MD (CDC/CCID/NCIRD)
Subject: RE: Follow-up to vaccine campaign memo
Attachments: Sec-Decision Memo -vaccination program.6-12-09.doc; attachment1-BACKROUND for

vaccine sec-decision memo_061109.doc; cost of vaccinating summary v2.doc
Sec-Decision Memo attachment1-BACK cost of vaccinating

-vaccination... ROUND for vacc... summary v2...
Here is the memo and two attachments (background and a costing one-pager for the per dose
vaccine administration estimates) for today's briefing. They have been reviewed by Dr.
Frieden, though I don't expect him to be able t make the 12:30 call.
Let me know if these don't come through okay and thanks for your help!
Anne Schuchat, MD
Director, National Center for Immunization and Respiratory Diseases Rear Admiral, US
Public Health Service Centers for Disease Control and Prevention
E-05
Atlanta, GA 30333
404-639-8200
Sent: Friday, June 12, 2009 6:31 AM
To: Schuchat, Anne MD (CDC/CCID/NCIRD)
Cc: Wright, Casey (HHS/ASPR/OPSP)
Subject: Follow-up to vaccine campaign memo
Good morning RADM Schuchat, Casey informed me last night that you have a revised draft of
the memo per input received a couple days ago. I also understand you will be out most of
next week so wanted to put this discussion on the COS mtg agenda today as I agree that
time is of the essence.
In order to facilitate that, I would like to obtain a copy of the draft memo that is
currently awaiting Dr. Frieden's review to share with ASRT as soon as possible this
morning to ensure they are satisfied with the revisions. This will hopefully ensure a good
discussion at the 12:30 mtg.
Please let me know as soon as you can this morning or if you have questions, feel free to
call me at 202-731-6450 or 202-690-8209.
Thank you
Ilka
1
H1N1 VACCINE COST ESTIMATES
PLAN A - H1N1 Vaccine (no adjuvant - licensed product)
2009 2010 Totals

Activity/Product Jun. Jul. Aug. Sept. Oct. Nov. Dec. Jan. Feb.
Vaccine Development $ 150.0 $ - $ - $ - $ - $ - $ - $ - $ - $ 150.0
Vaccine Scale up Development $ 90.0 $ 90.0
Bulk Vaccine Antigen Mfg. $ 179.2 $ 246.4 $ 519.8 $ 632.8 $ 692.0 $ 692.0 $ 692.0 $ 692.0 $ - $ 4,346.2
Formulation/Fill Finish Mfg. $ - $ - $ - $ 83.0 $ 43.9 $ 43.9 $ 43.9 $ 43.9 $ - $ 258.6
Syringes/Needles $ - $ - $ - $ 250.0 $ - $ - $ - $ - $ - $ 250.0
Cost Monthly Totals $ 419.2 $ 246.4 $ 519.8 $ 965.8 $ 735.9 $ 735.9 $ 735.9 $ 735.9 $ - $ 5,094.8
Cost Cumulative Totals $ 419.2 $ 665.6 $ 1,185.4 $ 2,151.2 $ 2,887.1 $ 3,623.0 $ 4,358.9 $ 5,094.8 $ -
Bulk Vaccine Dose Monthly Subtotals 19.2 29.6 64.1 82.4 85.6 85.6 85.6 85.6 537.7
Bulk Vaccine Dose Cumulative Totals 19.2 48.8 112.9 195.3 280.9 366.5 452.1 537.7
Final Vaccine Dose Monthly Subtotals 0.0 0.0 0.0 0.0 195.3 85.6 85.6 85.6 85.6 537.7
Final Vaccine Dose Cumulative Totals 0.0 0.0 0.0 0.0 195.3 280.9 366.5 452.1 537.7
PLAN B - H1N1 Vaccine (with adjuvant @ 2 fold effect - EUA)
Vaccine Development $ 150.0 $ - $ - $ - $ - $ - $ - $ - $ 150.0
Vaccine Scale up Development $ 90.0 $ 35.0 $ 125.0
Bulk Vaccine Antigen Mfg. $ 179.2 $ 246.4 $ 519.8 $ 632.8 $ 692.0 $ 480.0 $ - $ - $ 2,750.2
Bulk Adjuvant Mfg. $ 588.6 $ 456.8 $ 523.8 $ 783.5 $ 791.8 $ 500.5 $ 3,645.0
Formulation/Fill Finish Mfg. $ - $ - $ - $ 161.0 $ 54.0 $ 35.0 $ - $ - $ 250.0
Syringes/Needles $ - $ - $ - $ 250.0 $ - $ - $ - $ - $ 250.0
Monthly Totals $ 1,007.8 $ 703.2 $ 1,043.6 $ 1,862.3 $ 1,537.8 $ 1,015.5 $ - $ - $ 7,170.2

Cumulative Totals $ 1,007.8 $ 1,711.0 $ 2,754.6 $ 4,616.9 $ 6,154.7 $ 7,170.2 $ 7,170.2 $ 7,170.2
Bulk Vaccine Dose Monthly Subtotals 38.4 59.2 125.0 161.6 164.8 48.0 0.0 0.0 597.0
Bulk Vaccine Dose Cumulative Totals 38.4 97.6 222.6 384.2 549.0 597.0
Bulk Adjuvant Dose Monthly Subtotals 102.8 76.5 86.5 125.0 126.5 79.7 480.0
Bulk Adjuvant Dose Cumulative Totals 102.8 179.3 265.8 390.8 517.3 597.0
Final Vaccine Dose Monthly Subtotals 384.2 164.8 48.0 597.0
Final Vaccine Dose Cumulative Totals 384.2 549.0 597.0
05/17/09 RR
Draft: For Official Use Only (FOUO) – not for widespread distribution
1 Implementation Goal
2 The goal of the U.S. pandemic influenza vaccination program during a pandemic is to vaccinate
3 all persons in the U.S. who choose to be vaccinated as efficiently and effectively as possible.
4 The Guidance on Allocating and Targeting Pandemic Influenza Vaccine provides national
5 guidance on priority vaccination of CI/KR and general population target groups (Appendix A).
6 Implementing large-scale pandemic influenza vaccination campaigns is largely the domain of
7 state and local public health departments.
8
9
10 General Principles
11
12 Uniformity and flexibility
13 Uniformity across states and localities in adhering national prioritization recommendations as
14 specified in Guidance on Allocating and Targeting Pandemic Influenza Vaccine is considered by
15 the federal government to be a significant national interest. Accordingly, state and local health
16 departments are very strongly encouraged to vaccinate individuals in a manner consistent with
17 the national recommendations. However, the federal government recognizes that unique
18 demographic, geographic and organizational structures and capabilities across the U.S. will
19 necessitate allowing for a substantial amount of flexibility in how state and local health
20 departments implement large-scale vaccination campaigns during an influenza pandemic. In
21 other words, the federal government places an extremely high priority on maintaining uniformity
22 in adhering to national recommendations on vaccinating prioritized target groups according to
23 priority tiers, but at the same time realizes that the planning and shaping of the specific
24 operational components of large-scale vaccination campaigns in the community during an
25 influenza pandemic is best conducted at the state and local levels.
26
27 Pro rata distribution
28 Vaccine will be allocated and distributed to states on a pro rata basis in proportion to population.
29
30 Distribution of vaccine from the federal government and transfer of authority to states
31 The federal government will provide pandemic influenza vaccine to states free of charge. This
32 includes both procurement and distribution of vaccine to pre-designated “ship-to sites” specified
33 by states in advance of an influenza pandemic. Once delivered to ship-to sites, a transfer of
34 responsibility will occur where physical control and security of, and accountability for vaccine
35 will become a state or local responsibility or the responsibility of the agency or facility receiving
36 vaccine. Allocation and distribution of vaccine within a state will be a state and local
37 responsibility. States should have detailed plans in place for receipt, storage and handling,
38 repackaging, transportation and security of vaccine. State and local health department will also
39 be responsible for working with communities to designate sites for vaccination clinics and to
40 ensure these clinics will have the necessary staffing and resources to conduct sustained large-
41 scale vaccination during an influenza pandemic.
42
43 Simultaneous vaccination within a priority tier
44 Target groups and individuals prioritized for vaccination within a specific tier should have equal
45 priority for vaccination. For example all target groups and individuals within Tier 1 should be
46 vaccinated simultaneously with equal priority regardless of vaccination category (see Appendix
1
1 A). Supply constraints may necessitate subprioritization within target groups within a tier, but
2 this does not change the principle simultaneous vaccination within a priority tier.
3
4 Sequential vaccination by priority tier
5 Vaccination should occur sequentially by priority tier, with Tier 1 being the highest priority and
6 therefore vaccinated first followed by the remaining tiers in sequence (e.g., Tier 1ÆTier 2ÆTier
7 3ÆTier 4ÆTier 5).
8
9 Multiple vaccine supply scenarios
10 Much of the pandemic influenza planning to date has been based on limited vaccine supply
11 scenarios. Advances in manufacturing technology, production capacity and antigen-sparing
12 substances known as adjuvants have the potential to dramatically increase the available supply of
13 pandemic influenza vaccines should the U.S. need to respond to an influenza pandemic. At this
14 stage in pandemic preparedness planning, it would be prudent for state and local health
15 departments to plan for multiple vaccine supply scenarios to include at a minimum (1) an
16 extremely limited supply scenario where subprioritization within tiers will be necessary, (2) a
17 limited supply scenario that would cover prioritized occupationally defined priority groups and a
18 limited number of prioritized general population groups, (3) a moderate supply scenario that
19 would allow vaccination to extend into risk-based general population target groups and (4) a
20 supply scenario where high vaccine availability would allow for large-scale vaccination of all
21 U.S. residents simultaneously.
22
23
24
2
1 Appendix A. Vaccination target groups, estimated populations, and tiers for severe, moderate
2 and less severe pandemics as defined by the Pandemic Severity Index (PSI). Persons in
3 occupational groups not specifically targeted for vaccination in Moderate and Less Severe
4 pandemics are targeted according to their age and health status in the general population.
5
6
7
8 Source: Guidance on Allocating and Targeting Pandemic Influenza Vaccine available at
9 http://www.pandemicflu.gov/vaccine/allocationguidance.pdf
3
Self-Reported Influenza Vaccination Within the Past 12 Months,
Selected Priority US Populations,
1989-2006; National Health Interview Survey (NHIS)
100
All,
Vaccine shortage:
≥65 years
90 2004-2005 season
High risk,
80
50-64 years
Coverage level (%)
70
Health care
60 workers
50 Healthy,
40 50-64 years
30 High risk,
20 18-49 years
10
Pregnant
0 women
19 9
19 0
91
19 2
19 3
19 4
19 5
19 6
97
19 8
20 9
20 0
20 1
20 2
03
20 4
20 5
06
8
9
9
9
9
9
9
9
9
0
0
0
0
0
19
19
19
20
Year
Centers for Disease Control and Prevention. National Health Interview Survey—Self-Reported Influenza Vaccination Coverage
Trends (1989-2006). http://www.cdc.gov/flu/professionals/vaccination/pdf/vaccinetrend.pdf. Accessed May 8, 2008.
Figure 1
From mmwr October 3, 2008 / 57(39);1081

Figure 1
From mmwr September 26, 2008 / 57(38);1043-1046

Estimated Size of ACIP-Recommended
Groups
HR Adults 19-49
300
Adults > = 50 years
250 Children 6mo-18 yrs
24-59 mos. of age

200
6-23 mos. of age
Millions
150 50-64 year healthy individuals
Household contacts
100
Health care workers
50 Nursing home residents
Pregnant women
0
1964 1974 1984 1994 2004 2006 2008 <65 years with a high risk
condition
Year > =65 years
Considerations regarding use of private health system to deliver H1N1 vaccine
Seasonal influenza distribution and delivery background

Seasonal influenza vaccine is largely driven by private purchase through pre-booking in
January and February of the calendar year for vaccine administration in October through
December. Vaccine is manufactured by several companies and either directly shipped to
provider offices or sent through a number of intermediary distributors. The public health
system is engaged in <10% of vaccine procurement and delivery. Vaccine coverage rates
are fairly low, and there is substantial variation year-to-year in the timing, equity, and
acceptability of the vaccine distribution. Past shortages have highlighted providers
concerns that they were receiving vaccine later than retail sites or large hospital-based
programs. The ability of this relatively delicate system to absorb a large increase in
vaccination in a short period of time in a way that is fair, equitable, and respects the
pandemic priority setting and state and local planning is questionable. The attached
powerpoint represents the low coverage that has been achieved so far in most risk groups.
Pediatric and family practitioner stakeholders have requested public health assistance in
assuring school-aged children can be vaccinated with seasonal influenza, because health
service utilization is challenged by the potential additional office visits this would entail.
Pandemic influenza planning assumptions and strategies

The goal of the U.S. pandemic influenza vaccination program during a pandemic is to
vaccinate all persons in the U.S. who choose to be vaccinated as efficiently and
effectively as possible. The Guidance on Allocating and Targeting Pandemic Influenza
Vaccine provides national guidance on priority vaccination of Critical Infrastructure/Key
Resources and general population target groups, and state plans have been developed
with this guidance in mind. Implementing large-scale pandemic influenza vaccination
campaigns was intended to be largely the domain of state and local public health
departments. Assurance of security, respecting the prioritized use of early shipments of
available vaccine, and requirements related to tracking utilization are built into the state
plans. Government managed vaccination can avoid introducing inequities and potential
inefficiencies related to billing procedures and can avoid potential barriers to vaccination
such as co-payments or out-of-pocket expenses. The pandemic planning assured
government’s ability to direct and control vaccine from manufacturing to vaccine
recipient, and the state-based distribution plans were built and exercised on federal
guidance on pandemic vaccine allocation/ prioritization plans. These plans also
incorporate assuring security of vaccine in transit and facility security where vaccine
would be delivered, and reduce risk of counterfeit product entering the supply chain.
Concerns and limitations with adding H1N1 vaccine delivery on to the private
health system responsibilities
Security, equity, and counterfeiting risks could be introduced by an early shift from a
public distribution and delivery model to a private sector one. Seasonal influenza vaccine
is not currently covered consistently by the numerous insurance plans and complexity of
billing, and copayments for individuals may be problematic and counter to the pandemic
planning, which attempted to ensure fairness and respect of the priority use of limited
resources for greatest public benefit. The capacity of the private system to handle
substantial increased vaccination may be limited, particularly with a high-demand state,
which is likely to occur if a second wave of H1N1 or disruptive school outbreaks are
occurring in the fall. We know this is the case for school-aged children, as pediatric and
family practitioners have requested public support in getting these new population groups
immunized for seasonal flu recommendations. Most health care institutions and
providers would prioritize their time toward management (diagnosis, treatment with
antivirals or other support) of ill persons and likely appreciate the public delivery of
vaccine. It would also be challenging for provider offices where many are seeking care
for respiratory illness to expose persons coming for H1N1 vaccination to possible
infection. The efficiency of vaccinating large numbers of people is constrained by the
private office model of service delivery. Large clinics can be established for the purpose
of H1N1 vaccination that does not interrupt other important services, and that
incorporates customized needs of an H1N1 campaign (e.g., additional security, additional
record-keeping, ans communication and logistics needs related to reminding people about
second dose requirements and adverse event monitoring). Furthermore, potential
emergency use authorization (EUA) administration of vaccine would add further
complexity best managed in a customized location. In addition, it will be difficult for a
healthcare practitioner with supply on hand to deny or delay vaccine to a longstanding
patient merely because that patient is not a member of a priority category; therefore,
relying on private healthcare providers to follow a pandemic priority list may be
unrealistic.
Potential inflection point for shifting H1N1 vaccine delivery to private health care
system
After the critical work force has been vaccinated, and/or after ongoing epidemiologic
data support the focus of H1N1 disease on traditional risk groups (e.g., elderly,
chronically ill, very young children), the private system might take over. However,
worth considering is that the highest coverage of influenza vaccine currently (~70%) is
among persons >65, and they are likely to be the last group vaccinated based on the
current epidemiologic patterns. It may be possible to shift to a private health care system
delivery if surge on health care is not excessive, and communities are cooperating with
delivery instructions effectively. If demand subsides or for some reason is unexpectedly
low for an H1N1 vaccination, and the support for large-scale clinics is not justifiable,
shifting to the private health system may be appropriate. There are some population
subsets, such as children under two years of age or possibly pregnant women, where
patient acceptability may be higher in a doctor’s office, and this could be incorporated
into the state planning.
Potential cost implications of private health system administration of H1N1 vaccine

Because anticipated per-dose delivery costs are $6.50 at a mass vaccination clinic, ~$10
at a school-associated vaccination program, $18 for Medicare reimbursement, and about
$20 for private insurance (with variability), the shift to a private system delivery does not
actually save money, although the government might recoup upfront investments if a
recovery system could be implemented.
Recommendations
Initial use of public or school-associated clinics, with planning for use of private system
for select populations (e.g., <3 years of age; pregnant women) and late in stage of
vaccination.
Attachments and supporting materials

Influenza vaccination coverage in various populations
ACIP recommended population groups for seasonal flu
Federal purchase or reimbursement for seasonal influenza
Brief summary of state guidance for pandemic vaccination
Summary of HHS Novel Influenza A (H1N1) Costs Associated
with Vaccine Production, Vaccination, and Compensation
(dollars in millions)
The table below highlights HHS's current estimates of vaccine production, vaccination, and
compensation activities for FY 2009 and FY 2010. For vaccine production, it provides two scenarios.
Under both scenarios, the table reflects the costs of a full-scale vaccine production and immunization
program for the total U.S. population. If we were to decide not to vaccinate, the costs will be
substantially lower.
Scenario A reflects the total cost of purchasing antigen for 300 million people, if the science indicates
that the addition of adjuvants does not provide an adequate immune response. It also includes the
costs of adjuvants through September, which is when we expect to find out about their effectiveness.
These adjuvants would be stockpiled and used later.
Scenario B assumes that the science will indicate that adjuvants produce an adequate immune
response and that it will have a two-fold effect on the amount of antigen needed.
In addition, the range for the vaccination campaign reflects the variation in costs associated with a
public vaccination campaign versus a mixed source vaccination campaign. The range for compensation
FY 2009 FY 2010
Scenario A: Antigen Only: Obligations Costs
Vaccine Production:
Vaccine Development............................................................ 150 --
Vaccine Scale-Up.................................................................. 90 --
Bulk Vaccine Antigen Manufacturing (300M courses)......... 4,346 --
Bulk Adjuvant Manufacturing............................................... 2,353 --
Formulation/Fill Finish.......................................................... 259 --
Syringes/Needles................................................................... 250 --
Subtotal, Vaccine Production........................................... 7,448 --
Less, Amounts from $1.5B, Currently Existing Balances... -800 --
Subtotal, Additional Resources for Vaccine Prod....... 6,648 --
Vaccination Campaign:
Administration/Distribution Costs........................................ 276
Vaccine Safety and Effectiveness Monitoring....................... 47 range of $3.9
Pneumococcal Polysacharide Vaccine................................... 115 to $4.3 billion
Communications Campaign/National Coordination/TA....... 15
Subtotal, Vaccination Campaign..................................... 453
Compensation (does not include vents and respirators)..... 16 range of $330
to $900 million
Total, Scenario A Additional Resources....................... 7,117
FY 2009 FY 2010
Scenario B: Antigen and Adjuvant: Obligations Costs
Vaccine Production:
Vaccine Development............................................................ 150 --
Vaccine Scale-Up.................................................................. 125 --
Bulk Vaccine Antigen Manufacturing................................... 2,750 --
Bulk Adjuvant Manufacturing............................................... 2,353 1,292
Formulation/Fill Finish.......................................................... 259 --
Syringes/Needles................................................................... 250 --
Subtotal, Vaccine Production........................................... 5,887 1,292
Less, Amounts from $1.5B, Currently Existing Balances... -800 --
Subtotal, Additional Resources for Vaccine Prod....... 5,087 1,292
Vaccination Campaign:
Administration/Distribution Costs........................................ 276
Vaccine Safety and Effectiveness Monitoring....................... 47 range of $3.9
Pneumococcal Polysacharide Vaccine................................... 115 to $4.3 billion
Communications Campaign/National Coordination/TA....... 15
Subtotal, Vaccination Campaign..................................... 453
Compensation (does not include vents and respirators range of $330
or reflect costs associated with adjuvants)........................... 16 to $900 million
Total, Scenario B Additional Resources....................... 5,556
Vaccine cost scenarios (see next 2 tabs and follow-on scenario tabs for explanation of methods)
Preparatory period FY09 Implementation period FY10 Totals

Grants to states $519,817,105 $7,051,139,474 $7,570,956,579
CDC/contractors $61,950,000 $38,400,000 $100,350,000
Pneumo vaccine $115,000,000 $0 $115,000,000
Total funds $696,767,105 $7,089,539,474 $7,786,306,579
Scenario #1: Low thru-put for school-based clinics and no cost to the government for private sector transactions (insurance reimbursement)

Grants to states $484,185,526 $6,552,297,368 $7,036,482,895
CDC/contractors $61,950,000 $38,400,000 $100,350,000
Pneumo vaccine $115,000,000 $0 $115,000,000
Total funds $661,135,526 $6,590,697,368 $7,251,832,895
Scenario #2: High thru-put for school-based clinics and no cost to the government for private sector transactions (insurance reimbursement)

Grants to states $535,069,737 $7,264,676,316 $7,799,746,053
CDC/contractors $61,950,000 $38,400,000 $100,350,000
Pneumo vaccine $115,000,000 $0 $115,000,000
Total funds $712,019,737 $7,303,076,316 $8,015,096,053
Scenario #3: Low thru-put for school-based clinics and government assuming costs for private sector transactions (no insurance reimbursement)

Grants to states $499,438,158 $6,765,834,211 $7,265,272,368
CDC/contractors $61,950,000 $38,400,000 $100,350,000
Pneumo vaccine $115,000,000 $0 $115,000,000
Total funds $676,388,158 $6,804,234,211 $7,480,622,368
Scenario #4: High thru-put for school-based clinics and government assuming costs for private sector transactions (no insurance reimbursement)
Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10
Implementation funds to states $0 $276,000,000 $0 $0 $1,104,000,000 $2,760,000,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
Vaccine safety monitoring $1,000,000 $15,000,000 $4,000,000 $0 $1,000,000 $0 $0 $4,000,000 $0 $0 $0 $0 $5,000,000 $0 $0 $0
Vaccine effectiveness monitoring $10,000,000 $0 $12,000,000 $0 $6,000,000 $0 $6,000,000 $0 $0 $0 $0 $0 $0 $0 $0 $0
CRA monitoring $1,700,000 $0 $0 $800,000 $0 $0 $500,000 $0 $0 $0 $0 $0 $0 $0 $0 $0
H1N1 vaccine coverage monitoring $0 $0 $0 $2,000,000 $0 $4,000,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
Enhanced seasonal influenza vaccine
coverage monitoring $0 $0 $0 $900,000 $0 $900,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
Communications campaign $0 $1,000,000 $1,550,000 $450,000 $16,650,000 $575,000 $450,000 $650,000 $475,000 $4,475,000 $575,000 $350,000 $425,000 $250,000 $125,000 $0
Pneumococcal polysacharide vax* $0 $115,000,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
National coordination/tech assist. $2,000,000 $2,000,000 $4,000,000 $4,000,000 $6,000,000 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0 $0
Total program costs $14,700,000 $409,000,000 $21,550,000 $8,150,000 $1,133,650,000 $2,765,475,000 $6,950,000 $4,650,000 $475,000 $4,475,000 $575,000 $350,000 $5,425,000 $250,000 $125,000 $0
Total $4,375,800,000
*ACIP pneumo vaccines working group recommendations for high risk individuals, procurement needed b/c of limited supply
Assumes:
The estimated per dose administration cost of vaccination in a publicly run large-scale influenza vaccination clinics
The pre-VMBIP per dose distribution charge
That vaccine utilization monitoring will transition from CRA to population-based surveys once a measurable amount of vaccine has been administered in the community
CRA monitoring $1,700,000 $0 $0 $800,000 $0 $0 $500,000 $0 $0 $0 $0 $0 $0 $0 $0 $0
Total $4,656,600,000
Assumes:
The estimated per dose administration cost of vaccination in a mixed public/school and private settings (private reimbursements are no cost to the USG)
The CDC SNS estimtes for cost of a needle/syringe unit and distribution costs per unit
Obligation
CRA monitoring $1,700,000 $0 $0 $800,000 $0 $0 $500,000 $0 $0 $0 $0 $0 $0 $0 $0 $0
Total $11,275,800,000
Assumes:
The estimated per dose administration cost of vaccination for Medicare reimbursement for a flu shot
All residents 300,000,000 100.00% $ 18.00 $5,400,000,000
cost/dose $ 18.00 Total costs including insurance reimbursement
Costs using the medicare reimbursement fee
All residents 300,000,000 100.00% $ 6.50 $1,950,000,000

All U.S. residents vaccinated through public clinics
Pregnant 3,100,000 1.03% $ 18.00 $55,800,000

6-35 mo 10,300,000 3.43% $ 20.00 $206,000,000
3-18 y/o 65,000,000 21.67% $ 10.00 $650,000,000
adults 221,600,000 73.87% $ 6.50 $1,440,400,000
300,000,000 100.00% $2,296,400,000
Vaccination througha mix of public clinics, school-based clinics and private settings (all costs)
Pregnant 3,100,000 1.03% $ - $0

6-35 mo 10,300,000 3.43% $ - $0
3-18 y/o 65,000,000 21.67% $ 10.00 $650,000,000
adults 221,600,000 73.87% $ 6.50 $1,440,400,000
300,000,000 100.00% $2,090,400,000
cost/dose $ 6.97 Total costs excluding costs not realized by USG (private insurance reimbursement)
Vaccination througha mix of public clinics, school-based clinics and private settings (just costs realized by the federal government)
Public H1N1 vaccination campaign
Phase I: 40M doses/20M courses H1N1 vax Phase II: 160M doses/80M courses H1N1 vax Phase III: 400M doses/200M courses H1N1vax
40M doses/20M corses 40,000,000 160M doses/80M courses 160,000,000 400M doses/200M corses 400,000,000
Administration cost of a dose $6.50 Administration cost of a dose $6.50 Administration cost of a dose $6.50
Distribution cost (per dose) $0.40 Distribution cost (per dose) $0.40 Distribution cost (per dose) $0.40
Total cost (per dose) $6.90 Total cost (per dose) $6.90 Total cost (per dose) $6.90
Total admin/distro costs (40M) $276,000,000 Total admin/distro costs $1,104,000,000 Total admin/distro costs (40M) $2,760,000,000
Cost of needle/syringe unit $0.35 Cost of needle/syringe unit $0.35 Cost of needle/syringe unit $0.35
Distribution cost (per unit) $0.05 Distribution cost (per unit) $0.05 Distribution cost (per unit) $0.05
Total cost (per unit) $0.40 Total cost (per unit) $0.40 Total cost (per unit) $0.40
Total cost needle/syringe units (40M) $16,000,000 Total cost needle/syringe units (160M) $64,000,000 Total cost needle/syringe units (400M) $160,000,000
Vaccine safety monitoring $20,000,000 Vaccine safety monitoring $5,000,000 Vaccine safety monitoring $5,000,000
Vaccine effictiveness monitoring $10,000,000 Vaccine effictiveness monitoring $18,000,000 Vaccine effictiveness monitoring $6,000,000
CRA monitoring $1,500,000 CRA monitoring $1,500,000 CRA monitoring $0
H1N1 vaccine coverage monitoring $2,000,000 H1N1 vaccine coverage monitoring $2,000,000 H1N1 vaccine coverage monitoring $2,000,000
Enhanced seasonal influenza vaccine Enhanced seasonal influenza vaccine Enhanced seasonal influenza vaccine
coverage monitoring $600,000 coverage monitoring $600,000 coverage monitoring $600,000
Communications campaign $22,000,000 Communications campaign $6,000,000 Communications campaign $0
Pneumococcal polysacharide vax* $115,000,000
National coordination/TA $6,000,000 National coordination/TA $6,000,000 National coordination/TA $6,000,000
Total associated program costs $177,100,000 Total associated program costs $39,100,000 Total associated program costs $19,600,000
Total vax program costs $469,100,000 Total vax program costs $1,207,100,000 Total vax program costs $2,939,600,000
Cumulative program costs for vaccination, does not include the cost of vaccine:
40M total doses/20M courses $469,100,000 200M total doses/100M courses $1,676,200,000 600M total doses/300M courses $4,615,800,000
Assumes:
The estimated per dose administration cost of vaccination in a publicly run large-scale influenza vaccination clinics
Mixed public, school-based, pediatrician/FP office H1N1 vaccination campaign
Assumes:
The estimated per dose administration cost in mixed settings (doctor office for infants/toddlers, schools for 5-18 y/o, and public clinics for adults)
Assumes:
Assumes:
White paper on private vs. public distribution of h1n1 vaccine Page 1 of 1
From: Turman, Richard (HHS/ASRT)

Sent: Monday, May 18, 2009 12:03 AM
To: Turman, Richard (HHS/ASFR)
Subject: White paper on private v public
Attachments: Influenza Vaccination coverage in various groups.ppt; H1N1_VaxDistroImpl.doc; Federally
paid influenza vaccine 2007_08.xls; private vs public h1n1 distribution final edits.doc
3/24/2010
(b)(6)

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Chief of Staff

a. NVAC and ACIP Summary and Reflections (Gellin / Schuchat)

i. NVAC Financing Recommendations are included at the end of these

ii. NVAC Safety Recommendations can be found here:

iii. ACIP Recommendations can be found here:

i. Antiviral use guidance

CDC mentioned that work on antiviral use guidance is ongoing and it

ii. Outreach to provider groups

Conversations with providers need to be ratcheted up and cover a

a. Continuing Discussion of School Guidance (Redd )

a. Comprehensive Vaccine Safety presentation to Dr. Lurie

b. Tribal Access to State Planning Funds (Lurie)

a. H1N1 Vaccine: Fill and Finish Decision Making (Robinson)

ASPR / BARDA presented three options on the timing of the 2009-H1N1

i. Action: ASPR / BARDA will circulate a table displaying week by

outstanding concerns at Wednesday’s COS meeting, and brief the

a. School Preparedness Guidance

Not discussed. On agenda for Wednesday’s meeting.

1. Pillar updates (10 minutes)

Yesterday’s MPHISE meeting went well. The SORT tool, otherwise

ii. Community Mitigation

iii. Medical Countermeasures

It continues to be difficult to learn how States are progressing with their

A memo on antiviral and PPE purchase in support of HHS workforce

a. Overview o (b)(5) briefing (Lurie/Petrou)

However, the meeting confirmed that HHS needs a better way to

b. Update on funding/spend plan development (ASRT)

a. Purchasing of IV antiviral drugs (scheduled for discussion on Monday)

5. Due Dates for Documents

1. Pillar Updates (10 minutes)

a. Pneumococcal Vaccine Communications Plan (Redd)

Communications Plan Goal: Reinforce ACIP recommendations for use of

b. H1N1 Vaccine Communications Plan (Butler)

Estimates of vaccine production will be provided every Friday at the COS

a. Purchasing of IV Antiviral Drugs (scheduled for discussion week of August

b. Pneumococcal Vaccine Purchase Strategy (Robinson / Schuchat / Redd)

c. Status of Vaccine Priority Group Recommendations (Schuchat / Redd)

5. Due Dates for Documents

August 14, 2009

1. Pillar updates (10 minutes)

a. Vaccine Production Timetable (Lurie/Robinson)

i. Dr. Lurie expects a copy of the PCAST report to be shared shortly. An

ii. The ASH requested a master summary of advisory committee

v. The OMB Office of Information and Regulatory Affairs (OIRA) will be

a. Status of Vaccine Priority Group Recommendations (Schuchat / Redd)

a. Pneumococcal Vaccine Implementation Paper (Robinson/Butler)

Will be discussed in further detail next week

b. Vaccine Communications Plan (Seasonal, Pneumococcal and H1N1) (Butler)

a. This Week: Guidance Release Dates and Communications Strategy (Michael)

ii. Post-secondary education guidance is nearing completion with release planned

When the ACIP Statement is released, our response to questions related to

CDC is drafting materials to facilitate State and local planning for

Action: Elin Gursky/team will present a proposed roll-out strategy for

a. Purchasing of IV Antiviral Drugs (Petrou/Lurie)

There should be a Secretarial decision by tomorrow on the purchase of IV antiviral drugs.

a. Pneumococcal Vaccine Implementation Paper (Butler/Robinson) - N/A

b. Vaccine Communications Plan (Seasonal, Pneumococcal and H1N1) (Butler) – N/A

a. State Assessment Teams

August 21, 2009

a. Spend Plan Update (Turman)

b. Final ACIP Statement (Redd/Schuchat)

c. Purchasing of IV Antiviral Drugs (Petrou/Lurie)

Secretary Sebelius has approved the purchase of IV Antiviral Drugs. ASPR/BARDA is