CDC H1N1 Vaccination Planning Q&A
June 25, 2009
Vaccine purchase
Q1. How will H1N1 vaccine be purchased?
A1. For planning purposes, planners should assume H1N1 vaccine will be
purchased by the federal government and made available for the U.S population at
no cost.
Vaccine distribution
Q2. When will the decision to administer vaccine be made?
A2. For planning purposes, it should be assumed that vaccine will be
administered beginning in the fall.
Q3. When will vaccine shipping begin?
A3. Actual dates cannot be provided at this time as they are affected by several
factors including manufacturing time and time needed to conduct clinical trials.
For planning purposes, planners should assume shipping of vaccine will begin
mid-October.
Q4. How many manufacturers are producing vaccine?
A4. Five manufacturers are producing vaccine for the U.S.: Sanofi Pasteur,
Novartis, GSK, Medimmune, and CSL.
Q5. How much vaccine can be expected to be available for shipping when
shipping begins?
A5. Given uncertainties around vaccine yield and formulation, it is not
possible to provide specific numbers at this time. Planners should use the
following 3 hypothetical scenarios for planning purposes: the initial amounts
manufactured by the five manufacturers considered together will total 40 million,
80 million, or 160 million doses of vaccine. For planning purposes, planners
should assume that vaccine will become available for shipping from the 5
manufacturers over a one month period. The above assumptions are based on a
15ug/dose formulation which is subject to change based on clinical trials.
Q6. How much vaccine can be expected in subsequent shipments?
A6. The actual weekly production is unknown at this time. For planning
purposes, planners should plan for the following 3 hypothetical scenarios: weekly
production from the 5 manufacturers will total 10 million, 20 million, and 30
million doses. However, weekly production could be larger depending on
manufacturing capacity. These amounts are less than the initial amount because
the initial amount represents several weeks of production.
Q7. How will vaccine be shipped to projects areas (CDC Public Health
Emergency Preparedness grantees)?
A7. Plans are currently being developed. Two main options are being explored
based on previous pandemic planning: shipping by manufacturers and their
commercial distributors to project area-designated ship-to sites, and centralized
distribution, which would likely allow vaccine shipments to a larger number of
ship-to sites. Both options would require an active role of the state immunization
program in designating ship-to sites and relative allocations. More information on
this will be provided in the coming weeks.
Q8. Where will vaccine be shipped to?
A8. Vaccine will be shipped to locations designated by project areas (CDC
Public Health Emergency Preparedness grantees).
Q9. Will project areas (CDC Public Health Emergency Preparedness
grantees) be able to limit the amount of vaccine they receive?
A9. Yes, project areas will be able to state what proportion of their initial and
weekly allocations they wish to receive.
Q10. How frequently will vaccine shipments arrive?
A10. The frequency of shipments will depend upon several factors, including
the method of distribution used and the frequency of vaccine orders placed by the
states. As details of distribution are finalized, CDC will communicate with states
about the anticipated time period between placing vaccine orders and receiving
shipments. CDC will provide for a minimum of weekly shipments should states
choose to receive shipments weekly.
Q11. Can the number of ship-to sites currently designated by project areas in
their pandemic plans be changed?
A11. Yes, there is some flexibility with respect to changing the number of shipto
sites; this will be especially true if centralized distribution is employed.
Q12. Will vaccine be in multi-dose vials?
A12. The majority of vaccine will be in multi-dose vials, the remainder in single
dose vials or nasal sprayers. The aim is to have enough vaccine in single dose
vials for young children and pregnant women.
Vaccine allocation
Q13. How will vaccine be allocated among project areas (the CDC PHEP
grantees)?
A13. Vaccine will be allocated to each project area in proportion to its
population (pro rata). Estimated allocations under the different planning scenarios
have been sent to each project area.
Page 3 of 6
Q14. Will there be a separate allocation for DoD dependants, retirees and
civilian employees?
A14. There is no separate allocation for these groups. Military facilities may be
willing to vaccinate these groups, but will need to be allocated vaccine for these
populations by the project areas.
Q15. Will there be a separate vaccine allocation for IHS-served populations
and other tribal communities?
A15. There will be no separate allocation. States and local areas need to work
with their tribal populations to ensure access to vaccine.
Ancillary supplies
Q16. Will syringes and needles be provided with vaccine?
A16. HHS plans to provide needles and syringes. Plans for ensuring the
distribution of these products to ship-to sites are currently being developed.
Q17. Will any other ancillary supplies be provided?
A17. Plans are being made to also provide sharps containers and alcohol swabs.
Vaccine administration
Q18. Will two doses of vaccine be required?
A18. This will not be known until the late summer- early fall, once clinical trials
are completed. For planning purposes, planners should assume that two doses will
be needed for persons under 50.
Q19. What will be the recommended interval between the first and second dose?
A19. This will not be known until clinical trials are complete. For planning
purposes, planners should assume 21-28 days between the first and second
vaccination.
Q20. How much Thimerosal-free vaccine will be available?
A20. It is anticipated that enough thimerosal-free vaccine in pre-loaded syringes
or nasal sprayers will be available for young children and pregnant women.
Q21. Will there be federal requirements to recall persons for their second dose,
if a second dose is needed?
A21. We do not anticipate a federal requirement to send out recall notices.
Providing information on second dose at the time of the first dose, as well as
using the media to disseminate this message will be the primary means of
educating persons about second dose administration.
Q22. Will it be necessary for the first and second dose need to be the same
product?
Page 4 of 6
A22. Ideally, first and second doses would be from the same product. However,
practical considerations may make this difficult to implement so it would be
preferable if products could be used interchangeably. A definitive answer on this
issue will not be available until the late summer ? early fall once clinical trials are
conducted.
Q23. Can seasonal vaccine and H1N1 vaccine be administered at the same
time?
A23. This will not be known until the clinical trials have been completed. For
planning purposes, planners should assume co-administration is possible.
Q24. Will vaccine be adjuvanted?
A24. This may not be known until early fall, once clinical trials are completed.
Q25. If vaccine is adjuvanted, how will it be formulated?
A25. Formulation will vary by provider. For Novartis, vaccine may be
preformulated with adjuvant. For CSL, GSK and Sanofi Pasteur, mixing of
vaccine and adjuvant at the site of administration will be necessary. Specific
information on storage requirements and procedures for mixing vaccine and
adjuvant will be provided by CDC. Medimmune vaccine will not be adjuvanted.
Q26. Will the vaccine be administered under EUA (Emergency Use
Authorization) and if so what are the implications?
A26. Every effort will be made to avoid the need for administering the vaccine
under EUA, however the need for EUA will not be known until the late summer ?
early fall. CDC will provide information on EUA requirements so that planners
can plan for that contingency.
Q27. Can public health clinics charge for vaccine administration?
A27. If federal funds are provided to project areas to cover vaccine
administration costs, it is likely that public health would not be allowed to charge
for vaccine administration. Decisions are pending and will be communicated as
they are made.
Priority groups:
Q28. Will priority groups change?
A28. The ACIP and other federal advisory bodies will be reviewing the existing
priority groups over the summer, considering available epidemiologic data from
this spring?s experience in the Northern hemisphere and from the upcoming
Southern hemisphere influenza season, as well as other relevant data. Depending
on what population groups are most affected, it is possible that vaccine will be
recommended only for specific population groups.
Page 5 of 6
Q29. Will there be flexibility in how states implement prioritization?
A29. State and local health departments are strongly encouraged to adhere to
national guidelines on vaccine prioritization. Uniformity in prioritizing vaccine is
considered a significant national interest. There may be instances where specific
local needs should be taken into consideration when implementing prioritization,
but deviation from national guidelines should be minimized.
Q30. Given the potential for large amounts of vaccine available during the first
month of vaccine shipments, are priority groups needed?
A30. These issues will be discussed and decisions communicated as they are
made.
Q31. Will there be requirements regarding documentation of priority group
membership?
A31. For priority groups not based on occupation, federal requirements for
vaccinators to require documentation of priority group status such as a doctor?s
note documenting pregnancy or high risk status are unlikely. If vaccination is
recommended for critical infrastructure personnel, systems will need to be put in
place to ensure persons presenting for vaccination have been identified by their
employer as critical personnel.
Doses administered monitoring
Q32. What are the minimum data elements required by CDC?
A32. Options are being explored and plans are not finalized. Planners should
plan for minimum data requirements including age/priority groups, 1st or 2nd dose,
data of vaccination, and state. These requirements may however change. Changes
will be communicated as they are made.
Pneumococcal vaccination
Q33. Are there any changes in recommendations for pneumococcal vaccines?
A33. The ACIP recommends that persons recommended for pneumococcal
vaccine receive it in light of the potential for increased risk of pneumococcal
disease associated with influenza. There are at present no recommendations to
give pneumococcal vaccine to groups for whom it is not currently recommended.
ACIP will revisit this question over the summer as epidemiologic data from the
Southern hemisphere influenza season and from the U.S. become available.
Private sector administration
Q34. Are there federal requirements that vaccine be administered in the public
sector?
A34. There are no such requirements at this time but the federal government has
not finalized plans.
Q35. Will insurance plans reimburse private providers for administration?
Page 6 of 6
A35. This issue is being explored, early indications suggest health insurance
plans will reimburse claims for the administration of H1N1 vaccine to their
members.
Q36. Will private providers be able to charge patients for vaccine
administration if they are uninsured?
Q36. This is unknown at this time.
June 25, 2009
Vaccine purchase
Q1. How will H1N1 vaccine be purchased?
A1. For planning purposes, planners should assume H1N1 vaccine will be
purchased by the federal government and made available for the U.S population at
no cost.
Vaccine distribution
Q2. When will the decision to administer vaccine be made?
A2. For planning purposes, it should be assumed that vaccine will be
administered beginning in the fall.
Q3. When will vaccine shipping begin?
A3. Actual dates cannot be provided at this time as they are affected by several
factors including manufacturing time and time needed to conduct clinical trials.
For planning purposes, planners should assume shipping of vaccine will begin
mid-October.
Q4. How many manufacturers are producing vaccine?
A4. Five manufacturers are producing vaccine for the U.S.: Sanofi Pasteur,
Novartis, GSK, Medimmune, and CSL.
Q5. How much vaccine can be expected to be available for shipping when
shipping begins?
A5. Given uncertainties around vaccine yield and formulation, it is not
possible to provide specific numbers at this time. Planners should use the
following 3 hypothetical scenarios for planning purposes: the initial amounts
manufactured by the five manufacturers considered together will total 40 million,
80 million, or 160 million doses of vaccine. For planning purposes, planners
should assume that vaccine will become available for shipping from the 5
manufacturers over a one month period. The above assumptions are based on a
15ug/dose formulation which is subject to change based on clinical trials.
Q6. How much vaccine can be expected in subsequent shipments?
A6. The actual weekly production is unknown at this time. For planning
purposes, planners should plan for the following 3 hypothetical scenarios: weekly
production from the 5 manufacturers will total 10 million, 20 million, and 30
million doses. However, weekly production could be larger depending on
manufacturing capacity. These amounts are less than the initial amount because
the initial amount represents several weeks of production.
Q7. How will vaccine be shipped to projects areas (CDC Public Health
Emergency Preparedness grantees)?
A7. Plans are currently being developed. Two main options are being explored
based on previous pandemic planning: shipping by manufacturers and their
commercial distributors to project area-designated ship-to sites, and centralized
distribution, which would likely allow vaccine shipments to a larger number of
ship-to sites. Both options would require an active role of the state immunization
program in designating ship-to sites and relative allocations. More information on
this will be provided in the coming weeks.
Q8. Where will vaccine be shipped to?
A8. Vaccine will be shipped to locations designated by project areas (CDC
Public Health Emergency Preparedness grantees).
Q9. Will project areas (CDC Public Health Emergency Preparedness
grantees) be able to limit the amount of vaccine they receive?
A9. Yes, project areas will be able to state what proportion of their initial and
weekly allocations they wish to receive.
Q10. How frequently will vaccine shipments arrive?
A10. The frequency of shipments will depend upon several factors, including
the method of distribution used and the frequency of vaccine orders placed by the
states. As details of distribution are finalized, CDC will communicate with states
about the anticipated time period between placing vaccine orders and receiving
shipments. CDC will provide for a minimum of weekly shipments should states
choose to receive shipments weekly.
Q11. Can the number of ship-to sites currently designated by project areas in
their pandemic plans be changed?
A11. Yes, there is some flexibility with respect to changing the number of shipto
sites; this will be especially true if centralized distribution is employed.
Q12. Will vaccine be in multi-dose vials?
A12. The majority of vaccine will be in multi-dose vials, the remainder in single
dose vials or nasal sprayers. The aim is to have enough vaccine in single dose
vials for young children and pregnant women.
Vaccine allocation
Q13. How will vaccine be allocated among project areas (the CDC PHEP
grantees)?
A13. Vaccine will be allocated to each project area in proportion to its
population (pro rata). Estimated allocations under the different planning scenarios
have been sent to each project area.
Page 3 of 6
Q14. Will there be a separate allocation for DoD dependants, retirees and
civilian employees?
A14. There is no separate allocation for these groups. Military facilities may be
willing to vaccinate these groups, but will need to be allocated vaccine for these
populations by the project areas.
Q15. Will there be a separate vaccine allocation for IHS-served populations
and other tribal communities?
A15. There will be no separate allocation. States and local areas need to work
with their tribal populations to ensure access to vaccine.
Ancillary supplies
Q16. Will syringes and needles be provided with vaccine?
A16. HHS plans to provide needles and syringes. Plans for ensuring the
distribution of these products to ship-to sites are currently being developed.
Q17. Will any other ancillary supplies be provided?
A17. Plans are being made to also provide sharps containers and alcohol swabs.
Vaccine administration
Q18. Will two doses of vaccine be required?
A18. This will not be known until the late summer- early fall, once clinical trials
are completed. For planning purposes, planners should assume that two doses will
be needed for persons under 50.
Q19. What will be the recommended interval between the first and second dose?
A19. This will not be known until clinical trials are complete. For planning
purposes, planners should assume 21-28 days between the first and second
vaccination.
Q20. How much Thimerosal-free vaccine will be available?
A20. It is anticipated that enough thimerosal-free vaccine in pre-loaded syringes
or nasal sprayers will be available for young children and pregnant women.
Q21. Will there be federal requirements to recall persons for their second dose,
if a second dose is needed?
A21. We do not anticipate a federal requirement to send out recall notices.
Providing information on second dose at the time of the first dose, as well as
using the media to disseminate this message will be the primary means of
educating persons about second dose administration.
Q22. Will it be necessary for the first and second dose need to be the same
product?
Page 4 of 6
A22. Ideally, first and second doses would be from the same product. However,
practical considerations may make this difficult to implement so it would be
preferable if products could be used interchangeably. A definitive answer on this
issue will not be available until the late summer ? early fall once clinical trials are
conducted.
Q23. Can seasonal vaccine and H1N1 vaccine be administered at the same
time?
A23. This will not be known until the clinical trials have been completed. For
planning purposes, planners should assume co-administration is possible.
Q24. Will vaccine be adjuvanted?
A24. This may not be known until early fall, once clinical trials are completed.
Q25. If vaccine is adjuvanted, how will it be formulated?
A25. Formulation will vary by provider. For Novartis, vaccine may be
preformulated with adjuvant. For CSL, GSK and Sanofi Pasteur, mixing of
vaccine and adjuvant at the site of administration will be necessary. Specific
information on storage requirements and procedures for mixing vaccine and
adjuvant will be provided by CDC. Medimmune vaccine will not be adjuvanted.
Q26. Will the vaccine be administered under EUA (Emergency Use
Authorization) and if so what are the implications?
A26. Every effort will be made to avoid the need for administering the vaccine
under EUA, however the need for EUA will not be known until the late summer ?
early fall. CDC will provide information on EUA requirements so that planners
can plan for that contingency.
Q27. Can public health clinics charge for vaccine administration?
A27. If federal funds are provided to project areas to cover vaccine
administration costs, it is likely that public health would not be allowed to charge
for vaccine administration. Decisions are pending and will be communicated as
they are made.
Priority groups:
Q28. Will priority groups change?
A28. The ACIP and other federal advisory bodies will be reviewing the existing
priority groups over the summer, considering available epidemiologic data from
this spring?s experience in the Northern hemisphere and from the upcoming
Southern hemisphere influenza season, as well as other relevant data. Depending
on what population groups are most affected, it is possible that vaccine will be
recommended only for specific population groups.
Page 5 of 6
Q29. Will there be flexibility in how states implement prioritization?
A29. State and local health departments are strongly encouraged to adhere to
national guidelines on vaccine prioritization. Uniformity in prioritizing vaccine is
considered a significant national interest. There may be instances where specific
local needs should be taken into consideration when implementing prioritization,
but deviation from national guidelines should be minimized.
Q30. Given the potential for large amounts of vaccine available during the first
month of vaccine shipments, are priority groups needed?
A30. These issues will be discussed and decisions communicated as they are
made.
Q31. Will there be requirements regarding documentation of priority group
membership?
A31. For priority groups not based on occupation, federal requirements for
vaccinators to require documentation of priority group status such as a doctor?s
note documenting pregnancy or high risk status are unlikely. If vaccination is
recommended for critical infrastructure personnel, systems will need to be put in
place to ensure persons presenting for vaccination have been identified by their
employer as critical personnel.
Doses administered monitoring
Q32. What are the minimum data elements required by CDC?
A32. Options are being explored and plans are not finalized. Planners should
plan for minimum data requirements including age/priority groups, 1st or 2nd dose,
data of vaccination, and state. These requirements may however change. Changes
will be communicated as they are made.
Pneumococcal vaccination
Q33. Are there any changes in recommendations for pneumococcal vaccines?
A33. The ACIP recommends that persons recommended for pneumococcal
vaccine receive it in light of the potential for increased risk of pneumococcal
disease associated with influenza. There are at present no recommendations to
give pneumococcal vaccine to groups for whom it is not currently recommended.
ACIP will revisit this question over the summer as epidemiologic data from the
Southern hemisphere influenza season and from the U.S. become available.
Private sector administration
Q34. Are there federal requirements that vaccine be administered in the public
sector?
A34. There are no such requirements at this time but the federal government has
not finalized plans.
Q35. Will insurance plans reimburse private providers for administration?
Page 6 of 6
A35. This issue is being explored, early indications suggest health insurance
plans will reimburse claims for the administration of H1N1 vaccine to their
members.
Q36. Will private providers be able to charge patients for vaccine
administration if they are uninsured?
Q36. This is unknown at this time.