Release Date:  February 3, 1999



National Institute of Allergy and Infectious Diseases

The Government is conducting market research to determine the interest and
capability of influenza vaccine manufacturers to participate in producing
batches of influenza virus vaccines to support clinical studies. Proposals are
not being solicited at this time.  The vaccines required for the clinical
studies are to be prepared from avian influenza virus subtypes with high
pandemic potential.  This market research is part of the NIAID/NIH
contribution to the Influenza Pandemic Preparedness Plan.  Information has
been gathered on relevant influenza A virus subtypes, and candidate avian
viruses for use in clinical studies have been prioritized: H5N1, H7N7
(Eurasian lineage) and H7N3 (North American lineage), H2N2, H9N2, and H1N1
(avian-like H1).  Pilot lots of inactivated vaccine, live-attenuated vaccine,
and recombinant protein vaccine against each virus subtype listed above will
be prepared  safety and immunogenicity of the vaccines can be evaluated in
controlled clinical trials sponsored by the Government. The overall objective
of this activity is to gain knowledge that will better prepare us for dealing
with an influenza pandemic.

As a first step, the Government would like to proceed with the development of
influenza A H5N1 virus vaccines.  A reassortant produced with the A/Ann
Arbor/6/60 ca virus is currently available for H5N1 live-attenuated vaccine
production. Additional appropriate reference viruses and reassortants for the
preparation of the H5N1-inactivated vaccines are being prepared. It is
anticipated that reassortants produced using A/Puerto Rico/8/34 as the high
growth donor strain will be provided; however, if this is not possible,
reassortants produced with the A/Ann Arbor/6/60 ca virus may be used. For
recombinant protein vaccines, the Government or industry might be sources for
plasmids for specific influenza A virus hemagglutinins. 

For each vaccine lot, the manufacturer would be expected to provide no less
than 2000 single dose containers (in doses to be established by the
Government) produced according to current good manufacturing practices to
permit use of the vaccines in clinical trials.  The manufacturer would also be
expected to take responsibility for all release testing including required and
appropriate tests for safety, sterility and potency, and to provide full
documentation to the Government (NIH and FDA) to support Phase I and Phase II
clinical evaluations of the vaccine.

The Government is also seeking manufacturer input on the following issues:

o  Do manufacturers have a preference for a particular reassortant background
(i.e. PR-8 versus AA/6/60)? 

o  If manufacturers are not able to participate in initial production of H5N1
vaccines, is there interest in any/all of the other subtypes listed above?

The timeframe for completing production of the vaccines is flexible; however,
it is anticipated that the effort would be finished prior to the start of the
2000-2001 influenza vaccine production.  Therefore, it would be useful for the
Government to know the approximate lead-time foreseen to begin this effort
upon notice of contract award.

Provide a brief (maximum 8 pages) description of your institution's interest,
capability and capacity to conduct this effort.  As part of this description,
you may include a "rough" cost estimate of your approach to the effort.  This
estimate should identify the total number of hours (or total percentage), the
direct labor cost (combined amount, not separated by labor category), the
materials and supplies, computer costs, and any other direct costs.  Please
identify your institution's fringe benefit and indirect (overhead) rates as
well as any profit (or other fees) which may be applied to the direct costs. 
This estimate will assist NIAID with its planning for this acquisition.  Your
institution will not be held to these figures should the NIAID choose to
negotiate a contract award.


Responses should be sent to the address below no later than Friday, February
12, 1999.  You are reminded that the government is not soliciting proposals at
this time.

Questions regarding this effort may be directed to:

Mr. Paul D. McFarlane
Contracts Management Branch
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C07
Bethesda, MD  20892-7610
Telephone:  (301) 496-0349

Dr. Pamela McInnes
Respiratory Diseases Branch
National Institute of Allergy and Infectious Diseases
Telephone:  (301) 496-5305

Return to Volume Index

Return to NIH Guide Main Index

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.