[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49776-49777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20367]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
The Development and Evaluation of Next-Generation Smallpox
Vaccines; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) Center for Biologics
Evaluation and Research (CBER) and the National Institutes of Health,
the National Institute of Allergy and Infectious Diseases are
announcing a public workshop entitled ``The Development and Evaluation
of Next-Generation Smallpox Vaccines.'' The purpose of the public
workshop is to identify and discuss the key issues related to the
development and evaluation of next-generation smallpox vaccines. The
public workshop will include presentations on the human response to
smallpox vaccines and development of animal models for demonstration of
effectiveness of next-generation smallpox vaccines.
Date and Time: The public workshop will be held on September 16,
2011, from 8 a.m. to 5:30 p.m.
Location: The public workshop will be held at the Hilton Washington
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
Contact Person: Bernadette Williamson-Taylor, Center for Biologics
Evaluation and Research (HFM-43), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000,
Fax: 301-827-3079, e-mail: [email protected] (in the subject
line type ``Smallpox Workshop'').
Registration: Mail, fax, or email your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to the contact person by August 23, 2011. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space available basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Bernadette Williamson-Taylor (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION: Smallpox is a serious, highly contagious,
and sometimes fatal infectious disease. Although the World Health
Organization declared the disease eradicated in 1980, the threat of
smallpox as a biological weapon remains. Vaccination is the only
prevention for the disease and there are currently no FDA-approved
treatments.
First-generation smallpox vaccines were prepared on the skin of
calves or other animals or in chicken eggs. Although these vaccines
were not evaluated for efficacy in well-controlled trials, they were
highly effective as evidenced by the successful global eradication of
smallpox. Manufacturing of these vaccines has ceased and they are no
longer licensed in the United States.
In 2007, FDA licensed the first second-generation smallpox vaccine,
ACAM2000. This vaccine is based on a single plaque-purified vaccinia
virus derivative of Dryvax (a previously licensed first-generation
vaccine) and is aseptically propagated using cell culture technology
under modern manufacturing practices and standards. Both ACAM2000 and
Dryvax are derived from the New York City Board of Health strain and
produce a vesicular or pustular lesion (referred to as a ``vaccine
take'') that has been shown to correlate with protection. In clinical
trials, ACAM2000 elicited vaccinia-neutralizing antibodies and cell-
mediated immune responses, with both clinical and immunological
outcomes similar to Dryvax.
Because ACAM2000 may cause serious adverse reactions, there is a
desire to develop safer vaccines should there be a need to vaccinate
the general population due to a threat of an attack with the smallpox
virus. Currently, the next-generation smallpox vaccines under
development do not produce the characteristic ``vaccine take.'' In
addition, it is not ethical or feasible to evaluate the effectiveness
of these vaccines in humans as the natural disease has been eradicated.
Therefore, the effectiveness of these next-generation smallpox vaccines
may be based on animal efficacy data, if scientifically appropriate,
and to comparative human immune response data. As for any biologic
product, licensure of new smallpox vaccines requires demonstration of
safety, purity, and potency.
The public workshop will: (1) Discuss regulatory challenges and
approaches related to the licensure of next-generation smallpox
vaccines; (2) discuss the strengths and weaknesses of various animal
models relative to their ability to mimic human disease that can be
used to predict the effectiveness of
[[Page 49777]]
next-generation smallpox vaccines in humans; (3) discuss the most
appropriate methods to bridge immunogenicity of next-generation
smallpox vaccines to licensed smallpox vaccines in clinical trials; and
(4) discuss viable methods of extrapolating clinical efficacy of next-
generation smallpox vaccines from immunogenicity and efficacy data from
relevant animal models.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Division of Freedom of Information Office (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857, approximately 15 working days after the public
workshop at a cost of 10 cents per page. A transcript of the public
workshop will be available on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Dated: August 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20367 Filed 8-10-11; 8:45 am]
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