[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Pages 49776-49777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20367]



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.


    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: CBERTraining@fda.hhs.gov (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 
    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]