2011-14722. Vaccine To Protect Children From Anthrax-Public Engagement Workshop

AGENCY:

Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

The National Biodefense Science Board's (NBSB) Anthrax Vaccine (AV) Working Group (WG) will hold a public engagement workshop on July 7, 2011, to discuss vaccine to protect children from anthrax. This meeting is open to the public and prior registration is required. The public may attend in-person or by teleconference.

DATES:

The NBSB's AV WG will hold a public engagement workshop on July 7, 2011, to discuss vaccine to protect children from anthrax. The meeting will be from 9 a.m. to 4 p.m. ET.

ADDRESSES:

Washington Plaza Hotel, 10 Thomas Circle Northwest, Washington, DC. The call-in details will be posted as they become available on the Workshop's July meeting Web page at http://www.phe.gov/​PREPAREDNESS/​LEGAL/​BOARDS/​NBSB/​Pages/​default.aspx.

FOR FURTHER INFORMATION CONTACT:

E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pursuant to section 319M of the Public Health Service Act (42 U.S.C. 247d-7f) and section 222 of the Public Health Service Act (42 U.S.C. 217a), the Department of Health and Human Services established the NBSB. The Board shall provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. The Board may also provide advice and guidance to the Secretary and/or the Assistant Secretary for Preparedness and Response on other matters related to public health emergency preparedness and response.

Background: In a letter dated 27 April 2011, the Assistant Secretary for Preparedness and Response (ASPR), Dr. Nicole Lurie asked the NBSB to consider issues related to the use of anthrax vaccine adsorbed (AVA), BioThrax®, for children. AVA is currently in the Strategic National Stockpile and licensed for use only by healthy persons 18 to 65 years of age for traditional pre-exposure vaccination. It may be used in a declared emergency under an Emergency Use Authorization (EUA) for this same population as post-exposure prophylaxis in combination with licensed antibiotics for prevention of anthrax disease. However, the pediatric population is not covered by the EUA due to lack of safety and immunological data related to the vaccine. If there was known exposure of a population of individuals to anthrax there would be subsequent decisions about, for example, deployment of medical countermeasures (MCMs), evacuation versus sheltering-in-place, and the airborne spread of anthrax outside the city.

Questions about the need for a vaccine program for populations that may continue to live in impacted areas may be raised. Because studies have been done to show safety and effectiveness of anthrax vaccine only for adults, if such an anthrax attack were to occur in the near future, the only way to use the existing vaccine to protect children would be to use an investigational new drug (IND) clinical protocol. These factors complicate operational response and public messaging.

The NBSB has previously identified the need to look at other MCMs for pediatric populations. This Public Engagement Workshop provides an opportunity to include the public in the discussion about vaccines to protect children from anthrax or treat children exposed to anthrax. The forum includes discussion of the types of data and types of studies that may be needed to show whether existing FDA-approved vaccines, could also be used for children. No decisions or recommendations will be made at the Workshop.

Availability of Materials: The meeting agenda and materials will be posted prior to the meeting on the Workshop's July meeting Web page at http://www.phe.gov/​PREPAREDNESS/​LEGAL/​BOARDS/​NBSB/​Pages/​default.aspx.

Procedures for Providing Public Input: Any member of the public planning to attend in-person must register in advance by e-mailing [e-mail] with “Vaccine to Protect Children from Anthrax—Public Engagement Workshop” as the subject line and provide name, address, and affiliation. If you need special assistance, such as sign language interpretation or other reasonable accommodations, please include that in your registration e-mail. A “listen-only” teleconference number will be provided on the Web site. Written comments and/or questions may be submitted in advance or during the Workshop and will be provided to the Workshop hosts. There will be two scheduled public comment periods during the Workshop. Public comments will be limited to 2 minutes per person.

Dated: June 8, 2011.

Nicole Lurie,

Assistant Secretary for Preparedness and Response.