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October 2007 NVAC Meeting Minutes - page 31 / 40





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October 2007 NVAC Meeting Minutes

Appendix: Subcommittee Minutes

Subcommittee on Vaccine Development and Supply—Chair: Dr. Cornelia L. Dekker (Dr. Lance K. Gordon was acting chair for this session)

Attendees: Alina Baciu, IOM; Dr. Norman W. Baylor, FDA; Dr. Karen Broder (Lcdr., USPHS), CDC; Dr. George Curlin, NIH; Dr. Cornelia L. Dekker, Subcommittee Chair (Telecon); Shannon Dzubin, Novartis; Dr. Scott K. Fridkin, CDC (Telecon); Dr. Lance K. Gordon, NVAC Representative Member; Dr. Phil Hosbach, sanofi pasteur; Eleanor Joseph, CRA International; Megan Lindley, CDC; Alison C. Mawle, CDC (Telecon); Dr. Barbara Mulach, NIAID/NIH; Jennifer Salesa, NVAC; Dr. Anne Schuchat, (Radm., USPHS), CDC; Dr. Benjamin Schwartz (Capt., USPHS), NVPO; Dr. Ray Strikas, (Capt., USPHS), NVPO; Dr. Richard Tardiff, ORISE; Elizabeth Thoburn, Merck; Dr. Greg Wallace, CDC; Dr. Bruce G. Weniger, CDC (Telecon); Dr. Laura York, Wyeth Vaccines Research; Keith Maynard, notetaker.

Dr. Gordon welcomed participants and turned the meeting over to Dr. Dekker, who was participating by teleconference. She introduced the agenda, which comprised (1) a discussion of the latest draft of the report she is writing for the Subcommittee, addressing adjuvants and dose sparing; (2) discussion of the Subcommittee’s role in the development effort for a new National Vaccine Plan; and (3) discussion of a possible Subcommittee role with regard to Staphylococcus vaccines.

Draft Report: Dose Optimization Strategies for Vaccines: The Role of Adjuvants and Other Technologies—Dr. Cornelia L. Dekker, Subcommittee Chair

Dr. Dekker stated that the most current draft of Dose Optimization Strategies for Vaccines: The Role of Adjuvants and Other Technologies, dated October 17, 2007, reflected information received to date regarding ongoing efforts of the Federal agencies. She asked for additional input, with the goal of having the document completed for a telephone review by the full NVAC committee and approval in early December. If that goal cannot be met for administrative reasons, approval of the document would be an agenda item for the February NVAC meeting.

Responding to the request for information on NIH-sponsored adjuvant studies, Dr. Mulach stated that NIH grants for such studies were available and research in the area was ongoing. Dr. Dekker will consult with NIH colleagues and provide the information by e-mail.

Dr. Baylor, when asked, stated that research related to adjuvants was ongoing at FDA but that he was not at liberty to discuss it. When asked about any initiatives with regard to the development of FDA guidelines similar to the WHO adjuvant guidelines, he stated that FDA recognizes the need for such guidelines. He will provide a brief summary for the report.

Dr. Schwartz stated that current NVPO adjuvant efforts were limited to those related to pandemic influenza preparedness. He stated that there is a need for research on the use of novel adjuvants with flu vaccines where proprietary rights to the adjuvants and flu antigens are held by different companies. The issues of access to proprietary technologies and the supporting regulatory data packages necessary to enable such research were discussed. Dr. Schwartz called for studies of H5N1 vaccines to be extended to subpopulations other than healthy adults, such as elderly and immunocompromised individuals.

Dr. Schwartz said that NVPO, at one point, considered prioritizing the Unmet Needs program funds to establishing new methods for FDA to ascertain adjuvant safety. Although such exclusive funding did not occur, research into such methods was still a priority.

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