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October 2007 NVAC Meeting Minutes - page 17 / 40





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October 2007 NVAC Meeting Minutes

Since the last NVAC meeting, the FDA has approved the Acambis 2000 Smallpox vaccine. This happened in August of this year. This is the first vaccine that the FDA has approved that requires a RiskMAP (Risk Minimization Action Plan). This requires the providers of the vaccine and patients who will be receiving the vaccine to be educated about the risks of the vaccine.

In September, the FDA approved the expansion of indications for FluMist (the nasal spray influenza vaccine) to include children between 2 and 5 years of age. Also in September, the FDA approved another flu vaccine, Afluria. Afluria is manufactured by CSL Biotherapies out of Australia. Now there are six U.S. licensed manufacturers of flu vaccine in the United States.

Dr. Baylor also mentioned a Federal Register notice on the development of safety and effectiveness assessments for vaccines for pandemic influenza. He explained that this document was for interested parties to provide comments and information in order to help the FDA develop programs to look at adverse effects following administration of pandemic flu vaccines. The notice was part of the mandate for the FDA from the President’s National Strategy for Pandemic Influenza from November of 2005.

Dr. Baylor’s last update concerned the FDA Amendment Act of 2007, which was passed on September 27. One of the purposes of this act was to reauthorize the Prescription Drug User Fee Act. It also reauthorizes the Medical Device User Fee Act. There are 11 titles in this act in addition to the user fees. Title 6 establishes the Reagan-Udall Foundation. This Foundation’s mission is to advance the mission of FDA to modernize product development, accelerate innovation, and enhance product safety. The foundation will be supported by private funding; however, some FDA funding will go toward operations. Another highlight of this act is that it includes a priority review, which is usually 6 months, for tropical diseases such as tuberculosis, cholera, malaria, and dengue fever. This serves as an incentive for manufacturers. If a manufacturer receives approval for a vaccine or medical product for a tropical disease, the act allows them to get a voucher for a priority review for something else. This act provides FDA with the opportunity to look at issues and license products for developing countries.


In response to a question about the domestic and international capacity of the flu vaccine, Dr. Baylor estimated that between 120 and 130 million doses of the flu vaccine were manufactured this year. However, he explained that some manufacturers, especially the new manufacturers, are still not at their full capacity. Dr. Gellin commented that the World Health Organization (WHO) estimated that around 350 million doses of trivalent influenza vaccine were manufactured; however, again, existing manufacturers could create more. Dr. Hosbach explained that while this year, close to 130 million doses of flu vaccine were manufactured, next year, 170 million doses could be produced. However, he reminded the Committee that every year manufacturers throw out vaccine. Therefore, production for next year’s flu vaccine will decrease unless there is an increase in demand or unless the recommendations for flu vaccine are expanded.

Regarding the tropical disease initiative, Dr. Feinberg asked if the FDA would be serving as the regulatory authority for vaccines targeting diseases primarily in other countries. He also asked if this might resemble the article 58 mechanism that the European Regulatory Authorities use. Dr. Baylor stated that this effort was not equivalent to article 58 as FDA works with sponsors to develop products and looks at protocols and clinical trials. He went on to explain that the FDA does have a global vaccine initiative as there is the desire to license products for diseases that are not in the United States.

National Vaccine Program Office (NVPO)—Dr. Bruce G. Gellin

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