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1、 VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE FDA Regulatory Pathway To Facilitate the Licensure and Availability of Pandemic (H1N1) 2009 Influenza Virus Vaccines Norman W. Baylor, Ph.D. Director, Office of Vaccines Research and Review FDA/CBER 23 July 20091Introduction FDA is conveni
2、ng the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to present our approach to facilitate the licensure and availability of vaccines against the pandemic (H1N1) 2009 Influenza virus. FDA is collaborating with other government agencies (NIH, CDC, BARDA, NVPO, and DHHS), the Wo
3、rld Health Organization, other National Regulatory Authorities, and the vaccine industry to facilitate the licensure of safe and effective vaccines against pandemic (H1N1) 2009 influenza virus.2Regulatory Pathway to Licensure Over the coming weeks, the US Government and the vaccine manufacturers wil
4、l need to make critical decisions: formulation of a pandemic (H1N1) 2009 influenza vaccine, and recommendations for vaccination of targeted groups and potentially the entire U.S. population Due to the rapid spread and the uncertainty of the pandemic this fall, FDA has considered regulatory pathways
5、to facilitate licensure and has determined that monovalent unadjuvanted vaccines against pandemic (H1N1) 2009 influenza virus can be licensed as strain change supplements to existing BLAs: is consistent with licensure of new seasonal vaccines is consistent with past regulatory actions facilitates av
6、ailability if vaccination is recommended 3Outline of AgendaFDA will present considerations for manufacturing and testing of vaccines, the regulatory approach to the clinical evaluation of vaccines, and an overview of post marketing safety monitoring and evaluation.CDC will provide an update on surve
7、illance and epidemiology of pandemic (H1N1) 2009 influenza virus.NIH will provide an overview of their proposed clinical studies.BARDA will present an overview of DHHS role in preparedness and procurement of pandemic (H1N1) 2009 influenza virus vaccines.Influenza vaccine manufacturers will provide b
8、rief overviews of their plans for manufacturing and clinical evaluation of pandemic (H1N1) 2009 influenza virus vaccines.42009 H1N1 Influenza Pandemic Declaration“On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have
9、been met. I have therefore decided to raise the level of influenza pandemic alert from phase 5 to phase 6. The world is now at the start of the 2009 influenza pandemic.” -Dr. Margaret Chan, Director General, WHO, 11 June 200952009 H1N1 Influenza Pandemic“The 2009 influenza pandemic has spread intern
10、ationally with unprecedented speed. In past pandemics, influenza viruses have needed more than six months to spread as widely as the new H1N1 virus has spread in less than six weeks”- WHO, July 16, 20096Cumulative Number of Confirmed Human Cases of Pandemic 2009 Influenza (H1N1) Reported to WHOUS Ca
11、ses: 40,617 US Deaths: 263July 16, 2009Global Total Cases: 139,629 Global Deaths: 8677Southern HemisphereThe Southern hemisphere, currently reporting pandemic (H1N1) 2009 influenza virus activity, may be a predictor of activity in the Northern hemisphere in the fall 8Planning considerations: Current
12、 situation and expectations: Continued circulation of pandemic (H1N1) 2009 influenza virus The number of cases will continue to increase Vaccines will be an important intervention against pandemic (H1N1) 2009 influenza virus An adequate supply of vaccine is necessary for preparedness Uncertainties:
13、Possibility of development of increased virulence and associated morbidity, especially in children and young adults Possibility of widespread antiviral drug resistance Severity of the 2009 H1N1 influenza pandemic Antigenic drift9ConclusionThe pandemic (H1N1) 2009 influenza virus is continuing to spr
14、ead globally, and there are uncertainties about how the virus will behave during the U.S. 2009-10 influenza season.FDA is committed to ensuring the availability of safe and effective vaccines against the pandemic (H1N1) 2009 influenza virus in the event of recommendations to use the vaccines.As part
15、 of the governments efforts in pandemic preparedness FDA, along with other Agencies within DHHS, believe that licensure of monovalent, non-adjuvanted vaccines against the pandemic (H1N1) 2009 influenza virus as a strain change is the most expeditious pathway for providing safe and effective vaccines
16、 to the public.Availability of adjuvanted vaccines, if needed, under a Emergency Use Authorization is an option.Discussions concerning recommendation for use and implementation of immunization programs for pandemic (H1N1) 2009 influenza vaccine are ongoing within other parts of the government and by other advisory committees, and are separate from licensure of the vaccine. 10Discussi
