30 March 2006

US To buy 50 million N-95 Respirators as part of Updated Pandemic Flu Planning 

The Secretary of the Department of Health and Human Services, Michael Leavitt, posted online (www.pandemicflu.gov) this month (March 13th) a 12-page update on the US Pandemic Influenza Plan that includes purchase this year of 50 million N-95 respirators. Other non-pharmaceutical countermeasures for a future flu pandemic to be stockpiled this year by the US include 6,000 ventilators, 50 million surgical masks and an unstated number of face shields, gloves, and gowns.

Such countermeasures are a welcome addition to the US preparedness stockpile for the future flu pandemic, as well as for other respiratory-transmitted biological threats, both natural and man-made. In particular, the addition of the 50 million N-95 respirators will prove extremely helpful for optimal protection of health care and other first responders in situations when the future pandemic flu virus is transmitted not only by droplets, but by smaller droplet nuclei ("airborne precautions"), for which fit-tested N-95 respirators are required.

This updated plan by Health and Human Services (HHS) also reported that this month over 14 million courses (not doses) of the anti-flu drugs "Tamiflu" (oral capsules) and "Relenza" (an inhaled drug) had been purchased. Thus, the total national stockpile has been increased to almost 20 million courses. The overall US goal is 81 million courses of anti-flu drugs by the end of 2008 (33 months from now). HHS plans to purchase 50 million of these courses and subsidize by 25% the remaining 31 million courses that the individual states must purchase.

Much information is contained in this document on pre-pandemic vaccines (e.g., against the two current clades of H5N1 virus) and future pandemic flu vaccine(s) (that can only be made after a pandemic flu virus appears in the world). Most immediately notable, HHS Secretary Leavitt noted that the US is beginning development of a 2nd H5N1 vaccine based on an antigenically distinct clade of the virus that has evolved and spread in several areas. This new clade of H5N1 is based on an H5N1 virus isolated from a person in Indonesia in 2005. Thus, is referred to as an "Indonesia 2005" strain of H5N1, in contrast to the initial H5N1 vaccine currently being studied and stockpiled in the USA that is referred to as "Vietnam 2004".

Additional pre-pandemic and pandemic vaccine issues addressed in this update include development and funding for research of cell-culture based influenza vaccines, liability protection for the vaccine industry, new FDA written guidance (posted on the FDA website www.fda.gov) on criteria for clinical development and licensure of avian and pandemic flu vaccines, and recognition of the importance of "antigen-sparing" vaccines that use vaccine adjuvants or are given intradermally (ID) rather than intramuscularly (IM).

Overall, this 12-page document is a very practical and useful update on multiple fronts in the preparedness effort against the future pandemic influenza. In particular, the purchase of 50 million N-95 respirators is critically important.

Stockpiling of N-95s and fit-testing of emergency response personnel has been repeatedly advocated by this author over the past 24 months, since coordinating the purchase of approximately 500,000 N-95 respirators (and 2.5 million surgical masks) by the Washington, DC Department of Health in anticipation of both natural threats (e.g., pandemic flu, another SARS-like virus, others) and bioterrorism threats (smallpox, genetically-engineered threats, reaerosolized anthrax over large urban areas, and others).

Daniel R. Lucey, MD, MPH

Director, Center for Biologic Countermeasures and Emerging Diseases

Washington Hospital Center EROne Institutes

Co-Director, Master of Science Program in

Biohazardous Threat Agents and Emerging Infectious Diseases

Georgetown University School of Medicine

Washington, DC

Website: www.BePast.org

Email:Daniel.R.Lucey@Medstar.net

Cairo, Egypt (on travel for H5N1 symposium)