| Home > Events > Disease, Disaster, and Democracy, 2006 > Conference Speakers > Roundtable 1 Roundtable I: Who Receives the Limited Doses of Pandemic Flu Vaccine? An Exercise in Shared Decision-Making Participants and issues | Purpose and scenario | Transcript | Summary | Audio Background Information Worrisome Virus Signs While it is not possible to predict when the next pandemic will occur, the unprecedented spread of highly pathogenic H5N1 avian influenza in birds since 2003 and the associated human cases have heightened the alert that the next pandemic may be brewing.[1] Containment Hinges on Vaccine Medical and public health authorities generally agree that vaccination is the best means by which to contain the spread of a pandemic virus. Vaccine development, thus, is central to the U.S. government’s preparedness and to those around the world. Obstacles to Vaccine Development Successful development of a pandemic vaccine must overcome several challenges: - Influenza viruses evolve continuously. Thus, vaccines produced today based on circulating H5N1 may be poorly matched to the eventual circulating pandemic virus. The bottom line is that pandemic vaccine can not be produced until the pandemic strain emerges and is identified.
- To counter a new strain of flu such as H5N1 that has never circulated through the human population, will likely require 2 doses per person to offer adequate protection. If 2 doses of the vaccine are required, we will need to manufacture twice as much vaccine, which will add to the delay in vaccine production and distribution.
- Manufacturing capacity is limited. Most experts agree that once the pandemic strain is identified, it will be at least 6-8 months before any vaccine is available for distribution. It will take much longer to produce enough vaccine courses to cover entire populations.
Federal Action on Vaccine Development Currently there are no domestic influenza vaccine production facilities prepared to produce the 300 million vaccine courses that would be necessary to protect the entire U.S. population from a pandemic influenza strain. Other countries are faced with the same problem as well. - The current goal of the U.S. Department of Health and Human Services (HHS) is to establish domestic capacity to quickly produce vaccines for the entire U.S. population in the event of a pandemic. Currently HHS predicts that we will be able to meet that goal within 60 months. That will bring us to summer of 2011.
- One of the inhibitors to influenza vaccine production is that scientists rely upon 1950’s egg based technologies as their production method. There are other, faster cell-based production technologies, but in the past there have not been incentives for manufacturers to make the switch. Only recently have investments being made in cell-based methods.
Federal Action on Vaccine Rationing If and when pandemic vaccine does become available, some pre-determined prioritization structure will be necessary because the vaccine is still likely to be scarce, and it will take time to distribute widely to the population. HHS’s National Vaccine Advisory Committee (NVAC) has been tasked with outlining a possible prioritization structure. - The NVAC held a special joint committee meeting with the Advisory Committee of Immunization Practices (ACIP) on July 19, 2005 to formulate recommendations regarding prioritization for influenza vaccines in the event of a pandemic.
- The NVAC voted unanimously to recommend the priority structure depicted in the table below, with the understanding that, “as a pandemic event unfolds, it may be determined that an alternate structure may be more effective.”
- The ACIP voted independently of NVAC for the same structure.
- These decisions on vaccine priority groups were made primarily based on medical judgments with priority given to those most likely to suffer complications from the virus (namely elderly and immunocompromised individuals). There is limited attention given to prioritization of those persons most likely to spread the disease (namely children).
NVAC Recommended Pandemic Influenza Vaccine Priority Groups [4] | Priority Groups | Approximate Number
| | Priority Group 1 | A
| Health care workers (HCWs) providing direct patient care, essential healthcare support personnel | 9 million | Key influenza vaccine and drug plant employees
| 40,000 | | B | High-risk patients over age 65 with a chronic condition that increases the risk of a severe influenza infection, patients aged 6 months to 64 years with two such chronic conditions, and people hospitalized in the past year with influenza, pneumonia, or a chronic condition | 25.8 million
| C
| Pregnant women and people in a household with infants or severely immune-compromised patients | 10.7 million
| | D | Key government leaders and critical public health pandemic responders
| 151,000 | Priority Group 2
| A | All seniors, anyone with a chronic condition, and children aged 6 to 23 months
| 59 million | B
| Other public health emergency responders and critical infrastructure personnel, including utility and some transportation workers
| 8.5 million
| | Priority Group 3 | | Key government health decision-makers and funeral home workers | 500,000
| Priority Group 4
| | Healthy individuals aged 2 to 64 years
| 180 million |
References - Borio L, Waldhorn R. CBN Report: Update on Strategies to Develop Pandemic Vaccines. Center for Biosecurity of the University of Pittsburgh Medical Center. February 14, 2006. Available at: http://www.upmc-cbn.org/index.html?dup_id=80 Accessed on May 16, 2006.
- National Strategy for Pandemic influenza: implementation plan. U.S. Homeland Security Council. May, 2006. Available at: http://www.whitehouse.gov/homeland/nspi_implementation.pdf. Accessed May 16, 2006.
- NVAC – June 7-8, 2005 Meeting and NVAC/ACIP – July 19, 2005 Joint Committee Meeting. Letter from the Director of the National Vaccine Program, HHS. Available at: http://www.hhs.gov/nvpo/nvac/documents/chairletter.pdf Accessed on: May 16, 2006.
- Nuzzo, J. CBN Report: NVAC Priorities. Center for Biosecurity of the University of Pittsburgh Medical Center. August 2, 2005. Available at: http://www.upmc-cbn.org/index.html?dup_id=22 Accessed on May 16, 2006.
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