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Novel A (H1N1) Influenza
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Novel A (H1N1) influenza is a new flu virus of swine origin that first caused illness in Mexico and the United States in March and April, 2009. It is thought that the H1N1 virus spreads in the same way that regular seasonal influenza viruses spread, through the coughs and sneezes of people who are sick with the virus, and by touching infected objects and then touching your nose or mouth. H1N1 infection has been reported to cause a wide range of flu-like symptoms, including fever, cough, sore throat, body aches, headache, chills and fatigue. The estimated incubation period could range from 1 to 7 days, although the incubation period for most cases will likely range from 1 to 4 days. A summary of clinical features has been published by the WHO (Wkly Epi Rec 2009; 84:185-189). Information on hospitalized cases in the US can be found at (MMWR 2009; 58(17):453-458 and MMWR 2009: 58(19): 536-541), while data concerning disease in pregnant woman due to the H1N1 virus is referenced at (MMWR 2009; 58(18)497-500).
With the H1N1 virus continuing to cause illness, hospitalizations, and deaths in the US during the normally flu-free summer months and some uncertainty about what the upcoming flu season might bring, the DoD along with the DHHS have taken important planning steps in preparation for an H1N1 vaccination effort to counter a possibly severe upcoming flu season. Vaccines are the best tool we have to prevent influenza.
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MILVAX H1N1 Update
The ACIP, a panel made up of medical and public health experts, met 29 July 09, to make recommendations on who should receive the new H1N1 vaccine when it becomes available. While some issues are still unknown, such as how severe the virus will be during the fall and winter months, the ACIP considered several factors, including current disease patterns, populations most at-risk for severe illness based on current trends in illness, hospitalizations and deaths, how much vaccine is expected to be available, and the timing of vaccine availability.
The civilian groups recommended to receive the novel H1N1 influenza vaccine include:
- Pregnant women
- Household contacts and caregivers for children younger than 6 months of age
- Healthcare and emergency medical services personnel
- All people from 6 months through 24 years of age
- Children from 6 months through 18 years; Young adults 19 through 24 years
- Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza
LTC Patrick Garman, PhD, Deputy Director, MILVAX
Two regulatory options exist for H1N1 vaccines; 1) Licensure: an H1N1 vaccine manufactured using the same process as the U.S. licensed inactivated influenza vaccine, or seasonal live attenuated influenza vaccine will be licensed for use in the U.S., or 2) Emergency Use Authorization (EUA): Currently, no U.S licensed vaccine contains the adjuvants MF-59 or ASO3. It is expected that an H1N1 vaccine manufactured using the same process as U.S. licensed seasonal inactivated influenza vaccine but administered with MF-59 or ASO3 will be authorized for emergency use only. Products by statute, that are eligible for emergency use are those that “may be effective” in preventing serious or life threatening disease. If enough doses of licensed unadjuvanted vaccine can be secured and the H1N1 virus pandemic remains mild the use of a licensed product would be preferred over the use of a vaccine under an EUA.LTC Patrick Garman, PhD, Deputy Director, MILVAX
The H1N1 vaccine will contain an A/Califormia/7/2009(H1N1)v-like virus. Manufactures are reporting lower yields for the A/Califormia/7/2009(H1N1)v-like virus relative to the normal seasonal influenza vaccines, but additional studies to assess virus yields are ongoing. This should not ultimately affect the number of doses available.LTC Patrick Garman, PhD, Deputy Director, MILVAX
The ACIP, a panel made up of medical and public health experts, met 29 July 09, to make recommendations on who should receive the new H1N1 vaccine when it becomes available. While some issues are still unknown, such as how severe the virus will be during the fall and winter months, the ACIP considered several factors, including current disease patterns, populations most at-risk for severe illness based on current trends in illness, hospitalizations and deaths, how much vaccine is expected to be available, and the timing of vaccine availability.
The civilian groups recommended to receive the novel H1N1 influenza vaccine include:
- Pregnant women
- Household contacts and caregivers for children younger than 6 months of age
- Healthcare and emergency medical services personnel
- All people from 6 months through 24 years of age
- Children from 6 months through 18 years; Young adults 19 through 24 years
- Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza
LTC Patrick Garman, PhD, Deputy Director, MILVAX
Two regulatory options exist for H1N1 vaccines; 1) Licensure: an H1N1 vaccine manufactured using the same process as the U.S. licensed inactivated influenza vaccine, or seasonal live attenuated influenza vaccine will be licensed for use in the U.S., or 2) Emergency Use Authorization (EUA): Currently, no U.S licensed vaccine contains the adjuvants MF-59 or ASO3. It is expected that an H1N1 vaccine manufactured using the same process as U.S. licensed seasonal inactivated influenza vaccine but administered with MF-59 or ASO3 will be authorized for emergency use only. Products by statute, that are eligible for emergency use are those that “may be effective” in preventing serious or life threatening disease. If enough doses of licensed unadjuvanted vaccine can be secured and the H1N1 virus pandemic remains mild the use of a licensed product would be preferred over the use of a vaccine under an EUA.LTC Patrick Garman, PhD, Deputy Director, MILVAX
The H1N1 vaccine will contain an A/Califormia/7/2009(H1N1)v-like virus. Manufactures are reporting lower yields for the A/Califormia/7/2009(H1N1)v-like virus relative to the normal seasonal influenza vaccines, but additional studies to assess virus yields are ongoing. This should not ultimately affect the number of doses available.LTC Patrick Garman, PhD, Deputy Director, MILVAX
The CDC reported the level of cross reactive antibody to the novel influenza A(H1N1) virus in stored and pre- and post vaccination sera from 359 U.S. children and adults vaccinated with seasonal influenza vaccines from 2005 to 2009 (MMWR 2009;58:521-524). The results suggest that while older persons may have some level of pre-existing immunity to the novel H1N1 strain, children and younger adults have no or low levels of serum antibody, respectively, that are cross reactive to the novel influenza A(H1N1) virus. Translation: Because most people have little or no pre-existing immunity to the novel influenza A(H1N1) virus there may be a need for a two dose regimen as a single dose of monovalent novel influenza A(H1N1) vaccine may not provide an adequately protective immune response.
LTC Patrick Garman, PhD, Deputy Director, MILVAX
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 | MSNBC 22 Aug 09
U.S. preps for vast swine flu vaccine effort; Effort to innoculate half of population within months is unprecedented
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| | Time 21 Aug 09
Who Should Get Swine Flu Shots First?
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| | CNN 20 Aug 09
Kids roll up sleeves for H1N1 clinical trial
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ALARACT PDF 29 Apr 09| | SWINE INFLUENZA A (H1N1) INFORMATION
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USNORTHCOM PDF 29 Apr 09| | USNORTHCOM FORCE PROTECTION DIRECTIVE 09-119 (MEXICO THEATER
CLEARANCE)
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MMI-09-4003| | ALARACT 117/2009 - SWINE INFLUENZA A (H1N1) INFORMATION
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| Disease: |
Influenza - H1N1 |
| Author(s): |
Gaydos J, Top FH, Hodder RA, Russell PK |
| Title: |
Swine Influenza A Outbreak, Fort Dix, New Jersey, 1976 |
| Publication: |
Emerging Infectious Diseases, Vol. 12, No. 1 |
| Date: |
2006 |
| Subject: |
Threat |
| Link: |
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| File: |
Gaydos_EID_VOL12_NO1.pdf |
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