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Questions
Flu Vaccine:
& Answers
Q&A What are the appropriate biosafety practices and containment conditions for work with the
1918 strain of influenza?
Vaccine Dosage & Biosafety Level 3 or Animal Biosafety Level 3 practices, procedures and facilities, plus
Administration enhancements that include special procedures (discussed in the next question below), are
Vaccine Supply for recommended for work with the 1918 strain. There are four biosafety levels that correspond to
2010-11 Season the degree of risk posed by the research and involve graded levels of protection for personnel,
the environment, and the community. Biosafety Level 4 provides the most stringent containment
Vaccine Supply and conditions, Biosafety Level 1 the least stringent. These biosafety levels consist of a combination of
Distribution in the
United States laboratory practices and techniques, safety equipment, and laboratory facilities that are
appropriate for the operations being performed. The specific criteria for each biosafety level are
Vaccine Effectiveness detailed in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories.
Flu Shot What is Biosafety Level 3 "enhanced"? What are the specific enhancements used for work
Nasal Spray Vaccine with the 1918 strain of influenza?
(LAIV) A Biosafety Level 3 facility with specific enhancements includes primary (safety cabinets, isolation
chambers, gloves and gowns) and secondary (facility construction, HEPA filtration treatment of
Thimerosal
exhaust air) barriers to protect laboratory workers and the public from accidental exposure. The
Guillain-Barré specific additional ("enhanced") procedures used for work with the 1918 strain include:
Syndrome (GBS)
l Rigorous adherence to additional respiratory protection and clothing change protocols;
Antiviral Drugs: Key
Facts l Use of negative pressure, HEPA-filtered respirators or positive air-purifying respirators
(PAPRs);
Antiviral Drugs: Q&A
l Use of HEPA filtration for treatment of exhaust air; and
Antiviral Drug
Resistance l Amendment of personnel practices to include personal showers prior to exiting the
laboratory.
Links, Information, &
Resources Further details of the biosafety recommendations for work with various human and animal
influenza viruses, including 1918 virus, can be found in the interim CDC/NIH guidance for such
Good Health Habits work at Interim CDC-NIH Recommendation for Raising the Biosafety Level Laboratory Work
Preventing the Flu: Involving Noncontemporary Human Influenza Viruses.
Q&A
Can these experiments be done safely using containment provided by BSL-3 with
enhancements?
Highly trained laboratorians can work with the 1918 influenza virus strain safely using BSL-3-
enhanced containment. Researchers at CDC have specialized training and go through a rigorous
Info for Businesses & biosafety (and security) clearance process. For the work reported in the Science article, the lead
Employees CDC researcher provided routine weekly written reports to CDC management officials, including
What
Diagnosis
To Do If You Get the agency's Chief Science Officer, and was instructed to notify agency officials immediately of any
Sick concerns related to biosafety or biosecurity.
Symptoms
Antiviral Drugs A BSL-3 facility with specific enhancements includes primary (safety cabinets, isolation cabinets,
gloves, gowns) and secondary (facility construction) barriers to protect laboratory workers and the
Taking Care of Yourself public from accidental exposure. Specific enhancements include change-of-clothing and shower-out
Taking
Make Care
a SickofRoom requirements, and the use of a powered air purifying respirator (PAPR; half body suits). The
Someone Who is Sick primary and secondary barriers plus additional personal safety practices provide appropriate
Follow Sick Room Rules
containment for conducting such influenza research. CDC evaluated the specific studies to be
Clean the Sick Room conducted as well as the highly experienced scientific team conducting the research and concluded
Tips for Caregivers that this work could proceed under BSL-3 containment with enhancements.
Prevent Fluid Loss Why was BSL-3-enhanced containment used for work on the 1918 H1N1 virus when most
human influenza viruses of the H1N1 subtype are handled under much less stringent
Check for Fluid Loss containment?
When to Get Medical The appropriate biosafety measures for working a given pathogen depend upon a number of
Help for Fluid Loss factors, including previous experience with the pathogen or similar pathogens, the virulence and
transmissibility of the pathogen, the type of experiment, and the availability of vaccines and/or
Medicine Safety antimicrobial drugs effective against the pathogen. Prior to reconstruction of the 1918 virus, CDC
Medicine Safety & carefully evaluated the specific studies to be conducted and concluded that this research could
Children safely and securely be done under BSL-3-enhanced containment. All viruses containing one or
Treat Fever more gene segments from the 1918 influenza virus were generated and handled under high-
containment (BSL 3-enhanced) laboratory conditions in accordance with guidelines of NIH and
Treat Dry Cough CDC. The recommendations for biosafety levels are made by a panel of experts and are followed
Treat Other Symptoms in a stringent manner.
A higher level of containment (biosafety level 4) is utilized for work on novel or exotic pathogens
for which there is no treatment or vaccine. This is not the case for the 1918 virus. Decedents of
Questions & Answers the 1918 influenza virus still circulate today, and the current influenza vaccine provides some
protection against the 1918 virus. In addition, two types of antiviral drugs, rimantadine
(Flumadine) and oseltamivir (Tamiflu), are effective against viruses bearing 1918 virus gene
products targeted by the antiviral drugs.
Info
2010-11
Primary
for Health
ACIP
Changes and
Professionals
Recommendations
Updates in the ACIP The physical and engineering design of BSL-3-enhanced containment is very similar to that used in
Recommendations BSL-4 laboratories. The BSL-3 laboratory also has state-of-the-art directional airflow control which
ACIP filters outgoing air, and all waste is autoclaved or decontaminated before it leaves the work area,
Recommendations: preventing escape of infectious agents.
Introduction and
Biology of Influenza Recent media reports have described the disappearance of plague-infected mice from a U.S.
laboratory. Could mice infected with the 1918 influenza virus escape or be removed from CDC
Options for laboratories?
Controlling Influenza The rigorous biosafety and biosecurity precautions used at CDC for experiments done with the
Summary of influenza 1918 virus make it extremely unlikely that an animal infected with the 1918 virus could escape or
vaccination be removed from CDC laboratories. For the experiments described in this report, all animals used
recommendations, were properly contained and accounted for.
2010
Earlier this year, samples of a "non-contemporary" influenza virus strain (H2N2) were
Recommendations for shipped to laboratories worldwide as part of proficiency testing panels. Could the 1918
Using TIV and LAIV pandemic influenza virus be inadvertently distributed in a similar manner?
During the Influenza No. The "non-contemporary" H2N2 virus was available from many sources and inadvertently
Season shipped by private suppliers as part of the proficiency panel. CDC currently has no plans to
Comparisons of LAIV distribute this virus.
and TIV Efficacy
Influenza Vaccine
Biosecurity Issues
Composition & Major Does the generation of the 1918 Spanish influenza pandemic virus containing the complete
Differences coding sequence of the eight viral gene segments violate the Biological Weapons Convention?
No. Article I of the Biological Weapons Convention (BWC) specifically allows for microbiological
Vaccine Supply research for "prophylactic, protective, or other peaceful purposes. Article X of the BWC encourages
Considerations the "fullest possible exchange of… scientific and technological information" for the use of biological
Dosage, agents for the prevention of disease and other peaceful purposes. Further, Article X of the BWC
Administration, and provides that the BWC should not hamper technological development in the field of peaceful
Storage bacteriological activities. Because the emergence of another pandemic virus is considered likely, if
Influenza Vaccination not inevitable, characterization of the 1918 virus may enable us to recognize the potential threat
Coverage Levels posed by new influenza virus strains, and it will shed light on the prophylactic and therapeutic
countermeasures that will be needed to control pandemic viruses.
Additional Information
about Vaccination of Does the report provide a "blueprint" for bioterrorists to develop and unleash a devastating
Specific Populations pandemic on the world?
Persons for Whom No. This report does not provide the blueprint for bioterrorist to develop a pandemic influenza
Annual Vaccination is strain. The reverse genetics system that was used to generate the 1918 virus is a widely used
Recommended laboratory technique. While there are concerns that this approach could potentially be misused for
Persons Who Should purposes of bioterrorism, there are also clear and significant potential benefits of sharing this
Not Be Vaccinated information with the scientific community: namely, facilitating the development of effective
interventions, thereby strengthening public health and national security.
Timing of Vaccination
Is the 1918 influenza virus a select agent?
Adverse Events After The Intra-governmental Select Agents and Toxins Technical Advisory Committee convened on
Receipt of TIV
September 30, 2005, and recommended that the reconstructed 1918 influenza virus be added to
Adverse Events After the list of HHS select agents. Following this recommendation, CDC amended its regulations and
Receipt of Live, designated all reconstructed replication competent forms of the 1918 pandemic influenza virus
Attenuated Influenza containing any portion of the coding regions of all eight gene segments (reconstructed 1918
Vaccine (LAIV)
Influenza virus) as a select agent.
What is the Select Agent Program?
The Centers for Disease Control and Prevention (CDC) regulates the possession, use and transfer
Vaccination
Influenza Vaccination of select agents and toxins that have the potential to pose a severe threat to public health and
Coverage
safety. The CDC Select Agent Program oversees these activities and registers all laboratories and
Vaccine Supply Update other entities in the United States of America that possess, use or transfer a select agent or toxin.
Influenza Vaccination: The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final
A Summary for
Clinicians rules for the possession, use, and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R.
Part 331, and 9 C.F.R. Part 121) in the Federal Register on March 18, 2005. All provisions of these
Seasonal Influenza final rules supersede those contained in the interim final rules and became effective on April 18,
Vaccine Safety: A 2005.
Summary for Clinicians
Selecting the Viruses
in the Influenza (Flu)
Vaccine
Large-Scale Influenza
Vaccination Clinic
Planning
Flu Vaccine
Effectiveness
Reallocating Influenza
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Antiviral
Summary Drugs
Influenza
2010-11
Antiviral Treatment
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2010-2011
2010-2011 Influenza
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Summary for Clinicians
Infection
InfectionControl
Control
Guidance for the
Prevention & Control
of Influenza in Acute-
Care Facilities
Preventing the
Spread of Influenza
(the Flu) in Child Care
Settings: Guidance for
Administrators, Care
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Control of Influenza
Outbreaks in
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Preventing &
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Transmission in Long-
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Prevention & Control
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Diagnosis
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Rapid Diagnostic
Testing: Information
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Guidance for Clinicians
on the Use of Rapid
Influenza Diagnostic
Tests for the 2010-
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Influenza Diagnostic
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