 |
 |
 |
 |
 |
July
2007: VOLUME
1, NUMBER 9
Influenza
Vaccines
 |
 |
eInfluenza
Review is proud
to announce our
accredited
PODCASTS for 2007. Listen
here. |
Participants
can now receive 0.5 credits per
podcast after completing an online
post test via the links provided
on this page. In addition to
our monthly newsletters, there will
be other podcasts throughout
the duration of this program.
The eInfluenza Review podcast is a discussion between our July
author, Lisa L. Maragakis, MD,
MPH and Robert Busker, eInfluenza Review’s
Medical Editor.
To learn more about podcasting
and how to enjoy this exciting new feature of eInfluenza Review, please visit
this page.
In
this issue...
Annual influenza vaccination
of healthcare personnel, children, and populations at high risk for
influenza complications is one of the most effective means of limiting
the transmission, morbidity, and mortality of influenza. Compliance
with recommended influenza vaccination is limited — among other
factors — by dislike of injections, fear of adverse effects, and
periodic vaccine shortages. While intranasal administration of live
attenuated influenza vaccine avoids the need for an injection, it raises
concerns about potential secondary transmission of live vaccine virus
from vaccine recipients to immunocompromised individuals. In addition,
influenza vaccine shortages and the threat of pandemic influenza necessitate
the development of more efficient and reliable vaccine production methods,
as well as vaccines that are effective against avian influenza viruses
such as H5N1.
In this issue, we examine a study
of the duration of viral shedding after live attenuated influenza vaccination
in adults; review current evidence regarding the safety and transmissibility
of live attenuated influenza vaccine; report on strategies for distribution
of a limited vaccine supply; review recent data on an influenza vaccine
production technique that does not rely on the use of embryonated eggs;
and discuss the safety and immunogenicity of a new vaccine against avian
influenza H5N1. |
|
 |
|
 |
 |
 |
|
 |
Program
Directors
John
G. Bartlett, MD
Professor of Medicine
Department of Medicine
The Johns Hopkins
University
School of Medicine
Jonathan
M. Zenilman, MD
Professor of Medicine
Chief, Infectious
Diseases Division
The Johns Hopkins
University
School of Medicine
Jason
E. Farley, PhD(c), MPH, NP
Adult Nurse Practitioner,
Infectious Disease
Clinical Instructor,
Department of Medicine
The Johns Hopkins
University
School of Medicine |
|
|
 |
 |
 |
 |
GUEST
AUTHOR OF THE MONTH |
|
 |
 |
 |
 |
 |
Commentary
& Reviews: |
 |
Lisa
L. Maragakis, MD, MPH
Assistant
Professor of Medicine
Department
of Medicine
The Johns
Hopkins University
School
of Medicine |
|
 |
Guest
Faculty Disclosure
Lisa
L. Maragakis, MD, MPH has disclosed no relationship with commercial
supporters.
Unlabeled /Unapproved Uses
The author has indicated that there will be no reference
to unlabeled/ unapproved uses of drugs or products in this presentation.
Program
Directors' Disclosures |
|
|
 |
|
 |
 |
 |
| At
the conclusion of this activity, participants should be able to: |
 |
  |
 |
Describe
recent evidence on the safety, efficacy, and transmissibility of
live attenuated influenza vaccine |
 |
  |
 |
Detail
the proposed strategies of influenza vaccine allocation to be used
during a vaccine shortage in an annual epidemic or pandemic setting |
 |
  |
 |
Discuss
the challenges inherent in the development of new production techniques
for vaccines against avian influenza viruses |
|
|
 |
|
 |
 |
|
 |
 |
COMPLETE
THE POST TEST
Step 1.
Click on the appropriate link
below. This will take you to the post-test.
Step 2.
If you have participated in a
Johns Hopkins on-line course, login. Otherwise, please register.
Step 3.
Complete the post-test and course
evaluation.
Step 4.
Print out your certificate.


Pharmacy credit is only available via PDF mail-in form:
 |
|
 |
|
 |
 |
 |
|
 |
 |
 |
Influenza
vaccination is the primary tool to prevent transmission, morbidity,
and mortality from the influenza virus. Despite this, vaccination
rates among healthcare personnel and high-risk populations remain
low due to a variety of factors, including dislike of injections
and concern about vaccine side effects.1 Live attenuated
influenza vaccine (LAIV) administered intranasally alleviates the
need for injection and may be more easily accepted for that reason;
however, concern about secondary transmission of the live attenuated
vaccine virus from vaccine recipients to other individuals has limited
acceptance of LAIV, especially by healthcare personnel. The article
by Talbot and colleagues addresses this concern by measuring the
amount and duration of vaccine virus shedding in adults following
LAIV administration. Before this (and other) evidence-based data
about the duration of viral shedding were available, LAIV was rarely
used for vaccination of healthcare personnel; when it was, prolonged
furloughs for as long as a month were used to prevent transmission
of live vaccine virus to patients. From Talbot et al, we now know
that the duration of viral shedding is less than a week, and the
amount of virus shed is well below the amount required to infect
another individual. Similarly, in their randomized, controlled trial
study of LAIV in young children, Vesikari and colleagues demonstrated
that transmissibility of the vaccine strain is extremely low even
in the daycare setting. These investigators also found that viral
shedding after vaccine administration showed stable attenuation
and temperature sensitivity that limited the LAIV vaccine strain’s
ability to cause clinical disease. These data should reassure practitioners
that LAIV is a safe alternative to inactivated influenza vaccine,
even in the healthcare setting, and that secondary transmission
of LAIV strains should not be a concern except in the most severely
immunocompromised individuals. However, more data are needed to
assess the risk of secondary transmission for this vulnerable population.
The threat of pandemic
influenza has been highlighted by direct transmission of highly pathogenic
avian influenza viruses such as H5N1 to humans, and influenza vaccine
production, distribution, and allocation are critical to effective
preparedness planning. The influenza vaccine shortage of 2004-2005
taught us an important lesson about how quickly the cumbersome process
of influenza vaccine production can be brought to a halt. Both the
article by Cosgrove et al and the position paper from the Society
of Healthcare Epidemiology of America were written in response to
this vaccine shortage: these documents provide important guidance
about how to best deal with the allocation of influenza vaccine in
the event of a shortage, and reinforce the importance of influenza
vaccination of healthcare workers.
The two articles
by Treanor and colleagues address other important topics relevant
to preparedness planning for pandemic influenza. The first describes
a new influenza vaccine production technique that is more efficient
and much less cumbersome than the egg-based method currently employed.
New and more efficient vaccine production methods are critical to
ensuring that our health care system can respond to an identified
influenza strain in a timely manner and avoid vaccine shortages.
The second article describes a study of the newly developed and recently
licensed human vaccine against avian influenza H5N1.
Taken together, the
articles in this review inform us about new options for using, allocating,
producing, and developing new vaccines to optimize protection from — and
preparedness for — epidemic and pandemic influenza.
References
|
|
 |
|
|
|
|
 |
 |
 |
  |
 |
 |
DURATION
OF VIRAL SHEDDING AFTER LIVE ATTENUATED INFLUENZA VACCINATION |
|
 |
 |
 |
Talbot
TR, Crocker DD, Peters J, et al. Duration of virus shedding
after trivalent intranasal live attenuated influenza vaccination
in adults. Infect Control Hosp Epidemiol. 2005;26:494-500.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
|
In
this study of healthy adults, Talbot and colleagues prospectively examined
the duration of viral shedding from the nasal mucosa following intranasal
administration of live attenuated influenza vaccine (LAIV). Investigators
recruited 20 healthy adult volunteers between the ages of 18 and 49
years and administered trivalent LAIV (FluMist™) intranasally
with 0.25 mL in each nostril. The vaccine contained the A/New Caledonia/20/99
(H1N1), A/Panama/2007/99 (H3N2), and B/Hong Kong/330/2001 influenza
strains. After LAIV vaccination, study participants returned for scheduled
clinic visits on days 3, 7, 10, and between days 17-21. Investigators
collected nasal wash samples using 15 mL of lactated Ringer’s solution
prior to vaccination and at each clinic visit. The nasal wash specimens
were inoculated into tissue culture and cytopathic effect was used to
detect influenza viruses, with indirect immunofluorescent and specific
monoclonal antibody assays used to identify the influenza strains recovered.
Each subject’s immunity was assessed at baseline and between 17 through
21 days after vaccination by performing hemagglutination inhibition
antibody titers to each of the 3 vaccine strains, as well as mucosal
and serum IgA antibody detection.
All 20 subjects completed the
study, although 3 study subjects missed one of the follow-up clinic
visits. Prior to vaccination none of nasal washes contained influenza
virus. On day 3 after LAIV administration, 10 of 20 (50%) of subjects’ nasal
washes contained vaccine strain influenza. By day 7 following LAIV,
there was a significant decline in viral shedding, with influenza virus
detected in only 1 of 18 (5.5%) nasal wash specimens. No influenza virus
(0%) was recovered from nasal washes on days 10 or 17 to 21. Quantitative
titrations were used to determine the amount of virus shed, with only
1 of the 11 samples found to contain enough virus to register at the
lowest level of detection (5 plaque-forming units [PFU]/mL). All 3 vaccine
strains were recovered from various study subjects. While the investigators
found that subjects with evidence of influenza B-specific mucosal IgA
antibody at baseline were significantly less likely to shed the vaccine
influenza B strain, no such association was found regarding baseline
influenza A immunity.
This study – demonstrating that mucosal shedding of influenza virus
following intranasal administration of LAIV occurs at low levels for
several days and significantly declines by 7 days – should help to allay
concerns about the potential inadvertent transmission of vaccine virus
strains from adult LAIV vaccine recipients to unvaccinated individuals.
Quantities of viral shedding were well below estimates of the dose required
to infect another person, and the investigators did not recover any
mucosally shed influenza viruses beyond 7 days. Other studies of viral
shedding after LAIV, including the one by Vesikari and colleagues discussed
herein, have found similar results; however, somewhat longer periods
of viral shedding were observed in children as compared with adults.1 It
should be noted that even though some vaccine strains of influenza are
shed at low levels, these strains are attenuated and modified to restrict
the virus’ ability to replicate above 37°C.2 Therefore,
even if transmission of vaccine strains does occur, the cold-adapted
virus is not suited to cause disease because it cannot replicate efficiently
in the warm temperatures of the lower airways.3 The Vaccine
Adverse Event Reporting System (VAERS) reported 22 cases of possible
secondary transmission among 2,500,000 vaccinees.4 The majority
of possible transmissions occurred in healthcare personnel who administered
the vaccines, and there was no documented transmission to immunocompromised
individuals. Nonetheless, due to a lack of clinical data and concern
about potential transmission, LAIV is not recommended for close contacts
or healthcare personnel caring for severely immunocompromised individuals.3,5 Talbot
and colleagues provide data, however, that indicate that 7 days after
LAIV administration is sufficient time for avoiding contact even with
severely immunocompromised patients, and their study is reassuring for
other uses of LAIV without concern of secondary transmission.
References
| 1. |
Keitel
WA, Couch RB, Quarles JM, Cate TR, Baxter B, Maassab HF. Trivalent
attenuated cold-adapted influenza virus vaccine: reduced viral shedding
and serum antibody responses in susceptible adults. J Infect
Dis. 1993;167:305-311. |
 |
| 2. |
MedImmune
Vaccines, Inc. Influenza Virus Vaccine, Live Intranasal FluMist
[package insert]. 2003. Gaithersburg, MD, MedImmune Vaccines, Inc.
Ref Type: Generic |
 |
| 3. |
Kamboj
M, Sepkowitz KA. Risk
of transmission associated with live attenuated vaccines given to
healthy persons caring for or residing with an immunocompromised
patient. Infect Control Hosp Epidemiol. 2007;28:702-707 |
 |
| 4. |
Izurieta
HS, Haber P, Wise RP, et al. Adverse
events reported following live, cold-adapted, intranasal influenza
vaccine. JAMA. 2005;294:2720-2725. |
 |
| 5. |
Fiore
AE, Shay DK, Haber P, et al. Prevention
and control of influenza. Recommendations of the Advisory Committee
on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007;56:1-54. |
|
|
 |
|
|
|
 |
 |
 |
  |
 |
 |
SAFETY
AND TRANSMISSIBILITY OF LIVE ATTENUATED INFLUENZA VACCINE |
|
 |
 |
 |
Vesikari
T, Karvonen A, Korhonen T, et al. A randomized, double-blind
study of the safety, transmissibility and phenotypic and genotypic
stability of cold-adapted influenza virus vaccine. Pediatr
Infect Dis J. 2006;25:590-595.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
|
Vesikari
and colleagues conducted this prospective, randomized, double-blind,
placebo-controlled trial to assess the safety, transmissibility, and
stability of live attenuated influenza vaccine (LAIV) in children. The
main objective of the study was to estimate the probability of transmission
of LAIV vaccine strains from vaccine recipients to unvaccinated individuals
(placebo recipients) in a daycare setting. Investigators randomized
197 healthy children between the ages of 9 and 36 months who attended
daycare to receive either intranasal placebo or LAIV. They measured
viral shedding with nasal swabs for 21 days after vaccination and also
assessed the safety and stability of the vaccine strain.
Ninety-eight randomly selected
healthy children received the LAIV vaccine. Eighty percent of them shed
one or more influenza vaccine strains following vaccination, with almost
all viral shedding occurring in the 12 days after LAIV administration.
Safety and adverse events were similar between LAIV and placebo groups.
Phenotypic assessment of shed LAIV vaccine strains showed that the strains
maintained the cold-adaptation and temperature sensitivity that limits
their ability to replicate in the lower airways. Genotypic analysis
also demonstrated stability of the shed viruses, as all retained their
attenuated genotype, with no reversion to wild-type virus seen. One
episode of LAIV vaccine strain transmission occurred from a LAIV recipient
to a placebo recipient. Investigators therefore calculated the probability
of vaccine strain transmission to a child after contact with a vaccinated
child as 0.58% (95% confidence interval, 0-1.7%). Further, the transmission
event did not result in any adverse outcomes or clinical evidence of
influenza.
This study demonstrates several
important features of LAIV. As discussed above in the report by Talbot
et al, the vaccine strains have 3 characteristics that limit their ability
to cause clinical disease: they are genetically altered to attenuate
their virulence; they are cold-adapted to grow at low temperatures;
and they are heat-sensitive to prevent them from efficiently replicating
in the lower airways. Vesikari and colleagues have elegantly demonstrated
that the vaccine strains remain genotypically and phenotypically stable
after LAIV administration, so that the viruses that are shed retain
their intended characteristics rather than reverting to a more virulent
state. In addition, this study shows that LAIV was well tolerated among
young children 9 to 36 months. Although the children showed both high
rates and long duration of vaccine virus strains shedding, and despite
the daycare setting being ideal for transmission of organisms, the investigators
found an extremely low rate of secondary transmission of the vaccine
strains, with only one documented episode. Importantly, the placebo
recipient who later acquired the vaccine strain did not have any signs
or symptoms of disease from the transmission event. Like Talbot’s findings
above, these data are reassuring and indicate that LAIV is a well-tolerated
alternative to inactivated, injectable influenza vaccine, and should
pose little concern about secondary transmission outside of the severely
immunocompromised population. |
|
 |
|
|
|
 |
 |
 |
  |
 |
 |
STRATEGIES
FOR USE OF A LIMITED VACCINE SUPPLY |
|
 |
 |
 |
Cosgrove
SE, Fishman NO, Talbot TR, et al. Strategies for use of
a limited influenza vaccine supply. JAMA. 2005;293:229-232.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
|
 |
Talbot
TR, Crocker DD, Peters J, et al. Duration of virus shedding
after trivalent intranasal live attenuated influenza vaccination
in adults. Infect Control Hosp Epidemiol. 2005;26:494-500.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
|
The
shortage of inactivated influenza vaccine during the 2004-2005 influenza
season challenged healthcare institutions to examine vaccine allocation
strategies in order to best protect patients and healthcare personnel.
These 2 articles — a commentary by Cosgrove and colleagues published
during the shortage, and a Position Paper from the Society for Healthcare
Epidemiology of America (SHEA) – present guidance for the allocation
of influenza vaccine during times of shortage. Given the arduous nature
of influenza vaccine production and the probability of an upcoming influenza
pandemic, it is likely that the topic of vaccine allocation in the face
of insufficient supply will remain an important one to consider.
The commentary by Cosgrove et
al, in addition to discussing appropriate allocation of inactivated
influenza vaccine, also examined the potential for an expanded role
of LAIV for the vaccination of healthcare personnel. The most obvious
goal of such vaccination is to protect healthcare workers so that they
can remain healthy and at work to provide patient care and keep the
healthcare facility functioning. Another less obvious but extremely
important reason to vaccinate healthcare workers (which is often overlooked
by healthcare workers themselves) is that vaccinating healthcare personnel
reduces patient mortality. A study of influenza vaccination in a long-term
care facility found that, while vaccination of patients had no effect
on mortality, vaccination of healthcare personnel lowered patient mortality
from 17% to 10%.1 Cosgrove and colleagues clearly place vaccination
of healthcare personnel as a high priority for these reasons. Talbot
et al also outline the rationale for vaccination of healthcare personnel
in the SHEA Position Paper, which proposes a comprehensive program to
improve compliance with influenza vaccination. The proposed strategy
calls for healthcare workers to sign an “active declination” form if
they choose not to have the vaccine, and for vaccine uptake to be used
as a patient safety measurement.
Patient benefit from vaccination
of healthcare personnel makes allocation decisions even more complex
in times of vaccine shortage. While the Centers for Disease Control
and Prevention provides guidance for defining groups of individuals
who are at high risk of complications from influenza and who should
therefore be vaccinated, in times of vaccine shortage, it becomes more
difficult to reach consensus on what constitutes a “chronic medical
condition” that places a patient at higher risk. One vaccine allocation
strategy espoused by Cosgrove et al is to avoid influenza vaccination
in times of shortage for people who are unlikely to have an adequate
immunologic response to the vaccine. These groups include patients who
received a hematopoietic stem cell transplant within less than 6 months,
a solid organ transplant within less than 3 months, and patients with
HIV and CD4 counts <100/microliter. Cosgrove suggests that other
prevention and prophylaxis methods may be more effective for these patients,
while simultaneously conserving a scare vaccine supply. Other strategies
involve the use of syringes with minimal dead space to yield up to 2
additional doses per 5 mL vial, and as yet unproven but promising strategies
such as administration of partial doses of vaccine to stretch limited
supplies.2,3 In addition, the SHEA document reminds us of
the importance of utilizing other infection control and prevention strategies,
including proper respiratory etiquette, restriction of febrile healthcare
workers from patient care activities, droplet precautions, rapid diagnostic
tests, prompt treatment of influenza cases, and the appropriate use
of antiviral chemoprophylaxis. This type of comprehensive program, in
conjunction with strategies to extend and appropriately allocate vaccine
in times of shortage, is likely to remain at the forefront of planning
for future shortages and the threat of pandemic influenza.
References
| 1. |
Potter
J, Stott DJ, Roberts MA, et al. Influenza
vaccination of health care workers in long-term-care hospitals reduces
the mortality of elderly patients. J Infect Dis. 1997;175:1-6. |
 |
| 2. |
Belshe
RB, Newman FK, Cannon J, et al. Serum
antibody responses after intradermal vaccination against influenza. N
Engl J Med. 2004;351:2286-2294. |
 |
| 3. |
Kenney
RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose
sparing with intradermal injection of influenza vaccine. N
Engl J Med. 2004;351:2295-2301. |
|
|
 |
|
|
|
 |
 |
 |
 |
 |
 |
NEW
INFLUENZA VACCINE PRODUCTION STRATEGIES |
|
 |
 |
 |
Treanor
JJ, Schiff GM, Hayden FG, et al. Safety and immunogenicity
of a baculovirus-expressed hemagglutinin influenza vaccine: a randomized
controlled trial. JAMA. 2007;297:1577-1582.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
|
The
production process for traditional inactivated influenza vaccine is
cumbersome, lengthy, and relies on massive numbers of embryonated eggs
as substrate. Thus, the development of more rapid and efficient methods
of vaccine production is a high priority. This article by Treanor and
colleagues reports on the results of a randomized controlled trial designed
to determine the safety and efficacy of an experimental influenza virus
hemagglutinin vaccine (rHA0) produced using recombinant baculoviruses
in insect cells. The trial randomized 460 healthy adult patients at
3 medical centers to receive a single injection of saline placebo (n=154),
or 75 micrograms (n=153) or 135 micrograms (n=153) of rHA0 vaccine containing
influenza A/New Caledonia/20/99 (H1N1), influenza A/Wyoming/3/03 (H3N2),
and influenza B/Jiangsu/10/03 virus. Serum samples were examined both
prior to and 30 days after immunization to assess immunogenicity. The
primary efficacy endpoint was culture-proven influenza illness. Adverse
events and safety were also assessed.
The investigators report that
no differences were found in safety or adverse outcomes between the
2 vaccine groups and the placebo arm, with low rates overall. Serum
studies revealed that hemagglutinin inhibition antibody response to
H1 occurred in 3% of the placebo patients, 51% of the low-dose rHA0
vaccine recipients, and 67% of the high-dose rHA0 recipients. Antibody
responses to H3 were 77% of high-dose recipients vs 11% of placebo recipients;
responses to influenza B were even better, with 92% of high-dose recipients
compared to 4% of placebo recipients. Seven cases (4.6%) of culture-confirmed
influenza occurred in the placebo arm, as compared to 2 cases (1.3%)
in the low-dose arm, and 0 cases in the high-dose arm.
By both immunogenicity and efficacy
outcomes, this trial showed the experimental rHA0 vaccine to be safe,
immunogenic, and effective in conferring some degree of protection against
a drifted H3Ns virus during the 2004-2005 influenza season. These results
are encouraging, since the newly developed production method avoids
many of the pitfalls of the traditional embryonated egg process — particularly
the problem of amassing so many eggs, which cannot be accomplished rapidly
in response to an emerging threat. The threat of avian influenza further
complicates the picture, with the potential prospect of pandemic human
disease coupled with avian disease that reduces the supply of hens’ eggs
needed to produce influenza vaccine. The recombinant DNA techniques
utilized in this trial seem well suited to influenza vaccine production — they
do not utilize eggs and are already used to produce other vaccines (eg,
hepatitis B virus). Although the numbers were too small to conclusively
demonstrate efficacy of the vaccine, preliminary results showing protective
efficacy in a healthy adult population are very promising. |
|
 |
|
|
|
 |
 |
 |
  |
 |
 |
HUMAN
VACCINE AGAINST THE AVIAN INFLUENZA VIRUS H5N1 |
|
 |
 |
 |
Treanor
JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and
immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N
Engl J Med. 2006;354:1343-1351.
(For non-journal subscribers, an additional fee may apply for
full text articles.) |
|
In
this article, Treanor and colleagues describe a multi-center, double-blind
study of the safety and immunogenicity of an inactivated subvirion influenza
A H5N1 vaccine. Four hundred fifty-one healthy adults from 18 to 64
years of age were randomly assigned to receive 2 doses of intramuscular
injection (28 days apart) of placebo, or 1 of 4 different doses of H5N1
vaccine containing H5 hemagglutinin antigen. Serum samples were obtained
prior to vaccination and at 28 days after the second injection, and
were tested for the presence of H5 antibody to demonstrate immunogenicity.
Study subjects were followed clinically for 56 days to assess safety
of the vaccine.
The vaccine was developed from
a human isolate of influenza A/Vietnam/1203/2004. Fifty-four percent
of study subjects who received 2 doses of 90 micrograms of vaccine,
the highest vaccine dose in this trial, achieved H5 neutralization antibody
titers of greater than 1:40, the level generally associated with protection
against influenza. This level of antibody was seen in 43%, 22%, and
9% of the subjects receiving the lower doses of vaccine. None of the
placebo recipients developed H5 antibodies. The most common adverse
events were mild pain at the injection site, headache, and muscle pain,
and were apparently dose-dependent. There were no differences in systemic
complaints between vaccine groups and placebo recipients.
The H5N1 subtype of avian influenza
continues to cause widespread infections in domestic and wild birds,
particularly in Asia, Africa, and Europe, and has demonstrated the ability
to be transmitted directly from birds to humans, with an extremely high
(54%) human mortality rate. While human-to-human transmission has apparently
been quite rare, the threat of pandemic H5N1 avian influenza in a human
population naïve to this viral sub-type urgently necessitates the development
of vaccine against this virus. Contrary to the novel influenza vaccine
production technique outlined in the article above, in this study Treanor
and colleagues elected to use the traditional method employed to produce
annual inactivated influenza vaccine in embryonated eggs. The investigators
chose this method with the intention of expediting the acceptance and
licensure of the vaccine, since this production method would be viewed
by regulatory agencies as a change in strain rather than the development
of a brand new product. Indeed, the United States Food and Drug Administration
(FDA) recently approved this vaccine as the first US vaccine for humans
against the avian influenza virus H5N1.1 The 2-dose administration
schedule was chosen because the investigators recognized that higher
doses would likely be required to generate immunity to a completely
novel strain such as H5. The vaccine has been purchased by the US government
for the National Stockpile in order to enhance preparedness for pandemic
avian influenza. Further research is now focusing on adjuvants, priming,
and other dose-sparing strategies to make vaccination against H5N1 more
feasible should pandemic H5N1 influenza occur.
References
|
|
 |
|
|
|
 |
|
 |
 |
 |
| Accreditation
Statement · back
to top |
 |
This
activity has been planned and implemented in accordance with the
Essential Areas and Policies of the Accreditation Council for Continuing
Medical Education through the joint sponsorship of the Johns Hopkins
University School of Medicine, The Institute for Johns Hopkins Nursing
and The University of Tennessee College of Pharmacy. The Johns Hopkins
University School of Medicine is accredited by the ACCME to provide
continuing medical education for physicians.
The Institute for
Johns Hopkins Nursing is accredited as a provider of continuing nursing
education by the American Nursing Credentialing Center's Commission
on Accreditation. |
 |
| Credit
Designations · back
to top |
 |
Physicians
The Johns Hopkins
University School of Medicine designates this educational activity
for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM.
Physicians should only claim credit commensurate with the extent
of their participation in the activity.
Nurses
This 1.0 contact
hour Educational Activity (Provider Directed/Learner Paced) is provided
by The Institute for Johns Hopkins Nursing. Each newsletter carries
a maximum of 1.0 contact hour or a total of 12.0 contact hours for
the twelve newsletters in this program.
Pharmacists
This
program is accredited
for one hour credit (0.1 CEUs) and is co-sponsored by the University
of Tennessee College of Pharmacy who is accredited by the Accreditation
Council for Pharmacy Education as a provider of continuing pharmacy
education. A statement of CE credit will be mailed within 4 weeks
of successful completion and evaluation of the program. ACPE Program
#064-999-07-279-H01-P.
Grievance Policy: A participant, sponsor, faculty
member or other individual wanting to file a grievance with respect
to any aspect of a program sponsored or co-sponsored by the UTCOP
may contact the Associate Dean for Continuing Education in writing.
The grievance will be reviewed and a response will be returned within
45 days of receiving the written statement. If not satisfied, an
appeal to the Dean of the College of Pharmacy can be made for a second
level of review. |
 |
| Post-Test
· back
to top |
 |
| To
take the post-test for eInfluenza Review you will need to visit The
Johns Hopkins University School of Medicine's CME website or The
Institute for Johns Hopkins Nursing. If you have already registered
for another Hopkins CME program at these sites, simply enter the
requested information when prompted. Otherwise, complete the registration
form to begin the testing process. A passing grade of 70% or higher
on the post-test/evaluation is required to receive CME/CNE/CPE credit. |
 |
| Statement
of Responsibility · back
to top |
 |
| The
Johns Hopkins University School of Medicine and The Institute for
Johns Hopkins Nursing take responsibility for the content, quality,
and scientific integrity of this CME/CNE/CPE activity. |
 |
| Target
Audience · back
to top |
 |
| This
activity has been developed for the Primary Care Physicians, Internists,
Infectious Disease Specialists, Pharmacists, and Nurses. There are
no fees or prerequisites for this activity. |
 |
| Learning
Objectives · back
to top |
 |
| At
the conclusion of this activity, participants should be able
to: |
 |
  |
 |
Describe
the recent evidence regarding the safety and transmissibility
of live attenuated influenza vaccine |
 |
  |
 |
Detail
the proposed strategies of influenza vaccine allocation to be
used during a vaccine shortage in an annual epidemic or pandemic
setting |
 |
  |
 |
Discuss
the challenges inherent in the development of new production
techniques for vaccines effective against avian influenza viruses |
|
 |
| Internet
CME/CNE/CPE Policy · back
to top |
 |
The
Offices of Continuing Education (CE) at The Johns Hopkins University
School of Medicine,
The Institute for
Johns Hopkins Nursing and The University of Tennessee College of
Pharmacy are committed to protect the privacy of its members and
customers. The Johns Hopkins University maintains its Internet site
as an information resource and service for physicians, other health
professionals and the public.
The Johns Hopkins
University School of Medicine, The Institute for Johns Hopkins Nursing
and
The University of
Tennessee College of Pharmacy will keep your personal and credit
information confidential when you participate in a CE Internet-based
program. Your information will never be given to anyone outside The
Johns Hopkins University and The University of Tennessee College
of Pharmacy program. CE collects only the information necessary to
provide you with the service you request. |
 |
| Faculty
Disclosure · back
to top |
 |
As
a provider accredited by the Accreditation Council for Continuing
Medical Education (ACCME), it is the policy of Johns Hopkins University
School of Medicine to require the disclosure of the existence of
any significant financial interest or any other relationship a faculty
member or a provider has with the manufacturer(s) of any commercial
product(s) discussed in an educational presentation.
The presenting faculty
reported the following:
 |
  |
 |
John
G. Bartlett, MD has disclosed that he has served on
the HIV Advisory Board for GlaxoSmithKline, Abbott and Bristol-Myers
Squibb. |
 |
  |
 |
Jonathan
M. Zenilman, MD has disclosed no relationship with
commercial supporters. |
 |
  |
 |
Jason
E. Farley, PhD(c), MPH, NP has disclosed no relationship
with commercial supporters. |
Guest
Authors Disclosures |
 |
| Disclaimer
Statement · back
to top |
 |
| The
opinions and recommendations expressed by faculty and other experts
whose input is included in this program are their own. This enduring
material is produced for educational purposes only. Use of Johns
Hopkins University School of Medicine name implies review of educational
format design and approach. Please review the complete prescribing
information of specific drugs or combination of drugs, including
indications, contraindications, warnings and adverse effects before
administering pharmacologic therapy to patients. |
 |
Copyright ©
JHUSOM, IJHN, UTCOP,
and eInfluenza Review
Created by DKBmed. |
 |
Johns Hopkins University
School of Medicine CME/CNE Office
720 Rutland Avenue,
Baltimore, MD 21205-2196 |
|
|
 |
|
|
 |
 |
 |
COMPLETE
THE POST TEST
Step 1.
Click on the appropriate link below. This
will take you to the post-test.
Step 2.
If you have participated in a Johns Hopkins
on-line course, login. Otherwise, please register.
Step 3.
Complete the post-test and course evaluation.
Step 4.
Print out your certificate.


Pharmacy credit is only available via PDF mail-in form:
 |
 |
 |
 |
|
| |
|