Influenza Vaccination Recommendations 2015-2016

Influenza Vaccination Recommendations 2015-2016


(music) In compliance with continuing
education requirements, all presenters must disclose any
financial or other associations with the manufacturers
of commercial products, suppliers of commercial
services, or commercial supporters
as well as any use of unlabeled product(s)
or product(s) under investigational use. CDC, our planners,
content experts, and their spouses/partners wish to disclose they have
no financial interests or other relationships
with the manufacturers of commercial products, suppliers of commercial
services, or commercial supporters. Planners have reviewed content
to ensure there is no bias. Content will not include any
discussion of the unlabeled use of a product or a product
under investigational use with the exception of Dr.
Grohskopf’s discussion of influenza vaccines. She will be discussing
use of influenza vaccines in a manner recommended
by the Advisory Committee on Immunization Practices,
but not approved by the Food and Drug Administration. CDC did not accept
commercial support for this continuing
education activity. Welcome to Influenza Vaccination
Recommendations 2015-2016. During this program we will
Describe the Advisory Committee on Immunization Practices’
influenza vaccine recommendations. Describe the benefits of
influenza vaccination. Describe best practices for
influenza vaccine storage, handling, and administration. Implement disease detection and
prevention health care services for example, smoking
cessation, weight reduction, diabetes screening,
blood pressure screening, immunization services, to prevent health problems
and maintain health. Influenza is a highly
infectious viral illness that can cause serious
illness and even death. It is estimated that in any
given year, between five and twenty percent of the U.S.
population become infected with an influenza virus. Most cases will cause several
days of illness but will resolve without the need
for medical care. The severity of influenza
illness depends on a person’s prior
immunologic experience with influenza viruses, any
underlying chronic diseases, and the strain of influenza
with which they get infected. The incubation period for
influenza is usually two days, but varies from one
to four days. Classic influenza
illness is characterized by the abrupt onset of
fever, myalgia, sore throat, nonproductive cough,
and headache. Additional symptoms may include
rhinorrhea or runny nose, headache, substernal chest
burning, and ocular symptoms such as eye pain and
sensitivity to light. Children are more
likely than adults to have nausea and vomiting. The most frequent complication
of influenza is pneumonia, either as a direct viral
infection of the lungs or a secondary bacterial
pneumonia caused most commonly by Streptococcus pneumoniae
or Staphylococcus aureus. The risk for complications
and hospitalizations from influenza is higher among
persons fifty years of age and older, children younger
than five years of age, persons of any age with certain
underlying medical conditions, pregnant women, and American
Indians and Alaska Natives. An average of more than
two hundred thousand hospitalizations per year
are related to influenza, more than fifty percent of which
occur among persons sixty five years of age and older. CDC recommends a flu
vaccine as the best way to protect against influenza. Flu vaccines protect
against three or four different
influenza viruses, depending on which vaccine
formulation is administered. Influenza vaccination can reduce
the number of flu illnesses and prevent serious outcomes like flu-related
hospitalizations. Vaccination is especially
important for persons at high risk of serious
flu-related complications and their close contacts,
including health care personnel. During the 2014-2015 influenza
season, flu vaccines were not as effective as usual. The circulating H3N2
virus was very different from the H3N2 virus
in the vaccine, AND it was the most common
influenza virus which circulated in the U.S. This resulted
in vaccine effectiveness of only twenty three percent
overall, thirteen percent against H3N2 viruses
and fifty five percent against less common
influenza B viruses. Vaccine effectiveness is usually
approximately sixty percent when the circulating
viruses are well-matched to the viruses in the vaccine. This means that usually
a vaccinated person is about sixty percent less
likely to get sick with the flu and need a doctor’s visit
than an unvaccinated person. CDC is optimistic that the
2015-2016 vaccine will offer good protection against
the flu this season. Two of the vaccine virus
components from last season, the influenza A H3N2 virus
and the influenza B virus, were updated for the
2015-2016 vaccine. Laboratory data as of
September fifth, 2015, suggest that most
circulating viruses are like the vaccine viruses
included in the vaccines for the upcoming season. The Advisory Committee on
Immunization Practices, or ACIP, has published recommendations
for the use of seasonal influenza vaccines
for the 2015-2016 season. For an overview of the
recommendations we spoke to Dr Lisa Grohskopf with
the Influenza Division of the National Center
for Immunization and Respiratory Diseases. Routine annual influenza
vaccination is recommended for all persons six
months of age and older who do not have
contraindications. Optimally, vaccination
should occur before the onset of influenza activity. Vaccination should continue
to be offered as long as influenza viruses are
circulating in the community. The 2015-2016 U.S.-licensed
trivalent influenza vaccines contain hemagglutinin derived from an A/California/7/2009
H1N1-like virus, an A/Switzerland/9715293/2013
H3N2-like virus, and a B/Phuket/3073/2013-like
virus from the Yamagata lineage. Quadrivalent influenza vaccines
contain these vaccine viruses AND a B/Brisbane/60/2008-like
virus from the Victoria lineage. Various influenza vaccine
products are available for the 2015-2016 season. A table listing the
products is available online. Inactivated influenza
vaccines, abbreviated as IIV, are available as trivalent
and quadrivalent products. Age indications vary by product,
formulation, and presentation. Live attenuated influenza
vaccine, abbreviated as LAIV, is available only as a
quadrivalent product. LAIV is indicated for
healthy persons two through forty nine years of
age who are not pregnant. (music) There is new and
updated information on influenza vaccine products
for the 2015-2016 season. First, Afluria IIV is approved for intramuscular administration
via the Stratis needle-free jet injector for persons eighteen
through sixty four years of age. Next, the age indication for the
recombinant influenza vaccine, Flublok, which was
previously eighteen through forty nine
years, has been expanded to persons eighteen
years of age and older. And finally, Fluzone Intradermal
Quadrivalent is approved for persons eighteen through
sixty four years of age. It is expected that the
quadrivalent formulation will replace the previously available
trivalent Fluzone Intradermal. In cases where more than one
type of vaccine is appropriate and available, ACIP does not
express a preference for use of any particular product. (music) A severe allergic reaction to influenza vaccine
is a contraindication to future receipt
of the vaccine, regardless of the
component suspected of being responsible
for the reaction. Severe allergic and anaphylactic
reactions can occur in response to various influenza
vaccine components, but such reactions are rare. With the exceptions of the recombinant
influenza vaccine Flublok, and the cell culture-based
inactivated influenza vaccine Flucelvax, influenza vaccines
are prepared by propagation of virus in embryonated eggs. Recommendations for influenza
vaccination of persons who report an allergy
to eggs remain unchanged from last season. A flow chart to assist
health care personnel in assessing egg allergy
is available online. (music) Children six months
through eight years of age require two doses of
influenza vaccine, administered at least four weeks apart, during their first
season of vaccination. Some children in this age group who have received influenza
vaccine previously will also need two doses. For the 2015-2016 season,
children six months through eight years of age who
have previously received a total of two or more doses
of trivalent or quadrivalent influenza
vaccine before July first 2015, require only one dose. It does not matter if the two
previous doses were administered during the same season
or consecutive seasons. Children in this age group who have not previously received
a total of two or more doses of trivalent or quadrivalent
influenza vaccine before July first 2015, require
two doses administered at least four weeks apart. A flow chart to assist
healthcare personnel in determining the number of doses needed is
available online. (music) Last season, ACIP recommendations stated a
preference for LAIV versus IIV for healthy children two
through eight years of age. Data from subsequent
studies of LAIV and IIV vaccine effectiveness
indicated that LAIV did not perform
as well as expected. For the 2015-2016 season, LAIV
is no longer preferred to IIV for healthy children two
through eight years of age. For healthy children two
through eight years of age who have no contraindications
or precautions, either LAIV or IIV is an appropriate option. No preference is expressed for
LAIV or IIV for any person two through forty nine years of age when either vaccine
is appropriate. An age-appropriate formulation
of vaccine should be used. (music) Beginning in the
2010-2011 influenza season, ACIP recommended annual
influenza vaccination for all persons six
months of age and older. But, protection of
persons at higher risk for influenza-related
complications or those with increased risk
of transmission to others should continue to be
a focus of vaccination efforts. These persons include children
younger than five years, adults fifty years
of age and older, persons with chronic medical
conditions, pregnant women, American Indians
and Alaska Natives, and health care personnel. The full recommendations
and additional resources, including patient education
materials, are available at www.cdc.gov/flu Health care
personnel continue to demonstrate their commitment
to combating influenza disease. As more influenza
vaccines become available, immunization providers will
need to choose the type of vaccine most appropriate
for their patient population. In this section of our
program, we will focus on frequently asked questions
about influenza vaccine storage, handling, and administration. (music) During influenza season we
receive a number of questions from health care personnel. Let’s address some of the most
frequently asked questions. What are CDC’s recommendations
for storing influenza vaccines? CDC recommends storing
influenza vaccine in a stand-alone refrigerator or a pharmaceutical
purpose-built unit. These units can vary in size, from compact under-the
counter style to large stand-alone units. If a household combination
refrigerator/freezer is used to store vaccines, CDC recommends using only
the refrigerator compartment for refrigerated vaccines. CDC does not recommend
storing ANY vaccine, including influenza
vaccines, in a dormitory or bar-style
refrigerator/freezer unit under any circumstances. Using dormitory-style units
to store Vaccines for Children or other vaccines purchased
with public funds is prohibited. At what temperature should
influenza vaccine be stored? And what type of
thermometers should be used for measuring temperatures
in a vaccine storage unit? All influenza vaccines,
including both inactivated and live attenuated,
vaccines should be stored in the refrigerator
between thirty five and forty six degrees
Fahrenheit or two and eight degrees Celsius. CDC recommends providers
use a calibrated continuous temperature monitoring
device with a Certificate of Traceability and
Calibration Testing. Digital data loggers
are recommended for continuous temperature
monitoring. When conducting influenza
vaccination clinics at an off-site or
satellite facility, what are the storage
recommendations for this situation? CDC does not recommend
routine transport of vaccines. If at all possible, have the
vaccine delivered directly to the off-site or
satellite facility. If vaccines must be
transported to the facility, here are the Do’s and Don’ts. Do take a limited
amount of vaccine, only enough for the workday. Transportation and workday
time should not total more than eight hours. CDC does recommend using a
portable refrigerator unit or qualified container. Portable refrigerators and qualified containers
are commercially available for purchase. CDC also recommends using
a calibrated temperature monitoring device. The device should have a valid
certificate of calibration, recording capabilities to monitor the temperature
continuously, and a digital display
and buffered probe. When transporting vaccine, do place it in the
passenger area of the vehicle. Upon arrival, promptly unpack
the vaccine and place it in an appropriate storage
unit, if available. If the vaccine must be kept
in the transport container, read and document
temperatures hourly. Now here are the Don’ts. When transporting vaccine, do not reuse manufacturer
shipping containers and supplies. Do not use frozen gel
packs, ice, or dry ice. These can freeze the vaccine. Additional information
is available in the Vaccine Storage
and Handling Toolkit. How do you correctly interpret
expiration dates on vaccine? And do all flu vaccines expire
at the end of flu season? No, all flu vaccines do not
expire at the end of flu season. Although most influenza
vaccines expire on June 30th, some expire during flu season. For example, live
attenuated influenza vaccine, abbreviated LAIV, generally has
a shelf life of eighteen weeks. In addition, there
can be confusion about expiration dates
for multidose vials. Most influenza vaccines in
multidose vials can be used through the expiration
date printed on the label, as long as the vaccine is stored
properly and not contaminated, or unless the manufacturer
indicates otherwise. Sometimes the manufacturer
specifies that once the multidose
vial has been entered or the rubber stopper punctured,
the vaccine must be used within a certain number of days. This is commonly referred to
as the beyond use date or BUD. When using a multidose
vial of influenza vaccine for the first time, check the
package insert to determine if the vaccine has a BUD. If it does, calculate the beyond
use date using the time interval found in the vaccine’s
package insert. Initial and label the
vaccine vial with the BUD. Between uses, store the
vaccine appropriately until the vial is empty or the
beyond use date is reached. Any vaccine not used before
the BUD should be discarded, even if there is
vaccine left in the vial. Is it OK for a large clinic that
administers lots of flu vaccine to draw up vaccines at the
beginning of the clinic day? CDC recommends only drawing up vaccine just before
administration. Vaccine manufacturers
do not recommend that vaccines be
predrawn in advance. These syringes are
not approved for use as a storage system
for drug products. CDC recommends using
manufacturer-filled syringes for large immunization clinics. If vaccine must be predrawn,
it should not be drawn up in advance of the clinic. Drawing up doses
of vaccine hours or even days before a
clinic is not acceptable. At the clinic site, no more
than one multidose vial, or ten doses, should
be drawn up at one time by each person administering
vaccine. At the end of the workday,
any remaining vaccine in provider-predrawn
syringes should be discarded. What are the routes
of administration for influenza vaccines? Influenza vaccines
are administered by three different
routes, intramuscular, intradermal and intranasal. Most inactivated influenza
vaccine products are administered by intramuscular,
or IM, injection. There are only two
routinely recommended sites for IM administration
of vaccines. These are the vastus
lateralis muscle in the anterolateral thigh and the deltoid muscle
in the upper arm. Injection at these sites reduces
the chance of involving neural or vascular structures. The needle should be long
enough to reach the muscle mass and prevent vaccine from seeping
into subcutaneous tissue, but not so long as to
involve underlying nerves, blood vessels, or bone. Health care personnel should
be familiar with the anatomy of the area where the
vaccine will be injected. Guidance on recommended
injection sites and needle selection
can be found in ACIP’s General
Recommendations on Immunization and in the Epidemiology
and Prevention of Vaccine-Preventable
Diseases text book, also known as the Pink Book. Because there are no
large blood vessels in the recommended sites, ACIP states that
aspiration before injection of vaccines is not necessary. As of August 2014, the Pharmajet
Stratis needle-free injection system was approved by the Food
and Drug Administration or FDA for use with one
influenza vaccine product – Afluria vaccine. Additional information
can be found on the Pharmajet
Stratis website. Fluzone Intradermal
is administered by the intradermal, or ID route. This formulation is not the same
as intramuscular formulations of inactivated influenza
vaccine. Other inactivated influenza
vaccine formulations should NOT be administered by
the intradermal route. For the intradermal injection, a manufacturer-filled
microinjection syringe is used to administer a zero
point one milliliter dose into the dermal layer
of the skin in the deltoid region
of the upper arm. Detailed administration
instructions are included in the package insert. The third route used to administer influenza
vaccine is intranasal, abbreviated as NAS. The live attenuated
influenza vaccine, FluMist, is currently the only vaccine
administered by this route. The vaccine dose is inside
a special sprayer device. A plastic clip on the
plunger divides the dose into two equal parts, which should be administered
into each nostril. Detailed information on the
nasal administration of LAIV, is included in the manufacturer’s
product information. What guidance is there
for preventing injury if patients faint
after vaccination? Since 2005, the Vaccine
Adverse Event Reporting system or VAERS has received an
increasing number of reports of syncope or fainting in
adolescents and young adults. Immunization providers should
take appropriate measures to reduce the risk of
injury from syncope. These include having
the patient seated when administering the vaccine
and knowing the symptoms that precede fainting such as
weakness, dizziness, and pallor and take appropriate
measures to prevent injuries if such symptoms occur. ACIP recommends providers
strongly consider observing patients for 15 minutes
after vaccination. Information on this
topic is posted on the CDC’s Vaccine
Safety webpage. Can pregnant health care
personnel administer LAIV? Yes, a pregnant women may
safely administer L-A-I-V. Health care personnel with
underlying medical conditions, those who are 50 years
of age and older, may also safely administer LAIV. The only exception to this
would be health care personnel with immunosuppression
severe enough to require a protective
environment. A person with this level of immunosuppression is
highly unlikely to be working. What should be documented in
the medical record when a dose of flu vaccine is administered? By federal law, certain
information must be documented in the patient’s paper or
electronic medical record or on a permanent office log. This includes: the vaccine
manufacturer; the lot number of the vaccine; the date
the vaccine is administered; the name and title of the person
who administered the vaccine and the address of the facility where the permanent
record will be kept; the Vaccine Information
Statement, or VIS edition date which is located on
the back of the VIS in the lower right
corner; finally, the date the VIS is given to the
patient, parent, or guardian. The National Childhood
Vaccine Injury Act requires that a VIS be given to
parents, legal representatives, or adult patients before
administering any vaccine. Best practice guidelines
also include documenting the expiration date, route,
dosage or volume, and site. Health care personnel are
also strongly encouraged to document the dose in the Immunization
Information System, or IIS. In addition, your facility may
require other documentation. Follow your facility’s
policies and procedures for medical documentation. Here’s our final question,
what strategies can be used to help prevent influenza
vaccine administration errors? A common error is
inadvertent administration of expired vaccine. Always check the expiration
date before preparing or administering vaccine. Expired vaccine should
never be administered. A 2014 MMWR article
highlighted VAERS reports of expired LAIV being
administered. As noted earlier, LAIV generally
has an 18-week shelf life. The vaccination occurred after
the first week of November in 95 percent of the reports, which is approximately
18 weeks from July first. This indicates that expiration
dates were not being checked. Fortunately, no adverse
health events were documented in 98 percent of the reports. In addition to administration
of expired vaccine, other administration
errors we frequently hear about include wrong
dosage or amount; influenza vaccine
administered outside of the product’s indications;
and wrong route, among others. Strategies to prevent
administration errors include: educate all staff
administering vaccine about the influenza vaccine
inventory; store vaccines with similar packaging
on different shelves of the refrigerator; label the
vaccine in the storage unit with age or other
unique indications; use standard ACIP abbreviations. A link to the standardized
abbreviations list can be found on the ACIP web page. If you or your staff have
additional questions, send them to us by e-mail at [email protected] Continuing
education is available for this program only
through the CDC/ATSDR Training and Continuing Education
online system at www2a.cdc.gov/TCEonline. There are two very important
pieces of information to receive CE for this program. First is the course number. The course number for
this program is WD2589. That’s WD2589. You must also
have a verification code to complete the evaluation
and posttest. The verification
code is FluRecs. That’s capital F,
lowercase l and u, uppercase R, lowercase ecs. That’s capital F,
lowercase l and u, uppercase R, lowercase ecs. Thank you for joining us. It has been our pleasure
to bring you this program.

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