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The Omnicare HealthLine September 2016
Focus on Seasonal Influenza 2016-2017 - by Allen Lefkovitz
“Annual influenza vaccination is the primary means of preventing influenza and its complications,” according to the Centers for Disease Control and Prevention (CDC). CDC also states that “Complications, hospitalizations, and deaths from seasonal influenza are typically greatest among persons aged ≥ 65 years, children aged
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New products and changes have occurred since the last influenza season.
• Fluad, a standard dose trivalent vaccine, has an adjuvant (MF59®, a squalene based emulsion) which elicits a greater immune response. It is specifically approved for those 65 years and older.
• Flucelvax Quadrivalent, which replaces the previously available trivalent formulation and is now approved for use in those 4 years and older (previously only available for people 18 to 64 years of age). Also the tip caps and plungers of the prefilled syringes are no longer made with natural rubber latex.
• The only standard dose Fluzone formulation that remains is Fluzone Quadrivalent (Fluzone trivalent has been discontinued).
Since 6 of the 8 types of influenza vaccine are approved for use in the elderly, the question invariably arises as to which product is best. Although ACIP discusses that a clinical study demonstrated a 24.2% greater efficacy with Fluzone High- Dose compared to standard dose Fluzone, the ACIP recommendations repeatedly state “No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is otherwise appropriate.” Likewise, the ACIP guidance points out that there have not been any studies yet that compare Fluzone High-Dose to the new adjuvanted Fluad. More specifics about all available products for 2016-2017 are summarized in Table 1 on page 4.
Highlights from the CDC and the 2016-2017 ACIP Recommendations
• As it takes 2 weeks to develop necessary antibodies, ACIP clarified their recommendation about timing of vaccination by stating “Health care providers should offer vaccination by the end of October, if possible.” ACIP still encourages vaccine administration “be offered as long as influenza viruses are circulating and unexpired vaccine is available.”
• Influenza vaccination should not be delayed in order to procure any specific vaccination if an appropriate, alternative vaccination is already available.
• In June 2016 ACIP made an interim recommendation that live attenuated influenza vaccine (LAIV4) (the “nasal flu vaccine”) NOT be used during the 2016-2017 season. Although still FDA approved and available, recent data on LAIV4 that were reviewed by ACIP indicated no significant effectiveness. This follows ACIP recommending LAIV4 over inactivated influenza vaccine (IIV) for children during the 2014-2015 season, and rescinding that preference for the 2015-2016 season.
• For all children aged 6 months to 8 years, 2 doses of the 2016-2017 vaccine should be administered (at least 4 weeks apart) UNLESS they have received 2 or more doses during any previous season (these 2 doses did not need to be during the same or even consecutive seasons).
• Recommendations for persons with egg allergy were extensively modified (see Allergic Reactions and Influenza Vaccination on page 3)
• Adequate supplies are anticipated for the upcoming season, but higher risk individuals who especially should be targeted for receiving vaccination in the event of limited supplies include:
Everyone 6 months through 5 years or 50 years of age or older
Residents of nursing homes and other
long-term care facilities
Those with chronic pulmonary (e.g., asthma) or cardiovascular*, renal,
hepatic, neurological, hematologic, or metabolic disorders (e.g., diabetes)
Persons who are immunosuppressed
(e.g., due to medication, HIV infection)
Women who are or will be pregnant during the
Persons 18 years and younger who receive
long-term aspirin therapy
American Indians / Alaskan natives
Persons who are extremely obese (BMI greater than or equal to 40)
Healthcare personnel who have contact with patients
Household contacts (including children) and
caregivers of persons with medical conditions that put them at higher risk
*Chronic cardiovascular disorders excludes
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Allergic Reactions and Influenza Vaccination Severe allergic reactions to vaccines are considered “very rare” (< 1.5 cases per 1 million doses), but are most commonly associated with an allergy to eggs, certain antibiotics (e.g., neomycin, gentamicin), gelatin, or latex. CDC generally suggests that if a person reports history of a severe allergy (e.g., anaphylaxis) to any substance contained in a vaccine, an alternative vaccine that does not contain that substance should be considered instead of complete avoidance of vaccination. However, a previous severe allergic reaction to influenza vaccine, regardless of the component suspected of being responsible for the reaction, is a contraindication to future receipt of the vaccine.
Except for the trivalent, recombinant influenza vaccine (RIV3) and the cell culture-based inactivated influenza vaccine (ccIIV4), all influenza vaccines are prepared by growing viruses in embryonated chicken eggs; however, even ccIIV4 contains a very small amount of total egg protein, such that only Flublok is completely egg-free.
For several years, ACIP has provided specific guidance on which influenza may or may not be used by persons with various types of egg allergies. Based upon continued assessment of vaccine safety data, ACIP has modified their previous recommendation that egg-allergic recipients should be observed for 30 minutes after vaccination. Instead, everyone vaccinated (regardless of allergies) should be monitored for 15 minutes after vaccination.
Additionally, anyone with a history of severe allergic reaction to eggs (i.e., more than hives) now may receive any recommended and age appropriate influenza vaccine, but they should be vaccinated only in an inpatient or outpatient medical setting under the supervision of a healthcare provider who is able to recognize and manage severe allergic conditions.
Influenza Vaccination and Long-Term Care With the heightened awareness around antibiotic stewardship in long-term care (LTC), a comprehensive immunization program is an important strategy.
Within their “Core Elements for Antibiotic Stewardship in Nursing Homes” program, CDC included a Fact Sheet for residents and families entitled “Top 10 Infection Prevention Questions to Ask a Nursing Home’s
Leaders”. Question #4 of the Fact Sheet asks “Is the flu vaccine mandatory for all staff working in this nursing home?” Additionally on this subject CDC reminds residents and families that “The nursing home
should also know what percentage of residents received the flu vaccine during the last flu season.”
ACIP continues to recommend that all health-care facilities offer free and convenient access to influenza vaccination for all healthcare professionals (HCP), including night, weekend, and temporary staff, with particular emphasis on workers who provide direct care for persons at high risk for influenza-related complications. Although conclusive supporting data are not available for all of the following, strategies to help protect older individuals in LTC include:
Vaccination of all employees
with any potential patient contact
Frequent hand washing
Masks Nasal Swabs for early detection
Restricting Access of visitors or employees
with symptoms of influenza-like illness
Despite the many efforts to encourage annual influenza immunizations to employees in LTC, the residents we serve remain at significant risk. During the 2014-2015 season, CDC says influenza vaccine coverage of all healthcare professionals (HCP) continued to increase to 77.3%; however, LTC HCP remain as having the lowest coverage rate, at only 63.9% (only slightly higher than 63% in 2013-2014).
To support increasing this rate, CDC has developed a toolkit specifically for long-term care which is available for free at: www.cdc.gov/flu/toolkit/long-term-care/. Likewise, the ACIP summary of recommendations and many other helpful influenza resources can be found at: http://www.cdc.gov/flu/.
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Table 1 – Influenza Vaccine Formulations Available for the 2016-2017 Season
Trade Name Manufacturer Contains Mercury? Recommended Age Group
Trivalent, Inactivated Influenza Vaccine (IIV3)
Afluria® Seqirus Only in MDV ≥ 9 years¥
Fluvirin® Seqirus Yesδ ≥ 4 years
Fluzone® High-Dose Sanofi Pasteur No ≥ 65 years
Trivalent, Inactivated Influenza Vaccine (aIIV3) with Adjuvant (MF-59®)
Fluad™ Seqirus Noδ ≥ 65 years
Trivalent, Recombinant Influenza Vaccine (RIV3)
Flublok® Protein Science