Sentry BioPharma Services provides vaccine product management services to a wide group of clients from U.S. Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.  This is Sentry’s second article concerning influenza this season with an emphasis on preventing the flu within the general population of the United States.  Sentry acknowledges the Centers for Disease Control and Prevention (CDC) and its continued efforts in disseminating important information to benefit the health and well-being of all Americans.

New Flu Information for 2016-2017

Getting an annual flu vaccine is the first and best way to protect yourself and your family from
the flu. Flu vaccination can reduce flu illnesses, doctors’ visits, and missed work and school due to flu, as well as prevent flu-related hospitalizations. The more people who get vaccinated, the more people will be protected from flu, including older people, very young children, pregnant women and people with certain health conditions who are more vulnerable to serious flu complications. This page summarizes information for the 2016-2017 flu season.

What’s new this flu season?

A few things are new this season:

• Only injectable flu shots are recommended for use this season.
• Flu vaccines have been updated to better match circulating viruses.
• There will be some new vaccines on the market this season.
• The recommendations for vaccination of people with egg allergies have changed.

What flu vaccines are recommended this season?

This season, only injectable flu vaccines (flu shots) should be used. Some flu shots protect against three flu viruses and some protect against four flu viruses.

Options this season include:

• Standard dose flu shots. Most are given into the muscle (usually with a needle, but one can be given to some people with a jet injector). One is given into the skin.
• A high-dose shot for older people.
• A shot made with adjuvant for older people.
• A shot made with virus grown in cell culture.
• A shot made using a vaccine production technology (recombinant vaccine) that does not require the use of flu virus.

Live attenuated influenza vaccine (LAIV) – or the nasal spray vaccine – is not recommended for use during the 2016-2017 season because of concerns about its effectiveness.

Table 1 below illustrates all the influenza vaccines that are FDA-approved for use in the United States during the 2016-2017 season.  Also, Table 2 identifies Contraindications and precautions to the use of influenza vaccines — United States, for the 2016–17 influenza season:

TABLE 1. Influenza vaccines — United States, 2016–17 influenza season

Trade name	Manufacturer	Presentation	Age indication	Mercury (from thimerosal) µg/0.5 mL	Latex	Route
Inactivated influenza vaccine, quadrivalent (IIV4), standard dose†
Fluarix Quadrivalent	GlaxoSmithKline	0.5 mL single-dose prefilled syringe	≥3 yrs	NR	No	IM§
Flulaval Quadrivalent	ID Biomedical Corp. of Quebec (distributed by GlaxoSmithKline)	0.5 mL single-dose prefilled syringe	≥3 yrs	NR	No	IM
		5.0 mL multi-dose vial	≥3 yrs	<25	No	IM
Fluzone Quadrivalent	Sanofi Pasteur	0.25 mL single-dose prefilled syringe	6–35 mos	NR	No	IM
		0.5 mL single-dose prefilled syringe	≥36 mos	NR	No	IM
		0.5 mL single-dose vial	≥36 mos	NR	No	IM
		5.0 mL multidose vial	≥6 mos	25	No	IM
Fluzone Intradermal¶ Quadrivalent	Sanofi Pasteur	0.1 mL single-dose prefilled microinjection system	18 through 64 yrs	NR	No	ID**
Inactivated influenza vaccine, quadrivalent, cell culture-based (ccIIV4), standard dose†
Flucelvax Quadrivalent	Seqirus	0.5 mL single-dose prefilled syringe	≥4 yrs	NR	No	IM
Inactivated Influenza Vaccine, trivalent (IIV3), standard dose†
Afluria	Seqirus	0.5 mL single-dose prefilled syringe	≥9 yrs††	NR	No	IM
		5.0 mL multi-dose vial	≥9 yrs†† (needle and syringe) 18 through 64 years (jet injector)	24.5	No	IM
Fluvirin	Seqirus	0.5 mL single-dose prefilled syringe	≥4 yrs	≤1	Yes§§	IM
		5.0 mL multi-dose vial	≥4 yrs	25	No	IM
Adjuvanted Inactivated Influenza Vaccine, trivalent (aIIV3), standard dose†
Fluad	Seqirus	0.5 mL single-dose prefilled syringe	≥65 yrs	NR	Yes§§	IM
Inactivated Influenza Vaccine, trivalent (IIV3), High Dose¶¶
Fluzone High-Dose	Sanofi Pasteur	0.5 mL single-dose prefilled syringe	≥65 yrs	NR	No	IM
Recombinant Influenza Vaccine, trivalent (RIV3)***
FluBlok	Protein Sciences	0.5 mL single-dose vial	≥18 yrs	NR	No	IM
Live Attenuated Influenza Vaccine, quadrivalent (LAIV4)†††
FluMist Quadrivalent	MedImmune	0.2 mL single-dose prefilled intranasal sprayer	2 through 49 yrs	NR	No	NAS

Abbreviations: ACIP = Advisory Committee on Immunization Practices; ID = intradermal; IM = intramuscular; NAS = intranasal; NR = not relevant (does not contain thimerosal).
*Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm . Availability of specific products and presentations might change and differ from what is described in this table.
^†Standard dose intramuscular IIVs contain 15 µg of each vaccine HA antigen (45 µg total for trivalents and 60 µg total for quadrivalents) per 0.5mL dose.
^§For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration may be found in the ACIP General Recommendations on Immunization, available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm.
^¶Quadrivalent inactivated influenza vaccine, intradermal: a 0.1-mL dose contains 9 µg of each vaccine HA antigen (36μg total).
**The preferred injection site is over the deltoid muscle. Fluzone Intradermal Quadrivalent is administered using the delivery system included with the vaccine.
^††Age indication per package insert is ≥5 years; however, ACIP recommends that Afluria not be used in children aged 6 months through 8 years because of increased risk for febrile reactions noted in this age group with Seqirus’ 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5 through 8 years who has a medical condition that increases the child’s risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the benefits and risks of influenza vaccination with Afluria before administering this vaccine. Afluria may be used in persons aged ≥9 years. Afluria is licensed for administration by jet injector for persons aged 18 through 64 years only.
^§§Syringe tip cap might contain natural rubber latex.
^¶¶High-dose IIV3 contains 60 μg of each vaccine antigen (180 μg total) per 0.5mL dose.
***RIV3 contains 45 μg of each vaccine HA antigen (135 μg total) per 0.5mL dose.
^†††ACIP recommends that Flumist (LAIV4) not be used during the 2016–17 season.

TABLE 2. Contraindications and precautions to the use of influenza vaccines — United States, 2016–17 influenza season*

Vaccine	Contraindications	Precautions
IIV	History of severe allergic reaction to any component of the vaccine† or after previous dose of any influenza vaccine	Moderate to severe illness with or without fever History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
RIV	History of severe allergic reaction to any component of the vaccine	Moderate to severe illness with or without fever History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine
LAIV	For the 2016–17 season, ACIP recommends that LAIV not be used. Content below is provided for information.
	History of severe allergic reaction to any component of the vaccine† or after a previous dose of any influenza vaccine Concomitant aspirin or salicylate-containing therapy in children and adolescents Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a health care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months Children and adults who have immunosuppression (including immunosuppression caused by medications or by HIV) Close contacts and caregivers of severely immunosuppressed persons who require a protected environment Pregnancy Receipt of influenza antiviral medication within the previous 48 hours	Moderate to severe illness with or without fever History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine Asthma in persons aged ≥5 years Other underlying medical conditions that might predispose to complications after wild-type influenza infection (e.g., chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)

Abbreviations: ACIP = Advisory Committee on Immunization Practices; IIV = Inactivated Influenza Vaccine; LAIV = Live-Attenuated Influenza Vaccine; RIV = Recombinant Influenza Vaccine.
* Immunization providers should check Food and Drug Administration–approved prescribing information for 2016–17 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, and precautions. Package inserts for US-licensed vaccines are available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm .
^† History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of IIV and LAIV. However, ACIP recommends that any licensed, recommended, and appropriate IIV or RIV may be administered to persons with egg allergy of any severity (see Influenza Vaccination of Persons with a History of Egg Allergy).

What viruses do 2016-2017 flu vaccines protect against?

There are many flu viruses and they are constantly changing. The composition of U.S. flu vaccines is reviewed annually and updated to match circulating flu viruses. Flu vaccines protect against the three or four viruses that research suggests will be most common. For 2016-2017, three-component vaccines are recommended to contain:

• A/California/7/2009 (H1N1) pdm09-like virus,
• A/Hong Kong/4801/2014 (H3N2)-like virus and a
• B/Brisbane/60/2008-like virus (B/Victoria lineage).

Four component vaccines are recommended to include the same three viruses above, plus an additional B virus called B/Phuket/3073/2013-like virus (B/Yamagata lineage).

When and how often should I get vaccinated?

Everyone 6 months and older should get a flu vaccine every year by the end of October, if possible. However, getting vaccinated later is OK. Vaccination should continue throughout the flu season, even in January or later. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime, may need two doses of flu vaccine. A health care provider can advise on how many doses a child should get.

Can I get a flu vaccine if I am allergic to eggs?

The recommendations for people with egg allergies have been updated for this season.

• People who have experienced only hives after exposure to egg can get any licensed flu vaccine that is otherwise appropriate for their age and health.
• People who have symptoms other than hives after exposure to eggs, such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who have needed epinephrine or another emergency medical intervention, also can get any licensed flu vaccine that is otherwise appropriate for their age and health, but the vaccine should be given in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions. (Settings include hospitals, clinics, health departments, and physician offices). People with egg allergies no longer have to wait 30 minutes after receiving their vaccine.

Flu Activity

What sort of flu season is expected this year?

It’s not possible to predict what this flu season will be like. While flu spreads every year, the timing, severity, and length of the season varies from one year to another.

Will new flu viruses circulate this season?

Flu viruses are constantly changing so it’s not unusual for new flu viruses to appear each year. For more information about how flu viruses change, visit How the Flu Virus Can Change.

Will the United States have a flu epidemic?

The United States experiences epidemics of seasonal flu each year. This time of year is called “flu season.” In the United States, flu viruses are most common during the fall and winter months. Influenza activity often begins to increase in October and November. Most of the time flu activity peaks between December and March and can last as late as May. CDC monitors certain key flu indicators (for example, outpatient visits of influenza-like illness (ILI), the results of laboratory testing and flu hospitalization and deaths). When these indicators rise and remain elevated for a number of consecutive weeks, flu season is said to have begun. Usually ILI increases first, followed by an increase in flu-associated hospitalizations, which is then followed by increases in flu-associated deaths.

For the most current influenza surveillance information, please see FluView at Weekly U.S. Influenza Surveillance Report.

When will flu activity begin and when will it peak?

The timing of flu is very unpredictable and can vary in different parts of the country and from season to season. Seasonal flu viruses can be detected year-round, however, seasonal flu activity can begin as early as October and continue to occur as late as May. Flu activity most commonly peaks in the United States between December and March.

How many people die from flu each year?

CDC does not count how many people die from flu each year. Unlike flu deaths in children, flu deaths in adults are not nationally reportable. However, CDC uses mortality data collected by the National Center for Health Statistics to monitor relative levels of flu-associated deaths. This system tracks the proportion of death certificates processed that list pneumonia or influenza as the underlying or contributing cause of death of the total deaths reported. This system provides an overall indication of whether flu-associated deaths are elevated, but does not provide an exact number of how many people died from flu. For more information, see Overview of Influenza Surveillance in the United States, “Mortality Surveillance.”

CDC also uses modeling studies to estimate numbers of flu-related deaths, but these studies apply only to past seasons and are not done each year. For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States.

Why is it difficult to know how many people die from flu?

There are several factors that make it difficult to determine accurate numbers of deaths caused by flu regardless of reporting. Some of the challenges in counting influenza-associated deaths include the following: the sheer volume of deaths to be counted; the lack of testing (not everyone that dies with an influenza-like illness is tested for influenza); and the different coding of deaths (influenza-associated deaths are often a result of complications secondary to underlying medical problems, and this may be difficult to sort out). For more information, see Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu.

Protective Actions

What should I do to protect myself from flu this season?

CDC recommends a yearly flu vaccine for everyone 6 months of age and older as the first and most important step in protecting against this serious disease.

In addition to getting a seasonal flu vaccine, you can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others. In addition, there are prescription medications called antiviral drugs that can be used to treat influenza illness. Visit What you Should Know About Flu Antiviral Drugs for more information.

What should I do to protect my loved ones from flu this season?

Encourage your loved ones to get vaccinated. Vaccination is especially important for people at high risk for developing flu-related complications, and their close contacts. Also, if you have a loved one who is at high risk of flu complications and they develop flu symptoms, encourage them to get a medical evaluation for possible treatment with influenza antiviral drugs. CDC recommends that people who are at high risk for serious flu complications who get flu symptoms during flu season be treated with influenza antiviral drugs as quickly as possible. People who are not at high risk for serious flu complications may also be treated with influenza antiviral drugs, especially if treatment can begin within 48 hours.

Some children 6 months through 8 years of age will require two doses of flu vaccine for adequate protection from flu. Children in this age group who are getting vaccinated for the first time will need two doses of flu vaccine, spaced at least 28 days apart. Some children who have received flu vaccine previously and children who have only received one dose in their lifetime also may need two doses. Your child’s doctor or other health care professional can tell you if your child needs two doses. Visit Children, the Flu, and the Flu Vaccine for more information.

Children younger than 6 months are at higher risk of serious flu complications, but are too young to get a flu vaccine. Because of this, safeguarding them from flu is especially important. If you live with or care for an infant younger than 6 months of age, you should get a flu vaccine to help protect them from flu. See Advice for Caregivers of Young Children for more information. Also, studies have shown that getting the flu vaccine during pregnancy can protect the baby after birth for several months.

In addition to getting vaccinated, you and your loved ones can take everyday preventive actions like staying away from sick people and washing your hands to reduce the spread of germs. If you are sick with flu, stay home from work or school to prevent spreading flu to others.

Vaccine and Vaccination

How much flu vaccine will be available this season?

Flu vaccine is produced by private manufacturers, so supply depends on manufacturers. For the 2016-2017 season, manufacturers projected they would provide between 157 million and 168 million doses of injectable vaccine for the U.S. market. (Projections may change as the season progresses.)

Will live attenuated intranasal influenza vaccine (LAIV) be available this season even though it is not recommended for use?

FluMist Quadrivalent is still an FDA-licensed product. As such, there may be some supply of FluMist Quadrivalent on the U.S. market during the 2016-2017 season. It is important for clinicians and the public to be aware that because of concerns about this vaccine’s effectiveness, CDC recommends that this vaccine not be used during the 2016-2017 influenza season.

Where can I find information about vaccine supply?

Information about flu vaccine supply is available at Seasonal Influenza Vaccine & Total Doses Distributed.

When will flu vaccine become available?

Flu vaccine is produced by private manufacturers, so the timing of vaccine availability depends on when production is completed. As of late September, more than 90 million doses of 2016-2017 flu vaccine had already been distributed in the United States. Vaccine supply updates are available at the link above.

When should I get vaccinated?

Getting vaccinated before flu activity begins helps protect you once the flu season starts in your community. It takes about two weeks after vaccination for the body’s immune response to fully respond and for you to be protected so make plans to get vaccinated. CDC recommends that people get a flu vaccine by the end of October, if possible. However, getting vaccinated later can still be beneficial. CDC recommends ongoing flu vaccination as long as influenza viruses are circulating, even into January or later. Children aged 6 months through 8 years who need two doses of vaccine should get the first dose as soon as possible to allow time to get the second dose before the start of flu season. The two doses should be given at least 28 days apart.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

For additional information please visit:

https://www.cdc.gov/flu/

https://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html