Fluzone Intradermal

Influenza Vaccines

For storage information, see the specific product information within the How supplied section.
 
NOTE: According to U.S. federal laws, the healthcare provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.
Obtain a patient's current health status and immunization history to determine vaccine adverse reactions. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Depending on the adverse reaction, subsequent vaccination, if needed, may be contraindicated.
The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of anaphylaxis in the event of a serious allergic reaction.
Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. The vaccine cannot cause influenza.
Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization; materials are free of charge from the Centers for Disease Control. Provision of the Vaccine Information Statements is required by the National Childhood Vaccine Injury Act of 1986.

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not mix with any other vaccine.
When concomitant administration of other vaccines is required, they should be given with different syringes and at different injection sites.

Before administration, clean skin over the injection site with a suitable cleansing agent.
For products supplied as a suspension, shake well immediately before use.
For vials, use a sterile syringe and needle to withdraw vaccine from vial. It is recommended that small syringes (0.5 mL) be used to minimize product loss. For prefilled syringes, attach a sterile needle.[41686]
For adults and older children, a needle length of at least 1 inch can be considered; needles less than 1 inch might be of insufficient length to penetrate muscle tissue in certain adults and children.[28647]
For children 3 years and older, the needle size required for deltoid injection ranges from 5/8- to 1-inch.
For children 1 to 2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90 degree angle.
For the majority of infants younger than 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.[43236]
Inject into the anterolateral aspect of the mid-thigh (for infants younger than 1 year of age) or the deltoid muscle of the upper arm (for children and adults). Do NOT administer in the gluteal muscle.[41686] [43236]
Doses from Afluria vials may be administered to adults (18 to 64 years) using the PharmaJet Stratis needle-free injection system. This spring-loaded device delivers a single IM dose by creating a narrow fluid stream that rapidly penetrates the skin. Safety and efficacy of needless injectors have not been established in geriatric (older than 64 years) nor pediatric (less than 18 years) patients.[41448]
Storage of opened vials: Acceptable storage varies depending on vaccine formulation and brand. See How Supplied section or directly contact the manufacturer for specific vaccine being used.

Intradermal administration (Fluzone Intradermal only):
Gently shake the device and remove the needle cap.
Insert the needle perpendicular to the skin in the region of the deltoid. Maintain light pressure on the surface of the skin and push the plunger to inject the dose. Do not aspirate.
After needle removal from the skin, firmly push the plunger to activate the needle shield.

anaphylactic shock / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
erythema multiforme / Delayed / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
muscle paralysis / Delayed / Incidence not known
optic neuritis / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
vasculitis / Delayed / Incidence not known
seizures / Delayed / Incidence not known

erythema / Early / 1.0-60.0
migraine / Early / 1.0-1.0
wheezing / Rapid / 1.0-1.0
encephalopathy / Delayed / Incidence not known
neuropathic pain / Delayed / Incidence not known
confusion / Early / Incidence not known
dyspnea / Early / Incidence not known
dysphonia / Delayed / Incidence not known
dysphagia / Delayed / Incidence not known
lymphadenopathy / Delayed / Incidence not known
thrombocytopenia / Delayed / Incidence not known
conjunctivitis / Delayed / Incidence not known
photophobia / Early / Incidence not known
sinus tachycardia / Rapid / Incidence not known

injection site reaction / Rapid / 1.0-89.0
pruritus / Rapid / 0.2-46.9
irritability / Delayed / 1.7-42.9
malaise / Early / 1.0-38.1
drowsiness / Early / 13.0-37.7
myalgia / Early / 1.0-36.4
anorexia / Delayed / 1.0-32.3
headache / Early / 1.0-24.7
diarrhea / Early / 1.0-24.2
fatigue / Early / 1.0-20.0
ecchymosis / Delayed / 0.5-17.0
fever / Early / 0-16.0
arthralgia / Delayed / 0.3-15.0
vomiting / Early / 1.4-14.8
shivering / Rapid / 2.6-12.1
nausea / Early / 0.4-12.0
rhinorrhea / Early / 2.7-11.2
diaphoresis / Early / 1.0-10.0
rhinitis / Early / 1.0-10.0
chills / Rapid / 2.0-7.3
nasal congestion / Early / 1.0-7.0
back pain / Delayed / 1.5-1.5
abdominal pain / Early / 1.4-1.4
dysmenorrhea / Delayed / 1.3-1.3
cough / Delayed / 1.0
infection / Delayed / 1.0
pharyngitis / Delayed / 1.0
rash / Early / Incidence not known
urticaria / Rapid / Incidence not known
throat irritation / Early / Incidence not known
hypoesthesia / Delayed / Incidence not known
insomnia / Early / Incidence not known
paresthesias / Delayed / Incidence not known
tremor / Early / Incidence not known
dizziness / Early / Incidence not known
syncope / Early / Incidence not known
vertigo / Early / Incidence not known
laryngitis / Delayed / Incidence not known
chest pain (unspecified) / Early / Incidence not known
flushing / Rapid / Incidence not known
pallor / Early / Incidence not known

Afluria Quadrivalent, FLUAD Quadrivalent, Fluarix Quadrivalent, Flublok Quadrivalent, FLUCELVAX Quadrivalent, Flulaval Quadrivalent, Fluzone Quadrivalent

Rx

Inactivated influenza vaccine (IIV)
Used to confer immunity against 3 (2 type A and 1 type B) or 4 (2 type A and 2 type B) strains likely to circulate during annual flu season
Annual immunizations required; recommended for all people at least 6 months of age

0.7 mL IM as a single dose.

0.5 mL IM as a single dose.

0.5 mL IM as a single dose.

0.5 mL IM. For children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[54943] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

0.25 mL or 0.5 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.25 mL or 0.5 mL IM at least 4 weeks after the initial dose.[54943] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

0.5 mL IM as a single dose.

0.5 mL IM as a single dose.

0.5 mL IM as a single dose. 

0.5 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[52652] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

0.5 mL IM as a single dose.

0.5 mL IM as a single dose.

0.5 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[55717] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

0.5 mL IM as a single dose.

0.5 mL IM as a single dose.

0.5 mL IM. For children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[61129] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

0.25 mL IM. For infants and children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.25 mL IM at least 4 weeks after the initial dose.[61129] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

0.5 mL IM as a single dose.

0.5 mL IM as a single dose.

0.5 mL IM. For children who have not received at least 2 doses of influenza vaccine before the beginning of the influenza season, administer a second dose of 0.5 mL IM at least 4 weeks after the initial dose.[60831] The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current influenza season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

0.5 mL IM as a single dose.

0.1 mL intradermally as a single dose.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.

Afluria Quadrivalent/Alfuria/FLUAD/FLUAD Quadrivalent/Fluarix Quadrivalent/Flublok Quadrivalent/FLUCELVAX/FLUCELVAX Quadrivalent/Flulaval/Flulaval Quadrivalent/Fluvirin/Fluzone/Fluzone High-Dose/Fluzone Quadrivalent/Influenza A Virus A/Delaware/55/2019 CVR-45 (H1N1) Antigen (MDCK Cell Derived, Propiolactone Inactivated) , Influenza A Virus A/Darwin/11/2021 (H3N2) Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus B/Singapore/WUH4618/2021 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus B/Singapore/INFTT-16-0610/2016 antigen (MDCK Cell Derived, Propiolactone inactivated)/Influenza A Virus A/Georgia/12/2022 CVR-167 (H1N1) Antigen (MDCK Cell Derived. Propiolactone Inactivated), Influenza A Virus A/Darwin/11/2021 (H3N2) Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus B/Singapore/WUH4618/2021 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus B/Singapore/INFTT-16-0610/2016 antigen (MDCK Cell Derived, Propiolactone inactivated)/Influenza A Virus A/Guangdong-Maonan/SWL1536/2019 CNIC-1909 (H1N1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/Hong Kong/2671/2019 NIB-121 (H3N2) Antigen (Formaldehyde Inactivated), Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen/Influenza A Virus A/Victoria/2570/2019 IVR-215 (H1N1) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza A Virus A/Darwin/6/2021 IVR-227 (H3N2) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Austria/1359417/2021 BVR-26 Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Phuket/3073/2013 BVR-1B Hemagglutinin Antigen (Formaldehyde Inactivated)/Influenza A Virus A/Victoria/2570/2019 IVR-215 (H1N1) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza A Virus A/Darwin/9/2021 SAN-010 (H3N2) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Phuket/3073/2013 Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Michigan/1/2021 Hemagglutinin Antigen (Formaldehyde Inactivated)/Influenza A Virus A/Victoria/2570/2019 IVR-215 (H1N1) Hemagglutinin Antigen (Propiolactone Inactivated), Influenza A Virus A/Darwin/6/2021 IVR-227 (H3N2) Hemagglutinin Antigen (Propiolactone Inactivated), Influenza B Virus B/Austria/1359417/2021 BVR-26 Hemagglutinin Antigen (Propiolactone Inactivated), Influenza B Virus B/Phuket/3073/2013 BVR-1B Hemagglutinin Antigen (Propiolactone Inactivated)/Influenza A Virus A/Victoria/4897/2022 IVR-238 (H1N1) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza A Virus A/Darwin/6/2021 IVR-227 (H3N2) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Austria/1359417/2021 BVR-26 Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Phuket/3073/2013 BVR-1B Hemagglutinin Antigen (Formaldehyde Inactivated)/Influenza A Virus A/Victoria/4897/2022 IVR-238 (H1N1) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza A Virus A/Darwin/6/2021 IVR-227 (H3N2) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Austria/1359417/2021 BVR-26 Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Phuket/3073/2013 Hemagglutinin Antigen (Formaldehyde Inactivated)/Influenza A Virus A/Victoria/4897/2022 IVR-238 (H1N1) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza A Virus A/Darwin/9/2021 IVR-228 (H3N2) Hemagglutinin Antigen (UV, Formaldehyde Inactivated), Influenza B Virus B/Austria/1359417/2021 BVR-26 Hemagglutinin Antigen (UV, Formaldehyde Inactivated), Influenza B Virus B/Phuket/3073/2013 Hemagglutinin Antigen (UV, Formaldehyde Inactivated)/Influenza A Virus A/Victoria/4897/2022 IVR-238 (H1N1) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza A Virus A/Darwin/9/2021 SAN-010 (H3N2) Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Phuket/3073/2013 Hemagglutinin Antigen (Formaldehyde Inactivated), Influenza B Virus B/Michigan/1/2021 Hemagglutinin Antigen (Formaldehyde Inactivated)/Influenza A Virus A/Victoria/4897/2022 IVR-238 (H1N1) Hemagglutinin Antigen (Propiolactone Inactivated), Influenza A Virus A/Darwin/6/2021 IVR-227 (H3N2) Hemagglutinin Antigen (Propiolactone Inactivated), Influenza B Virus B/Austria/1359417/2021 BVR-26 Hemagglutinin Antigen (Propiolactone Inactivated), Influenza B Virus B/Phuket/3073/2013 BVR-1B Hemagglutinin Antigen (Propiolactone Inactivated)/Influenza A Virus A/West Viginia/30/2022 (H1N1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/Darwin/6/2021 (H3N2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/Austria/1359417/2021 Recombinant Hemagglutinin Antigen, Influenza B Virus B/Phuket/3073/2013 Recombinant Hemagglutinin Antigen/Influenza A Virus A/Wisconsin/588/2019 (H1N1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/Darwin/6/2021 (H3N2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/Austria/1359417/2021 Recombinant Hemagglutinin Antigen, Influenza B Virus B/Phuket/3073/2013 Recombinant Hemagglutinin Antigen/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Iowa/06/2017 Antigen (MDCK Cell Derived, Propiolactone Inactivated), Influenza B Virus Phuket 3073/2013 antigen/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated)/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus B/Maryland/15/2016 antigen (Formaldehyde Inactivated), Influenza B Virus Phuket 3073/2013 antigen/Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Yamagata 16/88 antigen, Influenza B Virus Victoria 2/87 antigen lineages/Influenza B Virus B/Phuket/3073/2013 Recombinant Hemagglutinin antigen, Influenza A Virus H3N2 antigen, Influenza A Virus H1N1 antigen, Influenza B Virus B/Washington/02/2019 antigen (Formaldehyde Inactivated) Intramuscular Inj Susp: 0.5mL, 15-15-15mcg, 60-60-60mcg
Flublok Intramuscular Inj Sol: 0.5mL, 45-45-45mcg
Fluzone Intradermal Intradermal Inj Susp

0.5 mL/dose IM; 0.1 mL/dose intradermal (Fluzone Intradermal only). Safety and efficacy of Fluad and Fluzone High-Dose have not been established.

0.5 mL/dose IM; 0.7 mL/dose IM (Fluzone High-Dose only). Safety and efficacy of intradermal administration have not been established.

0.5 mL/dose IM for Fluzone, Fluarix, FluLaval, Afluria (excluding the needle-free injection system), and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.

3 to 12 years: 0.5 mL/dose IM for Fluzone, Fluarix, FluLaval, Afluria (excluding the needle-free injection system), and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.
1 to 2 years: 0.25 mL/dose IM for Afluria (excluding the needle-free injection system); 0.5 mL/dose IM for FluLaval, Fluarix, Fluzone, and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.

6 to 11 months: 0.25 mL/dose IM for Afluria (excluding the needle-free injection system); 0.5 mL/dose IM for Flulaval, Fluarix, Fluzone, and Flucelvax. Safety and efficacy of Fluzone High-Dose, Flublok, Fluad, and intradermal administration have not been established.
1 to 5 months: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Influenza virus vaccine imparts immunity against the influenza virus by stimulating production of antibodies that are specific to the disease. Vaccine recipients develop immunity only to those strains of the virus from which the vaccine was prepared. Influenza viruses are recognized by the surface antigens they carry, and two such antigens, hemagglutinin (H) and neuraminidase (N) have been identified and are used to classify the various viruses. Subtypes of these strains (H1, H2, H3, N1, N2) are associated with influenza A virus and have been recognized to cause disease in humans. Immunity to these surface antigens increases resistance to infection and decreases the severity of the disease if infection occurs. Eventually, antigenic variation can occur, and immunity to one strain may no longer impart immunity to distantly related subtypes of the virus. Influenza B viruses also exhibit antigenic variation, and new variants of both types of viruses continue to cause widespread epidemics of respiratory disease.

The inactivated influenza virus vaccine (IIV) is usually administered intramuscularly; intradermal vaccines are also available. The vaccine usually imparts a protective effect within 10 to 14 days of administration. Post-vaccine antibody titers are generally high enough in healthy young adults and children to provide resistance against infection by strains found in the vaccine as well as related strains. A hemagglutination-inhibiting antibody titer of at least 1:40 may be protective against influenza infection in up to 50% of people. Among 1007 patients 18 to 64 years of age who got Afluria, 94.2 to 99.9% had a postvaccination titer of at least 1:40. The duration of immunity imparted by the influenza vaccine generally lasts 6 to 12 months.

No adequate and well-controlled studies have been conducted in pregnant women. Based on available data from pregnancy registries of Flucelvax and Fluarix administered during pregnancy, there was no evidence of vaccine-associated risk of major birth defects or miscarriage. During animal studies, no evidence of impaired fertility or fetal harm was noted with influenza vaccines. Pregnancy may increase the risk of serious medical complications from influenza. Therefore, the Advisory Committee on Immunization Practices (ACIP) recommends that all women who are or will be pregnant (in any trimester) during the influenza season be routinely vaccinated with an inactivated influenza vaccine (vs. live-attenuated influenza vaccine). [63436] Many experts consider influenza vaccination safe during any stage of pregnancy. However, because spontaneous abortion is common in the first trimester and unnecessary drug-exposures have traditionally been avoided during this time, some experts prefer waiting until the second trimester of pregnancy to vaccinate. In addition to benefits to the mother, influenza vaccine administration during pregnancy appears to help protect newborns and infants. Fewer cases of laboratory-confirmed influenza occurred during the first 6 months of life among infants of the 159 mothers who received the inactivated influenza vaccine (6 cases) as compared with infants of 157 mothers who received the pneumococcal polysaccharide vaccine (16 cases). Some manufacturers have established pregnancy registries to monitor pregnancy outcomes and newborn health after vaccination. Patients who receive these vaccines during pregnancy are encouraged to enroll in these registries. For Sanofi Pasteur influenza vaccines (e.g., Fluzone and Flublok), patients are encouraged to contact Sanofi Pasteur at 800-822-2463. For Seqirus influenza vaccines (e.g., Afluria), patients are encouraged to contact Seqirus at 855-358-8966 or

Data are limited regarding use of the influenza virus vaccine during breast-feeding, and its excretion in human breast milk is unknown. The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) state inactivated virus vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA. [63436]