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Influenza A (H1N1) 2009 Monovalent Vaccine Live

Class: Vaccines
VA Class: IM100

Introduction

Live, attenuated virus vaccine.1 Influenza A (H1N1) 2009 monovalent vaccine live intranasal contains live (cold-adapted) 2009 influenza type A (H1N1) virus and is used to stimulate active immunity to the influenza virus strain contained in the vaccine.1

Uses for Influenza A (H1N1) 2009 Monovalent Vaccine Live

Prevention of 2009 Influenza A (H1N1) Virus Infection

Prevention of 2009 pandemic influenza A (H1N1) virus infection in adults 18 through 49 years of age, adolescents, and children ≥2 years of age.1

Influenza outbreaks caused by the 2009 influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus, were initially reported in several countries, including the US, beginning in March and April 2009.11 27 30 31 32 33 34 47 On June 11, 2009, the WHO declared that the first global influenza pandemic in 41 years was occurring and issued a phase 6 pandemic alert regarding 2009 influenza A (H1N1).30 48 A phase 6 pandemic is characterized by human-to-human transmission of an animal or human-animal reassortant virus and sustained community level outbreaks of the virus in 2 or more countries in a single WHO region and sustained community level outbreaks in at least one other country in a different WHO region.38

Influenza viruses can cause seasonal epidemics and, occasionally, global pandemics (an epidemic that affects the whole population).11 38 45 Prior to 2009, the 3 most recent influenza pandemics were the 1918 Spanish flu pandemic (caused 20–50 million deaths worldwide including about 500,000 deaths in the US), the 1957 Asian flu pandemic (caused 1–4 million deaths worldwide including about 70,000 deaths in the US), and the 1968 Hong Kong flu pandemic (1–4 million deaths worldwide including about 34,000 deaths in the US).38 45

The 2009 influenza A (H1N1) virus appears to be a triple-reassortant swine influenza virus containing genes from human, swine, and avian influenza A viruses.34 39 47 The virus contains a unique combination of gene segments not previously reported among human or swine influenza A in the US or elsewhere.31 34 39 47 The virus, however, may be antigenically similar to classical swine influenza A (H1N1) viruses and triple reassortant swine influenza A (H1N1) viruses that circulate in pigs and have been associated with sporadic human infections.39 47

The 2009 influenza A (H1N1) virus is antigenically and genetically distinct from circulating seasonal human influenza A (H1N1) viruses, and preliminary studies indicate that a majority of the population may be susceptible to the virus.27 39 The virus is expected to continue to circulate worldwide, including in the US, during the 2009–2010 influenza season in addition to strains of seasonal influenza A and B.11 14 27 30 42 50

Vaccination using an appropriate vaccine is the most effective strategy for preventing influenza and its complications.11 27

Seasonal influenza virus vaccines used for prevention of seasonal influenza are reformulated each year to contain antigens representative of the strains of influenza A and B viruses likely to circulate in the US during the upcoming influenza season.10 11 16 Seasonal influenza vaccines for the 2009–2010 influenza season are not expected to provide protection against 2009 influenza A (H1N1) infection.11 27

For prevention of 2009 influenza A (H1N1) infection, 2 different types of monovalent influenza vaccine are commercially available in the US: intranasal vaccine containing live, attenuated virus1 27 and parenteral vaccine containing inactivated virus.3 5 17 27 Both vaccine types are produced using an A/California/7/2009 (H1N1)v-like strain.1 3 5 17 27 (See Actions.)

Initial FDA approval of the commercially available intranasal live influenza A (H1N1) 2009 monovalent vaccine was based on safety and efficacy data for the seasonal intranasal live trivalent influenza vaccine produced by the same manufacturer (FluMist; manufactured by Medimmune) and was considered a strain change to the manufacturer's FDA-approved seasonal live influenza vaccine.44 Studies are ongoing to evaluate safety and efficacy of monovalent influenza A (H1N1) 2009 vaccines.1 27 44

Because initial supplies of influenza A (H1N1) 2009 vaccine may not be sufficient to meet demands for the vaccine, the USPHS Advisory Committee on Immunization Practices (ACIP) identified initial target groups for priority vaccination.27 These individuals are at higher risk for influenza or influenza-related complications, are likely to come in contact with influenza viruses as part of their occupation and could transmit the viruses to others in medical care settings, or are close contacts of infants too young to be vaccinated (<6 months of age).27 (See table.) As supplies of the vaccine increase and demand for vaccine among individuals in initial priority target groups is met, CDC or ACIP is likely to revise recommendations to include additional target groups (e.g., all individuals 25 through 64 years of age, adults ≥65 years of age).27 49

ACIP Recommendations for Priority Vaccination Against 2009 Pandemic Influenza A (H1N1) Virus:27

Initial Target Groups for Supplies

Pregnant women

Individuals who live with or provide care for infants <6 months of age (e.g., parents, siblings, day-care providers)

Health-care and emergency medical services personnel

Individuals 6 months through 24 years of age

Adults 25 through 64 years of age with medical conditions that put them at higher risk for influenza-related complications, including chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, cognitive, neurologic/neuromuscular, hematologic, or metabolic (including diabetes mellitus) disorders

Adults 25 through 64 years of age who are immunosuppressed, including those receiving immunosuppressive drugs and those with HIV infection

Subset of Initial Target Groups for Priority Vaccination if Vaccine Supplies are Limited

Pregnant women

Individuals who live with or provide care for infants <6 months of age (e.g., parents, siblings, day-care providers)

Health-care and emergency medical services personnel who have direct contact with patients or infectious materials

Children 6 months through 4 years of age

Children and adolescents 5–18 years of age who have medical conditions that put them at higher risk for influenza complications, including chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, cognitive, neurologic/neuromuscular, hematologic, or metabolic (including diabetes mellitus) disorders

Live intranasal influenza A (H1N1) 2009 vaccine may be used for prevention of 2009 influenza A (H1N1) virus infection in some (but not all) of the target groups identified for priority vaccination.1 Based on current prescribing information, live intranasal vaccine can be used in the following target groups identified for priority vaccination, unless contraindicated: otherwise healthy individuals 2 through 49 years of age who live with or provide care for infants <6 months of age (e.g., parents, siblings, day-care providers), otherwise healthy health-care and emergency services personnel through 49 years of age, and otherwise healthy individuals 2 through 24 years of age.1 Based on current prescribing information, parenteral inactivated influenza A (H1N1) 2009 vaccine can be used in any of the target groups identified for priority vaccination, unless contraindicated.3 5 17

Safety and efficacy of intranasal live influenza A (H1N1) vaccine have not been established in children <2 years of age or in adults ≥50 years of age.1

Safety of intranasal live influenza A (H1N1) vaccine has not been established in individuals with underlying medical conditions that may predispose them to influenza complications.1 (See Individuals with Medical Conditions that Increase Risk of Influenza Complications under Cautions.) In addition, only limited data are available regarding safety and efficacy of this vaccine in immunocompromised individuals,1 and live vaccines usually are not recommended in such individuals.19 (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.)

Information regarding influenza surveillance and updated recommendations for prevention and treatment of 2009 influenza A (H1N1) virus infection is available at . CDC information on treatment and prevention of seasonal influenza is available at .

Influenza A (H1N1) 2009 Monovalent Vaccine Live Dosage and Administration

Administration

Intranasal Administration

Administer intranasally using the prefilled, single-use sprayer supplied by the manufacturer.1

Do not administer IM, IV, or intradermally.1

Do not mix with any other vaccine or solution.19

Intranasal live influenza A (H1N1) 2009 vaccine must be administered by a health-care provider.1

Place recipient in an upright position.1 Administer approximately one-half the contents of the prefilled, single-use sprayer into each nostril.1 Consult manufacturer’s labeling for specific information regarding use of the sprayer.1

After administering vaccine, carefully dispose of the sprayer (i.e., discard using standard procedures for medical waste).1

May be administered simultaneously with other age-appropriate vaccines.49 However, simultaneous administration of intranasal live influenza A 2009 (H1N1) vaccine and seasonal intranasal live influenza vaccine is not recommended.27 49 (See Interactions.)

ACIP has identified specific target groups who should receive influenza A (H1N1) 2009 vaccine beginning as soon as initial supplies become available in October, unless contraindicated.27 These individuals are at higher risk for influenza or influenza-related complications, are likely to come in contact with influenza viruses as part of their occupation and could transmit influenza viruses to others in medical care settings, or are close contacts of infants too young to be vaccinated (<6 months of age).27 (See Uses.)

Dosage

Clinical studies are ongoing to determine the optimal dosage, number of doses, and vaccination schedule for intranasal live influenza A (H1N1) 2009 monovalent vaccine.1 27 44 The following dosages are based on available data to date.1

A single-dose regimen is recommended for adults and children ≥10 years of age.1 A 2-dose regimen is recommended for children 2 through 9 years of age.1

A single dose consists of the entire contents of the sprayer (0.2 mL).1

Pediatric Patients

Prevention of 2009 Influenza A (H1N1) Virus Infection
Children 2 through 9 Years of Age
Intranasal

2 doses administered approximately 1 month apart.1 Each dose consists of 0.2 mL (0.1 mL in each nostril).1

Children and Adolescents 10 through 17 Years of Age
Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).1

Adults

Prevention of 2009 Influenza A (H1N1) Virus Infection
Adults 18 through 49 Years of Age
Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).1

Special Populations

Hepatic Impairment

No specific dosage recommendations.1

Renal Impairment

No specific dosage recommendations.1

Geriatric Patients

Not indicated in adults ≥50 years of age, including geriatric adults.1 (See Geriatric Use under Cautions.)

Cautions for Influenza A (H1N1) 2009 Monovalent Vaccine Live

Contraindications

  • History of hypersensitivity (especially anaphylactic reactions) to egg or egg proteins, gentamicin, gelatin, or arginine.1

  • Life-threatening reaction to previous dose of any influenza vaccine.1

  • Children and adolescents 2–17 years of age receiving aspirin or aspirin-containing therapy, because of association of Reye's syndrome with aspirin use and wild-type influenza infection.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylactic reaction, facial edema, urticaria) reported with seasonal intranasal live influenza vaccine.1

Intranasal live influenza A (H1N1) 2009 vaccine is produced using eggs (the same process used for manufacture of seasonal intranasal live influenza vaccine)1 11 19 49 and can contain residual egg protein that may induce immediate hypersensitivity reactions, including anaphylaxis, in individuals with severe egg allergy.11 19 49 CDC and ACIP state that asking patients if they can eat eggs without adverse effects is a reasonable way to identify those who may be at risk for allergic reactions if they receive the vaccine.11 19 49 Those who can eat eggs or egg products safely usually can receive vaccines produced using chicken eggs;19 those with a history of anaphylactic or other immediate hypersensitivity reaction (e.g., hives, angioedema, allergic asthma) to eggs or egg proteins should not receive such vaccines.1 11 19 (See Contraindications under Cautions.)

Appropriate medical treatment and supervision must be readily available in case anaphylaxis occurs.1

Do not administer additional vaccine doses to any individual who had a life-threatening reaction to a previous dose.1 (See Contraindications under Cautions.)

Ongoing Safety Review

Safety and adverse effects reported with intranasal live influenza A (H1N1) 2009 vaccine are expected to be similar to those reported for seasonal intranasal live influenza vaccine (e.g., runny nose/nasal congestion, decreased appetite, irritability, lethargy, sore throat, fever, headache, muscle aches, chills).1 44 However, as with any medical product, serious adverse events may occur.44

FDA and CDC are closely monitoring safety of influenza A (H1N1) 2009 vaccines through a collaborative effort between CDC, US Department of Health and Human Services (HHS), and other government agencies.44 Only limited data are available to date regarding adverse effects reported with influenza A (H1N1) 2009 vaccine.44 (See Common Adverse Effects.)

Infants <24 Months of Age

Do not use in infants <24 months of age;1 increased risk of wheezing and hospitalization reported in clinical trials with seasonal intranasal live influenza vaccine in this age group.1 (See Pediatric Use under Cautions.)

Individuals with Asthma or Recurrent Wheezing

Do not use in individuals with asthma or in children <5 years of age with history of recurrent wheezing unless potential benefits outweigh risks;1 increased risk of wheezing in such individuals.1 (See Pediatric Use under Cautions.)

Do not use in individuals with severe asthma or active wheezing; not evaluated to date in such individuals.1

Guillain-Barré Syndrome

Carefully consider possible benefits and potential risks of intranasal live influenza A (H1N1) 2009 vaccine in individuals who experienced Guillain-Barré syndrome (GBS) within 6 weeks of any previous influenza vaccination.1

Unclear whether influenza vaccination increases risk of recurrence of GBS.11 14 AAP states that influenza vaccines should not be used in children who developed GBS within 6 weeks after a previous dose of any influenza vaccine.14 ACIP states that, as a precaution, individuals who are not at high risk for severe influenza complications and who developed GBS within 6 weeks of a previous dose of influenza vaccine generally should avoid influenza vaccination.11 Although data are limited, ACIP states that use of influenza vaccine can be considered in individuals with a history of GBS who are at high risk for severe complications from influenza.11

Individuals with Altered Immunocompetence and Their Close Contacts

Carefully consider possible benefits and potential risks in immunocompromised individuals.1 Only limited data available regarding safety and efficacy of intranasal live influenza vaccine in immunocompromised individuals (e.g., HIV-infected individuals).1

ACIP states live viral vaccines (including intranasal live influenza vaccine) usually should not be used in immunocompromised individuals, except in certain circumstances.19 These experts state use of live virus vaccines can be considered in patients with leukemia, lymphoma, or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.19 (See Specific Drugs under Interactions.)

In recommendations regarding seasonal influenza, CDC, National Institutes of Health (NIH), IDSA, AAP, and other experts state that HIV-infected children, adolescents, and adults should be vaccinated against influenza; however, the parenteral inactivated influenza vaccine (not the intranasal live vaccine) should be used in HIV-infected individuals.14 26 28

Because intranasal influenza A (H1N1) 2009 vaccine is a live viral vaccine, the vaccine virus potentially could be transmitted to immunocompromised close contacts.1 In recommendations regarding seasonal intranasal live influenza vaccine, ACIP states the intranasal live vaccine should not be administered to close contacts of severely immunocompromised individuals requiring a protective environment (e.g., hematopoietic stem cell transplant [HSCT] recipients); however, ACIP states that the vaccine may be administered to close contacts of less severely immunocompromised individuals (e.g., those not requiring a protective environment).11 In addition, ACIP states that health-care workers who have received the intranasal live vaccine should avoid contact with severely immunocompromised patients requiring a protective environment (e.g., HSCT recipients) for 7 days after vaccination; hospital visitors who have received the vaccine should avoid contact with severely immunosuppressed patients for 7 days after vaccination but may visit patients who are not severely immunosuppressed.11

Individuals with Medical Conditions that Increase Risk of Influenza Complications

Safety not established in individuals with underlying medical conditions that increase risk for complications following wild-type influenza infection.1 Individuals at increased risk of influenza complications include those with chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, cognitive, neurologic/neuromuscular, hematologic, metabolic (including diabetes mellitus) disorders, and immunodeficiency.11 14 Do not use in these individuals unless possible benefits outweigh risks.1 (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.)

Individuals with a History of Influenza

May be administered to individuals who have had an influenza-like illness.46 49 The vaccine is not harmful in individuals who previously had diagnosed or undiagnosed influenza illness, including 2009 influenza A (H1N1) infection,46 49 and is not harmful in individuals who already have some existing immunity to the 2009 influenza A (H1N1) virus.49

If influenza A (H1N1) 2009 vaccine is indicated (see Uses), CDC recommends that the vaccine be administered even in individuals who have had an influenza-like illness previously, unless such individuals had a confirmed diagnosis of 2009 influenza A (H1N1) infection based on results of a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test for 2009 influenza A (H1N1) virus.46 49 Individuals who had an influenza-like illness and were tested using a less specific test (e.g., rapid antigen detection assay) should not assume they had 2009 influenza A (H1N1) infection, even if they became ill after being exposed to an individual with confirmed 2009 influenza A (H1N1) infection.49

Transmission of Vaccine Virus

Intranasal influenza A (H1N1) 2009 vaccine contains live, attenuated virus.1 Studies using seasonal intranasal live influenza vaccine indicate that vaccine virus capable of infection and replication is present in nasal secretions of vaccine recipients and viral shedding can occur in adults and children who receive the intranasal live vaccine.1

Relationship between vaccine virus replication in vaccine recipients and transmission of vaccine virus to other individuals not established.1 Transmission of vaccine virus has occurred rarely between recipients of seasonal intranasal live influenza vaccine and their contacts.1

Duration of vaccine virus replication and shedding in vaccine recipients not established.1

Limitations of Vaccine Effectiveness

Studies using seasonal influenza vaccines indicate up to 2 weeks may be required for protection to develop following influenza vaccination.11 Preliminary studies using parenteral inactivated influenza A (H1N1) 2009 vaccine indicate an immune response can occur as early as 8–10 days after vaccination.51

May not protect all vaccine recipients against 2009 influenza A (H1N1) virus infection.1

Does not provide protection against seasonal influenza A and B viruses;27 seasonal influenza vaccines for the 2009–2010 influenza season are indicated to provide protection against seasonal influenza.11 27 46

Duration of Immunity

Studies using seasonal influenza vaccines indicate that immunity declines during the year after influenza vaccination.11 Data are not available to date regarding the duration of protection following vaccination with intranasal live influenza A (H1N1) 2009 vaccine.

Concomitant Illness

ACIP states that minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever), generally does not preclude vaccination.11 19

Improper Storage and Handling

Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.19

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.18 19

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.1 19 (See Storage under Stability.) If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.18 19

Specific Populations

Pregnancy

Category C.1

Manufacturer states that intranasal live influenza A (H1N1) 2009 vaccine should be used in pregnant women only when clearly needed.1

CDC, ACIP, American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), NIH, IDSA, and other experts state that parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) should be used in pregnant women.11 19 22 26 46

Because pregnant women are at risk for influenza complications, CDC and ACIP recommend that pregnant women receive priority vaccination against influenza A (H1N1) virus infection, unless contraindicated.27 46 (See Uses.)

Lactation

Not known whether intranasal live influenza A (H1N1) 2009 vaccine is distributed into milk.1 Manufacturer recommends caution.1

In recommendations regarding seasonal influenza vaccine, ACIP states that either intranasal live influenza vaccine or parenteral inactivated influenza vaccine can be used in nursing women, unless contraindicated.11 ACIP and CDC state that breastfeeding does not adversely affect immune response and is not a contraindication to vaccination.11 19

Pediatric Use

Safety and efficacy established only in children ≥2 years of age.1

Not indicated in infants <24 months of age.1 In a clinical trial evaluating seasonal intranasal live influenza vaccine, increased incidence of wheezing and hospitalization reported in infants 6–23 months of age compared with those who received parenteral inactivated influenza vaccine.1

Do not use in children with asthma or in children <5 years of age with a history of recurrent wheezing or a recent wheezing episode.1 11 14

In recommendations regarding seasonal intranasal live influenza vaccine, ACIP and AAP state that when considering use in children 2 through 4 years of age clinicians should screen for possible reactive airways diseases by consulting the child's medical record and asking the child's parent or guardian if wheezing or asthma episodes were identified by a health-care provider within the past 12 months.11 14 These experts recommended that parenteral inactivated influenza vaccine be used instead of intranasal live vaccine in such children.11 14

Because influenza A (H1N1) 2009 vaccine is not indicated in infants <6 months of age and because these infants are at risk for influenza and influenza-related complications, ACIP recommends that household and other close contacts (e.g., day-care providers) of infants <6 months of age receive priority vaccination with influenza A (H1N1) 2009 vaccine using a vaccine appropriate for their age and target group since this may provide some protection for these young infants.27

Adults 50–64 Years of Age

Not indicated for use in adults 50–64 years of age.1 Efficacy not demonstrated in adults 50–64 years of age.1 The parenteral inactivated vaccine is indicated for prevention of 2009 influenza A (H1N1) virus in this age group.3 5 17

Geriatric Use

Not indicated for use in geriatric individuals ≥65 years of age.1 The parenteral inactivated vaccine is indicated for prevention of 2009 influenza A (H1N1) virus in geriatric adults.3 5 17

Common Adverse Effects

Only limited data available to date regarding adverse effects of intranasal live influenza A (H1N1) 2009 vaccine.44 (See Ongoing Safety Review under Cautions.) Adverse effects expected to be similar to those reported with seasonal intranasal live influenza vaccine.44

Most common adverse effects reported with seasonal intranasal live influenza vaccine are runny nose/nasal congestion, decreased appetite, irritability, lethargy, abdominal pain, sore throat, fever, headache, muscle aches, decreased activity, and chills in children 2–17 years of age1 and runny nose, headache, sore throat, tiredness/weakness, muscle aches, cough, chills, nasal congestion, and sinusitis in adults 18–49 years of age.1

Interactions for Influenza A (H1N1) 2009 Monovalent Vaccine Live

Inactivated Vaccines and Toxoids

Safety and immunogenicity of intranasal live influenza A (H1N1) 2009 vaccine administered concomitantly with age-appropriate inactivated vaccines not determined to date.1 Manufacturer states risks versus benefits of concomitant administration of the intranasal live influenza A (H1N1) 2009 vaccine and inactivated vaccines should be considered.1

CDC states that intranasal live influenza A (H1N1) 2009 vaccine may be administered concomitantly with or at any time before or after inactivated vaccines, including seasonal parenteral inactivated influenza vaccine.49

Live Vaccines

CDC and ACIP state that intranasal live influenza A (H1N1) 2009 monovalent vaccine and seasonal intranasal live influenza vaccine should not be administered simultaneously.27 49 If an individual is eligible for and prefers the intranasal live formulations of the seasonal influenza vaccine and the influenza A (H1N1) vaccine, the live vaccines should be administered at least 4 weeks apart.49

In recommendations regarding seasonal intranasal live influenza vaccine, ACIP and AAP state that intranasal live influenza vaccine and other live vaccines generally may be administered simultaneously on the same day.11 14 19 CDC states that, with the exception of seasonal intranasal live influenza vaccine, intranasal live influenza A (H1N1) 2009 vaccine may be administered concomitantly with other live vaccines.49

Specific Drugs

Drug

Interaction

Comments

Antiviral agents active against influenza (amantadine, rimantadine, oseltamivir, zanamivir)

Concomitant use of intranasal live influenza A (H1N1) 2009 vaccine and antivirals used for treatment or prevention of influenza not studied;1 these antivirals potentially could decrease response to live influenza vaccine1 11

Do not administer intranasal live influenza A (H1N1) 2009 vaccine until at least 48 hours after influenza antiviral agent is discontinued; do not administer influenza antiviral agent until at least 2 weeks after the vaccine, unless medically necessary1

If influenza antiviral agent and intranasal live influenza A (H1N1) 2009 vaccine are administered concomitantly, consider revaccination if appropriate;1 in recommendations regarding seasonal intranasal live influenza vaccine, ACIP recommends revaccination if an influenza antiviral was given 2 days before to 14 days after vaccination11

Aspirin

Association of Reye's syndrome with aspirin and wild-type influenza infection 1

Intranasal live influenza A (H1N1) 2009 vaccine is contraindicated in children and adolescents receiving aspirin or aspirin-containing therapy1

Blood products

Live vaccines may be administered simultaneously with or at any time before or after whole blood, packed red blood cells, plasma, and platelet products without substantially decreasing antibody response to the vaccine19

Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific immune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])

No evidence that immune globulin preparations interfere with immune response to live vaccines19

Live vaccines may be given simultaneously with or at any interval before or after immune globulin preparations19

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)

Potential for decreased antibody response to live influenza vaccine and increased risk of adverse reactions19

ACIP and AAP state live viral vaccines should not be used in those receiving immunosuppressive therapy14 19

Optimum interval between discontinuance of immunosuppressive therapy and subsequent administration of a live viral vaccine has not been determined19

Live viral vaccines generally should not be administered for at least 3 months after discontinuance of immunosuppressive therapy, including chemotherapy or radiation for leukemia, other hematopoietic malignancies, or solid tumors, or after solid organ transplant 19

Systemic corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive;19 delay administration of live vaccines for at least 1 month after such therapy is discontinued19

Corticosteroid therapy involving short-term (<2 weeks), low- to moderate-dose systemic therapy (<20 mg prednisone or equivalent daily); long-term, alternate-day systemic therapy using short-acting drugs; maintenance physiologic doses (replacement therapy); topical therapy (e.g., cutaneous, ophthalmic); inhalation; or intra-articular, bursal, or tendon injections should not be immunosuppressive and does not usually contraindicate use of live vaccines19

Influenza vaccine (seasonal)

Seasonal intranasal live influenza vaccine: Data not available regarding concomitant administration with intranasal live influenza A (H1N1) 2009 vaccine;1 CDC and ACIP state simultaneous administration not recommended;27 49 if an individual is eligible for and prefers the intranasal live formulations of the seasonal vaccine and the influenza A (H1N1) vaccine, these vaccines should be administered at least 4 weeks apart 49

Seasonal parenteral inactivated influenza vaccine: Data not available regarding concomitant administration with intranasal live influenza A (H1N1) 2009 vaccine;1 CDC states intranasal live influenza A (H1N1) vaccine may be administered simultaneously with or at any time before or after seasonal parenteral inactivated influenza vaccine49

Intranasal preparations

Concomitant administration not evaluated1

Measles, mumps, and rubella vaccine live (MMR)

Studies using seasonal intranasal live influenza vaccine indicate simultaneous administration with MMR live and monovalent varicella vaccine in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 11 25 safety and immunogenicity of simultaneous administration not evaluated in infants >15 months of age1

In recommendations regarding seasonal intranasal live influenza vaccine, ACIP and AAP state that, if not given simultaneously with intranasal live influenza vaccine, give at least 4 weeks apart whenever possible11 14 19

Rotavirus vaccine live (RV)

Studies using seasonal intranasal live influenza vaccine indicate no evidence to date of reduced antibody responses if oral rotavirus vaccine live is administered concomitantly with the vaccine19

In recommendations regarding seasonal intranasal live influenza vaccine, ACIP states may be administered concomitantly with or at any interval before or after intranasal live influenza vaccine19

Varicella vaccine live (VAR)

Studies using seasonal intranasal live influenza vaccine indicate simultaneous administration with monovalent varicella vaccine live and MMR vaccine live in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 11 25 safety and immunogenicity of concomitant administration not evaluated in infants >15 months of age1

In recommendations regarding seasonal intranasal live influenza vaccine, ACIP and AAP state that, if not given simultaneously with intranasal live influenza vaccine, give at least 4 weeks apart whenever possible11 14 19

Stability

Storage

Intranasal Spray

Suspension

2–8°C; do not freeze.1

Does not contain thimerosal or any other preservatives.1

Actions

  • Intranasal live influenza A (H1N1) 2009 vaccine that is used for prevention of infections caused by 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus, is a monovalent vaccine containing live, attenuated (cold-adapted) influenza virus type A (H1N1).1 11

  • Intranasal live influenza A (H1N1) 2009 vaccine is a colorless to pale yellow liquid and may be clear to slightly cloudy.1

  • Intranasal live influenza A (H1N1) 2009 vaccine commercially available in the US is prepared from specific pathogen-free eggs inoculated with the reassortant virus strain, incubated to allow vaccine virus replication, and then harvested from allantoic fluids of these eggs infected with the live virus.1 The monovalent intranasal live influenza A (H1N1) 2009 vaccine is manufactured using the same methods used for the manufacture of trivalent seasonal intranasal live influenza vaccine.1 27

  • Influenza vaccines stimulate active immunity to influenza virus strains represented in the vaccines.1 Intranasal live influenza A (H1N1) 2009 vaccine commercially available in the US contains A/California/7/2009 (H1N1)v-like virus,1 10 11 the virus selected by the FDA and WHO to represent circulating strains of 2009 pandemic influenza A (H1N1).27 Between May and September 2009, the majority of influenza viruses circulating in the US were the 2009 influenza A (H1N1) strain, and all isolates of the virus characterized at the CDC were antigenically related to the virus strain chosen for the influenza A (H1N1) 2009 monovalent vaccine.42

  • Studies are ongoing to evaluate the immunologic response to intranasal live influenza A (H1N1) 2009 vaccine and efficacy of the vaccine for prevention of 2009 influenza A (H1N1) infection.44

  • Following administration of intranasal live influenza A (H1N1) 2009 vaccine, vaccine virus replicates in cells lining the nasopharynx to induce protective immunity.1

Advice to Patients

  • Prior to administration, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).

  • Advise patient and/or patient's parent or guardian of the risks and benefits of vaccine administration.1

  • Advise patient and/or patient's parent or guardian that intranasal live influenza A (H1N1) 2009 vaccine is a live, attenuated virus vaccine and that vaccine virus can be transmitted to close contacts.1 (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.)

  • Advise patients that influenza A (H1N1) 2009 vaccine, formulated to provide protection against 2009 pandemic influenza A (H1N1) infections, and seasonal influenza vaccine 2009–2010, formulated to provide protection against seasonal influenza A and B viruses, are available for prevention of influenza and that both vaccines may be indicated in some individuals.11 27 (See Uses.)

  • Advise patients that influenza vaccines only provide protection against illness due to influenza viruses represented in the vaccines and cannot provide protection against all respiratory illness.1

  • Advise patient and/or patient's parent or guardian that a single dose is recommended in adults, adolescents, and children ≥10 years of age, but that 2 doses are recommended in children 2 through 9 years of age.1

  • Ask patient and/or patient's parent or guardian if vaccinee has a history of asthma or recurrent wheezing.1 Advise patient's parent or guardian that a history of recurrent wheezing may be an asthma equivalent in children <5 years of age.1 (See Pediatric Use under Cautions.)

  • Importance of informing clinicians of adverse effects.1 Clinicians or individuals can report any adverse reactions that occur following vaccination to the manufacturer at 877-633-4411 or Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant medical problems (i.e., asthma, recurrent wheezing, GBS).1

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Influenza A (H1N1) 2009 monovalent vaccine is supplied through a centralized distribution system to designated providers (e.g., hospitals, clinics, physician offices, health departments) and is not available directly from the manufacturers.49 State/local public health departments are responsible for identifying and designating providers, facilitating vaccine orders, and allocating and directing the flow of vaccine to providers within each state.49 Consult the CDC website () and state/local health authorities for additional information.49

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension

106.5-7.5 FFU (fluorescent focus units) of A/California/7/2009 (H1N1)v per 0.2 mL*

Influenza A (H1N1) 2009 Monovalent Vaccine Live (preservative-free; available in 0.2-mL prefilled single-use sprayers)

MedImmune

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2010, Selected Revisions October 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. MedImmune Vaccines. Influenza A (H1N1) 2009 monovalent vaccine live, intranasal prescribing information. Gaithersburg, MD; 2009 Sep.

3. Novartis Vaccines and Diagnostics. Influenza A (H1N1) 2009 monovalent vaccine prescribing information. Cambridge, MA; 2009 Sep.

5. Sanofi Pasteur Inc. Influenza A (H1N1) 2009 monovalent vaccine prescribing information. Swiftwater, PA; 2009 Sept.

10. Centers for Disease Control and Prevention (CDC). Update: influenza activity--United States, September 28, 2008-April 4, 2009, and composition of the 2009-10 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2009; 58:369-74. [PubMed 19373198]

11. Fiore AE, Shay DK, Broder K et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009; 58:1-52. [PubMed 19644442]

12. GlaxoSmithKline Biologicals. Fluarix (influenza virus vaccine 2009-2010 formula) prescribing information. Research Triangle Park, NC; 2009 Jul.

13. Ohmit SE, Victor JC, Rotthoff JR et al. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med. 2006; 355:2513-22. [PubMed 17167134]

14. Committee on Infectious Diseases. Policy Statement--Recommendations for the Prevention and Treatment of Influenza in Children, 2009-2010. Pediatrics. 2009; :.

15. GlaxoSmithKline Biologicals. FluLaval (influenza virus vaccine 2009-2010 formula) prescribing information. Research Triangle Park, NC; 2009 Jul.

16. . Recommended composition of influenza virus vaccines for use in the 2009-2010 influenza season (northern hemisphere winter). Wkly Epidemiol Rec. 2009; 84:65-72. [PubMed 19248288]

17. CSL Biotherapies. Influenza A (H1N1) 2009 monovalent vaccine prescribing information. King of Prussia, PA; 2009 Sep.

18. Centers for Disease Control and Prevention. Vaccine management: recommendations for storage and handling of selected biologicals. 2007 Nov. From CDC website. Accessed 2008 Apr 7.

19. Kroger AT, Atkinson WL, Marcuse EK et al. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006; 55:1-48. [PubMed 17136024]

20. Centers for Disease Control and Prevention. Live, intranasal influenza vaccine information statement. 2009 Aug 11. From CDC website. Accessed 2009 Aug 25.

22. Centers for Disease Control and Prevention. Recommended adult immunization schedule—United States, 2009. MMWR Morb Mortal Wkly Rep. 2009; 57:Q1-4.

23. Centers for Disease Control and Prevention. Interim within-season estimate of the effectiveness of trivalent inactivated influenza vaccine- Marshfield, Wisconsin, 2007–08 influenza season. MMWR Morb Mortal Wkly Rep. 2008; 57(15):1–32.

24. Centers for Disease Control and Prevention. Health information for international travel, 2010. Atlanta, GA: US Department of Health and Human Services; 2010. Updates available from CDC website.

25. Nolan T, Bernstein DI, Block SL et al. Safety and immunogenicity of concurrent administration of live attenuated influenza vaccine with measles-mumps-rubella and varicella vaccines to infants 12 to 15 months of age. Pediatrics. 2008; 121:508-16. [PubMed 18310199]

26. Kaplan JE, Benson C, Holmes KH et al. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2009; 58:1-207; quiz CE1-4. [PubMed 19357635]

27. National Center for Immunization and Respiratory Diseases, CDC, Centers for Disease Control and Prevention (CDC). Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009; 58:1-8.

28. Mofenson LM, Brady MT, Danner SP et al. Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. MMWR Recomm Rep. 2009; 58:1-166. [PubMed 19730409]

30. World Health Organization. WHO guidelines for pharmacological management of pandemic (H1N1) 2009 influenza and other influenza viruses. 20 August 2009. From WHO website. Accessed 2009 Sept 10.

31. Centers for Disease Control and Prevention (CDC). Update: swine influenza A (H1N1) infections--California and Texas, April 2009. MMWR Morb Mortal Wkly Rep. 2009; 58:435-7. [PubMed 19407739]

32. Centers for Disease Control and Prevention (CDC). Swine-origin influenza A (H1N1) virus infections in a school - New York City, April 2009. MMWR Morb Mortal Wkly Rep. 2009; 58:470-2. [PubMed 19444151]

33. Centers for Disease Control and Prevention (CDC). Outbreak of swine-origin influenza A (H1N1) virus infection - Mexico, March-April 2009. MMWR Morb Mortal Wkly Rep. 2009; 58:467-70. [PubMed 19444150]

34. Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team, Dawood FS, Jain S et al. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009; 360:2605-15. [PubMed 19423869]

35. Harper SA, Bradley JS, Englund JA et al. Seasonal influenza in adults and children--diagnosis, treatment, chemoprophylaxis, and institutional outbreak management: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2009; 48:1003-32. [PubMed 19281331]

36. US Department of Health and Human Services. Pandemic flu information. From HHS website.

37. United States Department of Health and Human Services Food and Drug Administration. FDA Pandemic Influenza Preparedness Strategic Plan. March 17, 2008. From FDA website.

38. World Health Organization. Pandemic influenza preparedness and response WHO guidance document. April 2009. From WHO website. Accessed 2009 Sept 14.

39. Hancock K, Veguilla V, Lu X et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med. 2009; 361: ;

40. Greenberg ME, Lai MH, Hartel GF et al. Response after One Dose of a Monovalent Influenza A (H1N1) 2009 Vaccine -- Preliminary Report. N Engl J Med. 2009; : . [PubMed 19745216]

41. Neuzil KM. Pandemic Influenza Vaccine Policy -- Considering the Early Evidence. N Engl J Med. 2009; :. [PubMed 19745213]

42. Centers for Disease Control and Prevention. Update: Influenza activity–United States, April–August 2009. MMWR Morb Mortal Wkly Rep. 2009; 58:1009-12. [PubMed 19763079]

43. Centers for Disease Control and Prevention (CDC). Surveillance for pediatric deaths associated with 2009 pandemic influenza A (H1N1) virus infection - United States, April-August 2009. MMWR Morb Mortal Wkly Rep. 2009; 58:941-7. [PubMed 19730406]

44. Food and Drug Administration. Influenza A (H1N1) 2009 monovalent vaccines questions and answers. From FDA website. Accessed 2009 Sep 18.

45. US Department of Health & Human Services. HHS pandemic influenza plan. From HHS website. Accessed 2009 Sep 12.

46. Centers for Disease Control and Prevention. 2009 H1N1 influenza vaccine and pregnant women. September 18, 2009. From CDC website.

47. Garten RJ, Davis CT, Russell CA et al. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science. 2009; 325:197-201. [PubMed 19465683]

48. . New influenza A (H1N1) virus: global epidemiological situation, June 2009. Wkly Epidemiol Rec. 2009; 84:249-57. [PubMed 19537358]

49. Centers for Disease Control and Prevention. H1N1 clinicians questions and answers. September 21, 2009. From CDC website.

50. Centers for Disease Control and Prevention. Updated interim recommendations for the use of antiviral medications in the treatment and prevention of influenza for the 2009–2010 season. From CDC website. Accessed 2009 Sept 10.

51. National Institute of Allergy and Infectious Diseases (NIAID). Early results: in children, 2009 H1N1 influenza vaccine works like seasonal flu vaccine. Sept 21, 2009. From NIAID website.

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