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Please see full Prescribing Information for Fluzone® High-Dose (Influenza Vaccine), Flublok® (Influenza Vaccine), and Fluzone® (Influenza Vaccine).

Flublok Quadrivalent Influenza Vaccine ACIP RECOMMENDED
IN ADULTS AGED 18+

FLUBLOK: THE FIRST AND ONLY RECOMBINANT INFLUENZA VACCINE PROVEN TO HELP PREVENT INFLUENZA AND DEMONSTRATED TO REDUCE ITS COMPLICATIONS2,3*

*Flublok (quadrivalent) was proven to prevent more flu in older adults than Fluarix (quadrivalent standard-dose vaccine). The efficacy of Flublok (quadrivalent) is relevant to Flublok (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions.2


Flublok is a vaccine indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and influenza type B virus represented by antigens contained in the vaccine. Flublok is approved for use in persons 18 years of age and older.

RECOMBINANT TECHNOLOGY

Flublok combines the advantages of recombinant technology with a higher antigen dose3,4

Flu virus icon

AN EXACT STRAIN MATCH

The only recombinant flu vaccine that has a known and exact antigen content, Flublok ensures identical antigen match with WHO- and FDA-selected flu strains.4,5

DNA icon

Avoids Mutations

Cell- and egg-based flu vaccines have the potential to develop mutations during production, which may reduce their effectiveness.4

Shield icon

MAY PROVIDE CROSS PROTECTION

Recombinant technology leads to a broader immune response that may provide cross-protection, even in a mismatch season.4*

3x

3x THE ANTIGEN

In addition to its characteristics born of recombinant technology, Flublok also contains 3x the hemagglutinin (HA) antigen content of standard-dose flu vaccines, which has been associated with higher immunogenicity when compared to standard-dose flu vaccines.1-3†

Syringe icon

MAY INDUCE A MORE ROBUST ANTIBODY RESPONSE

According to a study published by the CDC in January 2024, vaccination with a higher-dose recombinant flu vaccine may induce a more robust antibody response than egg-based standard-dose flu vaccines.6

Flublok (quadrivalent) was evaluated in the pivotal trial against Fluarix (quadrivalent standard-dose vaccine). The efficacy of Flublok (quadrivalent) is relevant to Flublok (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions.2

*Flublok is produced using a novel production platform in which recombinant HA is expressed in insect cells using a baculovirus expression vector system (BEVS). Recombinant HA antigens produced using BEVS have been shown to induce significantly higher levels of broadly cross-reactive antibodies against highly conserved regions of HA compared to egg-derived vaccines, which may provide the potential for protection against drift-variant influenza viruses.4

†Flublok contains 45 micrograms (mcg) of HA per strain vs 15 mcg of HA per strain in a standard-dose influenza vaccine.1-3

CDC=Centers for Disease Control and Prevention; FDA=US Food and Drug Administration; WHO=World Health Organization.

CROSS-PROTECTION MAY BE A RESULT OF SIMPLER GLYCOSYLATION because recombinant DNA technology allows for broader access to conserved antigenic sites4

Glycosylation occurs during viral replication and in the vaccine manufacturing process, blocking access to antigenic sites on HA proteins, which are necessary for developing an immune response. Complex glycosylation interferes with antigenic site access.4,7

GLYCOSYLATION WITH TRADITIONAL IIV TECHNOLOGY4

More complex glycosylation makes it more difficult for HA proteins to bind to antigenic sites

Glycosylation with traditional IIV technology
Blue Circles = carbohydrates
Glycosylation with traditional IIV technology

VS

GLYCOSYLATION WITH RECOMBINANT DNA TECHNOLOGY4

With less complex glycosylation, there is more accessibility to antigenic sites on HA proteins

Glycosylation with recombinant DNA technology
Stalk Image = HA protein amino acids
Glycosylation with recombinant DNA technology

Graphical representation is for illustrative purposes only.

FDA=US Food and Drug Administration; HA=hemagglutinin; WHO=World Health Organization.

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HOW IT'S MADE

RECOMBINANT DNA TECHNOLOGY ELIMINATES THE NEED TO GROW INFLUENZA VIRUS AND AVOIDS THE POSSIBILITY OF MUTATION OR ADAPTATION3

WHO-/FDA-Selected Strain Identified
WHO-/FDA-Selected Strain Identified
Adapt
Adapt
Replicate HA Gene
Replicate HA Gene
Infect Egg/Cell
Infect Egg/Cell
Recombine
Recombine
Grow
Grow
Translate rHA Antigen
Translate rHA Antigen
Inactivate & Purify
Inactivate & Purify
Harvest & Purify
Harvest & Purify
Inactivated Influenza Vaccine
Inactivated Influenza Vaccine
Recombinant Influenza Vaccine
Recombinant Influenza Vaccine

Graphical representation is for illustrative purposes only.
FDA=US Food and Drug Administration; HA=hemagglutinin; rHA=recombinant hemagglutinin; WHO=World Health Organization.

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EFFICACY STUDY

IN A RANDOMIZED, CONTROLLED TRIAL VS FLUARIX

30% RELATIVE REDUCTION IN PCR-CONFIRMED FLU IN ADULTS AGED 50+2,3

STUDY DESIGN

  • Phase 3-4 randomized, controlled trial in adults aged 50+ (N≈9,000) during the 2014-2015 influenza season in which A (H3N2) was predominant and antigenically mismatched2,3
  • Patients were randomized 1:1 to receive Flublok or Fluarix2,3*

*Flublok (quadrivalent) was proven to prevent more flu in older adults than Fluarix (quadrivalent standard-dose vaccine). The efficacy of Flublok (quadrivalent) is relevant to Flublok (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions.2

PROVEN TO HELP PREVENT MORE CASES OF THE FLU THAN FLUARIX IN ADULTS AGED 50+2,3

Flublok prevented more cases of influenza than Fluarix, satisfying the primary criterion for noninferiority and the prespecified exploratory superiority criterion.

Primary endpoint: 30% rVE with Flublok  vs SD (any PCR-confirmed strain in adults aged 50+)
Secondary endpoint: 43% rVE with Flublok  vs SD (any culture-confirmed strain in adults aged 50+)

CI=confidence interval; PCR=polymerase chain reaction.

SAFETY IN ADULTS

  • Comparable safety profile to a standard-dose quadrivalent inactivated influenza vaccine in adults aged 50+3
  • Most common adverse events (≥10%) in the Flublok group in adults aged 50-643:
    • Injection-site reactions: tenderness (37%), pain (32%)
    • Systemic adverse reactions: headache (17%), fatigue (13%), muscle pain (11%)
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EFFICACY

IN PATIENTS AGED 18-49 YEARS

FLUBLOK: EFFECTIVE FLU PROTECTION, EVEN IN A SEASON WITH SIGNIFICANT ANTIGENIC MISMATCH2,8

STUDY DESIGN

  • Randomized, observer-blind, placebo-controlled trial to evaluate the protective efficacy and safety of Flublok (trivalent) against influenza in 4648 adults aged 18-49 years2,8
  • The study was undertaken during the 2007-2008 influenza season when there was significant mismatch between vaccine antigens and circulating viruses8*
  • Primary endpoint: CDC-defined influenza-like illness (ILI) defined by presence of documented fever ≥100 °F plus either sore throat or cough with positive culture for an influenza virus strain antigenically resembling a strain represented in Flublok. Vaccine efficacy against antigenically matched culture-confirmed CDC-ILI could not be determined reliably because 96% of the influenza isolates obtained were not antigenically matched to the strains represented in the vaccine2
FLUBLOK WAS ASSOCIATED WITH PREVENTING CULTURE-CONFIRMED INFLUENZA DESPITE SIGNIFICANT ANTIGENIC MISMATCH BETWEEN THE VACCINE ANTIGENS AND CIRCULATING VIRUSES2

ADDITIONAL EFFICACY ENDPOINTS

44.6%
(95% CI: 18.8, 62.6)
FEWER FLU CASES WITH FLUBLOK
due to ANY culture-confirmed CDC-defined ILI strain, regardless of match to the vaccine2
44.8%
(95% CI: 24.4, 60.0)
FEWER FLU CASES WITH FLUBLOK
due to ANY culture-confirmed ILI strain, regardless of match to the vaccine2
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REAL-WORLD EVIDENCE

FLUBLOK WAS STUDIED AGAINST STANDARD-DOSE VACCINES IN THE LARGEST RANDOMIZED REAL-WORLD FLU EFFECTIVENESS STUDY TO DATE (N=1,630,328)9,10

STUDY DESIGN

  • Modified cluster randomized observational study to evaluate Flublok vs standard-dose influenza vaccines9*
  • Study population: 1,630,328 members of the Kaiser Permanente Northern California (KPNC) healthcare system aged 18-64 years9
  • Evaluated over 2 flu seasons: 2018-2019 influenza season, when A (H1N1) was predominant until March 2019, when A (H3N2) viruses became predominant; and the 2019-2020 influenza season, when A (H1N1) was predominant with B cocirculation11-13
  • Patients aged 50-64 with comorbid conditions: Asthma: 14% (96,307); diabetes: 18% (119,430); chronic obstructive pulmonary disease: 2% (13,357); coronary heart disease: 4% (25,496)9

*Flublok (quadrivalent) was proven to prevent more flu in older adults than quadrivalent standard-dose vaccines.9 The efficacy of Flublok (quadrivalent) is relevant to Flublok (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions.2

PRIMARY ENDPOINT

Estimated relative vaccine effectiveness (RVE) of Flublok vs standard-dose flu vaccines against PCR-confirmed influenza in patients aged 50-649

Flublok was associated with greater protection9

Primary endpoint: 15.3% rVE vs SD (PCR-confirmed flu in adults aged 50-64)

FLU VACCINES TYPICALLY PREVENT 40%-60% OF FLU CASES IN A MATCHED FLU SEASON9

STUDY LIMITATIONS9

  • Data was limited to two influenza seasons; relative vaccine effectiveness may vary across seasons depending on the vaccine match with circulating strains
  • Primary outcome did not include infections in persons who did not undergo PCR testing, which limits generalizability
  • Although KPNC has a diverse population, it may not be representative of other populations in the US
  • Compliance with the weekly assigned vaccine schedule varied from time to time due to logistical constraints
  • The study had limited power to detect a clinically meaningful benefit of Flublok vs standard-dose vaccines with less frequent outcomes, such as hospitalized, PCR-confirmed influenza

Flublok was associated with fewer influenza hospitalizations compared to standard-dose vaccines14

STUDY DESIGN

  • Retrospective test-negative case-control study in approximately 15,000 patients aged 18+ to investigate the rVE of Flublok vs standard-dose vaccines against influenza hospitalization14*
  • In the primary analysis, Flublok was evaluated against standard-dose flu vaccines, including14,15:
  • Egg-based: Fluarix, Afluria, Fluaval, and Fluzone
  • Cell-based: Flucelvax

*Flublok (quadrivalent vaccine) was evaluated against quadrivalent standard-dose vaccines. The efficacy of Flublok (quadrivalent formulation) is relevant to Flublok (trivalent formation) because both vaccines are manufactured using the same process and have overlapping compositions.2

FLUBLOK rVE vs STANDARD-DOSE FLU VACCINES WHEN ADJUSTED FOR PROPENSITY SCORES WITH IPWs:
31%
(95% CI: 11, 46)
FEWER INFLUENZA HOSPITALIZATIONS WITH FLUBLOK IN ADULTS AGED 18+14

Secondary Endpoints: When adjusted for propensity scores with inverse probability weights (IPWs):

  • Flublok was associated with providing greater protection against influenza hospitalization vs standard-dose vaccines for the following populations14:
  • Female sex: 37% rVE (95% CI: 13, 54)
  • Age 18-64 years: 28% rVE (95% CI: 3, 46)
  • No high-risk condition: 60% rVE (95% CI: 29, 78)
  • Flublok was associated with providing greater (non–statistically significant) protection against influenza hospitalization vs standard-dose vaccines for the following populations14:
  • Male sex: 23% rVE (95% CI: -14, 48)
  • Age ≥65 years: 17% rVE (95% CI: -36, 48)
  • High-risk condition: 20% rVE (95% CI: -7, 40)

STUDY STRENGTHS AND LIMITATIONS14

  • The demographics of the study population were representative of the adult population of Allegheny County, with 79% being white and 51% being female, which contributes to generalizability
  • The University of Pittsburgh Medical Center hospitals in central and southwestern Pennsylvania are part of an integrated health system, with regular uploads of vaccination data from the state immunization registry; vaccination status was verified through the state registry with a specific data request
  • Although the EMR system of University of Pittsburgh Medical Center hospitals in central and southwestern Pennsylvania is robust, if vaccinations were not captured in the EMRs or state registry, they were classified as unvaccinated
  • Because data focused on hospitalizations, there may have been milder cases of influenza that were not captured in the EMRs because they didn’t require medical care
  • There is a possibility of selection bias among those who received influenza testing; for instance, clinicians might preferentially test unvaccinated subjects, which would increase the proportion of unvaccinated cases
  • While a relatively large cohort of adults is included in this study, the sample size of standard-dose flu vaccine recipients may have been inadequate to detect meaningful rVE estimates for specific subgroups

2019-2020 RETROSPECTIVE OBSERVATIONAL COHORT STUDY:

FLUBLOK WAS ASSOCIATED WITH SIGNIFICANTLY FEWER INFLUENZA HOSPITAL ENCOUNTERS COMPARED WITH STANDARD-DOSE INFLUENZA VACCINES16

STUDY DESIGN

  • Retrospective observational cohort study using real-world data (RWD) from Medicare claims to analyze the rVE of US-licensed influenza vaccines in preventing influenza hospital encounters among beneficiaries aged 65+; 12.7 million adults aged 65+ were eligible for analysis16

RELATIVE VACCINE EFFECTIVENESS (RVE) AGAINST INFLUENZA HOSPITAL ENCOUNTERS (95% CI)16

COHORT
VS EGG-BASED STANDARD-DOSE
Cell-based quadrivalent
2.8%
-2.8
8.2
Recombinant quadrivalent
13.3%
7.4
18.9
High-dose trivalent
6.8%
3.3
10.1
Adjuvanted trivalent
8.2%
4.2
12.0
-4%
-2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
2019-2020 SEASON CHARACTERISTICS

Influenza A (H1N1) and influenza B (Victoria) were predominating strains with no significant circulation of influenza A (H3N2)16

An H1N1 strain with an amino acid change emerged late in the season and likely did not substantially affect the vaccine efficacy16

Trivalent vaccines contained the influenza B (Victoria) lineage16

Note: Bolding indicates statistical significance.

  • The data above represents 1 of 3 primary analyses. Two additional primary analyses were conducted16:
  • Cell-cultured standard-dose quadrivalent flu vaccine vs egg-based standard-dose quadrivalent flu vaccine
  • Flublok vs egg-based standard-dose quadrivalent flu vaccine
  • The efficacy of Flublok (quadrivalent) is relevant to Flublok (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions2

STUDY LIMITATIONS

  • Lack of access to virological case confirmation may have led to underestimation of the magnitude of differences16
  • Residual confounding by unmeasured covariates could have affected results16
  • The observation period was cut off at the end of February to avoid potential bias from the overlap between influenza season and the escalation of the COVID-19 pandemic in the US16

SAFETY PROFILE SUPPORTED IN ONE OF THE LARGEST SAFETY STUDIES OF A FLU VACCINE IN PREGNANT WOMEN, INCLUDING OVER 14,000 PATIENTS2,17,18

STUDY DESIGN

  • This was a postlicensure, observational, retrospective safety surveillance study of over 14,000 pregnant individuals, including those with chronic conditions. 14,981 pregnant patients were exposed to Flublok Quadrivalent during the 28 days prior to conception (date of conception defined as the date of the last menstrual period [Day 0] plus 14 days) or during pregnancy2
  • The study was conducted during Northern Hemisphere influenza seasons 2018-2019 and 2019-2020. Prespecified outcomes included spontaneous abortion and congenital/fetal anomalies. Data were not collected on ectopic pregnancy or elective terminations2
  • Among 14,981 recipients of Flublok Quadrivalent with known pregnancy outcomes, 750 pregnant individuals received the vaccine during the 28 days prior to conception, 5092 during the first trimester, 4851 during the second trimester, and 4288 during the third trimester2
  • Among 5842 individuals exposed to Flublok Quadrivalent during the 28 days prior to conception or during the first trimester, miscarriage was reported in 464 (3.1%). Among individuals exposed to Flublok Quadrivalent at any time during pregnancy, 1113 pregnancies (7.7%) had infants with major birth defects (56, 360, 381, and 316 among individuals exposed during the 28 days prior to conception, first trimester, second trimester, and the third trimester, respectively)2

*The data for Flublok (quadrivalent) are relevant to Flublok (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions.2

FLUBLOK Demonstrated no increased risk Of MAJOR BIRTH DEFECTS AND MISCARRIAGES 2dagger THESE DATA SUPPORT THE SAFETY PROFILE OF FLUBLOK

†Retrospective safety surveillance study showed no evidence of a vaccine-associated increase in the risk of major birth defects.2

FLUBLOK Demonstrated no increased risk Of MAJOR BIRTH DEFECTS AND MISCARRIAGES 2dagger THESE DATA SUPPORT THE SAFETY PROFILE OF FLUBLOK
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SAFETY

SIMILAR SAFETY PROFILE COMPARED TO STANDARD-DOSE FLU VACCINES2

ADULTS AGED 50-64: REACTIONS, ANY GRADE2

SOLICITED INJECTION-SITE REACTIONS

Pain
Firmness/ Swelling
Redness

SOLICITED SYSTEMIC ADVERSE REACTIONS

Headache
Fatigue
Muscle Pain
Joint Pain
Nausea
Shivering/Chills
Fever (≥100.4°F)
0%
20%
40%
60%
80%
100%
SAFETY IN ADULTS AGED 50-64: REACTIONS, ANY GRADE
  • Rates of local and systemic adverse reactions were similar within 7 days of Flublok (trivalent) or standard- dose influenza vaccine administration2
  • Pooled data from 2 studies; comparators were Fluzone (trivalent standard-dose formulation) and Afluria (trivalent standard-dose formulation)2
Flublok TIV (n=972)
Standard-dose TIV (n=967)
TIV=trivalent.

SAFETY PROFILE IN ADULTS AGED 18-49 COMPARED TO PLACEBO8

ADULTS AGED 18-49: REACTIONS, ANY GRADE2

SOLICITED INJECTION-SITE REACTIONS

Pain
Redness
Swelling
Bruising

SOLICITED SYSTEMIC ADVERSE REACTIONS

Headache
Fatigue
Muscle Pain
Nausea
Joint Pain
Shivering/Chills
Fever (≥100.4°F)
0%
20%
40%
60%
80%
100%
Safety Trial in Adults Aged 18-49: Reactions, Any Grade
  • Safety data from a study of 4648 adults randomized to receive Flublok (trivalent; n=2344) or placebo (n=2304)8
  • Systemic symptoms following vaccination were similar between people receiving Flublok and placebo8
  • The most frequently reported systemic symptoms following vaccination were headache (15% with Flublok vs 16% with placebo) and fatigue (15% with Flublok vs 14% with placebo)8
    • 76% of headache complaints were mild
  • Flublok was associated with local injection-site pain (37% with Flublok vs 8% with placebo) that was significantly more frequent than after saline placebo2
    • 94% of all pain complaints after Flublok were rated as mild8
Flublok TIV (n=2272)
Placebo (n=2231)
TIV=trivalent.
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INDICATIONS

Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for active immunization for the prevention of disease caused by influenza A virus subtypes and type B virus contained in (or in the case of Flublok, represented by antigens contained in) the vaccine. Fluzone is approved for use in persons 6 months of age and older. Flublok is approved for use in persons 18 years of age and older. Fluzone High-Dose is approved for use in persons 65 years of age and older.

IMPORTANT SAFETY INFORMATION

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Do not administer Fluzone, Flublok, or Fluzone High-Dose to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (including egg protein for Fluzone and Fluzone High-Dose). Fluzone and Fluzone High-Dose should not be administered to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine.

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone, Flublok, or Fluzone High-Dose should be based on careful consideration of the potential benefits and risks.

If Fluzone, Flublok, or Fluzone High-Dose are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be attained.

Vaccination with Fluzone, Flublok, or Fluzone High-Dose may not protect all recipients.

Syncope (fainting) has been reported following vaccination with Fluzone, Flublok and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.

For Fluzone, in children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness and redness; the most common solicited systemic adverse reactions were irritability, drowsiness (6 months through 35 months), and myalgia (3 years through 8 years). In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache and myalgia. In adults over 65 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, myalgia, and malaise.

For Flublok, in adults 18 through 64 years of age, the most common injection site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, fatigue, and myalgia. In adults 65 years of age and older, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were fatigue and headache.

For Fluzone High-Dose, in adults 65 years of age and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.

For Fluzone, Flublok, and Fluzone High-Dose, other adverse reactions may occur.

Before administration, please see the full Prescribing Information for Fluzone, Flublok, or Fluzone High-Dose. Also, please see complete Patient Information for Fluzone or Fluzone High-Dose.

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MAT-US-2019705-v7.0-11/2024
MAT-US-2019705-v7.0-11/2024