Flublok 2026-2027 (influenza virus vaccine tv 2026-27(9 yrs and older)rcmb/PF)
Influenza Vaccine Intramuscular Syringe (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Seasonal influenza vaccine recombinant (RIV) stimulates active immunity to influenza virus infection. Seasonal influenza vaccine recombinant is prepared using recombinant DNA technology and contains recombinant hemagglutinin (HA) proteins representing influenza virus types A and type B likely to circulate in the US during the upcoming influenza season.
Seasonal influenza vaccine recombinant contains recombinant hemagglutinin (HA) proteins from influenza viruses and is used to stimulate active immunity to influenza virus infection. The vaccine is prepared using recombinant DNA technology and a continuous insect cell line (expresSF+(R)) derived from Sf9 cells of the fall armyworm (Spodoptera frugiperda) and a baculovirus vector. Each of the influenza recombinant HA proteins is expressed individually, extracted from the cells using Triton(R) X-100, and further purified by column chromatography.
The manufacturing process for influenza vaccine recombinant does not use live influenza viruses and does not involve eggs.
Each 0.5 mL of seasonal influenza vaccine recombinant for the 2026-2027 influenza season contains 45 mcg HA each of A/Missouri/11/2025 (H1N1), A/Darwin/1415/2025 (H3N2) and B/Pennsylvania/14/2025. Each 0.5 mL of influenza vaccine recombinant also contains sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, and polysorbate 20 and may also contain residual amounts of baculovirus and S. frugiperda cell proteins (no more than 14.3 mcg), baculovirus and cellular DNA (no more than 10 ng), and Triton(R) X-100 (no more than 100 mcg). Influenza vaccine recombinant does not contain egg proteins, antibiotics, or preservatives; the single-dose syringes do not contain natural rubber latex.
Following IM administration of influenza vaccine recombinant, the recombinant HA proteins contained in the vaccine act as antigens and induce a humoral immune response that can be measured by hemagglutination inhibition (HI) antibody.
USES: This vaccine is used to help prevent influenza ("flu") in people 6 months and older. Influenza can cause serious (rarely fatal) illness, especially in people at high risk from the infection (such as young children, older adults, people with chronic health problems). This vaccine is also called the seasonal flu shot.
It works by increasing the body's natural defense (immunity) against the virus. Vaccination is the best way to protect against this infection. It can help prevent the infection or decrease the seriousness of the illness if you become infected.
Since different types of flu viruses cause infection every flu season, a new vaccine is made and given every year. Vaccines may not fully protect everyone who receives them. The flu vaccine does not cause the flu.
Generic name: influenza virus vaccine tv 2026-27(9 yrs and older)rcmb/PF
Pronunciation: (IN-floo-EN-za)
Drug class: Influenza Vaccine
Therapeutic class: Biologicals
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Flublok 2026-2027
Indications
The following indications are listed for Flublok 2026-2027:
- Influenza Vaccination
Also known as: Vaccination To Prevent Influenza.
Dosing
No dosing information is available for this tab.
Seasonal influenza vaccine recombinant is administered only by IM injection. The vaccine should not be administered subcutaneously, intradermally, or IV.
Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; such reactions occur most frequently in adolescents and young adults. Appropriate measures should be taken to decrease the risk of injury if a patient becomes weak or dizzy or loses consciousness (e.g., vaccinees should sit or lie down during and for 15 minutes after vaccination). If syncope occurs, the patient should be observed until symptoms resolve.
When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separate syringes and different injection sites. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Flublok 2026-2027 Syringe | Maintenance | Inject 0.5 milliliter (135 mcg) by intramuscular route once. |
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Vaccines/Pariglasgene Brecaparvovec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)
DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)
There are no severe interactions for this drug.
Moderate Interaction: Assess the risk to the patient and take action as needed.
Vaccines/Hepatitis B Vaccine (Fendrix)
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)
CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)
DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)
Contraindications
*History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.
There are no contraindication contraindications for this drug.
- Guillain-barre syndrome
There are no moderate contraindications for this drug.
Adverse reactions
In children 9 through 17 years of age, the most common (>=10%) solicited injection-site adverse reaction was pain (34.4%); the most common (>=10%) solicited systemic adverse reactions were myalgia (19.3%), headache (18.5%), and malaise (16.1%).
In adults 18 through 49 years of age, the most common (>=10%) injection-site adverse reaction was pain (37%); the most common (>=10%) solicited systemic adverse reactions were headache (15%), fatigue (15%), and muscle pain (11%).
In adults 50 through 64 years of age, the most common (>=10%) injection site adverse reaction was pain (32%); the most common (>=10%) solicited systemic adverse reactions were headache (17%), fatigue (13%), and muscle pain (11%).
In adults 65 years of age and older, the most common (>=10%) injection site adverse reaction was pain (19%); the most common (>=10%) solicited systemic adverse reactions were fatigue (13%) and headache (10%).
Rare or Very Rare
- Anaphylaxis
- Angioedema
- Bell's palsy
- Brachial plexus disorder
- Cellulitis
- Dyspnea
- Encephalopathy
- Guillain-barre syndrome
- Hypersensitivity drug reaction
- Myelitis
- Optic neuritis
- Serum sickness
- Stevens-johnson syndrome
- Thrombocytopenic disorder
- Vasculitis
More Frequent
- Bruising
- Chills
- Erythema
- Fatigue
- Headache disorder
- Induration of skin
- Injection site pain
- Injection site sequelae
- Malaise
- Myalgia
- Pruritus of skin
Less Frequent
- Appetite changes
- Arthralgia
- Cough
- Diarrhea
- Ecchymosis
- Fever
- Injection site erythema
- Injection site inflammation
- Nausea
- Pharyngitis
- Vomiting
Rare or Very Rare
- Back pain
- Dizziness
- Extensive limb swelling after injection
- Flushing
- Lymphadenopathy
- Neuralgia
- Pain in oropharynx
- Paresthesia
- Seizure disorder
- Skin rash
- Syncope
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy of influenza vaccine recombinant have not been established in individuals younger than 9 years of age.
Diminished hemagglutination inhibition (HI) antibody responses have been observed in children 6 months of age through 8 years of age who received either the trivalent or quadrivalent influenza vaccine recombinant, suggesting that the vaccine would not be effective in children younger than 9 years of age.
The manufacturer states that data are insufficient to assess the risk of using influenza vaccine recombinant in pregnant women.
The available data from a post-licensure, observational, retrospective, safety surveillance study in 14,981 pregnant individuals found no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages with the quadrivalent form of influenza vaccine recombinant; patients were exposed to the vaccine during the 28 days prior to conception or during pregnancy. The manufacturer states that data from the quadrivalent vaccine are relevant to the current trivalent formulation since both vaccines use the same manufacturing process and have overlapping compositions.
A pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to seasonal influenza vaccine recombinant; clinicians are encouraged to contact the registry at 800-822-2463 or online at https://www.sanofipasteurpregnancyregistry.com.
It is not known whether influenza vaccine recombinant is distributed into human milk. Data are insufficient to assess the effects on the breast-fed infant or on milk production.
The benefits of breast-feeding and the importance of the vaccine to the woman should be considered along with the potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to influenza infection).
ACIP states that recombinant vaccines do not pose any unusual risks for women who are breast-feeding or their breast-fed infants.
The manufacturer makes no special population dosage recommendations.
Clinical studies of influenza vaccine recombinant did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Influenza vaccination | ||
| Z23 | ICD10CM | Encounter for immunization |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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