Contraindications for Influenza vacccine

1.

Elsevier ClinicalKey Drug Monograph

Content last updated: March 5, 2024.

Contraindications And Precautions The live-attenuated influenza vaccine (LAIV4) is contraindicated in individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components or persons who have had life-threatening reactions to any previous influenza vaccination. The FDA-approved product labeling states that LAIV4 is also contraindicated in patients with egg hypersensitivity because these vaccines are prepared using embryonated chicken eggs. The Advisory Committee on Immunization Practices (ACIP) recommends administering any licensed, age-appropriate influenza vaccine (i.e., inactivated influenza vaccine (IIV), quadrivalent recombinant influenza vaccine (RIV4), or LAIV4) to patients with egg allergy of any severity. Patients who have had symptoms other than urticaria after egg exposure (i.e., angioedema, respiratory distress, lightheadedness, or recurrent emesis) or required emergency medical intervention, may also receive any licensed, age-appropriate influenza vaccine; however, it is recommended that the vaccine only be administered in an inpatient or outpatient medical setting by a health care provider experienced in the recognition and management of severe allergic conditions. Severe allergic reactions to vaccines can occur in patients without a history of previous allergic reaction. A previous severe allergic reaction to influenza vaccine is a contraindication to receiving future influenza vaccines. Although no specific observation time is recommended for egg-allergic patients, ACIP recommends patients be observed for syncope for 15 minutes after vaccination. The American Academy of Pediatrics (AAP), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI) do not recommend any special precautions for egg-allergic recipients, regardless of severity. The AAAAI and ACAAI consider any special precautions (i.e., special observation periods or administration in a specialized medical setting) unnecessary due to the extremely rare risk of anaphylactic reactions after vaccination.

Contraindications And Precautions The safety of the quadrivalent live-attenuated influenza vaccine (LAIV4) in individuals with underlying medical conditions that may predispose them to complications after wild-type influenza infection (e.g., chronic pulmonary, including chronic obstructive pulmonary disease (COPD), cardiovascular, renal, metabolic, neurologic, hematologic, or hepatic disease) has not been established; only administer the LAIV4 if the potential benefit outweighs the potential risk. The American Academy of Pediatrics specifically recommends the use of the inactivated influenza virus vaccine for all pediatric patients with the following conditions: asthma; chronic pulmonary diseases, including chronic lung disease (CLD) and cystic fibrosis; hemodynamically significant cardiac disease; immunosuppressive disorders, including HIV infection; sickle cell disease or other hemoglobinopathy; chronic renal dysfunction (e.g., renal failure); chronic metabolic disease (e.g., diabetes mellitus); conditions that require long-term aspirin therapy, such as juvenile idiopathic arthritis or Kawasaki disease; and any condition that can compromise respiratory function or handling of secretions (e.g., neuromuscular disease such as multiple sclerosis, seizure disorder, spinal cord injuries, neurodevelopmental disorders).

2.

Elsevier ClinicalKey Drug Monograph

Content last updated: March 4, 2024.

Contraindications And Precautions All inactivated influenza vaccines (IIVs), with the exception of Flucelvax and Flublok, are contraindicated in persons with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components or persons who have had a life-threatening reaction to any previous influenza vaccination. Most of the vaccines available are contraindicated by the manufacturers in patients with egg hypersensitivity because these vaccines are prepared using embryonated chicken eggs. These vaccines contain only minimal amounts of egg protein; however, anaphylactic reactions can occur in individuals with severe egg allergies. Due to differences in manufacturing processes, Flucelvax and Flublok do not use eggs to propagate the virus; thus, they are only contraindicated in persons with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components. Flucelvax, however, cannot be considered 100% egg-free because the initial seed virus is created using reference virus stains from the World Health Organization, which have been passaged in eggs. For patients with a history of severe allergic reaction (e.g. anaphylaxis) to an influenza vaccine, the Advisory Committee on Immunization Practices (ACIP) has specific recommendations for vaccine receipt. A history of a severe allergic reaction to a previous dose of any influenza vaccine (i.e., any egg-based IIV, cell culture-based IIV (ccIIV, Flucelvax), recombinant influenza vaccine (RIV, Flublok), or live-attenuated influenza vaccine (LAIV) of any valency) is a contraindication to future receipt of all egg-based IIV4s and LAIV4.

3.

Elsevier ClinicalKey Clinical Overview

Screening and Prevention History of severe allergic reaction (eg, anaphylaxis) to any cell culture–based inactivated influenza vaccine of any valency is a contraindication to future receipt of cell culture–based quadrivalent inactivated influenza vaccine; also contraindicated for patients with severe allergic reaction (eg, anaphylaxis) to any vaccine component For quadrivalent recombinant influenza vaccine: History of a severe allergic reaction (eg, anaphylaxis) to any egg-based inactivated, cell culture–based inactivated, or live attenuated influenza vaccine of any valency is a precaution when using quadrivalent recombinant influenza vaccine; if administered, vaccination should occur under the supervision of a health care professional who can identify and manage severe allergic reactions History of severe allergic reaction (eg, anaphylaxis) to any recombinant influenza vaccine is a contraindication to future receipt of quadrivalent recombinant influenza vaccine; also contraindicated for patients with severe allergic reaction (eg, anaphylaxis) to any vaccine component Persons with history of Guillain-Barré syndrome occurring within 6 weeks of influenza vaccination should not receive influenza vaccine unless they are at high risk for complications from influenza, in which case benefit may outweigh risk; antiviral prophylaxis is an alternative Antiviral prophylaxis Pre- or postexposure chemoprophylaxis with the neuraminidase inhibitors oseltamivir and zanamivir may be given to adults and children aged 3 months or older for the following reasons: In conjunction with prompt administration of inactivated influenza vaccine to protect patients who are at high risk of developing complications from influenza in whom influenza vaccination is expected to be effective (but not yet administered) when influenza activity has been detected in the community To protect unvaccinated high-risk patients and their household contacts with recent exposure to influenza

4.

Food and Drug Administration (DailyMed).

Publish date: October 2, 2023.

Drug Interactions 7 DRUG INTERACTIONS The concurrent use of RELENZA (zanamivir) with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of potential interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of RELENZA (zanamivir), unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of RELENZA (zanamivir) [see Microbiology ( 12.4 )]. Live attenuated influenza vaccine, intranasal ( 7 ): • Do not administer until 48 hours following cessation of RELENZA (zanamivir). • Do not administer RELENZA (zanamivir) until 2 weeks following administration of the live attenuated influenza vaccine, unless medically indicated.

5.

Food and Drug Administration (DailyMed).

Publish date: May 5, 2024.

Drug Interactions 7 DRUG INTERACTIONS Live attenuated influenza vaccine (LAIV), intranasal: Avoid administration of LAIV within 2 weeks before or 48 hours after Oseltamivir (oseltamivir phosphate) use, unless medically indicated. (7) 7.1 Influenza Vaccines Live Attenuated Influenza Vaccine The concurrent use of Oseltamivir (oseltamivir phosphate) with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for Oseltamivir (oseltamivir phosphate) to inhibit replication of live vaccine virus and possibly reduce the efficacy of LAIV, avoid administration of LAIV within 2 weeks before or 48 hours after Oseltamivir (oseltamivir phosphate) administration, unless medically indicated. Inactivated Influenza Vaccine Inactivated influenza vaccine can be administered at any time relative to use of Oseltamivir (oseltamivir phosphate). 7.2 Drugs Without Clinically Significant Drug Interaction with Oseltamivir (oseltamivir phosphate) No dose adjustments are needed for either Oseltamivir (oseltamivir phosphate) or the concomitant drug when coadministering Oseltamivir (oseltamivir phosphate) with amoxicillin, acetaminophen, aspirin, cimetidine, antacids (magnesium and aluminum hydroxides and calcium carbonates), rimantadine, amantadine, or warfarin [see Clinical Pharmacology (12.3) ].

6.

Food and Drug Administration (DailyMed).

Publish date: December 0, 2023.

Precautions Live Attenuated Influenza Vaccine (LAIV): The concurrent use of rimantadine hydrochloride with live attenuated intranasal influenza vaccine has not been evaluated. However, because of potential interference between these products, the live attenuated intranasal influenza vaccine should not be administered until 48 hours after cessation of rimantadine hydrochloride and rimantadine hydrochloride should not be administered until two weeks after the administration of live attenuated intranasal influenza vaccine unless medically indicated. The concern about potential interference arises principally from the potential for antiviral drugs to inhibit replication of live vaccine virus. Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis: Oral administration of rimantadine to rats for 2 years at doses up to 100 mg/kg/d [approximately 11 to 14 times the maximum recommended human dose (MRHD) based on AUC] showed no evidence of increased tumor incidence. Mutagenesis: No mutagenic effects were seen when rimantadine was evaluated in several standard assays for mutagenicity. Impairment of Fertility: A reproduction study in male and female rats did not show detectable impairment of fertility at dosages up to 60 mg/kg/day (3 times the MRHD based on mg/m 2 ). Pregnancy Teratogenic Effects : There are no adequate and well-controlled studies in pregnant women. Rimantadine is reported to cross the placenta in mice. Rimantadine has been shown to be embryotoxic in rats when given at a dose of 200 mg/kg/d (11 times the MRHD based on mg/m 2 ). At this dose the embryotoxic effect consisted of increased fetal resorption in rats; this dose also produced a variety of maternal effects including ataxia, tremors, convulsions and significantly reduced weight gain. No embryotoxicity was observed when rabbits were given doses up to 50 mg/kg/d (approximately 0.1 times the MRHD based on AUC), but evidence of a developmental abnormality in the form of a change in the ratio of fetuses with 12 or 13 ribs were noted. This ratio is normally about 50:50 in a litter but was 80:20 after rimantadine treatment.