b'B:16.25"T:15.75"S:15.25"ABRYSVOTM(Respiratory Syncytial Virus Vaccine) Table 1Percentage of Participants with Local Reactions Reported, byTable 2Percentage of Participants with Systemic Reactions Reported, byfor vaccine-associated increase in the risk of congenital anomalies or fetalsolution for intramuscular injectionMaximum Severity, within 7 Days after VaccinationStudy 1a Maximum Severity, within 7 Days after VaccinationStudy 1a deaths. In this study, there was a numerical imbalance in preterm births, with BRIEF SUMMARY OF FULL PRESCRIBING INFORMATIONLocal Reactions ABRYSVO PLACEBO Systemic Reactions ABRYSVO PLACEBO more preterm infants born to individuals in the ABRYSVO group compared to INDICATIONS AND USAGE N=3,619-3,621b N=3,532-3,539b N=3,619-3,621b N=3,532-3,539b individuals in the placebo group.ABRYSVO is a vaccine indicated for active immunization for the prevention of% % % % A developmental and reproductive toxicity study was performed in female lower respiratory tract disease (LRTD) caused by respiratory syncytial virusInjection site painc Joint painc rabbits administered a vaccine formulation containing two times the antigen content of a single human dose of ABRYSVO prior to and during gestation. (RSV) in individuals 60years of age and older.Anyd 10.5 6.0Anyd 7.5 6.9 The study showed no evidence of harm to the fetus or to postnatal survival, DOSAGE AND ADMINISTRATIONMild 4.5 3.9 growth, or development.Administer a single dose (approximately 0.5mL) of ABRYSVO intramuscularly.Mild 9.4 5.3Moderate 2.9 2.9 DataCONTRAINDICATIONSModerate 1.1 0.7Severe 0.1 0.1 Human DataDo not administer ABRYSVO to individuals with a history of a severe allergic Severe 0.1 0 Nauseac In a randomized controlled clinical trial (NCT04424316), 3,682 pregnant reaction (e.g., anaphylaxis) to any component of ABRYSVO. Rednessd,eAnyd 3.4 3.7 individuals received ABRYSVO and 3,676 received placebo (0.5 mL dose, WARNINGS AND PRECAUTIONS containing the same buffer ingredients in the same quantities as in a single Management of Acute Allergic ReactionsAnyd 2.7 0.7Mild 2.5 3.1 dose of ABRYSVO) at 24 through 36 weeks gestation. The infant safety Appropriate medical treatment used to manage immediate allergic reactions Mild 1.5 0.5Moderate 0.9 0.6 population included 3,568 and 3,558 infants born to individuals in the ABRYSVO must be immediately available in the event an anaphylactic reaction occurs Severe 0 0.1 or placebo group, respectively. Among the infants born to individuals in the following administration of ABRYSVO.Moderate 1.1 0.2 e ABRYSVO group and in the placebo group, 202 (5.7%) and 169 (4.7%),Severe 0.1 0 Vomiting respectively, were born prematurely and 174 (4.9%) and 203 (5.7%), respectively, SyncopeAnyd 0.9 0.8 had reported congenital malformations or anomalies. There were 10 (0.3%) Syncope (fainting) may occur in association with administration of injectableSwellingd,e fetal deaths in the ABRYSVO group and 8 (0.2%) in the placebo group.vaccines, including ABRYSVO. Procedures should be in place to avoid injury Anyd 2.4 0.5Mild 0.7 0.7 Animal Datafrom fainting.Moderate 0.2 0.1 A developmental toxicity study was performed in female New Zealand White Altered ImmunocompetenceMild 1.5 0.2Severe 0 0.1 rabbits. Rabbits were administered 4 doses by intramuscular injection: at Immunocompromised individuals, including those receiving Moderate 0.9 0.2 Diarrheaf 3 weeks and at 1 week prior to mating, and on gestation days 10 and 24. On immunosuppressive therapy, may have a diminished immune response to Severe 0.1 0.1Anyd 5.9 5.2 each occasion, rabbits received 0.5 mL of a vaccine formulation containing ABRYSVO. a twice the antigen content of F glycoproteins of RSV A and RSV B (120 mcgNCT05035212Mild 4.4 4.2 RSV preF A and 120 mcg RSV preF B), stabilized in prefusion conformation Limitations of Vaccine Effectiveness b N = number of participants who provided e-diary data for a specific reaction Moderate 1.3 0.9 as contained in a single human dose of ABRYSVO. No adverse effects onVaccination with ABRYSVO may not protect all vaccine recipients. after vaccination. Severe 0.1 0.1 mating, female fertility, or on embryo/fetal or post-natal survival, growth, ADVERSE REACTIONS c Mild: does not interfere with activity; moderate: some interference witha or development were observed. There were no vaccine-related fetal NCT05035212 malformations or variations.In clinical trials, the most commonly reported (10%) adverse reactions wereactivity; severe: prevents daily activity.d b N = number of participants who provided e-diary data for a specific reactionLactationfatigue (15.5%), headache (12.8%), pain at the injection site (10.5%), and Any includes all participants who reported a reaction as mild, moderate, or after vaccination. muscle pain (10.1%). severe during Day 1 to Day 7 after vaccination. Risk Summaryc Mild: does not interfere with activity; moderate: some interference with Clinical Trials Experience e Mild: 2.5cm to 5cm; moderate: 5cm to 10cm; severe: 10cm (for dataIt is not known whether ABRYSVO is excreted in human milk. Data are not activity; severe: prevents daily routine activity.Because clinical trials are conducted under widely varying conditions, adversereported from e-diaries). available to assess the effects of ABRYSVO on the breastfed infant or on milkS:10.25" T:10.75" B:11"d Any includes all participants who reported a reaction as mild, moderate, orproduction/excretion. The developmental and health benefits of breastfeeding reaction rates observed in the clinical trials of a vaccine cannot be directlyTable 2Percentage of Participants with Systemic Reactions Reported, by a severe during Day 1 to Day 7 after vaccination. should be considered along with the mothers clinical need for ABRYSVO and compared to rates in the clinical trials of another vaccine and may not reflectMaximum Severity, within 7 Days after VaccinationStudy 1 e any potential adverse effects on the breastfed child from ABRYSVO or from the rates observed in practice.Mild: 1 to 2 times in 24 hours; moderate: 2 times in 24 hours; severe: Systemic Reactions ABRYSVO PLACEBO the underlying maternal condition. For preventative vaccines, the underlying The safety of ABRYSVO was evaluated in Study 1 (NCT05035212) in whichN=3,619-3,621b N=3,532-3,539b requires intravenous hydration. maternal condition is susceptibility to disease prevented by the vaccine. 17,215 participants received ABRYSVO and 17,069 received placebo (0.5mLf Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in % % ABRYSVO is not approved for use in individuals younger than 60 years of age.dose, containing the same buffer ingredients in the same quantities as in a Fever (38.0C) 24 hours; severe: 6 or more loose stools in 24 hours.Pediatric Usesingle dose of ABRYSVO). Study 1 is an ongoing Phase 3, multicenter,Solicited local and systemic reactions had a median duration of 1-2 days.randomized, double-blind, placebo-controlled study to assess the efficacy 38.0C 1.4 1.4 Unsolicited Adverse Events in Study 1 The safety and effectiveness of ABRYSVO in individuals younger than 18 years and safety of ABRYSVO in individuals 60years of age and older. This study 38.0C to 38.4C 0.6 0.8 of age have not been established.is being conducted in the USA, South Africa, Japan, Canada, Finland, theUnsolicited adverse events occurring within 1 month after vaccination wereGeriatric UseNetherlands, and Argentina. Demographic characteristics among participants 38.4C to 38.9C 0.8 0.6 similar between groups, reported in 8.9% and 8.5% of participants who received who received ABRYSVO and those who received placebo were generally 38.9C to 40.0C 0.1 0.1 ABRYSVO and placebo, respectively. ABRYSVO is approved for use in individuals 60 years of age and older. In similar with regard to age, sex, race, and ethnicity. Of the participants in 40.0C 0 0.1 Within 30 days after vaccination, atrial fibrillation was reported in 10 vaccineStudy 1, of the 17,215 recipients who received ABRYSVO 62% (n=10,756) the study, 51% were male and 78% were White, 13% were Black or Africanrecipients and 4 placebo recipients (of which 4 in the ABRYSVO group andwere aged 60-69 years of age, 32% (n=5,488) were 70-79 years of age and American, and 37% were Hispanic/Latino. The median age of participants Fatiguec 3 in the placebo group were serious adverse events); the onset of symptoms6% (n=970) were 80 years of agewas 67 years (range 59-97 years).Anyd 15.5 14.4 was 18 to 30 days post vaccination. The currently available information on atrialNONCLINICAL TOXICOLOGYSolicited local and systemic reactions were collected using electronic diaries Mild 9.3 8.4 fibrillation is insufficient to determine a causal relationship to the vaccine. ThereCarcinogenesis, Mutagenesis, Impairment of Fertilityfor 7 days after study vaccination in 7,169 participants (3,630 ABRYSVO Moderate 5.9 5.8 were no other notable patterns or numerical imbalances between groups forABRYSVO has not been evaluated for the potential to cause carcinogenicity, participants and 3,539 placebo recipients) from a subset of sites. For allspecific categories of unsolicited adverse events. genotoxicity, or impairment of male fertility. A developmental and reproductive participants, unsolicited adverse events were collected for one month after Severe 0.3 0.1 Serious Adverse Events in Study 1 toxicity study in female rabbits revealed no evidence of impaired female fertility.study vaccination; serious adverse events (SAEs) are collected throughoutHeadachec In Study 1, SAEs were reported by 2.3% of participants in both the ABRYSVOPATIENT COUNSELING INFORMATIONstudy participation.Any 12.8 11.7 and placebo groups. Three participants in the ABRYSVO group had SAEs which Solicited Local and Systemic Reactions in Study 1 d Prior to administration of this vaccine: Mild 9.0 8.4 were assessed as possibly related to study vaccination: Guillain-Barre Syndrome Inform vaccine recipient of the potential benefits and risks of vaccination Solicited local and systemic reactions reported within 7 days after vaccination Moderate 3.7 3.2 reported 7 days after vaccination, Miller Fisher Syndrome reported 8 dayswith ABRYSVO.in Study 1 are presented in Tables 1 and 2. after vaccination, and hypersensitivity reported 8 hours after vaccination.Advise vaccine recipient to report any adverse events to their healthcareSevere 0.1 0.1 USE IN SPECIFIC POPULATIONS provider or to the Vaccine Adverse Event Reporting System at Muscle painc Pregnancy 1-800-822-7967 and www.vaers.hhs.gov. Anyd 10.1 8.4 Risk Summary This products labeling may have been updated. For the most recentMild 6.5 5.5 All pregnancies have a risk of birth defect, loss, or other adverse outcomes.prescribing information, please visit www.pfizer.com. Moderate 3.5 2.8 In the US general population, the estimated background risk of major birthManufactured by PP-A1G-USA-0088-01 Severe 0.2 0.1 defects and miscarriages in clinically recognized pregnancies is 2% to 4%,Pfizer Inc., NY, NY 10001and 15% to 20%, respectively, and the estimated background risk of fetalUS License No. 2001(continued) deaths after 20 weeks is 0.6%. ABRYSVO is not approved for use in individuals younger than 60 years of age. This brief summary is based on ABRYSVO Data from a clinical trial (NCT04424316) that enrolled pregnant individuals whoprescribing informationLAB-1498-1.0were randomly assigned 1:1 to receive ABRYSVO or placebo (0.5 mL dose,Revised: 7/2023containing the same buffer ingredients in the same quantities as in a singleCPT Code 90678dose of ABRYSVO) at 24 through 36 weeks gestation revealed no evidence FS:7.25" FS:7.25"F:7.875" F:7.875"12059297_US OA HCP_US Med Jrnl_Ad Update_M2FR.indd 2 PREPARED BY 12/1/23 6:40 PM12059297_vc#12009360 US OA HCP US Med Jrnl Ad Update M2FRJob info Images FontsSpecial InstructionsDate: 12-1-2023 6:40 PM ABRYSVO Brief Master A size_FINAL.pdfNone Release files to Emily.Phelan@fcbhealth.com, Client: Pfizer (100%; 138KB) Emily.Carter@mccannhealth.comProduct: ABRYSVO-Older AdultClient Code: None Additional InformationWF Issue # 9989474 NoneReleasing as: PDFx1AFinal Size: 15.75"w x 10.75"hFinishing: NoneGutter: .375" Inks Additional Comments for SizingColors: 4cBlack NoneTeamProducer: Emily PhelanAD: N/AAE: Emily Carter Scale: 1"= 1"QC: None Bleed 16.25" w x 11" h16.25" w x 11" hProduction: Laura G Trim/Flat 15.75" w x 10.75" h15.75" w x 10.75" hDigital Artist: M. Tenga Live/Safety 15.25" w x 10.25" h15.25" w x 10.25" h Path: PrePress:Pfizer:ABRYSVO:12059297:_Packaged_Jobs:12059297_US OA HCP_U.d Jrnl_Ad Update_M2FR:12059297_US OA HCP_US Med Jrnl_Ad Update_M2FR.inddPDFX1A _'