sanofi pasteur flu vaccine lot numbers
We are currently innovating in our existing different technologies including egg-based flu vaccines, recombinant proteins, mRNA to develop and deliver vaccines that canprotect as many people as possible against flu and its complications. 800.422.0280. Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+ * Fluzone High-Dose Quadrivalent (Influenza. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. In children 6 months through 35 months of age receiving a 0.25 mL dose of Fluzone Quadrivalent in Study 1 (NCT01240746, see http://clinicaltrials.gov), the most common (10%) injection-site reactions were pain (57%)1 or tenderness (54%)2, erythema (37%), and swelling (22%); the most common solicited systemic adverse reactions were irritability (54%)2, abnormal crying (41%)2, malaise (38%)1, drowsiness (38%)2, appetite loss (32%)2, myalgia (27%)1, vomiting (15%)2, and fever (14%). The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent. Study 4 included 602 subjects 50 through 64 years of age for safety analysis, randomized to receive Flublok (n=300) or another U.S.-licensed trivalent influenza vaccine (Fluzone, manufactured by Sanofi Pasteur, Inc.) as an active control (n=302). Non-inferiority immunogenicity criteria based on HI antibody GMTs and seroconversion rates were also met when age subgroups (6 months to <36 months and 3 years to <9 years) were examined. Fluzone Quadrivalent contains 4 killed flu virus strains. 1 This was the impetus for the 1994 federal. Supplied as package of 10 (NDC 49281-422-10). In this study, children 6 months through 35 months of age received one or two doses of either 0.25 mL or 0.5 mL of Fluzone Quadrivalent. With protection against four flu strains, Fluzone High-Dose is the only influenza vaccine licensed for use in adults 65 years of age and older to have demonstrated superior efficacy in a randomized controlled trial versus a standard dose influenza vaccine for the prevention of laboratory-confirmed influenza illness and the only influenza vaccine with 10 years of data demonstrating protection from flu and its related complications.2,3,a,b In a meta-analysis of 15 published reports, including approximately 34 million people, those who received Fluzone High-Dose experienced an 18% reduction in cardiorespiratory hospitalizations and 28% decrease in pneumonia hospitalizations, both of which are reductions above what the standard dose vaccines provided.3, Fluzone High-Dose Quadrivalent builds on the legacy of the trivalent formulation, which was clinically proven to be 24.2% more effective at preventing flu than standard-dose Fluzone (Influenza Vaccine) in adults 65+.10 Based on data from Fluzone High-Dose (Influenza Vaccine), side effects were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.11, The efficacy of trivalent formulation is relevant to Fluzone High-Dose Quadrivalent since both products are manufactured according to the same process and have overlapping compositions.2, In a clinical study, Flublok Quadrivalent is the first and only recombinant influenza vaccine for adults 18+ that was proven to be 30% more effective than a standard dose vaccine at preventing flu infection in over 9,000 adults 50+.1 In adults 50+, the most common side effects were tenderness, and/or pain at the injection site; headache, and tiredness.1, aProven superiority in a clinical trial between Fluzone High-Dose (Influenza Vaccine) (trivalent formulation) and a standard-dose influenza vaccine2bIncludes 10 years of evidence (2009-2019) with Fluzone High-Dose (trivalent formulation)3, Important Safety Information for Fluzone Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone High-Dose Quadrivalent (Influenza Vaccine). The .gov means its official.Federal government websites often end in .gov or .mil. Do not use after the expiration date shown on the label. Michael Greenberg, MD, MPHNorth America Medial Head of Vaccines at Sanofi"ACIP's recommendation is a first step to help improve protection against flu and its complications for this 65 years and older high-risk population. This summary is not intended to take the place of talking with your healthcare provider. 47823. McKesson Acceptable Dating: we will ship >= 30 days. In adults 18 years and older, the most common (10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). Medically reviewed by Drugs.com. 49281051105. Vaccine sales in Q1 were up 15% due to strong travel and dynamic vaccine sales as they continue to recover and have now . Fluzone Quadrivalent is for people who are 6 months of age and older. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. McKesson Acceptable Dating: we will ship >= 180 days. ** Fluzone Quadrivalent is currently licensed for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, .25-mL prefilled syringes are not expected to be available for the 2020-21 influenza season. Clin Infect Dis. The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged 3 years. Table 5 summarizes solicited injection-site and systemic adverse reactions reported within 3 days post-vaccination via diary cards. CDC twenty four seven. Package inserts for U.S.-licensed vaccinesexternal icon. Andrew MK et al. Those who report having had reactions to egg involving symptoms other than urticaria (e.g., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or who required epinephrine or another emergency medical intervention should be vaccinated in an inpatient or outpatient medical setting (including, but not necessarily limited to, hospitals, clinics, health departments, and physician offices) supervised by a health care provider who is able to recognize and manage severe allergic reactions, if a vaccine other than ccIIV4 or RIV4 is used. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. Please read this information sheet before getting Fluzone Quadrivalent. The new facility building at Swiftwater has had an investment of $150m. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. GMT ratios (GMT0.5-mL dose divided by GMT0.25-mL dose) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 1.42 (95% CI: 1.16; 1.74), 1.48 (95% CI: 1.21; 1.82), 1.33 (95% CI: 1.09; 1.62), and 1.41 (95% CI: 1.17; 1.70), respectively. Store all Fluzone Quadrivalent presentations refrigerated at 2 to 8C (35 to 46F). In the follow-up period, there were two SAEs, 1 (0.5%) in the Fluzone Quadrivalent group and 1 (0.5%) in the TIV-2 group. The Lancet Respiratory Medicine. * Fluzone High-Dose Quadrivalent (Influenza Vaccine) and Flublok Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as assessed in randomized controlled trials, the gold standardin evaluating clinical evidence for vaccine licensure1,2* FluzoneHigh-Dose (Influenza Vaccine) is the first and only influenza vaccine with superior flu protection and 10 years of evidence in preventing flu-related hospitalizations in adults aged 65+2,3,a,b* As the leaders in flu, Sanofi is committed to protecting patients most at-risk for the flu and its related complications, including hospitalizations due to pneumonia & cardiovascular events4. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Vaccines manufactured by MedImmune (AstraZeneca), Pfizer, Merck and Bio CSL have the same lot number on their UoS and UoU so this issue does not have an impact on any of their vaccines. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. In children 3 years through 8 years of age, the most common (10%) injection-site reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). 3). A randomized, double-blind, placebo-controlled study was conducted at a single US center during the 1999-2000 (Year 1) and 2000-2001 (Year 2) influenza seasons. Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 8. Global surveillance of influenza identifies yearly antigenic variants. Forward-looking statements are statements that are not historical facts. If Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected. With protection against four flu strains, Fluzone High-Dose is the only influenza vaccine licensed for use in adults 65 years of age and older to have demonstrated superior efficacy in a randomized controlled trial versus a standard dose influenza vaccine for the prevention of laboratory-confirmed influenza illness and the only influenza . The preferred site for infants and young children is the anterolateral aspect of the thigh. Not all formulations are available from the VFC Program. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa131572711Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Cookies used to make website functionality more relevant to you. Vaccination with Fluzone Quadrivalent may not protect all recipients. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. 1) If GBS has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks. Fluzone Quadrivalent stimulates the immune system to protect against influenza, but does not prevent other respiratory infections. Product Dating. Drug class: Viral vaccines. Participants were monitored for unsolicited adverse events for 28 days after each dose and serious adverse events (SAEs) during the 6 months following the last dose. Package insert / product label Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Therefore, influenza vaccines are standardized to contain the hemagglutinins of influenza virus strains representing the influenza viruses likely to be circulating in the US during the influenza season. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%]7, Vaccination is especially important for people most at risk1, People over 65, children under 5, pregnant women and people with chronic medical conditions, Flu and Covid-19 vaccines can be administered at the same time8per a recent Sanofi study9, With our influenza vaccines, we seek to not only prevent influenza but also protect against its severe complications like heart attack and pneumonia. 2) Single-dose vial, 0.5 mL, for persons 6 months of age and older. We take your privacy seriously. 2) (See ref. Also please see complete Patient Information for Fluzone Quadrivalent andFluzone High-Dose Quadrivalent. pain, redness, and swelling where you got the shot. But not all flu vaccines are the same. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. Fluzone Quadrivalent/NDC 49281-422-88 We aim to ensure these vaccines, supported by a high level of evidence, are available to protect as many people as possible each flu season., Sandrine Samson, PhD Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2022-2023 influenza season: A/Victoria/2570/2019 IVR-215 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage).
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