Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. PDF Complete List of Vaccine Names and CPT/CVX Codes Vaccination of female rabbits with Fluzone Quadrivalent revealed no evidence of impaired female fertility [see Animal Data (8.1)]. in influenza and pediatrics vaccines, first worldwide . In the first year of the study the influenza B component of the vaccine and the majority of influenza B cases were of the Victoria lineage; in the second year the influenza B component of the vaccine and the majority of influenza B cases were of the Yamagata lineage: Any type/subtype# 227 (1.43) 300 (1.89) 24.2 (9.7; 36.5) Influenza A: 190 (1.20) COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Sanofi : FDA approves Fluzone High-Dose Quadrivalent (Influenza 0.5 mL each, For 6 months of age and older This study revealed no adverse effects to the fetus or pre-weaning development due to Fluzone Quadrivalent [see Animal Data (8.1)]. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. The most common side effects of Fluzone Quadrivalent are: These are not all of the possible side effects of Fluzone Quadrivalent. Supplied as package of 10 (NDC 49281-422-10). Fluzone High-Dose Quadrivalent is given to people 65 years of age and older. 2018 Mar 29;51(3):1701794. Generic Drug Name. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. Before administering a dose of vaccine, shake the prefilled syringe or vial. Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021). 60 mcg / 0.5 mL. Among participants in the three vaccine groups combined, 67.2% were female (Fluzone Quadrivalent, 68.4%; TIV-1, 67.9%; TIV-2, 65.3%), 88.4% Caucasian (Fluzone Quadrivalent, 91.1%; TIV-1, 86.8%; TIV-2, 87.4%), 9.6% Black (Fluzone Quadrivalent, 6.8%; TIV-1, 12.1%; TIV-2, 10.0%), 0.4% Hispanic (Fluzone Quadrivalent, 0.0%; TIV-1, 0.5%; TIV-2, 0.5%), and 1.7% were of other racial/ethnic groups (Fluzone Quadrivalent, 2.1%; TIV-1, 0.5%; TIV-2, 2.2%). These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). The committee recommended that the quadrivalent formulation of egg-based influenza vaccines for the U.S. 2021-2022 influenza season contain the following: The committee recommended that the quadrivalent formulation of cell- or recombinant based influenza vaccines for the U.S. 2021-2022 influenza season contain the following: For trivalent influenza vaccines for use in the U.S. for the 2021-2022 influenza season, depending on the manufacturing method of the vaccine, the committee recommended that the A(H1N1) pdm09, A(H3N2) and B/Washington/02/2019-like virus (B/Victoria lineage) viruses recommended above for the quadrivalent vaccines be used. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. Please read this information sheet before getting Fluzone Quadrivalent. Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). Protection from influenza virus infection has not been correlated with a specific level of hemagglutination inhibition (HI) antibody titer post-vaccination. J Am Geriatr Soc. About 16,000. employees globally, 65% of them dedicated to manufacturing and quality operations. Chang LJ, et al. NDC Number. problems with your immune system as the immune response may be diminished. Do not administer this product intravenously, intradermally, or subcutaneously. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Adults 65 Years of Age: A Phase 3 Randomized Clinical Trial. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre-specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups > 0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. Flublok Quadrivalent | FDA Call 1-800-VACCINE (1-800-822-2463) and choose the prompt for the RSS. Generic name: influenza vaccine Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. 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. We are pursuingnext generationinfluenza vaccines with multiple vaccine technologies to develop and bring forward tomorrows vaccines to people around the world as fast as possible. Cookies used to make website functionality more relevant to you. Accessed June 2022.10DiazGranados CA, et al. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463. ever had a severe allergic reaction to eggs or egg products. Centers for Disease Control and Prevention. We take your privacy seriously. 2019 Sep 16;37(39):5825-5834. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice. California Compliance Law - Sanofi Pasteur, 2023 Health Equity Accelerator Awards: Application Guidelines, 2022 Health Equity Accelerator Award Winners, Health Equity Accelerator Awards Aim to Expand Solutions for Bigger Impact, A Million Conversations: Addressing Disparities in Healthcare, Independent Medical Education (IME/CME) Grants, Prescribing Information - NDC #49281-562-10, Prescribing Information - NDC #49281-564-10/15. You can review and change the way we collect information below. A developmental and reproductive toxicity study was performed in female rabbits given a 0.5 mL/dose of Fluzone Quadrivalent prior to mating and during gestation (a single human dose is 0.5 mL). For Fluzone Quadrivalent, in children 6 months through 35 months of age, the most common side effects were pain, tenderness, redness, and/or swelling where you got the shot; irritability, abnormal crying, general discomfort, drowsiness, loss of appetite, muscle aches, vomiting, and fever. ** 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. Withdraw one dose of vaccine from the single-dose vial using a sterile needle and syringe. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. 8Grohskoph L. Influenza Vaccines for Persons Aged 65 Years: Evidence to Recommendations (EtR) Framework. Safety and effectiveness of Fluzone Quadrivalent in children below the age of 6 months have not been established. Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 9. It can lead to severe complications, increasing the risk of heart attack and pneumonia. Sanofi Pasteur #49281040010 Adacel Tdap Vaccine Indicated for People 10 to 64 Years of Age Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, Preservative Free Injection Single-Dose Vial 0.5 mL ADACEL TDAP ADLT VACCINE, SDV 2-2.5-5M.5ML (10/BX) Compare Features An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Seasonal Information for Influenza Virus Vaccine, Guidance, Compliance & Regulatory Information (Biologics), Influenza Vaccine for the 2021-2022 Season. BRIDGEWATER, N.J., July 1, 2022 /PRNewswire/ -- Today the US Food and Drug Administration (FDA) approved Sanofi's licensure request for vaccine approval for the upcoming 2022-2023 flu season, including: Fluzone High-Dose Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone Quadrivalent (Influenza Vaccine).5 This approval comes on the heels of the CDC's Advisory Committee on Immunization Practices (ACIP) preferential recommendation for adults 65+ including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent.6 Following this licensure, Sanofi will begin to ship their vaccines helping to ensure more people, including some of our most vulnerable population of 65 years and older, will be immunized with the vaccine best suited for their needs as recommended by the ACIP. In adults 18 years and older, the most common side effects were pain where you got the shot; muscle aches, headache, and general discomfort. 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 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. You should not get Fluzone Quadrivalent if you: Tell your healthcare provider if you or your child have or have had: Fluzone Quadrivalent is a shot given into the muscle of the arm. Prior to vaccination, always refer to the current Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza vaccines. For participants who received two doses, the doses were administered approximately 4 weeks apart. In this study, 1950 children 6 months through 35 months of age were randomly assigned to receive Fluzone Quadrivalent administered in either a volume of 0.25 mL (Group 1) or 0.5 mL (Group 2). ", About the Composition of Sanofi's 2022-2023 Licensed and Approved Influenza Vaccines, Each year, the FDA, World Health Organization (WHO), Centers for Disease Control and Prevention, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.9 Once strains are selected, flu vaccine manufacturers include the newly selected flu strains in their FDA-approved vaccines, and then submit applications to the FDA to include the new flu strains in their FDA-approved vaccines, including for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent and Fluzone Quadrivalent.9 Today those requests for licensure were approved for the upcoming 2022-2023 flu season.5, About Fluzone Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone High-Dose Quadrivalent (Influenza Vaccine). The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. Vaccine sales in Q1 were up 15% due to strong travel and dynamic vaccine sales as they continue to recover and have now . 49281051105. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. The table shows the patterns for the different lot numbers for the six VFC vaccines this difference impacts. Vaccines - Sanofi If Fluzone Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained. Product: Influenza (FluMist Quadrivalent) Bavarian Nordic A/S Hejreskovvej 10A DK-3490 Kvistgaard Phone: 1-800-675-9596 Email: info@bavarian-nordic.com Product: . The percentage of subjects 75 years of age or older was 35.4% in the Fluzone High-Dose Quadrivalent group and 35.8% in the Fluzone High-Dose group. The difference in fever rate (Group 2 minus Group 1) was 0.84% (95% CI: -2.13%; 3.80%), meeting the prespecified non-inferiority criterion (upper limit of the 2-sided 95% CI of the difference in fever rates <5%). (See ref. Three SAEs were reported during the follow-up period, 2 (0.9%) in the TIV-1 group and 1 (0.4%) in the TIV-2 group. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Influenza Vaccine for the 2021-2022 Season | FDA an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. Since 2001, two distinct lineages of influenza B (Victoria and Yamagata lineages) have co-circulated worldwide. [See Clinical Studies (14.6).] Forward-looking statements are statements that are not historical facts. Table 4 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards for the 0.25 mL and 0.5 mL volumes of Fluzone Quadrivalent in children 6 months through 35 months of age. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. Anyone can catch and spread flu. Fluzone High Dose Quadrivalent (Influenza Vaccine) Prescribing Information Patient Information www.sanofiflu.com Fluzone Quadrivalent (Influenza Vaccine) Prescribing Information Patient Information www.sanofiflu.com Imovax Rabies (Rabies Vaccine) Prescribing Information Imogam Rabies - HT (Rabies Immune Globulin (Human) USP, Heat Treated) The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. Fluzone Quadrivalent is supplied in 3 presentations: 1) Prefilled single-dose syringe (clear syringe plunger rod), 0.5 mL, for persons 6 months of age and older. Flublok Quadrivalent STN: 125285 Proper Name: Influenza Vaccine Tradename: Flublok Quadrivalent Manufacturer: Protein Sciences Corporation Indication: For active immunization against. Sanofi Pasteur Inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with Fluzone Quadrivalent during pregnancy. ACIP General Best Practice Guidelines for Immunization. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 47823. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. Swiftwater, PA: Sanofi3Lee JKH, Lam GKL, Shin T, et al. Requires Refrigeration. Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-422-88) (not made with natural rubber latex). Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination. Drug class: Viral vaccines. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 5, 2021, to select the influenza viruses for the composition of the influenza vaccine for the 2021-2022 U.S. influenza season. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury. Vaccine Administration: Making the Process More Efficient in Your people vaccinated annually with Sanofi's vaccines worldwide. Fluzone Quadrivalent is for people who are 6 months of age and older. McKesson Acceptable Dating: we will ship >= 30 days. However, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza vaccine that is otherwise appropriate for their age and health status. an A/Victoria/2570/2019 (H1N1) pdm09-like virus; an A/Cambodia/e0826360/2020 (H3N2)-like virus; a B/Washington/02/2019- like virus (B/Victoria lineage); a B/Phuket/3073/2013-like virus (B/Yamagata lineage). Study 2 (NCT02915302 see http://clinicaltrials.gov) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. (2019). The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Accessed, https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm, https://www.cdc.gov/flu/highrisk/index.htm, https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf, https://www.cdc.gov/flu/prevent/vaccine-selection.htm, https://www.nejm.org/doi/full/10.1056/nejmoa1315727. Swiftwater, PA: Sanofi2Fluzone High-Dose Quadrivalent [Prescribing Information]. Influenza Vaccine for the 2020-2021 Season | FDA Products: Comirnaty (COVID-19 vaccine) Sanofi U.S. 55 Corporate Drive Bridgewater, NJ 08807 Vaccines and biologics Fluzone Quadrivalent should not be combined through reconstitution or mixed with any other vaccine. Dosing for infants and children age 6 through 35 months: Afluria 0.25 mL Fluarix 0.5 mL Flucelvax 0.5 mL FluLaval 0.5 mL Fluzone 0.25 mL or 0.5 mL 4. Accessed June 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex. (See ref. Strength. Cookies used to make website functionality more relevant to you. Product Dating. Influenza Vaccine for the 2020-2021 Season Cumulative 2020/2021 Season Lot Release Status (Updated 2/24/2021) Flu vaccine lots that have been released by FDA and are available for. Do not use after the expiration date shown on the label. In Study 4 (NCT01218646) [see Adverse Reactions (6.1)], 660 adults 65 years of age and older were included in the per-protocol immunogenicity analysis. Saving Lives, Protecting People, Immunogenicity, Efficacy, and Effectiveness of Influenza Vaccines, Package inserts for U.S.-licensed vaccines. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. You will be subject to the destination website's privacy policy when you follow the link. Fluzone Quadrivalent is given to people 6 months of age and older. Influenza (seasonal) Fact Sheet. Available at: Warren-Gash C, et al. Inform the vaccine recipient or guardian: Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. Influenza disproportionately impacts people over 65, underrepresented communities, and people with co-morbidities such as diabetes, asthma, chronic obstructive pulmonary disease, and heart disease.7 Since 2010, it's estimated by the CDC that between 70% and 85% of seasonal flu-related deaths have occurred in people 65+, and between 50% and 70% of seasonal flu-related hospitalizations have occurred among people in this age group.4 ACIP's June 22nd recommendation will undoubtedly help reduce the risk of influenza cases and severe flu-related complications in this population at highest risk. 2019 Nov 20:1932296819883340, Kubale J, et al. Flu & People 65 Years and Older. It can lead to severe complications, increasing the risk of heart attack and pneumonia. During the 28 days following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE. Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Last updated on Nov 1, 2022. Sanofi Pasteur 49281040010 - McKesson Medical-Surgical This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Available at: https://www.cdc.gov/flu/highrisk/index.htm. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. This summary is not intended to take the place of talking with your healthcare provider. Accounts Receivable 800.453.5180 ** Fluzone Quadrivalent is currently licensed for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, 0.25-mL prefilled syringes are not expected to be available for the 202021 influenza season. Vaccine update: issue 337, April 2023 - GOV.UK In Study 2 (NCT02915302) [see Adverse Reactions (6.1)], 1027 children, 6 months through 35 months of age, were included in the per-protocol immunogenicity analysis. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. 3). Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed / Inactivated Poliovirus / Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, Preservative Free. A maximum of ten doses can be withdrawn from the multi-dose vial. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261). The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Among children 6 months through 8 years of age, unsolicited non-serious adverse events were reported in 1360 (47.0%) recipients in the Fluzone Quadrivalent group, 352 (48.0%) recipients in the TIV-1 group, and 346 (48.0%) recipients in the TIV-2 group. Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine. A world leader. For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common side effects were tenderness, and/or pain where you got the shot; headache, tiredness, muscle aches, and joint pain. COVID-19 Vaccine Lot Number and Expiration Date Tool. Ten SAEs were reported during the 28-day follow-up period: 5 (0.5%) in Group 1 and 5 (0.5%) in Group 2. What are the possible side effects of Fluzone Quadrivalent? Download the Seasonal Influenza Crosswalk table. Fluzone Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV, based on pre-specified criteria (the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). CDC twenty four seven. Tuberculin Purified Protein Derivative (Mantoux) - Food and Drug Procedures should be in place to avoid injury from fainting. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fluzone Quadrivalent and any potential adverse effects on the breastfed child from Fluzone Quadrivalent or from the underlying maternal condition. While patients can receive vaccinations from a variety of sources, offering them within the "medical home" leads to increased immunization rates. Td (sanofi pasteur) Age indications for use of products in the VFC program may differ from age indications on this guide or in the package inserts. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea, injection-site induration, and headache. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons 12 months through 35 months of age, or the deltoid muscle in persons 36 months of age.

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