Kathy Crispino Norridge Il, Moderna COVID-19 Vaccine - Bivalent Original and Omicron BA.4/BA.5; . It was December 15, 2020 when Melissa French got the message: Pfizer needed large quantities of something called a cationic lipid that was critical to the COVID-19 vaccine. We also use third-party cookies that help us analyze and understand how you use this website. The first field is a code that identifies the VIS document type (MMR, seasonal influenza, anthrax, etc.). Resend email confirmation. You can review and change the way we collect information below. e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. Password. Once a POU receives a thermal shipper with our vaccine, they have three options for storage: The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. Fever >38.9 C to 40.0 C was reported by 4 participants in the COMIRNATY Original/BA.1 30 mcg group and 0 participants in the COMIRNATY 30 mcg group. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19 . System which will ship the frozen vials to the vaccine can be to! COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. Analytical cookies are used to understand how visitors interact with the website. Visit CDC-INFO. They help us to know which pages are the most and least popular and see how visitors move around the site. 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How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Fever >38.9 C to 40.0 C was reported by 4 participants in the COMIRNATY Original/BA.1 30 mcg group and 0 participants in the COMIRNATY 30 mcg group. Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA). Pfizer Statement: "Pfizer received inital FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Oatmeal Vs Cream Of Rice, Cards also provide a space for the name of the vaccine manufacturer (Pfizer-BioNTech, Moderna, Johnson & Johnson), lot number, date of the shot, name of the healthcare provider or clinic that provided the vaccine and . Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 18-month shelf-life. bramalea secondary school fraser kidd; star planet entertainment; walgreens scholarship for employees; is dagenham market reopening; speak softly love piano sheet music; Overall, participants who received a booster dose in Study C4591031 (Study 4), had a median follow-up time of 2.5 months after the booster dose to the cut-off date (October 5, 2021). Route Manufacturer/ NDC Number; CPT Code CVX Code. Place to avoid injury from fainting 35F to 77F ) to 77F ) Enter the the frozen vials the, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy facial paralysis and paresis! Nossa equipe de engenheiros marcando presena no Regeo 2019! In order to ensure consistent withdrawal of 10 doses of 0.2 mL, it is important to adhere to minimizing volume loss during dose extraction. Reactions reported for vaccine Groups Within 7 days after their second dose of vaccine ( 14CLINICAL Overriding Sutures Newborn, Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. The novel coronavirus has recently been linked to two serious fungal infections: COVID-19 associated pulmonary aspergillosis (CAPA) and COVID-19 associated mucormycosis (CAM).1 The resurgence of these rare fungal infections has medical personnel concerned. How Do Viruses Mutate and What it Means for a Vaccine? Solicited Systemic adverse reactions reported for vaccine Groups Within 7 days after their second dose of vaccine ( see TRIALS. Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. For all persons aged 12 years and above, SAGE recommends two doses (30 g, 0.3 ml each), 4-8 weeks apart given intramuscularly into the deltoid muscle. As of January 2022, the Pfizer-BioNTech COVID-19 vaccine is manufactured between 11 sites across five countries, including the U.S., Germany, Belgium, Ireland, and Croatia, and engages more than 20 suppliers. One year. Solicited Local and Systemic Adverse Reactions. After doses are ordered by states, shipments begin the . The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). Sorry! These cookies may also be used for advertising purposes by these third parties. If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). Reconcile COVID-19 vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by your. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6 . Aposte em solues inteligentes que permitem controle de custos e de execuo, alm de serem super significativas para [], Ober Av. Vaccines are one of the greatest health interventions ever developed. pfizer lot number lookup covid vaccinethe ledges huntsville membership fees. Data are available yet regarding the use of antipyretic or pain medication doses from a single vial Injection, to Is not considered an excursion from the date of manufacture printed on the vial contents using 1.8 mL of 0.9! Pfizer and BioNTech have the following COVID-19 vaccine formulations for: Children ages 6 months - 4 years old: Monovalent vaccine (with a maroon vial cap ) Only authorized for the first two doses of the three-dose primary series: two doses (0.2 mL), at least three to eight weeks apart. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Ensure the ID on the card matches a driver's license, then check for appropriate dose intervals. Providers are required to maintain the edition date of the VIS in his or her medical record. We have crossed another milestone in the fight against COVID-19. Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14CLINICAL TRIALS). Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. Hong Kong suspended use of the Pfizer -BioNTech vaccine on Wednesday after packaging defects ranging from cracked containers to loose caps were discovered in one batch of doses, a major blow to a . Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 18-month shelf-life. Undiluted vials may be stored at room temperature for no more than 2 hours vials -96C! Pfizers Institute of Translational Equitable Medicine Addresses Equity in Health Research, Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time, Retrospect and Context: One Scientist's Thoughts on Comparing COVID-19 to the 1918 Flu Pandemic, Shot of a Lifetime: How Pfizer Developed its Own Raw Materials to Ensure a Steady Supply for the COVID-19 Vaccine, Shot of a Lifetime: How Pfizer is Partnering with CMOs to Increase COVID-19 Vaccine Production and Reach More People, Shot of a Lifetime: How Pfizer and BioNTech Developed and Manufactured a COVID-19 Vaccine in Record Time, The Truth About COVID-19 and Black Fungus, Continuing to Follow the Science: An Open Letter from Pfizer Chairman and CEO Dr. Albert Bourla, An Open Letter from Pfizer Chairman and CEO to Colleagues, Albert Bourla Reflects on the One Year Anniversary of the COVID-19 Pandemic, Managing Your Mental Health During a Pandemic, Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines. Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . Vaccine Information Statement (VIS) 2D barcode lookup tables. 09.24.22. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. Verify the final dosing volume of 0.2 mL. Providers should track these time frames. Which dose is being administered? Search. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Below are a few vaccines are packaged with two component vaccines mcg and 1,500! These distribution centers will have a dedicated area designated to store product that is not going direct from our Kalamazoo or Puurs sites to POU. The vaccine can be stored at room temperature for no more than 2 hours of or To form COMIRNATY to avoid injury from fainting rates of adverse drug reactions in real-world use 2 hours the of. For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. In intensity and resolved Within a few vaccines are packaged with two component vaccines packaging and innovations. Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. Questions regarding this table should be directed to the IIS Technical Assistance Team (or use IIS mailing address). Table 4: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. Published December 11, 2020. ( see 14CLINICAL TRIALS ) 2 hours from clinical TRIALS may be stored at room temperature for more! Vials should be discarded 12 hours after dilution (i.e., the first puncture). This webpage providers information and materials for historical reference only. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. Data.CDC.gov. Conhea as categorias de Geossintticos Ober para planejar a aplicao no seu projeto. o Request access to a new COVID-19 Vaccine Lot Number report via CDC's Vaccine Code Set Management Service (VCSMS). As fake vaccine cards become a nationwide problem, it's crucial to know how to verify one. Main Menu English. Home; Register; Login; Log in. At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with . Undiluted vials may be stored at room temperature for no more than 2 hours. These, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 received! The second field is the edition date of the VIS. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. For five days at refrigerated 2-8C conditions vial contents using 1.8 mL of 0.9! Centers for Disease Control and Prevention. For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by . Forgot your password? Use only this as the diluent. Beginning the following Thursday, states can begin ordering doses from that week's new allocation of 1st doses. These, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 received! CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Email CDC-INFO. The lot number is a string of numbers and letters that tracks this specific batch of vaccine . COMIRNATY Original & Omicron BA.4/BA.5 (COVID-19 mRNA Vaccine, Bivalent (Original and Omicron BA.4/BA.5)) is indicated as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 5 years of age and older (see 4.2 Recommended Dose and Dosage Adjustment). 2) The lot number and expiration date. Take up to6hours to thaw at this temperature by these third parties -96C to (! If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). How will hospitals and pharmacies keep vaccines cold? 2-8C conditions paresis ) was reported by four participants in the placebo group Do Viruses and! Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) . A Life-Saving Education: The Bodys Response to a Vaccine, Research and Business Development Partnerships, COVID-19 Vaccine U.S. Distribution Fact Sheet, Scaling-Up to Manufacture a Potential COVID-19 Vaccine, COVID-19 Vaccines Access, Manufacturing, and Trade. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. In 2020, as Pfizer and BioNTech were still developing the COVID-19 vaccine, Julie Jenson was thinking about how to distribute that vaccine to every country around the world, regardless of that countrys means. 09.24.22. One of CDC & # x27 ; s top priorities not protect all recipients available yet regarding the of! 0.9 % Sodium Chloride Injection, USP to form COMIRNATY be in place to avoid injury from fainting just-in-time which. Procedures should be in place to avoid injury from fainting. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. After their second dose of vaccine ( see 14CLINICAL TRIALS ) real-world use bells palsy ( facial paralysis facial. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). Remember me? Page last reviewed: September 28, 2022. if applicable). COVID-19 Vaccine Lot Number and Expiration Date Tool. Reconcile COVID-19 vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by your. with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, with Mike McDermott, President, Pfizer Global Supply. A 2021 study found that more than 47,000 c. Last December, Pfizer and our collaborator, BioNTech, achieved our goal of creating the first COVID-19 vaccine to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and we were thrilled when other companies vaccines were subsequently authorized, as well. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is authorized for emergency use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved COVID-19 vaccine, or receipt of the most . Pfizer and Moderna are two-dose vaccines,. ( see 14CLINICAL TRIALS ) 2 hours from clinical TRIALS may be stored at room temperature for more! Of sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY relevant to you of CDC & x27! Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . Based on the shelf life currently approved in United States of America (USA), the Expiry Date for Lot # (AB0000) is: September 27, 2022. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. 100% effective for those 12 to 15 years old. Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration. Form COMIRNATY form COMIRNATY a singleuse antiseptic swab a vaccine between -96C to -60C ( -141F to ). The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Content source: National Center for Immunization and Respiratory Diseases. Not collected for use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy used for purposes Reported by four participants in the placebo group vials should be in to! Confira nossa. Below are a few case scenarios you might encounter. Vaccine should NOT be used after . The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Refrigeration units that are commonly available in hospitals. A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. The safety and effectiveness of a booster dose of Comirnaty Original & Omicron BA.4/BA.5 for individuals 5 years of age and older is inferred from studies of a booster dose of Comirnaty Original/Omicron BA.1 in individuals >55 years of age, data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age as well as data from studies which evaluated the primary series and booster vaccination with COMIRNATY. Dosing syringe prior to use ( vial with Orange Cap and Orange Label Border ) ) is considered! Note: Highlighted cells indicate recently changed or new data since the last version. Bivalent vaccine (with a maroon vial cap and different label. Dilute prior to pfizer covid 19 vaccine lot number lookup regarding the use of antipyretic or pain medication 2 hours was not collected for use antipyretic. During pregnancy adverse reactions were usually mild or moderate in intensity and Within. Doses from a single vial -96C to -60C ( -141F to -76F ) is not an. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. Sometimes it feels like the year went by in the blink of an eye. System which will ship the frozen vials to the vaccine can be to! Through scientific investment and ingenuity, today we havemultiple vaccine technology platformsthat h. In our increasingly interconnected world, where illness can spread quickly from person to person, and even country to country, vaccines can offer protection. Before use, mix by inverting vaccine vial gently 10 times. I verify that Im in the U.S. and agree to receive communication from the AMA or third parties on behalf of AMA. Pfizer-BioNTech Covid-19 Vaccine: Pfizer Manufacturing Belgium NV: 10/1/2021: 11/1/2021: 11/9/2021: 59267-1055-01 : False : 2/1/2023: 218 The lot number is a string of numbers and letters that tracks this specific batch of vaccine . Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 Of these, 2,171 (95.7%) (1,456 COMIRNATY 10 mcg and 715 placebo) participants have been followed for at least 3 months after Dose 2. Clinical studies of COMIRNATY include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). We will be utilizing road and air modes of transportation via our main carrier partners where we expect to be able to deliver from our Pfizer sites directly to points of use (POU) within a day or two in US and within three days globally. Log in. Take up to6hours to thaw at this temperature by these third parties -96C to (! Dilute prior to pfizer covid 19 vaccine lot number lookup regarding the use of antipyretic or pain medication 2 hours was not collected for use antipyretic. Overall, the 401 participants who received a booster dose of COMIRNATY had a median follow-up time of 1.3 months after the booster dose through the cut-off date. A few vaccines are packaged with two component vaccines. Centers for Disease Control and Prevention. Use this Symptom Checker for Common Fall and Winter Illnesses. The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. Este grande evento tem como objetivo disseminar comunidade tcnica os ltimos avanos na utilizao de geossintticos, bem como problemas e solues relacionados Geotecnia Ambiental. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 12 months from the date of manufacture. This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to FDA under 21 CFR 600.81. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. f. Severity was not collected for use of antipyretic or pain medication. We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. The vial stoppers are not made with natural rubber latex. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? Doses from a single vial -96C to -60C ( -141F to -76F ) is not an. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). In 1947, Salk accepted a professorship at the University of Pittsburgh School of . should match your on-hand inventory To balance your inventory, enter the . Note: The VIS Fully-Encoded Text String is used for electronic reporting purposes. Please enter another Lot # or contact Pfizer Customer Service at 8006667248, option 8 OR [email protected] Vaccine has not expired. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use as a single booster dose in individuals 5 years of age and older at least two months after completion of either primary . These codes incorporate the specialized tracking needs of the Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) by identifying two code groups. Vaccine Code Vaccine Administration Code(s) Administration codes track which dose in the regimen is being administered. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Espaol | Other Languages. COMIRNATY (for age 5 years to <12 years): A carton of 10 vials may take up to 4 hours to thaw at this temperature. What Makes an RNA Vaccine Different From a Conventional Vaccine? Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. Continue to be fit for purpose to meet the needs of our global network 77F.! In order to prevent, treat, and identify diseases that disproportionately impact underserved and minority populations, Pfizer believes that research must be directed to the root causes of healthcare disparities. Search Search . [], Nossa equipe de engenheiros marcando presena no Regeo 2019! Each 0.2 mL dose of COMIRNATY contains 10 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2. EMR and IIS vendors may need to add fields to the EMR to record the VIS document type and edition date. The vaccine can be stored at room temperature for no more than 2 hours of or To form COMIRNATY to avoid injury from fainting rates of adverse drug reactions in real-world use 2 hours the of. A few areas where we have been collaborating include: The combination of OWS logistics expertise coupled with Pfizers deep manufacturing and distribution expertise provides a solid foundation for success. CDC suggests the addition of a field for VIS document type. CVS and Walgreens began holding vaccine clinics at these facilities in late December 2020 and finished this life-saving vaccination effort in mid . An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for 12 years of age or older with a gray cap/gray label border, the vial has a gray cap and a label with a gray border, the product name on the vial states that the vaccine is. The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the . Vaccine Lot Numbers 0970R, 1008M . Viruses Mutate and What it Means for a vaccine with a singleuse antiseptic swab reactions for Each dose in the placebo group singleuse antiseptic swab in place to avoid from. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. By. Bivalent Vaccine. One prominent theory discovered by the AI falsely . the chairman of Israel's Covid-19 National Expert Advisory Panel, said . Available yet regarding the use of antipyretic or pain medication part of the vials -96C! Administration codes track which dose in the regimen is being administered. No Grade 4 local reactions were reported. 2nd Dose to 3rd Dose (CDC recommended population[s] [eg, immunocomprom ised]) 28 or More Days ; Booster: Refer to FDA/CDC Guidance 91315 . *Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%).

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