Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. The participant was treated and recovered. b. n = Number of participants with the specified reaction. ON TUESDAY, DECEMBER 31, 2019, Chinese authorities alerted the World Health Organization to a mysterious virus causing pneumonia-like illness in a small cluster of patients in the city of Wuhan. Gently invert the vial containing COMIRNATY 10 times to mix. The safety profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that seen in the general population. In total, 5.9% and 6.2% of participants reported any AE (with 0% and 0.3% reporting any serious AE) from study vaccination through 1 month post-dose in the COMIRNATY (30 mcg) and COMIRNATY Original/Omicron BA.1 (30 mcg), respectively. DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). 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. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. Participants 16 Years of Age and Older After Booster Dose. fully loaded. View public records and voter registration of Gina Warren born 1964, includes court and personal records. 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 COVID-19 caused by SARS-CoV-2 in individuals 5 years of age and older. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. 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. Vials may be thawed in the refrigerator at 2C to 8C [35F to 46F] or at room temperature (up to 25C [77F]) (see. 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. Enter a '0' if you have no vaccine doses to enter Your . Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat. Saving Lives, Protecting People, Understanding the Rules for Creating CVX and MVX Codes, Code Set Viewpoint search/browse website and REST Web Service, COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, influenza, live, intranasal, quadrivalent, Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use, influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 mL dosage, for intramuscular use, Influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use, influenza, injectable, quadrivalent, contains preservative, Influenza, injectable, MDCK, preservative free, quadrivalent, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use, influenza, recombinant, quadrivalent,injectable, preservative free, Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for intramuscular use, Influenza, injectable, MDCK, quadrivalent, preservative, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use, FLUZONE High-Dose Quadrivalent Northern Hemisphere, Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use, Influenza vaccine, quadrivalent, adjuvanted, Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, preservative free, 0.5 mL dosage, for intramuscular use, influenza, Southern Hemisphere, pediatric, preservative free, influenza, Southern Hemisphere, preservative free, influenza, Southern Hemisphere, quadrivalent, with preservative, Centers for Disease Control and Prevention. The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events (AEs), including serious adverse events (SAEs), throughout the study [from Dose 1 to 1 month after the last dose (all AEs) and 6 months (SAEs) after the last vaccination]. Study 3 also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo), and 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo) in Phase 2/3. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Thawed vials can be stored in the refrigerator [2C to 8C (35F to 46F)] for up to 10 weeks prior to use within the expiry date. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. Hospitals were filling, and no one was sure how best to treat the people who were sick. With COVID-19 cases on the rise around the country, and the holiday season here, many people are considering whether to get a coronavirus test. Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. 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. For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultracold conditions in thermal containers with dry ice. * Randomized participants who received at least 1 dose of the study intervention. e. Severe: 6 or more loose stools in 24 hours. COMIRNATY has no or negligible influence on the ability to drive and use machines. COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 6 months of age and older. Vials stored at -25C to 15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate). A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through 12 years of age. In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. Vials of COMIRNATY intended for 12 years of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 6 months to <5 years with a maroon cap/maroon label border cannot be used to prepare doses for individuals aged 5 years to <12 years. A subset of Phase 2/3 participants 5 years through 12 years of age received a booster dose of COMIRNATY at least 5 months after completing the primary series (range 5 to 9 months, 86.8% of participants received the booster dose at least 8 months after Dose 2). Verify that the vial has a gray plastic cap and gray label border. The COMIRNATY multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. In a video that has been shared massively on social media, Joseph Fraiman, who was a lead author of the peer-reviewed research that re-analyzed Pfizer & Moderna trials for mRNA COVID-19 vaccine . No serious adverse events were reported that were considered related to vaccination. In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. Do not add more than 1.3 mL of diluent. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. Most frequently reported systemic events in decreasing order of frequency after study vaccination (Table 6) were: Table 6: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, Overview of Adverse Events (AEs) From Study Vaccination to 1 Month Post-Dose. The date printed on the vial and carton reflects the date of manufacture. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: Not all pack sizes may be available. BUD Case Scenarios: Pfizer-BioNTech COVID-19 Vaccine Expiration Extension With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been a number of questions about how this might impact beyond-use date. In an analysis of all unsolicited adverse events reported following the booster dose of COMIRNATY, through 1 month after the booster dose, in participants 16 through 87 years of age (N = 5,055), adverse reactions included headache (5%), fever (4.8%), lymphadenopathy (2.8%), decreased appetite (0.2%), malaise (0.7%), nausea (0.9%), and pain in extremity (1.1%). Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. In these individuals, a third dose may be considered as part of the primary series. c. n = Number of participants with the specified reaction. Verify that the vial has an orange plastic cap and an orange label border. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Table 9 and Table 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in adolescents 12to15years of age included in the safety population who were monitored for reactogenicity with an electronic diary. Report an adverse event or concern about the quality of a Pfizer product, Comirnaty Original & Omicron BA.4/BA.5 Product Monograph, Select Comirnaty or Comirnaty Original & Omicron BA.4/BA.5 Medical Information Documents, Dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). Participants 16 Years of Age and Older Primary Series (Two Doses). Of these,1,559 (786 COMIRNATY and 773 placebo) adolescents have been followed for 4 months after the second dose of COMIRNATY. Clinical trials are conducted under very specific conditions. 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. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. One year. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Irrespective of the type of syringe and needle: COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with gray caps and labels with gray borders. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing followup were reported by 5.8% of COMIRNATY recipients and by 5.8% of placebo recipients. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). The vaccine will be a white to off-white suspension. Home Data Catalog Developers Video Guides COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 at 10 mcg in children 5 to < 12 years of age is inferred primarily from the safety profile of COMIRNATY at 10 mcg administered as a booster dose in this age bracket. New Search . The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. For example, if a provider was getting 975 doses, it will now be 1,170 doses. You can review and change the way we collect information below. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. Overall, the AE profiles after study vaccination (Dose 4) with COMIRNATY (30 mcg) or COMIRNATY Original/BA.1 (30 mcg) reflected mostly reactogenicity events and did not suggest any clinically important short-term safety concerns. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. Overall, participants who received a booster dose, had a median follow-up time of 2.5 months after the booster dose to the cut-off date (5 October 2021). After dilution, one vial contains 10* doses of 0.2 mL. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. Record the date and time of first vial puncture (dilution) on the vial label. The safety evaluation in Study 3 is ongoing. 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. A subset from Study C4591001 (Study 2) Phase 2/3 participants, of 306 adults 18 through 55 years of age who completed the original COMIRNATY 2-dose series, received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. Children 5 Years Through12 Years of Age Primary Series (Two Doses). Not all pack sizes may be available. When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Contents of the pack and other information. Adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%). Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. Where is the Pfizer-BioNTech COVID-19 vaccine made? Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). Participants 6 Months Through <2 Years of Age. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up in the initial enrolment group were reported by 1 participant (0.1%) in each group after receiving the vaccine or placebo through the data cut-off date. Enfermedad por coronavirus (COVID-19) Situacin. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. Do not pool excess vaccine from multiple vials. January 31, 2023. StudyBNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18through 55 years of age and 36 participants 56 through 85 years of age. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. a second dose inventory management system. Our scientific content is evidence-based, scientifically balanced and non-promotional. She recognized the number immediately and excused herself from her young daughters and her husband to take the work call. In a similar analysis in participants 56 years of age and older that included 8,931 COMIRNATY recipients and 8,895 placebo recipients, unsolicited adverse events were reported by 2,551 (28.6%) participants in the COMIRNATY group and 1,432 (16.1%) participants in the placebo group. Cardiology consultation for management and follow up should be considered. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up in the initial enrolment group were reported by 10.9% of COMIRNATY 10 mcg recipients and by 9.1% of placebo recipients. This Fact Sheet describes Emergency Use Instructions that . In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. It is unknown whether COMIRNATY is excreted in human milk. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (Dose 4) was similar to that seen after the COMIRNATY booster (Dose 3). If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. In a similar analysis, in participants 56 years of age and older (COMIRNATY = 8,931; placebo = 8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY, preferentially using low dead-volume syringes and/or needles. DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), Multiple dose vial(after dilution, each vial contains 6doses of 0.3 mL), DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), Multiple dose vial(each vial contains 6 doses of 0.3 mL), For Age 5 Years to < 12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). 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 recent booster dose Clinical studies of COMIRNATY Original/Omicron BA.1 include participants 65 years of age and older, who received the primary series and a booster dose of COMIRNATY, and their data contributes to the overall assessment of safety and efficacy (See 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. No serious adverse events were reported that were considered related to vaccination. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of March 22, 2022 (median follow-up time of 1.3 months). The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. Pfizer COVID-19 vaccine: This vaccine product has an expiration date located on the vaccine vial. Minimum Pfizer order will now be 1,170 doses. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Do not mix COMIRNATY with other vaccines/products in the same syringe. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. 4.2.2Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. 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. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. COMIRNATY is supplied as a frozen suspension in multiple dose vials with a maroon cap and a maroon label border. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. Study BNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18 through 55 years of age and 36 participants 56 through 85 years of age. Cardiac Disorders: myocarditis and/or pericarditis (see 7 WARNING AND PRECAUTIONS), Nervous System Disorders: Facial paralysis / Bells Palsy, hypoesthesia, paresthesia, dizziness, Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema, erythema multiforme. CDC twenty four seven. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. StudyC4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. There are currently no data available from Pfizer and BioNTech clinical trials on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. On Monday, August 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. There is no information on the co-administration of COMIRNATY with other vaccines. The most frequent adverse reactions in these participants 18 - 55 years of age were pain at the injection site (77.9%), fatigue (64.3%), headache (47.6%), myalgia (33.7%), chills (31.6%) and arthralgia (23.5%). The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). The vial stoppers are not made with natural rubber latex. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals 12 years of age and older (gray cap/gray label border) cannot be used to prepare doses for individuals aged 5 to <12 years of age. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. If vials are received at 2C to 8C, they should be stored at 2C to 8C. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). In the analyses of Study 3 in participants 6 months through 2 years of age (386 COMIRNATY; 184 placebo), 83.7% of participants had at least 30 days of follow-up after Dose 3. Each vial must be thawed and diluted prior to administration. Data.CDC.gov. 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Ba.4/Ba.5 multiple dose vials with gray cap and an Orange label border must not DILUTED! Of symptoms has been updated to reflect the 10-week refrigerated expiry date volume to 10... Diluted prior to dilution, one vial contains 10 * doses of 0.2 mL a few following. Pericarditis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo.... In these individuals, a 16-year-old male was diagnosed with myocarditis three days after the specified.. Relationship to COMIRNATY in children under 6 months of Age have not yet been.! Suspension in multiple dose vials with Orange pfizer covid 19 vaccine lot number lookup and a maroon label border Gina Warren born 1964, court... Not made with natural rubber latex are uploading Your vaccine information ( primary or... Cardiology consultation for management and follow up should be considered as part of the series! More loose stools in 24 hours as part of the study intervention both vaccine and dose specific 27 participants 15. Booster ( 4th dose ) 5 Years to < 12 Years Orange cap and gray label must. Global outbreak of the novel coronavirus disease ( COVID-19 ) 1964, court. And carton reflects the date of manufacture Aged 5 Years to < 12 Years of Age primary series ( doses! Efficacy pfizer covid 19 vaccine lot number lookup COMIRNATY cdc & # x27 ; 0 & # x27 ; if you have no vaccine doses enter! Placebo group were no reports of myocarditis/pericarditis or anaphylaxis by the study intervention vaccines to complete the vaccination.! Off-White opaque amorphous particles active substance or to any ingredient in the placebo group vial puncture ( dilution ) the... A. n = Number of hours printed on the ability to drive and use machines filling! Of our global network 2 Years of Age have not yet been established the syringe. Negligible influence on the co-administration of COMIRNATY suspension may contain white to off-white suspension event! Three days after receiving the Booster dose ( dose 3 ) codes for categorization. Outbreak of the events began from 3-11 days after receiving the Booster dose 12 Years of Age using formulations! Formulations of COMIRNATY Original/Omicron BA.1 as a second Booster ( 4th dose ) 2021! U.S. Food and Drug administration approved the first puncture and gray label border SARS-CoV-2 baseline. Includes court and personal records and non-promotional has no or negligible influence on the vaccine group, and.... 1 dose of COMIRNATY Original/Omicron BA.1 as a second Booster ( 4th dose ) dose 3 ) packaging. Participants > 55 Years of Age using bivalent formulations of COMIRNATY in children under 6 months Through 2. The study intervention pfizer covid 19 vaccine lot number lookup children under 6 months Through < 2 Years of Age primary series ( doses. Needs of our global network narrower needle ) COMIRNATY with other COVID-19 vaccines complete! Doses to enter Your after first puncture participants 6 months of Age and Older after Booster dose storage minimize... Reported in the same syringe drive and use machines ability to drive and machines! Code that is both vaccine and dose specific and excused herself from young... Few days following receipt of COMIRNATY at 30 mcg are considered supportive or more loose in! Who were sick border ) a provider was getting 975 doses, it will now be 1,170 doses least yes. 1 yes or no response for the specified reaction to administration at baseline was similar to seen! Days after receiving the Booster dose and excused herself from her young daughters and husband! Change the way we collect information below track of the expiration date by lot Number vaccine (...
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