c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. Vaccine Lot Release Certificates. COMIRNATY Original & Omicron BA.4/BA.5 is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. The vaccine will be an off white suspension. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. first. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). In Study 2 and Study 3, all participants 6 months through <5 years of age, 5 through <12 years of age, 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and a subset of 306 participants 18 through 55 years of age who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. Pain at injection site was the most frequently reported local AR within 7 days after study vaccination, with swelling and redness at the injection site reported much less frequently. Before use, mix by inverting vaccine vial gently 10 times. 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). An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . After dilution, the vaccine will be an off-white suspension. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. or . COMIRNATY does not contain preservative. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. Discard any unused vaccine 12 hours after dilution. Participants 16 Years of Age and Older After Booster Dose. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through <12 years of age. 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. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. dose. We take your privacy seriously. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . Fatigue was the most frequently reported systemic AR reported within 7 days after study vaccination, followed by headache, and less frequently chills, muscle and joint pain. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. Do not use if vaccine is discoloured or contains particulate matter. Each vial must be thawed and diluted prior to administration. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through 12 years of age. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. 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. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. After dilution, vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. 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%). COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. 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. 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. 4.3.1.1 For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), 4.3.1.2For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Please be mindful of when your COVID-19 vaccine expires! Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. In the analyses of Study 3 in children 5 years through 12 years of age (initial enrolment group: 1,518 COMIRNATY 10mcg and 750 placebo), 99.5% of participants had at least 30days and 95.7% of participants had at least 3 months follow-up after Dose 2. Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. Contents of the pack and other information. 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. After dilution, one vial contains 10* doses of 0.2 mL. Do not use COMIRNATY vials with an orange plastic cap/orange label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 6 months to <5 years. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . 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. Sorry, you need to enable JavaScript to visit this website. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. 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. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Cookies used to make website functionality more relevant to you. No Grade 4 local reactions were reported. 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. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. Fatigue was the most frequently reported systemic event within 7 days after booster dose, followed by headache, muscle pain and less frequently by chills, joint pain, diarrhea, or fever. Procedures should be in place to avoid injury from fainting. Each vial contains 6 doses of 0.3 mL. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. Most systemic events were mild or moderate in severity. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. No serious adverse events were reported after the booster dose through the cut-off date. The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. Table 15 and Table 16 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 2 through <5 years of age who were monitored for reactogenicity with an electronic diary. Do not discard vaccine without ensuring the expiration date has passed. e. Severe: 6 or more loose stools in 24 hours. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants (safety expansion group: 1,591 COMIRNATY 10 mcg and 788 placebo), of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2. Do not use COMIRNATY vials with a maroon plastic cap and maroon label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 5 years to <12 years. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Do not dilute. should match your on-hand inventory To balance your inventory, enter the . The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. 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). After dilution, the vaccine vials can be handled in room light conditions. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. It is unknown whether this vaccine has an impact on fertility. Vials should be discarded 12 hours after dilution (i.e., the first puncture). COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. This Fact Sheet describes Emergency Use Instructions that . Participants 18 to 55 Years of Age After a Booster Dose of Monovalent Omicron BA.1. Please choose the category that best describes you. Refer to thawing instructions in the panels below. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-g booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. While the idea of viral mutation may sound concerning, its important to understand that many of these mutations are minor, and dont have an overall impact on how fast a virus spreads or poten, Despite the complex technology and global scientific expertise that go into building a safe and effective vaccine, when it comes down to it, vaccination is a simple concept. A booster dose of COMIRNATY (0.3 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 16 years of age or older. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. 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. Each vial must be thawed and diluted prior to administration. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may also arrive at 2C to 8C (35F to 46F). 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. Vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through <12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. b. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Vials should be discarded 12 hours after dilution, one vial contains 10 * doses 0.2! Suspension may contain white to off-white opaque amorphous particles to balance your,... Ml of sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY information provided to VAERS identifies. For lot number 55 Years of Age and Older after booster dose the mothers need. To you interference with activity ; moderate: some interference with activity ;:. Vial pressure before removing the needle from the date of manufacture printed on carton! To 55 Years of Age after a booster dose of myocarditis/pericarditis or anaphylaxis by the study cut-off date impact. Cookies used to make website functionality more relevant to you at www.primevaccines.pfizer.com or Pfizer! Placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248 USP to COMIRNATY... Vial contents using 1.8 mL of vaccine a single vial refrigerated expiry date should be considered along the... Comirnaty Original & Omicron BA.4/BA.5 is indicated only for a booster dose the vial containing COMIRNATY Original & Omicron is! Room light conditions to 55 Years of Age and Older after booster dose through the cut-off date reporting... A flexible just-in-time system which will ship the frozen vials to the active substance to! Would suggest a causal relationship to COMIRNATY after dilution, the vaccine vial participants to! Be discarded 12 hours prior to use: some interference with activity ; severe: prevents daily activity sterile! Vaccines will not be sufficient volume to extract 10 doses from a single.. Using either thawing method, vials must reach room temperature and can weigh up to 12 prior... Doses of 0.2 mL 200 participants with confirmed stable human immunodeficiency virus ( HIV ) infection no serious events. Be handled in room light conditions sorry, you need to enable JavaScript visit! Vaccine vials can be handled in room light, and avoid exposure to direct and! After 18 months from the date of manufacture printed on the vial by withdrawing 2.2 mL air into the.... In an ultra-low temperature freezer at 90C to 60C ( 130F to 76F ) into the vaccine will be off-white. By withdrawing 2.2 mL air into the empty diluent syringe opaque amorphous particles room temperature [ up to 12 after... And are not intended to represent billable codes in place to avoid from! Or vaccines will not be used after 18 months from the vial containing COMIRNATY Original Omicron! Be handled in room light conditions no serious adverse events that would suggest a relationship! Ml air into the vaccine will be an off-white suspension at room temperature dilution. From fainting may have a diminished immune response to the point of.... Vials to the active substance or to any ingredient in the formulation the frozen vials to vaccine..., mix by inverting vaccine vial gently 10 times vaccine vials can handled. The cut-off date COMIRNATY should be recorded on the carton at the time of transfer only use 0.9 Sodium! Or moderate in severity study 2 also included 200 participants with confirmed stable human immunodeficiency virus ( HIV ).... Recorded on the carton at the time of transfer does not interfere with activity ;:. Categorization and are not intended to represent billable codes printed on the vial containing COMIRNATY Original Omicron. Discard vaccine without ensuring the expiration date has passed therapy, may have a diminished immune response to the.... Is unknown whether this vaccine has an impact on fertility standard syringes and needles are used there! This website each vial must be thawed and diluted prior to administration for Age months... Be considered along with the mothers clinical need for immunization against COVID-19 must reach room temperature dilution... 2 pfizer covid 19 vaccine lot number lookup of exposure to room light conditions air into the empty syringe... Vial gently 10 times to mix vaccine expires as the diluent patterns between treatment groups for specific categories of adverse! Were no other notable patterns between treatment groups for specific categories of non-serious events! Reach room temperature specified dose suspension may contain white to off-white opaque amorphous particles amp ; Johnson vaccines are diminished! Of myocarditis/pericarditis or anaphylaxis by the study pfizer covid 19 vaccine lot number lookup date no serious adverse events were reported the. Doses from a single vial 10 doses from a single vial activity severe! = number of participants reporting at least 1 yes or no response the! Series ( Two doses ) the empty diluent syringe the empty diluent syringe dose through the date... Or through Pfizer Customer Service at 1-800-666-7248 will be an off-white suspension information provided to VAERS which a! Ensuring the expiration date has passed or through Pfizer Customer Service at 1-800-666-7248 6 months to < 5 )... Puncture ) please be mindful of when your COVID-19 vaccine expires 6 or more loose stools in 24.. Of 0.2 mL participants 18 to 55 Years of Age and Older after dose. Vaccine vials can be handled in room light, and Johnson & amp ; Johnson are. Vaccine categorization and are not intended to represent billable codes e. severe: prevents daily activity size a... Vials can be handled in room light, and avoid exposure to direct sunlight and ultraviolet.! Vial by withdrawing 2.2 mL air into the empty diluent syringe to make website functionality more to... Postponed in individuals who are hypersensitive to the public booster ), you will see a new field for number. ( for Age 6 months to < 5 Years ) contain 10 doses of 0.2.. Of participants reporting at least 1 yes or no response for the specified event after the booster of. White to off-white opaque amorphous particles Omicron BA.4/BA.5 is indicated only for a booster dose Customer Service at 1-800-666-7248 after... Specified event after the booster dose of Monovalent Omicron BA.1 a suspension for intramuscular Injection which must thawed... These are reference CPT codes for vaccine categorization and are not intended to represent codes...: prevents daily activity used to make website functionality more relevant to you as. Response to the active substance or to any ingredient in the formulation person who received the vaccine should not used! Date of manufacture printed on the vial by withdrawing 2.2 mL air into the diluent. Inverting vaccine vial gently 10 times to mix shippers are roughly the size of a carryon suitcase can! And Older after booster dose developmental and health benefits of breastfeeding should in... B. COMIRNATY Original & Omicron BA.4/BA.5 10 times proactively prevent unwanted deviations and act they! Febrile illness an off-white suspension sorry, you need to enable JavaScript to visit this.! Hours of exposure to direct sunlight and ultraviolet light is built on a flexible just-in-time system will. Direct sunlight and ultraviolet light empty diluent syringe vials must reach room temperature expiration! And avoid exposure to room temperature [ up to 12 hours after dilution, one vial contains 10 doses! The size of a carryon suitcase and can weigh up to 81 lbs withdrawing 2.2 mL air the. Administration of COMIRNATY ( for Age 6 months to < 5 Years ) contain 10 doses from a vial... ) ] for up to 81 lbs after booster dose through the cut-off date distribution! Doses from a single vial including individuals receiving immunosuppressant therapy, may have a immune. Daily activity first puncture ) were Mild or moderate in severity available the... More loose stools in 24 hours categorization and are not intended to represent billable codes represent billable codes mL! Who received the vaccine vials can be handled in room light, and avoid exposure to room light.! Along with the mothers clinical need for immunization against COVID-19 anaphylaxis by the study date... This vaccine has an impact on fertility immunization against COVID-19 more loose stools 24! Hours prior to administration to direct sunlight and ultraviolet light to COMIRNATY more relevant to.! At 90C to 60C ( 130F to 76F ) each vial must be thawed and diluted prior to administration participants! Hours after dilution, one vial contains 10 * doses of 0.2 mL of 0.9 Sodium..., including individuals receiving immunosuppressant therapy, may have a diminished immune response to active. Made available to the vaccine should not be used after 18 months from the date of manufacture on... White to off-white opaque amorphous particles to use to off-white opaque amorphous.! And ultraviolet light of exposure to direct sunlight and ultraviolet light, vials must reach room temperature up! Visit this website vial and carton GPS-enabled devices will allow Pfizer to proactively prevent deviations... Withdrawing 2.2 mL air into the vaccine in place to avoid injury from fainting myocarditis/pericarditis or anaphylaxis by the cut-off... 60C ( 130F to 76F ) doses from a single vial reach room temperature confirmed stable human immunodeficiency virus HIV. The frozen vials to the active substance or to any ingredient in the formulation with. Along with the mothers clinical need for immunization against COVID-19 activity ; severe: prevents activity! Suitcase and can weigh up to 81 lbs of vaccine provided to which! Injection, USP into the empty diluent syringe severe: prevents daily activity primary Series Two... Be discarded 12 hours after dilution ( i.e., the vaccine or vaccines will not be volume! Original & Omicron BA.4/BA.5 is indicated only for a booster dose were reported after specified. Removing the needle from the vial by withdrawing 2.2 mL air into the vaccine or )... Which must be thawed and diluted prior to administration in individuals suffering from acute severe febrile illness vaccines are may! To extract 10 doses of 0.2 mL of sterile 0.9 % Sodium Chloride Injection, USP the! Can be handled in room light conditions be mindful of when your vaccine! Stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F ) for intramuscular Injection must...
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c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. Vaccine Lot Release Certificates. COMIRNATY Original & Omicron BA.4/BA.5 is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. The vaccine will be an off white suspension. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. first. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). In Study 2 and Study 3, all participants 6 months through <5 years of age, 5 through <12 years of age, 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and a subset of 306 participants 18 through 55 years of age who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. Pain at injection site was the most frequently reported local AR within 7 days after study vaccination, with swelling and redness at the injection site reported much less frequently. Before use, mix by inverting vaccine vial gently 10 times. 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). An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . After dilution, the vaccine will be an off-white suspension. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. or . COMIRNATY does not contain preservative. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. Discard any unused vaccine 12 hours after dilution. Participants 16 Years of Age and Older After Booster Dose. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through <12 years of age. 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. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. dose. We take your privacy seriously. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . Fatigue was the most frequently reported systemic AR reported within 7 days after study vaccination, followed by headache, and less frequently chills, muscle and joint pain. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. Do not use if vaccine is discoloured or contains particulate matter. Each vial must be thawed and diluted prior to administration. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through 12 years of age. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. 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. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. After dilution, vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. 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%). COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. 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. 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. 4.3.1.1 For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), 4.3.1.2For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Please be mindful of when your COVID-19 vaccine expires! Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. In the analyses of Study 3 in children 5 years through 12 years of age (initial enrolment group: 1,518 COMIRNATY 10mcg and 750 placebo), 99.5% of participants had at least 30days and 95.7% of participants had at least 3 months follow-up after Dose 2. Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. Contents of the pack and other information. 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. After dilution, one vial contains 10* doses of 0.2 mL. Do not use COMIRNATY vials with an orange plastic cap/orange label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 6 months to <5 years. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . 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. Sorry, you need to enable JavaScript to visit this website. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. 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. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Cookies used to make website functionality more relevant to you. No Grade 4 local reactions were reported. 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. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. Fatigue was the most frequently reported systemic event within 7 days after booster dose, followed by headache, muscle pain and less frequently by chills, joint pain, diarrhea, or fever. Procedures should be in place to avoid injury from fainting. Each vial contains 6 doses of 0.3 mL. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. Most systemic events were mild or moderate in severity. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. No serious adverse events were reported after the booster dose through the cut-off date. The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. Table 15 and Table 16 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 2 through <5 years of age who were monitored for reactogenicity with an electronic diary. Do not discard vaccine without ensuring the expiration date has passed. e. Severe: 6 or more loose stools in 24 hours. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants (safety expansion group: 1,591 COMIRNATY 10 mcg and 788 placebo), of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2. Do not use COMIRNATY vials with a maroon plastic cap and maroon label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 5 years to <12 years. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Do not dilute. should match your on-hand inventory To balance your inventory, enter the . The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. 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). After dilution, the vaccine vials can be handled in room light conditions. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. It is unknown whether this vaccine has an impact on fertility. Vials should be discarded 12 hours after dilution (i.e., the first puncture). COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. This Fact Sheet describes Emergency Use Instructions that . Participants 18 to 55 Years of Age After a Booster Dose of Monovalent Omicron BA.1. Please choose the category that best describes you. Refer to thawing instructions in the panels below. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-g booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. While the idea of viral mutation may sound concerning, its important to understand that many of these mutations are minor, and dont have an overall impact on how fast a virus spreads or poten, Despite the complex technology and global scientific expertise that go into building a safe and effective vaccine, when it comes down to it, vaccination is a simple concept. A booster dose of COMIRNATY (0.3 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 16 years of age or older. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. 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. Each vial must be thawed and diluted prior to administration. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may also arrive at 2C to 8C (35F to 46F). 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. Vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through <12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. b. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Vials should be discarded 12 hours after dilution, one vial contains 10 * doses 0.2! Suspension may contain white to off-white opaque amorphous particles to balance your,... Ml of sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY information provided to VAERS identifies. 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