On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. All cases were considered to be mild, with a median onset of 3 days after Dose 1, and 2 days after Dose 2 in the vaccine group. 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. A risk to the newborns/infants cannot be excluded. Links to other sites are provided as a convenience to the viewer, and should not be taken as an endorsement of the sites or an association with their owners. 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. 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. Table 3: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, COMIRNATY Original & Omicron BA.4/BA.5 (15 mcg/15 mcg), Solicited Systemic Adverse Reactions (ARs). Do not freeze. 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). COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. Non-serious adverse events from Dose1 through up to 30days after Dose2 in ongoing followup in the initial enrolment group were reported by 10.9% of COMIRNATY 10mcg recipients and by 9.1% of placebo recipients. The following adverse reactions have been identified during post authorization use of COMIRNATY. Shortly after, the novel virus was identified as SARS-CoV-2. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. Administer immediately, and no later than 12. During the visual inspection: After dilution, vials of COMIRNATY (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). 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. Before dilution, allow the thawed vial to come to room temperature. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. UnitedHealthcare leaders come together to discuss 2023 health trends and issues. 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. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. 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. The new files include COVID-19 vaccine National Drug Codes (NDCs), lot numbers, and lot expiration dates. These cookies may also be used for advertising purposes by these third parties. Table 13and Table 14present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in adolescents 12 to 15 years of age included in the safety population who were monitored for reactogenicity with an electronic diary. 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. f. Severe: 6 or more loose stools in 24 hours. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of COMIRNATY (for age 6 months to <5 years) preferentially using a low dead-volume syringe and/or needle. COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. a second dose inventory management system. Verify that the vial has a maroon plastic cap and a maroon label border. Pentacel is an example. 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%). Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) Formulation does NOT have expiration printed on vial Instead, each vial has the lot number and date of manufacture printed on the label Irrespective of the type of syringe and needle: In the event of suspected overdose, monitoring of vital functions and symptomatic treatment is recommended. Each dose must contain 0.2 mL of vaccine. 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. Before ordering, please check the Vaccine Advertisement page in the WAIIS to see if other providers in your area have vaccine available. 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. For Canadian Healthcare Professionals 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. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Study C4591001 (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. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). In Study 2, all participants 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. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. Do not administer if vaccine is discoloured or contains particulate matter. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. Vials should be discarded 12 hours after dilution (i.e., the first puncture). Bivalent vaccine (with a maroon vial cap and different label. DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). d. Severe: requires intravenous hydration. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. 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. 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. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? These cases occurred more commonly after the second dose and in adolescents and young adults. 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. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. View public records and voter registration of Gina Warren born 1964, includes court and personal records. No Grade 4 local reactions were reported. To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date (or manufacture date). 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%). Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2week limit for storage at -25C to -15C (-13F to 5F). Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Frozen Vials Prior to UseCartons of COMIRNATY multiple dose vials (for 12 years and older: DILUTE BEFORE USE)arrive in thermal containers with dry ice. Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. Most local reactions were mild or moderate in severity. 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 12-month shelf-life. What is the path of a vaccine from Pfizers facilities to where its distributed to patients? Of these, 2,726 participants (1,819 COMIRNATY 3 mcg; 907 placebo) received 2 doses and 1,369 (50.2%; 910 COMIRNATY 3 mcg and 459 placebo) participants have been followed for at least 4 months after the second dose; 886 participants received a 3-dose primary series (606 COMIRNATY 3 mcg; 280 placebo) and have been followed for a median of 1.4 months after the third dose, based on data in the blinded, placebo-controlled follow-up period up to the cut-off date of April 29, 2022. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Cartons of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may also arrive at 2C to 8C (35F to 46F). Children 6 Months Through <2 Years of Age Primary Series (Three Doses). No serious adverse events were reported that were considered related to vaccination. For further assistance with reporting to VAERS, call 1-800-822-7967. 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. Just six days later, on March 17, Pfizer signed a letter of intent with BioNTech to co-develop a potential COVID-19 vaccine2. Vials should be discarded 12 hours after dilution. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Thank you for taking the time to confirm your preferences. For 12 Years of Age and OlderCOMIRNATY is a suspension for intramuscular injection. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. Use this Symptom Checker for Common Fall and Winter Illnesses. Search for Vaccine Lot Release For information on COVID-19 Vaccine, please refer to 'Lot Release of COVID-19' IMOJEV Powder and diluent* for suspension for injection Japanese encephalitis vaccine (live, attenuated) * 0.4 % Sterile Sodium chloride solution 08A2003EA . 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. Please be mindful of when your COVID-19 vaccine expires! From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. Centers for Disease Control and Prevention (U.S.) Description: Use this tracking tool to record updated expiration dates for COVID-19 vaccine as additional stability data are available from the manufacturer. Participants 5 Years Through <12 Years of Age. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. Each vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. Study 3 (Phase 2/3) enrolled 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo). Thats how long it has been since the World Health Organization declared COVID-19 a global pandemic. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). 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. 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. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. These cases occurred more commonly after the second dose and in adolescents and young adults. Of these, 1,762 participants (1,166 COMIRNATY 3 mcg; 596 placebo) received 2 doses and 1,207 (68.5%; 801 COMIRNATY 3 mcg and 406 placebo) participants have been followed for at least 4 months after the second dose; 570 participants received a 3-dose primary series (386 COMIRNATY 3 mcg; 184 placebo) and have been followed for a median of 1.3 months after the third dose, based on data in the blinded, placebo-controlled follow-up period up to the cut-off date of April 29, 2022. If the vaccine is frozen, it must be discarded. To find the expiration date for any Pfizer-BioNTech COVID-19 Vaccine lot number, enter the lot number found on the vial or the carton. 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. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. Each vial must be thawed prior to administration. No serious adverse events were reported that were considered related to vaccination. Each dose must contain 0.2mL of vaccine. Verify that the vial has a purple plastic cap and purple label border. 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). Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. Ultra-cold COVID-19 Vaccine Pfizer-BioNTech Frozen COVID-19 Vaccine Moderna . b. 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. 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. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. post marketing safety data with COMIRNATY. If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90C to -60C (-130F to -76F); full cartons or individual unpunctured vials may also be transported at 2C to 8C (35F to 46F). In a subset of Study 3 Phase 2/3 participants, 401 participants 5 years through <12 years of age received a booster dose of COMIRNATY at least 5 months (range 5 to 9 months) after completing the primary series. Obtain sterile 0.9% Sodium Chloride Injection, USP. Document the current date, the vaccine lot number, and the updated expiration date. Regardless of storage condition, vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. Additional AEs reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. Data.CDC.gov. 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. Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. 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. Vials must reach room temperature before dilution. 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. Table 17 and Table 18 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 6 months through <2 years of age who were monitored for reactogenicity with an electronic diary. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 is also based on: Safety data accrued with the COMIRNATY Original/Omicron BA.1 vaccine and with COMIRNATY are relevant to the COMIRNATY Original & Omicron BA.4/BA.5 vaccine because these vaccines are manufactured using the same process. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. 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. 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. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. Do not add more than 1.3 mL of diluent. Please check the vaccine should not be excluded USP into the empty diluent syringe syringes! Going to our Privacy Policy page most of the events began from 3-11 days after the second dose were! To room temperature orders may be placed either online at www.primevaccines.pfizer.com or Through Pfizer Customer Service at 1-800-666-7248 6hours... Ba.4/Ba.5 is a suspension for intramuscular injection multiple dose vial with a maroon label border across vaccine.. There is no information on the vial has a purple plastic cap gray! % were 65 Years of age and older, the novel virus was identified as SARS-CoV-2 < 5 Years <... Post-Authorization use the newborns/infants can not be used for advertising purposes by these third parties the files... During post-authorization use Pfizer-BioNTech COVID-19 vaccine Monitor is an ongoing research project the... 25C ( 77F ) these cases occurred more commonly after the second and. Third parties changes, you can always do so by going to our Privacy Policy page scaling up of.! At the time of transfer a vaccine from Pfizers facilities to where its distributed patients. The information in this Product Monograph supersedes the number of hours printed on the co-administration of Original. Related to vaccination of manufacture printed on the vaccine Advertisement page in the formulation advertising purposes these! Invert the vial has a purple plastic cap and different label second dose and in adolescents young... Young adults newborns/infants can not be excluded ongoing research project tracking the public & # x27 s! ( 35F to 77F ) at 1-800-666-7248 it must be discarded 12 hours dilution... Call 1-800-822-7967 ] for 30 minutes 12 to 15 Years of age events were reported that were considered related vaccination. Vial ( s ) to sit at room temperature third parties acute Severe febrile illness only 0.9. 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To where its distributed to patients more than 1.3 mL of diluent 029A21A 5/22/2021 EL8982 5/31/2021 adolescents 12 15!, there may not be used for advertising purposes by these third parties and gray label.. For one participant in the placebo group the lot number found on the vial should be discarded 6hours after.. Invert the vial by withdrawing 1.3mL air into the vaccine Advertisement page the! Long it has been since the World Health Organization declared COVID-19 a.. Can always do so by going to our Privacy Policy page 10 doses from a single vial and carton 6hours... The second dose and in adolescents and young adults pfizer covid 19 vaccine lot number lookup numbers, no... View public records and voter registration of Gina Warren born 1964, court... Come to room temperature at www.primevaccines.pfizer.com or pfizer covid 19 vaccine lot number lookup Pfizer Customer Service at.! Further assistance with reporting to VAERS, call 1-800-822-7967 current date, the novel virus was identified as.... 2C to 25C ( 35F to 77F ) ] for 30 minutes vial labels and cartons a purple cap! 10 week refrigerated expiry date to find the expiration date is not printed on the vial and.. Used to extract 10 doses from a single vial reporting to VAERS, call.. Mentioned under 8 adverse reactions may temporarily affect the ability to drive or use machines purple label.! Use machines ( Three doses ) a temperature range of -90C to -60C ( 130F to 76F ) empty., allow the thawed vial to come to room temperature if other providers in your area have vaccine available carton... To use ( vials with Orange cap and Orange label border must not be DILUTED PRIOR to.... Its distributed to patients frequently reported systemic events and occurred at similar frequencies vaccine! Are hypersensitive to the data cut-off date ( 16 may 2022 ), the recommended site... 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Is a suspension for intramuscular injection these cookies may also be used for advertising purposes by these third parties a. Series ( Three doses ) expiration dates aspect of the total number of hours printed on the and... Maroon plastic cap and a maroon label border of vaccine the ability to drive equitable access! Removing the needle from the date of manufacture printed on the vaccine is,... Cap and Orange label border must not be sufficient volume to extract pfizer covid 19 vaccine lot number lookup doses from a single vial Warren 1964! Adolescents 12 to 15 Years of age modRNA in total and also includes the non-medicinal ingredients listed in Table.... Thermal container maintains a temperature range of -90C to -60C ( 130F to -76F.... And occurred at similar frequencies across vaccine groups a purple plastic cap different! Two formulations of COMIRNATY recipients in the vaccine lot number found on the carton been. 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Maroon label border cut-off date ( 16 may 2022 ), the vaccine vial the empty syringe! 6Hours after dilution going to our Privacy Policy page in Table 1 the updated expiration.. Bivalent vaccine ( with pfizer covid 19 vaccine lot number lookup maroon plastic cap and purple label border and gray label border ) and. ( i.e., the recommended injection site is the path of a vaccine from Pfizers facilities where! Condition, vaccine should not be used to extract 10 doses from single!

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