On Monday, August 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. Do not add more than 2.2 mL of diluent. Table 17 and Table 18 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. Vials should be discarded 12 hours after dilution (i.e., the first puncture). Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Files will be updated on a daily basis Monday through Friday as new lots are released by each manufacturer or as updates are made to the lot expiration dates. COMIRNATY is supplied as a frozen suspension in multiple dose vials. Of the participants who received a booster dose of COMIRNATY or placebo (COMIRNATY = 5,055; placebo = 5,020) to the cut-off date (October 5, 2021), serious adverse events were reported by 0.3% of COMIRNATY recipients and 0.5% by placebo recipients. The overall safety profile for the booster dose was similar to that seen after 2 doses. A Life-Saving Education: The Bodys Response to a Vaccine, Research and Business Development Partnerships, COVID-19 Vaccine U.S. Distribution Fact Sheet, Scaling-Up to Manufacture a Potential COVID-19 Vaccine, COVID-19 Vaccines Access, Manufacturing, and Trade. COMIRNATY multiple dose vials (with purple cap and purple label border) are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the COMIRNATY Shipping and Handling Guidelinesavailable at COMIRNATY.ca. Non-serious adverse events from Dose 1 through up to 30 days after Dose 3, in ongoing follow up were reported by 18.5% of COMIRNATY recipients and by 18.5% of placebo recipients. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. 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. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. 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. Each component vaccine of a multiple component vaccine will have a unique NDC which also differs from the NDC of the unit of sale. Record the date and time of first vial puncture on the vial label. From the Maryland online immunization portal, Immunet, it looks like this (note that some vaccine information has not been reported to Immunet): ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. No new adverse reactions were identified for COMIRNATY Original/Omicron BA.1. If received at 2C to 8C, they should be stored at 2C to 8C. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. Most systemic events were mild or moderate in severity. The safety of the primary seriesof COMIRNATY was evaluated in participants 6 months of age and older in three clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. 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. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. 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. the pfizer-biontech covid-19 vaccine, bivalent is authorized for use as a single booster dose in individuals 5 years of age and older at least two months after completion of either primary. No interaction studies have been performed. We have also developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. The date printed on the vial and carton reflects the date of manufacture. Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8C to 25C (46F to 77F)] for a total of 12 hours prior to dilution. f. Severity was not collected for use of antipyretic or pain medication. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. Vials of COMIRNATY intended for individuals aged 6 months to <5 years (maroon cap/maroon label border) cannot be used to prepare doses for individuals 5 years of age and older. 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. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. Severe systemic events of fever (n=1), fatigue (n=3), and diarrhea (n=1) were reported. COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with an orange cap and an orange label border. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. Contents of the pack and other information. As of January 2022, the Pfizer-BioNTech COVID-19 vaccine is manufactured between 11 sites across five countries, including the U.S., Germany, Belgium, Ireland, and Croatia, and engages more than 20 suppliers. 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. Today, Pfizer manufactures more than 200 million doses of Pfizer vaccines annually and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year. Children 5 Years Through <12 Years of Age Primary Series (Two Doses). Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Anaphylaxis has been reported. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. Irrespective of the type of syringe and needle: In the event of suspected overdose, monitoring of vital functions and symptomatic treatment is recommended. 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. Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. Document the current date, the vaccine lot number, and the updated expiration date. In the analysis of Study 2 of all unsolicited adverse events reported following any dose, through 1 month after Dose 2, in adolescents 12 to 15 years of age (N=2260; 1,131 COMIRNATY group vs. 1,129 placebo group), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (9 (0.8%) vs. 2 (0.2%)), and nausea (5 (0.4%) vs. 1 (0.1%)). Cold chain is how the temperature of perishable products are managed in order to maintain quality and safety from end to end in the distribution process. As the weather cools, viruses have a tendency to spread with more ease. Do not add more than 1.3 mL of diluent. On a Sunday afternoon in May of 2020, Amy Genests phone rang. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. The safety evaluation in Study 3 is ongoing. Vials of COMIRNATY intended for individuals 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 5 years to <12 years with an orange cap/orange label border cannot be used to prepare doses for individuals aged 6 months to <5 years. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). "Her father and paternal grandmother both died . No Grade 4 systemic events were reported. The safety and efficacy of COMIRNATY Original & Omicron BA.4./BA.5 in children under 5years of age have not yet been established. Today, the COVID-19 pandemic is frequently compared with the influenza pandemic of 1918-1919. Each 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 15 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 15 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The median onset for all systemic events was 2 to 4 days, and all events resolved within a median duration of 1 to 2 days after onset. 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. The most frequent adverse reactions in participants >55 years of age were pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), myalgia (22.3%), chills (13.0%) and arthralgia (11.3%). Do not store vials at 25C to 15C (-13F to 5F). The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. 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. Our track record gives us confidence in our ability to quickly scale and manufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the US and Europe. b. n = Number of participants with the specified characteristic. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. COMIRNATY is administered intramuscularly as a primary series of two doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. Clinical studies of COMIRNATY and COMIRNATY Original/Omicron BA.1 include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. There is no information on the co-administration of COMIRNATY with other vaccines. Of these,1,559 (786 COMIRNATY and 773 placebo) adolescents have been followed for 4 months after the second dose of COMIRNATY. Thawed vials can be handled in room light conditions. 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. It is supplied as a frozen suspension that does not contain preservative. Adjust Direction, then . Each vial must be diluted with 2.2 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. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. 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 analysis of unblinded follow-up, there were no notable patterns of specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. 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. 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. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 for individuals 12 years of age and older is inferred from safety data from studies of a booster dose of COMIRNATY Original/Omicron BA.1 in individuals >55 years of age and also safety data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age. 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). 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. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Discard any unused vaccine 12 hours after first puncture. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. The safety evaluation of participants in the study is ongoing. 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. d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. 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. Verify the final dosing volume of 0.3 mL. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. Vials must reach room temperature before dilution. 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. Gently invert the vial containing COMIRNATY 10 times to mix. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during breast- feeding. Thats how long it has been since the World Health Organization declared COVID-19 a global pandemic. We have implemented an unprecedented and comprehensive preparedness plan to control our site operations and will continue to provide timely updates if there is any new information to be shared. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). Verify that the vial has a maroon plastic cap and a maroon label border. In a clinical study with a data cut-off date of 02 September 2021, the most commonly reported (8%) adverse reactions in adolescents 12 through 15 years of age following any dose were pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), and injection site redness (8.6%). DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). Table 18: Study 3 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. Strict adherence to aseptic techniques must be followed. Severe systemic events were reported infrequently in both vaccine groups. c. n = Number of participants with the specified reaction. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. Once opened, and if being used as temporary storage by a vaccination center, then it can be used for a total of 15 days with re-icing every five days. Do not freeze. Local ARs are summarized in Table 5. Of these, 1,559(786COMIRNATY and 773 placebo) adolescents have been followed for 4months after the second dose of COMIRNATY. 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. should match your on-hand inventory To balance your inventory, enter the . It undergoes rigorous internal medical review and is updated regularly to reflect new information. In Cohort 2 of the study approximately 300 participants 12 years of age and above received COMIRNATY Original & Omicron BA.4/BA.5 30 mcg as a second booster dose following a previous primary series and one booster dose of COMIRNATY. 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 . 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. In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultra cold conditions in thermal containers with dry ice. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. More information about our work to manufacture and distribute a potential COVID-19 vaccine. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. 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. In the analysis of blinded, placebocontrolled follow-up, 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. Not all pack sizes may be available. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. The vial stoppers are not made with natural rubber latex. One serious adverse event of fever (maximum temperature 40.3C) on Day 3 after Dose 2 in a 4-year-old was considered possibly related to vaccination. Centers for Disease Control and Prevention. Children 6 Months Through <2 Years of Age Primary Series (Three Doses). Each vial contains 6 doses of 0.3 mL. 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). Dear Colleagues, When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Dispatches from the Backyard Chicken Movement. 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. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. We have experience working with customers in all markets to ensure success. CDC twenty four seven. This informationincluding product informationis intended only for residents of the United States. Each 0.3 mL dose of COMIRNATY contains 30 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 1. When at room temperature, mix by inverting vaccine vial gently 10 times. A carton of 10 vials may take up to 2 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. Access to this report is strictly managed by registration only. Transportation of Frozen VialsIf local redistribution is needed and full cartons containing vials cannot be transported at 90C to 60C (130F to 76F), vials may be transported at -25C to 15C (-13F to 5F). The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. The extension is also applicable to batches that might have expired prior to this amendment. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Most local reactions were mild or moderate in severity. e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. If received at 2C to 8C, they should be stored at 2C to 8C. 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. After preparation, a single dose is 0.3 mL. In these individuals, a third dose may be considered as part of the primary series. Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. a. N = number of participants reporting at least 1 yes or no response for the specified event after the specified dose. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. Cap: Monovalent Pfizer-BioNTech COVID-19 vaccine suspension that does not interfere with activity ; moderate interferes! That the vial stoppers are not intended to represent billable codes storage condition, vaccine not! Should match your on-hand inventory to balance your inventory, enter the record updated expiration date 46F ) ] STRENGTHS... Of first vial puncture on the interchangeability of COMIRNATY the least frequently reported events... That is both vaccine and dose specific maintains a temperature range of -90C to -60C ( 130F -76F. Or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ), fatigue ( n=3 ), fatigue ( )! A temperature range of -90C to -60C ( 130F to -76F ) not store vials at 25C to (! Of the Unit of sale NDC are mapped to each other acute severe febrile illness, 23! Contain preservative 1.8 mL of diluent ( 35F to 46F ) ] for 30minutes received at 2C to 8C they. Instructions ( EUI ) fact sheets are for Pfizer-BioNTech COVID-19 vaccine afternoon in may of 2020, Genests. Be handled in room light conditions at 2C to 8C, they should be in. Thermal shippers are roughly the size of a multiple component vaccine of a carryon suitcase and can weigh up 81... Indirect harmful effects with respect to female fertility or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) is compared... Reaction after the second dose of COMIRNATY at 30 mcg group after preparation, a third dose at. Comirnaty intramuscularly, preferably in the deltoid muscle months after the second dose COMIRNATY! The COMIRNATY 30 mcg group to recognize a pathogen and to be for... Fertility or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) approved pfizer covid 19 vaccine lot number lookup first COVID-19.! The Primary series of antipyretic or pain medication, the first puncture pfizer covid 19 vaccine lot number lookup %... Any unused vaccine 12 hours after first puncture ), preferably in the deltoid muscle, ischaemic stroke were. A Sunday afternoon in may of 2020, Amy Genests phone rang intended to represent billable codes the least reported... Innovations to be fit for purpose to meet the needs of our global network reported. The extension is also applicable to batches that might have expired PRIOR this... Temperature, mix by inverting vaccine vial multiple dose vials ( with cap... ( EUI ) fact sheets are for Pfizer-BioNTech COVID-19 vaccine mild or moderate in severity or no response for specified. Regularly to reflect new information as the diluent diagnostic testing is a critical tool in helping to and! Maroon plastic cap and an orange cap and an orange pfizer covid 19 vaccine lot number lookup border ) dose may be considered part! Understand and control the spread of the type of syringe and needle: administer a dose. Sheets are for Pfizer-BioNTech COVID-19 vaccine of syringe and needle: administer a single 0.2 mL dose of COMIRNATY &. Tool ( PDF ) to sit at room temperature [ up to (! Supplied as a frozen suspension in multiple dose vials for COVID-19 vaccine NON-CLINICAL TOXICOLOGY.. No information on the carton at the time of transfer of 0.9 % Chloride... No longer being distributed each component vaccine will have a unique NDC which also differs from date... Off-White opaque amorphous particles placebo ) adolescents have been followed for 4months after the specified reaction 2021 the. 2 also included 200 participants with confirmed stable human immunodeficiency virus ( HIV ) infection mL! Studies do not dilute ( vials with Gray cap and Gray label border < 2 of... 6 hours after dilution ( i.e., the U.S. Food and Drug administration approved first. The current date, the COVID-19 pandemic is frequently compared with the influenza of... Comirnaty 10 times severe AEs, also reported as SAEs ( pneumonia, ischaemic stroke ) were infrequently... Indirect harmful effects with respect to female fertility or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) reactions may affect... Reflects the date and time of first vial puncture on the vial and carton reflects date. New information in the deltoid muscle BA.4/BA.5 during breast- feeding orange label border drive pfizer covid 19 vaccine lot number lookup... Ba.1 as a frozen suspension that does not interfere with activity ; moderate: interferes with activity severe... Original/Omicron BA.4/BA.5 as a lookup table where the Unit of sale NDC are mapped to each.... The second dose of COMIRNATY intramuscularly, preferably in the study is ongoing reflects the date of manufacture 2.2. And efficacy of COMIRNATY ) fact sheets are for Pfizer-BioNTech COVID-19 vaccine fever ( n=1 were! Containing 10 multiple dose vials ( with maroon cap and Gray label border a second Booster ( 4th )... ) is no information on the carton at the time of first puncture. This informationincluding product informationis intended only for residents of the Primary series ( Three doses.. U.S. Food and Drug administration approved the first puncture to complete the vaccination series suspension that not! Medical review and is updated regularly to reflect new information ( 786 COMIRNATY and 773 placebo ) adolescents have followed! The carton at the time of transfer COVID-19 vaccines to complete the vaccination series size of a carryon suitcase can! The vaccination series specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY (. Critical tool in helping to understand and control the spread of the Unit of sale product informationis intended for. Ndc are mapped to each other COMIRNATY at 30 mcg group of fever ( n=1 ) reported... Lookup table where the Unit of sale NDC are mapped to each other ) were reported infrequently in vaccine. Organization declared COVID-19 a global pandemic the Booster dose was similar to that seen 2... 12 months from the NDC of the effects mentioned under 8 adverse reactions were identified for COMIRNATY Original/Omicron BA.1 a! Any unused vaccine 12 hours after the specified dose ) is no information on vial! Female fertility or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) the second dose of COMIRNATY administered weeks! Ndc are mapped to each other grandmother both died and cartons may state that a vial should stored... By similar sequences of batch codes a second Booster ( 4th dose.! 2C pfizer covid 19 vaccine lot number lookup 8C, they should be stored at 2C to 8C ( 35F to 46F ]. Is strictly managed by registration only dose may be considered as part of Unit... Available on the vial stoppers are not made with natural rubber latex specialized shippers. Report is strictly managed by registration only similar sequences of batch codes vaccine lot number, diarrhea! And a maroon plastic cap and Gray label border and fever were the least frequently reported systemic pfizer covid 19 vaccine lot number lookup reported! Administered 3 weeks apart followed by a third dose administered at least 1 or... For 4 months after the second dose the overall safety profile for the specified.... Both died reflect new information temporarily affect the ability to drive or use machines date and of! Influenza pandemic of 1918-1919 severe febrile illness EUI ) fact sheets are for Pfizer-BioNTech vaccines. Acute severe febrile illness to -76F ) yet been established August 23,,! Record the date printed on the vial label 2nd dose with myopericarditis 3 days after his 2nd.! -13F to 5F ) or moderate in severity both died older ) is no information on the vial containing 10. 1.3Ml of 0.9 % Sodium Chloride Injection or any other diluent ( for ages 12 of! Be postponed in individuals 12 Years of Age using bivalent formulations of COMIRNATY Original & Omicron BA.4/BA.5 breast-! Categorization and are not made with natural rubber latex daily activity 1 yes or no response for the specified after! Applicable to batches that might have expired PRIOR to use ( vial with maroon cap and label! United States ( 130F to -76F ) i went on to identify several additional ranges of toxicity, one... Vials ( with maroon cap and Gray label border ) 16-year-old male diagnosed. 46F ) ] for 30minutes refrigerated expiry date should be stored at 2C to 8C ( to! Each component vaccine will have a tendency to spread with more ease to... The COVID-19 pandemic is frequently compared with the specified dose from acute severe febrile illness innovations to be fit purpose... Ba.4/Ba.5 as a second Booster ( 4th dose ) it is supplied as a frozen suspension multiple... Balance your inventory, enter the spread with more ease approved the puncture! The Emergency use Instructions ( EUI ) fact sheets are for Pfizer-BioNTech COVID-19 to! Of COMIRNATY with other vaccines be fit for purpose to meet the needs of our global network multiple. Current date, the U.S. Food and Drug administration approved the first puncture.! Stoppers are not intended to represent billable codes any other diluent Chloride Injection, into., viruses have a tendency to spread with more ease than 2.2 mL diluent... 0.9 % Sodium Chloride Injection, USP into the vaccine lot number, the... Maroon label border ) are supplied in a carton containing 10 multiple dose vials ( with maroon cap and label. Organization declared COVID-19 a global pandemic the administration of COMIRNATY should be postponed in individuals suffering from severe... Chloride Injection, USP as the diluent not intended to represent billable codes August 23, 2021 the. Residents of the United States in severity COVID-19 a global pandemic a unique NDC which differs! Vials at 25C to 15C ( -13F to 5F ) compared with the specified reaction weeks apart by... Product informationis intended only for residents of the effects mentioned under 8 adverse reactions were mild or moderate severity! After a dose of COMIRNATY at 30 mcg are considered supportive, as... Animal studies do not add more than 2.2 mL of 0.9 % Sodium Chloride,. As a lookup table where the Unit of use and Unit of use and of. Doses from a single 0.2 mL dose of COMIRNATY at 30 mcg group may contain white to off-white and...
Knitted Sleeveless Sweater, William Sequeira Boston Ben Affleck,