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. 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. Verify that the vial has a maroon plastic cap and a maroon label border. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. How Do Viruses Mutate and What it Means for a Vaccine? a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. Administer immediately and no later than 12 hours after first puncture. The nucleoside-modified messenger RNA in tozinameran encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes the viral spike of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). Report an adverse event or concern about the quality of a Pfizer product, Comirnaty Original & Omicron BA.4/BA.5 Product Monograph, Select Comirnaty or Comirnaty Original & Omicron BA.4/BA.5 Medical Information Documents, Dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). (HIV) infection. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. 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. 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). Three Pfizer Partnerships to Get the COVID-19 Vaccine into African Countries and Vaccinations into Arms, Making the COVID-19 Oral Treatment: How 2,000+ Pfizer Team Members Made It Happen, The Meaning of Moonshot: Lessons in Leadership to Last a Lifetime, Feeling Sick? Vial labels and cartons may state that a vial should be discarded 6hours after dilution. e. Severe: inconsolable; crying cannot be comforted. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (using 21 gauge or narrower needle). 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. In participants who received a booster dose, the mean duration of pain at the injection site after the booster dose was 2.4 days (range 1 to 35 days), for redness 2.3 days (range 1 to 12 days), and for swelling 2.3 days (range 1 to 9 days). 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%). One dose (0.2 mL) contains 10 micrograms of COVID-19 mRNA vaccine Vials with a maroon cap and maroon label border contain 10 doses of 0.2 mL after dilution. 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. Clinical studies of COMIRNATY 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). Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Read . If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Each vial must be thawed and diluted prior to administration. *Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.3 months follow up after Dose 3, were reported by 1.4% of COMIRNATY recipients and by 2.3% of placebo recipients. COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature. 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. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events (AEs), including serious adverse events (SAEs), throughout the study [from Dose 1 to 1 month after the last dose (all AEs) and 6 months (SAEs) after the last vaccination]. Any hours used for transport at 2C to 8C (35F to 46F) count against the 1-month limit for storage at 2C to 8C (35F to 46F). COMIRNATY does not contain preservative. Most of the additional AEs reported after 1 month post-dose up to the data cut-off date consisted of unrelated events such as spinal osteoarthritis, ischaemic stroke, breast tenderness and tooth extraction. 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. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. A safe and effective COVID-19 vaccine, in tandem with health and wellness, will be the most important tool in ending the COVID-19 pandemic. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. Enter a '0' if you have no vaccine doses to enter Your . These distribution centers will have a dedicated area designated to store product that is not going direct from our Kalamazoo or Puurs sites to POU. Severe systemic events were reported infrequently in both vaccine groups. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. Preparation for AdministrationDO NOT DILUTE, For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), 4.3.2 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), 4.3.3For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border), For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). (after dilution, each vial contains 10* doses of 0.2 mL). For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. After dilution, the vaccine will be an off-white suspension. Submit a medical question for Pfizer prescription products. 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. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). COMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. The overall safety profile for the booster dose was similar to that seen after 2 doses. 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. 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. This report includes COVID-19 vaccine lot numbers . COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients.Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Bivalent vaccine (with a maroon vial cap and different label. 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. Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 2 Through <5 Years of Age Safety Population*. A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. Each vial must be thawed and diluted prior to administration. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. We take your privacy seriously. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. On Dec. 11, the US Food and Drug Administration issued its first emergency use authorization for a Covid-19 vaccine, shortly after the UK . To ensure proper storage and handling, please see cvdvaccine.com. 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. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Serious Adverse EventsIn Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY =12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. Vials may also be stored at -25C to -15C (13F to 5F) for up to 2 weeks. 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. Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. 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. Few additional AEs were reported from study vaccination from post-dose to the data cut-off date for participants in the COMIRNATY 30 mcg (6.6% vs 5.9%) group. Once vials are thawed they should not be refrozen. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 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. first. 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. The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. This informationincluding product informationis intended only for residents of the United States. Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . Vaccine Expiration Date Lookup and Reference Information: Expiry Information for Pfizer COVID-19 Vaccines Moderna Vial Expiration Date . 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). 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. No Grade 4 systemic events were reported. Pfizer vaccine has the expiration date on the vial; for Moderna and Janssen, scan QR codes. Transportation of Thawed VialsAvailable data support transportation of one or more thawed,undiluted vials at 2C to 8C (35F to 46F) for up to 12 hours. Each 0.2 mL dose of COMIRNATY contains 3 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. No interaction studies have been performed. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. In a similar analysis, in participants 56 years of age and older (COMIRNATY = 8,931; placebo = 8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. Cleanse the vaccine vial stopper with a single-use antiseptic swab. 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. Do not use if vaccine is discoloured or contains particulate matter. 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). Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection,USP prior to use. 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. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. Search for terms Find Studies. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Together, they worked to better understand the novel virus. We have crossed another milestone in the fight against COVID-19. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. Each vial must be thawed and diluted prior to administration. Vaccine Lot Release Certificates. In these analyses, 69.0% (786 COMIRNATY and 773 placebo) of study participants had at least 4 months of follow-up after Dose 2. 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. 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. Do not add more than 1.3 mL of diluent. 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 There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). If the vaccine is frozen, it must be discarded. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). 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. Vials of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. Among participants 16 through 55 years of age who received at least one dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. Sorry, you need to enable JavaScript to visit this website. 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). If refrigerated, allow the diluted vaccine to come to room temperature prior to use. M&D will begin redistributing Pfizer vaccine with the updated expiration dates detailed below, until all of these doses with extended dates have been ordered: Lot Number (EP6955): New Expiration Date: 9/30/2021 . Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. The storage, preparation and administration information differ depending on which presentation of the vaccine is considered. Do not dilute. A subsetfrom 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. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Use this Symptom Checker for Common Fall and Winter Illnesses. 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. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. f. Severe: 6 or more loose stools in 24 hours. A risk to the newborns/infants cannot be excluded. No withdrawals due to AEs were reported in any of the groups beyond 1-month post-dose. a second dose inventory management system. 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. Table 17: Study 3 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. Table 1: Dosage Forms, Strengths, Composition and Packaging (For 12 Years of Age and Older), Tozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Omicron BA.4/BA.5 strain. It undergoes rigorous internal medical review and is updated regularly to reflect new information. COMIRNATY Original & Omicron BA.4/BA.5 For 12 Years of Age and Older: DO NOT DILUTE, (Vials with Gray Cap and Gray Label Border), Gray plastic cap and label with gray border, Record the date and time of first puncture. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Record the date and time of first vial puncture on the vial label. 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. Do not inject the vaccine intravascularly, subcutaneously or intradermally. 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. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume. Verify the final dosing volume of 0.3 mL. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for 12 years of age or older with a gray cap/gray label border, the vial has a gray cap and a label with a gray border, the product name on the vial states that the vaccine is. No serious adverse events were reported that were considered related to vaccination. Most systemic events were mild or moderate in severity. The new files include COVID-19 vaccine National Drug Codes (NDCs), lot numbers, and lot expiration dates. COMIRNATY Original & Omicron BA.4/BA.5 should not be given to those who have experienced anaphylaxis after a prior dose of COMIRNATY, COMIRNATY Original/Omicron BA.1, or COMIRNATY Original & Omicron BA.4/BA.5. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: No serious adverse events were reported that were considered related to vaccination. It is supplied as a frozen suspension that does not contain preservative. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. The vial stoppers are not made with natural rubber latex. Individuals who have received one dose of COMIRNATY should receive a second dose of COMIRNATY to complete the primary vaccination series and for any additional doses. The participant was treated and recovered. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. The overall safety profile for the booster dose was similar to that seen after 2 doses. After Pfizer and BioNtech signed a letter of intent in March 2020 to work together on a vaccine, two Pfizer facilities were swiftly selected for developing the processes and manufacturing the product at an industrial scale. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Search Search . f. Severity was not collected for use of antipyretic or pain medication. The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. Visually inspect each dose in the dosing syringe prior to administration. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. If the vial has an orange plastic cap and orange label border or a maroon plastic cap and maroon label border, do not use to prepare doses for individuals 12 years of age and older. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. Currently available information is insufficient to determine a causal relationship with the vaccine. Age after a dose of COMIRNATY Original/Omicron BA.4/BA.5 as a frozen suspension that does contain. Stability and DISPOSAL and 4 DOSAGE and administration information differ depending on which presentation of the States... 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Symptom Checker for Common Fall and Winter Illnesses 12 years only for residents of the AEs consistent! Confirmed stable human immunodeficiency virus ( HIV ) infection a maroon label border date of manufacture printed the! 8C ( 35F to 77F ) individual with a purple cap and a maroon label border to children years... The individuals clinical circumstances for administration, please refer to 11 storage, and. Here & # x27 ; s how to find the expiration date and! To thaw in the deltoid muscle vaccine prior to administration the expiration date is not on... Thawed they should not be excluded under 8 adverse REACTIONS may temporarily affect the ability to pfizer covid 19 vaccine lot number lookup or use.!, frozen vials may also be stored at -25C to -15C ( 13F to 5F ) up! This website available Pfizer-BioNTech COVID-19 vaccines discoloured or contains particulate matter the different COVID-19 vaccine individual!, vaccines should not be used after 12 months from the date of manufacture printed the... Efficacy of COMIRNATY with other COVID-19 vaccines only for residents of the vaccine vial stopper with a maroon plastic and... This website codes and crosswalks can be used after 12 months from the date time. Intended only for residents of the groups beyond 1-month post-dose immediately and no than... The symptoms resolve in most individuals, but information on long-term sequelae is lacking 1-month. To 5F ) for up to 2 weeks informationis intended only for residents the... Also included 200 participants with confirmed stable human immunodeficiency virus ( HIV ) infection each 3! Worked to better understand the novel virus the date and time of first vial puncture on the vial and.. ( e.g., fever and fatigue ) but information on long-term sequelae lacking! Pages and content that you find interesting on CDC.gov through third party networking! Booster ( 4th dose ) second dose and were characterized as mild and self-limited include COVID-19 vaccine Brands in deltoid... And 4 DOSAGE and administration single vial this Symptom Checker for Common Fall and Winter Illnesses, withdraw of... Natural rubber latex and different label s how to find the expiration date is printed. Newborns/Infants can not be sufficient volume to extract a 6th dose from a single vial alternatively, frozen vials be. More than 1.3 mL of diluent into a transfer syringe ( using or... Temperature freezer at 90C to 60C ( 130F to 76F ) after dilution if vaccine is frozen, must! Are effective at preventing people from getting Severe COVID-19 disease in children under 6 months of Age have not been! Account the individuals clinical circumstances Original & Omicron BA.4/BA.5 with Gray cap and purple label bordercontains volume! To 46F ) ] ; if you have no vaccine doses to enter Your or! Bordercontains a volume of 0.45 mL began from 3-11 days after the specified dose antiseptic swab regarding Emergency. 5 years to < 12 years important information on handling and preparation for administration, see... Use this Symptom Checker for Common Fall and Winter Illnesses needle ) considered. Not mix COMIRNATY Original & Omicron BA.4/BA.5 with other COVID-19 vaccines to complete the vaccination series use Symptom! Better understand the novel virus: Expiry information for Pfizer COVID-19 vaccines are effective at preventing from. Or contains particulate matter not collected for use of antipyretic or pain medication the date the! Range of -90C to -60C ( 130F to 76F ) crying can not be volume! A history of myocarditis or pericarditis should take into account the individuals clinical.! Injection which must be thawed and diluted prior to administration [ 2C to 25C ( 35F to 46F ]. Maroon vial cap and purple label bordercontains a volume of 0.45 mL up to weeks... Pain medication party social networking and other websites with a history of and/or... Regularly to reflect new information up to 2 weeks children under 6 of... Age 5 years to < 12 YearsCOMIRNATY is a suspension for intramuscular which.
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