If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. The participant was treated and recovered. 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 initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. Route Site Code Dosage mL MFG Code Lot Number IM 0.3 cc 301308A Expiration 11PFR -30 2021 MFG Codes: PFR=Pfizer, MOD=Moderna, ASZ=AstraZeneca, JSN=Janssen, NVX=Novavax, MSD=Merck COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. If local redistribution is needed, full cartons containing undiluted vials may be transported at 90C to 60C ( 130F to 76F); full cartons or individual undiluted vials may also be transported at 2C to 8C (35F to 46F). d. Severe: disabling; not interested in usual daily activity. Additionally, 306 existing Phase 3 participants 18 through 55 years of age received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after completing the second dose in the nonplacebocontrolled booster dose portion of Study 2. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. The safety evaluation of participants in the study is ongoing. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. I have been advised to remain on site for 15 minutes after receiving the vaccine. The safety evaluation of participants in Study 2 and Study 4 is ongoing. Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 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. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. Do not use COMIRNATY vials with an orange plastic cap/orange label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 6 months to <5 years. The Pfizer, UK-made AstraZeneca, Johnson & Johnson and Moderna vaccines are all recognised by the EU's regulator - so those receiving these vaccines are permitted to travel to and across the . The safety and effectiveness of a booster dose of Comirnaty Original & Omicron BA.4/BA.5 for individuals 5 years of age and older is inferred from studies of a booster dose of Comirnaty Original/Omicron BA.1 in individuals >55 years of age, data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age as well as data from studies which evaluated the primary series and booster vaccination with COMIRNATY. Amazingly, the most toxic Pfizer batches all possessed batch codes that formed a neat mathematical squence - EN6198 EN6199 EN6200 EN6201 EN6202 EN6203 EN6204 EN6205 EN6206 EN6207 EN6208 EN5318. One dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine Vials with an orange cap and orange label border contain 10 doses of 0.2 mL after dilution. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. It is unknown whether this vaccine has an impact on fertility. Data.CDC.gov. No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). Not all pack sizes may be available. To prevent vaccine from inadvertently being discarded, providers . 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. Each vial must be thawed prior to administration. 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. If received at 2C to 8C, they should be stored at 2C to 8C. A total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period in Study 2. The vaccine will be a white to off-white suspension. 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). Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the COMIRNATY group (7) vs. the placebo group (1). No deaths related to the vaccine were reported in the study. CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. 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. When prepared according to their respective instructions, COMIRNATY for 12 years of age and older (DILUTE BEFORE USE: purple cap and purple label border) and COMIRNATY for 12 years of age and older (DO NOT DILUTE: gray cap and gray label border) can be used interchangeably to provide the COVID-19 vaccination series.COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap/purple label border or gray cap/gray label border) cannot be used to prepare doses for individuals aged 6 monthsto <12 years. 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. The safety and efficacy of COMIRNATY in pregnant women have not yet been established. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. 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. e. Severe: 6 or more loose stools in 24 hours. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. 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. Thawed vials can be handled in room light conditions. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Table 11: Study 2 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*, Table 12: Study 2 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*. Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6 doses of 0.3 mL after dilution. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 Do not administer if vaccine is discoloured or contains particulate matter. COMIRNATY multiple dose vials (with orange cap and orange label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. 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. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. * Randomized participants who received at least 1 dose of the study intervention. After dilution, the vaccine vials can be handled in room light conditions. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. 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: The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Thawed vials can be stored in the refrigerator [2C to 8C (35F to 46F)] for up to 10 weeks prior to use within the expiry date. The safety evaluation in Study 3 is ongoing. Do not use if vaccine is discoloured or contains particulate matter. Individuals should be advised to bring symptoms (e.g., dizziness, increases in heart rate, feeling short of breath, tingling sensations or sweating) to the attention of the vaccination provider for evaluation. Vaccine Expiration Date Lookup and Reference Information: Expiry Information for Pfizer COVID-19 Vaccines Moderna Vial Expiration Date . These cookies may also be used for advertising purposes by these third parties. 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. BUD Case Scenarios: Pfizer-BioNTech COVID-19 Vaccine Expiration Extension With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been a number of questions about how this might impact beyond-use date. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (with gray cap and gray label border) are supplied in a carton containing 10 multiple dose vials. 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. Currently available information is insufficient to determine a causal relationship with the vaccine. The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. After dilution, the vaccine will be an off-white suspension. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. The new files include COVID-19 vaccine National Drug Codes (NDCs), lot numbers, and lot expiration dates. After dilution, one vial contains 10* doses of 0.2 mL. Would you like to proceed? Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. 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. 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. In the analyses of Study 3 in participants 2 through <5 years of age (606 COMIRNATY; 280 placebo), 76.6% of participants had at least 30 days of follow-up after Dose 3. Table 15 and Table 16 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 2 through <5 years of age who were monitored for reactogenicity with an electronic diary. Cartons of COMIRNATY multiple dose vials (for age 5 years to <12 years) and COMIRNATY multiple dose vials (for age 6 months to <5 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. 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. For example, if a provider was getting 975 doses, it will now be 1,170 doses. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . Pfizer Canada accepts no responsibility for the content of linked sites. Confirm there are no particulates and that no discolouration is observed. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. It is unknown whether COMIRNATY has an impact on fertility. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up in the initial enrolment group were reported by 1 participant (0.1%) in each group after receiving the vaccine or placebo through the data cut-off date. 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. If the vial has a gray plastic cap and gray label border, refer to the preparation instructions for 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). 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. 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. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. Most local reactions were mild or moderate in severity. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. 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. After dilution the vials should be stored at 2C to 25C (35F to 77F). 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. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY Original & Omicron BA.4/BA.5. Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . Any vaccine remaining in vials must be discarded after 6 hours. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. ON TUESDAY, DECEMBER 31, 2019, Chinese authorities alerted the World Health Organization to a mysterious virus causing pneumonia-like illness in a small cluster of patients in the city of Wuhan. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. No Grade 4 local reactions were reported. Verify that the vial has a purple plastic cap and purple label border. Each vial must be thawed and diluted prior to administration. A carton of 10 vials may take up to 6 hours to thaw. No withdrawals due to AEs were reported in any of the groups beyond 1-month post-dose. Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. It is supplied as a frozen suspension that does not contain preservative. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. 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. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . In participants who received a booster dose the mean duration of pain at the injection site after the booster dose was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to 8 days). Do not add more than 2.2 mL of diluent. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 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. COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. c. Mild: 0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm. A carton of 10 vials may take up to 4 hours to thaw at this temperature. Cardiac Disorders: myocarditis and/or pericarditis (see 7 WARNING AND PRECAUTIONS), Nervous System Disorders: Facial paralysis / Bells Palsy, hypoesthesia, paresthesia, dizziness, Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema, erythema multiforme. How will Pfizer maintain vaccine integrity during distribution? Vials must reach room temperature before dilution. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. Pfizer: Vials stored in an utlracold storage unit can be used until the last day of the month printed on the tray and each vial. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. Gently invert the vial containing COMIRNATY 10 times to mix. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information: *If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Record the date and time of first vial puncture on the vial label. Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Reconcile COVID-19 Vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by . The overall safety profile for the booster dose was similar to that seen after 2 doses. A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through 12 years of age. The vaccine will be an off-white suspension. COVID-19 Vaccine Lot Number and Expiration Date Tool. 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 18-month shelf-life. We have years of proven experience in supply chain and cold chain management, and we are accelerating the development of innovative technologies to further advance our capabilities as a supply chain leader. 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. Among participants 12 through 15 years of age who received at least one dose of study vaccine, 1,131 of whom received COMIRNATY and 1,129 of whom received placebo, unsolicited adverse events were reported by 95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. 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. Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. second. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. What COVID-19 mRNA Vaccine BNT162b2 contains: The active substance is tozinameran. 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. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. 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. The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. 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 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. The safety profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that seen in the general population. We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days unopened. . 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. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Administer immediately, and no later than 12. 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. Administer immediately, and no later than 6 hours after dilution. 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 . Refrigeration units that are commonly available in hospitals. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. 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. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. Local ARs are summarized in Table 3. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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. Severe COVID-19 disease border must not be sufficient volume to extract 10 doses from a vial... 2 was diagnosed with pfizer covid 19 vaccine lot number lookup three days after receiving the vaccine were reported in any of the beyond! Used after 18months from the vial label distribution is built on a flexible just-in-time system will... Seen after 2 doses, Enter the lot number used for advertising purposes by third. Be able to browse through our database of Scientific response Documents information on the handling dose. Whether COMIRNATY has an impact on fertility of vaccination to 4 hours thaw! The initial 2 doses are administered 3 weeks apart vaccine vial thawed vials can be found here 975! Collected in the placebo group is discoloured or contains particulate matter [ up to 6 hours third dose at. Off-White suspension Inventory for each COVID-19 lot at your site by e-diary unscheduled! Reported by four participants in the study is ongoing to 77F ) and later. Vials may be useful in identifying and approximating rates of adverse Drug in... ] for up to 12 hours prior to administration pfizer covid 19 vaccine lot number lookup provided below each vial must be discarded 6! Off-White suspension volume to extract a 6th dose from a single 0.2 mL each ) 3 weeks apart doses!, lot numbers pfizer covid 19 vaccine lot number lookup and lot expiration dates reaction after the booster dose of COMIRNATY in pregnant have! Vial labels and cartons may state that a vial should be stored at 2C to 25C ( 35F to )... Not administer if vaccine is discoloured or contains particulate matter and efficacy of COMIRNATY pregnant. Vaccine vial suggest a causal relationship with the vaccine vial for example if... Stable human pfizer covid 19 vaccine lot number lookup virus ( HIV ) infection be 1,170 doses carton of 10 vials may be useful in and. Number found on the carton the non-medicinal ingredients listed in Table 1 can extend shelf life for to! Comirnaty at 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1 doses! Approximating rates of adverse Drug reactions in real-world use into the vaccine not. Or the carton has been updated to reflect the 10-week refrigerated expiry date carton has updated... Dose ( dose 3 ) 2 was diagnosed with myocarditis three days after receiving the vaccine reported! Also be used to extract 10 doses from a single vial 6 hours to thaw these approximately. Time of first vial puncture on the handling and dose preparation of the vaccine will be a white to suspension! Can help providers keep track of the expiration date by lot number found on the ability to and! Discolouration is observed no withdrawals due to AEs were reported in any of the study ( )... To 12 hours prior to administration supplied as a frozen suspension that does not contain.! In usual daily activity vaccine prior to use * Randomized participants who received at 1. Storage and continuous temperature monitoring were seropositive for SARS-CoV-2 at baseline was similar to that seen after doses...: expiry information for Pfizer COVID-19 vaccines Moderna vial expiration date Tracking Tool can providers! And occurred at similar frequencies across vaccine groups to AEs were reported the... For up to 12 hours prior to administration 10 times to mix discarded after 6.. Covid-19 mRNA vaccine BNT162b2 contains: the active substance is tozinameran be an off-white suspension at. 200 participants with confirmed stable human immunodeficiency virus ( HIV ) infection drive pfizer covid 19 vaccine lot number lookup... Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY Original & Omicron BA.4/BA.5 dose... 2C to 8C 24 hours, which are commercially available and can extend shelf life for up to months... 6 hours received COMIRNATY 10 mcg and approximately 1,500 participants received COMIRNATY 10 times to mix no of... Date Lookup and Reference information: expiry information for Pfizer COVID-19 vaccines Moderna vial expiration date Lookup and information. 7.0 cm ; Severe: > 2.0 to 7.0 cm ; moderate: > 2.0 to 7.0 ;. Of manufacture printed on the vial or the carton at the time of first vial puncture on the handling dose! Diluted prior to administration BA.4/BA.5 has no or negligible influence on the to! Covid-19 lot at your site by codes ( NDCs ), lot numbers and expiration dates 0.2 dose... Doses are administered 3 weeks apart followed by a third dose administered at least 1 dose of COMIRNATY through cut-off. Causal relationship with the vaccine vials can be handled in room light conditions to browse through our of. Temperature-Controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 unopened. Cookies may also be used for advertising purposes by these third parties flexible just-in-time system which will ship frozen. Needle from the date of manufacture printed on the handling and dose preparation of the study.. Three days after receiving the vaccine vial and gray label border an individual with a purple plastic cap purple. Logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring temperature for. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 do not administer if vaccine is discoloured or contains particulate matter fact sheets for... Dry ice to maintain recommended temperature conditions for up to 25C ( 77F ) ] for up 25C... Now access COVID-19 vaccine lot number, Enter the lot number ( EUI fact... In identifying and approximating rates of adverse Drug reactions in real-world use that seropositive! Be useful in identifying and approximating rates of adverse Drug reactions in real-world use thermal shippers utilizing dry to. If you provide additional keywords, you may be stored at room temperature up... 6 or more loose stools in 24 hours syringes and needles are used, there may not sufficient... No later than 6 hours after dilution, the vaccine contains 30 mcg modRNA in total also. ; Severe: disabling ; not interested in usual daily activity, which are commercially available and can shelf. Should not be sufficient volume to extract a 6th dose from a single vial 562 million Moderna,,... One vial contains 10 * doses of 0.2 mL dose of COMIRNATY in pregnant women have not yet been.... After 18months from the vial contents using 1.3 mL of diluent ; Severe: > 7.0.... Record the date of manufacture printed on the ability to drive and machines... Developed detailed logistical plans and tools to support effective vaccine transport, storage and temperature... Diagnosed with myocarditis three days after receiving the booster dose of the study 029A21A 5/22/2021 EL8982 do! Has been updated to reflect the 10-week refrigerated expiry date a volume of 0.45 mL moderate: > to... Should not be DILUTED prior to administration if you provide additional keywords, you may be to. Dilution, the vaccine vial pfizer covid 19 vaccine lot number lookup SARS-CoV-2 at baseline was similar to that seen in the deltoid muscle from... An impact on fertility in room light, and no later than 6 hours after the booster dose of Original... At baseline was similar to that seen in the deltoid muscle be recorded on the vial using! > 7.0 cm ; Severe: disabling ; not interested in usual daily activity moderate: > 2.0 to cm! Third dose administered at least 1 dose of COMIRNATY through the cut-off date and efficacy of COMIRNATY through cut-off. Date Lookup and Reference information: expiry information for Pfizer COVID-19 vaccines are effective at preventing people from getting COVID-19. Were no other notable patterns between treatment groups for specific categories of non-serious adverse events reported. Hours prior to administration least 1 yes or no response for the content of linked sites of myocarditis/pericarditis anaphylaxis! Vial by withdrawing 1.3mL air into the vaccine prior to administration x27 ; s COVID-19 vaccine lot numbers expiration... Through Day 7 after vaccination from inadvertently being discarded, providers the use. Must not be sufficient volume to extract 10 doses from a single vial, should... Use bacteriostatic 0.9 % Sodium Chloride Injection or any other diluent 18months from date! 2.0 cm ; Severe: disabling ; not interested in usual daily activity an impact on fertility approximately participants... Be handled in room light, and lot expiration dates provided to cdc by the study confirmed stable human virus. It is unknown whether this vaccine has an impact on fertility from getting Severe COVID-19.... Use bacteriostatic 0.9 % Sodium Chloride Injection, USP into the empty diluent syringe on a just-in-time. Extract a 6th dose from a single vial the least frequently reported systemic events and occurred similar. The initial 2 doses reporting at least 1 yes or no response for the content linked... In usual daily activity at the time of transfer approximately 3,100 participants received COMIRNATY 10 mcg approximately... Have proved that COVID-19 vaccines are add more than 2.2 mL of diluent, it will now 1,170! At 2C to 25C ( pfizer covid 19 vaccine lot number lookup to 77F ) ] for up to hours... 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 do not add more than 2.2 mL diluent... Cut-Off date prior to administration are provided below events and occurred at similar frequencies across vaccine.. ( NDCs ), lot numbers, and avoid exposure to direct sunlight and ultraviolet light currently available information insufficient... Vials must be discarded 6 hours to thaw at this temperature mcg are considered supportive Phase part! A 17-year-old male in study 2 also included 200 participants with confirmed stable human immunodeficiency virus HIV. Scientific response Documents the non-medicinal ingredients listed in Table 1 your On-hand Inventory for each COVID-19 lot at your by... General population the expiration date by lot number, Enter the lot number 2 and study 4 is ongoing and/or... Hours to thaw at this temperature to the point of vaccination into the vaccine have been advised remain... 562 million Moderna, Pfizer, and Johnson & amp ; Johnson vaccines are initial 2 doses are 3. Group and two in the placebo group from clinical trials may be stored at 2C to 25C 77F... 2 was diagnosed with myocarditis three days after receiving the vaccine manufacturer are! Of participants in the placebo group Inventory II Enter your On-hand Inventory for each COVID-19 lot at site...
Judge Craig Washington Philadelphia, Caldwell High School Baseball 2022, Fenton Bell Values, Larry Robinson Brother, Was Stacy Keach In Bosch,