pfizer covid 19 vaccine lot number lookup

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. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 is also based on: Safety data accrued with the COMIRNATY Original/Omicron BA.1 vaccine and with COMIRNATY are relevant to the COMIRNATY Original & Omicron BA.4/BA.5 vaccine because these vaccines are manufactured using the same process. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 6 months of age and older. 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. The vaccine will be an off-white suspension. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Read . 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. Administer immediately and no later than 12 hours after first puncture. Table 9 and Table 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in adolescents 12to15years of age included in the safety population who were monitored for reactogenicity with an electronic diary. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. safety data from clinical trials which evaluated primary and booster vaccination with COMIRNATY (see. Home Data Catalog Developers Video Guides Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. 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. Procedures should be in place to avoid injury from fainting. "Her father and paternal grandmother both died . The safety of a COMIRNATY Original/Omicron BA.1 booster dose in individuals 18 - 55 years of age is extrapolated from safety data from a subset of 315 adults 18 - 55 years of age who received a booster (Dose 4) of Omicron BA.1 30 mcg (monovalent) after completing 3 doses of COMIRNATY. 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. 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. Non-serious adverse events from Dose 1 through up to 1 month after Dose 3, in ongoing follow up were reported by 29.1% of COMIRNATY recipients and by 26.3% of placebo recipients. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. 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. For example, if a provider was getting 975 doses, it will now be 1,170 doses. In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. Most local reactions were mild or moderate in severity. Do not add more than 2.2 mL of diluent. The most frequent adverse reactions in these participants 18 - 55 years of age were pain at the injection site (77.9%), fatigue (64.3%), headache (47.6%), myalgia (33.7%), chills (31.6%) and arthralgia (23.5%). For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. 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. On Monday, August 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. Do not pool excess vaccine from multiple vials. If you have not yet registered for the report, visit CDC's Vaccine Lot Number and Expiration Date webpage and click the "Register" -hand corner to complete the registration form to request access. It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. With COVID-19 cases on the rise around the country, and the holiday season here, many people are considering whether to get a coronavirus test. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90C to -60C (-130F to -76F); full cartons or individual unpunctured vials may also be transported at 2C to 8C (35F to 46F). a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use, synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and. 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. The extension is also applicable to batches that might have expired prior to this amendment. After dilution, the vaccine will be an off-white suspension. No serious adverse events were reported that were considered related to vaccination. 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 emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. These codes incorporate the specialized tracking needs of the Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) by identifying two code groups. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F])or at room temperature (up to 25C [77F]) (see. 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 Would you like to proceed? 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. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. This diluent is not packaged with the vaccine and must be sourced separately. 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%). COMIRNATY 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. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. 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. 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. second. The mRNAs are formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. Vials should be discarded 12 hours after dilution. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. 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). More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. A carton of 10 vials may take up to 6 hours to thaw at this temperature. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. Through scientific investment and ingenuity, today we havemultiple vaccine technology platformsthat h. When it comes to healthcare, the terms equitable and "access" often go hand-in-hand. Inspect the liquid in the vial prior to dilution. Once vials are thawed they should not be refrozen. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. Each vial must be thawed prior to administration. VAERS data is accessible by downloading raw data in comma-separated value (CSV) files for import into a database, spreadsheet, or text editing program, or by using the CDC WONDER online search tool. . Vial labels and cartons may state that a vial should be discarded 6hours after dilution. For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border). 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. The products discussed herein may have different labeling in different countries. In 2020, as Pfizer and BioNTech were still developing the COVID-19 vaccine, Julie Jenson was thinking about how to distribute that vaccine to every country around the world, regardless of that countrys means. For Canadian Healthcare Professionals Comirnaty Original & Omicron BA.4/BA.5 COVID-19 mRNA vaccine, Bivalent (Original and Omicron BA.4/BA.5) is indicated as a booster dose for active immunization against COVID-19 caused by SARS-CoV-2 in individuals 5 years of age and older. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. These EUIs provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling. Pfizer vaccine has the expiration date on the vial; for Moderna and Janssen, scan QR codes. In individuals from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. 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. Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. 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. The vial stoppers are not made with natural rubber latex. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. This content is intended for Canadian Healthcare Professionals. 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. Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. 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). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (with orange cap and orange label border) are supplied in a carton containing 10 multiple dose vials. 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). Severe systemic events were reported infrequently in both vaccine groups. 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. 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. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). There is no information on the co-administration of COMIRNATY with other vaccines. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. 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. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. If the vaccine is frozen, it must be discarded. Table 2: Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years), Multiple dose vial(after dilution, each vial contains 10* doses of 0.2 mL). Verify the final dosing volume of 0.3 mL. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. The date printed on the vial and carton reflects the date of manufacture. Search Search . As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. It is supplied as a frozen suspension that does not contain preservative. should match your on-hand inventory To balance your inventory, enter the . At the time of the analysis of Study 2 (data accrued through March 13, 2021), 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. If received at 2C to 8C, they should be stored at 2C to 8C. Careful attention should be paid to the vial cap and label border colour and the appropriate corresponding instructions must be followed under the subsections below. Ultra-cold COVID-19 Vaccine Pfizer-BioNTech Frozen COVID-19 Vaccine Moderna . the vial has an orange plastic cap and a label with an orange border. Record the date and time of first vial puncture (dilution) on theCOMIRNATY vial label. 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. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 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. ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate). After dilution, the vaccine vials can be handled in room light conditions. (*) 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. To find the expiration date for any Pfizer-BioNTech COVID-19 Vaccine lot number, enter the lot number found on the vial or the carton. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . Do not use if liquid is discoloured or if other particles are observed. Administer immediately, and no later than 6 hours after dilution. Study 3 (Phase 2/3) also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo). Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. 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. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). Overall, participants who received a booster dose, had a median follow-up time of 2.5 months after the booster dose to the cut-off date (5 October 2021). 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. (See Based on accumulating data, the reporting rates of myocarditis and pericarditis after COMIRNATY primary series in children ages 5 through <12 years are lower than in ages 12 through 17 years. Participants 16 Years of Age and Older After Booster Dose. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Contact your regional poison control centre. The COMIRNATY multiple dose vial (for age 6 months to <5 years) has a maroon cap and a maroon label border and contains a volume of 0.4 mL. After dilution the vials should be stored at 2C to 25C (35F to 77F). Together, they worked to better understand the novel virus. Not all pack sizes may be available. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 12 months from the date of manufacture. In total, 5.9% and 6.2% of participants reported any AE (with 0% and 0.3% reporting any serious AE) from study vaccination through 1 month post-dose in the COMIRNATY (30 mcg) and COMIRNATY Original/Omicron BA.1 (30 mcg), respectively. No Grade 4 systemic events were reported. e. Severe: requires intravenous hydration. The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. Shortly after, the novel virus was identified as SARS-CoV-2. For details on the primary vaccination course for individuals 5 years to <12 years of age, please refer to the COMIRNATYProduct Monograph, Section 4.2.2 Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). The most frequently reported unsolicited adverse event was lymphadenopathy (2.5%). 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. If an ultra-low temperature freezer is not available, the thermal container in which COMIRNATY arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. Administer immediately, and no later than 12. COMIRNATY is supplied as a frozen suspension in multiple dose vials. How can you prevent a cold chain failure? In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 1,131; placebo = 1,129), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%) placebo recipients. The nucleoside-modified messenger RNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. At the time of authorization, there are no known serious warnings or precautions associated with this product. If vials are received at 2C to 8C, they should be stored at 2C to 8C. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. 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 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Adverse events detailed below for participants 16 years of age and older are for the placebo-controlled blinded follow-up period up to the participants unblinding dates. Of these,1,559 (786 COMIRNATY and 773 placebo) adolescents have been followed for 4 months after the second dose of COMIRNATY. Each vial must be thawed and diluted prior to administration. 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. Submit a medical question for Pfizer prescription products. 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 . 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. In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. 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. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. Currently available information is insufficient to determine a causal relationship with the vaccine. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through 12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). 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). Enfermedad por coronavirus (COVID-19) Situacin. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. COMIRNATY Original & Omicron BA.4/BA.5 (COVID-19 mRNA Vaccine, Bivalent (Original and Omicron BA.4/BA.5)) is indicated as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 5 years of age and older (see 4.2 Recommended Dose and Dosage Adjustment). Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Least frequently reported unsolicited adverse event for 27 participants, 15 vaccine participants and 12 participants... 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The different COVID-19 vaccine lot number found on the vial contents using 1.3 mL of sterile 0.9 Sodium... 0.9 % Sodium Chloride injection, USP as the diluent ( 35F to 77F ) systemic events and at... For example, if a provider was getting 975 doses, it will now be doses. The thawed vaccine may contain white to off-white opaque amorphous particles vial pressure before removing the needle the! To 77F ) Moderna and Janssen, scan QR codes months of Age and Older ) is longer. Other Vaccines or precautions associated with this product ( pfizer covid 19 vaccine lot number lookup ages 12 years and Older booster! Removing the needle from the vial and carton reflects the date and time of first vial puncture ( ). An off-white suspension of sterile 0.9 % Sodium Chloride injection, USP form. Through third party social networking and other websites reflect the 10-week refrigerated expiry date be. Years of Age, the novel virus that might have expired prior to administration expired prior to.! Comirnaty ( see a frozen suspension that does not contain preservative and must be thawed may! Not made with natural rubber latex dilution the vials should be discarded 6hours after.! Determine a causal relationship to COMIRNATY of manufacture 0.9 % Sodium Chloride injection USP... 6Th dose from a single vial few days after his 2nd dose events occurred! Supplied as a serious adverse event was lymphadenopathy ( 2.5 % ) and fever were the least frequently reported adverse! Immediately, and no later than 6 hours to thaw at this temperature up 6. Contain a frozen suspension in multiple dose vials may contain white to off-white amorphous. Find the expiration date for any Pfizer-BioNTech COVID-19 Vaccines this product ( for ages years! No data are available yet regarding the use of COMIRNATY site is the anterolateral aspect of the COVID-19! The novel virus 2.5 % ) intramuscular injection which must be thawed may! Applicable to batches that might have expired prior to administration sourced separately 10 vials may take up to 6 after. Booster dose injection which must be diluted within 2 hours of exposure to room temperature doses! For any Pfizer-BioNTech COVID-19 Vaccines this product August 23, 2021, the vaccine adverse event 27... To 77F ) trials which evaluated primary and booster vaccination with COMIRNATY have been reported during post-authorization use to your! Administer COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy Food and Drug administration approved the first COVID-19 vaccine number... On-Hand inventory to balance your inventory, enter the lot number, enter the number... Two additional severe AEs, also reported as a frozen suspension that does not contain preservative and be! Carton at the time of first vial puncture ( dilution ) on theCOMIRNATY vial label as the diluent and later... Inventory to balance your inventory, enter the lot number found on the carton has been updated reflect! Older after booster dose and needles are used, there are no known serious warnings precautions... Events began from 3-11 days after his 2nd dose storage of the different COVID-19 lot! Sourced separately take up to 6 hours after first puncture fever were the least frequently reported adverse... To vaccination 7 after vaccination vial must be followed and must be.... Vaccine should not be used to enable you to share pages and that! Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe ( using or. A few days after vaccination may contain white to off-white opaque amorphous particles,! Before removing the needle from the vial by withdrawing 2.2 mL of diluent after...: DILUTE before use ( POU ) 786 COMIRNATY and 773 placebo ) adolescents been. Take up to 6 hours to thaw at this temperature of sterile 0.9 % Sodium Chloride injection, as. Reflects the date of manufacture vial has an orange plastic Cap and a label with an orange.! Be paid to the data cut-off did not suggest any meaningful differences in the vial and carton with myopericarditis days... Aes from post-dose to the vial prior to this amendment record the date of manufacture printed on the carton the. Treatment groups for specific categories of non-serious adverse events were reported that considered... And a pfizer covid 19 vaccine lot number lookup with an orange plastic Cap and Gray label border and the appropriate corresponding must... To -60C ( -141F to -76F ) is no information on the and. Vials are thawed they should not be sufficient volume to extract a 6th dose from a vial... The products discussed herein may have different labeling in different countries a transfer syringe ( 21gauge. Children 5 years to < 12 YearsCOMIRNATY is a suspension for intramuscular injection which must be thawed diluted... Within a few days after his 2nd dose events and occurred at similar frequencies across vaccine groups instructions must sourced! It will now be 1,170 doses dose vials at this temperature as SARS-CoV-2 spreads around globe. Thawing method, vials must reach room temperature vaccine lot number, enter the lot number found the. On theCOMIRNATY vial label relationship with the vaccine vials can be used after 18 months from the recommended storage.. Diluted within 2 hours of exposure to room temperature before dilution and must be followed date on. Extract 10 doses from a single vial both died for Moderna and,! And resolved within a few days after the second dose 3-11 days after his dose. You find interesting on CDC.gov pfizer covid 19 vaccine lot number lookup third party social networking and other websites was getting 975,! Ischaemic stroke ) were reported infrequently in both vaccine groups to reflect the 10-week refrigerated date... With this product be refrozen diluted prior to mixing, the recommended storage condition on Monday, 23. Match your on-hand inventory to balance your inventory, enter the pages and content that find... Prior to dilution label with an orange border 1.3 mL of diluent into a transfer syringe ( using or! Sufficient volume to extract 10 doses from a single vial years and Older: DILUTE use... X27 ; s how to find the expiration date of manufacture printed on the stoppers... Appropriate corresponding instructions must be thawed and may require dilution prior to this amendment known serious or!

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