pfizer covid 19 vaccine lot number lookup

Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. A little over 100 years ago, about 500 million people, or one-third of the global population at the time, fell ill. At least 50 million died, with 675,000 deaths occurring in the U.S.1 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. Confirm there are no particulates and that no discolouration is observed. Administer immediately, and no later than 6 hours after dilution. This diluent is not packaged with the vaccine and must be sourced separately. Vaccine Expiration Date Lookup and Reference Information: Expiry Information for Pfizer COVID-19 Vaccines Moderna Vial Expiration Date . These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. Vials must reach room temperature before dilution. The safety evaluation in Study 3 is ongoing. On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees . o Request access to a new COVID-19 Vaccine Lot Number report via CDC's Vaccine Code Set Management Service (VCSMS). The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. Here are some examples of where to find the lot number, depending on your data source. Do not add more than 1.3 mL of diluent. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. or . COMIRNATY Original & Omicron BA.4/BA.5 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE, (Vials with Orange Cap and Orange Label Border), Orange plastic cap and label with orange border. A few areas where we have been collaborating include: The combination of OWS logistics expertise coupled with Pfizers deep manufacturing and distribution expertise provides a solid foundation for success. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. COMIRNATY is supplied as a frozen suspension in multiple dose vials. How is Pfizer utilizing a cold chain process to distribute its vaccine? 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. The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. StudyBNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18through 55 years of age and 36 participants 56 through 85 years of age. We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. Visually inspect each dose in the dosing syringe prior to administration. 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. 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. The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. Additional adverse events reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). 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. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for age 5 years to <12 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Below are a few case scenarios you might encounter. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. Not all pack sizes may be available. 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). 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. Inspect the liquid in the vial prior to dilution. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. 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. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). A carton of 10 vials may take up to 4 hours to thaw at this temperature. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. 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. COVID-19 vaccine, receive an additional dose of hat same mRNA . The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. 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 benefits and risks of the Pfizer COVID 19 vaccine and had the chance to ask questions which were answered to my satisfaction. Cardiology consultation for management and follow up should be considered. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. All participants were monitored for solicited local and systemic reactions and use of antipyretic medication after vaccination with an electronic diary during the 7 days following the dose of vaccination. The date printed on the vial and carton reflects the date of manufacture. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 12 years of age and older. 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). Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). Thank you for taking the time to confirm your preferences. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). 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. However, the vaccines do not only reduce the chance . Vials should be discarded 12 hours after dilution. 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. Do not dilute. 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%). 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. If received at 2C to 8C, they should be stored at 2C to 8C. One serious adverse event of fever (maximum temperature 40.3C) on Day 3 after Dose 2 in a 4-year-old was considered possibly related to vaccination. Dispatches from the Backyard Chicken Movement. 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. Ultra-cold COVID-19 Vaccine Pfizer-BioNTech Frozen COVID-19 Vaccine Moderna . The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. Participants 5 Years Through12 Years of Age. 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. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing followup were reported by 5.8% of COMIRNATY recipients and by 5.8% of placebo recipients. In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2,260 adolescents (1,131 COMIRNATY; 1,129 placebo) were 12 to 15 years of age. 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 . The liquid is a white to off-white suspension and may contain. Of these, 2,726 participants (1,819 COMIRNATY 3 mcg; 907 placebo) received 2 doses and 1,369 (50.2%; 910 COMIRNATY 3 mcg and 459 placebo) participants have been followed for at least 4 months after the second dose; 886 participants received a 3-dose primary series (606 COMIRNATY 3 mcg; 280 placebo) and have been followed for a median of 1.4 months after the third dose, based on data in the blinded, placebo-controlled follow-up period up to the cut-off date of April 29, 2022. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. 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 . Vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. Each vial must be thawed prior to administration. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.4 months follow-up after Dose 3, were reported by 0.7% of COMIRNATY recipients and by 0.9% of placebo recipients. Among the participants, the median age was 53.0 years (range 16 through 87 years of age), including 1,175 booster dose recipients (23.1%) who were 65 years of age, 49.1% were male and 50.9% were female, 79.0% were White, 14.9% were Hispanic/Latino, 9.2% were Black or African American, 5.5% were Asian, and 1.7% were American Indian/Alaska Native. Severe local reactions were reported by 1 (1.0%) participant in the 12 to 17 years of age group who received a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 30 mcg. Verify the final dosing volume of 0.3 mL. (HIV) infection. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. 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. Verify that the vial has a purple plastic cap and purple label border. If received at 2C to 8C, they should be stored at 2C to 8C. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. e. Severe: inconsolable; crying cannot be comforted. 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. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. After dilution the vials should be stored at 2C to 25C (35F to 77F). 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. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) This product information is intended only for residents of the United States. A risk to the newborns/infants cannot be excluded. Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. d. Severe: requires intravenous hydration. Children 5 Years Through 12 Years of Age After Booster Dose. Document the current date, the vaccine lot number, and the updated expiration date. 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. Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2week limit for storage at -25C to -15C (-13F to 5F). Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. 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). Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. 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. f. Severity was not collected for use of antipyretic or pain medication. 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. The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. 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). COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. The vial stoppers are not made with natural rubber latex. 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. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine. Do not use if vaccine is discoloured or contains particulate matter. 4.2.3Vaccination Schedule for Individuals Aged 6 Months to <5 Years. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultracold conditions in thermal containers with dry ice. In Study C4591031 (Study 4), a placebo-controlled booster study, participants 16 years of age and older recruited from Study C4591001 (Study 2) received a booster dose of COMIRNATY (5,081 participants), or placebo (5,044 participants) at least 6 months after the second dose of COMIRNATY. Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications Overview List of applications received List of authorized products Date published: 2022-12-09 Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here. 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. 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. 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. d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Refer to thawing and dose preparation instructions in the panels below. In the analysis of Study 2 of all unsolicited adverse events reported following any dose, through 1 month after Dose 2, in adolescents 12 to 15 years of age (N=2260; 1,131 COMIRNATY group vs. 1,129 placebo group), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (9 (0.8%) vs. 2 (0.2%)), and nausea (5 (0.4%) vs. 1 (0.1%)). Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. Note: Events and use of antipyretic or pain medication were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. b. n = Number of participants with the specified reaction. 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. After dilution the vials should be stored at 2C to 25C (35F to 77F). Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C (35F to 46F) . 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. CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. Submit a medical question for Pfizer prescription products. All information these cookies collect is aggregated and therefore anonymous. Solicited Local and Systemic Adverse Reactions. Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14CLINICAL TRIALS). Once thawed and stored under 2-8C conditions, the vials cannot be re-frozen or stored under frozen conditions. 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. 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. An Open Letter from Albert Bourla to Pfizer Employees Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Participants 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]. In an analysis of all unsolicited adverse events reported following the booster dose of COMIRNATY, through 1 month after the booster dose, in participants 16 through 87 years of age (N = 5,055), adverse reactions included headache (5%), fever (4.8%), lymphadenopathy (2.8%), decreased appetite (0.2%), malaise (0.7%), nausea (0.9%), and pain in extremity (1.1%). The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 for individuals 12 years of age and older is inferred from safety data from studies of a booster dose of COMIRNATY Original/Omicron BA.1 in individuals >55 years of age and also safety data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age. 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. Use only this as the diluent. The vaccine will be an off white suspension. 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. This diluent is not packaged with the vaccine and must be sourced separately. 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. Discard any unused vaccine 12 hours after dilution. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. Check Your COVID-19 Vaccine Expiration Dates Several lots of Pfizer, Moderna, and J&J COVID-19 vaccine product have their expiration dates in June and July. 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. Not all pack sizes may be available. A 2021 study found that more than 47,000 c. Last December, Pfizer and our collaborator, BioNTech, achieved our goal of creating the first COVID-19 vaccine to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and we were thrilled when other companies vaccines were subsequently authorized, as well. 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. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. 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. A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals 12 years of age and older (gray cap/gray label border) cannot be used to prepare doses for individuals aged 5 to <12 years of age. How will hospitals and pharmacies keep vaccines cold? Additional data assessed by the MHRA that support the use of COVID-19 mRNA Vaccine BNT162b2 as a heterologous booster dose are based on the COV-Boost study [EudraCT Number: 2021-002175-19), which . Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. 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. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. 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. 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%). 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. Regardless of storage condition, vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). Hospitals were filling, and no one was sure how best to treat the people who were sick. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID . We have also developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. 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. To COMIRNATY f. Severity was not collected for use of antipyretic or pain medication they should be stored 2C! Than 1.3 mL of sterile 0.9 % Sodium Chloride Injection, USP form. Participants with the mothers clinical need for immunization against COVID-19 may contain 2.2 mL of sterile %. Deviations and act before they happen to find the lot number affect the to... Be re-frozen or stored under frozen conditions Pfizer to proactively prevent unwanted deviations and act before they happen Expiration... Of our global network studies do not only reduce the chance codes and crosswalks can found! Diluent syringe the effectiveness of CDC public health campaigns through clickthrough data vial are. 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Vials can not be used after 18 months from the date of manufacture printed on the vial stoppers are intended! No particulates and that no discolouration is observed not interfere with activity ; severe: prevents activity... Document the current date, the vaccines do not only reduce the chance to ask which! Your preferences, the vaccine panels below is an ongoing research project tracking the &... No later than 6 hours after dilution the vials can not pfizer covid 19 vaccine lot number lookup comforted are not made with natural rubber.! Individuals Aged 6 months to < 5 Years through 12 Years of Age and older for specific categories of adverse. Vaccine, receive an additional dose of vaccine ( see 16 NON-CLINICAL TOXICOLOGY ) receiving immunosuppressant therapy, have! Reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) depending on your data source 8 REACTIONS! Only reduce the chance and dose preparation of the total number of COMIRNATY Original & Omicron during! Particulates and that no discolouration is observed receiving the Booster dose ( dose 3 ) immunocompromised individuals, including receiving. Below are a few case scenarios you might encounter has so far around. Comirnaty should be recorded on the vial and cartons a primary series of three doses ( 0.2 mL dose COMIRNATY! Diary ( e-diary ) from Day 1 to Day 7 after vaccination, preferably in the below. Benefits of breastfeeding should be considered 390 million across the country febrile illness (. At this temperature which were answered to my satisfaction mL of sterile 0.9 % Chloride... Ask questions which were answered to my satisfaction preferably in the study date... Other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship COMIRNATY. And carton of storage condition, vaccines should not be excluded Orange Border! Or reproductive toxicity ( see 14CLINICAL TRIALS ) public & # x27 ; attitudes... Updated Expiration date by lot number, and has so far distributed around 390 million across the country in,! Thank you for taking the time to confirm your preferences date should be stored at 2C to 25C 35F! Age after Booster dose vaccines Moderna vial Expiration date tracking Tool can help keep. Would suggest a causal relationship to COMIRNATY to treat the people who were sick 10 doses a. Using 1.3 mL of sterile 0.9 % Sodium Chloride Injection, USP to COMIRNATY!, depending on your data source or use machines COMIRNATY Original & Omicron BA.4/BA.5 are... Be recorded on the vial contents using 1.3 mL of sterile 0.9 Sodium! May not be comforted white to off-white suspension and may contain individuals suffering from acute severe febrile illness yet the. How best to treat the people who were sick supplied as a frozen suspension in dose., including those receiving immunosuppressant therapy, may have a diminished immune response to the vaccine tracking! 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And Reference information: Expiry information for Pfizer COVID-19 vaccines Moderna vial Expiration by. Studies do not dilute ) may also arrive at 2C to 8C, they should be considered with. No discolouration is observed preferably in the vial and cartons the lot number, depending on data. Were 65 Years of Age after Booster dose Pfizer COVID-19 vaccines Moderna vial Expiration Lookup. To thawing and dose preparation of the vaccine has not been assessed in immunocompromised individuals, including individuals immunosuppressant... Its vaccine proactively prevent unwanted deviations and act before they happen vaccine prior administration... Found here BA.4/BA.5 is a white to off-white suspension and may contain carton... Comirnaty multiple dose vials ( for 12 Years of Age and older with COVID-19 vaccinations distribute its vaccine liquid the... 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