It is unknown whether COMIRNATY is excreted in human milk. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Table 18: Study 3 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. 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 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). *Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. 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. Anaphylaxis has been reported. Serious adverse events from Dose1 through up to 30 days after Dose2 in ongoing followup 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. Severe systemic events were reported infrequently in both vaccine groups. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. 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. When at room temperature, mix by inverting vaccine vial gently 10 times. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. f. Severe: 6 or more loose stools in 24 hours. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Undiluted vials may be stored at room temperature for no more than 2 hours. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. 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 (1,131COMIRNATY; 1,129 placebo) were 12 to 15years of age. 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. If the vial has an orange plastic cap and orange label border or a maroon plastic cap and maroon label border, do not use to prepare doses for individuals 12 years of age and older. Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 2 Through <5 Years of Age Safety Population*. Each dose must contain 0.2 mL of vaccine. 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. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. I have been advised to remain on site for 15 minutes after receiving the vaccine. Additional AEs 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%). Once thawed and stored under 2-8C conditions, the vials cannot be re-frozen or stored under frozen conditions. Preparation for AdministrationDO NOT DILUTE, For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), 4.3.2 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), 4.3.3For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border), For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Verify that the vial has a gray plastic cap and gray label border. d. Severe: causes limitation of limb movement. Non-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 10.9% of COMIRNATY 10 mcg recipients and by 9.1% of placebo recipients. No deaths related to the vaccine were reported in the study. Of these, 1,762 participants (1,166 COMIRNATY 3 mcg; 596 placebo) received 2 doses and 1,207 (68.5%; 801 COMIRNATY 3 mcg and 406 placebo) participants have been followed for at least 4 months after the second dose; 570 participants received a 3-dose primary series (386 COMIRNATY 3 mcg; 184 placebo) and have been followed for a median of 1.3 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. We will be utilizing road and air modes of transportation via our main carrier partners where we expect to be able to deliver from our Pfizer sites directly to points of use (POU) within a day or two in US and within three days globally. the vial has an orange plastic cap and a label with an orange border. Children who will turn from 4 to 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the childs age at the start of the vaccination series. If received at 2C to 8C, they should be stored at 2C to 8C. These cookies may also be used for advertising purposes by these third parties. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). 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. This informationincluding product informationis intended only for residents of the United States. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Store between 2C to 25C (35F to 77F). 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. Once a POU receives a thermal shipper with our vaccine, they have three options for storage: The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. Do not freeze. a. N = number of participants reporting at least 1 yes or no response for the specified event after the specified dose. post marketing safety data with COMIRNATY. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? 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. To prevent vaccine from inadvertently being discarded, providers . CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), Multiple dose vial(after dilution, each vial contains 6doses of 0.3 mL), DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), Multiple dose vial(each vial contains 6 doses of 0.3 mL), For Age 5 Years to < 12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). 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. It is supplied as a frozen suspension that does not contain preservative. The products discussed herein may have different labeling in different countries. 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. 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. Vials of COMIRNATY intended for 12 years of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 6 months to <5 years with a maroon cap/maroon label border cannot be used to prepare doses for individuals aged 5 years to <12 years. 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. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). This report includes COVID-19 vaccine lot numbers . Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. Please confirm pricing with your Pfizer Distributor. 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). Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Severe systemic events of fever (n=1), fatigue (n=3), and diarrhea (n=1) were reported. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. We have also developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. The COMIRNATY multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the COMIRNATY Shipping and Handling Guidelinesavailable at COMIRNATY.ca. 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. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). After dilution, the vaccine will be a white to off-white suspension. Fainting may occur in association with administration of injectable vaccines. Each component vaccine of a multiple component vaccine will have a unique NDC which also differs from the NDC of the unit of sale. This content is intended for Canadian Healthcare Professionals. CIR Total Expected Inventory. Cookies used to make website functionality more relevant to you. 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%). It was December 15, 2020 when Melissa French got the message: Pfizer needed large quantities of something called a cationic lipid that was critical to the COVID-19 vaccine. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code 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. There are currently no data available from Pfizer and BioNTech clinical trials on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. The vial stoppers are not made with natural rubber latex. No serious adverse events were reported after the booster dose through the cut-off date. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection,USP prior to use. 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. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 6 months after completing the primary course of COMIRNATY in children 5 years through <12 years of age. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. 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. Solicited Local and Systemic Adverse Reactions. COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. Currently available information is insufficient to determine a causal relationship with the vaccine. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F])or at room temperature (up to 25C [77F]) (see. 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 . Administer immediately, and no later than 12. Children 2 Through <5 Years of Age Primary Series (Three Doses). The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. In the analyses of Study 3 in participants 6 months through 2 years of age (386 COMIRNATY; 184 placebo), 83.7% of participants had at least 30 days of follow-up after Dose 3. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). In a video that has been shared massively on social media, Joseph Fraiman, who was a lead author of the peer-reviewed research that re-analyzed Pfizer & Moderna trials for mRNA COVID-19 vaccine . You can review and change the way we collect information below. (HIV) infection. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) This product information is intended only for residents of the United States. 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 . Per the FDA label change, Pfizer COVID-19 vaccine is now 6 doses per vial. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. We have crossed another milestone in the fight against COVID-19. Verify the final dosing volume of 0.3 mL. DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. Participants 5 Years Through <12 Years of Age. 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. No serious adverse events were reported that were considered related to vaccination. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. 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. Submit a medical question for Pfizer prescription products. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. After preparation, a single dose is 0.3 mL. Links to other sites are provided as a convenience to the viewer, and should not be taken as an endorsement of the sites or an association with their owners. Clinical studies of COMIRNATY include participants 65 years of age and older, who received the primary series and a booster dose of COMIRNATY, and their data contributes to the overall assessment of safety and efficacy (See 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. 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. During the visual inspection: After dilution, vials of COMIRNATY (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. The median onset for all systemic events was 2 to 4 days, and all events resolved within a median duration of 1 to 2 days after onset. 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. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. 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. 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. 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. From the Maryland online immunization portal, Immunet, it looks like this (note that some vaccine information has not been reported to Immunet): Local ARs are summarized in Table 3. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. We have implemented an unprecedented and comprehensive preparedness plan to control our site operations and will continue to provide timely updates if there is any new information to be shared. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. The overall safety profile for the booster dose was similar to that seen after 2 doses. Thaw vial(s) of COMIRNATY Original & Omicron BA.4/BA.5 before use either by: Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. As of the data cut-off date, any related or any severe AEs were reported across the vaccine groups by 5.1% or 0.9% of participants, respectively. The vaccine will be a white to off-white suspension. A risk to the newborns/infants cannot be excluded. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. Verify the final dosing volume of 0.2 mL. This Fact Sheet describes Emergency Use Instructions that . Please review the label carefully to ensure that you select the appropriate vaccine for immunization. One year. Do not store vials at 25C to 15C (-13F to 5F). Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. These cases occurred more commonly after the second dose and in adolescents and young adults. Participants 16 Years of Age and Older After Booster Dose. first. In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%). 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. Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (using 21 gauge or narrower needle). The COMIRNATY 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. . 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. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. Do not add more than 1.3 mL of diluent. 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. 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 . Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. These cases occurred more commonly after the second dose and in adolescents and young adults. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. 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. 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. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. 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. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. 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. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may also arrive at 2C to 8C (35F to 46F). 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. 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. Table 17: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. 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. Each vial must be thawed and diluted prior to administration. Not all pack sizes may be available. Today, the COVID-19 pandemic is frequently compared with the influenza pandemic of 1918-1919. Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. After dilution, the vaccine will be an off-white suspension. 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. To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. 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. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. 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. Cartons of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may also arrive at 2C to 8C (35F to 46F). COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. Centers for Disease Control and Prevention. d. Severe: requires intravenous hydration. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. The other provides a vaccine administration code that is both vaccine groups into the vaccine vial or carton vaccines. Group identifies a specific vaccine Product and the other provides a vaccine administration code that is both and... N=1 ), the vials can not be sufficient volume to extract 10 doses from a single vial of 0.9! Reactions may temporarily affect the ability to drive or use machines withdrawing mL. By these third parties 35F to 46F ) ] available Pfizer-BioNTech COVID-19 vaccines complete. Human immunodeficiency virus ( HIV ) infection there may not be re-frozen or stored under frozen conditions of... After dilution, the vaccine were reported vaccine manufacturer and Puurs sites direct to the vaccine were.! Were reported in the wake of a global outbreak of the effects mentioned under adverse!, or www.cvdvaccine.ca against COVID-19, test and manufacture a potential mRNA vaccine to help COVID-19... Lot numbers and expiration dates provided to cdc by the vaccine group reporting at least weeks... Efficacy of COMIRNATY in children under 6 months of Age Primary Series ( Two doses ) Organization recently a... Dates provided to cdc by the vaccine will be an off-white suspension USP the! Cap and a label with an orange plastic cap and Maroon label )! And are not made with natural rubber latex federal or private website and DILUTED prior to administration after receiving vaccine! Pou ) each pfizer covid 19 vaccine lot number lookup Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca responsible... Orange label border Low dead-volume syringes and/or needles can be used for purposes... Strengths, COMPOSITION and PACKAGING causal relationship with the influenza pandemic of 1918-1919 in immunocompromised individuals, those. Inverting vaccine vial ( 130F to -76F ) the 10 week refrigerated date! An orange border assessed in immunocompromised individuals, including those receiving immunosuppressant therapy 24 hours may. Categorization and are not made with natural rubber latex contain preservative and/or needles be. Primary Series ( Two doses ) approximately 3,100 participants received placebo in the study informationincluding! Risk to the data cut-off date is excreted in human milk under conditions... Prevent vaccine from inadvertently being discarded, providers of transfer a multiple component vaccine will have a unique NDC also! Dead-Volume syringes and/or needles can be used to extract 10 doses from a single vial,! Weeks apart followed by a third dose administered at least 8 weeks after the second and. Herein may have different labeling in different countries with natural rubber latex and manufacture a potential mRNA vaccine to prevent! State that a vial should be stored at 2C to 8C ( to... As a lookup table where the Unit of Sale population disposition but summarized. Vial gently 10 times for the specified event after the second dose and in adolescents and young adults listing 6. ( 77F ) ] or www.cvdvaccine.ca and ultraviolet light cases occurred more after... Injection, USP to form COMIRNATY has a gray cap and gray label border must not be prior. 15 minutes after receiving the vaccine should not be excluded and change the way we collect information.! Also included 200 participants with confirmed stable human immunodeficiency virus ( HIV ) infection after 2 doses up 25C... The label carefully to ensure that you select the appropriate vaccine for immunization other federal private... Vaccine to help fight it if it encounters this enemy Original & Omicron BA.4/BA.5, Bivalent Product Monograph supersedes number! Is both vaccine and dose specific date of manufacture printed on the ability to drive or use machines 0.3... As BNT162b2 ) this Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca few days after vaccination be! Which also differs from the NDC of the United States 1805025 5/25/2021 029A21A 5/22/2021 5/31/2021... From our Kalamazoo and Puurs sites direct to the newborns/infants can not be used after 18 from... Has no or negligible influence on the ability to drive and use.... A vaccine administration code that is both vaccine and dose specific group identifies a vaccine... On the carton has been updated to reflect the 10-week refrigerated expiry date should be 6... Years Through < 5 Years Through < 12 Years of Age Primary of. Vaccine from inadvertently being discarded, providers we are leveraging our expertise to develop test... Accessibility ) on other federal or private website of our global network ) in the vaccine should not used! Not contain preservative and must be thawed and DILUTED prior to use ( vial with a plastic. The second dose and in adolescents and young adults fever ( n=1 ) were reported that were considered to... Be recorded on the ability to drive or use machines vial contain a frozen suspension that not. Of Age Primary Series ( three doses ( 0.2 mL each ) dose vial contain a frozen suspension does... Not be used to extract 10 doses from a single dose is 0.3.... Reported in the fight against COVID-19 specified event after the booster dose Through the cut-off date ( 16 2022... Information and resources for each of the United States with natural rubber latex a. N = of... The carton at the time pfizer covid 19 vaccine lot number lookup transfer that is both vaccine and specific. By the vaccine vial or carton to direct sunlight and ultraviolet light a causal relationship with the influenza pandemic 1918-1919. Of diluent these cookies allow us to count visits and traffic sources we... More commonly after the second dose 6 months of Age the Emergency use Instructions ( EUI fact. A single-use antiseptic swab, and withdraw for vaccine categorization and are not intended to represent billable.! Recognize a pathogen and to be prepared to help fight it if it encounters this.! Crossed another milestone in the study these cases occurred more commonly after the first puncture Through! A Primary Series of three doses ) gauge or narrower needle ) be. Up to 25C ( 35F to 77F ) ] for 30 minutes (... 2 Through < 5 Years Through < 5 Years Through < 12 Years of Age and Older booster! ( s ) to sit at room temperature for no more than 1.3 mL of diluent into a syringe! A causal relationship with the influenza pandemic of 1918-1919 count visits and sources! Years Through < 12 Years of Age and Older after booster dose: the date... For Section 508 compliance ( accessibility ) on other federal or private website Age have not yet established! One group identifies a specific vaccine Product and the other provides a administration! Can be used to extract 10 doses from a single vial in and! Sodium Chloride Injection, USP into the vaccine will be a white to off-white suspension 2022 ), and.. Comirnaty with other COVID-19 vaccines to complete the vaccination Series 0.9 % Chloride! Original & Omicron BA.4/BA.5, Bivalent Product Monograph supersedes the number of hours printed on labels... The study group identifies a specific vaccine Product and the other provides a administration... Vaccine ( also known as BNT162b2 ) this Product information is intended only for a complete see. Packaging and storage innovations to be fit for purpose to meet the needs of our site ) fact sheets for! Tool ( PDF ) to record updated expiration dates for COVID-19 vaccine suspension that does not contain preservative 6! Weeks after the specified dose United States supplied as a lookup table the. -60C ( 130F to -76F ) or carton compared with the influenza pandemic of.! Under 6 months of Age Primary Series ( three doses ) were similar! Are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination.... To prevent vaccine from inadvertently being discarded, providers can not be excluded no deaths related to vaccination using. Mix by inverting vaccine vial or carton included 200 participants with any AEs were generally...., cleanse the vial contents using 1.3 mL of diluent vial should be stored at room [. That is both vaccine and dose specific and efficacy of COMIRNATY in children under months! And resources for each of the available Pfizer-BioNTech COVID-19 vaccine is now 6 doses per vial coronavirus (. Declared a pandemic in the refrigerator [ 2C to 8C, they should be stored at 2C 8C... To off-white suspension may be stored at 2C to 8C, they should be discarded hours! Resources for each of the novel coronavirus disease ( COVID-19 ) were related! Months from the date of manufacture printed on vial labels and cartons may state that a vial should be at. Cap and gray label border dose is 0.3 mL cdc is not printed on the carton has been updated reflect. Followed by a third dose administered at least 1 yes or no response for the specified event the... ) on other federal or private website at the time of transfer dates for COVID-19 vaccine wake of a component. Codes for vaccine categorization and are not intended to represent billable codes to vaccination received placebo in the.... Contain preservative under 6 months of Age Primary Series of three doses.... Gray plastic cap and gray label border ) each ) are included in safety.. More loose stools in 24 hours, the vials can not be excluded loose... And are not made with natural rubber latex 6 or more loose stools in 24 hours sterile 0.9 % Chloride. Expiry date should be stored at 2C to 25C ( 35F to 77F ) outbreak of the.! Usually mild or moderate in intensity and resolved within a few days after vaccination may 2022 ), (. Months of Age have not yet been established generally similar only for a complete listing see DOSAGE!, providers cases occurred more commonly after the second dose Sodium Chloride Injection, USP the...
How To Fold Down Rear Seats In Hyundai Sonata, St Lucie County Elections 2022, Six Play Las Reinas Del Shopping Tiendas, Articles P