During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. The safety evaluation of participants in the study is ongoing. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. 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. Each 0.3 mL dose of COMIRNATY contains 30 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 1. 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. 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. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. 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. 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. 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. with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, with Mike McDermott, President, Pfizer Global Supply. 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]. Pfizer Canada accepts no responsibility for the content of linked sites. Among participants 12 through 15 years of age who received at least one dose of study vaccine, 1,131 of whom received COMIRNATY and 1,129 of whom received placebo, unsolicited adverse events were reported by 95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. 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. Non-serious adverse events from Dose1 through up to 30days after Dose2 in ongoing followup in the initial enrolment group were reported by 10.9% of COMIRNATY 10mcg recipients and by 9.1% of placebo recipients. We have crossed another milestone in the fight against COVID-19. Gently invert the vial containing COMIRNATY 10 times to mix. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). 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. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Vials should be discarded 12 hours after dilution. Disclaimer Table 7: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 8: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 9: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Table 10: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Study 2 also included 200 participants with confirmed stable human immunodeficiency virus. "Her father and paternal grandmother both died . (HIV) infection. The safety profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that seen in the general population. 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). Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. After dilution, the vial should be held between 2C to 25C (35F to 77F). 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%). f. Severity was not collected for use of antipyretic or pain medication. For example, if a provider was getting 975 doses, it will now be 1,170 doses. No interaction studies have been performed. Most systemic events were mild or moderate in severity. 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. Healthcare professionals are advised to consider the possibility of myocarditis and/or pericarditis in their differential diagnosis if individuals present with chest pain, shortness of breath, palpitations or other signs and symptoms of myocarditis and/or pericarditis following immunization with a COVID-19 vaccine. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-g booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. January 31, 2023. 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 Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. The vial stoppers are not made with natural rubber latex. Visually inspect each dose in the dosing syringe prior to administration. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. 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. The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. Individuals who have received one dose of COMIRNATY should continue to receive COMIRNATY to complete the vaccination series. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . Do not add more than 1.3 mL of diluent. a second dose inventory management system. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY, preferentially using low dead-volume syringes and/or needles. dose. Thank you for taking the time to confirm your preferences. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. This site is intended . 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. It is supplied as a frozen suspension that does not contain preservative. 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 should be discarded 12 hours after dilution (i.e., the first puncture). 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. COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Sorry, you need to enable JavaScript to visit this website. It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. 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. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. should match your on-hand inventory To balance your inventory, enter the . 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. 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. 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. The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (Dose 4) was similar to that seen after the COMIRNATY booster (Dose 3). COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. You can order COVID-19 vaccines through the Washington State Immunization Information System (WAIIS). 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. 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 . COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 COMIRNATY is supplied as a frozen suspension in multiple dose vials. The products discussed herein may have different labeling in different countries. In the analyses of Study 3 in participants 2 through <5 years of age (606 COMIRNATY; 280 placebo), 76.6% of participants had at least 30 days of follow-up after Dose 3. For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results. Each 0.2 mL dose of COMIRNATY contains 3 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2. No serious adverse events were reported after the booster dose through the cut-off date. Each 0.2 mL dose of COMIRNATY contains 10 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. Table 5: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. Sometimes it feels like the year went by in the blink of an eye. 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. 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. The most frequent adverse reactions in participants 5 years through <12 years of age following the booster dose (data cut-off date of March 22, 2022; median follow-up time of 1.3 months) were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), myalgia (18.3%), chills (10.5%), injection site redness (15.6%), and swelling (16.4%). 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. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. 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. e. Severe: inconsolable; crying cannot be comforted. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. 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). This diluent is not packaged with the vaccine and must be sourced separately. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study. Do not mix COMIRNATY with other vaccines/products in the same syringe. It is supplied as a frozen suspension that does not contain preservative. Each vial contains 6 doses of 0.3 mL. Do not administer if vaccine is discoloured or contains particulate matter. A risk to the newborns/infants cannot be excluded. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). CIR Total Expected Inventory. Please choose the category that best describes you. This could allow for early diagnosis and treatment. Would you like to proceed? 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. Each dose must contain 0.2mL of vaccine. Each dose must contain 0.3 mL of vaccine. Not all pack sizes may be available. b. n = Number of participants with the specified reaction. COMIRNATY Original & Omicron BA.4/BA.5 should not be given to those who have experienced anaphylaxis after a prior dose of COMIRNATY, COMIRNATY Original/Omicron BA.1, or COMIRNATY Original & Omicron BA.4/BA.5. A carton of 10 vials may take up to 6 hours to thaw. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. All cases were considered to be mild, with a median onset of 3 days after Dose 1, and 2 days after Dose 2 in the vaccine group. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. To ensure proper storage and handling, please see cvdvaccine.com. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. After dilution, vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. A few vaccines are packaged with two component vaccines. 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 . Overall, participants who received a booster dose in Study C4591031 (Study 4), had a median follow-up time of 2.5 months after the booster dose to the cut-off date (October 5, 2021). Contact your regional poison control centre. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. Table 13 and Table 14 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. the benefits and risks of the Pfizer COVID 19 vaccine and had the chance to ask questions which were answered to my satisfaction. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. Vaccine Lot Release Certificates. Thats how long it has been since the World Health Organization declared COVID-19 a global pandemic. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Children 5 Years Through <12 Years of Age Primary Series (Two Doses). 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. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. The vaccine should not be used after 18 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. It is unknown whether COMIRNATY is excreted in human milk. 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. The diluted vaccine will be a white to off white suspension. After mixing, the vaccine should appear as a white to off-white suspension with no visible particles. Each vial must be thawed and diluted prior to administration. The date printed on the vial and carton reflects the date of manufacture. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. For further assistance with reporting to VAERS, call 1-800-822-7967. 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. COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with an orange cap and an orange label border. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. A free web-based tool to manage vaccine administration and registration Information Immunization Systems (IIS) IIS consolidate immunization information into one reliable source VTrckS CDC's vaccine order management system and platform for all COVID-19 vaccine ordering IZ Gateway A cloud-based message routing service intended to enable data exchange The thawed suspension may contain white to off-white opaque amorphous particles. Local ARs are summarized in Table 3. Verify that the vial has an orange plastic cap and an orange label border. At the time of authorization, there are no known serious warnings or precautions associated with this product. Dispatches from the Backyard Chicken Movement. Do not add more than 2.2 mL of diluent. In Study 2 and Study 3, all participants 6 months through <5 years of age, 5 through <12 years of age, 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and a subset of 306 participants 18 through 55 years of age who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. Home Data Catalog Developers Video Guides On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. 1) The manufacturer In the U.S., there are three COVID-19 vaccines authorized for emergency use: Pfizer-BioNTech, Moderna and Johnson & Johnson. Pfizer and BioNTech have the following COVID-19 vaccine formulations for: Children ages 6 months - 4 years old: Monovalent vaccine (with a maroon vial cap ) Only authorized for the first two doses of the three-dose primary series: two doses (0.2 mL), at least three to eight weeks apart. Vials must reach room temperature before dilution. When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Aes from post-dose to the accuracy of a non-federal website note: Reactions were usually or! Ask questions which were answered to my satisfaction carton of 10 vials may take up to (... In human milk removing the needle from the date of manufacture, in the vaccine should not be excluded label! 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