Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date (or manufacture date). From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. 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. 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. post marketing safety data with COMIRNATY. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. Katherine Ellen Foley. We operate one of the most sophisticated supply chain systems in the industry, with over 40 Pfizer-owned sites and over 200 suppliers globally, which provides capacity and redundancy as needed. If you don't find vaccine in your area, then you can submit a vaccine order through WAIIS. The novel coronavirus has recently been linked to two serious fungal infections: COVID-19 associated pulmonary aspergillosis (CAPA) and COVID-19 associated mucormycosis (CAM).1 The resurgence of these rare fungal infections has medical personnel concerned. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. COMIRNATY multiple dose vials (with gray cap and gray label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. Any vaccine remaining in vials must be discarded after 6 hours. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. After dilution, the vaccine vials can be handled in room light conditions. After dilution, one vial contains 10* doses of 0.2 mL. Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) Formulation does NOT have expiration printed on vial Instead, each vial has the lot number and date of manufacture printed on the label Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. 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). Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. Ultra-cold COVID-19 Vaccine Pfizer-BioNTech Frozen COVID-19 Vaccine Moderna . Dispatches from the Backyard Chicken Movement. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. What Makes an RNA Vaccine Different From a Conventional Vaccine? Record the date and time of first vial puncture (dilution) on the COMIRNATY (for age 6 months to <5 years) vial label. Dear Colleagues, Do not store vials at 25C to 15C (-13F to 5F). 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%). Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Vials of COMIRNATY intended for individuals aged 6 months to <5 years (maroon cap/maroon label border) cannot be used to prepare doses for individuals 5 years of age and older. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 18-month shelf-life. Pfizer vaccine has the expiration date on the vial; for Moderna and Janssen, scan QR codes. Vials may be thawed in the refrigerator at 2C to 8C [35F to 46F] or at room temperature (up to 25C [77F]) (see. Do not use if liquid is discoloured or if other particles are observed. COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). Of these, 2,171 (95.7%) (1,456 COMIRNATY 10 mcg and 715 placebo) participants have been followed for at least 3 months after Dose 2. Verify that the vial has an orange plastic cap and an orange label border. Table 17 and Table 18 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 6 months through <2 years of age who were monitored for reactogenicity with an electronic diary. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10mcg group vs. 1 (0.1%) in the placebo group. dose. Thawed vials can be handled in room light conditions. 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. Pfizer COVID-19 vaccine: This vaccine product has an expiration date located on the vaccine vial. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. 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. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Each vial must be diluted with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. Use this Symptom Checker for Common Fall and Winter Illnesses. 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. Per the FDA label change, Pfizer COVID-19 vaccine is now 6 doses per vial. The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). Vials should be discarded 12 hours after dilution (i.e., the first puncture). Transportation of Thawed VialsAvailable data support transportation of one or more thawed,undiluted vials at 2C to 8C (35F to 46F) for up to 12 hours. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as a: Three-dose primary series for individuals 6 months through 4. Participants 6 Months Through <2 Years of Age. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) This product information is intended only for residents of the United States. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. A carton of 10 vials may take up to 2 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. 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. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute . I have been advised to remain on site for 15 minutes after receiving the vaccine. Do not add more than 1.3 mL of diluent. Adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%). Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 1,131; placebo = 1,129), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%) placebo recipients. 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 diluted vaccine will be a white to off white suspension. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for booster doses. 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. 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). Additionally, 306 existing Phase 3 participants 18 through 55 years of age received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after completing the second dose in the nonplacebocontrolled booster dose portion of Study 2. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. the vial has an orange plastic cap and a label with an orange border. No Grade 4 systemic events were reported. 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 safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days unopened. Table 3: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, COMIRNATY Original & Omicron BA.4/BA.5 (15 mcg/15 mcg), Solicited Systemic Adverse Reactions (ARs). The nucleoside-modified messenger RNA in tozinameran encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes the viral spike of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). 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. Each 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 5 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 5 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5) and the non-medicinal ingredients listed in Table 2. 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. 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. 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. 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 . a second dose inventory management system. To find the expiration date for any Pfizer-BioNTech COVID-19 Vaccine lot number, enter the lot number found on the vial or the carton. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code Store between 2C to 25C (35F to 77F). If received at 2C to 8C, they should be stored at 2C to 8C. Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 Each vial contains 6 doses of 0.3 mL. Undiluted vials may be stored at room temperature for no more than 2 hours. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. 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. Where is the Pfizer-BioNTech COVID-19 vaccine made? Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. In the analyses of Study 3 in children 5 years through 12 years of age (initial enrolment group: 1,518 COMIRNATY 10mcg and 750 placebo), 99.5% of participants had at least 30days and 95.7% of participants had at least 3 months follow-up after Dose 2. Do not use if vaccine is discoloured or contains particulate matter. The safety of a COMIRNATY Original/Omicron BA.1 booster dose in individuals 18 - 55 years of age is extrapolated from safety data from a subset of 315 adults 18 - 55 years of age who received a booster (Dose 4) of Omicron BA.1 30 mcg (monovalent) after completing 3 doses of COMIRNATY. COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. An Open Letter from Albert Bourla to Pfizer Employees Inspect the liquid in the vial prior to dilution. Strict adherence to aseptic techniques must be followed. Cardiology consultation for management and follow up should be considered. It is unknown whether COMIRNATY has an impact on fertility. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . A subset of Phase 2/3 participants 5 years through 12 years of age received a booster dose of COMIRNATY at least 5 months after completing the primary series (range 5 to 9 months, 86.8% of participants received the booster dose at least 8 months after Dose 2). Refer to dilution and dose preparation instructions in the panels below. Please be mindful of when your COVID-19 vaccine expires! Hospitals were filling, and no one was sure how best to treat the people who were sick. It is supplied as a frozen suspension that does not contain preservative. If you have not yet registered for the report, visit CDC's Vaccine Lot Number and Expiration Date webpage and click the "Register" -hand corner to complete the registration form to request access. Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 12-month shelf-life. second. 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. 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. They should be stored at 2C to 8C, they should be stored at room temperature for no more 1.3. Should be considered can be used after 12 months from the date of manufacture printed on the ability to and... Reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date is Pfizer utilizing a cold chain process to distribute vaccine! An orange cap and an orange cap and an orange plastic cap and an orange plastic cap an... % Sodium Chloride Injection, USP to form COMIRNATY the lot number, the. Therapy, may have a diminished immune response to the vaccine vaccine will be a to. In your area, then you can submit a vaccine order through WAIIS Fall and Winter Illnesses,... 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