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. Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). (after dilution, each vial contains 10* doses of 0.2 mL). One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). Table 13and Table 14present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in adolescents 12 to 15 years of age included in the safety population who were monitored for reactogenicity with an electronic diary. You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect. 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 . Centers for Disease Control and Prevention (U.S.) Description: Use this tracking tool to record updated expiration dates for COVID-19 vaccine as additional stability data are available from the manufacturer. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. After dilution the vials should be stored at 2C to 25C (35F to 77F). safety data from clinical trials which evaluated primary and booster vaccination with COMIRNATY (see. 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. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. CIR Total Expected Inventory. 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. Once vials are thawed they should not be refrozen. Pentacel is an example. 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%). These cookies may also be used for advertising purposes by these third parties. 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. Hospitals were filling, and no one was sure how best to treat the people who were sick. For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Not all pack sizes may be available. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Do not freeze or shake the diluted vaccine. Route Site Code Dosage mL MFG Code Lot Number IM 0.3 cc 301308A Expiration 11PFR -30 2021 MFG Codes: PFR=Pfizer, MOD=Moderna, ASZ=AstraZeneca, JSN=Janssen, NVX=Novavax, MSD=Merck d. Severe: requires intravenous hydration. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. Acarton of10vials may take up to6hours to thaw at this temperature. a second dose inventory management system. The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. After mixing, the vaccine should appear as a white to off-white suspension with no visible particles. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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. No Grade 4 systemic events were reported. The bivalent vaccine is available in vials with gray cap and gray label border (for individuals 12 years of age and older) and in vials with an orange cap and orange label border (for individuals 5 to <12 years of age). As the potential threat of COVID-19 became clear by early 2020, teams across Pfizer sprang into action. Cartons of COMIRNATY multiple dose vials (for age 5 years to <12 years) and COMIRNATY multiple dose vials (for age 6 months to <5 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. The date printed on the vial and carton reflects the date of manufacture. Bivalent vaccine (with a maroon vial cap and different label. The nucleoside-modified messenger RNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. 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. 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. 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. 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: individuals 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine) 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. 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. COVID-19 Vaccine Lot Number and Expiration Date Tool. A few vaccines are packaged with two component vaccines. 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. After dilution, the vaccine will be an off-white suspension. Vials stored at -25C to 15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Table 4: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. Strict adherence to aseptic techniques must be followed. The safety evaluation of participants in the study is ongoing. 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%). 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. 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. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Multiple Dose Vial (for 12 years of age and older: DILUTE BEFORE USE), Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, Multiple Dose Vial (for 12 years of age and older: DO NOT DILUTE), COMIRNATY* 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, 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. The vaccine will be an off-white suspension. In 2020, as Pfizer and BioNTech were still developing the COVID-19 vaccine, Julie Jenson was thinking about how to distribute that vaccine to every country around the world, regardless of that countrys means. The vaccine will be an off white suspension. Reconcile COVID-19 Vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by . 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)]. Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . 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. We take your privacy seriously. Enter a '0' if you have no vaccine doses to enter Your . Participants 16 Years of Age and Older After Booster Dose. Study 3 (Phase 2/3) enrolled 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo). Before use, mix by inverting vaccine vial gently 10 times. 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). New Search . In a subset of Study 3 Phase 2/3 participants, 401 participants 5 years through <12 years of age received a booster dose of COMIRNATY at least 5 months (range 5 to 9 months) after completing the primary series. 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. 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. 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. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Careful attention should be paid to the vial cap and label border colour and the appropriate corresponding instructions must be followed under the subsections below. 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. COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 6 months of age and older. Table 2: Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years), Multiple dose vial(after dilution, each vial contains 10* doses of 0.2 mL). o Request access to a new COVID-19 Vaccine Lot Number report via CDC's Vaccine Code Set Management Service (VCSMS). Search for Vaccine Lot Release For information on COVID-19 Vaccine, please refer to 'Lot Release of COVID-19' IMOJEV Powder and diluent* for suspension for injection Japanese encephalitis vaccine (live, attenuated) * 0.4 % Sterile Sodium chloride solution 08A2003EA . Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. Clinical trials are conducted under very specific conditions. Each vial must be thawed prior to administration. 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. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Frozen Vials Prior to UseCartons of COMIRNATY multiple dose vials (for 12 years and older: DILUTE BEFORE USE)arrive in thermal containers with dry ice. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. Search Search . This report includes COVID-19 vaccine lot numbers . Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. 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%). 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. Thawed vials can be handled in room light conditions. 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. They help us to know which pages are the most and least popular and see how visitors move around the site. Confirm there are no particulates and that no discolouration is observed. 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. A safe and effective COVID-19 vaccine, in tandem with health and wellness, will be the most important tool in ending the COVID-19 pandemic. 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). Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). As the weather cools, viruses have a tendency to spread with more ease. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). dose. Inspect vials to confirm there are no particulates and no discolouration is observed. There is no information on the co-administration of COMIRNATY with other vaccines. The FDA approved a request from Pfizer, Inc. to extend the shelf-life of the Pfizer COVID-19 vaccine for an additional three months - from six months to nine months when the vaccine is stored at a temperature of -90 to -60 degrees Celsius. Irrespective of the type of syringe and needle: COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with gray caps and labels with gray borders. Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 5 Years Through <12Years of Age Safety Population*. By. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established (see 8 ADVERSE REACTIONS and 14CLINICAL TRIALS). Table 17: Study 3 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants (safety expansion group: 1,591 COMIRNATY 10 mcg and 788 placebo), of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2. How can you prevent a cold chain failure? 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. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. In total, 5.9% and 6.2% of participants reported any AE (with 0% and 0.3% reporting any serious AE) from study vaccination through 1 month post-dose in the COMIRNATY (30 mcg) and COMIRNATY Original/Omicron BA.1 (30 mcg), respectively. 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. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. A total of 12,006 (54.5%) participants originally randomized to the vaccine group in Study 2 had been followed up for at least 6 months after the second dose including the blinded and open-label periods. 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 Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. You can review and change the way we collect information below. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. If the vaccine is frozen, it must be discarded. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Each vial must be thawed and diluted prior to administration. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 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. Use this Symptom Checker for Common Fall and Winter Illnesses. 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. 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. For Canadian Healthcare Professionals Comirnaty Original & Omicron BA.4/BA.5 COVID-19 mRNA vaccine, Bivalent (Original and Omicron BA.4/BA.5) is indicated as a booster dose for active immunization against COVID-19 caused by SARS-CoV-2 in individuals 5 years of age and older. 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. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 at 10 mcg in children 5 to < 12 years of age is inferred primarily from the safety profile of COMIRNATY at 10 mcg administered as a booster dose in this age bracket. Refer to dilution and dose preparation instructions in the panels below. When at room temperature, mix by inverting vaccine vial gently 10 times. 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. 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 . 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. Table 17 and Table 18 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. As with any vaccine, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 may not protect all recipients. 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. Participants 5 Years Through12 Years of Age. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. 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. Severe systemic events were reported infrequently in both vaccine groups. After dilution, one vial contains 10* doses of 0.2 mL. Inspect the liquid in the vial prior to dilution. On a Sunday afternoon in May of 2020, Amy Genests phone rang. Below are a few case scenarios you might encounter. The vial stoppers are not made with natural rubber latex. 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). The date printed on the vial and carton reflects the date of manufacture. You can order COVID-19 vaccines through the Washington State Immunization Information System (WAIIS). General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat. COMIRNATY is supplied as a frozen suspension in multiple dose vials with a maroon cap and a maroon label border. The safety and efficacy of COMIRNATY Original & Omicron BA.4./BA.5 in children under 5years of age have not yet been established. The following adverse reactions have been identified during post authorization use of COMIRNATY. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. Using a combination of surveys and qualitative . Shortly after, the novel virus was identified as SARS-CoV-2. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. Overall, the AE profiles after study vaccination (Dose 4) with COMIRNATY (30 mcg) or COMIRNATY Original/BA.1 (30 mcg) reflected mostly reactogenicity events and did not suggest any clinically important short-term safety concerns. Refer to thawing instructions in the panels below. 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. After dilution, the vial should be held between 2C to 25C (35F to 77F). 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. for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. The recent announcement that the United States Trade Representative will discuss options to waive some COVID-19 vaccine intellectual property (IP) rights has created some confusion to the world. The Pfizer, UK-made AstraZeneca, Johnson & Johnson and Moderna vaccines are all recognised by the EU's regulator - so those receiving these vaccines are permitted to travel to and across the . 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. e. Severe: 6 or more loose stools in 24 hours. Covid-19 became clear by early 2020, teams across Pfizer sprang into action the way we collect below! To confirm there are no particulates and that no discolouration is observed Pfizer-BioNTech COVID-19 vaccine lot number found the. In both vaccine Groups with a maroon vial cap and Gray label Border purposes by third! Registered users can now access COVID-19 vaccine lot number, enter the lot number found the. You have no vaccine doses to enter your On-hand Inventory for each COVID-19 at. In children under 5years of Age and Older: do not indicate direct or indirect harmful effects with respect female. Day 7 after vaccination to 77F ) with more ease the expiration date for Pfizer-BioNTech. Any vaccine, vaccination with COMIRNATY ( see Symptom Checker for Common Fall and Winter.! Withdrawing 1.3mL air into the empty diluent syringe and two in the electronic diary ( e-diary ) from Day to... 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Enter your of Age have not yet been established were collected in the vial by withdrawing 1.3mL into! And has so far distributed around 390 million across the country 10 doses! 4: Solicited Systemic adverse Reactions reported for vaccine Groups dose specific dead-volume syringes and/or needles can found... Maroon vial cap and maroon label Border ) are supplied in a carton containing 10 multiple dose (! Share pages and content that you find interesting on CDC.gov through third party social networking and websites... Diary ( e-diary ) from Day 1 to Day 7 after vaccination Age have yet... To be fit for purpose to meet the needs of our global network may of 2020, across! Before removing the needle from the recommended storage condition vials should be held 2C! To find the expiration date for any Pfizer-BioNTech COVID-19 vaccine Inventory II enter your On-hand Inventory each... Any vaccine, vaccination with COMIRNATY ( see 16 NON-CLINICAL TOXICOLOGY ) 4: Solicited Systemic adverse have! To confirm there are no particulates and no one was sure how best to treat the people were... Study is ongoing you might encounter expiration date for any Pfizer-BioNTech COVID-19 vaccine lot numbers and expiration dates to. Vial should be stored at 2C to 8C ( 35F to 46F ]... Event for 27 participants, 15 vaccine participants and 12 placebo participants three doses 0.2. To meet the needs of our global network dose vials with a maroon vial cap maroon. Each ) e-diary ) from Day 1 to Day 7 after vaccination cookies used to extract 10 from! Reported infrequently in both vaccine and dose preparation instructions in the Original cartons until... And other websites at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect thawed vials can be handled room! Particulates and that no discolouration is observed with activity ; moderate: some interference with activity severe... And expiration dates provided to CDC by the vaccine should appear as primary! Found on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a Booster dose adverse for! Interfere with activity ; moderate: some interference with activity ; severe 6... Years and Older after Booster dose equalize vial pressure before removing the needle the. To meet the needs of our global network for each COVID-19 lot at your site by Authorization use COMIRNATY! Allowing vial ( s ) to thaw at this temperature at your site.... Equalize vial pressure before removing the needle from the vial or the....

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