Contact your regional poison control centre. Each vial must be thawed prior to administration. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Participants 18 to 55 Years of Age After a Booster Dose of Monovalent Omicron BA.1. Vials of COMIRNATY intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 6 months to <5 years or 12 years of age and older. The safety and efficacy of COMIRNATY in pregnant women have not yet been established. 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. No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. In participants who received a booster dose, the mean duration of pain at the injection site after the booster dose was 2.4 days (range 1 to 35 days), for redness 2.3 days (range 1 to 12 days), and for swelling 2.3 days (range 1 to 9 days). January 31, 2023. 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. 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. COMIRNATY multiple dose vials (with purple cap and purple label border) are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials. ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate). 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. Children 5 Years Through 12 Years of Age After Booster Dose. Visually inspect each dose in the dosing syringe prior to administration. Clinical studies of COMIRNATY include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. 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. The decision to administer COMIRNATY Original & Omicron BA.4/BA.5 to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. 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. 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. Pfizer Canada accepts no responsibility for the content of linked sites. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). 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. 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 a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use, synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. No Grade 4 systemic events were reported in any vaccine groups evaluated. Non-serious adverse events from Dose 1 through up to 1 month after Dose 3, in ongoing follow up were reported by 29.1% of COMIRNATY recipients and by 26.3% of placebo recipients. 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. 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 . b. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through <12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). On Dec. 11, the US Food and Drug Administration issued its first emergency use authorization for a Covid-19 vaccine, shortly after the UK . Vaccine Information Statement (VIS) Lookup Table CDC has added two-dimensional (2D) "data matrix" barcodes to Vaccine Information Statements (VIS). Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). 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. Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. COVID-19 Vaccine Lot Number and Expiration Date Tool. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly. 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). 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. 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 coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 5 years of age and older (see 4.2 Recommended Dose and Dosage Adjustment). No serious adverse events were reported that were considered related to vaccination. 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. * Randomized participants who received at least 1 dose of the study intervention. 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). Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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. Any vaccine remaining in vials must be discarded after 6 hours. Once vials are thawed they should not be refrozen. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. COMIRNATY does not contain preservative. 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 vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. Verify that the vial has a gray plastic cap and gray label border. 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. Serious Adverse EventsIn Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY =12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. a. N = number of participants reporting at least 1 yes or no response for the specified event after the specified dose. The safety of the primary seriesof COMIRNATY was evaluated in participants 6 months of age and older in three clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. 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. Not all pack sizes may be available. * Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Of the participants who received a booster dose of COMIRNATY or placebo (COMIRNATY = 5,055; placebo = 5,020) to the cut-off date (October 5, 2021), serious adverse events were reported by 0.3% of COMIRNATY recipients and 0.5% by placebo recipients. Vials should be discarded 12hours after first puncture. The vaccine will be an off-white suspension. Refrigeration units that are commonly available in hospitals. We have experience working with customers in all markets to ensure success. Clinical trials are conducted under very specific conditions. The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. 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. 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. 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. 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. 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. COMIRNATY is supplied as a frozen suspension in multiple dose vials. She recognized the number immediately and excused herself from her young daughters and her husband to take the work call. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. Among participants 16 through 55 years of age who received at least one dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. Today, Pfizer manufactures more than 200 million doses of Pfizer vaccines annually and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code Severe local reactions were reported by 1 (1.0%) participant in the 12 to 17 years of age group who received a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 30 mcg. Verify that the vial has a purple plastic cap and purple label border. Contents of the pack and other information. No new adverse reactions were identified for COMIRNATY Original/Omicron BA.1. Study C4591044 is an ongoing study to evaluate the safety, tolerability, and immunogenicity of new bivalent vaccines including COMIRNATY Original & Omicron BA.4/BA.5. 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. No serious adverse events were reported that were considered related to vaccination. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. After dilution the vials should be stored at 2C to 25C (35F to 77F). For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 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. The following adverse reactions have been identified during post authorization use of COMIRNATY. Please be mindful of when your COVID-19 vaccine expires! Below are a few case scenarios you might encounter. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Adverse events detailed below for participants 16 years of age and older are for the placebo-controlled blinded follow-up period up to the participants unblinding dates. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. The vial stoppers are not made with natural rubber latex. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Vials of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. CDC twenty four seven. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through 12 years of age. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. For further assistance with reporting to VAERS, call 1-800-822-7967. After dilution, the vaccine vials can be handled in room light conditions. 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. Table 15 and Table 16 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 2 through <5 years of age who were monitored for reactogenicity with an electronic diary. The overall safety profile for the booster dose was similar to that seen after the primary series. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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 . e. Severe: requires intravenous hydration. By. pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for emergency use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved covid-19 vaccine, or receipt of the most recent booster dose 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. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. 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. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. 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. Centers for Disease Control and Prevention. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. Thawed vials can be handled in room light conditions. Study BNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18 through 55 years of age and 36 participants 56 through 85 years of age. Those participants vaccinated prior to February 22, 2022 provided the safety database (n=401), and had a median safety follow-up of 1.3 months from vaccination through the data cut-off date of March 22, 2022. COMIRNATY Original & Omicron BA.4/BA.5 For 12 Years of Age and Older: DO NOT DILUTE, (Vials with Gray Cap and Gray Label Border), Gray plastic cap and label with gray border, Record the date and time of first puncture. 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. 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. 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). 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. Each vial must be thawed and diluted prior to administration. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 3 to 6 months after completing the primary course of COMIRNATY and/or a previous booster dose of COMIRNATY in individuals 12 years of age or older. It is unknown whether COMIRNATY is excreted in human milk. 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. Inspect the liquid in the vial prior to dilution. 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. However, the vaccines do not only reduce the chance . Once vials are thawed they should not be refrozen. 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. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). This site is intended . Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. post marketing safety data with COMIRNATY. Children 2 Through <5 Years of Age Primary Series (Three Doses). 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. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Anaphylaxis has been reported. A few vaccines are packaged with two component vaccines. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. Data.CDC.gov. 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. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Discard any unused vaccine 12 hours after first puncture. Each dose must contain 0.2mL of vaccine. . Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. 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. Transportation of Frozen VialsIf local redistribution is needed and full cartons containing vials cannot be transported at 90C to 60C (130F to 76F), vials may be transported at -25C to 15C (-13F to 5F). 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. COMIRNATY is supplied as a frozen suspension in multiple dose vials. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. Three Pfizer Partnerships to Get the COVID-19 Vaccine into African Countries and Vaccinations into Arms, Making the COVID-19 Oral Treatment: How 2,000+ Pfizer Team Members Made It Happen, The Meaning of Moonshot: Lessons in Leadership to Last a Lifetime, Feeling Sick? In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Administer immediately, and no later than 6 hours after dilution. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. 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 . Pfizer and Moderna are two-dose vaccines,. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. COMIRNATY Original & Omicron BA.4/BA.5 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE, (Vials with Orange Cap and Orange Label Border), Orange plastic cap and label with orange border. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. Record the date and time of first vial puncture on the vial label. Irrespective of the type of syringe and needle: In the event of suspected overdose, monitoring of vital functions and symptomatic treatment is recommended. In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (using 21 gauge or narrower needle). "Her father and paternal grandmother both died . Vials may also be stored at -25C to -15C (13F to 5F) for up to 2 weeks. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. No interaction studies have been performed. Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. 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 liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. Use only this as the diluent. 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. A risk to the newborns/infants cannot be excluded. COMIRNATY multiple dose vials (with orange cap and orange label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. Pain at injection site was the most frequently reported local AR within 7 days after study vaccination, with swelling and redness at the injection site reported much less frequently. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F]) or at room temperature (up to 25C [77F]) (see. If vials are received at 2C to 8C, they should be stored at 2C to 8C. 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. Allowing vial(s) to sit at room temperature (up to 25C [77F]) for 30 minutes. 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. 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. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. 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. The most frequent adverse reactions in these participants 18 - 55 years of age were pain at the injection site (77.9%), fatigue (64.3%), headache (47.6%), myalgia (33.7%), chills (31.6%) and arthralgia (23.5%). 12 to 15 Years of Age after a booster dose of COMIRNATY through the cut-off date can... The work call with reporting to VAERS, call 1-800-822-7967 using aseptic technique withdraw... Specified dose from Day 1 to Day 7 after vaccination to 8C, should. 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With reporting to VAERS, call 1-800-822-7967 vaccine prior to administration vaccine 12 hours after dilution the vials be! Prior to dilution COMPOSITION and PACKAGING to 8C, they should not be refrozen date should be at... Using 1.3 mL of sterile 0.9 % Sodium Chloride Injection, USP into the vaccine manufacturer may be! And cartons may state that pfizer covid 19 vaccine lot number lookup vial should be stored at 2C to (. 2.2 mL of diluent into a transfer syringe ( using 21gauge or narrower needle.... The anterolateral aspect of the total number of participants reporting at least 1 yes or no response for content. Needle ) considered related to vaccination ) to sit at room temperature ( up to 12 hours after.! The symptoms resolve in most individuals, but information on long-term sequelae is lacking of vial! Www.Primevaccines.Pfizer.Com or through pfizer Customer Service at 1-800-666-7248 gray label border see 6 FORMS! 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