Refer to thawing instructions in the panels below. 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. 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 . 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. In the analyses of Study 3 in children 5 years through <12 years of age (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo), 99.5% of participants had at least 30 days and 95.7% of participants had at least 3 months follow-up after Dose 2. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. Sometimes it feels like the year went by in the blink of an eye. Do not store vials at 25C to 15C (-13F to 5F). 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. This informationincluding product informationis intended only for residents of the United States. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. What is the path of a vaccine from Pfizers facilities to where its distributed to patients? Cleanse the vaccine vial stopper with a singleuse antiseptic swab. dose. Thus, each tray of the Pfizer COVID-19 vaccine is now 1,170 does (195 vial x 6 doses/vial). 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: Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border). Regardless of storage condition, vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. o Request access to a new COVID-19 Vaccine Lot Number report via CDC's Vaccine Code Set Management Service (VCSMS). Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). 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 safety and effectiveness of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 for individuals 5 years of age and older is inferred from studies of a booster dose of COMIRNATY Original/Omicron BA.1 in individuals >55 years of age, data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age as well as data from studies which evaluated the primary series and booster vaccination with COMIRNATY. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. post marketing safety data with COMIRNATY. 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. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. For example, if a provider was getting 975 doses, it will now be 1,170 doses. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. COMIRNATY does not contain preservative. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. 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. Per the FDA label change, Pfizer COVID-19 vaccine is now 6 doses per vial. For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Katherine Ellen Foley. Participants 16 Years of Age and Older After Booster Dose. Obtain sterile 0.9% Sodium Chloride Injection, USP. After dilution, the vaccine will be a white to off-white suspension. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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). Visually inspect each dose in the dosing syringe prior to administration. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. 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. No withdrawals due to AEs or deaths were reported. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 2 (0.2%) of COMIRNATY recipients vs. 0 (0%) of placebo recipients. 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 . 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%). 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. Tables 3 through 6 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in the subset of participants 16 years of age and older (n=9,839) in the safety population who were monitored for reactogenicity with an electronic diary. * Randomized participants who received at least 1 dose of the study intervention. As with any vaccine, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 may not protect all recipients. 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. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultra cold conditions in thermal containers with dry ice. 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. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. 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. Study C4591007 (Study 3) is a Phase 1/2/3 study comprised of an open-label vaccine dose finding portion (Phase 1) and a multicenter, multinational, randomized, saline placebo-controlled, observer-blind immunogenicity and efficacy portion (Phase 2/3) that has enrolled approximately 4,600 participants 5 years through <12 years of age. 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. Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in Canada. 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. Vaccines are one of the greatest health interventions ever developed. Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. 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. 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. 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 liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. 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. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. These distribution centers will have a dedicated area designated to store product that is not going direct from our Kalamazoo or Puurs sites to POU. No withdrawals due to AEs were reported in any of the groups beyond 1-month post-dose. Participants 18 to 55 Years of Age After a Booster Dose of Monovalent Omicron BA.1. If an ultra-low temperature freezer is not available, the thermal container in which COMIRNATY arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. In the analyses of Study 3 in participants 6 months through 2 years of age (386 COMIRNATY; 184 placebo), 83.7% of participants had at least 30 days of follow-up after Dose 3. 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. Children 5 Years Through12 Years of Age Primary Series (Two Doses). 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