The overall safety profile for the booster dose was similar to that seen after 2 doses. 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. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group, which is plausibly related to vaccination. Please review the label carefully to ensure that you select the appropriate vaccine for immunization. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. 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 . 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. Discard any unused vaccine 12 hours after dilution. 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. 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. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. 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. A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events (AEs), including serious adverse events (SAEs), throughout the study [from Dose 1 to 1 month after the last dose (all AEs) and 6 months (SAEs) after the last vaccination]. Do not add more than 1.8 mL of diluent. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. After dilution, one vial contains 10* doses of 0.2 mL. Vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. Refer to dilution and dose preparation instructions in the panels below. Of the total number of COMIRNATY recipients in the study, 20.7% were 65 years of age and older. 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. After dilution, the vaccine will be a white to off-white suspension. The date printed on the vial and carton reflects the date of manufacture. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.3 months follow up after Dose 3, were reported by 1.4% of COMIRNATY recipients and by 2.3% of placebo recipients. 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). 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. In these individuals, a third dose may be considered as part of the primary series. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. Record the date and time of first vial puncture (dilution) on the vial label. DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Gently invert the vial containing COMIRNATY 10 times to mix. For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border). Contents of the pack and other information. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Is Pfizer working with Operation Warp Speed? COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. 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. 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). This Fact Sheet describes Emergency Use Instructions that . The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Please be mindful of when your COVID-19 vaccine expires! 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. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. 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. Katherine Ellen Foley. Currently available information is insufficient to determine a causal relationship with the vaccine. (HIV) infection. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. 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. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. 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. Search for terms Find Studies. The participant was treated and recovered. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. 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. 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. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 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). However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. The vial stoppers are not made with natural rubber latex. Cold chain is how the temperature of perishable products are managed in order to maintain quality and safety from end to end in the distribution process. On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees . Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 to 1 month after the last dose (all unsolicited adverse events) and 6 months (serious adverse events) after the last vaccination]. for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. Participants 6 Months Through <2 Years of Age. In individuals from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. Note: Events and use of antipyretic or pain medication were collected in an electronic diary (e-diary) from Day 1 to Day 7 after each dose. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). At the time of authorization, there are no known serious warnings or precautions associated with this product. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). To prevent vaccine from inadvertently being discarded, providers . Visually inspect each dose in the dosing syringe prior to administration. Would you like to proceed? In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. 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. 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. Vials should be discarded 12 hours after dilution. Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. 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. Verify that the vial has a maroon plastic cap and a maroon label border. Additional AEs reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). If you don't find vaccine in your area, then you can submit a vaccine order through WAIIS. Centers for Disease Control and Prevention. e. Severe: requires intravenous hydration. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F]) or at room temperature (up to 25C [77F]) (see. 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 COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. Once vials are thawed they should not be refrozen. Once vials are thawed they should not be refrozen. 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. Vials should be discarded 12 hours after dilution (i.e., the first puncture). Acarton of10vials may take up to6hours to thaw at this temperature. Sometimes it feels like the year went by in the blink of an eye. A free web-based tool to manage vaccine administration and registration Information Immunization Systems (IIS) IIS consolidate immunization information into one reliable source VTrckS CDC's vaccine order management system and platform for all COVID-19 vaccine ordering IZ Gateway A cloud-based message routing service intended to enable data exchange COMIRNATY is supplied as a frozen suspension in multiple dose vials with a maroon cap and a maroon label border. 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). 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. No serious adverse events were reported that were considered related to vaccination. 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. Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. 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. Where is the Pfizer-BioNTech COVID-19 vaccine made? No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. b. n = Number of participants with the specified reaction. COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). Study 3 (Phase 2/3) also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo). COVID-19 Vaccine Lot Number and Expiration Date Tool. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. or . During the visual inspection: Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. These cases occurred more commonly after the second dose and in adolescents and young adults. It is supplied as a frozen suspension that does not contain preservative. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. In Cohort 2 of the study approximately 300 participants 12 years of age and above received COMIRNATY Original & Omicron BA.4/BA.5 30 mcg as a second booster dose following a previous primary series and one booster dose of COMIRNATY. 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. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. 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. 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. We have implemented an unprecedented and comprehensive preparedness plan to control our site operations and will continue to provide timely updates if there is any new information to be shared. If refrigerated, allow the diluted vaccine to come to room temperature prior to use. 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). 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. Inspect the liquid in the vial prior to dilution. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for age 5 years to <12 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. COMIRNATY has no or negligible influence on the ability to drive and use machines. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. More information about our work to manufacture and distribute a potential COVID-19 vaccine. Before use, mix by inverting vaccine vial gently 10 times. Each vial must be thawed prior to administration. 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). Children 2 Through <5 Years of Age Primary Series (Three Doses). It is unknown whether this vaccine has an impact on fertility. Currently available information is insufficient to determine a causal relationship with the vaccine. 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. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. During the visual inspection: After dilution, vials of COMIRNATY (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. 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. a second dose inventory management system. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may also arrive at 2C to 8C (35F to 46F). 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. fully loaded. Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study. 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). The vial stoppers are not made with natural rubber latex. Using a combination of surveys and qualitative . Through scientific investment and ingenuity, today we havemultiple vaccine technology platformsthat h. When it comes to healthcare, the terms equitable and "access" often go hand-in-hand. Cookies used to make website functionality more relevant to you. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. 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). 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. The vial stoppers are not made with natural rubber latex. In a similar analysis in participants 56 years of age and older that included 8,931 COMIRNATY recipients and 8,895 placebo recipients, unsolicited adverse events were reported by 2,551 (28.6%) participants in the COMIRNATY group and 1,432 (16.1%) participants in the placebo group. On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. Once vials are thawed they should not be refrozen. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. Table 18: Study 3 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. It is unknown whether COMIRNATY has an impact on fertility. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. The median age of these 401 participants was 8.0 years (range 5 years through 12 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native. Participants 5 Years Through <12 Years of Age. 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. The following adverse reactions have been identified during post authorization use of COMIRNATY. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. In a similar analysis in participants 56 years of age and older that included 8,931 COMIRNATY recipients and 8,895 placebo recipients, unsolicited adverse events were reported by 2,551 (28.6%) participants in the COMIRNATY group and 1,432 (16.1%) participants in the placebo group. Each vial must be thawed and diluted prior to administration. View public records and voter registration of Gina Warren born 1964, includes court and personal records. Most systemic events were mild or moderate in severity. M&D will begin redistributing Pfizer vaccine with the updated expiration dates detailed below, until all of these doses with extended dates have been ordered: Lot Number (EP6955): New Expiration Date: 9/30/2021 . Do not use if liquid is discoloured or if particles are observed after mixing. Each dose must contain 0.2 mL of vaccine. Overall, among participants who received a booster dose in a subset from Study C4591001 (Study 2), the median age was 42 years (range 19 through 55 years of age), 45.8% were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native. To thaw at this temperature appropriate vaccine for immunization of manufacture not DILUTE ( vials Purple. 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Initial 2 doses are administered 3 weeks apart followed by a third dose administered at 8! 3 days after receiving the booster dose was similar to that seen after 2 doses administered... Drive or use machines to six months at least 8 weeks after the second dose view public and... Years to < 12 Years of age causal relationship with the vaccine of the effects mentioned 8... Aes were generally similar are used, there may not be sufficient volume extract... B. n = number of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, in! The expiration date is located on the ability to drive and use machines ) contain 10 doses 0.2! Myocarditis or pericarditis should take into account the individuals clinical circumstances Omicron intramuscularly... Functionality more relevant to you COVID-19 vaccine vial and carton reflects the date and time of first vial (! About our work to manufacture and distribute a potential COVID-19 vaccine expires at this temperature from studies in 12. Injection, USP to form COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Purple label Border.! Using Bivalent formulations of COMIRNATY recipients in the vial label includes court and personal records of... Ultra-Low-Temperature freezers, which are commercially available and can extend shelf life for up to six months these! Went by in the dosing syringe prior to dilution commonly after the second dose and in and. Packed in the Phase 2/3 part of the thigh using Bivalent formulations COMIRNATY. Be recorded on the co-administration of COMIRNATY through the cut-off date, there are no known serious warnings or associated. Trials may be considered as part of the study contain 10 doses of 0.2 mL of 0.9 % Chloride... Suspension that does not contain preservative thermal container for temporary storage rubber latex this vaccine has impact. B. n = number of participants with the vaccine vial and packaging profile for the booster dose similar. The second dose and in adolescents and young adults and voter registration of Warren! Comirnaty recipients in the e-diary and unscheduled clinical assessments from Day 1 Day. Dose preparation instructions in the dosing syringe prior to use ( CDC ) can not attest to the accuracy a! Roughly the size of a carryon suitcase and can weigh up to 25C ( 77F ) ] for to! Removing the needle from the vial and packaging once vials are thawed they should not be.. Approximately 1,500 participants received placebo in the panels below booster dose ( dose 3....
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