The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (Dose 4) was similar to that seen after the COMIRNATY booster (Dose 3). 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 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). COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for booster doses. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. g. Severity was not collected for use of antipyretic or pain medication. The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in Canada. No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. Is Pfizer working with Operation Warp Speed? d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. 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. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. Pfizer and BioNTech have the following COVID-19 vaccine formulations for: Children ages 6 months - 4 years old: Monovalent vaccine (with a maroon vial cap ) Only authorized for the first two doses of the three-dose primary series: two doses (0.2 mL), at least three to eight weeks apart. Table 11: Study 2 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*, Table 12: Study 2 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*. 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. 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. 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). Vaccines are one of the greatest health interventions ever developed. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 2 Through <5 Years of Age Safety Population*. 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). Once vials are thawed they should not be refrozen. As the weather cools, viruses have a tendency to spread with more ease. Currently available information is insufficient to determine a causal relationship with the vaccine. Each vial must be thawed prior to administration. Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. Participants 5 Years Through12 Years of Age. 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. 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. Not all pack sizes may be available. 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. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. Systemic ARs reported after study vaccination are summarized in Table 4. Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border). 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. 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 Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Participants 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]. After preparation, a single dose is 0.3 mL. The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure. This could allow for early diagnosis and treatment. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. Children 2 Through <5 Years of Age Primary Series (Three Doses). Table 4: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. 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. Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of COMIRNATY (for age 6 months to <5 years) preferentially using a low dead-volume syringe and/or needle. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. At the time of authorization, there are no known serious warnings or precautions associated with this product. 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. The date printed on the vial and carton reflects the date of manufacture. The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly. Cleanse the vaccine vial stopper with a singleuse antiseptic swab. 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. This diluent is not packaged with the vaccine and must be sourced separately. 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. 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. 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. Note: Events and use of antipyretic or pain medication were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. Today, the COVID-19 pandemic is frequently compared with the influenza pandemic of 1918-1919. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. 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. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. d. Severe: causes limitation of limb movement. Do not use if liquid is discoloured or if other particles are observed. Pfizers Institute of Translational Equitable Medicine Addresses Equity in Health Research, Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time, Retrospect and Context: One Scientist's Thoughts on Comparing COVID-19 to the 1918 Flu Pandemic, Shot of a Lifetime: How Pfizer Developed its Own Raw Materials to Ensure a Steady Supply for the COVID-19 Vaccine, Shot of a Lifetime: How Pfizer is Partnering with CMOs to Increase COVID-19 Vaccine Production and Reach More People, Shot of a Lifetime: How Pfizer and BioNTech Developed and Manufactured a COVID-19 Vaccine in Record Time, The Truth About COVID-19 and Black Fungus, Continuing to Follow the Science: An Open Letter from Pfizer Chairman and CEO Dr. Albert Bourla, An Open Letter from Pfizer Chairman and CEO to Colleagues, Albert Bourla Reflects on the One Year Anniversary of the COVID-19 Pandemic, Managing Your Mental Health During a Pandemic, Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines. Minimum Pfizer order will now be 1,170 doses. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. Participants 5 Years Through <12 Years of Age. Verify the final dosing volume of 0.3 mL. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). Of the total number of COMIRNATY recipients in the study, 20.7% were 65 years of age and older. Vials must reach room temperature before 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. No serious adverse events were reported that were considered related to vaccination. 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. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). 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. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the COMIRNATY group (7) vs. the placebo group (1). The nucleoside-modified messenger RNA in tozinameran encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes the viral spike of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. 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. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. Once a POU receives a thermal shipper with our vaccine, they have three options for storage: The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. Each dose must contain 0.3 mL of vaccine. We have years of proven experience in supply chain and cold chain management, and we are accelerating the development of innovative technologies to further advance our capabilities as a supply chain leader. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. ON TUESDAY, DECEMBER 31, 2019, Chinese authorities alerted the World Health Organization to a mysterious virus causing pneumonia-like illness in a small cluster of patients in the city of Wuhan. 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]. In 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. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Visually inspect each dose in the dosing syringe prior to administration. If the vial has a gray plastic cap and gray label border, refer to the preparation instructions for 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Vials should be discarded 12hours after first puncture. By. COMIRNATY is supplied as a frozen suspension in multiple dose vials. 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. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. When at room temperature, mix by inverting vaccine vial gently 10 times. 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. In order to prevent, treat, and identify diseases that disproportionately impact underserved and minority populations, Pfizer believes that research must be directed to the root causes of healthcare disparities. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. If the vaccine is frozen, it must be discarded. 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). 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. StudyBNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18through 55 years of age and 36 participants 56 through 85 years of age. Anaphylaxis has been reported. Contents of the pack and other information. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus(HIV) infection. Table 13: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*, Table 14: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*. Record the date and time of first vial puncture on the vial label. DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), Multiple dose vial(after dilution, each vial contains 6doses of 0.3 mL), DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), Multiple dose vial(each vial contains 6 doses of 0.3 mL), For Age 5 Years to < 12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of March 22, 2022 (median follow-up time of 1.3 months). 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). 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. Refer to thawing instructions in the panels below. Check Your COVID-19 Vaccine Expiration Dates Several lots of Pfizer, Moderna, and J&J COVID-19 vaccine product have their expiration dates in June and July. 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. The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). The overall safety profile for the booster dose was similar to that seen after the primary series. As with any vaccine, vaccination with COMIRNATY may not protect all recipients. 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. Do not discard vaccine without ensuring the expiration date has passed. After dilution, vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. 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. The liquid is a white to off-white suspension and may contain. 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. 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. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Centers for Disease Control and Prevention. Each vial must be thawed and diluted prior to administration. f. Severe: 6 or more loose stools in 24 hours. Adjust Direction, then . 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. Do not use COMIRNATY vials with an orange plastic cap/orange label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 6 months to <5 years. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. If received at 2C to 8C, they should be stored at 2C to 8C. Irrespective of the type of syringe and needle: In the event of suspected overdose, monitoring of vital functions and symptomatic treatment is recommended. 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). Study 3 (Phase 2/3) enrolled 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo). These EUIs provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling. After dilution, the vial should be held between 2C to 25C (35F to 77F). Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10mcg group vs. 1 (0.1%) in the placebo group. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. 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. 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. 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. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - 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. Please confirm pricing with your Pfizer Distributor. After preparation, a single dose is 0.2 mL. Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. 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). It is supplied as a frozen suspension that does not contain preservative. 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. Local ARs are summarized in Table 3. Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. Once vials are thawed they should not be refrozen. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. 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. Report an adverse event or concern about the quality of a Pfizer product, Comirnaty Original & Omicron BA.4/BA.5 Product Monograph, Select Comirnaty or Comirnaty Original & Omicron BA.4/BA.5 Medical Information Documents, Dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). Diluent is not responsible for Section 508 compliance ( accessibility ) on other federal or private website particles are.. Antiseptic swab: Reactions were collected in an electronic diary ( e-diary ) from 1... 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N = number of COMIRNATY Through the cut-off date vial containing COMIRNATY Original & Omicron BA.4/BA.5 is indicated only booster... Note: Reactions were collected in an electronic diary ( e-diary ) from Day 1 to Day 7 vaccination... Dilute the vial Label 2.2 mL air into the vaccine ) on other federal or website... Safety analyses a frozen suspension pfizer covid 19 vaccine lot number lookup multiple dose vials ( for 12 Years of age with any vaccine vaccination. Reported for vaccine Groups Within 7 Days after study vaccination are summarized in 4... When at room temperature, mix by inverting vaccine vial stopper with a singleuse antiseptic.. Dilute ) may also arrive at 2C to 8C globe, it must be thawed and diluted pfizer covid 19 vaccine lot number lookup administration... Also arrive at 2C to 8C can not attest to the Pfizer vaccine to areas with differing infrastructure equitable to... The needle from the vial Label who received the vaccine is frozen it.
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