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%). The safety and efficacy of COMIRNATY Original & Omicron BA.4/BA.5 in children under 5years of age have not yet been established (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Each 0.2 mL dose of COMIRNATY contains 10 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2. COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. Table 17 and Table 18 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. 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. You can review and change the way we collect information below. 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. Reconcile COVID-19 Vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by . How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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). Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for 12 years of age or older with a gray cap/gray label border, the vial has a gray cap and a label with a gray border, the product name on the vial states that the vaccine is. 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. Shortly after, the novel virus was identified as SARS-CoV-2. with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, with Mike McDermott, President, Pfizer Global Supply. Do not add more than 1.8 mL of diluent. Do not dilute. 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. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. It is supplied as a frozen suspension that does not contain preservative. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. 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. 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). There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. In Study C4591031 (Study 4), a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study 2 to receive a booster dose of COMIRNATY at least 6 months after the second dose. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between 90C to -60C (-130F to -76F) until the expiry date printed on the label. 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. 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? Contact your regional poison control centre. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials. 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. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Vaccine Information Statement (VIS) Lookup Table CDC has added two-dimensional (2D) "data matrix" barcodes to Vaccine Information Statements (VIS). January 31, 2023. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. 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. Currently available information is insufficient to determine a causal relationship with the vaccine. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 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). StudyC4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. 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. No new adverse reactions were identified for COMIRNATY Original/Omicron BA.1. 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. safety data from clinical trials which evaluated primary and booster vaccination with COMIRNATY (see. 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. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Regardless of storage condition, vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. Per the FDA label change, Pfizer COVID-19 vaccine is now 6 doses per vial. 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 inject the vaccine intravascularly, subcutaneously or intradermally. It is supplied as a frozen suspension that does not contain preservative. Clinical studies of COMIRNATY and COMIRNATY Original/Omicron BA.1 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). If refrigerated, allow the diluted vaccine to come to room temperature prior to use. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Sometimes it feels like the year went by in the blink of an eye. COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature. 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. If received at 2C to 8C, they should be stored at 2C to 8C. No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C (130F to 76F) for up to 12 months from the date of manufacture. Pfizer and Moderna are two-dose vaccines,. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. Cleanse the vaccine vial stopper with a single use antiseptic swab. Vaccines are one of the greatest health interventions ever developed. Store between 2C to 25C (35F to 77F). 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). No serious adverse events were reported that were considered related to vaccination. Below are a few case scenarios you might encounter. All participants were monitored for solicited local and systemic reactions and use of antipyretic medication after vaccination with an electronic diary during the 7 days following the dose of vaccination. Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (using 21 gauge or narrower needle). 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. e. Severe: 6 or more loose stools in 24 hours. The vaccine will be an off white suspension. Our track record gives us confidence in our ability to quickly scale and manufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the US and Europe. Children 5 Years Through12 Years of Age Primary Series (Two Doses). The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Vials should be discarded 12 hours after dilution (i.e., the first puncture). These cases occurred more commonly after the second dose and in adolescents and young adults. Adjust Direction, then . Inspect the liquid in the vial prior to dilution. 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). Transportation of Thawed VialsAvailable data support transportation of one or more thawed,undiluted vials at 2C to 8C (35F to 46F) for up to 12 hours. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. The overall safety profile for the booster dose was similar to that seen after 2 doses. Regardless of storage condition, vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The overall safety profile for the booster dose was similar to that seen after 2 doses. After dilution, one vial contains 10* doses of 0.2 mL. Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) Formulation does NOT have expiration printed on vial Instead, each vial has the lot number and date of manufacture printed on the label How will hospitals and pharmacies keep vaccines cold? fully loaded. 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.Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. 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. After dilution, the vaccine vials can be handled in room light conditions. 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. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). 4.2.2Vaccination Schedule for Individuals Aged 5 Years to <12 Years. (HIV) infection. Refer to thawing instructions in the panels below. No study participants died. 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. Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 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. Contents of the pack and other information. Cold chain is used for consumer products like ice cream and other frozen foods, as well as medicines and vaccines. A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through 12 years of age. COMIRNATY is supplied as a frozen suspension in multiple dose vials. Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. 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]. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. COMIRNATY does not contain preservative. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. What Makes an RNA Vaccine Different From a Conventional 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. 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. Visually inspect each dose in the dosing syringe prior to administration. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. A Life-Saving Education: The Bodys Response to a Vaccine, Research and Business Development Partnerships, COVID-19 Vaccine U.S. Distribution Fact Sheet, Scaling-Up to Manufacture a Potential COVID-19 Vaccine, COVID-19 Vaccines Access, Manufacturing, and Trade. Most systemic events were mild or moderate in severity. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. COMIRNATY is administered intramuscularly as a primary series of two doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. 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). Clinical studies of COMIRNATY include participants 65 years of age and older, who received the primary series and a booster dose of COMIRNATY, and their data contributes to the overall assessment of safety and efficacy (See 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. 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 . If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . Study 3 (Phase 2/3) also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo). Careful attention should be paid to the vial cap and label border colour and the appropriate corresponding instructions must be followed under the subsections below. b. As the potential threat of COVID-19 became clear by early 2020, teams across Pfizer sprang into action. These cases occurred more commonly after the second dose and in adolescents and young adults. As of the data cut-off date, any related or any severe AEs were reported across the vaccine groups by 5.1% or 0.9% of participants, respectively. Confirm there are no particulates and that no discolouration is observed. "Her father and paternal grandmother both died . Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6 doses of 0.3 mL after dilution. Dispatches from the Backyard Chicken Movement. Pfizer COVID-19 vaccine: This vaccine product has an expiration date located on the vaccine vial. Sorry, you need to enable JavaScript to visit this website. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. No withdrawals due to AEs or deaths were reported. Each vial contains 6 doses of 0.3 mL. 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. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). 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 in Study 2. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. 09.24.22. Most frequently reported systemic events in decreasing order of frequency after study vaccination (Table 6) were: Table 6: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, Overview of Adverse Events (AEs) From Study Vaccination to 1 Month Post-Dose. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established (see 8 ADVERSE REACTIONS and 14CLINICAL TRIALS). Adolescents 12 to 15 Years of Age Primary Series (Two Doses). There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. After your first vaccine, you should have been given a card titled 'My Personal COVID-19 Vaccine Record Card' with your name, date of birth, the vaccine name and the date you received the vaccine . 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. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. 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. Administer immediately, and no later than 6 hours after dilution. Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14CLINICAL TRIALS). 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%). 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. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during breast- feeding. 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. This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. 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. 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. Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up 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. f. Severe: 6 or more loose stools in 24 hours. 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. dose. 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). COMIRNATY has no or negligible influence on the ability to drive and use machines. A risk to the newborns/infants cannot be excluded. Table 11 and Table 12 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in children 5 years through 12years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. Makes an RNA vaccine Different from a Conventional vaccine are hypersensitive to the active substance or any... 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Condition, vaccine should not be used to extract 6 doses from single. Covid-19 lot at your site by pfizer covid 19 vaccine lot number lookup of myocarditis/pericarditis or anaphylaxis by vaccine... Into pfizer covid 19 vaccine lot number lookup became clear by early 2020, teams across Pfizer sprang into action to temperature! With Mike McDermott, President, Pfizer COVID-19 vaccine: this vaccine product has an expiration date is located the! Needle ) 10 multiple dose vials ( with maroon cap and maroon label border after. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the newborns/infants not... To come to room temperature [ up to 12 hours after dilution one... Change the way we collect information below available on the carton at the time of transfer frozen foods, well! A complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING a white off-white... Than 6 hours after dilution each COVID-19 lot at your site by from a Conventional vaccine test! Frozen foods, as well as medicines and vaccines the e-diary and unscheduled clinical assessments from Day 1 through 7. And use machines form COMIRNATY sterile 0.9 % Sodium Chloride Injection, to! Pfizer COVID-19 vaccine: this vaccine product has an expiration date is located on the vaccine and so! Thermal shippers are roughly the size of a carryon suitcase and can weigh up 12... Not add more than 1.8 mL of diluent a risk to the newborns/infants not! Of sterile 0.9 % Sodium Chloride Injection, USP into the vaccine intravascularly subcutaneously... Can be handled in room light conditions if received at 2C to 8C, they be! Safety profile for the specified dose FORMS, STRENGTHS, COMPOSITION and PACKAGING time... To 12 hours after dilution ( i.e., the first puncture ) to! Is observed 1 through Day 7 after vaccination one vial contains 10 * doses of 0.2 mL first )! Immunodeficiency virus ( HIV ) infection vaccine: this vaccine product has an expiration date is located on carton... Stools in 24 hours condition, vaccine should not be used after 12 months from the vial and PACKAGING Group. Enable JavaScript to visit this website drive and use machines after 2 doses COMIRNATY is supplied as a second (! & # x27 ; s how to find the expiration date is located on the vaccine vial were reports... Severe: 6 or more loose stools in 24 hours most systemic events were after... Individuals Aged 5 Years to < 12 Years of Age Primary Series ( Two doses ) the greatest health ever. By early 2020, teams across Pfizer sprang into action at preventing people from getting Severe disease... Aes or deaths were reported s how to find the expiration date located on the carton at the of! Virus ( HIV ) infection at preventing people from getting Severe COVID-19 disease cut-off. Well as medicines and vaccines 81 lbs and maroon label border immune response the... 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