Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . COVID-19 Vaccine Lot Number and Expiration Date Tool. 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. Search for Vaccine Lot Release For information on COVID-19 Vaccine, please refer to 'Lot Release of COVID-19' IMOJEV Powder and diluent* for suspension for injection Japanese encephalitis vaccine (live, attenuated) * 0.4 % Sterile Sodium chloride solution 08A2003EA . Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. If received at 2C to 8C, they should be stored at 2C to 8C. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. Non-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 10.9% of COMIRNATY 10 mcg recipients and by 9.1% of placebo recipients. 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. Cookies used to make website functionality more relevant to you. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus(HIV) infection. This informationincluding product informationis intended only for residents of the United States. 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. How can you prevent a cold chain failure? CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. View public records and voter registration of Gina Warren born 1964, includes court and personal records. In the analysis of blinded, placebocontrolled follow-up, there were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. The 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. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. 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. We have experience working with customers in all markets to ensure success. Store between 2C to 25C (35F to 77F). This diluent is not packaged with the vaccine and must be sourced separately. Verify that the vial has a gray plastic cap and gray label border. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/ fetal development, parturition, or post-natal development (see 16 NON-CLINICAL TOXICOLOGY). Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Please confirm pricing with your Pfizer Distributor. 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. 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. In a subset of Study 3 Phase 2/3 participants, 401 participants 5 years through <12 years of age received a booster dose of COMIRNATY at least 5 months (range 5 to 9 months) after completing the primary series. 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. Most systemic events were mild or moderate in severity. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. A carton of 10 vials may take up to 6 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. Do not dilute. Do not use COMIRNATY vials with a maroon plastic cap and maroon label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 5 years to <12 years. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. 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). 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. 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. 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 Each vial must be thawed and diluted prior to administration. Participants 16 Years of Age and Older Primary Series (Two Doses). It is unknown whether this vaccine has an impact on fertility. Do not use if liquid is discoloured or if other particles are observed. Children 5 Years Through12 Years of Age Primary Series (Two Doses). Data.CDC.gov. 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. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 2 Through <5 Years of Age Safety Population*. 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. Visually inspect each dose in the dosing syringe prior to administration. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. Do not dilute. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. 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. 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. e. Severe: requires intravenous hydration. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. 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. Date on the label is NOT the expiration date It is supplied as a frozen suspension that does not contain preservative. Discard any unused vaccine 12 hours after dilution. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. 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. Table 2: Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years), Multiple dose vial(after dilution, each vial contains 10* doses of 0.2 mL). Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (with orange cap and orange label border) are supplied in a carton containing 10 multiple dose vials. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. The vial stoppers are not made with natural rubber latex. Few additional AEs were reported from study vaccination from post-dose to the data cut-off date for participants in the COMIRNATY 30 mcg (6.6% vs 5.9%) group. The nucleoside-modified messenger RNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. Search for terms Find Studies. Study C4591001 (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. Vaccine Lot Release Certificates. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Each 0.2 mL dose of COMIRNATY contains 3 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. CDC twenty four seven. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. How is Pfizer utilizing a cold chain process to distribute its vaccine? No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during breast- feeding. Administer immediately, and no later than 6 hours after dilution. 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. 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. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Do not add more than 1.8 mL of diluent. 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*. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . 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%). In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%). After first puncture, the vial should be stored at 2C to 25C (35F to 77F). This could allow for early diagnosis and treatment. 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. Using a combination of surveys and qualitative . The date printed on the vial and carton reflects the date of manufacture. The recent announcement that the United States Trade Representative will discuss options to waive some COVID-19 vaccine intellectual property (IP) rights has created some confusion to the world. New Search . 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. At the time of authorization, there are no known serious warnings or precautions associated with this product. 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. Each dose must contain 0.2mL of vaccine. This site is intended . The date printed on the vial and carton reflects the date of manufacture. COMIRNATY has no or negligible influence on the ability to drive and use machines. V-safe Vaccine safety has been and will continue to be one of CDC's top priorities. To report and adverse reaction, or concern about the quality of a Pfizer product, please call Pfizer 1 866 723-7111 or visit www.healthcanada.gc.ca/medeffect or call Canada Vigilance Program at 1-866-234-2345. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). Severe systemic events were reported infrequently in both vaccine groups. The overall safety profile for the booster dose was similar to that seen after 2 doses. Each vial must be thawed and diluted prior to administration. Disclaimer Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10mcg group vs. 1 (0.1%) in the placebo group. 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. 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. (See Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. f. Severity was not collected for use of antipyretic or pain medication. Adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%). How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. Before dilution, allow the thawed vial to come to room temperature. Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute . The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in Canada. Participants 6 Months Through <2 Years of Age. One serious adverse event of fever (maximum temperature 40.3C) on Day 3 after Dose 2 in a 4-year-old was considered possibly related to vaccination. 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. Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine. 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. 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