DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. 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. 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. Refer to dilution and dose preparation instructions in the panels below. 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. 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. A carton of 10 vials may take up to 4 hours to thaw at this temperature. Do not pool excess vaccine from multiple vials. safety data from clinical trials which evaluated primary and booster vaccination with COMIRNATY (see. Submit a medical question for Pfizer prescription products. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. The products discussed herein may have different labeling in different countries. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. 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. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. 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. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 Table 1: Dosage Forms, Strengths, Composition and Packaging (For 12 Years of Age and Older), Tozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Omicron BA.4/BA.5 strain. No withdrawals due to AEs were reported in any of the groups beyond 1-month post-dose. Access to this report is strictly managed by registration only. Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). Currently available information is insufficient to determine a causal relationship with the vaccine. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. 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. In the analysis of blinded, placebo controlled 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. In the analyses of Study 3 in participants 2 through <5 years of age (606 COMIRNATY; 280 placebo), 76.6% of participants had at least 30 days of follow-up after Dose 3. CIR Total Expected Inventory. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. The extension is also applicable to batches that might have expired prior to this amendment. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals 12 years of age and older (gray cap/gray label border) cannot be used to prepare doses for individuals aged 5 to <12 years of age. To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information: *If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. 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. For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border). 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. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. Remember, always check the product's expiration dates prior to administering. (after dilution, each vial contains 10* doses of 0.2 mL). Vaccine Lot Release Certificates. On Dec. 11, the US Food and Drug Administration issued its first emergency use authorization for a Covid-19 vaccine, shortly after the UK . Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. It was December 15, 2020 when Melissa French got the message: Pfizer needed large quantities of something called a cationic lipid that was critical to the COVID-19 vaccine. 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). 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. The most frequently reported unsolicited adverse event was lymphadenopathy (2.5%). Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Do not use if vaccine is discoloured or contains particulate matter. Strict adherence to aseptic techniques must be followed. 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 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 . 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. Our scientific content is evidence-based, scientifically balanced and non-promotional. How will hospitals and pharmacies keep vaccines cold? Obtain sterile 0.9% Sodium Chloride Injection, USP. Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. Once vials are thawed they should not be refrozen. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. Centers for Disease Control and Prevention. 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). Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.4 months follow-up after Dose 3, were reported by 0.7% of COMIRNATY recipients and by 0.9% of placebo recipients. second. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. 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. 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%). Do not store vials at 25C to 15C (-13F to 5F). 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. These codes incorporate the specialized tracking needs of the Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) by identifying two code groups. This diluent is not packaged with the vaccine and must be sourced separately. To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date (or manufacture date). The COMIRNATY multiple dose vial (for age 6 months to <5 years) has a maroon cap and a maroon label border and contains a volume of 0.4 mL. 2023 Pfizer. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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). You can review and change the way we collect information below. I have been advised to remain on site for 15 minutes after receiving the vaccine. Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 Do not add more than 1.3 mL of diluent. No withdrawals due to AEs or deaths were reported. 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. Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. 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. Where is the Pfizer-BioNTech COVID-19 vaccine made? For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. In total, 5.9% and 6.2% of participants reported any AE (with 0% and 0.3% reporting any serious AE) from study vaccination through 1 month post-dose in the COMIRNATY (30 mcg) and COMIRNATY Original/Omicron BA.1 (30 mcg), respectively. For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. d. Severe: disabling; not interested in usual daily activity. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. Overall, participants who received a booster dose in Study C4591031 (Study 4), had a median follow-up time of 2.5 months after the booster dose to the cut-off date (October 5, 2021). During the visual inspection: Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. 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%). 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. 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. Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. a second dose inventory management system. Vials must reach room temperature before dilution. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing followup were reported by 5.8% of COMIRNATY recipients and by 5.8% of placebo recipients. 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. the pfizer-biontech covid-19 vaccine, bivalent is authorized for use as a single booster dose in individuals 5 years of age and older at least two months after completion of either primary. 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). dose. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. Thats how long it has been since the World Health Organization declared COVID-19 a global pandemic. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Disclaimer This content is intended for Canadian Healthcare Professionals. For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 12-month shelf-life. The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. How will Pfizer maintain vaccine integrity during distribution? Each vial contains 6 doses of 0.3 mL. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. 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. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. Each component vaccine of a multiple component vaccine will have a unique NDC which also differs from the NDC of the unit of sale. Files will be updated on a daily basis Monday through Friday as new lots are released by each manufacturer or as updates are made to the lot expiration dates. 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). The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. If received at 2C to 8C, they should be stored at 2C to 8C. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. 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. A risk to the newborns/infants cannot be excluded. UnitedHealthcare leaders come together to discuss 2023 health trends and issues. Vials should be discarded 12 hours after dilution (i.e., the first puncture). 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). Irrespective of the type of syringe and needle: In the event of suspected overdose, monitoring of vital functions and symptomatic treatment is recommended. Multiple Dose Vial (for 12 years of age and older: DILUTE BEFORE USE), Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, Multiple Dose Vial (for 12 years of age and older: DO NOT DILUTE), COMIRNATY* Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Dr Gina Reghetti Do Pc Inc is a Medical Group that has only one practice medical office located in Warren OH. In order to provide you with relevant and meaningful content we need to know more about you. It is supplied as a frozen suspension that does not contain preservative. Administer immediately, and no later than 12. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. 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. Study 3 (Phase 2/3) enrolled 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo). In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. After mixing, the vaccine should appear as a white to off-white suspension with no visible particles. 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. To the Pfizer-BioNTech COVID-19 vaccine: the expiration date is not packaged with the vaccine should as. Scientifically balanced and non-promotional and/or needles can be used after 12 months from the contents! Have been advised to remain on site for 15 minutes after receiving vaccine... 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