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. 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). 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 Undiluted vials may be stored at room temperature for no more than 2 hours. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. There is no information on the co-administration of COMIRNATY with other vaccines. The safety evaluation of participants in Study 2 and Study 4 is ongoing. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. They help us to know which pages are the most and least popular and see how visitors move around the site. It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. Verify that the vial has an orange plastic cap and an orange label border. a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use, synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and. As with any vaccine, vaccination with COMIRNATY may not protect all recipients. Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. Do not use if vaccine is discoloured or contains particulate matter. Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. Cold chain is used for consumer products like ice cream and other frozen foods, as well as medicines and vaccines. The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. 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. How is Pfizer utilizing a cold chain process to distribute its vaccine? If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. 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. Strict adherence to aseptic techniques must be followed. This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. How Do Viruses Mutate and What it Means for a Vaccine? 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. Vaccine Lot Release Certificates. In these analyses, 69.0% (786 COMIRNATY and 773 placebo) of study participants had at least 4 months of follow-up after Dose 2. 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. 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. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. Individuals should be advised to bring symptoms (e.g., dizziness, increases in heart rate, feeling short of breath, tingling sensations or sweating) to the attention of the vaccination provider for evaluation. Cleanse the vaccine vial stopper with a single use antiseptic swab. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of COMIRNATY. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? (after dilution, each vial contains 10* doses of 0.2 mL). You will be subject to the destination website's privacy policy when you follow the link. 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. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. 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. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. We have crossed another milestone in the fight against COVID-19. Each vial must be thawed and diluted prior to administration. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Read . 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. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. January 31, 2023. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. The date printed on the vial and carton reflects the date of manufacture. 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. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. When prepared according to their respective instructions, COMIRNATY for 12 years of age and older (DILUTE BEFORE USE: purple cap and purple label border) and COMIRNATY for 12 years of age and older (DO NOT DILUTE: gray cap and gray label border) can be used interchangeably to provide the COVID-19 vaccination series.COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap/purple label border or gray cap/gray label border) cannot be used to prepare doses for individuals aged 6 monthsto <12 years. Shortly after, the novel virus was identified as SARS-CoV-2. One year. Do not add more than 2.2 mL of diluent. Participants 6 Months Through <2 Years of Age. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 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? These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Confirm there are no particulates and that no discolouration is observed. 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 . 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. The bivalent vaccine is available in vials with gray cap and gray label border (for individuals 12 years of age and older) and in vials with an orange cap and orange label border (for individuals 5 to <12 years of age). The thawed suspension may contain white to off-white opaque amorphous particles. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). 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. 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. e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. Participants 16 Years of Age and Older After Booster Dose. 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. It is unknown whether COMIRNATY has an impact on fertility. COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). (See VAERS data is accessible by downloading raw data in comma-separated value (CSV) files for import into a database, spreadsheet, or text editing program, or by using the CDC WONDER online search tool. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. In a video that has been shared massively on social media, Joseph Fraiman, who was a lead author of the peer-reviewed research that re-analyzed Pfizer & Moderna trials for mRNA COVID-19 vaccine . Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Adjust Direction, then . In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. Systemic ARs reported after study vaccination are summarized in Table 4. Verify the final dosing volume of 0.3 mL. Of these, 1,559(786COMIRNATY and 773 placebo) adolescents have been followed for 4months after the second dose of COMIRNATY. 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. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. 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. Please review the label carefully to ensure that you select the appropriate vaccine for immunization. While the idea of viral mutation may sound concerning, its important to understand that many of these mutations are minor, and dont have an overall impact on how fast a virus spreads or poten, Despite the complex technology and global scientific expertise that go into building a safe and effective vaccine, when it comes down to it, vaccination is a simple concept. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION and packaging series of three doses 0.2. And packaging located on the vial and carton reflects the date of manufacture DOSAGE FORMS, STRENGTHS COMPOSITION. Identifies a specific lot number: Pfizer COVID-19 vaccine: the expiration date not... 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