Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. Vials should be discarded 12 hours after first puncture. through 4 years. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 Vaccine. This Fact Sheet may have been updated. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. SPECIAL BULLETIN COVID-19 #198: Pfizer Vaccine for 12 Years and Older In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. Remember to bring your card when you return. % Dry ice replenishment every 5 days. The Countermeasures Injury Compensation Program. The observed risk is highest in males 12 through 17 years of age. Individuals 12 years of age and older may receive a booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent. In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). The new gray cap formulation does not require reconstitution with diluent and will not come with it. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which is supplied in a single dose and multiple dose vial with a gray cap and a label with a gray border, should not be used in individuals 5 through 11 years of age.2 SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in 2 clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. The safety population includes participants 16 years of age and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. Updated 4/21/2022: Shelf Life Extension for Pfizer-BioNTech COVID Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals younger than 6 months of age. 4 0 obj PDF Pfizer COVID-19 Vaccine Formulations - Texas Original formula Purple cap uses a PBS buffer. During the visual inspection. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials with gray caps and labels with gray borders. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. <> All Purple Cap Pfizer (for ages 12+) has expired and should be disposed of (see the "Spoiled, Wasted and Expired COVID-19 Vaccines" section below for instructions) . The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a gray cap and a label with a gray border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. 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. Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. Information to include: The following steps are highlighted to provide the necessary information for safety tracking: There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. Tell the vaccination provider about all of your medical conditions, including if you: The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle. PDF Transitioning to Pfizer's Comirnaty Gray Cap Formulation - EZIZ It was reported that Comirnaty would be available in October or November. IIS COVID-19 Vaccine Related Code | CDC Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with gray caps and labels with gray borders also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose. "p]}18{y%dQ~Q9q^A&O2k yP-Y^_+a"X$"T The vaccination provider must communicate to the individual receiving the Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information consistent with the "Vaccine Information Fact Sheet for Recipients and Caregivers" prior to the individual receiving Pfizer-BioNTech COVID-19 Vaccine. Table 1: Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 3: Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, Table 4: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, (Kamar N, Abravanel F, Marion O, et al. If you have any questions, contactvaccines@phila.gov. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.7 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. No. Do not pool excess vaccine from multiple vials. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. Give Pfizer-BioNTech COVID-19 vaccine DO NOT DILUTE (gray cap); 30 micrograms, 0.3 mL, intramuscular (IM); and Give the second dose 3-8 weeks following the first dose. For more information on how to sign up, visit: www.cdc.gov/vsafe. <> had a severe allergic reaction to any ingredient in these vaccines. cases of COVID-19 that result in hospitalization or death. endobj PDF New York City Department of Health and Mental Hygiene Pfizer-BioNTech COVID-19 Vaccines | FDA Contact your local or state public health department. endobj 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. Disclaimer: Subject to change due to FDA EUA approval. Once punctured, the vial must be discarded after 12 hours (the packaging may indicate 6 . No. Expiration Dating Extension | FDA In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) or placebo separated by 21 days. 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. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. \2 !+b# In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%). 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. 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