The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in Tables 3 and 4. Please see the, 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. 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). Storage in boxes or bins can help maintain temperature longer, especially if power is lost. The chance of having this occur is very low. Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. 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. It is important that the information reported to FDA be as detailed and complete as possible. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). Storage of the vaccine COMIRNATY is stored at -90 C to -60C. 2022 . Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. No cases of Bell's palsy were reported in the placebo group. After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders is 0.2 mL for individuals 5 through 11 years of age [see Dosage and Administration (2.1)]. 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). Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. Thawed vials can be handled in room light conditions. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. 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. It is predominantly a respiratory illness that can affect other organs. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. Apr 25, 2023. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? 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. The vaccine efficacy information is presented in Table 8. Vials must reach room temperature before dilution. The vaccine is administered as a 2-dose series, 3 weeks apart. You can get COVID-19 through contact with another person who has the virus. Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or https://TIPS.HHS.GOV. VACCINE FORMULATION AND DESCRIPTION . The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. View Comirnaty information, press release and frequently asked questions. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Wyeth/Pfizer: Nov 2021: Bexsero: Meningococcal Group B: GlaxoSmithKline: Jan 2022: Pneumovax 23: Pneumococcal (polysaccharide) Merck: Apr 2021: Prevnar 13: . The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)]. for Healthcare professionals: PACLITAXEL, Vial U.S. Do not add more than 1.8 mL of diluent. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.10. Vaccines: COVID-19: DEAR COLLEAGUE LETTERS: 16-year-old Visit: HPV: MenACWY Dose #2: DONATE TO IAC: Remember to bring your card when you return. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. See section 3 for vaccine volume and spacing based on age and vaccine formulation. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is made in the same way as COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine but it also contains an Omicron component to help prevent COVID-19 caused by the Omicron variant of SARS-CoV-2. Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native. Undiluted vials may be stored at room temperature for no more than 2 hours. To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below. Package insert / product label Dosage form: injection, suspension. The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The observed risk is highest in males 12 through 17 years of age. This Full EUA Prescribing Information may have been updated. These NDC will not be manufactured. (package insert). Therefore, the EMA recommended the updating of package insert for the Comirnaty vaccine to include heavy menstrual bleeding as a side effect of unknown frequency. After dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. For the most recent Fact Sheet, please see www.cvdvaccine.com. The package insert also includes J&J contact details and information about the safe storage of the vaccine. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. CDC issued initial Emergency Use Instructions (EUI) for the Pfizer-BioNTech COVID-19 vaccine on November 17, 2021, and another EUI for the Moderna COVID-19 vaccine on February 11, 2022. . Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Purple Cap, Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage, Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent, Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap . Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. The information in this Full EUA Prescribing Information regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons. Physician Prescribing Information Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. These multiple dose vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC 59267-1000-2). 1. (Primary series completed) CoV-2 infection, including recommendations after receiving If the recipient has received 3 or more doses of any monovalent COVID-19 vaccine, administer a booster dose of See this Fact Sheet for instructions for preparation and administration. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. If you are immunocompromised, you may receive a third primary series dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). There are 2 formulations of Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older: This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older and MUST BE DILUTED PRIOR TO USE. Solicited Local and Systemic Adverse Reactions. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. 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 Pfizer-BioNTech COVID-19 Vaccine. SARS-CoV-2 neutralization assay - NT50 (titer). The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. J. Novavax monovalent vaccine may be used as a first booster in an adult patient Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the 56-year stratum. section at the end of this Fact Sheet. Jcovden [package insert]. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group. 28 Apr 2023 21:26:45 There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. 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. It is approved as a 2-dose series for prevention of COVID-19 in individuals 12 years of age and older. The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. After dilution, 1 vial contains 6 doses of 0.3 mL. 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. . A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. Amtrak issued a memo to employees saying that it would allow those who have not been vaccinated against COVID-19 to opt for regular testing. 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%). Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. This is what's important. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp/, email cicp@hrsa.gov, or call: 1-855-266-2427. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: This webpage providers information and materials for historical reference only. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. What is an Emergency Use Authorization (EUA)? From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. A separate fact sheet is provided for J&J COVID-19 vaccine recipients and their caregivers. CDC's vaccine excipient summary and the National Institutes of Health DailyMed database can also be used as a resource. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. On This Page. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). I. Administer a dose of Pfizer or Moderna bivalent COVID-19 vaccine according to ACIP recommendations and the vaccine package insert. By James SamsonDecember 15, 2021. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use can be used interchangeably. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. Primary Series: The Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) are given for the primary series. Association and the American Nurses Association also released a statement applauding the FDA's full approval of the Pfizer COVID-19 vaccine. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) 1. 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. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? . The Advisory Committee on Immunization Practices (ACIP) met on April 19, 2023, to review FDA's April 18 amendments to the emergency use authorizations (EUAs) for use of bivalent mRNA COVID-19 vaccines.The amendments further simplify U.S. COVID-19 vaccine recommendations and provide additional flexibility for people at higher risk of COVID-19 complications. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. After dilution, 1 vial contains 6 doses of 0.3 mL. Pfizer-BioNTech COVID-19 Vaccine(N=18,242)n (%), Native Hawaiian or other Pacific Islander, Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation). Meet the honorees The Crossword Where they . WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? The vaccine must be thawed prior to preparation and . Tables 1 through 6 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine and placebo. Daily Mail reported that the timeline of this rollout would depend on the findings of in-house trials that will look into whether vaccines are safe and effective in children aged six months to five years. CDC does not have a specific recommendation for brands of containers or bins for storage of vaccine. 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. In a clinical trial, approximately 300 individuals greater than 55 years of age received one dose of a bivalent vaccine that differs from the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in that it contains a different Omicron component. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors. Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). Pfizer-BioNTech Bivalent COVID-19 Vaccine with gray cap and gray label border is supplied as a frozen suspension for intramuscular injection in single dose vials (containing 0.48 mL per vial) and multiple dose vials (containing 2.25 mL per vial). Some vials also may have a purple label border. Document date and time the vaccine was diluted on the Pfizer vaccine vial v. Clean top of Pfizer vaccine vial with alcohol prep pad and with draw 0.2ml of . The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. Janssen's website has detailed descriptions and images of its COVID-19 vaccine labeling and packaging. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION, REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS, CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA. 2022 Nov10 [cited 2023 Jan 17]. Last Reviewed: September 28, 2022. The vaccines also contain various salts, fats and other ingredients to help your body use the mRNA. Symptoms may appear 2 to 14 days after exposure to the virus. Oxford-AstraZeneca COVID-19 vaccines have shown a few cases of blood clotting disorders . Currently available information is insufficient to determine a causal relationship with the vaccine. FDA amends EUA and expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 Years.
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