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. 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. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with purple caps is 0.3 mL for individuals 12 years of age and older [see Dosage and Administration (2.1)]. The vaccine is administered as a 2-dose series, 3 weeks apart. Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. Storage of the vaccine COMIRNATY is stored at -90 C to -60C. Vials must reach room temperature before dilution. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. This information in the package insert supersedes the storage conditions printed on the vial cartons. ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? From an independent report (Kamar N, Abravanel F, Marion O, et al. . QUALITATIVE AND QUANTITATIVE COMPOSITION . 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. a 2-dose primary series to individuals 12 years of age and older; and. 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. The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution are administered intramuscularly. Package insert / product label Dosage form: injection, suspension. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. From an independent report (Kamar N, Abravanel F, Marion O, et al. Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2-week limit for storage at -25C to -15C (-13F to 5F). WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? There is a remote chance that these vaccines could cause a severe allergic reaction. If you're curious about what's in the vaccine, the package insert also lists all of the ingredients of the Comirnaty vaccine (formerly known as Pfizer's vaccine): . The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. 30 mcg of a nucleosidemodified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. 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. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Side effects that have been reported with these vaccines include: These may not be all the possible side effects of these vaccines. 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. Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). The full list of ingredients are included in the vaccine package inserts: View the Pfizer package insert for ages 12+ View the Pfizer package insert for ages 5 to 11; View the Moderna package insert; View the Johnson & Johnson package insert Symptoms may appear 2 to 14 days after exposure to the virus. This week, Frank D'Amelio, chief financial officer at . 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. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? WHAT YOU NEED TO KNOW BEFORE YOU GET ANY OF THESE VACCINES. Jcovden [package insert]. The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. A third dose of the Pfizer-BioNTech COVID-19 vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. Pfizer-BioNTech COVID-19 Vaccine at least 4 weeks (28 days) after the second dose. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. For the most recent Fact Sheet, please see www.cvdvaccine.com. Data presented at the Vaccines and Related Biologics Products Advisory Committee (VRBPAC), June 10 Data and VaST assessment presented at ACIP meeting on June 23. Package Inserts and Manufacturers for some US Licensed Vaccines and Immunoglobulins. During the visual inspection. 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. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427. 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. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, when administered as a booster dose, is authorized for use as: a single booster dose in children 6 months through 4 years of age at least 2 months . For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. section at the end of this Fact Sheet. 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. COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent include the following ingredients: Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older contains the following additional ingredients: COMIRNATY (COVID-19 Vaccine, mRNA) contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: In clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. Getting rid of any unwanted vaccine A doctor, nurse or pharmacist will dispose of any unused vaccine. Next COVID-19 Vaccine Details Next. An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. (package insert). Observe patient for 30 minutes following vaccination iii. The duration of protection against COVID-19 is currently unknown. J. Novavax monovalent vaccine may be used as a first booster in an adult patient Perforated bins may allow for better air circulation around the vaccine, thus helping to maintain correct temperature. Dosage and Administration; . For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. Serious and unexpected side effects may occur. 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). Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. Purple plastic cap and purple label border. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . Lead Stories contacted Janssen and Johnson & Johnson to ask about the video and why the insert panels are blank. I. Administer a dose of Pfizer or Moderna bivalent COVID-19 vaccine according to ACIP recommendations and the vaccine package insert. 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: The vaccines also contain various salts, fats and other ingredients to help your body use the mRNA. After dilution, 1 vial contains 6 doses of 0.3 mL. 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). Product Name Pfizer-BioNTech COVID-19 Vaccine Page 4 / 13 Revision date 07-Dec-2021 Version 3 Suitable Extinguishing Media Dry chemical, CO2, alcohol-resistant foam or water spray. If local redistribution is needed and full cartons containing vials cannot be transported at -90C to -60C (-130F to -76F), vials may be transported at -25C to -15C (-13F to 5F). 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. 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. You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. See below the CDC-issued EUI fact sheets for healthcare providers and recipients/caregivers regarding Pfizer-BioNTech COVID-19 vaccine . It is also authorized under EUA to provide: The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either: This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which you may receive because there is currently a pandemic of COVID-19. On April 18, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent to simplify the vaccination schedule for most . The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. Covid-19 Vaccine Pfizer, Bivalent package insert / prescribing information for healthcare professionals. Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. See section 3 for vaccine volume and spacing based on age and vaccine formulation. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older9. FDA amends EUA and expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 Years. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older. 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. 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). 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. V-safe also provides dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. Each vial MUST BE DILUTED before administering the vaccine. See this Fact Sheet for instructions for preparation and administration. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. 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). It must be kept in the original package in order to protect from light. WHERE WILL MY VACCINATION INFORMATION BE RECORDED? 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. Remember to bring your card when you return. . 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. Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. Talk to your vaccination provider if you have questions. 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. . It is predominantly a respiratory illness that can affect other organs. In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. 28 Apr 2023 21:26:45 WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET ANY OF THESE VACCINES? This Fact Sheet may have been updated. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. . Heavy menstrual bleeding in product information Pfizer and Moderna vaccines [Internet]. Do not add more than 1.8 mL of diluent. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. The vaccine will be an off-white suspension. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) The chance of having this occur is very low. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. PEG is a primary ingredient in osmotic laxatives and oral . V-safe is a voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The vaccine elicits an immune response to the S antigen, which protects against COVID-19. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. Oxford-AstraZeneca COVID-19 vaccines have shown a few cases of blood clotting disorders . ___ Package Inserts : Additional Immunization Resources : Photos: Adult Vaccination: Screening Checklists: Ask the Experts: Shop IAC: CDC Schedules . a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. 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. 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. By James SamsonDecember 15, 2021. Overall in a similar analysis in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. 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. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html. This product information is intended only for residents of the United States. A 69-year-old man complained of reddish bruises on his wrist after the first dose of the Pfizer-BioNTech COVID-19 vaccine. Once thawed remove the cap of the Pfizer vaccine and inject 1.3ml of 0.9% sodium chloride that comes in the ancillary kit of the vaccine iii. 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. 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. Covid-19 vaccines safety update [Internet]. Thawed vials can be handled in room light conditions. The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. Solicited reactogenicity data in 16 and 17 year-old participants are limited. A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021. The Countermeasures Injury Compensation Program. for Healthcare professionals: PACLITAXEL, Vial U.S. PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2injection, suspensionPfizer Manufacturing Belgium NV, FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS), EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19), PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER DILUTE BEFORE USE. Physician Prescribing Information Record the date and time of dilution.Use within 6 hours after dilution. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine, when prepared according to their respective instructions for use, can be used interchangeably. Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. Under the EUA, it is your choice to receive or not receive any of these vaccines. 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). For the most recent Fact Sheet, please see www.cvdvaccine.com. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. 5.2. CDC does not have a specific recommendation for brands of containers or bins for storage of vaccine. 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)]. Pfizer-BioNTech COVID-19 Vaccines (CDC) Moderna COVID-19 vaccine (mRNA) Moderna COVID-19 Vaccines (CDC) Novavax COVID-19 vaccine, Adjuvanted (protein subunit) 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)]. or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks (range 12 to 20 weeks) prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of . If you have questions, visit the website or call the telephone number provided below. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. The safety evaluation in Study 2 is ongoing. Solicited Local and Systemic Adverse Reactions. Should you decide not to receive any of these vaccines, it will not change your standard medical care. WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have been shown to prevent COVID-19. FDA Approval - 6/3/22. Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native. For more information on how to sign up, visit: www.cdc.gov/vsafe. The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. This diluent is not packaged with the vaccine and must be sourced separately. 2022 Nov10 [cited 2023 Jan 17]. Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Data have not yet been submitted to FDA on administration of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent at the same time with other vaccines. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10). The vial stoppers are not made with natural rubber latex.
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