The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. This posting and memorandum replace FDAs March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. :v9dvVe0NK2+ During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. The storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir. Each vial MUST BE DILUTED before administering the vaccine. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are, State Dept. 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. It is important that the information reported to FDA be as detailed and complete as possible. This Fact Sheet may have been updated. Each vial must be thawed before dilution. June 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 4 additional DuoDote lots that are no longer useable and should be properly disposed of. Use Pfizer expiration date tool at https://lotexpiry.cvdvaccine.com Check beyond-use date/times Unpunctured vials may be stored between 2C and 8C (36F- 46F) for up to 10 weeks Unpunctured vials may be stored between 8C and 25C (46F and 77F) for a total of 12 hours Without the expiration date extension, this vaccine could only be used up to the expiration date (12/20/2022)-not the full 10 weeks. IuaPmrE&n-W.2Icy^&PM | ,5A^D|"c%&g;'hy,/A Hr|G,,NNS!YFcZ. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. AAP original research, including a robust practice-based research network, addresses important questions regarding pediatric practice and the health and well being of children. The vaccine expires on the last day of the 18th month. For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" Thawed vaccine cannot be refrozen. Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals younger than 6 months of age. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. Created Date: 12/3/2021 11:57:01 AM . This authorization is based on safety and effectiveness data in this age group and adults. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. B~o[_o$Pz{%y .=8X 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. FDA has authorized Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide better protection against COVID-19 caused by the Omicron variant of SARS-CoV-2. WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET ANY OF THESE VACCINES? 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. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. This shelf-life extension applies to refrigerated vials of J&J/Janssen COVID-19 vaccine that have been held in accordance with the manufacturer's storage conditions. You can find the latest versions of these browsers at https://browsehappy.com. Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart to individuals 12 years of age and older. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. 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. In the absence of real-time stability data, initial reagent stability claims typically do not exceed a four-to-six-month expiration date. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. The possible side effects of these vaccines are still being studied. SLEP is the federal, fee-for-service program through which the labeled shelf life of certain federally stockpiled medical materiel (e.g., in the SNS) can be extended after select products undergo periodic stability testing conducted by FDA. 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. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. The safety evaluation in Study 2 is ongoing. Establishing clear standard operating procedures (SOPs) for COVID-19 vaccine storage, handling, and administration to minimize vaccine waste. a 2-dose primary series to individuals 12 years of age and older; and. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Based on the shelf life currently approved in United States of America (USA), the Expiry Date for Lot # (AB0000) is: If you have a medical question/general inquiry on a Pfizer product, please visithttps://www.pfizer.com/products/information and choose your location. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. The chance of having this occur is very low. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. body > div[data-webbuilder-block-is-swe] { To access the most recent Fact Sheets, please scan the QR code provided below. Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany, Manufactured by Pfizer Inc., New York, NY 10017, Long Version (Full EUA Prescribing Information) Begins On Next Page, FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION, FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*. For example, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) oversees the Strategic National Stockpile (SNS), which has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local medical supplies to run out. A recording of this webinar, slides and Q&A(under Resources tab) are available in CDC TRAIN (free account required). endstream endobj 158 0 obj <>stream The AAP is dedicated to the health of all children and the pediatric professionals who care for them. SSL Certificate ASM %text %textAccountNo %textAccountName %textAccountAddressName2 %textAccountAddressName3 . An additional 6 DuoDote lots are no longer useable and should be properly disposed of. ,W7@M"NV?lG=nVk`SJt*"75Nry"E"nP8%T&v:$'4B5 "WY2Vvf5,psc=l(Zb0|4;"on#t|uL;5p~hn;ZVAJ0yTL)L/d)K.>gb[>FpZ[LRJaRjm7v(HU{K\:{g_%N;plI|~j-;||O-RqISR0jJc[:E*\CB8 Learn more about all our membership categories. Talk to your vaccination provider if you have questions. Available data support transportation of one or more thawed vials at 2C to 8C (35F to 46F) for up to 48 hours. helix-grid, helix-mega-menu, helix-layout-container, helix-core-grid, helix-core-header, helix-core-page-break, helix-core-card-group, helix-core-footer, helix-core-band { 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. If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. If received at 2C to 8C, they should be stored at 2C to 8C. 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. Serious and unexpected side effects may occur. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. 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)]. 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. Adverse reactions following administration of the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, decreased appetite, rash, and pain in extremity (see Full EUA Prescribing Information). If you are pregnant or breastfeeding, discuss your options with your healthcare provider. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Youll find additional information on Pfizer storage and handling here. Once punctured, vials can be stored between 2C to 25C (36F to 77F) for up to 12 hours. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. 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. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1 below), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid. JB@W51q/S 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). July 26, 2022 When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. An additional 1 DuoDote lot is no longer useable and should be properly disposed of. 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. No more than 2 hours at room temperature (up to 25C/77F). Check Lot. 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. Based on stability data provided by the manufacturers and reviewed by FDA, the following extended use dates are supported for specific lot numbers indicated in the searchable table below.. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Observation 6 . Do not discard vaccine without ensuring the expiration date has passed. 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]. TPOXX supplied by the, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 694KB) and the EUA Letter of Authorization (PDF, 293KB) for Evusheld. Shelf-life expiration dates have been extended multiple times as additional data becomes available. Storage for longer than 10 weeks requires an Ultra Cold freezer. Pfizer does not have an expiration date look -up tool. * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed. 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. Ultra Cold -90C to -60C (-130F to -76F)*Do NOT store at -25C to -15C (-13F to 5F). 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). However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. During the visual inspection. It appears you are using Internet Explorer as your web browser. Cartons and vials of Pfizer-BioNTech COVID-19 vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for three months beyond the printed date as long as authorized storage conditions between -90C to -60C (-130F to -76F) have been maintained. Vials must reach room temperature before dilution. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. Peds (5-11) has a 6-month expiration if held frozen at ULT oMFG date + 6 months = expiration date oThis includes the month of manufacturee.g., 8/2021 includes August. August 7, 2020: Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 86 KB) - FDA issued a memo to government public health and emergency response stakeholders extending for the second time the expiration dates of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. 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). July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. Table 7 presents the specific demographic characteristics in the studied population. Always use the earliest date. This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions. In the following analyses of Study 2 in adolescents 12 through 15 years of age (1,131 of whom received Pfizer-BioNTech COVID-19 Vaccine and 1,129 of whom received placebo), 98.3% of study participants had at least 30 days of follow-up after Dose 2. 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. 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. That means . No further extensions are anticipated beyond 10 years.Also see, from FDA: Influenza (Flu) Antiviral Drugs and Related Information, and from HHS/ASPR:HHS Increases Access to Tamiflu through the Strategic National Stockpile (December 21, 2022), andImproving Access to Influenza Countermeasures for U.S. Jurisdictions. Based on the date the vaccine was placed in the refrigerator, the . MCM Legal, Regulatory and Policy Framework, Recalls, Market Withdrawals and Safety Alerts, MCM Legal, Regulatory and Policy Framework, MCM-Related Legal and Policy Presentations, Publications and Q&As, State, Tribal, Local, and Territorial Public Health Preparedness, Guidance and Other Information of Special Interest to MCM Stakeholders, Availability of Regulatory Management Plans, Vaccine EUA Questions and Answers for Stakeholders. Fact Sheet for Healthcare Providers Administering Vaccine - Novavax, Janssen COVID-19 Vaccine Storage and Handling Summary, COVID-19 Vaccine Lot Number and Expiration Date Report, COVID-19 Vaccine Quick Reference Guide for Healthcare Professionals, COVID-19 Vaccine Lot Number and Expiration Date Report from the CDC. Recently the Food and Drug Administration (FDA) extended the expiration date for Pfizer-BioNTech COVID-19 Vaccine (monovalent and bivalent) from 12 to 18 months from manufacturer date. /J>^KNEX|H|]@"_=QB /D8Qa"nIZD !s7%^/_ _]EB(b?yq7&1=YOXv+"&(h*p r 3DV3?3pTWPlT" 5^-q3cL+t+m3_r{ixn+k]`vy+`jYGNN7jC7oH{ZjhN4_|UYQ,2CpA1kZ$8@kLcZ!2$qJBj"d0. 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). For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. This information in the package insert supersedes the storage conditions printed on the vial cartons. 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. In addition, if extended Tamiflu or Relenza product is dispensed during an influenza emergency response, stakeholders should inform health care providers and recipients about this products expiration dating extension. February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GlaxoSmithKline LLCs monoclonal antibody, sotrovimab, from 24 months to 30 months. Know your Vaccine Products and Storage Needs, Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, Long-term Follow-up Care for Childhood, Adolescent and Young Adult Cancer Survivors, Roadmap for Care of Cancer Survivors: Joint Report Updates Recommendations, American Academy of Pediatrics Offers Guidance for Caring and Treatment of Long-Term Cancer Survivors, Childhood Cancer Survivors: What to Expect After Treatment, Transition Plan: Advancing Child Health in the Biden-Harris Administration, Childrens Health Care Coverage Fact Sheets, Prep- Pediatric Review and Education Programs, Practice Research in the Office Setting (PROS), Pediatrician Life and Career Experience Study (PLACES), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Fact Sheet for Health Care Providers Administering Vaccine (5 11 years), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary, Pfizer-BioNTech COVID-19 Vaccine (Gray Cap) Age 12 and Over, Fact Sheet for Health Care Providers Administering Vaccine (12 years and up), FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron), CDC US COVID-19 Vaccine Product Information, CDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Moderna COVID-19 Vaccine Storage and Handling Summary, Fact Sheet for Health Care Providers Administering Vaccine (6 months 5 years), Fact Sheet for Health Care Providers Administering Vaccine (6 11 years). The duration of protection against COVID-19 is currently unknown. WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry (see Table 1 below) when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The safety evaluation in Study 2 is ongoing. There is a remote chance that these vaccines could cause a severe allergic reaction. 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. The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including these vaccines. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. N Engl J Med), a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or the previously provided extension dates, unless otherwise notified by the Agency. 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. The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older. The lot number you entered (AB0000) does not exist. 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. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Manufactured forBioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany, Manufactured byPfizer Inc., New York, NY 10017, VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. December 2022 - June 30, 2023. N Engl J Med), Table 5: Study 2 Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 6: Study 2 Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 7: Demographics (population for the primary efficacy endpoint), Table 8: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection, Table 9: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection, Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) Participants Without Evidence of Infection up to 1 Month After Dose 2 Dose 2 Evaluable Immunogenicity Population, 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 older.