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. PFIZER CUSTOMER SERVICE. An official website of the United States government, : 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. The manufacture date is printed on the vial (dark blue cap) and carton. The vaccine can be used for the full 10 . Advise the recipient or caregiver to read the Vaccine Information Fact Sheet for Recipients and Caregivers. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. 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). The vaccine efficacy information is presented in Table 8. Available Vaccines for COVID-19 include: PFIZER's NEW BOOSTER & MODERNA's NEW BOOSTER Appointment * Name * First Name Last Name Date of Birth * Month Day Year Phone Number * Please enter a valid phone number. The top 15 blockbuster patent expirations coming this decade | Fierce Pharma. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. 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). 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 is a suspension for intramuscular injection. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6. Record the date and time of first use on the Moderna COVID-19 Vaccine label. 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. December 5, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. 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). No. FDA will continue to evaluate the available data and provide updated information as soon as possible. Thawed vials can be handled in room light conditions. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. stream All 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise.6. Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. 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. To avoid the need to replace entire stockpiles every few years at significant expense, and because it was recognized through testing that certain products remained stable beyond their labeled expiration dates when properly stored, the Shelf-Life Extension Program (SLEP) was established in 1986. 7`xk j "d%%%%`2sA09!--psT(r9e"GQ(r9:_E9+]P+{W]wE = FOi4x= FOi4xX,2H}6i[}oim ~pi>_ ?# Read below to find the specifics on COVID-19 vaccine storage and expiry. Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) Date Vaccine Administered: _____ Vaccine Site Manufacturer Dose Lot Number COVID-19 RD LD Pfizer 0.2 ml FK5127 Signature and Title of Vaccine Administrator: _____ 2020-2021 COVID-19 Authorization form (11/5/2021) Title: Child COVID-19 Vaccine Administration Record Author: dhrobins Created Date: 11/10/2021 9:07:32 AM . All rights reserved. Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursDiscard 6 hours after puncturing vial. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. CN&0: Relenza inhalation powder (reminder of previous extension) To calculate the expiration date, add 18 months to the manufacture date including the month of manufacture. 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. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Vaccine expires 18 months after the manufacture date. May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) On September 21, 2021, FDA and ASPR authorized an extension of the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. FDA granted this extension following a thorough review of data submitted by Eli Lilly. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. This authority is limited to medical products for CBRN emergencies. 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. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. Do NOT store at -25C to -15C (-13F to 5F). The expiry date on the vaccine vile might be different as compared to the online platform. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. In response, FDA has issued an EUA for the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, and for certain uses of FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19. The Fact Sheets for both orange and gray cap vials provided by the FDA now reads, "regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons". Observation 6 . Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. Establishing clear standard operating procedures (SOPs) for COVID-19 vaccine storage, handling, and administration to minimize vaccine waste. Dates: Are the intervals between the doses of Moderna or Pfizer vaccinations within the appropriate intervals, approximately 21 days apart for the Pfizer vaccination and approximately (within. Table 7 presents the specific demographic characteristics in the studied population. Please refer to the table on this page for updates. Shelf-life expiration dates have been extended multiple times as additional data becomes available. In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children. d The vaccine is currently under emergency use authorization review by the Food and Drug Administration . For more information on how to sign up, visit: www.cdc.gov/vsafe. 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 and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld. Thaw and then store undiluted vials in the refrigerator [2C to 8C (35F to 46F)] for up to 1 month. However, stakeholders that apply this extension to their stockpiled products should clearly note in their stockpiles that FDA has allowed for its extension (e.g., by placing a placard on the outside of a pallet or shipping box). The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). Some vials also may have a purple label border. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The Countermeasures Injury Compensation Program. Count out 18 months, using the month printed on the vial as month 1. The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. 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. 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.2, 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.3, SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS. Procedures should be in place to avoid injury from fainting. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. 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. [-130F to -76F]). It is predominantly a respiratory illness that can affect other organs. Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report 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 cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. 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. 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*, Pfizer-BioNTech COVID-19 VaccineN=1005Casesn1Surveillance Time (n2#), PlaceboN=978Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=1119Casesn1Surveillance Time (n2#), PlaceboN=1110Casesn1Surveillance Time (n2#). The program is administered by the U.S. Department of Defense (DoD). Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. c|D|b9P$AMXb.a FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. Specific shelf-life information for IVDs authorized under an EUA can be found on the outer packaging, and reagent vials and containers for the product, or by contacting the IVD manufacturer directly with the catalog number, lot number, and manufacturing date for the specific reagent in question. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be B~o[_o$Pz{%y .=8X 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. Booster Dose: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is administered as a single booster dose at least 2 months after: WHO SHOULD NOT GET COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? This Full EUA Prescribing Information may have been updated. 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. For patients for whom enrollment in this trial is not feasible (e.g., a clinical trial site is not geographically accessible), use of tecovirimat under CDCs expanded access protocol (EA-IND) should be consistent with CDCs guidelines for tecovirimat use. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. If you are immunocompromised, you may receive a third primary series dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. Vaccine should NOT be used after the expiration date or beyond-use date/time. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? 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.