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. Login with Single Sign On . FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. 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. 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. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. 2 0 obj Do NOT store at -25C to -15C (-13F to 5F). 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). Thaw and then store undiluted vials in the refrigerator [2C to 8C (35F to 46F)] for up to 1 month. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. However, the U.S. Government recommends retaining the product in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the U.S. January 18, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life from 18 months to 24 months for the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). Table 7 presents the specific demographic characteristics in the studied population. The storage, preparation, and administration information in this Fact Sheet 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. 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. If received at 2C to 8C, they should be stored at 2C to 8C. Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are NOT eligible for extension. Allow vials to thaw at room temperature for 30 minutes. A carton of 10 vials may take up to 4 hours to thaw at refrigerator temperature (2C to 8C [35F to 46F]). 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. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. 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. The observed risk is highest in males 12 through 17 years of age. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. If you have questions, visit the website or call the telephone number provided below. To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. Pfizer-BioNTech COVID-19 Vaccine at least 3 to 8 weeks after the first dose. La vacuna contra el COVID-19 de Pfizer-BioNTech para nios de 5 a 11 aos de edad se administra como una serie primaria de dos dosis, con 3 semanas de diferencia, pero es una dosis ms baja (10. 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. From an independent report (Kamar N, Abravanel F, Marion O, et al. Read below to find the specifics on COVID-19 vaccine storage and expiry. Current testing focuses on military-significant or contingency use products, drugs that have limited commercial use (e.g., nerve agent antidotes), and drugs that are purchased in very large quantities, such as ciprofloxacin and doxycycline. Refrigerated (thawed vials) at 2C and 8C (36F and 46F) for up to 10 weeks. That means . Remember to bring your card when you return. Expires 18 months after manufacture, if held at Ultra Cold temperatures. [-130F to -76F]). 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. Printed Expiry Date Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. Vials must reach room temperature before dilution. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. HOWEVER, with this extension, the expiration date is now AFTER the BUD. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. All rights reserved. Don't worry. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. Find valuable resources to assist you in your pediatrics career from pre-med and training to finding a job and growing a thriving practice. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.74MB) and the Letter of Authorization for Emergency Use Authorization (EUA) 091 (PDF, 1.03MB). There may be clinical trials or availability under EUA of other COVID-19 vaccines. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. 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? Access the expiration date by scanning the QR code located on the vaccine carton. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. AAP original research, including a robust practice-based research network, addresses important questions regarding pediatric practice and the health and well being of children. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. 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. If appropriate, FDA can also choose to not take enforcement action with respect to products that are held or used beyond their labeled expiration date. 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). Always use the earliest date. The top 15 blockbuster patent expirations coming this decade | Fierce Pharma. 9 6sOvKB/SA~P=f}pK\"8 8oM~[2]'K v.J v~_SCmGnbv`kKMw36:\H&L(hA9Z;5fH3*B>z^J=b|,L'~ gTr The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. 4 0 obj This authorization is based on safety and effectiveness data in this age group and adults. June 3, 2020: On February 11, 2020, HHS issued a message(PDF, 162 KB) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. 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. %PDF-1.7 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. B~o[_o$Pz{%y .=8X Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. 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. A recording of this webinar, slides and Q&A(under Resources tab) are available in CDC TRAIN (free account required). 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. 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. Vaccine should NOT be used after the expiration date or beyond-use date/time. This Fact Sheet may have been updated. In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . 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. 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 bamlanivimab and etesevimab, emerge and become prevalent in the United States. Solicited Local and Systemic Adverse Reactions. 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. 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. 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. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. Before PAHPRA, the distribution, dispensing, or use of products with extended expiry, and any related labeling adjustments, were possible through an EUA or FDA enforcement discretion. Check Lot. SARS-CoV-2 neutralization assay - NT50 (titer). V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. 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. Room temperature: Up to 25C (77F). For more information, visit: www.cdc.gov/vsafe. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. Youll find additional information on Pfizer storage and handling here. Learn more about the American Academy of Pediatrics including our mission, leadership and commitment to the optimal health and well-being of all children. Reagent stability studies are needed to support shelf-life expiration dates for in vitro diagnostics (IVDs) authorized under an EUA for emergency use during the COVID-19 pandemic, however they generally do not need to be completed at the time of initial review of the EUA request and/or EUA issuance, but should be initiated immediately following authorization, if not before. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. Each vial MUST BE DILUTED before administering the vaccine. [Note: this guidance was finalized on April 24, 2019.] No. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Due to the high frequency of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the Emergency Use Authorization (EUA). Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). Solicited reactogenicity data in 16 and 17 year-old participants are limited. 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. 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.