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). People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. As soon as you land on the tool page, You will have to enter 2 things. H\j0~ Table 7 presents the specific demographic characteristics in the studied population. x]_sLN m33/FRNs?U?bwH%$C Xf~]M7/9yT+O.NU7E/'?mglg2quj?@|#,'1hFTDJE.5Y|*?MM.9#]Pl::te&'Zp Due to the high frequency of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the EUA. ,W7@M"NV?lG=nVk`SJt*"75Nry"E"nP8%T&v:$'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 9C to 25C (47F to 77F) for up to 12 hours, Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursRoom Temperature 9C to 25C (47F to 77F) for up to 2 hours. 2C to 8C (36F to 46F)Unpunctured vials until the expiration date Do not freeze. To access a Pfizer expiration date lookup tool, kindly click on the above-given button. 3 0 obj Please note, Internet Explorer is no longer up-to-date and can cause problems in how this website functionsThis site functions best using the latest versions of any of the following browsers: Edge, Firefox, Chrome, Opera, or Safari. The vaccine expires 18 months after manufacture date if stored frozen at ultra-cold temperatures (-90C to -60C [-130F to -76F]). The date that is listed on the vaccine vial is the manufacture date, and the QR code on the vaccine vial links to the EUA fact sheet. At the time of the analysis of Study 2 for the EUA, 37,586 [18,801 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of 2 months after the second dose. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. Refrigerated (thawed vials) at 2C and 8C (36F and 46F) for up to 10 weeks. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. *d,aur A4ton)9R yYe5V@brte/-b{L1f^U73hq$ '>8#3,$ D eu,oCZN U[ Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. *Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials may also arrive at refrigerator temperature 2C to 8C. Some vials also may have a purple label border. 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. 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. 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. 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. For more information, visit: www.cdc.gov/vsafe. There are multiple COVID-19 vaccines authorized for use across several brands (Moderna, Pfizer-BioNTech, Janssen, Novavax) . 2023 National Community Pharmacists Association, FDA extends Pfizer vaccine expiration dates, The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. Dickson, as usual. Program participants are U.S. Federal agencies that sign a Memorandum of Agreement with the Department of Defense, and SLEP remains limited to federal stockpiles at this time. WHAT YOU NEED TO KNOW BEFORE YOU GET ANY OF THESE VACCINES. From an independent report (Kamar N, Abravanel F, Marion O, et al. 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. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. Following are several examples of how FDA has addressed expiry dating challenges following PAHPRAs enactment and before PAHPRA: Vaccines authorized for emergency use as products that are not approved under a biologics license application and are still being studied under investigational new drug applications do not have fixed expiry dates. <> SSL Certificate. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. 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. 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. 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. WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? H310F@lpXBU / endstream endobj 72 0 obj <>/Metadata 3 0 R/OpenAction 73 0 R/Outlines 7 0 R/PageLayout/SinglePage/Pages 69 0 R/StructTreeRoot 12 0 R/Type/Catalog/ViewerPreferences<>>> endobj 73 0 obj <> endobj 74 0 obj <. Once punctured, vials can be stored between 2C to 25C (36F to 77F) for up to 12 hours. Count out 18 months, using the month printed on the vial as month 1. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. TPOXX supplied by the, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). 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. The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . Evaluation of a future extension of shelf-life for sotrovimab is ongoing. The site is secure. The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. 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). As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. Fierce Healthcare. Please refer to the table on this page for updates. Vials must reach room temperature before dilution. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. FDA will continue to evaluate the available data and provide updated information as soon as possible. After dilution, the vial should be held between 2C to 25C (35F to 77F). HOWEVER, with this extension, the expiration date is now AFTER the BUD. May 20, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. Pfizer-BioNTech COVID -19 Vaccine Products . 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. FDA also recommended relabeling of such product prior to dispensing. All 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. 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. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be 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. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). 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. 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. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. 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. The observed risk is highest in males 12 through 17 years of age. This diluent is not packaged with the vaccine and must be sourced separately. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. 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. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Fierce Biotech. Youll find additional information on Pfizer storage and handling here. 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. 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. Please refer to the table on this page for updates. 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. It is predominantly a respiratory illness that can affect other organs. 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). V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. d The vaccine is currently under emergency use authorization review by the Food and Drug Administration . See Overall Safety Summary (Section 6) for additional information. CPT Codes - Ages 12 & Up Covid-19 Vaccination (Pfizer) 91300 ____ Administration FIRST Dose 0001A____ Administration SECOND Dose 0002A____ Diagnosis Code Encounter for Immunization Z23____ Product Name: COVID 19 Vaccine Mcf: . Vaccine may be thawed in the refrigerator or at room temperature. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? The prevalence of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose. The lot number you entered (AB0000) does not exist. CAN I RECEIVE COMIRNATY (COVID-19 VACCINE, mRNA), PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT AT THE SAME TIME AS OTHER VACCINES? The vaccine elicits an immune response to the S antigen, which protects against COVID-19. 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. Pfizer-BioNTech COVID-19 vaccines can be stored at standard refrigeration temperatures for up to 10 weeks. 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. 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 . The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. 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. Learn how your gifts makes that possible. 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. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. 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. Each vial must be thawed before dilution. 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. January 17, 2013: Before PAHPRA, in addition to FDAs June 2010 letter below, a CDC message to states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, [b]ased on FDAs review of scientific data, FDA has concluded that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles to be used for a maximum of ten [10] years beyond their date of manufacture, June 22, 2010: Before PAHPRA, following the 2009-2010 H1N1 influenza response, FDA issued a letter [ARCHIVED] to CDC leadership regarding the disposition of Tamiflu and Relenza lots. visibility: inherit; <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 11 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 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). Relenza inhalation powder (reminder of previous extension) Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). To find the expiry date on your product, please download the data tables (by date or by batch number). November 26, 2019: This posting and FDAs November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of MMT AtroPen (atropine), CANA (diazepam), DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injectors for use during nerve agent emergencies. 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*. 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. July 2, 2021:FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the new use date has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. 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. 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. 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. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Sign In. 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 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. 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. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. The vaccine is administered as a 2-dose series, 3 weeks apart. 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. 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. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. 2 0 obj 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. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4MB) and the Letter of Authorization (PDF, 375KB). Pfizer does not have an expiration date look -up tool. Simply follow the below-given step-by-step tutorial to find the expiry date of your Pfizer COVID vaccine. Room temperature: Up to 25C (77F). 4 0 obj The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Copyright 2023 American Academy of Pediatrics. HWrF+H, rZRJlqI)B@EE4zzz^^8|.II_x2Mi4eYrv[n^IL#NLI{owb7'g^[ g|\Z0dF]/QXbFL@UWu7ZSV8l9'caP)gpSL^: ]N]?2W7A(&5#4?&QFb:h\Q9ov?v FReZG+,LGe[pHv2nK::pWF[lmGd-G^1O'DxpZJj/k9s#a_dMv."&| For further assistance with reporting to VAERS, call 1-800-822-7967. Observation 6 . An additional 6 DuoDote lots are no longer useable and should be properly disposed of. The program is administered by the U.S. Department of Defense (DoD). Count out 18 months, using the month printed on the vial as month 1. 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. Thawed vials can be handled in room light conditions. If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. 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 0.1% of placebo recipients. Always use the earliest date. It is important that the information reported to FDA be as detailed and complete as possible. The possible side effects of these vaccines are still being studied. 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). Purple plastic cap and purple label border. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. 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? 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. During the visual inspection. An additional 1 DuoDote lot is no longer useable and should be properly disposed of. body > div[data-webbuilder-block-is-swe] { 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. 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. No. Purple plastic cap and purple label border. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. Currently available information is insufficient to determine a causal relationship with the vaccine. No. 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.
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