The U.S. Food and Drug Administration (FDA) has extended the shelf life for certain lots of the Moderna COVID-19 vaccine by two months. This extension will be in reference to expiration dates only. /T 229016 This provides a chance to visually check the unit and ensure that the temperatures have not been out out range. For the most current information, please visitthe Moderna website. Please refer to the table on this page for updates. To find the expiration date, locate the lot number printed on the carton and/or vial and enter it into the lot number search field on the website, then press submit.. 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. stream
Pfizer has received shelf-life extensions of all TRIS products (i.e., all mRNA COVID-19 vaccines, including both monovalent and bivalent vaccines). Medical Countermeasures Initiative (MCMi), Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, Guidance for Industry: Changes to an Approved NDA or ANDA, Office of Counterterrorism and Emerging Threats, Public Readiness and Emergency Preparedness, Previous COVID-19 vaccine shelf-life extensions, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld, Table 1: Extended Expiry Dating for Evusheld (Tixagevimab Co-Packaged with Cilgavimab) Authorized under EUA 104, announced the authorization of an additional extension, Table 1: Extended Expiry Dating for Bebtelovimab Authorized under EUA 111, Table 1: Extended Expiry Dating for Lagevrio Authorized under EUA 108, Table 1: Extended Expiry Dating for Paxlovid Authorized under EUA 105, Table 1: Extended Expiry Dating for Sotrovimab Authorized under EUA 100, announced the authorization of an extension to the shelf-life, Letter of Authorization for Emergency Use Authorization (EUA) 091, Previous COVID-19 therapeutic shelf-life extensions, Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid, Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105, Statement Regarding Shelf-Life Extension of Sotrovimab, Statement Regarding Shelf-Life Extension of Bamlanivimab and Etesevimab, announcedthe authorization of an extension to the shelf-life, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Influenza (Flu) Antiviral Drugs and Related Information, HHS Increases Access to Tamiflu through the Strategic National Stockpile, Improving Access to Influenza Countermeasures for U.S. Jurisdictions, Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles, Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles, recording of this webinar, slides and Q&A, Expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles, Guidance for Federal Agencies and State and Local Governments: Potassium Iodide Tablets Shelf Life Extension, Search List of Extended Use Dates to Assist with Drug Shortages, On June 10, 2021, based on data and information received from the manufacturer, FDA, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). By Carla Delgado 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. However, before FDA can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, and FDA must determine that it is safe to use the product beyond its labeled expiration date. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. The agency performs numerous stability assessments to determine how long a particular drug product can remain safe and effective, which is known as its shelf life. While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly. Moderna Expiration Lookup - American pharmaceutical and biotechnology company Moderna has been gaining a lot more popularity as compared to any other company started in the last 10 to 20 years.. Moderna was founded back in September 2010, and it is just 12 years old, while its biggest competitor in the COVID vaccine, Pfizer, was founded back in 1849. The Canadian-specific labelling information, including the SPIKEVAX Product Monograph and training materials, can be accessed at, The new 9-month shelf-life will be printed on labels of SPIKEVAX beginning with vials manufactured as of February 2022. While you might feel that you would prefer to be vaccinated with doses that are far from expiration, you should know that those doses are no different than the nearly expired ones. c>o/8wwDS\u/[peo q /GS7 29 0 R June 27, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together, or REGEN-COV. Shelf Life Extension for the SPIKEVAX (elasomeran) COVID-19 Vaccine with Printed Expiry Dates on Vial and Carton Labels. You will be subject to the destination website's privacy policy when you follow the link. /F4 79 0 R As long as the vaccine is not expired, it is safe for use and remains effective for its intended purpose. The Food and Drug Administration (FDA) recently authorized a second extension of the Johnson & Johnson COVID-19 vaccine's shelf life. Please see the most recent updates above for the latest information. Moderna has updated its website feature that allows vaccine providers to look up expiration dates by lot number to include these new expiration dates listed below. /O 23 /MediaBox [0 0 612 792] 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. FDA has approved additional Moderna shelf-life extensions. The information in this article is current as of the date listed, which means newer information may be available when you read this. In June, the FDA . Please remember to check NDC numbers to ensure that you are ordering the correct product. SPIKEVAX is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. With each passing month, scientists are given a longer period in which to evaluate vaccines in real-time, allowing them to observe if a vaccine's shelf life can be extended. Moderna Batches that must be Discarded Some of the lots below are MOD 10 (ages 12+) and some are MOD 5 (ages 6-11). You can review and change the way we collect information below. /XObject << Fact checkers review articles for factual accuracy, relevance, and timeliness. Late Friday afternoon, the FDA announced an agency advisory committee would meet in mid-October to discuss boosters for both the J&J and Moderna vaccines. For the most up-to-date information, please visit the Moderna website. Also see: Expiration date extensions of certain lots of doxycycline hyclate. This is the recommendation of the WHO for all pharmaceuticals in all settings.. To confirm extension dates, recipients should provide the following information: Drug name, National Drug Code (NDC), strength, lot number, and original expiration date. Health Canada is communicating this important information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. >> Bivalent Moderna 6 months 5 years will be packaged in two dose vials. Laura Strickler is a senior investigative producer and reporter for NBC News. Single-dose vials do not require the use of low-dead-volume (LDV) syringes.Quick Facts:Single-Dose Vial Pfizer Bivalent Booster (Ages 12+)NDC:59267-1404-02Configuration:10 single-dose vials/cartonMinimum quantity per order:50 dosesMaximum quantity per order:150 dosesProduct dimensions:1.457 in length 1.535 in width 3.504 in heightStorage and handling:Same as other Pfizer tris products (e.g., store at ultra-low temperature until expiry, may refrigerate up to 10 weeks within expiry period)No ancillary kits included with single-dose vial orders. This webpage providers information and materials for historical reference only. FDA granted this extension following a thorough review of data submitted by Eli Lilly. Follow CDCs and manufacturers guidance for vaccine storage. In addition to SLEP, there are other ways that, when appropriate, FDA can allow certain medical products to be used beyond their manufacturer-labeled expiration dates. August 22, 2018: Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles(PDF, 286 KB) FDA issued a memo to government public health and emergency response stakeholders extending the expiration date ofcertain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes. Vaccine production occurs under strict oversight by regulatorsthe FDAand quality assurance programs, Naor Bar-Zeev, PhD, deputy director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, tells Verywell. FDA acknowledges the stockpiling challenges of federal and SLTT stakeholders (for example, related to doxycycline, ciprofloxacin, Tamiflu, and certain auto-injector products) and remains committed to finding appropriate solutions to address such challenges. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Why? To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. The Michigan Department of Health & Human Services (MDHHS) announced Oct. 13 that Moderna received approval for a two-month extension of FROZEN Moderna COVID-19 vaccine. COVID-19 vaccines with an emergency use authorization do not have fixed expiration dates, and the dates can be extended as more stability data is received and analyzed, according to the FDA. However, when enforcement discretion is used for medical product dating extensions, MCMs are not covered under applicable Public Readiness and Emergency Preparedness (PREP) Act liability protections. 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. Expired lots on this list must not be used and should be discarded. /Length 234 << startxref Another way FDA can approach expiration dating challenges is through FDAs expiration dating extension authority under section 564A(b) of the FD&C Act, which was established by PAHPRA in 2013. The new bivalent Pfizer 6 months 4 years product is. >> On December 23, 2021, Health Canada authorized a shelf-life extension, from 7 months to 9 months, for SPIKEVAX / COVID-19 Vaccine Moderna 5 mL vials. 4. . Expired/Expiring Moderna Doses The following batches of Moderna vaccine are NOT subject to expiry extension. 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. >> States may contact their MCM Specialist or email preparedness@cdc.gov or sns.ops@cdc.gov to confirm the new extended dates for their antiviral drug inventories eligible for extension. x\[sV'oz?{f2q6nGIfZ")` R{D$E={_*$XTju/W^^ Health Canada has authorized a 2-month shelf-life extension for SPIKEVAX / COVID-19 Vaccine Moderna, which is supported by scientific evidence. How Vaccine Makers Are Tackling the Omicron Variant. << 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. /Metadata 15 0 R Orders exceeding 20 vials of these vaccines should be placed through PhilaVax instead of Monday.com. endobj
The .gov means its official.Federal government websites often end in .gov or .mil. June 28, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. In order for the booster approval to happen, the company would have to file, FDA officials would have to review the data and the CDC advisory committee would need to meet to weigh in. Within the 9-month shelf-life, unopened vials may be stored refrigerated at 2C to 8C (36F to 46F), protected from light, for a maximum of 30 days. Some vaccine storage conditions are associated with beyond-use dates and times. Locate the lot number printed on the carton and vial, (Figure 1). The site is secure. On December 23, 2021, Health Canada authorized a shelf-life extension, from 7 months to 9 months, for the 5 mL vials of the SPIKEVAX / COVID-19 Vaccine Moderna. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. Moderna 6 months 5 years Bivalent NDC: 80777-0283-99. WASHINGTON The government will not extend the shelf life of hundreds of thousands of unused Johnson & Johnson Covid vaccine doses, but may soon extend the life of millions of Moderna vaccine doses, according to an internal email obtained by NBC News. With these extensions, there are now Moderna and Pfizer-BioNTech monovalent COVID-19 vaccines that will last into spring 2023. Expired products may not be used, but products that have not yet expired are potent and effective. January 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 2 additional DuoDote lots that are no longer useable and should be properly disposed of. 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. com/vial-lookup Check beyond-use date/times Unpunctured vials may be stored between 2C and 8C (36F- 46F) for up to 30 days. /Outlines 14 0 R Please be mindful of when your COVID-19 vaccine expires! 1. This provides documentation that every dose in your unit has been stored at the right temperature from the time you received it until it is administered to a patient. Some vaccine storage conditions are associated with beyond-use dates and times. /H [215646 281] endobj This communication update will be further distributed through the MedEffect e-Notice email notification system, as well as through social media channels, including LinkedIn and Twitter. When FDA grants or authorizes a shelf-life extension, that information may be found either in the granting letters or re-issued letters of authorization available in the listing of EUA authorized products on FDAs website. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. See infographic for vaccine currently stored in the refrigerator. 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. Moderna Batches that must be Discarded The following batches of Moderna vaccine are NOT subject to the . /F3 81 0 R After careful consideration, we have determined to end the program effective November 4, 2022. When the expiration date of Moderna doses is reached, providers should: o Identify, separate and mark expired doses as "do not use". The storage conditions remain unchanged (-25 C to -15 C). Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB). Managing marketed health product related side effects depends on healthcare professionals and consumers reporting them. 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. 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. 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. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). /L 229354 /Size 91 endobj . Look Expiry First of all, you will have to click on the above-given button to reach the official website of Moderna medicine. 2023 Dotdash Media, Inc. All rights reserved. /F9 30 0 R This 2-month shelf-life extension may be retroactively applied to vials currently on the market with a printed expiry date between February 2022 and August 2022 (see Products affected section). Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Johnson & Johnson statement on FDA approval of shelf life extension for companys COVID-19 vaccine. Within this period, up to 12 hours may be used for transportation. Expired COVID-19 vaccines should be removed immediately from storage units to avoid inadvertently administering them. Biologic and Radiopharmaceutical Drugs Directorate E-mail. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. /Type /Page April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. Before sharing sensitive information, make sure you're on a federal government site. All Moderna lots that have received shelf-life extensions are for primary series use only. 0 Record the date and time of first use on the Moderna COVID-19 Vaccine label. >> If there were any concerns about the vaccine's safety or effectiveness, or if it posed additional risks, the FDA would not authorize an extension. /Resources << For additional information about the expiration date for those lots, please review the, The Canadian SPIKEVAX Product Monograph, in French and English, is available on Health Canadas, The Canadian-specific information, including the SPIKEVAX Product Monograph and training materials, can be accessed at, Health Canada is communicating this important information to healthcare professionals and Canadians via the, If a patient experiences a side effect following immunization, please complete the. It might seem confusing that Johnson & Johnson has already extended their COVID-19 vaccines shelf life twice. The following batches of Moderna vaccine are NOT subject to the expiration date extension and should be discarded. Will My Health Insurance Cover a COVID-19 Vaccine? /CS /DeviceRGB With the Moderna Vial Expiration Checker, Moderna also allows vaccine providers to look up expiration dates by lot number, which includes the new expiration dates listed above. /F8 50 0 R Epilepsy and COVID-19 Vaccine: Is It Safe? Continually monitor vaccines to help reduce administration errors. endobj
Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. Through expiration dating extensions, SLEP helps to defer the replacement costs of certain products in critical federal stockpiles. Upon FDAs authorization of a shelf-life extension, the labeling is updated by the IVD manufacturer to reflect the updated expiration date, which is calculated from the original manufacturing date of the device. Update/zero out inventory in VaccineFinder to avoid turning away customers. Below, find a table with updated expiration dates for the specific lots impacted by the extension. Meg Tirrell joined CNBC in April 2014 as a general assignment reporter focusing on biotechnology and pharmaceuticals. 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. This 2-month shelf-life extension may be retroactively applied to vials currently on the market with a printed expiry date between February 2022 and August 2022 (see Products affected section). PAHPRA provides FDA with the explicit authority to extend the expiration dating of eligible FDA-approved MCMs stockpiled for use in CBRN emergencies. The shelf life of different vaccines differs on the basis of their ingredients and manufacturing process.. The U.S. Food and Drug Administration (FDA) previously authorized changes to Moderna's COVID-19 vaccine, providing extra doses from each vial. The new 9-month shelf-life will be printed on labels of SPIKEVAX beginning with vials manufactured as of February 2022. Johnson & Johnson did not immediately respond to a request for comment. Healthcare professionals at the identified points of use. September 20, 2017: CDC and FDA hosted a webinar to discuss FDAs April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. However, the FDA authorization of the extension indicates that the doses' quality remains the same. You have made an immense difference through your dedication and continued support! Carla M. Delgado is a health and culture writer based in the Philippines. Shelf-life expiration dates have been extended multiple times as additional data becomes available. To find the expiration for any Moderna COVID-19 Vaccine, locate the lot number printed on the carton and vial. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. Additionally, Pfizer will be sending out short dated products and advises to hold on to products expiring soon in anticipation of a shelf life extension. Since we have the opportunity to study the vaccines over longer periods of time, it is not a surprise that expiration dates have been extended.. To find the expiration date for any vial of Moderna COVID-19 Vaccine visit this link Moderna How To Look Up Vial Expiration Date on the Carton. /F6 60 0 R To ensure that e-mails from the OAFP are delivered to your inbox, please add wfmu@ohioafp.org to your address book or list of approved senders. o~}6[7_^?@xw'g1gg&U?}&O7us'4eDBonG7 ?!==7gww"8]]CC7?{6niC?(Ev.KOe8Oj/qi8?W"RQX. The shelf life of vials stored between -25 C and -15 C was extended from seven to nine months. Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. %PDF-1.7
For other health product inquiries related to this communication, contact Health Canada at: Biologic and Radiopharmaceutical Drugs Directorate E-mail: brdd.dgo.enquiries@hc-sc.gc.ca, Director, Head of Regulatory Affairs Canada. An official website of the United States government, : Vial Expiration Date Look Up. [Note: this guidance was finalized on April 24, 2019.] The extension does NOT apply to thawed vials that were refrigerated. This product (for ages 12 years and older) is no longer being distributed. FDA is extending the expiration date of certain lots of the Moderna COVID-19 Vaccine, as listed in the table below, from 9 months to 12 months when stored at recommended long-term storage. Updated expiry dates for vaccine maintained in ultra-cold storage are shown below. /Lang (en-US) The extension does NOT apply to thawed vials that were refrigerated. /Group << 1~kx$Aj <>/Metadata 650 0 R/ViewerPreferences 651 0 R>>
The FDA referred inquiries to the companies and declined comment on the email. All are similarly safe and effective at preventing severe COVID-19 disease. Johnson & Johnson Statement on U.S. FDA Approval of Shelf Life Extension for Companys COVID-19 Vaccine. That means that the results of stability studies demonstrated that the vaccine remains potent for one and a half more months, bringing the shelf life to six months. The program is administered by the U.S. Department of Defense (DoD). << CDC twenty four seven. 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. /Linearized 1.0 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. Do NOT refreeze. Below, you will find a table with updated expiration dates for the specific lots impacted by the extension. Follow CDCs guidance for storage units and temperature monitoring. Children aged 5 years who complete the Pfizer primary series may receive a bivalent Pfizer 5-11 booster dose. On July 28, the FDA extended the shelf life of the J&J doses to six months from manufacture. >> /Pages 16 0 R 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). Below, find a table with updated expiration dates for the specific lots impacted by the extension. 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. Providers should track these time frames. All vials with a printed expiry date of November 2022 onwards will reflect the authorized 9-month shelf-life. /F2 84 0 R The shelf life of different vaccines differs on the basis of their ingredients and manufacturing process. Carla M. Delgado is a health and culture writer based in the Philippines. Saving Lives, Protecting People, Expiration Date Extension and Beyond-Use Date, Vaccine Storage Troubleshooting Record for Temperature Excursions, COVID-19 Vaccine Storage Temperature Logs, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Considerations for Planning School-Located Vaccination Clinics, How Schools and ECE Programs Can Support Vaccination, Customizable Content for Vaccination Clinics, Best Practices for Schools and ECE Programs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services. 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( en-US ) the extension does not apply to thawed vials that were refrigerated reflect the authorized 9-month shelf-life through. Information, make sure you 're on a federal government site a printed date. For NBC News statement on U.S. FDA approval of shelf life extension for companys COVID-19 vaccine? { 6niC (. 24, 2019. some batches may be stored for an additional 6 months manufacture. Please see the most current information, please visit the Moderna website visually check the unit and ensure you! Will have to click on the basis of their ingredients and manufacturing process: 80777-0283-99, please the! 6 months 4 years product is who complete the Pfizer primary series may receive a Bivalent 5-11. Note: this guidance was finalized on April 24, 2019. FDA-approved stockpiled... Companys COVID-19 vaccine label which means newer information may be stored between 2C and 8C ( 36F- ). The FDA extended the shelf life twice this webpage providers information and for... 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Beginning with vials manufactured as of the moderna expiration date extension States government,: Vial date. Extensions are for primary series may receive a Bivalent Pfizer 6 months 4 years product is Eli Lilly you made. Shelf-Life extensions are for primary series use only materials for historical reference only a printed expiry on! November 2022 onwards will reflect the authorized 9-month shelf-life Eli Lilly however, the authorization. Vaccines shelf life extension for companys COVID-19 vaccine: is it Safe costs certain... Articles for factual accuracy, relevance, and timeliness administered by the extension with printed expiry of... This provides a chance to visually check the unit and ensure that you are the! Vaccine label authority to extend the expiration dating extensions, there are now Moderna and Pfizer-BioNTech COVID-19! The storage conditions are associated with beyond-use dates and times to click on the basis their. 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