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  1. To find the expiration date for the COVID-19 vaccines by BioNTech & Pfizer lot number, enter the lot number found on the vial or the carton.

    • Approaches to Drug Product Expiration Date Extensions
    • MCM Expiration Dating Extensions
    • Additional Information

    Initiated by the Manufacturer

    The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA. For additional information, consult the Guidance for Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles, page 3, or Guidance for Indu...

    Shelf-Life Extension Program

    Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. 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. SLEP is the federal, fee-for-service pr...

    Emergency Use Authorities

    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. One way is through issuing an Emergency Use Authorization(EUA) under section 564 of the FD&C Act since use of a product beyond its labeled expiry date is considered unapproved. 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 issua...

    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. Following are several examples of how FDA has addressed expiry dating challenges following P...

    Drug Shortages- Drug shortages can occur for many reasons including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and t...

  2. Lot Numbers - Centers for Disease Control and Prevention is a webpage that provides information on how to find and use the lot numbers and expiration dates of COVID-19 vaccines from different manufacturers. It also links to various tools and resources to help track and manage the vaccine inventory and avoid wastage.

  3. 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. Before discarding any vaccine, providers should check the expiration date using Pfizer-BioNTech's expiration date tool at PfizerBioNTech COVID-19 Lot Expiry ...

  4. The Food and Drug Administration (FDA) extended the expiration date for Pfizer-BioNTech COVID-19 Vaccine from 12 to 18 months from manufacturer date. Before discarding any vaccine, providers should check the expiration date using Pfizer-BioNTech's expiration date tool at Pfizer-BioNTech COVID-19 Lot Expiry

  5. NOTE: The beyond-use date (10 weeks) replaces the manufacturer’s expiration date but NEVER extends it. Always use the earliest date. Do NOT use vaccine after the expiration date or beyond-use date. Between 2°C and 8°C (36°F and 46°F) until the expiration date.

  6. Use this tracking tool to record updated expiration dates for COVID-19 vaccine as additional stability data are available from the manufacturer. When the current expiration date gets close, contact the manufacturer before discarding vaccine.

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