Shelf-life Extension for the Pfizer Pediatric Vaccine - Iowa The QR code on the label is a link to the EUA factsheet. COVID-19 Vaccine Storage & Expiry - AAP The codes for each Pfizer batch can be obtained from the VAERS database, and the batches ordering by the total . If local redistribution is needed and full cartons containing vials cannot be transported at -90C to -60C (-130F to -76F), vials may be transported at -25C to -15C (-13F to 5F). PFIZER CUSTOMER SERVICE. Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. Symptoms may appear 2 to 14 days after exposure to the virus. 1-800-666-7248. Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 30mg, 45mg, and 75mg capsules held in strategic stockpiles to be used for a maximum of 20 years beyond their date of manufacture. Refrigerator: Between 2C and 8C (36F and 46F). The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. B~o[_o$Pz{%y .=8X What is an Emergency Use Authorization (EUA)? <> In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. PDF Pfizer-BioNTech COVID-19 Vaccine - CDC Read below to find the specifics on COVID-19 vaccine storage and expiry. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) 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 hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.7 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. 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. October 21, 2020: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. There are multiple COVID-19 vaccines authorized for use across several brands (Moderna, Pfizer-BioNTech, Janssen, Novavax) . Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. During the visual inspection. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. Find valuable resources to assist you in your pediatrics career from pre-med and training to finding a job and growing a thriving practice. A carton 0f 10 multiple-dose vials may take up to 6hours to thaw at this temperature. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. 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. <> Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. For more information, visit: www.cdc.gov/vsafe. This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. 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). Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2-week limit for storage at -25C to -15C (-13F to 5F). First of all, you will have to enter the lot number along with the country you live in. 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. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of the SARS-CoV-2 Wuhan-Hu-1 strain. Allow vial(s) to thaw at room temperature [up to 25C (77F)] for 30 minutes. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The vaccine expires on the last day of the 18th month. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). Fierce Biotech. Under the EUA, it is your choice to receive or not receive any of these vaccines. 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. PDF Pfizer-BioNTech COVID-19 Vaccine - CDC From an independent report (Kamar N, Abravanel F, Marion O, et al. Count out 18 months, using the month printed on the vial as month 1. 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. Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Pfizer does not have an expiration date look -up tool. * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed. When you get your first COVID-19 vaccine, you will get a vaccination card. 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 received at 2C to 8C, they should be stored at 2C to 8C. 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). The top 15 blockbuster patent expirations coming this decade | Fierce Pharma. GLCP Vaccine Sign Up - Jotform a single booster dose to individuals 12 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved COVID-19 vaccine; or, a single booster dose to individuals 12 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html, https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Clinical Trial Results and Supporting Data for EUA (18.1), https://www.cdc.gov/vaccines/programs/iis/about.html. To access a Pfizer expiration date lookup tool, kindly click on the above-given button. 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. Refrigerator: Between 2C and 8C (36F and 46F) A carton of 10 vials may take up to 6hours to thaw at this temperature. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Learn how your gifts makes that possible. 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. 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. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. Thank you for using the Janssen COVID-19 Vaccine expiry checker. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). 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. 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 Industry: Changes to an Approved NDA or ANDA. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -90C to -60C (-130F to -76F) until the expiry date printed on the label. The safety evaluation in Study 2 is ongoing. Get the latest news from the AAP including press statements, the AAP Voices Blog, the Pediatrics OnCall Podcast and more! 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. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. :v9dvVe0NK2+ The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. Postmarketing data with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. 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. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . 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. September 2022 - March 31, 2023. This information in the package insert supersedes the storage conditions printed on the vial cartons. 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. In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%). Do NOT store at -25C to -15C (-13F to 5F). A carton of 10 vials may take up to 2 hours to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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. November 2022 - May 31, 2023. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) 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 hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. } 3 0 obj Pfizer-BioNTech COVID-19 Vaccine at least 3 to 8 weeks after the first dose. Procedures should be in place to avoid injury from fainting. To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc. For general questions, visit the website or call the telephone number provided below. The Countermeasures Injury Compensation Program. Copyright 2023 American Academy of Pediatrics. Table 7 presents the specific demographic characteristics in the studied population. This finalizes the draft guidance published on April 25, 2017. An additional 6 DuoDote lots are no longer useable and should be properly disposed of. IuaPmrE&n-W.2Icy^&PM | ,5A^D|"c%&g;'hy,/A Hr|G,,NNS!YFcZ. JB@W51q/S Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. stream 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 U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. 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. Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. FDA granted this extension following a thorough review of data submitted by Eli Lilly. 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. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group. Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). PDF Pfizer-BioNTech COVID-19 Vaccines - CDC WHERE WILL MY VACCINATION INFORMATION BE RECORDED? From an independent report (Kamar N, Abravanel F, Marion O, et al. 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. 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). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. 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 expiration date for Pfizer orange and gray cap vaccine has now been extended to 9 months (while held at ULT frozen.) Also see: Expiration date extensions of certain lots of doxycycline hyclate. For the most recent Fact Sheet, please see www.cvdvaccine.com. Theres a place for you in the Academy no matter where you are in your career. If you have product questions, please contact us. For the most recent Fact Sheet, please see www.cvdvaccine.com. 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). Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. Pfizer Expiration Date Lookup Tutorial - All Latest Updates Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). 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). Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. a 2-dose primary series to individuals 12 years of age and older; and. Additionally, see The Vaccine Storage and Handling Toolkit, developed by experts at the CDC, for additional information. vaccine's BUD is 2/12/2023. All rights reserved. September 6, 2022: FDA and HHS/ASPR authorized an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). )$p-M?4s6.1K@, i During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 7`xk j "d%%%%`2sA09!--psT(r9e"GQ(r9:_E9+]P+{W]wE = FOi4x= FOi4xX,2H}6i[}oim ~pi>_ ?# The vaccine will be an off-white suspension. The letter noted that, based on FDA-approved supplemental New Drug Applications for Relenza inhalation powder and Tamiflu capsules that provided an expiration dating period of 7 years, it would be scientifically supportable for the expiry extension (i.e., for a maximum of 7 years) to apply to certain lots of Tamiflu and Relenza that have already been manufactured. b s3"/fB`i:be#!GEaGf*bKn!/Px Z(S?|dG-^ZzT_ebT{|K. y*L|oDp8)jw=(9o} The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials with purple caps; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu 75 mg capsules held in strategic stockpiles to be used for a maximum of 15 years beyond their date of manufacture[and] for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture CDC has clarified that states should contact their MCM Specialist or email preparedness@cdc.gov to confirm extended dates for antiviral drug inventories eligible for extension. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. FK5127 HIGH TOXICITY WARNING Vaccines possessing these codes may result in a HIGH risk of DEATH, DISABILITY or SERIOUS ILLNESS . 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). Solicited reactogenicity data in 16 and 17 year-old participants are limited. Do not refreeze. 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. 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. After dilution, the vial should be held between 2C to 25C (35F to 77F). 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. <>/Metadata 258 0 R/ViewerPreferences 259 0 R>> For example, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) oversees the Strategic National Stockpile (SNS), which has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local medical supplies to run out. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. To access the most recent Fact Sheets, please scan the QR code provided below. PAHPRA provides FDA with the explicit authority to extend the expiration dating of eligible FDA-approved MCMs stockpiled for use in CBRN emergencies. c|D|b9P$AMXb.a This diluent is not packaged with the vaccine and must be sourced separately. %PDF-1.7 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. FK5127. https://www.pfizer.com/products/information. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. It is important that the information reported to FDA be as detailed and complete as possible. FDA also recommended relabeling of such product prior to dispensing. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers.