For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19, please see www.clinicaltrials.gov. Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals younger than 6 months of age. 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. |/FWjSZl;u!hU$xO=6 :sfuoHDZ-Uqw&+q;#"To-C*HRgZ^lw?BG:+Y7ZBJnw{%8q|\TM|tiv zGjt7e *Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials may also arrive at refrigerator temperature 2C to 8C. Establishing clear standard operating procedures (SOPs) for COVID-19 vaccine storage, handling, and administration to minimize vaccine waste. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. H\j0~ In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling. 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. Know your Vaccine Products and Storage Needs, Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, Long-term Follow-up Care for Childhood, Adolescent and Young Adult Cancer Survivors, Roadmap for Care of Cancer Survivors: Joint Report Updates Recommendations, American Academy of Pediatrics Offers Guidance for Caring and Treatment of Long-Term Cancer Survivors, Childhood Cancer Survivors: What to Expect After Treatment, Transition Plan: Advancing Child Health in the Biden-Harris Administration, Childrens Health Care Coverage Fact Sheets, Prep- Pediatric Review and Education Programs, Practice Research in the Office Setting (PROS), Pediatrician Life and Career Experience Study (PLACES), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Fact Sheet for Health Care Providers Administering Vaccine (5 11 years), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary, Pfizer-BioNTech COVID-19 Vaccine (Gray Cap) Age 12 and Over, Fact Sheet for Health Care Providers Administering Vaccine (12 years and up), FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron), CDC US COVID-19 Vaccine Product Information, CDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Moderna COVID-19 Vaccine Storage and Handling Summary, Fact Sheet for Health Care Providers Administering Vaccine (6 months 5 years), Fact Sheet for Health Care Providers Administering Vaccine (6 11 years). The Countermeasures Injury Compensation Program. Each vial must be thawed before dilution. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. 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. 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. TPOXX supplied by the, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. 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. If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. 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. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. 2 0 obj Recipients should contact their MCM specialists with any questions regarding confirmation. 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. AAP original research, including a robust practice-based research network, addresses important questions regarding pediatric practice and the health and well being of children. COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent include the following ingredients: Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older contains the following additional ingredients: COMIRNATY (COVID-19 Vaccine, mRNA) contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: In clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. } Vials must reach room temperature before dilution. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. 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. Created Date: 12/3/2021 11:57:01 AM . 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. 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. 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). You may also be given an option to enroll in v-safe. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. 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. endstream endobj 159 0 obj <>stream The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. The top 15 blockbuster patent expirations coming this decade | Fierce Pharma. Manufactured forBioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany, Manufactured byPfizer Inc., New York, NY 10017, VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. Pfizer-BioNTech COVID-19 vaccines can be stored at standard refrigeration temperatures for up to 10 weeks. Below are a few case scenarios you might encounter. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron) CDC US COVID-19 Vaccine Product InformationCDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines. Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. PDF Pfizer-BioNTech COVID-19 Vaccine - CDC 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. 'g}/kM&Mg Do not refreeze. November 2022 - May 31, 2023. Vaccine may be thawed in the refrigerator or at room temperature. A recording of this webinar, slides and Q&A(under Resources tab) are available in CDC TRAIN (free account required). 1-800-666-7248. A carton 0f 10 multiple-dose vials may take up to 6hours to thaw at this temperature. section at the end of this Fact Sheet. Current testing focuses on military-significant or contingency use products, drugs that have limited commercial use (e.g., nerve agent antidotes), and drugs that are purchased in very large quantities, such as ciprofloxacin and doxycycline. 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. Pfizer-BioNTech COVID-19 Vaccine at least 3 to 8 weeks after the first dose. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. Thawed vaccine cannot be refrozen. You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. hb``f``Vc```)a@@,& L8zf0edRg2gea`%QX` WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? Vials must reach room temperature before dilution. Pfizer-biontech Covid-19 Vaccine 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? Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the 56-year stratum. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The vaccine efficacy information is presented in Table 8. Primary Series (Monovalent)6 months 5 years: Dark Blue Cap / Magenta Label6-11 years primary series: Dark Blue Cap / Purple Label 12 years and up: Red Cap / Light Blue Label, Updated (Bivalent) Booster 6 months 5 years: Dark Pink Cap/Label with Yellow Box6 years and up: Dark Blue Cap / Gray Border LabelNote: Both 0.25mL (6 11 years) and 0.5mL (12+ years older) doses may be withdrawn from the same multiple-dose vial. A medical product is typically labeled by the manufacturer with an expiration date. body > div[data-webbuilder-block-is-swe] { 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. helix-grid, helix-mega-menu, helix-layout-container, helix-core-grid, helix-core-header, helix-core-page-break, helix-core-card-group, helix-core-footer, helix-core-band { 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. FDA granted this extension following a thorough review of data submitted by Eli Lilly. The Secretary of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. Pfizer does not have an expiration date look -up tool. Refrigerator: Between 2C and 8C (36F and 46F). Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. The AAP is dedicated to the health of all children and the pediatric professionals who care for them. The beyond-use time (12 hours) replaces the manufacturer's expiration date but NEVER extends it. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. The duration of protection against COVID-19 is currently unknown. The manufacture date is printed on the vial (gray cap). /J>^KNEX|H|]@"_=QB /D8Qa"nIZD !s7%^/_ _]EB(b?yq7&1=YOXv+"&(h*p r 3DV3?3pTWPlT" 5^-q3cL+t+m3_r{ixn+k]`vy+`jYGNN7jC7oH{ZjhN4_|UYQ,2CpA1kZ$8@kLcZ!2$qJBj"d0. 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. After dilution, 1 vial contains 6 doses of 0.3 mL. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. It does not start in These multiple dose vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC 59267-1000-2). Home Page - COVID-19 VACCINE LOT NUMBER AND EXPIRATION DATES An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) or placebo separated by 21 days. 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). To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below. As soon as you land on the tool page, You will have to enter 2 things. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). 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). As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the "Vaccine Information Fact Sheet for Recipients and Caregivers" (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of the Pfizer-BioNTech COVID-19 Vaccine, including: For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov. Frozen vials transported at -25C to -15C (-13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with purple caps contain 6 doses of 0.3 mL of vaccine. The vaccine expires on the last day of the 18th month. 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. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. 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. For more information, visit: www.cdc.gov/vsafe. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). 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. However, the U.S. Government recommends retaining the product in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the U.S. January 18, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life from 18 months to 24 months for the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). d The vaccine is currently under emergency use authorization review by the Food and Drug Administration . PRODUCT INFORMATION. The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older. 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. 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. endstream endobj 158 0 obj <>stream 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. No cases of Bell's palsy were reported in the placebo group. Pfizer-BioNTech COVID-19 Lot Expiry The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . SSL Certificate ASM %text %textAccountNo %textAccountName %textAccountAddressName2 %textAccountAddressName3 . 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. Pfizer Expiration Date Lookup Process in Simple Steps [Vaccine/Booster Expires 18 months after manufacture, if held at Ultra Cold temperatures. Please see the most recent updates above for the latest information. First of all, you will have to enter the lot number along with the country you live in. Once punctured, vials can be stored between 2C to 25C (36F to 77F) for up to 12 hours. This posting and memorandum replace FDAs March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. Pfizer-BioNTech COVID -19 Vaccine Products . April 24, 2019: FDA published a final guidance for government public health and emergency response stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. 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. Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursDiscard 6 hours after puncturing vial. 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. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. An extended expiration date means the manufacturer provided data. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. In Study 2, all participants 12 through 15 years of age, and 16 years of age and older in the reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Dates: Are the intervals between the doses of Moderna or Pfizer vaccinations within the appropriate intervals, approximately 21 days apart for the Pfizer vaccination and approximately (within. August 23, 2021. 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. 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. In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children. 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. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Overall in a similar analysis in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Vaccine expires 18 months after the manufacture date. Relenza inhalation powder (reminder of previous extension) The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. October 2022 - April 30, 2023. The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration . SSL Certificate. [Note: this guidance was finalized on April 24, 2019.] 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. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. Overview Job aid on how to verify the expiration date for Pfizer-BioNTech COVID-19 Vaccine paediatric formulation using the QR code found on the secondary packaging label. M&D will begin redistributing Pfizer vaccine with the updated expiration dates detailed below, until all of these doses with extended dates have been ordered: Lot Number (EP6955): New Expiration Date: 9/30/2021 Lot Numbers (EN6207, ER8734, EW0150, ER8729, EW0158, ER8727, EW0162, ER8733): New Expiration Date: 10/31/2021 There may be clinical trials or availability under EUA of other COVID-19 vaccines. display: contents; If you have questions, visit the website or call the telephone number provided below. 7`xk j "d%%%%`2sA09!--psT(r9e"GQ(r9:_E9+]P+{W]wE = FOi4x= FOi4xX,2H}6i[}oim ~pi>_ ?# Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. Sign In. Fierce Life Sciences Events. COVID-19 disease is caused by a coronavirus called SARS-CoV-2. Any vaccine remaining in vials must be discarded after 6 hours. Thawed vials can be handled in room light conditions. 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. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. 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 .

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