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. Adverse reactions following administration of the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, decreased appetite, rash, and pain in extremity (see Full EUA Prescribing Information). Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. 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. You may also be given an option to enroll in v-safe. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1 below), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid. HOWEVER, with this extension, the expiration date is now AFTER the BUD. Without the expiration date extension, this vaccine could only be used up to the expiration date (12/20/2022)-not the full 10 weeks. This draft guidance was prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturers labeled expiration date so the replacement of stockpiled product could be deferred. To confirm extension dates, recipients should provide the following information: Drug name, National Drug Code (NDC), strength, lot number, and original expiration date. Login with Single Sign On . Currently available information is insufficient to determine a causal relationship with the vaccine. May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) On September 21, 2021, FDA and ASPR authorized an extension of the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. For more information on how to sign up, visit: www.cdc.gov/vsafe. If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. vaccine's BUD is 2/12/2023. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. 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. For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. Pfizer-BioNTech COVID-19 Vaccine(N=18,242)n (%), Native Hawaiian or other Pacific Islander, Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation). Check that the carton has been updated to reflect the 10-week refrigerated expiry date. COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This authority is limited to medical products for CBRN emergencies. 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. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. After dilution, the vial should be held between 2C to 25C (35F to 77F). Available data support transportation of one or more thawed vials at 2C to 8C (35F to 46F) for up to 48 hours. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET ANY OF THESE VACCINES? Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Based on the shelf life currently approved in United States of America (USA), the Expiry Date for Lot # (AB0000) is: September 27, 2022 Vaccine is expired. Do NOT store at -25C to -15C (-13F to 5F). Unpunctured vials may be stored between8C to 25C (46F to 77F) for a maximum of 24 hours. <> First of all, you will have to enter the lot number along with the country you live in. 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. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. 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. In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. Please see the most recent updates above for the latest information. All rights reserved. In the absence of real-time stability data, initial reagent stability claims typically do not exceed a four-to-six-month expiration date. Don't worry. You can find the latest versions of these browsers at https://browsehappy.com. The lot number you entered (AB0000) does not exist. The extended expiration date is effective immediately for all currently available batches that have not yet expired. 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. To calculate the expiration date, add 18 months to the manufacture date including the month of manufacture. This Fact Sheet may have been updated. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Purple plastic cap and purple label border. As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. 1 0 obj 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. 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 safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. )$p-M?4s6.1K@, i More information, April 2019 guidance: Extending Expiration Dates of Stockpiled Doxycycline for Anthrax Preparedness, Expiration date extensions of certain lots of doxycycline hyclate, February 10, 2023: Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 221 KB) - On February 1, 2023, FDA issued a memo to government public health and emergency response stakeholders providing an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals (West-Ward) held in strategic stockpiles for anthrax emergency preparedness and response purposes. 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. 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. PRODUCT INFORMATION. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Vaccine may be thawed in the refrigerator or at room temperature. hb``f``Vc```)a@@,& L8zf0edRg2gea`%QX` 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 This Fact Sheet may have been updated. 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 above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with purple caps is 0.3 mL for individuals 12 years of age and older [see Dosage and Administration (2.1)]. 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. The vaccine expires on the last day of the 18th month. 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. 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). Always use the earliest date. 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. The site is secure. 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. 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. This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older. No cases of Bell's palsy were reported in the placebo group. c|D|b9P$AMXb.a 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. After dilution, 1 vial contains 6 doses of 0.3 mL. Refrigerated at 2C and 8C (36F and 46F) for up to 10 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. A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021. 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. Please refer to the table on this page for updates. Vials should be discarded 12 hours after dilution. Solicited reactogenicity data in 16 and 17 year-old participants are limited. 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), Table 1: Extended Expiry Dating for Sotrovimab Authorized under EUA 100, 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, 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, Table 1: Extended Expiry Dating for Paxlovid Authorized under EUA 105, 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, Update on 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, DoxycyclineExpirationExtensionRequest@fda.hhs.gov, Previous doxycyline shelf-life extensions, Additional Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held 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, February 22, 2023: On February 3, 2023, FDA approved a shelf-life extension of TPOXX (tecovirimat) Injection, 200 mg, from 24 months to 42 months for some lots of TPOXX injection. The safety and efficacy of TPOXX for the treatment of human mpox has not been established. CONTACT PFIZER. Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least 2 months after the second dose. Fierce Life Sciences Events. The expiration date for Pfizer orange and gray cap vaccine has now been extended to 9 months (while held at ULT frozen.) After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with purple caps contain 6 doses of 0.3 mL of vaccine. 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. Ultra Cold -90C to -60C (-130F to -76F)*. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. 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. 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. The top 15 blockbuster patent expirations coming this decade | Fierce Pharma. 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 bamlanivimab and etesevimab, emerge and become prevalent in the United States. Specific shelf-life information for IVDs authorized under an EUA can be found on the outer packaging, and reagent vials and containers for the product, or by contacting the IVD manufacturer directly with the catalog number, lot number, and manufacturing date for the specific reagent in question. visibility: inherit; Count out 18 months, using the month printed on the vial as month 1. TERMS OF USE. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. [-130F to -76F]). For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. 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. 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). The vaccine expires on the last day of the 18th month. That means . Before sharing sensitive information, make sure you're on a federal government site. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). Pull back plunger to 1.8 mL to remove air from vial. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. Heres an FDA fact sheet for vaccination providers. For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. 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. The safety population includes participants 16 years of age and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. Relenza inhalation powder (reminder of previous extension) Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form. 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 <. 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. It is predominantly a respiratory illness that can affect other organs. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. FDA granted this extension following a thorough review of data submitted by AstraZeneca. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) . Before discarding any vaccine, providers should check the expiration date using Pfizer-BioNTech's expiration date tool at PfizerBioNTech COVID-19 Lot Expiry . 9 6sOvKB/SA~P=f}pK\"8 8oM~[2]'K v.J v~_SCmGnbv`kKMw36:\H&L(hA9Z;5fH3*B>z^J=b|,L'~ gTr 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. The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. Expiry Checker: Janssen COVID-19 Vaccine Under Emergency Use Authorization. Cartons and vials of Pfizer-BioNTech COVID-19 vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for three months beyond the printed date as long as authorized storage conditions between -90C to -60C (-130F to -76F) have been maintained. (Federal Register notice). Please refer to the table on this page for updates. FDA granted this extension following a thorough review of data submitted by Eli Lilly. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? The observed risk is highest in males 12 through 17 years of age. The manufacture date is printed on the vial (dark blue cap) and carton. For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration . 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. 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. 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 Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture. The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. July 26, 2022 When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. <>/Metadata 258 0 R/ViewerPreferences 259 0 R>> Refrigerator: Between 2C and 8C (36F and 46F)A carton of 10 single-dose vials may take up to 2 hours to thaw at this temperature. CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov)FDA EUA Fact Sheet for Providers. 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. 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 { 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. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. 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. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed. 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. 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).
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