Fact Sheet for Healthcare Providers Administering Vaccine - Novavax, Janssen COVID-19 Vaccine Storage and Handling Summary, COVID-19 Vaccine Lot Number and Expiration Date Report, COVID-19 Vaccine Quick Reference Guide for Healthcare Professionals, COVID-19 Vaccine Lot Number and Expiration Date Report from the CDC. %
Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below. 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. Please refer to the table on this page for updates. 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. 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. This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. What is an Emergency Use Authorization (EUA)? In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children. Vaccine may be thawed in the refrigerator or at room temperature. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. 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. HWrF+H, rZRJlqI)B@EE4zzz^^8|.II_x2Mi4eYrv[n^IL#NLI{owb7'g^[ g|\Z0dF]/QXbFL@UWu7ZSV8l9'caP)gpSL^:
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FReZG+,LGe[pHv2nK::pWF[lmGd-G^1O'DxpZJj/k9s#a_dMv."&| 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. The safety and efficacy of TPOXX for the treatment of human mpox has not been established. Each vial MUST BE DILUTED before administering the vaccine. 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. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. 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. Follow good vaccine storage and practices by outlined by the. The lot number you entered (AB0000) does not exist. Your close contacts should be vaccinated as appropriate. Table 7 presents the specific demographic characteristics in the studied population. Sign In. November 2022 - May 31, 2023. This diluent is not packaged with the vaccine and must be sourced separately. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. First of all, you will have to enter the lot number along with the country you live in. Room temperature: Up to 25C (77F). Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. 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. 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). You can get COVID-19 through contact with another person who has the virus. FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). During the visual inspection. It does not start in Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. How to Tell If a COVID-19 Vaccine Card Is Fake or Real - Business Insider Each vial must be thawed before dilution. endstream
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In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. Pfizer-BioNTech COVID-19 Vaccine at least 3 to 8 weeks after the first dose. 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. If you have questions, visit the website or call the telephone number provided below. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. 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. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. The vaccine efficacy information is presented in Table 8. Pfizer Expiration Date Lookup Process in Simple Steps [Vaccine/Booster Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. 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. Vials stored at -25C to -15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . Always use the earliest date. WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? This includes working to ensure that MCM-related policy supports programs like SLEP. 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. Please refer to the table on this page for updates. The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in Tables 3 and 4. endobj
December 2022 - June 30, 2023. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older9. 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. In addition, you can report side effects to Pfizer Inc. at the contact information provided below. Individuals 12 years of age and older may receive a booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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). Due to the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Purple plastic cap and purple label border. /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. December 14, 2022: On April 28, 2022, 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. WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? Vaccinations may not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. Observation 6 . After dilution, the vial should be held between 2C to 25C (35F to 77F). Vials should be discarded 12 hours after dilution.). Vaccine Site - Pfizer Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) display: contents; The duration of protection against COVID-19 is currently unknown. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. Additionally, see The Vaccine Storage and Handling Toolkit, developed by experts at the CDC, for additional information. 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. Tables 1 through 6 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine and placebo. Home Page - COVID-19 VACCINE LOT NUMBER AND EXPIRATION DATES PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2injection, suspensionPfizer Manufacturing Belgium NV, FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS), EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19), PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER DILUTE BEFORE USE. The codes for each Pfizer batch can be obtained from the VAERS database, and the batches ordering by the total . hb``f``Vc```)a@@,&
L8zf0edRg2gea`%QX` Before sharing sensitive information, make sure you're on a federal government site. Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. Heres an FDA fact sheet for vaccination providers. Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. 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 storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use. 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#). COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. FDA will continue to evaluate the available data and provide updated information as soon as possible. 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? 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. For more information on how to sign up, visit: www.cdc.gov/vsafe. This authority is limited to medical products for CBRN emergencies. Please enter the lot number found on the product carton or vial to obtain its expiration date. The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. The vaccine will be an off-white suspension. Vials stored at -25C to -15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). 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. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. 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. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. 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 sotrovimab, emerge and become prevalent in the United States. 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. In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. 2C to 8C (36F to 46F) for up to 30 days Cannot be re-frozen, Do NOT refreeze thawed vaccine.Do NOT dilute.Do NOT shake but swirl the vial gently after thawing and between each withdrawal. 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. N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. Janssen COVID-19 Vaccine Expiry Checker To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427. l0{TuE"95Z)`]`{$D0; ,L RHs r @@g`: 9
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After dilution, 1 vial contains 6 doses of 0.3 mL. The chance of having this occur is very low. The QR code on the label is a link to the EUA factsheet. Shelf-life Extension for the Pfizer Pediatric Vaccine - Iowa Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. Without the expiration date extension, this vaccine could only be used up to the expiration date (12/20/2022)-not the full 10 weeks. <>
Irrespective of the type of syringe and needle: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine (see Full EUA Prescribing Information). Ultra Cold -90C to -60C (-130F to -76F)*. 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. 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. To calculate the expiration date, add 18 months to the manufacture date including the month of manufacture. 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. Youll find additional information on Pfizer storage and handling here. This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. Symptoms may appear 2 to 14 days after exposure to the virus. The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. 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. NOTE: Expiration dates extension does NOT apply to vials dated July 2021 and earlier. Moderna Fact Sheet for Bivalent Booster Dose for 18 6 years and older. This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). <>
The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.Thawed vaccine cannot be refrozen. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. After dilution, 1 vial contains 6 doses of 0.3 mL. 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. Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. Should you decide not to receive any of these vaccines, it will not change your standard medical care. The expiration date is set at the end of the shelf-life. Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are, State Dept. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. 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. 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. Printed Expiry Date An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Refrigerated (thawed vials) at 2C and 8C (36F and 46F) for up to 10 weeks. In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10). La vacuna contra el COVID-19 de Pfizer-BioNTech para nios de 5 a 11 aos de edad se administra como una serie primaria de dos dosis, con 3 semanas de diferencia, pero es una dosis ms baja (10. Learn how your gifts makes that possible. Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below. IuaPmrE&n-W.2Icy^&PM
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,5A^D|"c%&g;'hy,/A Hr|G,,NNS!YFcZ. For those doses that are close to expiry, if they are being held under appropriate conditions for ensuring their integrity for use, they can potentially be quarantined to see if data on new stability studies warrant extension of the initial expiry date according to appropriate policies and procedures. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. =RpB_\n6Z.7I yn\i(hI(kcVs3&LIh \. Peds (5-11) has a 6-month expiration if held frozen at ULT oMFG date + 6 months = expiration date oThis includes the month of manufacturee.g., 8/2021 includes August. <>/Metadata 258 0 R/ViewerPreferences 259 0 R>>
For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. 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). 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. Relenza inhalation powder (reminder of previous extension) https://www.cdc.gov/coronavirus/2019-ncov/index.html. PDF Pfizer-BioNTech COVID-19 Vaccine - cdc.gov 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. B~o[_o$Pz{%y .=8X The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. 3 0 obj
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. body > div[data-webbuilder-block-is-swe] { CN&0: No. 4 0 obj
This shelf-life extension applies to refrigerated vials of J&J/Janssen COVID-19 vaccine that have been held in accordance with the manufacturer's storage conditions. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 1-800-666-7248. 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 population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. The vaccine is administered as a 2-dose series, 3 weeks apart. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. SARS-CoV-2 neutralization assay - NT50 (titer). MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION4. 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). 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.10. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
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