In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). Please refer to the table on this page for the new updates. An extended expiration date means the manufacturer provided data. 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 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. The codes for each Pfizer batch can be obtained from the VAERS database, and the batches ordering by the total . Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Additionally, see The Vaccine Storage and Handling Toolkit, developed by experts at the CDC, for additional information. Count out 18 months, using the month printed on the vial as month 1. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). 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. FDA also recommended relabeling of such product prior to dispensing. FDA granted this extension following a thorough review of data submitted by Eli Lilly. It is predominantly a respiratory illness that can affect other organs. October 2022 - April 30, 2023. To access the most recent Fact Sheets, please scan the QR code provided below. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. A third dose of the Pfizer-BioNTech COVID-19 vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. <> You can find the latest versions of these browsers at https://browsehappy.com. You can get COVID-19 through contact with another person who has the virus. Before sharing sensitive information, make sure you're on a federal government site. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. The updated 12-hour timeline from the Fact Sheet supersedes the number of hours printed on vial labels and cartons. Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. N Engl J Med), Table 5: Study 2 Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 6: Study 2 Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 7: Demographics (population for the primary efficacy endpoint), Table 8: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection, Table 9: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection, Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) Participants Without Evidence of Infection up to 1 Month After Dose 2 Dose 2 Evaluable Immunogenicity Population, 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 older. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Follow good vaccine storage and practices by outlined by the. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. 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 lot number you entered (AB0000) does not exist. 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. 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. Providers should track these time frames. visibility: inherit; A medical product is typically labeled by the manufacturer with an expiration date. 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. 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. The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . See Overall Safety Summary (Section 6) for additional information. Available data support transportation of one or more thawed vials at 2C to 8C (35F to 46F) for up to 48 hours. Before discarding any vaccine, providers should check the expiration date using Pfizer-BioNTech's expiration date tool at PfizerBioNTech COVID-19 Lot Expiry . Health care providers should encourage their patients with mpox infection to be evaluated for enrollment in this trial. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. FDA has authorized Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide better protection against COVID-19 caused by the Omicron variant of SARS-CoV-2. 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. The safety evaluation in Study 2 is ongoing. 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. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. Each vial must be thawed before dilution. 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). Vaccine should NOT be used after the expiration date or beyond-use date/time. After dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. 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. 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. N Engl J Med), a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. 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. Primary Series: The Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) are given for the primary series. 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. 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. 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. Shelf-life expiration dates have been extended multiple times as additional data becomes available. Pfizer does not have an expiration date look -up tool. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. 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. Solicited reactogenicity data in 16 and 17 year-old participants are limited. Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or https://TIPS.HHS.GOV. Each vial MUST BE DILUTED before administering the vaccine. SARS-CoV-2 neutralization assay - NT50 (titer). The chance of having this occur is very low. 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. 3 0 obj If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. *d,aur A4ton)9R yYe5V@brte/-b{L1f^U73hq$ '>8#3,$ D eu,oCZN U[ The storage, preparation, and administration information in this Fact Sheet 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. 4 0 obj Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. An additional 1 DuoDote lot is no longer useable and should be properly disposed of. 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. What is an Emergency Use Authorization (EUA)? To access a Pfizer expiration date lookup tool, kindly click on the above-given button. 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. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. 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. Under the EUA, it is your choice to receive or not receive any of these vaccines. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. 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. /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. SSL Certificate. After dilution, 1 vial contains 6 doses of 0.3 mL. Following approval, the FDA revised its fact sheet for health care providers administering vaccines to note cartons and vials of the Pfizer vaccine with an expiration date of August 2021 through . 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. 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. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region.

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