*Cartons of Pfizer-BioNTech COVID-19 Vaccine vials may also arrive at refrigerator temperature 2C to 8C. Some vials also may have a purple label border. Solicited reactogenicity data in 16 and 17 year-old participants are limited. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. 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. Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. 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. Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. (Primary series completed) If the recipient has received 2 or more doses of a monovalent COVID-19 vaccine (Pfizer-BioNTech or Moderna), administer 1 booster dose of bivalent Pfizer-BioNTech COVID-19 Vaccine at least 8 weeks (2 months) after the previous dose. 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). c Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. Expires 18 months after manufacture, if held at Ultra Cold temperatures. endobj It is predominantly a respiratory illness that can affect other organs. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion. 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). 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. The codes for each Pfizer batch can be obtained from the VAERS database, and the batches ordering by the total . In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Vaccine Site - Pfizer In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. States may contact their MCM Specialist or email [email protected] or [email protected] to confirm the new extended dates for their antiviral drug inventories eligible for extension. 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. 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). Thawed vials can be handled in room light conditions. COVID-19 disease is caused by a coronavirus called SARS-CoV-2. 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. Storage for longer than 10 weeks requires an Ultra Cold freezer. Should you decide not to receive any of these vaccines, it will not change your standard medical care. See Overall Safety Summary (Section 6) for additional information. Refrigerator: Between 2C and 8C (36F and 46F) A carton of 10 vials may take up to 6hours to thaw at this temperature. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. endobj Room temperature: Up to 25C (77F). HOWEVER, with this extension, the expiration date is now AFTER the BUD. Check Lot. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. Pfizer Expiration Date Lookup Process in Simple Steps [Vaccine/Booster H\j0~ Solicited Local and Systemic Adverse Reactions. 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. 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, [email protected], 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. Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -90C to -60C (-130F to -76F) until the expiry date printed on the label. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. After dilution, the vial should be held between 2C to 25C (35F to 77F). Pfizer-BioNTech COVID-19 Vaccines | FDA (Federal Register notice). 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. 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. The program is administered by the U.S. Department of Defense (DoD). *d,aur A4ton)9R yYe5V@brte/-b{L1f^U73hq$ '>8#3,$ D eu,oCZN U[ Always use the earliest date. 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. 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. Schedule Vaccines at GLCP | Grass Lake Community Pharmacy 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). CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? Booster Dose: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is administered as a single booster dose at least 2 months after: WHO SHOULD NOT GET COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? Primarily FDA-approved prescription drug (not biological) products are nominated by program participants as SLEP candidates. Some vaccine storage conditions are associated with beyond-use dates and times. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. JB@W51q/S To calculate the expiration date,add 18 months to the manufacture dateincludingthe month of manufacture. 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. Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are NOT eligible for extension. Copyright 2023 American Academy of Pediatrics. Health care providers should encourage their patients with mpox infection to be evaluated for enrollment in this trial. The manufacture date is printed on the vial (gray cap). Expiry Checker: Janssen COVID-19 Vaccine Under Emergency Use Authorization. WHERE WILL MY VACCINATION INFORMATION BE RECORDED? The duration of protection against COVID-19 is currently unknown. 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. Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. 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. After dilution, the vial should be held between 2C to 25C (35F to 77F). <> 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. SSL Certificate. <>/Metadata 258 0 R/ViewerPreferences 259 0 R>> Find valuable resources to assist you in your pediatrics career from pre-med and training to finding a job and growing a thriving practice. /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. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. 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)]. Vaccine expires 18 months after the manufacture date. In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%). The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. The observed risk is highest in males 12 through 17 years of age. 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 Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Undiluted vials may be stored at room temperature for no more than 2 hours. [Note: this guidance was finalized on April 24, 2019.] No more than 2 hours at room temperature (up to 25C/77F). FDA will continue to evaluate the available data and provide updated information as soon as possible. Purple plastic cap and purple label border. 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. B~o[_o$Pz{%y .=8X Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are, State Dept. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 11 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Please refer to the table on this page for updates. To access the most recent Fact Sheets, please scan the QR code provided below. Evaluation of a future extension of shelf-life for sotrovimab is ongoing. Observation 6 . SARS-CoV-2 neutralization assay - NT50 (titer). The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.10. 7`xk j "d%%%%`2sA09!--psT(r9e"GQ(r9:_E9+]P+{W]wE = FOi4x= FOi4xX,2H}6i[}oim ~pi>_ ?# d The vaccine is currently under emergency use authorization review by the Food and Drug Administration . In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. Available Vaccines for COVID-19 include: PFIZER's NEW BOOSTER & MODERNA's NEW BOOSTER Appointment * Name * First Name Last Name Date of Birth * Month Day Year Phone Number * Please enter a valid phone number. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. As the expiration date approaches, contact the manufacturer to determine if it has been extended. ,W7@M"NV?lG=nVk`SJt*"75Nry"E"nP8%T&v:$'4B5 "WY2Vvf5,psc=l(Zb0|4;"on#t|uL;5p~hn;ZVAJ0yTL)L/d)K.>gb[>FpZ[LRJaRjm7v(HU{K\:{g_%N;plI|~j-;||O-RqISR0jJc[:E*\CB8 The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). August 23, 2021. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Shelf-life Extension for the Pfizer Pediatric Vaccine - Iowa 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. Allow vial(s) to thaw at room temperature [up to 25C (77F)] for 30 minutes. 1 0 obj Vials should be discarded 8 hours (dark pink cap product) or 12 hours (blue and red cap products) after the first puncture. 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. 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. This Fact Sheet may have been updated. Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2-week limit for storage at -25C to -15C (-13F to 5F). Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html). The safety and efficacy of TPOXX for the treatment of human mpox has not been established. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. Purple plastic cap and purple label border. PDF IMMUNIZATION COVID-19 UPDATE - Louisiana Department of Health Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. 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. Each vial must be thawed before dilution. 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. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Tamiflu capsules, provided that the products have been stored under labeled storage conditions. Record the date and time of first use on the Moderna COVID-19 Vaccine label. The vaccine efficacy information is presented in Table 8. 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. https://www.cdc.gov/coronavirus/2019-ncov/index.html. 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. 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. KmX;@=VP$Zx_[9AA1&3. Pfizer-BioNTech vaccine expiration date extension and beyond-use date A carton of 10 vials may take up to 2 hours to thaw in the refrigerator [2C to 8C (35F to 46F)]. Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. The vaccine expires on the last day of the 18th month. 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. 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). A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. Login with Single Sign On .