Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. Thawed vials can be handled in room light conditions. 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. 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. The AAP is dedicated to the health of all children and the pediatric professionals who care for them. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. All rights reserved. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. Symptoms may appear 2 to 14 days after exposure to the virus. 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. =RpB_\n6Z.7I yn\i(hI(kcVs3&LIh \. For example, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) oversees the Strategic National Stockpile (SNS), which has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency (for example, a terrorist attack, flu outbreak, or earthquake) severe enough to cause local medical supplies to run out. 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. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. The lot number you entered (AB0000) does not exist. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine, when prepared according to their respective instructions for use, can be used interchangeably. 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. JB@W51q/S The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . Vaccine expires 18 months after the manufacture date. Adverse Reactions Identified in Post Authorization Experience. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. [-130F to -76F]). 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). For more information on how to sign up, visit: www.cdc.gov/vsafe. A carton of 10 vials may take up to 4 hours to thaw at refrigerator temperature (2C to 8C [35F to 46F]). 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. 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. (Federal Register notice) Please contact DoxycyclineExpirationExtensionRequest@fda.hhs.gov with questions regarding thisguidance. Allow vials to thaw at room temperature for 30 minutes. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. helix-grid.hydrated, helix-mega-menu.hydrated, helix-layout-container.hydrated, helix-core-grid.hydrated, helix-core-header.hydrated, helix-core-page-break.hydrated, helix-core-card-group.hydrated, helix-core-footer.hydrated, helix-core-band.hydrated { 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. 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. Don't worry. Sign In. Access the expiration date by scanning the QR code located on the vaccine carton. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. 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. 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. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used. Exp Date: 01/2022 . Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 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. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. These multiple dose vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC 59267-1000-2). If local redistribution is needed and full cartons containing vials cannot be transported at -90C to -60C (-130F to -76F), vials may be transported at -25C to -15C (-13F to 5F). Do NOT store at -25C to -15C (-13F to 5F). Some vials also may have a purple label border. If received at 2C to 8C, they should be stored at 2C to 8C. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. Record the date and time of dilution.Use within 6 hours after dilution. There is a remote chance that these vaccines could cause a severe allergic reaction. This posting and memorandum replace FDAs March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. PFIZER-BIONTECH COVID-19 VACCINE- 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 Countermeasures Injury Compensation Program. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. Printed Expiry Date The information in this Full EUA Prescribing Information regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons. Fierce Healthcare. 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 enter the lot number found on the product carton or vial to obtain its expiration date. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? When FDA grants or authorizes a shelf-life extension, that information may be found either in the granting letters or re-issued letters of authorization available in the listing of EUA authorized products on FDAs website. For further assistance with reporting to VAERS, call 1-800-822-7967. The duration of protection against COVID-19 is currently unknown. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. Youll find additional information on Pfizer storage and handling here. 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. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. An extended expiration date means the manufacturer provided data. 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. 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. The program is administered by the U.S. Department of Defense (DoD). Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older. 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. July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. |/FWjSZl;u!hU$xO=6 :sfuoHDZ-Uqw&+q;#"To-C*HRgZ^lw?BG:+Y7ZBJnw{%8q|\TM|tiv zGjt7e Therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the Agency. For patients for whom enrollment in this trial is not feasible (e.g., a clinical trial site is not geographically accessible), use of tecovirimat under CDCs expanded access protocol (EA-IND) should be consistent with CDCs guidelines for tecovirimat use. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. 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 . The Pfizer-BioNTech and Moderna COVID-19 vaccines both have a shelf life of up to six months, but Pfizer's requires ultra-cold storage to last that long, the company said in November. 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? HWrF+H, rZRJlqI)B@EE4zzz^^8|.II_x2Mi4eYrv[n^IL#NLI{owb7'g^[ g|\Z0dF]/QXbFL@UWu7ZSV8l9'caP)gpSL^: ]N]?2W7A(&5#4?&QFb:h\Q9ov?v FReZG+,LGe[pHv2nK::pWF[lmGd-G^1O'DxpZJj/k9s#a_dMv."&| PFIZER.COM. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. 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. First of all, you will have to enter the lot number along with the country you live in. There are multiple COVID-19 vaccines authorized for use across several brands (Moderna, Pfizer-BioNTech, Janssen, Novavax) . COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors. Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. 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. Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). c Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. Any vaccine remaining in vials must be discarded after 6 hours. 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. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. 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 access a Pfizer expiration date lookup tool, kindly click on the above-given button. 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. endobj 'g}/kM&Mg 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. Following initial FDA authorization, FDA has extended and authorized shelf-life expiration dates after reviewing real-time data generated by the IVD manufacturer. The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS): The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using 1 of the following methods: IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. Dickson, as usual. From an independent report (Kamar N, Abravanel F, Marion O, et al. Pfizer-BioNTech COVID -19 Vaccine Products . To calculate the expiration date,add 18 months to the manufacture dateincludingthe month of manufacture. 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. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 694KB) and the EUA Letter of Authorization (PDF, 293KB) for Evusheld. The vial stoppers are not made with natural rubber latex. 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. FAQs: What happens to EUAs when a public health emergency ends? The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. On April 13, 2022, FDA granted an extension (PDF, 374 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine.FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 . In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). 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. endstream endobj 159 0 obj <>stream Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Please refer to the table on this page for updates. SARS-CoV-2 neutralization assay - NT50 (titer). Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the 56-year stratum. NCPA b s3"/fB`i:be#!GEaGf*bKn!/Px Z(S?|dG-^ZzT_ebT{|K. y*L|oDp8)jw=(9o} Vials should be discarded 12 hours after dilution.). Please refer to the table on this page for updates. TERMS OF USE. Some vaccine storage conditions are associated with beyond-use dates and times. } Symptoms may appear 2 to 14 days after exposure to the virus. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. 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. In response, FDA has issued an EUA for the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, and for certain uses of FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19. 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. Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 Vaccine. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise.6. While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly. If you have product questions, please contact us. Vials should be discarded 8 hours (dark pink cap product) or 12 hours (blue and red cap products) after the first puncture. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. endstream endobj 158 0 obj <>stream Information is not yet available about potential long-term sequelae. September 2022 - March 31, 2023.