The observed risk is highest in males 12 through 17 years of age. This Fact Sheet may have been updated. 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. Thawed vials can be handled in room light conditions. Each vial MUST BE DILUTED before administering the vaccine. The vaccine efficacy information is presented in Table 8. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. After dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. 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. Wyeth/Pfizer: Nov 2021: Bexsero: Meningococcal Group B: GlaxoSmithKline: Jan 2022: Pneumovax 23: Pneumococcal (polysaccharide) Merck: Apr 2021: Prevnar 13: . The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. 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*, Pfizer-BioNTech COVID-19 VaccineN=1005Casesn1Surveillance Time (n2#), PlaceboN=978Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=1119Casesn1Surveillance Time (n2#), PlaceboN=1110Casesn1Surveillance Time (n2#). Active ingredient. Information to include: The following steps are highlighted to provide the necessary information for safety tracking: There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. J. Novavax monovalent vaccine may be used as a first booster in an adult patient 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). PAXLOVID (nirmatrelvir tablets; ritonavir tablets) | Pfizer Medical Fact check: Blank packaging insert in J&J vaccine is on purpose Covid-19 Vaccine Pfizer, Bivalent: PI - Drugs.com CDC's vaccine excipient summary and the National Institutes of Health DailyMed database can also be used as a resource. Manufactured forBioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany, Manufactured byPfizer Inc., New York, NY 10017, VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. This week, Frank D'Amelio, chief financial officer at . See section 3 for vaccine volume and spacing based on age and vaccine formulation. Purple plastic cap and purple label border. PDF Pfizer-BioNTech COVID-19 Vaccine, BIVALENT - niaid.nih.gov If you're curious about what's in the vaccine, the package insert also lists all of the ingredients of the Comirnaty vaccine (formerly known as Pfizer's vaccine): . Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc. For general questions, visit the website or call the telephone number provided below. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Symptoms may appear 2 to 14 days after exposure to the virus. Do not add more than 1.8 mL of diluent. 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). 28 Apr 2023 21:26:45 A separate fact sheet is provided for J&J COVID-19 vaccine recipients and their caregivers. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Undiluted vials may be stored at room temperature for no more than 2 hours. Solicited reactogenicity data in 16 and 17 year-old participants are limited. Record the date and time of dilution.Use within 6 hours after dilution. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Amtrak issued a memo to employees saying that it would allow those who have not been vaccinated against COVID-19 to opt for regular testing. 2:22 U.K . Currently available information is insufficient to determine a causal relationship with the 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. The vaccine must be thawed prior to preparation and . . During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. In a clinical trial, approximately 300 individuals greater than 55 years of age received one dose of a bivalent vaccine that differs from the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in that it contains a different Omicron component. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Version 3 Page 1 / 13 - Pfizer 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. This is the Product Information that was approved with the submission described in this AusPAR. Therefore, the EMA recommended the updating of package insert for the Comirnaty vaccine to include heavy menstrual bleeding as a side effect of unknown frequency. 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. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. Table 7 presents the specific demographic characteristics in the studied population. It is predominantly a respiratory illness that can affect other organs. 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. 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. A 69-year-old man complained of reddish bruises on his wrist after the first dose of the Pfizer-BioNTech COVID-19 vaccine. Procedures should be in place to avoid injury from fainting. Primary Series: The Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) are given for the primary series. CDC Publishes Hidden Pfizer Document With An Admission That Proves Association and the American Nurses Association also released a statement applauding the FDA's full approval of the Pfizer COVID-19 vaccine. Some vials also may have a purple label border on the label. Information is not yet available about potential long-term sequelae. Package Inserts and Manufacturers for some US Licensed Vaccines and Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. 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). From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). COVID mRNA Vaccines and Blood Clots The doctors of disinformation are wrong, again. . 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. 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. 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. 2022 . This information in the package insert supersedes the storage conditions printed on the vial cartons. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. Vials must reach room temperature before dilution. Heavy menstrual bleeding in product information Pfizer and Moderna vaccines [Internet]. Tootypetodrunk on Twitter: "RT @HopeRising19: Canada has just updated Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? Storage of the vaccine COMIRNATY is stored at -90 C to -60C. Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), syncope, and dizziness have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. COVID-19 - immunize.org 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. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. A partially blank package insert in J&J's vaccine cartons directs providers to the FDA's fact sheet for the most accurate information about the shot. 6. To access the most recent Fact Sheets, please scan the QR code provided below. Note: Both the Pfizer-BioNTech and Moderna COVID-19 vaccines contain polyethylene glycol (PEG). . The safety of a Pfizer-BioNTech COVID-19 Vaccine booster dose in individuals who completed primary vaccination with another authorized or approved COVID-19 Vaccine . To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: FDA Product Approval: View All - immunize.org Tell the vaccination provider about all of your medical conditions, including if you: The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle. V-safe is a voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. Other vaccines to prevent COVID-19 may be available under EUA, including bivalent vaccines that contain an Omicron component of SARS-CoV-2. 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. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. PDF Missouri Department of Health and Senior Services P.O. Box 570 This product (for ages 12 years and older) is no longer being distributed. Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. pdf package insert attached and at link Download the PDF here August 23, 2021: FDA approves Comirnaty (COVID-19 Vaccine, mRNA), which was previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older. Do not refreeze. Cardiac Disorders: myocarditis, pericarditis, Gastrointestinal Disorders: diarrhea, vomiting, Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm), Nervous System Disorders: syncope, dizziness. 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. 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. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. It is important that the information reported to FDA be as detailed and complete as possible. PACLITAXEL | Pfizer Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. PDF Immunization Pharmacy Protocol - Oregon 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. Please see the, Table 1:Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 3: Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, Table 4: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, (Kamar N, Abravanel F, Marion O, et al. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. 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. 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. If you have questions, visit the website or call the telephone number provided below. 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. Vaccines: COVID-19: DEAR COLLEAGUE LETTERS: 16-year-old Visit: HPV: MenACWY Dose #2: DONATE TO IAC: 5.2. VACCINE FORMULATION AND DESCRIPTION . Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. 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. section at the end of this Fact Sheet. ii. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. 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. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. You may also be given an option to enroll in v-safe. 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. 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. When you get your first COVID-19 vaccine, you will get a vaccination card. The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. Pfizer-biontech Covid-19 Vaccine 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. 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: During the visual inspection. 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). COVID-19 Vaccines (Pfizer/BioNTech) Quick Finder (Primary series completed) CoV-2 infection, including recommendations after receiving If the recipient has received 3 or more doses of any monovalent COVID-19 vaccine, administer a booster dose of The thermal container maintains a temperature range of -90C to -60C (-130F to -76F). COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). 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]. 5 Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of May 2021 through February 2022 printed on the label may remain in use for 3months beyond the printed date, as long as 3. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines. From an independent report (Kamar N, Abravanel F, Marion O, et al. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine - FDA Grants Full Approval A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. This Full EUA Prescribing Information may have been updated. 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. 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. Official Vaccine Product Information from FDA: vaccine product approval FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . 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. PDF 1, MD FACOG FACS; C. Daniel Mullins 2 1, MSc; COVID-19 Vaccination COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) PDF Missouri Department of Health and Senior Services 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? Jcovden [package insert]. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: RT @HopeRising19: Canada has just updated its package insert for Comirnaty #pfizer #CovidVaccines Updated in March 2023 it's interesting to see what they are STILL saying about the use of their covid injection in PREGNANT and BREAST FEEDING women It's certainly NOT what their Mininstry of Show more . This is the only active ingredient in the vaccine. Comirnaty Package Insert: Pfizer-BioNTech: Comirnaty Product Approval : Spikevax Package Insert: Moderna: Spikevax Product Approval ; EUA Full Prescribing Information: Pfizer-BioNTech: Letter of Authorization . . Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. After dilution, 1 vial contains 6 doses of 0.3 mL. This information in the package insert supersedes the storage conditions printed on the vial cartons. Data presented at the Vaccines and Related Biologics Products Advisory Committee (VRBPAC), June 10 Data and VaST assessment presented at ACIP meeting on June 23. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. This diluent is not packaged with the vaccine and must be sourced separately. Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. After dilution, 1 vial contains 6 doses of 0.3 mL. No. See Overall Safety Summary (Section 6) for additional information. For more information, visit: www.cdc.gov/vsafe. Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks.

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