pfizer covid vaccine package insert

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? Primary Series: The Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) are given for the primary series. Pfizer-BioNTech COVID-19 Vaccines | CDC 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. COVID-19 Vaccines (Pfizer/BioNTech) Quick Finder Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES. After dilution, 1 vial contains 6 doses of 0.3 mL. 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: Frozen vials transported at -25C to -15C (-13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Polysorbate allergy is a precaution to Pfizer-BIONTech COVID-19 vaccine (due to I. Administer a dose of Pfizer or Moderna bivalent COVID-19 vaccine according to ACIP recommendations and the vaccine package insert. * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed. For the most recent Full EUA Prescribing Information, please see www.cvdvaccine.com. 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. This information in the package insert supersedes the storage conditions printed on the vial cartons. 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. 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. PACLITAXEL (paclitaxel) This product information is intended only for residents of the United States. A third primary series dose may be administered at least 4 weeks after the second dose to individuals with certain kinds of immunocompromise. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. Covid-19 Vaccine Pfizer, Bivalent: PI - Drugs.com 2022 Nov10 [cited 2023 Jan 17]. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have been shown to prevent COVID-19. Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. 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. No. Pfizer-BioNTech COVID-19 Vaccines (CDC) Moderna COVID-19 vaccine (mRNA) Moderna COVID-19 Vaccines (CDC) Novavax COVID-19 vaccine, Adjuvanted (protein subunit) Individuals using assistive technology may not be able to fully please If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. The possible side effects of these vaccines are still being studied. During the visual inspection. A doctor, nurse or pharmacist will prepare the injection for you before you are given it. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) Tootypetodrunk on Twitter: "RT @HopeRising19: Canada has just updated Document date and time the vaccine was diluted on the Pfizer vaccine vial v. Clean top of Pfizer vaccine vial with alcohol prep pad and with draw 0.2ml of . The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. 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. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. 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. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? 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. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. 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. 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. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. https://fda.gov/media/167211/download " No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during pregnancy." 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): . Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. PAXLOVID (nirmatrelvir tablets; ritonavir tablets) | Pfizer Medical For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. 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. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic. Symptoms may appear 2 to 14 days after exposure to the virus. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. See section 3 for vaccine volume and spacing based on age and vaccine formulation. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. Some vials also may have a purple label border. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Product Name Pfizer-BioNTech COVID-19 Vaccine Page 4 / 13 Revision date 07-Dec-2021 Version 3 Suitable Extinguishing Media Dry chemical, CO2, alcohol-resistant foam or water spray. Pfizer-BioNTech Bivalent COVID-19 Vaccine with gray cap and gray label border is supplied as a frozen suspension for intramuscular injection in single dose vials (containing 0.48 mL per vial) and multiple dose vials (containing 2.25 mL per vial). To access the most recent Fact Sheets, please scan the QR code provided below. Special hazards arising from the substance or mixture Specific hazards arising from the chemical Fine particles (such as mists) may fuel fires/explosions. Daily Mail reported that the timeline of this rollout would depend on the findings of in-house trials that will look into whether vaccines are safe and effective in children aged six months to five years. Background Clinical trials for both the Moderna and Pfizer -BioNTech 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. Fact Check: Video Of Blank Product Insert Inside J&J Vaccine Box Does For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE. Amtrak announced yesterday that it will temporarily halt a COVID-19 jab mandate for employees after issuing a warning about possible service reductions due to labor shortages. First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). The safety evaluation in Study 2 is ongoing. 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. Pull back plunger to 1.8 mL to remove air from vial. 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 diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. 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. Comirnaty Package Insert: Pfizer-BioNTech: Comirnaty Product Approval : Spikevax Package Insert: Moderna: Spikevax Product Approval ; EUA Full Prescribing Information: Pfizer-BioNTech: Letter of Authorization . Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. The lab reports showed the prolongation of activated partial thromboplastin time and the presence of a factor VIII inhibitor. AusPAR - COMIRNATY - BNT162b2 (mRNA) - Pfizer Australia Pty Ltd - PM-2020-05461-1-2 FINAL 25 January 2021. Solicited Local and Systemic Adverse Reactions. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group. 28 Apr 2023 21:26:45 The vaccines also contain various salts, fats and other ingredients to help your body use the mRNA. Jcovden [package insert]. This Fact Sheet may have been updated. 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. a 2-dose primary series to individuals 12 years of age and older; and. Vaccines: COVID-19: DEAR COLLEAGUE LETTERS: 16-year-old Visit: HPV: MenACWY Dose #2: DONATE TO IAC: FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. Serious and unexpected side effects may occur. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. If you are immunocompromised, you may receive a third primary series dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). 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. 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. Next COVID-19 Vaccine Details Next. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 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. 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: Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. Tip: Read Package Inserts - Twitter . Thaw and then store undiluted vials in the refrigerator [2C to 8C (35F to 46F)] for up to 1 month. This information in the package insert supersedes the storage conditions printed on the vial cartons. This Full EUA Prescribing Information may have been updated. . 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. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use can be used interchangeably.2, 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.3, SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS. These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. See this Fact Sheet for instructions for preparation and administration. Do not refreeze. Package insert / product label Dosage form: injection, suspension. Visually inspect each dose in the dosing syringe prior to administration. If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Purple plastic cap and purple label border. Physician Prescribing Information 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. PDF Pfizer-BioNTech COVID-19 Vaccine, BIVALENT - niaid.nih.gov PACLITAXEL | Pfizer FDA Approval - 6/3/22. The safety evaluation in Study 2 is ongoing. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, when administered as a booster dose, is authorized for use as: a single booster dose in children 6 months through 4 years of age at least 2 months . 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. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). This is what's important. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. 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. Vials must reach room temperature before dilution. PDF INGREDIENTS INCLUDED IN COVID-19 VACCINES - Alabama Department of AZULFIDINE (sulfasalazine) | Pfizer Medical Information - US Your close contacts should be vaccinated as appropriate. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. NAME OF THE MEDICINE BNT162b2 [mRNA] 2. From an independent report (Kamar N, Abravanel F, Marion O, et al. COVID mRNA Vaccines and Blood Clots The doctors of disinformation are wrong, again. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report 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 cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. 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? 6. 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. It is predominantly a respiratory illness that can affect other organs. Note: the front and back panels of this insert were intentionally left blank. PDF Immunization Pharmacy Protocol - Oregon Covid-19 Vaccine Pfizer, Monovalent,5 yr to 11 yr - Drugs.com 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. Getting rid of any unwanted vaccine A doctor, nurse or pharmacist will dispose of any unused vaccine. . This product (for ages 12 years and older) is no longer being distributed. 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. PDF AUSTRALIAN PRODUCT INFORMATION - COMIRNATY (BNT162b2 [mRNA]) COVID-19 There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. . Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. Includes: indications, dosage, adverse reactions and pharmacology. (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 Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. For more information on how to sign up, visit: www.cdc.gov/vsafe. Vials must be kept frozen and protected from light, in the original cartons, until ready 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#). Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. 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. Data have not yet been submitted to FDA on administration of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent at the same time with other vaccines. Purple plastic cap and purple label border. Active ingredient. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained.
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