Storage in boxes or bins can help maintain temperature longer, especially if power is lost. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) 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]. 5.2. 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? Includes: indications, dosage, adverse reactions and pharmacology. 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. This product information is intended only for residents of the United States. (package insert). It includes vaccine ingredients, a list of side effects and information about who should and should not receive the shot. In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html. A 69-year-old man complained of reddish bruises on his wrist after the first dose of the Pfizer-BioNTech COVID-19 vaccine. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. 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. 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. 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. 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. N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. Your close contacts should be vaccinated as appropriate. In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). COMIRNATY [package insert]. This Full EUA Prescribing Information may have been updated. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. On April 18, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent to simplify the vaccination schedule for most . 1. Covid-19 vaccines safety update [Internet]. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. PDF COVID-19 Vaccine Safety Technical (VaST) Work Group PDF INGREDIENTS INCLUDED IN COVID-19 VACCINES - Alabama Department of Heavy menstrual bleeding in product information Pfizer and Moderna vaccines [Internet]. Information is not yet available about potential long-term sequelae. (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 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? PDF Pfizer-BioNTech COVID-19 Vaccine, BIVALENT - niaid.nih.gov The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. Any vaccine remaining in vials must be discarded after 6 hours. Covid-19 Vaccine Pfizer, Bivalent package insert / prescribing information for healthcare professionals. 2:22 U.K . Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. 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. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. 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. Only NDCs for the subsequently BLA approved tri sucrose formulation will be produced." 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. 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#). Purple plastic cap and purple label border. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. No. PDF Missouri Department of Health and Senior Services 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. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES. This Fact Sheet may have been updated. a 2-dose primary series to individuals 12 years of age and older; and. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. AusPAR - COMIRNATY - BNT162b2 (mRNA) - Pfizer Australia Pty Ltd - PM-2020-05461-1-2 FINAL 25 January 2021. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Side effects that have been reported with these vaccines include: These may not be all the possible side effects of these vaccines. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. 1 . 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 Description (13)]. 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. No more than 2 hours at room temperature (up to 25C/77F). 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. 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. The vaccine is administered as a 2-dose series, 3 weeks apart. Adverse Events following Immunization with COVID-19 Vaccines: A This Fact Sheet may have been updated. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. 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): . 30 mcg of a nucleosidemodified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. Observe patient for 30 minutes following vaccination iii. The full list of ingredients are included in the vaccine package inserts: View the Pfizer package insert for ages 12+ View the Pfizer package insert for ages 5 to 11; View the Moderna package insert; View the Johnson & Johnson package insert See below the CDC-issued EUI fact sheets for healthcare providers and recipients/caregivers regarding Pfizer-BioNTech COVID-19 vaccine . PACLITAXEL | Pfizer RED ALERT: American Babies Could Be Given Pfizer's COVID Vaccine By This information in the package insert supersedes the storage conditions printed on the vial cartons. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? 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. 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. Do not add more than 1.8 mL of diluent. Source: National Center for Immunization and Respiratory Diseases. 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. COVID-19 - immunize.org Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap is authorized for use to provide: COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. These NDC will not be manufactured. For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. 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. The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials with purple caps; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. 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). 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 . Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. https://www.cdc.gov/coronavirus/2019-ncov/index.html. . 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: Dosage and Administration; . COVID-19 Bivalent Vaccine Boosters | FDA The vaccine will be an off-white suspension. PDF 1, MD FACOG FACS; C. Daniel Mullins 2 1, MSc; COVID-19 Vaccination For more information on how to sign up, visit: www.cdc.gov/vsafe. 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. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. 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. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427. New York, NY: Pfizer Inc.; 2022. 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. Visually inspect each dose in the dosing syringe prior to administration. 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). 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. In addition, you can report side effects to Pfizer Inc. at the contact information 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. To access the most recent Fact Sheets, please scan the QR code provided below. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Once thawed remove the cap of the Pfizer vaccine and inject 1.3ml of 0.9% sodium chloride that comes in the ancillary kit of the vaccine iii. 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. After dilution, 1 vial contains 6 doses of 0.3 mL. Wyeth/Pfizer: Nov 2021: Bexsero: Meningococcal Group B: GlaxoSmithKline: Jan 2022: Pneumovax 23: Pneumococcal (polysaccharide) Merck: Apr 2021: Prevnar 13: . After dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. 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. Vaccines: COVID-19: DEAR COLLEAGUE LETTERS: 16-year-old Visit: HPV: MenACWY Dose #2: DONATE TO IAC: 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. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines. Other vaccines to prevent COVID-19 may be available under EUA, including bivalent vaccines that contain an Omicron component of SARS-CoV-2. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp/, email cicp@hrsa.gov, or call: 1-855-266-2427. 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. 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. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. Tootypetodrunk on Twitter: "RT @HopeRising19: Canada has just updated In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. 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. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. 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. Ask the Experts: Storage and Handling - immunize.org PACLITAXEL (paclitaxel) This product information is intended only for residents of the United States. This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). 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. This information in the package insert supersedes the storage conditions printed on the vial cartons. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. 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. Horsham, PA: Janssen Biotech, Inc.; 2023. The vaccine must be thawed prior to preparation and . 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. The possible side effects of these vaccines are still being studied. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Apr 25, 2023. See section 3 for vaccine volume and spacing based on age and vaccine formulation. Covid-19 Vaccine Pfizer, Monovalent,5 yr to 11 yr - Drugs.com This week, Frank D'Amelio, chief financial officer at . Vials must reach room temperature before dilution. 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. 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. PDF Immunization Pharmacy Protocol - Oregon The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. 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. Pfizer-biontech Covid-19 Vaccine MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION, REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS, CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA. 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 Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. V-safe also provides dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. CDC Publishes Hidden Pfizer Document With An Admission That Proves 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). AZULFIDINE (sulfasalazine) | Pfizer Medical Information - US The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. 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. It . Do not refreeze. WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? NAME OF THE MEDICINE BNT162b2 [mRNA] 2. 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. 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.
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