COVID-19 Vaccine Storage & Expiry - AAP For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border) Vial Storage Prior to Use. WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? Each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with gray caps and labels with gray borders is 0.3 mL for . PDF Gray Cap Pfizer-BioNTech Bivalent Booster - azdhs.gov What is an Emergency Use Authorization (EUA)? The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. Write "Pfizer-BioNTech COVID-19 Vaccine EUA" as the first line. 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. 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 gray cap and a label with a gray border and MUST NOT be diluted prior to use. Pfizer Gray Cap Transition Plan - Philadelphia 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. o Pfizer-BioNTech (orange cap): persons aged 5-11 years o Pfizer-BioNTech/Comirnaty (purple or gray cap): persons aged 12 years o Moderna: persons aged 18 years o J&J/Janssen: not authorized for use as an additional primary dose o Persons ages 5-11 years currently are not eligible for an additional primary dose. 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). Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion. In Study 2, all participants 12 through 15 years of age, and 16 years of age and older in the reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 5.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 5.8% of placebo recipients. 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. Recipient age: 5 - 11 years. WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? The prevalence of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose. The duration of protection against COVID-19 is currently unknown. The frozen vials may be stored in an ultra-low temperature freezer at -90C to -60C (-130F to -76F) for up to 12 months from the date of manufacture. Do not dilute Pfizer Tris Sucrose-gray cap prior to use. Solicited reactogenicity data in 16 and 17 year-old participants are limited. It is important that the information reported to FDA be as detailed and complete as possible. The possible side effects of these vaccines are still being studied. Pfizer (Purple Cap) Pfizer (Gray Cap) Pfizer (Orange Cap) Moderna (full dose) Moderna (booster dose) Janssen 6 (after dilution) 6 10 (after dilution) 10-11 or 14-15 depending 15 depending on the vial size Maximum of 20 5 0.3 mL 0.3 mL 0.2 mL 0.5 mL 0.25 mL 0.5 mL <>/Font<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 792 612] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 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. 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? 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. Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by: Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. %PDF-1.7 Anyone who placed a full order for Pfizer in Philavax this week will be receiving the new gray cap Pfizer next week. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months of age and older. The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Qs!gt:%4GbB:P[+$C$asU/btERKR|mq7OpsII-iYCF6{Ud\)t2E:7` ##$0r$nn~}&F!1SZLWD10oENy >+N~6\#AL`243 U*`"A92 ( uZ@#4^i82p]&meqQ%((a=`WaCyDLa-1Q*UGm2(&VZ2vF#|X X huZ',D++e6} s*Z|VD8W?S\a* The Purple cap and Gray cap are prepared differently. Talk to your vaccination provider if you have questions. 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. 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. 4 CONTRAINDICATIONS 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 . During the visual inspection. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form. The vaccine elicits an immune response to the S antigen, which protects against COVID-19. 2.0C to 8.0C. . "VQbTv\E!50.K@y$i9N)_G*LJj|JXnj*x}wMuU'`g2| ob nXoy)A;t^En'opVVUn}geMlxZlqN{$>JL'vR:7?.93rw+X? It's now December. No. N Engl J Med), safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. All Purple Cap Pfizer (for ages 12+) has expired and should be disposed of (see the "Spoiled, Wasted and Expired COVID-19 Vaccines" section below for instructions) . Do not pool excess vaccine from multiple vials. 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. Partials order placed via the Monday.com form this week and next week will be Pfizer purple cap. GRAY CAP AND GRAY LABEL BORDER . Pfizer-BioNTech COVID-19 Vaccine formulations authorized for use in individuals 12 years of age and older (each 0.3 mL dose containing 30 mcg modRNA) (gray and purple cap). <> For more information on how to sign up, visit: www.cdc.gov/vsafe. 1 0 obj V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. [ c+Ad!\W{f7`A|rc'R#rubd+7 5)BB d4l^tNwGu"V\.GFiF&DcV-iDGN!t`sw}|TsbaK*|i xL0d(3AAR,"BslUP! During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. Subsequent reporting of follow-up information should be completed if additional details become available. Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine. After mixing, the vaccine should appear as a white to off-white suspension with no visible particles. replace the current formulation (Pfizer purple cap) for people ages 12 and older. A new formulation of Pfizer's Adolescent/Adult COVID-19 vaccine will be transitioned to and replace the current PURPLE cap with PURPLE label border formulation that requires dilution before administration. This new formulation will be referred to as Tris Sucrose Adult or Tris-Adult and will have a GRAY cap with a GRAY label border and DOES . Pfizer vaccine 1170 (with the purple cap) is being retired and a new formulation of Pfizer vaccine for adults/adolescents will be available soon. When you get your first COVID-19 vaccine, you will get a vaccination card. % &fPI)7__?S@!xT lG It is predominantly a respiratory illness that can affect other organs. ?1t; /ztmS/3kSvn5Zbr?4L B? The vial stoppers are not made with natural rubber latex. Comirnaty FDA Approval August 23, 2021. 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. 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). No. If you need additional help submitting a report you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to info@vaers.org. Expiry dates based on 12 months from the date of the manufacture are shown below. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.10. Wondering if the only FDA approved vaccine is out there yet. on 12/23 Gray ap product won [t be available for order until late 12/23 or early 12/24 All order thresholds thereafter will be for the Pfizer Tris-Sucrose Adult product (Gray Cap) a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. 5 through 11 years. 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. 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. Serious and unexpected side effects may occur. Comirnaty (COVID-19 Vaccine, mRNA) - Pfizer Medical Information <> Vials should be discarded 12 hours after first puncture. The new gray cap formulation does not require reconstitution with diluent and will not come with it. Visually inspect each dose in the dosing syringe prior to administration. for thawing or use. The vaccination provider must communicate to the individual receiving the Pfizer-BioNTech COVID-19 Vaccine or their caregiver, information consistent with the "Vaccine Information Fact Sheet for Recipients and Caregivers" prior to the individual receiving Pfizer-BioNTech COVID-19 Vaccine. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Pfizer vaccine 1170 (with the purple cap) is being retired and a new formulation of Pfizer vaccine for adults/adolescents will be available soon. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. To access the most recent Fact Sheets, please scan the QR code provided below. The information in this Full EUA Prescribing Information supersedes the number of hours printed on vial labels and cartons. Adverse reactions following administration of the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, decreased appetite, rash, and pain in extremity (see Full EUA Prescribing Information). Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older who received the primary series and their data contributes to the overall assessment of safety and efficacy [see Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data for EUA (18.1)]. 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)]. Refer to thawing instructions in the panels below. !+3$` 'QeNS.3I(8PRP""VdT.#"@=w &C@& Under the EUA, it is your choice to receive or not receive any of these vaccines. Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. 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. '2127 ',/87( 35,257286( 9ldoodehovdqg fduwrqv pd\ vwdwhwkdw d yldo vkrxog eh glvfdughg krxuv diwhuwkh iluvwsxqfwxuh 7kh lqirupdwlrq lqwklv )dfw6khhw vxshuvhghv wkhqxpehu rikrxuv The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials with gray caps and labels with gray borders. Symptoms may appear 2 to 14 days after exposure to the virus. PFIZER-BIONTECH COVID-19 VACCINE - DailyMed Solicited Local and Systemic Adverse Reactions. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427. For the most recent Fact Sheet, please see www.cvdvaccine.com. These formulations are the Pfizer Pediatric vaccine (Orange cap, ages 5 to 11 year old, diluent required) and the Pfizer Adult/Adolescent Tris (Gray Cap, age 12+, no diluent). See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. x]YoF~Ef^=juwaG{0k]JY%y?j?q#"ILMm\/#(B2xM The Pfizer-BioNTech COVID-19 Vaccine, which is supplied in a multiple dose vial with an orange cap and a label with an orange border, is administered, after dilution, as a primary series of 2 doses (0.2 mL each) 3 weeks apart in individuals 5 through 11 years of age. 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. 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. 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. Vial Cap Color Orange Cap Gray Cap Red Cap Blue Cap Doses Per Vial 10 doses 6 doses 14 doses 5 doses STORAGE CONDITIONS Ultra-Low-Temperature Freezer [-90C to -60C (-130F to -76F)] 12 months2 12 months2 DO NOT STORE AT THIS The vaccine will be a white to off-white suspension. COVID-19: Vaccinator Guidance for Pfizer Vaccine Undiluted vials can be stored up to 9 months in an Ultra Low Temperature (ULT) Freezer -90C to -60C (-130F to -76F). Wondering if the only FDA approved vaccine is out there yet. Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. It was reported that Comirnaty would be available in October or November. SARS-CoV-2 neutralization assay - NT50 (titer). ~G]]Vk?DaMSf)nPw. From an independent report (Kamar N, Abravanel F, Marion O, et al. Advise the recipient or caregiver to read the Vaccine Information Fact Sheet for Recipients and Caregivers. Vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons. This formulation may be stored at 2-8C (36-46 F) for up to 10-weeks, and can be used on individuals 12 years of age and older. 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. Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), 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 0.3% of placebo recipients. <> PDF Pfizer BioNTech COVID-19 Booster Dose Recommendations for 16 - Michigan Updated 4/21/2022: Shelf Life Extension for Pfizer-BioNTech COVID 2 0 obj Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. 242 0 obj <>stream Gray Cap. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. gY+^[0+?|pP&'N verify the final dosing volume of 0.3 mL. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. Pfizer-BioNTech's COVID-19 Vaccine (Gray Cap) CANNOT be stored in the. Factor in remaining inventory of Pfizer 12+ Years (Purple Cap) before placing orders; if Pfizer 1170 order has expired, please create a new order for Pfizer tris-sucrose (12+ years, gray cap) There is a 300-dose minimum order (5 cartons) for Standard Orders Purple cap formulation may still be available through Small Orders 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). The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a gray cap and a label with a gray border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. 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. Do not reconstitute the gray cap Pfizer product. EUA for Booster dose of this formulation has ended. Give as a second dose at least 28 days after first dose if first dose was a different COVID-19 vaccine product. 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. Before use, mix by inverting vaccine vial gently 10 times. Expiration Dating Extension | FDA Procedures should be in place to avoid injury from fainting. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. cases of COVID-19 that result in hospitalization or death. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or https://TIPS.HHS.GOV. Purple cap and Gray Cap vials cannot be used for children younger than 12 years. k&Xg .*SgjcRAgZaACQRQkMbxj+qCccGnFG* 3.{(&0l;\^7Jg. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a gray cap and label with a gray border, which is authorized for use in individuals 12 years of age and older. PDF New Formulation of Pfizer Adolescent/Adult COVID-19 Vaccine 4 0 obj The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is made in the same way as COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine but it also contains an Omicron component to help prevent COVID-19 caused by the Omicron variant of SARS-CoV-2. 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). 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? There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. endobj For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. Gray cap vaccine may be stored at room temperature (8C to 25C/46F to 77F) for a total of 12 hours prior to the first puncture. 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. The Pfizer-BioNTech's COVID-19 Vaccine (Gray Cap) CANNOT be stored In. Pfizer-BioNTech COVID-19 Vaccine At-A-Glance Guidance below summarizes basic storage, preparation, scheduling, administration, and dosage for ALL Pfizer-BioNTech . People ages 12 years and older : Monovalent vaccine (with a gray cap ) Fully approved as a primary series: two doses (0.3 mL), three to eight weeks apart. Adverse Reactions Identified in Post Authorization Experience. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of myocarditis, cases of pericarditis, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine to recipients. Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. The information in this Fact Sheet supersedes the number of hours printed on vial labels and cartons. 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. 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. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 4 0 obj Gray Cap Bivalent. gray cap) ordering will begin on December 23 Pfizer 1170 (Purple Cap) will be unavailable for order after 9a.m.
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