Vials should be discarded 12 hours after the first puncture. /X8 16 0 R The Pfizer COVID-19 vaccine is the only vaccine available for those under 18. Thank you for taking the time to confirm your preferences. Vaccine expires 12 months after the manufacture date. These NDC codes are not included in CDC Vaccine Code Set files at this time. Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. single dose vials with gray caps and labels with gray borders, and. 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. At this time, there are no plans to distribute product with these NDCs., SARS-COV-2 (COVID-19) vaccine, mRNA, spike protein, LNP, preservative free, 100 mcg or 50 mcg dose, COVID-19, mRNA, LNP-S, PF, 100 mcg or 50 mcg dose, EUA 12/18/2020, 2-dose vaccine. 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. What is an Emergency Use Authorization (EUA)? One vial contains 6 doses of 0.3 mL. 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. Note: Adverse Reactions were collected in the electronic diary (e-diary) from day of vaccination (Day 1) to Day 7 after the booster dose. /X32 31 0 R % Overall, the 401 participants who received a first booster dose of Pfizer-BioNTech COVID-19 Vaccine had a median follow-up time of 1.3 months after the booster dose through the cutoff date. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. /Parent 2 0 R Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. Do : NOT. 9 0 obj Refer to thawing and preparation instructions in the panels below. Should you decide not to receive any of these vaccines, it will not change your standard medical care. It is supplied in single dose and multiple dose vials with gray caps and labels with gray borders. The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. 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. Department of Health & Human Services. 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. 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. In participants who received the bivalent vaccine (Original and Omicron BA.1), the mean duration of injection site pain, redness, and swelling was 2.2 days (range 1 to 12 days), 2.9 days (range 1 to 10 days), and 1.9 days (range 1 to 4 days), respectively. 5 through 11 years. multidose vial ; 10 doses per vial : Requires diluent : {"9L0 endstream endobj startxref 0 %%EOF 851 0 obj <>stream s+YQms`lc07L)FiW,ljQq5QW\l5 p.MMf_V0"J\6k]^Za5LWU+9558uw7ju7aEFrJZ`w@Eh$aE+UrJ]8'{SSNlS0WSks/iW \Wq:bhg?2gYa?p*.mOQr /l//c6nLqF4O? 'W:fk,oU?#;z}]0g1>* @0tQR5u,KINT`7v?P.0J. >> /Pages 2 0 R Information regarding the Novavax vaccine as well as both the EUA Provider Fact Sheet and the EUA Recipient and Caregiver Fact Sheets is now available on the following FDA web site link: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/novavax-covid-19-vaccine-adjuvanted?utm_medium=email&utm_source=govdelivery#additional. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. A carton of 10 vials may take up to 2 hours to thaw in the refrigerator[2C to 8C (35F to 46F)]. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 50 mcg/0.25 mL dosage, for intramuscular use, 100 mcg/0.5 mL for adult 18+ (Same formulation and concentration as EUA product). 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). endobj Multiple Dose Vial Record Date and Time of First Puncture. /X35 33 0 R Among the 12 Phase 1 participants 65 through 85 years of age, the median age was 69 years (range 65 through 75 years of age), 6 were male and all were White and Not Hispanic/Latino. Ultra Cold -90C to -60C (-130F to -76F)*. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). 780 0 obj <> endobj 817 0 obj <>/Filter/FlateDecode/ID[<137FCCBC0F064DD297C5B92622887046><5AED06E853B64B629434803E831759C5>]/Index[780 72]/Info 779 0 R/Length 159/Prev 224236/Root 781 0 R/Size 852/Type/XRef/W[1 3 1]>>stream /Parent 2 0 R EUA for Booster dose of this formulation has ended. /Marked true Bivalent: Gray capped vial with . /ExtGState << There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 0 Adverse reactions following administration of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine or the bivalent vaccine (Original and Omicron BA.1) that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, injection site redness, lymphadenopathy, nausea, malaise, pain in extremity, rash, and decreased appetite (see Full EUA Prescribing Information). These cookies may also be used for advertising purposes by these third parties. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. Single dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 single dose vials. Those participants vaccinated prior to February 22, 2022 provided the safety database (n=401), and had a median safety follow-up of 1.3 months from vaccination through the data cut-off date of March 22, 2022. /X36 34 0 R Get the latest news from the AAP including press statements, the AAP Voices Blog, the Pediatrics OnCall Podcast and more! In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. https://www.cdc.gov/coronavirus/2019-nCoV/index.html, Checkout today's featured content at stacks.cdc.gov. In Study 2, analyses of NT50 1 month after the booster dose compared to 1 month after the primary series in individuals 18 through 55 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after the booster vaccination demonstrated noninferiority for both geometric mean ratio (GMR) and difference in seroresponse rates. This Full EUA Prescribing Information may have been updated. endobj Pfizer-BioNTech COVID-19 Vaccine at least 3 weeks (21 days) after the first dose. All information these cookies collect is aggregated and therefore anonymous. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients. Multiple dose vials should be discarded 12 hours after first puncture. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. /G3 11 0 R Follow good vaccine storage and practices by outlined by the. It appears you are using Internet Explorer as your web browser. The Pfizer COVID-19 mRNA vaccine is approved for those 6 months of age and older. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 participants (1,131 Pfizer-BioNTech COVID-19 Vaccine; 1,129 placebo) were 12 through 15 years of age. Serious and unexpected side effects may occur. A: Yes, the gray cap product will replace the purple cap product. The above NDCs should be retired in systems effective 08/01/2022. 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. California voters have now received their mail ballots, and the November 8 general election has entered its final stage. See Overall Safety Summary (Section 6) for additional information. Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Original And Omicron BA.4/BA.5) Gray Cap EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. The safety evaluation in Study 3 is ongoing. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap. Note: Javascript is disabled or is not supported by your browser. 709 0 obj <>stream 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? /StructTreeRoot 3 0 R Participants were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. 1. /Nums [0 [38 0 R 39 0 R 40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R Please see information to include listed above. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. /X20 20 0 R In an analysis of Study 3 Phase 2/3, based on data up to the cutoff date of September 06, 2021, 2,268 participants [1,518 Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA); 750 placebo] were 5 through 11 years of age. Noninferiority of the anti-Original NT50 for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met, as the lower bound of the 2-sided 95% CI for GMR was >0.67 and the point estimate of the GMR was 0.8 (Table 9). The updated 12-hour timeline from the Fact Sheet supersedes the number of hours printed on vial labels and cartons. After dilution, the vial should be held between 2C to 25C (35F to 77F). g Pfizer-BioNTech COVID-19 Vaccine at least 4 weeks (28 days) after the second dose. Room temperature: Up to 25C (77F). A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 participants 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021. G. For Pfizer vaccine only: thaw, if needed. The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. This is the same total quantity of modRNA per dose as a dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent and as a dose of Pfizer-BioNTech COVID-19 Vaccine authorized for primary vaccination in individuals 12 years of age and older (and previously, but no longer, authorized for booster vaccination in individuals 12 years of age and older). In Study 2, 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]. Native Hawaiian or other Pacific Islander. Supplied in . >> /G23 13 0 R V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. 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. Currently available information is insufficient to determine a causal relationship with the vaccine. Safety surveillance data from the Ministry of Health of Israel on the administration of approximately 700,000 fourth doses of the Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) given at least 4 months after the third dose in participants 18 years of age and older (approximately 600,000 of whom were 60 years of age and older) revealed no new safety concerns. In addition, you can report side effects to Pfizer Inc. at the contact information provided below. Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either: This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in a single dose and multiple dose vial with a gray cap and a label with a gray border, which MUST NOT BE DILUTED PRIOR TO USE. The CPT vaccine product codes are included in the Preview COVID-19 table and the CDC vaccine code sets. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. Each dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent is 0.3 mL [see Dosage and Administration (2.1)]. Contact your local or state public health department. The manufacture date is printed on the vial (gray cap). The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Room temperature: Between 15C and 25C (3F and 77F). Each vial must be thawed before dilution. Please note, Internet Explorer is no longer up-to-date and can cause problems in how this website functionsThis site functions best using the latest versions of any of the following browsers: Edge, Firefox, Chrome, Opera, or Safari. The The FDA issued its initial Emergency Use Authorization for the Moderna COVID-19 vaccine on Friday December 18, 2020. We're 67,000 pediatricians committed to the optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults. The FDA issued its initial Emergency Use Authorization for the Pfizer BioNTech COVID-19 vaccine on Friday December 11, 2020. The efficacy information in participants 12 through 15 years of age is presented in Table 7. Individuals can consult with their health care provider if they have Each vial must be thawed prior to administration. 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. Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be stored at room temperature [8C to 25C (46F to 77F)] for a total of 12 hours prior to the first puncture. /ParentTree 9 0 R Neutralizing antibody titers, as measured by a pseudovirus neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein with D614G mutation, were assessed on Day 1 prior to administration of the booster dose and on Day 15 after the booster dose. /Contents 28 0 R Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. If these steps take close to, cannot attest to the accuracy of a non-federal website. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? This formulation will be available for ordering December 23 The USG will retire the current Pfizer PBS (1170 and 450 packs) ordering and transition to the Pfizer Tris-Adult formulation (300 Minimum Dose Quantity). 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). 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, Bivalent to recipients. In Study 4, a total of 610 participants greater than 55 years of age previously vaccinated with a 2-dose primary series and 1 booster dose of Pfizer-BioNTech COVID-19 Vaccine went on to receive a second booster dose with either Pfizer-BioNTech COVID-19 Vaccine or the bivalent vaccine (Original and Omicron BA.1). Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursDiscard 6 hours after puncturing vial. endorsement by CDC or any of its employees of the sponsors or Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Y/N = yes/no. Their median age was 66 years (range 56 through 87 years of age), 47.5% were male and 52.5% were female, 87.9% were White, 18.7% were Hispanic/Latino, 4.3% were Asian, and 6.2% were Black or African American. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. Primary Series (Monovalent)6 months 5 years: Dark Blue Cap / Magenta Label6-11 years primary series: Dark Blue Cap / Purple Label 12 years and up: Red Cap / Light Blue Label, Updated (Bivalent) Booster 6 years and up: Dark Blue Cap / Gray Border LabelNote: Both 0.25mL (6 11 years) and 0.5mL (12+ years older) doses may be withdrawn from the same multiple-dose vial. Best used for discovery & interchangable words, Recommended to be used in conjunction with other fields, Up-to-Date Info: To find the latest CDC information on this topic go to: /X34 32 0 R /Kids [6 0 R 7 0 R] Pfizer-BioNTech COVID-19 vaccine is preferentially recommended for individuals 12 years up to and including 29 years of age to start and/or complete their primary series. Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%). Booster dose: 30 . It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Only bivalent booster should be administered. May be used to record historic US administration if product is not known. CDC twenty four seven. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines. The Countermeasures Injury Compensation Program. The S-proteins of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 are identical. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. Pfizer-BioNTech COVID-19 Vaccine, Bivalent vials contain a frozen suspension without preservative. 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 (heterologous booster dose) is inferred from the safety of a Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) booster dose administered following completion of Pfizer-BioNTech COVID-19 Vaccine primary series (homologous booster dose) and from data from an independent National Institutes of Health (NIH) study Phase 1/2 open-label clinical trial (NCT04889209) conducted in the United States that evaluated a heterologous booster dose of the Pfizer-BioNTech COVID-19 Vaccine. Allowing the vial to thaw in the refrigerator [2C to 8C (35F to 46F)]. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*, REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS, CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA, Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial with Gray Cap and Label with Gray Border , https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html. 30 mcg/0.3 D9mL for primary series, IC 3rd dose and boosters. Adverse events were assessed through 28 days after the booster dose. /IDTree 10 0 R 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. The vaccine expires on the last day of the 12th month. this reason, some items on this page will be unavailable. PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- bnt162b2 original and omicron ba.4/ba.5injection, suspensionPfizer Manufacturing Belgium NV, FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS). /Tabs /S The duration of protection against COVID-19 is currently unknown. Vaccine expires 12 months after the manufacture date. One serious adverse event of fever (maximum temperature 40.3C) on Day 3 after Dose 2 in a 4-year-old was considered possibly related to vaccination. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) for active immunization to prevent COVID-19 in individuals 12 years of age and older. /ProcSet [/PDF /Text /ImageB /ImageC /ImageI] In the initial enrollment cohort, from Dose 1 through 30 days after Dose 2, lymphadenopathy was reported in 13 (0.9%) participants in the Pfizer-BioNTech COVID-19 Vaccine group vs. 1 (0.1%) in the placebo group. through 4 years. To access the most recent Fact Sheets, please scan the QR code provided below. EUA Fact Sheet for Vaccination Providers (5 through 11 Years), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Orange Cap. This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent. CPT administrative codes for doses are available on the AMA website. Abbreviations: GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoproteinbinding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. 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. The Pfizer-BioNTech COVID-19 Vaccine booster dose was administered 5.3 to 13.1 months (median 6.3 months) after the first booster dose. Information about available alternative vaccines and the risks and benefits of those alternatives. 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. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION3. There are new storage, handling, and administration requirements for Pfizer Tris Sucrose-gray cap: The vaccine may be stored in an ultracold freezer between -90C and -60C (-130F to -76F) >> Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).

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