After withdrawing a single dose of 0.2 mL of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, administer immediately. Abbreviations: LLOQ = lower limit of quantitation; NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2 nucleoproteinbinding; NT50 = 50% neutralizing titer 50; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or. Non-serious adverse events from Dose 1 through up to 1 month after Dose 3, in ongoing follow-up were reported by 29.1% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 26.3% of placebo recipients. Each 0.3 mL dose of . Currently available information is insufficient to determine a causal relationship with the vaccine. Data have not yet been submitted to FDA on administration of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent at the same time with other vaccines. The safety of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent is based on: The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process. endstream endobj 92 0 obj <>/CIDToGIDMap/Identity/DW 479/FontDescriptor 94 0 R/Subtype/CIDFontType2/Type/Font/W[0 [750 0 278 278 667 722 722 278 722 667 611 778 722 833 611 667 722 667 722 778 722 722 667 333 333 556 556 278 889 333 611 611 278 556 278 556 556 556 611 611 556 389 556 611 278 611 611 333 611 333 611 The Pfizer-BioNTech COVID-19 Vaccine, Bivalent does not contain preservative. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is supplied as a sterile, frozen suspension in multiple dose vials with orange caps and labels with orange borders. The virus that causes COVID-19 changes over time. Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which is supplied in a multiple dose vial with an orange cap and a label with an orange border, should not be used in individuals 12 years of age and older.2, SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS. Alternatively, 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. In the following analyses of Study 3 in participants 5 through 11 years of age (1,518 of whom received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 750 of whom received placebo), 99.5% of participants had at least 30 days of follow-up after Dose 2. Pfizer Bivalent Boosters. The 305 participants greater than 55 years who received a second booster dose with Pfizer-BioNTech COVID-19 received it 5.3 to 13.1 months after receiving the first booster dose and had a median follow-up time of 1.8 months up to a data cutoff date of May 16, 2022. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use to prevent COVID-19 in individuals 5 years of age and older as a single booster dose administered at least 2 months after. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 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 vaccine will be a white to off-white suspension. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. In an analysis of all unsolicited adverse events reported following the second booster dose, through 1 month after the booster dose, those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (n = 1; 0.3%) for the Pfizer-BioNTech COVID-19 Vaccine and (n = 1; 0.3%) for the bivalent vaccine (Original and Omicron BA.1), nausea (n = 1; 0.3%) for the Pfizer-BioNTech COVID-19 Vaccine and (n = 1; 0.3%) for the bivalent vaccine (Original and Omicron BA.1), and malaise (n = 0) for the Pfizer-BioNTech COVID-19 Vaccine and (n = 1; 0.3%) for the bivalent vaccine (Original and Omicron BA.1). People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Booster Dose: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is administered as a single booster dose at least 2 months after: completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine If cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent are received at 2C to 8C (35F to 46F), they should be stored at 2C to 8C (35F to 46F). The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Remember to bring the card when your child returns. 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. Note: Events and use of antipyretic or pain medication were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for intramuscular injection. Bivalent booster elicited approximately 4-fold higher neutralizing antibody titers against Omicron BA.4/BA.5 sublineages compared to the original COVID-19 vaccine in individuals older than 55 years of age . In this study, participants who had completed primary vaccination with a Moderna COVID-19 Vaccine 2-dose series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of 1 of 3 vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine. cases of COVID-19 that result in hospitalization or death. 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. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. Bivalent Vaccine (Original and Omicron BA.1) Administered as a Second Booster Dose. Overall 3,013 participants 6 months through 4 years of age and 3,109 participants 5 through 11 years of age in Study 3 (NCT04816643) and 22,851 participants 12 years of age and older in Study 1 (NCT04380701) and Study 2 (NCT04368728) have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine during the Phase 2/3 blinded placebo-controlled follow-up period. Abbreviations: 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. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the. For the most recent Fact Sheet, please visit www.modernatx.com/covid19vaccine-eua. A booster dose is particularly important for children with an underlying medical condition that places them at high risk of severe illness due to COVID-19. ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Noninferiority of the seroresponse rate to the Omicron BA.1 variant for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met as the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is >-5% (Table 12). 0000006216 00000 n The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. See Overall Safety Summary (Section 6) for additional information. Following the booster dose, the median follow-up time was 2.6 months (range 2.1 to 2.9 months) for Phase 1 participants and 2.6 months (range 1.1 to 2.8 months) for Phase 2/3 participants. 0000008004 00000 n FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. The liquid is a white to off-white suspension and may contain opaque amorphous particles. It is predominantly a respiratory illness that can affect other organs. Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. In an analysis of all unsolicited adverse events reported following the booster dose, through 1 month after the booster dose, in participants 18 through 55 years of age (N = 306), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (n = 16, 5.2%), nausea (n = 2, 0.7%), decreased appetite (n = 1, 0.3%), rash (n = 1, 0.3%), and pain in extremity (n = 1, 0.3%). Study C4591007 (Study 3) is a Phase 1/2/3 multicenter, randomized, dose-finding, open-label (Phase 1) and multinational, saline placebo-controlled, observer-blind, immunogenicity and efficacy (Phase 2/3) study that has enrolled 4,695 participants 5 through 11 years of age, of whom 3109 participants received Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) and 1538 participants received placebo in Phase 2/3. 0000007733 00000 n 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. No. Demographic characteristics in Study 3 were generally similar with regard to age, gender, race, and ethnicity among participants 6 through 23 months of age who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. During the trial, participants aged 18 years and older received either a 30-g or 60-g booster dose (fourth booster) of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted COVID-19 vaccine and . Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. American pharmaceutical company Pfizer and its German partner BioNTech announced Friday that a booster dose of their bivalent COVID-19 vaccine performs better against two circulating versions of the omicron variant, compared with a booster shot of their original vaccine. You can get COVID-19 through contact with another person who has the virus. 0000002134 00000 n Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine, Bivalent vial label. Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not authorized for use in individuals younger than 5 years of age. x L Their median age was 67 years (range 56 through 85 years of age), 53.1% were male and 46.9% were female, 89.8% were White, 14.8% were Hispanic/Latino, 5.2% were Asian, and 4.3% were Black or African American. Symptoms may appear 2 to 14 days after exposure to the virus. The median age of these 401 participants was 8.0 years (range 5 through 11 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native. See this Fact Sheet for instructions for preparation and administration. Tables 1 and 2 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine (10 mcg modRNA) and placebo in participants 5 through 11 years of age. This Fact Sheet may have been updated. The bivalent vaccine (Original and Omicron BA.1) contained 15 mcg of nucleoside-modified messenger RNA (modRNA) encoding the S-glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineage BA.1, for a total of 30 mcg modRNA per dose. Table 1 and Table 2 present the frequency and severity of reported solicited local reactions and systemic reactions, respectively, within 7 days of a second booster dose of Pfizer-BioNTech COVID-19 Vaccine or bivalent vaccine (Original and Omicron BA.1). This includes the Moderna Vaccine Fact Sheet, Pfizer Vaccine Fact Sheet, Pfizer Pediatric Fact Sheet, Janssen Vaccine Fact Sheet, Bivalent Pfizer Booster Fact Sheet, Bivalent Moderna Booster Fact Sheet, information about reporting side effects in V-safe, and Pre-Vaccination Screening Checklist. 0000001429 00000 n 0000003007 00000 n 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. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. Before dilution, mix by inverting vaccine vial gently 10 times. The current COVID-19 vaccines and boosters target the original type of COVID-19 discovered in late 2019. 0000001235 00000 n In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (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. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals 6 years of age and older. Store between 2C to 25C (35F to 77F). COVID-19 vaccines can help protect against severe illness, hospitalization and death from COVID-19. 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