(June 17, 2022), HOJA INFORMATIVA DE VACUNAS PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN PERSONAS DE 5 A 11 AOS 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 One-month after a 30-g booster dose of the bivalent vaccine, Omicron BA.4/BA.5-neutralizing antibody titers increased 13.2-fold from pre-booster levels in adults older than 55 years of age . This type of coronavirus has not 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, Bivalent. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). 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, Bivalent may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. After dilution, 1 vial contains 10 doses of 0.2 mL. COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) participant in the Pfizer-BioNTech COVID-19 Vaccine group vs. 0 (0.0%) in the placebo group. 0000002588 00000 n 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. See this Fact Sheet for instructions for preparation and administration. Additionally, a total of 23 Study 2 (Phase 1) participants (11 participants 18 through 55 years of age and 12 participants 65 through 85 years of age) received a first booster dose of Pfizer-BioNTech COVID-19 Vaccine approximately 8 months (range 7.9 to 8.8 months) after completing the primary series. 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). Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for up to 10 weeks. After dilution, the vial should be held between 2C to 25C (35F to 77F). The duration of protection against COVID-19 is currently unknown. A booster response to the Pfizer-BioNTech COVID-19 Vaccine was demonstrated regardless of the vaccine used for primary vaccination. Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of Pfizer-BioNTech COVID-19 Vaccine for Phase 2/3 participants 5 through 11 years of age. 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, orange caps and labels with orange borders, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccine-eua. Children ages 6-11 years: A 2-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended. In the expansion cohort from Dose 1 through the cutoff date, lymphadenopathy was reported in 6 (0.4%) participants in the Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA) group vs. 3 (0.4%) in the placebo group. In an analysis of Study 3 (Phase 2/3), based on data in the blinded placebo-controlled follow-up period up to the cutoff date of April 29, 2022, 570 participants 6 through 23 months of age who received a 3-dose primary series [386 Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA); 184 placebo] have been followed for a median of 1.3 months after the third dose. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. Currently available information is insufficient to determine a causal relationship with the vaccine. The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, Bivalent and the extent to which such risks and benefits are unknown. If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. 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. Check the vaccine for age . HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES SOBRE LA VACUNA CONTRA EL COVID-19 DE PFIZER-BIONTECH PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN NIOS DE 6 MESES A 4 AOS The Moderna and Pfizer bivalent boosters target two strains of COVID-19 - the original strain of the virus and the most widely-spread Omicron . The carton labels state: For age 5 years to <12 years. had a severe allergic reaction to any ingredient in these vaccines. 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. This Fact Sheet may have been updated. No serious adverse events were reported after the booster dose through the cutoff date. 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. COVID-19 is caused by a coronavirus called SARS-CoV-2. The safety evaluation in Study 2 is ongoing. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you. 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. Fact Sheet for Recipients and Caregivers about FDA-authorized Pfizer BioNTech COVID -19 Bivalent Original and Omicron BA.4/BA.5 for 12 Years of Age and Older. COVID-19 Vaccine, Bivalent may not protect everyone. v8Ygquw8dqu`xp(J\#;p3~~#L? ~'(e2R_V7N3,b)Xt.7Ps;Ic$C}wt For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine, Bivalent used to prevent COVID-19, visit www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427. 0000002134 00000 n In a second group of participants (expansion cohort) with a median of 2.4 weeks follow-up post Dose 2, no serious adverse events were reported that were considered related to vaccination. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.3 months follow-up after Dose 3 were reported by 1.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 2.3% of placebo recipients. 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. 0000033367 00000 n Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) participants have been followed for at least 2 months after the second dose. Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent on the breastfed infant or on milk production/excretion. A single booster dose (0.2 mL) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 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) after the last vaccination or 6 months (serious adverse events) after the last vaccination]. had a severe allergic reaction after a previous dose of the Pfizer-BioNTech COVID-19 Vaccine. For immediate release: September 3, 2022 (22-134) Contact: DOH Communications Bivalent boosters aim to provide better protection from currently-circulating variants of COVID-19. Novavax booster: You may get a monovalent Novavax booster if you are unable or unwilling to receive a Pfizer or Moderna updated (bivalent) COVID-19 booster and you meet the following requirements: You are 18 years of age or older; You completed a COVID-19 vaccine primary series at least 6 months ago; You have not gotten any other booster dose This diluent is not packaged with the vaccine and must be sourced separately. 2-dose series (two doses, given three to eight weeks apart and the Updated Booster for those aged 5 years and older). Pfizer and its partner BioNTech say their new booster contains 15 micrograms each of encoding for the spike protein of the original COVID variant and of the BA.4/BA.5 subvariants of omicron . Superiority of the anti-Omicron BA.1 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 >1. Age and immunocompromised status may play a part in determining eligibility; Moderna bivalent booster vaccine will be available to those 18+, Pfizer bivalent booster vaccine will be available to those 12+. It is predominantly a respiratory illness that can affect other organs. Your child is being offered the Pfizer-BioNTech COVID-19 Vaccine6 or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)7, hereafter referred to as the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. endobj First Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine. 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. If you are eligible for an updated bivalent COVID-19 vaccine booster, the updated booster dose that you receive does not need to be from the same manufacturer that made the vaccine that you received for your primary vaccination or previous booster with a monovalent COVID-19 vaccine. Do not administer Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (see Full EUA Prescribing Information). In participants who received a booster dose, the mean duration of pain at the injection site after the booster dose was 2.4 days (range 1 to 35 days), for redness 2.3 days (range 1 to 12 days), and for swelling 2.3 days (range 1 to 9 days). Monitor Pfizer-BioNTech COVID-19 Vaccine, Bivalent recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html). Do not store vials at -25C to -15C (-13F to 5F). Among the 1,835 participants 2 through 4 years of age who received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine, 49.1% were male and 50.9% were female, 80.1% were White, 14.4% were Hispanic/Latino, 7.1% were multi-racial, 6.9% were Asian, 5.1% were Black or African American, and 0.2% were American Indian/Alaska Native. The safety evaluation in Study 2 is ongoing. 0000008004 00000 n Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or moderate to severe asthma, Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension), Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation), Carton of 10 multiple dose vials: NDC 59267-0565-2, has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart), has a bleeding disorder or is on a blood thinner, is immunocompromised or is on a medicine that affects your child's immune system, has ever fainted in association with an injection, completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or. 3. 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). 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 the Pfizer-BioNTech COVID-19 Vaccine. the most commonly reported local adverse reactions following a second booster dose of the moderna bivalent vaccine were injection site pain (77%), fatigue (55%), headache (44%) and myalgia (40%). 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