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  1. Aug 31, 2022 · Individuals 12 years of age and older are eligible for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed...

  2. 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 COVID-19 vaccine; or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine The vaccine may not protect everyone.

  3. Mar 14, 2023 · The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose in children 6 months through 4 years of age at least 2...

    • Overview
    • Recommendations for Use of Bivalent COVID-19 Vaccines in Persons Aged ≥6 Years Without Immunocompromising Conditions
    • Recommendations for Use of Bivalent COVID-19 Vaccine for Children Aged 6 Months–5 Years
    • Additional Bivalent COVID-19 Doses for Adults Aged ≥65 Years and for Persons Aged ≥6 Months Who Are Moderately or Severely Immunocompromised
    • Implementation Considerations
    • Reporting of Vaccine Adverse Events
    • References

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    On April 18, 2023, FDA authorized, and on April 20, 2023, CDC recommended a single, age-appropriate bivalent mRNA dose for unvaccinated persons aged ≥6 years without moderate or severe immunocompromise. Previously vaccinated persons without moderate or severe immunocompromise were recommended to receive the vaccine ≥2 months after receipt of any monovalent vaccine dose (Table).

    CDC’s recommendation was based on input from ACIP during public meetings held on February 24, 2023, and April 19, 2023. At these meetings, discussions were guided by clinical trial data demonstrating that bivalent vaccines induce an immune response when administered as a primary series. Immunogenicity data demonstrated that a primary series of an Omicron BA.1-containing bivalent vaccine induced neutralization titers against BA.1 that were approximately 25 times those induced by the original monovalent vaccine†† (5). The percentage of patients reporting solicited systemic and local reactogenicity after receiving the BA.1-containing vaccine was similar to or less than the percentage reporting these reactions after a receipt of a monovalent vaccine.§§ Unsolicited adverse events generally represented illnesses and commonly reported events during infancy and childhood (5).

    CDC recommendations were also guided by ACIP discussions of seroprevalence data indicating that, for most older children, adolescents, and adults, future doses will provide an additional boost after previous infection, previous vaccination, or both. In a March–December 2022 nationwide seroprevalence study conducted among children aged 6 months–17 years, most children and adolescents had evidence of infection-induced immunity; prevalence of infection-induced immunity was highest among persons aged 5–11 and 12–17 years (93%) and lowest among children aged 6–11 months (63%) (6). Most adults also had preexisting antibodies against SARS-CoV-2. In a January–March 2022 seroprevalence study of adult blood donors aged ≥16 years, 96% had evidence of immunity from either previous infection, previous vaccination, or both (7).

    A rare risk for myocarditis and pericarditis has been identified after receipt of monovalent mRNA COVID-19 vaccines, primarily in adolescent and young adult males. Because data are limited, the risk for myocarditis or pericarditis after receipt of a bivalent dose is not known; however, preliminary estimates suggest that the risk is lower than that observed after a second primary series monovalent dose (8). Higher rates of myocarditis have also been associated with a shorter interval between doses (9). Because of the small number of doses administered among adolescent and young adult males, estimating the incidence of myocarditis after a bivalent dose was not possible; however, only a single case of myopericarditis has been observed in the Vaccine Safety Datalink (a postauthorization vaccine safety monitoring system) during the 7 days after receipt of a bivalent dose in a male aged 18–29 years (8).

    During December 2022–April 2023, FDA amended multiple authorizations for bivalent mRNA vaccines for children aged 6 months–5 years. During this period, CDC updated recommendations, with input from ACIP, for children in this age group for use of bivalent doses based on a child’s vaccination history (Table).

    Among children aged 6 months–4 years, either mRNA vaccine may be used; however, all doses administered to a given child must be from the same manufacturer. Among those receiving Moderna vaccine, ≥2 doses are authorized, including ≥1 bivalent vaccine dose. Among those receiving Pfizer-BioNTech vaccine, ≥3 doses are authorized, including ≥1 bivalent vaccine dose.

    Based on FDA authorizations, unvaccinated children aged 5 years are authorized to receive 2 doses of Moderna bivalent vaccine (with 4–8 weeks between doses) or 1 dose of Pfizer-BioNTech vaccine. Children aged 5 years who received 1 or 2 doses of monovalent Moderna vaccine are authorized to receive 1 dose of either the bivalent Moderna or Pfizer-BioNTech vaccine.¶¶ Those who received ≥1 doses of monovalent Pfizer-BioNTech vaccine are authorized to receive ≥1 bivalent Pfizer-BioNTech vaccine doses.

    CDC recommendations for pediatric immunization were guided by ACIP discussion of studies of bivalent vaccine given as a primary series in children, as well as booster doses among adults, demonstrating that a bivalent dose of either Moderna or Pfizer-BioNTech vaccine broadens the immune response in persons who have received a primary series and a previous monovalent booster dose (5). Compared with a monovalent booster dose (based on the ancestral SARS-CoV-2 strain), the immune response to Omicron was superior and that to the ancestral strain was noninferior among bivalent vaccine booster dose recipients. Monovalent booster doses of Moderna COVID-19 vaccines were studied in a clinical trial of 145 children aged 17 months–5 years who had received a Moderna primary series 8–13 months previously. Antibody levels after receipt of the monovalent booster dose in a subset of 56 children without previous SARS-CoV-2 infection were four times higher than were levels after the primary series in 294 young adults (11). Reactogenicity was similar to that observed after receipt of booster doses in other age groups. In a subset of 60 Pfizer-BioNTech pediatric trial participants aged 6 months–4 years who received a single bivalent Pfizer-BioNTech vaccine dose after completion of a 3-dose monovalent primary series, Omicron BA.4/BA.5–specific antibodies were higher compared with those among children who completed the 3-dose primary series of monovalent Pfizer-BioNTech vaccine and did not receive the bivalent booster dose. The bivalent dose was generally well-tolerated, with a lower frequency of postvaccination local and systemic reactions than previously observed in this age group with monovalent doses; no new or concerning safety findings were identified (12).

    In April 2023, FDA granted an EUA for additional bivalent doses for adults aged ≥65 years and for persons aged ≥6 months with immunocompromise. Adults aged ≥65 years have the option to receive 1 additional bivalent vaccine dose ≥4 months after receipt of the most recent bivalent dose (Table). Persons aged ≥6 months who are moderately or severely immunocompromised have the option to receive ≥1 additional bivalent doses ≥2 months after receipt of the most recent bivalent dose and additional bivalent mRNA doses, as indicated, based on individual circumstances and clinical judgment.*** The option to receive ≥1 additional bivalent mRNA vaccine doses may be based on the clinical judgment of a health care provider, a person’s risk for severe COVID-19 because of the presence of underlying medial conditions and age, and personal preference and circumstances.

    CDC made recommendations based on ACIP discussions of VE and clinical epidemiology of COVID-19 among moderately or severely immunocompromised persons and adults aged ≥65 years. Effectiveness of a bivalent vaccine booster dose against hospitalization in adults aged ≥18 years with immunocompromising conditions was 30% (95% CI = 12%–44%) at 7–59 days postvaccination and 31% (95% CI = 4%–50%) at 120–179 days (3). Among adults aged ≥65 years, waning of absolute VE has been noted after receipt of a bivalent dose. Effectiveness of bivalent vaccines against COVID-19–associated emergency department or urgent care encounters among immunocompetent adults aged ≥65 years declined from 61% (95% CI = 57%–64%) 7–59 days after vaccination to 25% (95% CI = 16%–34%) at 120–179 days (3). VE against COVID-19–associated hospitalization declined from 64% (95% CI = 59%–69%) 7–59 days after vaccination to 39% (95% CI = 26%–50%) at 120–179 days (3).

    Before the authorization of a bivalent dose for most persons, 11 mRNA COVID-19 vaccine products were licensed or authorized for use. Authorization of a bivalent dose for most persons reduced the total number of vaccine products to five and eliminated vials that appear similar (i.e., look-alike vials) (13); these recommendations will thereby simplify implementation for COVID-19 vaccine providers. Reducing the number of products will expand providers’ storage space and, in conjunction with the elimination of look-alike vials, might reduce vaccine administration errors.

    The transition from a monovalent primary series to a single bivalent dose for most persons, and additional bivalent doses for populations at higher risk for severe disease, allows the COVID-19 vaccination program to progress toward simpler, more flexible, evidence-based recommendations. COVID-19 vaccination remains critical to protecting against serious consequences of COVID-19, and all persons aged ≥6 months should stay up to date with recommended COVID-19 vaccination, including receiving ≥1 bivalent vaccine dose.

    Adverse events that occur after receipt of any COVID-19 vaccine should be reported to the Vaccine Adverse Event Reporting System (VAERS, https://vaers.hhs.gov or 1-800-822-7967). Vaccination providers are required by FDA to report vaccine administration errors, serious adverse events, cases of myocarditis, cases of pericarditis, cases of multisyste...

    1.Food and Drug Administration. COVID-19 vaccines: COVID-19 vaccines authorized for emergency use or FDA-approved. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2023. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

    2.Rosenblum HG, Wallace M, Godfrey M, et al. Interim recommendations from the Advisory Committee on Immunization Practices for the use of bivalent booster doses of COVID-19 vaccines—United States, October 2022. MMWR Morb Mortal Wkly Rep 2022;71:1436–41. https://doi.org/10.15585/mmwr.mm7145a2 PMID:36355612

    3.Link-Gelles R. COVID-19 vaccine effectiveness updates. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; April 19, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-04-19/05-COVID-Link-Gelles-508.pdf

    4.Link-Gelles R, Weber ZA, Reese SE, et al. Estimates of bivalent mRNA vaccine durability in preventing COVID-19-associated hospitalization and critical illness among adults with and without immunocompromising conditions—VISION Network, September 2022–April 2023. MMWR Morb Mortal Wkly Rep 2023;72:579–88. https://doi.org/10.15585/mmwr.mm7221a3 PMID:37227984

    5.Food and Drug Administration. FDA briefing document: future vaccination regimens addressing COVID-19. Presented at the Vaccines and Related Biological Products Advisory Committee meeting, Silver Spring, MD; January 26, 2023. https://www.fda.gov/media/164699/download

    6.Oliver S. COVID-19 vaccine: considerations for future planning. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; February 24, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-24/COVID-10-Oliver-508.pdf

  4. A booster dose of the BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the FDA for ages 5 years and older and has also been granted marketing authorization in the EU by the European Commission following a positive opinion from the EMA for ages 12 years and older.

  5. Oct 12, 2022 · Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age.

  6. Jan 25, 2023 · Bivalent boosters provided substantial additional protection against severe omicron infection in persons who had previously been vaccinated or boosted, although the effectiveness waned over...

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