Publications by authors named "Lauren E Roper"

Background: On September 2, 2022, bivalent COVID-19 mRNA vaccines, were recommended to address reduced effectiveness of COVID-19 monovalent vaccines during SARS-CoV-2 Omicron variant predominance.

Methods: Using national pharmacy-based SARS-CoV-2 testing program data from January 15 to September 11, 2023, this test-negative, case-control design study assessed bivalent COVID-19 vaccine effectiveness (VE) against symptomatic infection.

Results: VE against symptomatic infection of a bivalent dose between 2 weeks and 1 month after bivalent vaccination ranged from 46% (95% CI: 38%-52%) for those aged ≥ 65 years to 61% (95% CI 41%-75%) for those aged 12-17 years.

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Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in older adults. In May 2023, two subunit RSV vaccines (Arexvy [GSK] and Abrysvo [Pfizer]) received approval from the U.S.

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Article Synopsis
  • Respiratory syncytial virus (RSV) is a significant cause of respiratory issues and hospitalizations in older adults during fall and winter in the U.S., prompting new vaccination recommendations.
  • For the 2023-2024 season, a single dose of FDA-approved RSV vaccines is now recommended for all adults aged 75 and older, and for those aged 60-74 who are at higher risk for severe RSV.
  • The updated guidelines aim to improve vaccination rates among high-risk groups and include ongoing monitoring of vaccine effectiveness and safety to inform future decisions.
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  • Respiratory syncytial virus (RSV) is a major cause of hospitalization for infants in the U.S., leading to recommended preventative measures like nirsevimab (Bevfortus) for infants and the newly approved RSVpreF vaccine (Abrysvo) for pregnant individuals.
  • The FDA approved the RSVpreF vaccine in August 2023 for administration during weeks 32-36 of pregnancy to help protect infants under 6 months from RSV-related respiratory issues.
  • The CDC's Advisory Committee on Immunization Practices recommends that either the RSVpreF vaccine for mothers or nirsevimab for infants be used to protect against RSV, but not necessarily both for most infants.
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Respiratory syncytial virus (RSV) is a cause of severe respiratory illness in older adults. In May 2023, the Food and Drug Administration approved the first vaccines for prevention of RSV-associated lower respiratory tract disease in adults aged ≥60 years. Since May 2022, the Advisory Committee on Immunization Practices (ACIP) Respiratory Syncytial Virus Vaccines Adult Work Group met at least monthly to review available evidence regarding the safety, immunogenicity, and efficacy of these vaccines among adults aged ≥60 years.

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Article Synopsis
  • - Respiratory syncytial virus (RSV) is the top reason for hospitalizations in U.S. infants, and in July 2023, the FDA approved a new treatment called nirsevimab to help prevent RSV-related lung infections in infants and young kids.
  • - The ACIP has been reviewing nirsevimab's safety and effectiveness since October 2021, and in August 2023, recommended it for all infants under 8 months in their first RSV season and for at-risk children up to 19 months entering their second season.
  • - Nirsevimab is expected to be given mainly from October to March, based on RSV patterns from before the COVID-19 pandemic, and it can significantly
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Respiratory syncytial virus (RSV) is a cause of severe respiratory illness in older adults. In May 2023, the Food and Drug Administration approved the first vaccines for prevention of RSV-associated lower respiratory tract disease in adults aged ≥60 years. Since May 2022, the Advisory Committee on Immunization Practices (ACIP) Respiratory Syncytial Virus Vaccines Adult Work Group met at least monthly to review available evidence regarding the safety, immunogenicity, and efficacy of these vaccines among adults aged ≥60 years.

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  • The CDC has been providing guidelines for COVID-19 vaccine use in the U.S. during the national public health emergency, based on recommendations from the Advisory Committee on Immunization Practices (ACIP).
  • Between August 2022 and April 2023, the FDA approved a bivalent COVID-19 vaccine that targets both the original virus and Omicron BA.4/BA.5 strains for people aged 6 and older, as well as vaccines for younger children and additional doses for high-risk groups.
  • Currently, there are three approved COVID-19 vaccines in the U.S.: the bivalent mRNA Pfizer-BioNTech, the bivalent mRNA Moderna, and the monovalent Novavax, while mon
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Evidence has consistently demonstrated that COVID-19 messenger RNA (mRNA) vaccines are safe when given during pregnancy. COVID-19 mRNA vaccines protect pregnant people and their infants who are too young to receive COVID-19 vaccines. Although generally protective, monovalent vaccine effectiveness was lower during SARS-CoV-2 Omicron variant predominance, in part due to changes in the Omicron spike protein.

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  • On June 18, 2022, ACIP recommended the 2-dose Moderna vaccine for children 6 months-5 years and the 3-dose Pfizer-BioNTech vaccine for those 6 months-4 years based on safety and limited efficacy data.
  • Studies showed that the effectiveness of Moderna's vaccine in children aged 3-5 was 60% two weeks to two months after the second dose, while Pfizer's vaccine for children aged 3-4 had an effectiveness of 31% within two to four months after the third dose.
  • The CDC later expanded vaccine recommendations to include updated bivalent vaccines for children aged 6 months and older on December 9, 2022, to improve protection against current COVID
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  • The Omicron sublineage XBB emerged in the U.S. in August 2022 and became prevalent, representing over 50% of sequenced COVID-19 cases by January 2023.* * Vaccine effectiveness against COVID-19 can differ by variant, and recent data showed that bivalent boosters reduced symptomatic infections by 52% against BA.5 and 48% against XBB/XBB.1.5 in adults aged 18-49.* * Monitoring the effectiveness of COVID-19 vaccines is crucial as new variants arise, and bivalent vaccines are proving to offer additional protection against symptomatic infections caused by these emerging strains.*
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As of October 28, 2022, a total of 28,244* monkeypox (mpox) cases have been reported in the United States during an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), administered subcutaneously as a 2-dose (0.5 mL per dose) series (with doses administered 4 weeks apart), was approved by the Food and Drug Administration (FDA) in 2019 to prevent smallpox and mpox disease (2); an FDA Emergency Use Authorization issued on August 9, 2022, authorized intradermal administration of 0.

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Article Synopsis
  • - The FDA has approved four COVID-19 vaccines for primary series vaccination in the U.S., including options from Pfizer-BioNTech, Moderna, Johnson & Johnson, and Novavax, with dosage recommendations based on age and health status.
  • - To enhance protection amid decreasing vaccine effectiveness against the Omicron variant, the FDA authorized bivalent booster doses for individuals aged 5 and older who completed a primary vaccination series.
  • - The bivalent vaccines from Pfizer-BioNTech and Moderna contain equal mRNA from both the original virus and the Omicron strains, and health authorities recommend that eligible individuals receive the booster at least two months after their last vaccination.
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  • - The NVX-CoV2373 (Novavax) COVID-19 vaccine uses a recombinant spike protein nanoparticle combined with a Matrix-M adjuvant, aiming to protect adults aged 18 and older from COVID-19, with two doses administered three weeks apart.
  • - The FDA granted Emergency Use Authorization for this vaccine on July 13, 2022, and the Advisory Committee on Immunization Practices issued an interim recommendation shortly after its authorization.
  • - The vaccine demonstrated a notable efficacy of 89.6% against symptomatic COVID-19, although rare cases of myocarditis or pericarditis were reported, and further updates on its use are expected as more data emerges.
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  • The FDA granted Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines for young children, allowing 2 doses of Moderna for kids 6 months-5 years and 3 doses of Pfizer for those 6 months-4 years.
  • The ACIP issued interim recommendations for vaccination to help prevent COVID-19, confirming both vaccines met immunobridging criteria by comparing antibody responses in children to those in adults.
  • No significant safety issues were found in the vaccines, and the ACIP noted that the recommendations are provisional and will be updated with new data; vaccination is essential for protecting this age group.
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