Notice of Intent to Sole Source : Respiratory virus surveillance and COVID-19 vaccine effectiveness (VE) in preventing severe COVID-19, multisystem inflammatory syndrome (MIS-C), and related complications in US children.

NOTICE OF INTENT TO SOLE SOURCE. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases (DVD), hereby announces its intent to issue a sole source contract to The Children’s Hospital Corporation, 300 Longwood Ave, Boston, MA 02115-5724. As eligibility of newly authorized and licensed COVID-19 vaccines are expanded to younger age groups, real-world vaccine effectiveness against COVID-related hospitalizations, MIS-C, and associated severe outcomes requires continued monitoring. Continual monitoring is particularly important in the context of future novel SARS-CoV-2 variants, whose emergence could attenuate vaccine effectiveness against pediatric infections and complications. Additionally, as new variants emerge, the trajectory of the pandemic remains unclear and SARS-CoV-2 may co-circulate with influenza, respiratory syncytial virus (RSV), and other respiratory viruses, which cause substantial burden each year. Improving the effectiveness of vaccines to prevent severe acute respiratory illness (ARI) in children associated with SARS-CoV-2 and influenza, as well as MIS-C, is a top priority. With monoclonal antibody products and vaccines in phase 3 development for RSV, there is also an urgent need to establish RSV burden among critically ill children and assess risk factors for severe RSV illness in hospitalized children. The specific goals of this project are to: Evaluate effectiveness of vaccination with authorized SARS-CoV-2 vaccines in use in the United States to prevent COVID-19 and MIS-C hospitalization among children, including evaluation among expanding vaccine-eligible pediatric age subgroups, by race/ethnicity, underlying conditions, coinfections (with other pathogens including influenza), and duration of protection; and effectiveness of vaccination against laboratory-confirmed influenza in hospitalized children. Enroll hospitalized patients with ARI as cases (testing positive for SARS-CoV-2 or influenza, or meeting case definition for MIS-C), or controls (to include negative RT-PCR test results for SARS-CoV-2 or influenza), as well as potential community controls, using a case-control design and routine respiratory viral panel (RVP) testing. Evaluate vaccine effectiveness of SARS-CoV-2 vaccination against COVID-19-associated hospitalization (including MIS-C) by vaccine product and assess the duration of protection of these vaccines. Perform surveillance for severe RSV in hospitalized children by accessing results performed for clinical purposes and collecting clinical information on a sample of RSV patients of varying degrees of severity (i.e., admitted to the medical floor, stepdown unit, and ICU) to assess risk factors for severe disease. Access documented results of SARS-CoV-2, influenza, and RSV testing performed for clinical purposes, and collect and test (by RT-PCR) a subset of respiratory specimens for SARS-CoV-2, influenza, RSV, and other respiratory viruses. Submit all eligible SARS-CoV-2 and a subset of influenza respiratory specimens for sequencing to allow for sentinel genomic surveillance of hospitalized children. Conduct interviews or surveys, medical record reviews, and verify vaccination status of cases and controls. For a subset of inpatients, collect biospecimens (blood and respiratory specimens) from SARS-CoV-2 and influenza positive and negative patients of varying gradients in severity to contribute to a biospecimen repository to facilitate analyses and understanding of severe COVID-19, MIS-C, and influenza, evaluation of virus strains and host immune responses, antibody kinetics, cellular responses, and correlates of protection. Provide analytic dataset (and samples as appropriate) to CDC in a timely manner using data tools that CDC has existing access to (i.e., REDCap) and provide support as needed to CDC with data analysis. The attached Justification and Approval (J&A) and draft Statement of Work have been made available for review. The NAICS code for this acquisition is 541715, Research and Development in the Physical, Engineering, and Life Sciences (medical research and development laboratories or services (except biotechnology and nanotechnology research and development), with a size standard of 1000 employees.