Modification to Contract 75D30120C07986

CDC awarded modification number 00004 to contract number 75D30120C07986 to Westat, Inc., 1600 Research Blvd, Rockville, MD, 20850-3129, on 7 February 2022, in the amount of $23,363,420.00. This notice makes available a Justification and Approval for Other than Full and Open Competition (J&A) that applies to this contract. This contract modification was issued under the authority of FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. Contract 75D30120C07986, "Virtual Network to Investigate COVID-19" has six Objectives and associated Tasks associated with establishing a virtual network of healthcare and public health research systems with integrated medical, laboratory, and vaccination records for the purposes of assessing the epidemiology of mild to severe COVID-19 and evaluating the effectiveness of COVID-19 vaccines in preventing COVID-19 and associated medical burden among children and adults recommended to be vaccinated. This contract modification includes changes in three tasks and the period of performance. CDC requires that the contractor expand the number of patients included in evaluations in order to: (1) assess vaccine effectiveness (VE) among new populations, including children, who are now recommended to be vaccinated and new US regions such as the Southeast and Northeast regions (previously the populations were limited to early vaccine target groups and those in select US regions covered by the existing network sites); (2) compare the preventive benefits of 3rd or booster vaccinations to the original 2-dose vaccination regimens (previously 3rd or booster vaccinations were not available); and (3) assess the extent to which VE may decline due to reduced immunity with time since vaccination and/or changes in the virus variants circulating (previously Delta and Omicron variants as well as 3rd or booster doses were not considered in the study time period previously concluding in September 2022). To accomplish these updated objectives, additional patient data extraction, validation, and management as well as fields of customized data gathering is required. Additionally, these new topics will require additional analysis and reporting beyond what was anticipated in the original contract (reporting will increase from bi-weekly to as frequent as weekly for datasets with new VE measures). The quantity of network sites will increase by up to four (4) additional sites in order to gain the full breadth of new populations. Finally, because the populations recommended for vaccination and their recommended vaccination regimen have changed recently, CDC requires that the contractor extend the study activities an additional study year to conclude 30 September 2023 instead of 30 September 2022. In accordance with the attached J&A, Westat was determined to be the only responsible source capable of providing this modified work. Because Westat has completed all study activities to date, manages subcontracts with existing study sites, and has established systems to conduct all required evaluations, Westat is uniquely qualified to address CDC's expanded tasks and period of evaluation and is the only responsible source who can supply these services. The attached J&A is being made available within 14 days of contract award in accordance with FAR 6.305(a) and will remain active for 30 days in accordance with FAR 6.305(d)(3).