Risk factors and sequelae of MIS-C & COVID-19 VE - Modified Work

CDC awarded modification number 00001 to contract number 75D30121C10297 to The Children’s Hospital Corporation, 300 Longwood Ave, Boston, MA, 02115-5724, on 4 February 2022, in the amount of $994,000.00.

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 6.302-2, Unusual and Compelling Urgency, in accordance with the CDC Class Justification for Other than Full and Open Competition – COVID 19 Response. 

As the COVID-19 pandemic has progressed, CDC requires a better understanding of the clinical manifestations and risk factors associated with COVID-19 illness and MIS-C, particularly among children who are hospitalized. CDC also urgently needs to understand vaccine effectiveness (VE) of newly licensed vaccines against COVID-19 as these vaccines roll out, including against emerging variants, among hospitalized children.

The services require the Contractor to: (1) build upon the Network to study COVID-19 and MIS-C in hospitalized children; (2) continue enrollment of patients into the study across multiple United States sites; (3) update and populate the database of study data to incorporate the identified study objectives; (4) continue contributing to the biospecimen repository to facilitate analyses evaluating mechanisms of susceptibility to severe respiratory virus infection; (5) describe the spectrum of clinical manifestations and exposure history of COVID-19 and MIS-C patients; and (6) identify risk factors for severe COVID-19 and MIS-C outcomes.

The services also require the Contractor to conduct research into four study objectives: (1) Risk Factor Study. (2) Rheumatologic/Immunologic Study.  (3) Neurologic /Neurocognitive sequelae Study. And (4) Vaccine Effectiveness (VE) Evaluation.

Purpose of the Modification: It is this 4th Vaccine Effectiveness objective that is currently of critical importance.  No other CDC network has the potential to provide data on vaccine effectiveness in the most recent and youngest authorized group of children, those aged 5-11, that will be considered and incorporated in the upcoming vaccine policy discussions.  The primary focus of this contract modification will be to support enrollment of case and control patients for COVID-19 effectiveness evaluations by increasing the number of cases and controls by up to an additional 1,000 each.

In accordance with the attached J&A, The Children’s Hospital Corporation was determined to be the only responsible source capable of providing this modified work under this contract within the required time period.

The attached J&A is being made available within 30 days of contract award in accordance with FAR 6.305(b) and will remain active for 30 days in accordance with FAR 6.305(d)(3).

Awarded contract 75D30121C10297 to unknown vendor for unknown amount on 2022-02-04.