As the pandemic spread widely across communities, it became clear that other populations, including children and pregnant women could also develop severe infections and perhaps die from COVID-19 and its complications.
Although there are numerous registries and studies underway in the overall pediatric and pregnancy perinatal population, many clinical questions remain unanswered in the youngest pediatric subpopulation and also regarding mother-infant pairs.
In order to answer these questions, further data is needed on the natural history and clinical outcomes of COVID-19 specifically in children less than one year old and for pregnant women and their offspring
A data resource able to pull together data from multiple sources such as registries, cohort studies, EHRs, insurance claims data, and pregnancy clinical outcomes following COVID -19 infection, data on newborn/infant clinical outcomes following perinatal exposure and/or developing COVID-19 infection is needed.
This data resource would provide investigators, epidemiologists, regulators, drug developers and other key stakeholders, a single entry point for generating data driven answers to clinical questions in near real time.
On April 29, 2021, the FDA https://www.fda.gov Office of the Commissioner posted the grant funding notice Pediatric and Perinatal COVID-19 Registry with Clinical Trials Optional (RFA-FD-21-035) notice seeking applicants that have developed or have plans to develop a resource that will bring together multiple data sources on pediatric, maternal and perinatal COVID-19 infection.
The award budget is $1,000,000 for year 1 and $1,000,000 for year 2. Eligible applicants include higher education institutions, nonprofits, for-profits to include small businesses, and state, county, city, and Indian/Native American Tribal governments.
The Letter of Intent is due May 21, 2021 with the Application due July 6, 2021
Go to https://grants.nih.gov/grants/guide/rfa-filesRFA-FD-21-035.html#_Section_11.Award_1 for more information.