About FDA
Health Safety Assessment of Coronaviruses Circulating in Different Populations
Description: Investigate the molecular epidemiology of coronaviruses and define the seroepidemiology and cross-reactivity of circulating human coronaviruses with known human and animal coronaviruses. This is a collaborative effort with CBER.
Definition: Coronavirus is a genus of animal virus belonging to the family of Coronaviridae. Coronaviruses primarily infect the upper respiratory and gastrointestinal tract of mammals and birds. The most publicized human coronavirus is SARS-CoV which causes SARS. Coronaviruses are believed to cause a significant percentage of all common colds in human adults.
Assessing the epidemiology of coronaviruses will increase FDA's public health emergency preparedness to outbreaks and assist in the review of future vaccines developed to treat coronoaviruses.
Public Health Outcome: These studies will increase FDA’s public health emergency preparedness to any possible future coronavirus outbreaks (including SARS or SARS-like infections) and will be highly relevant for the review of future vaccines and diagnostic tests submission.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Standardize real-time RT-PCR (laboratory technique used to generate many copies of a DNA sequence by first assembling the desired DNA sequence from complimentary RNA) and infectivity assays to detect coronavirus and begin to determine if unprocessed vegetables may be potential vehicles for coronavirus zoonotic transmission to humans |
4/30/2010 (8/31/2010) |
Completed | 8/31/2010 |
|
2. Start sample collections from wildlife animals and concurrent coronavirus detection |
5/31/2010 |
Completed | 5/31/2010 |
|
3. Start human sample collections and concurrent coronavirus detection |
9/30/2010 |
Completed | 9/30/2010 |
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4. Continue sample collections from wildlife animals and concurrent coronavirus detection |
9/30/2010 |
Completed | 9/30/2010 |
|
5. Complete research on coronaviruses circulating in different populations |
9/30/2011 |
Completed | 9/30/2011 |
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6. Complete the assessment of research findings |
12/31/2012 |
Completed | 5/19/2011 |
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7. Develop draft technical report/manuscript/publication on results from coronaviruses study |
1/31/2013 |
Completed | 12/7/2011 |
|
8. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publication on coronaviruses circulating in different populations |
2/28/2013 |
On Track | |
|
9. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system |
2/28/2013 |
Not Yet Started | |
|
10. Submit final technical report, manuscript, and/or publication on coronaviruses circulating in different populations to a scientific journal |
4/1/2013 |
Not Yet Started |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
seroepidemiology
study of factors affecting health via blood serum
CBER
Center for Biologics Evaluation and Research
SARS
Severe Acute Respiratory Syndrome
RT-PCR
reverse transcription polymerase chain reaction
RNA
Ribonucleic acid
infectivity assays
test or procedure to determine the components and composition of a substance
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
