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U.S. Department of Health and Human Services

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.

Milestone DescriptionMilestone DateMilestone StatusMilestone 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

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

6. Complete the assessment of research findings

12/31/2012

Completed 5/19/2011

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

(FY 2013 Q3)

Completed 4/15/2013

9. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

2/28/2013

(FY 2013 Q3)

(FY 2013 Q4)

Completed 7/31/2013

10. Submit final technical report, manuscript, and/or publication on coronaviruses circulating in different populations to a scientific journal

4/1/2013

(FY 2013 Q3)

(FY 2013 Q4)

Completed 8/1/2013

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

coronaviruses

viruses that infect the upper respiratory and gastrointestinal tracts

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.