As of April 6, 2021, there are 355 different tests available. Each of these tests have their own regulatory requirements and their own manufacturer directions. Guidance on vaccines can change periodically as well. How is your organization keeping track of the latest information about the test or vaccine you are using?
Below is a high level snapshot of the FDA’s actions on tests and vaccines during a 1-week period (March 31 - April 6, 2021). It should be an indicator of how rapidly the COVID-19 vaccine and testing world can change.
One of the vital pieces of any vaccine and testing strategy implemented by providers, schools, governments, and employers is to ensure that the strategy is nimble enough to take advantage of positive changes to the regulatory environment and resilient enough to address negative changes. But the key is to be able to monitor and identify changes that will effect your strategy!
- April 6, 2021- FDA issues EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System, making it the first serology test authorized for use with a blood sample self-collected at-home. FDA COVID-19 Update
- April 1, 2021 - FDA issues an update to the Moderna vaccine EUA clarifying (i.e. increasing) the number of doses that are allowed to be taken from each of the two types of Moderna vaccine vials. FDA April 1 Moderna Update
- March 31, 2021 - FDA issues EUAs to three existing tests to allow them to be obtained Over-the-Counter (i.e. no prescription required) FDA OTC COVID-19 Testing
As of today, 355 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 258 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 22 antigen tests.