The FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date a total of four batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the
On
Testing updates:
As of today, 393 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 281 molecular tests and sample collection devices, 84 antibody and other immune response tests and 28 antigen tests. There are 52 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, five antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
The FDA has authorized 11 antigen tests and three molecular tests for serial screening programs. The FDA has also authorized 557 revisions to EUA authorizations.
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Coronavirus Disease 2019 (COVID-19)
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