In the phase 3 LIBERTY study, the investigational monoclonal antibody, VYD2311, had significantly fewer adverse events than an mRNA COVID-19 vaccine, and it did not blunt vaccine-induced neutralizing titers when the two were given together.
|Articles|February 5, 2020
FDA Issues Emergency Authorization For 2019 Novel Coronavirus Diagnostic
Author(s)Contagion® Editorial Staff
The US Food and Drug Administration has authorized the use of a new diagnostic for 2019 novel coronavirus.
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The US Food and Drug Administration (FDA) has
The Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel was previously only authorized for use in CDC laboratories. The new authorization allows use of the test at any CDC qualified lab in the nation.
An emergency use authorization allows an unapproved medical product to be used in an emergency when there are not adequate and available alternatives already approved.
The diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test. The test can be administered using common methods of collecting respiratory secretions such as oral and nasal swabs.
“A positive test result indicates likely infection with 2019-nCoV and infected patients should work with their health care provider to manage their symptoms and determine how to best protect the people around them. Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information,” FDA officials wrote.
FDA officials noted the January 31 announcement that Alex Azar, Secretary of the US Department of Health and Human Services (HHS) signed a
In a technical
On January 30, WHO
Contagion® will continue to follow the situation and provide updates as the 2019-nCoV response continues.
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