At the end of last month, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
You may have read that some drugs are now “approved” to treat COVID-19, or as the New York Times reported yesterday, that the US Food and Drug Administration (FDA) “approved” the first serology test for COVID-19, or that the dozens of marketed COVID-19 diagnostics are “approved” by FDA.
But in reality, FDA still has not approved any treatment or test for COVID-19 and has instead issued what are known as emergency use authorizations, or EUAs. From an outsider’s perspective, the difference between an approval and an EUA may seem like semantics, but EUAs and full approvals are significantly different.
This didn’t stop the Biden administration to lie even more.
Jen Psaki claimed yesterday that the vaccines are FDA approved.
She just blatantly lied to millions of people. The vaccine has NOT been approved or licensed by the FDA. They need at least two years of trials and data before they license it.
Because it has been released for EUA only, your employer can NOT mandate you get inoculated.
What is the COVID-19 Emergency Use Authorization (EUA)?
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under a EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.