The World Health Organization (WHO) issued emergency use authorization for Johnson & Johnson's coronavirus vaccine, paving the way for the one-shot dose to be used as part of the United Nation's international vaccine distribution effort
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What is an Emergency Use Authorization (EUA)? [ Emergency Use Authorization for Vaccines Explained | FDA ]
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 an 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.[...]
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What Does Emergency Use of a COVID-19 Vaccine Mean? [ What Does Emergency Use of a COVID-19 Vaccine Mean? | Health News | US News ]
What does emergency use of a COVID-19 vaccine mean?
It's when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing.
Before any vaccine is permitted in the U.S., it must be reviewed by the Food and Drug Administration, which requires study in thousands of people. Normally, the process to approve a new vaccine can take about a decade. But the federal government is using various methods to dramatically speed up the process for COVID-19 vaccines.
During a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines and other medical products. The first vaccines to get the provisional green light in the U.S. are almost certain to be made available under this process, known as emergency use authorization.
Instead of the usual requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market as long as their benefits are likely to outweigh their risks. It has already used its emergency powers to authorize hundreds of coronavirus tests and a handful of treatments during the pandemic.[...]
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WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19 [ WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19 ]
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