What does emergency use of a Covid-19 vaccine intent? It’s when regulators allow shots to be provided to sure people while studies of safety and effectiveness are ongoing.
Before any vaccine is permitted in the U.S., it should be reviewed by the Food and Drug Administration, which requires study in thousands of people. Most often, the process to approve a new vaccine can take approximately a decade. But the federal government is the usage of more than a few methods to dramatically speed up the process for Covid-19 vaccines.
Throughout 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 receive the provisional green light in the U.S. are nearly sure to be made to be had under this process, referred to as emergency use authorization.
Instead of the standard requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market so 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 throughout the pandemic.
But the agency has nearly no experience granting emergency use for vaccines and has laid out additional standards it is going to use to make decisions on upcoming Covid-19 shots.
In October, FDA officials told vaccine makers they must have two months of safety follow-up from half of the people enrolled in their studies before requesting emergency authorization. That data is expected to be enough for FDA to allow vaccinations of sure high-risk groups, such as front-line health workers and nursing home residents.
Full approval of a vaccine will likely require six months of safety follow-up in addition to extensive inspections of company manufacturing sites. The leading vaccine makers don’t seem to be expected to total that process until next spring or summer. Only then is the FDA expected to grant full approval, which would allow vaccinations of the general population.
(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)
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