Just a couple of days ago, in a recent Op-Ed to the New York Times, renowned Scripps Research investigator Eric Topol posits that the current crop of investigational COVD-19 vaccines—authorized under the U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) status—should be registered by the regulatory body, meaning full regulatory approval for inoculating against SARS-CoV-2.
Although all three investigational vaccine products developed by Pfizer-BioNTech, Moderna and Johnson & Johnson are available via the EUA category, two of them—Pfizer-BioNTech and Moderna—have announced their intention to submit applications to the FDA for full registration, meaning that the companies could market, even advertise these products directly to consumers within the United States.
Why Switch from EUA to Fully Registered?
Topol suggests this move could heighten confidence in the products, which as TrialSite has educated, remain investigational products under the EUA scheme. Additionally, statutory liability waiver comes along with the EUA category. The New York Times has implied that a fully registered product would carry more weight out in the marketplace, and would...
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