From WSJopinion: If the “emergency” label is holding people back from vaccinations, then there is no higher public-health priority than reassuring Americans that evidence shows the vaccine is safe and saving lives, writes The Editorial Board
Good, if belated, news: The Food and Drug Administration has finally decided to accelerate its effort to review Pfizer ’s Covid-19 vaccine for full approval. The agency disclosed the news last week amid political pressure and consternation that its delay may contribute to vaccine hesitancy.
Pfizer’s messenger RNA vaccine was approved last year under emergency-use authorization, and hundreds of millions of doses have been administered with few negative side effects. You’d think the benefits of the vaccine would prompt the FDA to move fast on full approval. But this is a government agency with bureaucratic rules for everything, and the White House seems not to have pressed the issue until the latest bounce in Covid infections.
The FDA had recently put Pfizer’s application on an accelerated process to offer approval within six months, rather than the typical 10 or more. But officials told the website STAT that the agency will now initiate a “sprint” for final review. Officials said this will mean shifting resources and manpower to the Pfizer review from plant inspections and perhaps reviewing other biologic applications.
President Biden has said he believes full FDA approval for Pfizer’s vaccine could come as early as September or October, which ought to be possible. If the “emergency” label is holding back vaccinations at all, then there is no higher public-health priority than reassuring Americans that the accumulated evidence shows that the vaccine is safe and saves lives.
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