Pfizer last week provided additional details about applying for full FDA approval of its COVID-19 shot.
It looks as though the first full approval of a COVID-19 vaccine will happen by January at the latest, according to the typical timeline for new therapies that are considered a priority by U.S. regulators.
“Many of us think it’s a very high priority for them to actually do full approvals for the vaccines that they’ve already authorized,” Dr. Lynn Goldman, an epidemiologist and dean of the Milken Institute School of Public Health at George Washington University, recently told me. “Full approval will not mean that they’re safer, in my view, but because, again, of the communication challenge around the fact that many people are hesitant about taking the vaccine.
iframe.twitter-tweet { width: 100% !important; } However, regulators say that speeding up the approval process, long considered the gold standard in pharmaceutical regulations worldwide, essentially defeats the purpose of getting more people vaccinated.
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