EXPLAINER: Final steps in US review of COVID-19 vaccine

WASHINGTON (AP) — Pfizer’s COVID-19 vaccine is entering the final phase of review before the U.S. government decides whether to allow millions to get the shots.

The Food and Drug Administration posted a positive review of the Pfizer vaccine on Tuesday and will hold a public hearing on Thursday. Next week, it will do the same thing for Moderna's coronavirus vaccine candidate.

A look at the process:

FDA REVIEW

The agency's scientific review is a key step — not just for the U.S. — but for countries around the world weighing whether to begin using a vaccine. Teams of FDA scientists scrutinize tens of thousands of pages of technical data provided by the companies, focusing on vaccine effectiveness, safety, side effects and the manufacturing process needed to ensure the quality and consistency of the doses.

Up until now, Pfizer and its partner BioNTech had only released minimal results about their vaccine’s safety and performance in company press releases. The details have yet to be reviewed and published in a medical journal.

Unlike most other regulatory agencies worldwide, the FDA reanalyzes raw company data to verify results. FDA Commissioner Stephen Hahn says that careful approach carries weight far beyond the U.S.

“The FDA is known around the world for its rigorous standards for safety and efficacy,” Hahn told The Associated Press. “I think you’ll see with the data we’re going to provide at the meeting that we have done our job.”

VACCINE EXPERT MEETING

Next, a group of about two dozen outside experts weighs in on the FDA’s findings and gives their own assessment. The panelists have expertise in vaccines, infectious diseases and medical statistics. The FDA is not required to follow their advice, though it usually does.

The daylong event also...