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Pfizer releases data that FDA will be relying on to make decision about granting an emergency use authorization

Vaccine is administered in 2 doses

DETROIT – The data from vaccine-maker Pfizer that the Food and Drug Administration will be relying on to make a decision about an Emergency Use Authorization this Thursday was made public on Tuesday.

The 92-page document and the FDA’s 53-page briefing document are full of details on who received the vaccine and how effective it was.

The summary lays out the demographics for the nearly 38,000 study participants, half of which received the vaccine and half of which receive a placebo. They were largely successful at recruiting a wide range of ethnically and medically diverse populations to conclude that their vaccine is extremely effective across the board.

Two doses of the Pfizer-BioNTech vaccine are administered 21 days apart. By design, 40 percent of those enrolled were older than 55.

The primary question was how effectively can the vaccine prevent COVID-19 infection 7 days after the second dose of the vaccine?

Most of the people, 58 percent, were between 16 and 55 years old. But 21 percent were older than 65. And 82 percent were White and 10 percent were Black. We’re also learning a lot more from this data about the potential side effects.

Watch the video above for the full report.

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About the Authors
Frank McGeorge, MD headshot

Dr. McGeorge can be seen on Local 4 News helping Metro Detroiters with health concerns when he isn't helping save lives in the emergency room at Henry Ford Hospital.

Kayla Clarke headshot

Kayla is a Web Producer for ClickOnDetroit. Before she joined the team in 2018 she worked at WILX in Lansing as a digital producer.

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