How soon could kids ages 5-11 get a COVID vaccine? Possibly by November, but the FDA and CDC must sign off on it.

How soon could kids ages 5-11 get a COVID vaccine? Possibly by November, but the FDA and CDC must sign off on it.

Drugmaker Merck asked U.S. regulators Monday to authorize its pill for treating COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.

It’s a move that has been highly anticipated by pediatricians and many parents as coronavirus cases have risen in that age group.

Pfizer and BioNTech have officially submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their COVID-19 vaccine for children aged 5 to 11.

A negative pressure tent invented at U-M has received emergency use authorization from the FDA.

In a rare weekend press conference, the U.S. Food and Drug Administration (FDA) -- who is responsible for authorizing widespread use of Pfizer’s coronavirus vaccine on Friday -- discussed some of people’s biggest concerns about the vaccine. Amid two recent cases of allergic reactions to Pfizer’s coronavirus vaccine in the U.K., FDA officials addressed concerns about individuals with a history of allergic reactions receiving the vaccine. FDA officials said Saturday that they’ve followed that process when reviewing Pfizer’s vaccine, and they feel confident that it is safe for this age group to receive the shots. During Saturday’s news briefing, officials made it clear that pressure from the White House did not force the FDA to authorize use of the vaccine too early. More: Report: White House to FDA chief: Approve Pfizer vaccine Friday or quit“We’re going to maintain the integrity of the scientific process,” Hahn added.

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. Two doses of the Pfizer-BioNTech vaccine are administered 21 days apart. The primary question was how effectively can the vaccine prevent COVID-19 infection 7 days after the second dose of the vaccine?