EMERGENCY USE AUTHORIZATION

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.

Please refresh the page if you do not see a player above at that time.] WASHINGTON — President Joe Biden is set to deliver remarks on his administration's Covid-19 response and vaccination efforts following the Food and Drug Administration's decision to fully approve Pfizer and BioNTech's Covid-19 vaccine. The mRNA vaccine, which will be marketed as Comirnaty, was on the U.S. market under an Emergency Use Authorization that was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention. Ahead of the president's remarks, Pentagon spokesman John Kirby said that the Defense Department was preparing updated guidance that requires all service members to receive the Pfizer vaccine.

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

Comparing the two groups, the Sheba study calculated that the vaccine was 47% effective between one and 14 days after inoculation, rising to 85% after 15 to 28 days. He said that despite the vaccine being "amazingly effective," scientists are still studying whether fully vaccinated people can transmit the virus to others. Pfizer says deep-freeze unnecessaryPfizer and BioNTech announced their submission of research data on storage temperatures to the FDA in a joint statement on Friday. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply." The other vaccine approved for use and already widely circulating in the U.S., made by Moderna, also currently requires deep-freeze storage and transport under FDA's usage guidelines.

Here's a look at our Q&A with Dr. Richard Besser, former acting CDC director and president of the Robert Wood Johnson Foundation. The Emergency Use Authorization for Pfizer's vaccine is a tremendous public health milestone. I am encouraged that these national leaders will do their part to lift up science and promote public health guidance. When I was acting director of the CDC at the start of the H1N1 pandemic in 2009, our nation's political leaders followed and promoted public health guidance. Economic support from Congress needs to be an integral part of our public health response.

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?

11/30: Red and Blue Moderna applies for emergency use authorization; White House decorated for the 2020 holidays

The complaint will describe the "retaliatory treatment to which he was subjected by HHS political leadership after raising appropriate science-based concerns about White House pressure on treatment and vaccines related to the COVID-19 pandemic," lawyers Debra Katz and Lisa Banks wrote Thursday. They added that the Trump administration is "making demonstrably false statements about Dr. Dr. Rick Bright seen in an undated photo provided by the U.S. Department of Health and Human Services. A source familiar with Bright's situation said that the Trump administration had been pushing for a nationwide expanded access program that would provide chloroquine with limited physician oversight. The administration settled on Emergency Use Authorization, an FDA authority that allows unapproved medical products to be used in medical emergencies, as a compromise between the two positions, which HHS political leadership directed Bright to implement.