Date: 05-Oct-2020

Coronavirus Tracker White House Objects To FDA Vaccine Rules President Trump Treated With Regeneron Antibodies

White House officials are raising objections to the standards the FDA wants to use in evaluating COVID-19 shots, and their disagreements could spell conflict when data start rolling in.

 

With President Donald Trump now in isolation with COVID-19 infection, some are speculating how he'll be treated. Regeneron and Eli Lilly refused to say whether the president might receive one of their experimental antibody cocktails.

Plus, LabCorp has developed a diagnostic test that doesn't need reagents, the RNA extraction agents that have run scarce at times during the pandemic. The worldwide case count passed 34.3 million Friday morning, with more than 1 million reported deaths, according to Johns Hopkins University's COVID-19 dashboard.

Please read below for the latest updates. Daily COVID-19 tracker entries from April 21 through Aug. 11 can be found here. Entries from Jan. 30 through April 20 are here.

UPDATED: Friday, Oct. 2 at 4:31 p.m. ET

Top White House officials appear unlikely to sign off on the FDA's proposed guidelines for deciding the fate of a COVID-19 vaccine, the Wall Street Journal reports. The officials have objected to various points, including a requirement that researchers monitor trial participants for side effects for two months after they receive a shot, the WSJ's sources said. The conflict doesn't bode well for the coming weeks, when late-stage trial data are expected to start rolling in.

Now that the news has sunk in about President Donald Trump's positive COVID-19 test, doctors are making suggestions about potential treatments—and drugmakers aren't talking. Regeneron and Eli Lilly wouldn't tell the New York Times whether Trump might receive their experimental antibodies. Steroids, convalescent plasma, Gilead Sciences' antiviral remdesivir and anti-inflammatories such as Lilly's Olumiant are also possibilities, of course. 

But late Friday afternoon, President Trump's doctor did disclose his treatment—and he was indeed treated with Regeneron's experimental antibody cocktail. He's also taking aspirin and famotidine, aka Pepcid, which is in clinical testing against COVID, but hasn't been proven effective. Then again, Trump may just be using it for heartburn.