TRUMP HAS COVID-19:
President Donald Trump is in quarantine at the White House after testing positive for coronavirus, a revelation that could upend his presidency and the 2020 election.
“Tonight, @FLOTUS and I tested positive for COVID-19,” he tweeted early Friday. “We will begin our quarantine and recovery process immediately. We will get through this TOGETHER!“
Trump has spent months downplaying the dangers of the virus and promoting unproven treatments, such as malaria drug hydroxychloroquine. More recently he has promised that a vaccine will be ready soon, possibly even before the election — a much speedier timetable than his top public health officials. He has also flouted basic precautions, like wearing a mask in public and when he’s near other people.
Trump, at 74 and overweight, is at higher risk for serious complications. Melania Trump, 50, also falls at an age with a greater risk. The virus can have a wide-ranging impact on different people, even at advanced age, from relatively mild symptoms to devastating breathing problems.
The White House physician said in a memo that the president and first lady were “both well“ and that Trump would continue to carry out his duties as president, though he made no mention of symptoms.
Trump’s campaign schedule has been upended. The White House canceled a planned rally set for Friday, and two in Wisconsin this weekend are sure to be scotched as well. His campaign rallies often feature large crowds of supporters tightly packed together, many without masks. He had also resumed indoor campaign events, even though health officials advise against crowded enclosed spaces.
MORE VAX POLITICAL PRESSURE:
This month is critical — to the election, to vaccines, to the pandemic. Health officials and pharmaceutical companies have tried to set realistic timelines for potential Covid-19 shots. The president continues to promise one will be ready in a matter of weeks. Rival Joe Biden questions whether anyone will trust it.
Drugmakers, again, try to distance themselves. Pfizer CEO Albert Bourla sent an internal memo Thursday attempting to reassure staff that the company — quite possibly the only one that could deliver results on a promising shot before the election — will not cave to political pressure.
“Tuesday night I joined the millions of Americans who tuned in to the Presidential debate. Once more, I was disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts,” Bourla said in an email obtained by POLITICO.
Pfizer joined eight other manufactures last month to release an unprecedented joint statement saying they would stick to science.
It’s a bigger hurdle. At the core is the question of whether the public will trust an emergency-authorized vaccine, especially one in the coming weeks.
FDA will not wait for a full application for a coronavirus vaccine in this environment, its vaccine chief Peter Marks said Tuesday. Those who call on the FDA to not use an emergency authorization for a vaccine in this setting
“simply don’t understand the nature of a biologics license application for a vaccine. They underestimate what goes into these,”
Marks said during a reception put on by the Friends of Cancer Research.
“Yes it would be nice to have all of the bells and whistles of a biologic license application,” he said, but FDA intends to make up for what’s missing with enhanced safety monitoring.
We shouldn’t hold our breath for new guidance. As far as the “EUA-plus” guidance that Marks initially said would be released soon, but which the White House took issue with, he added: “The companies know what we’re expecting.”
HHS ENDS ROLE IN REMDESIVIR DISTRIBUTION:
U.S. hospitals can now purchase the coronavirus drug remdesivir directly from commercial distributors, rather than going through states and the U.S. Department of Health and Human Services, Zachary Brennan reports.
The federal government had overseen distribution of the drug since the FDA authorized it for emergency use in May.
That’s changing because there is enough remdesivir to meet demand, John Redd, chief medical officer of the HHS Assistant Secretary for Preparedness and Response, said in a media briefing Thursday. Hospitals are not buying the full amount of remdesivir available to them, which he said was a sign of ample supply.
HHS TEAMS WITH ROCKEFELLER ON SCHOOL TESTING STRATEGY:
HHS and the Rockefeller Foundation announced Thursday they are working together on a pilot program to use Abbott’s BinaxNOW antigen tests to support K-12 school reopenings.
HHS says at least 120,000 of the tests will be distributed to pilot cities Louisville, New Orleans and Tulsa. Rhode Island will also partake as a pilot state.
“This pilot program will generate real-world evidence, and identify best practices and lessons learned, as well as metrics on how to effectively integrate testing into school opening and reopening for K-12 students and teachers,” HHS testing czar Brett Giroir said.
https://www.politico.com/newsletters/prescription-pulse/2020/10/02/trum…
