White House Pressure For Fast-Tracked Vaccine Collides With Safety Warnings

Reuters: Exclusive: FDA Commissioner Disputes Trump, Says No 'Deep State' Thwarting Vaccine 
The U.S. Food and Drug Administration (FDA) does not harbor “deep state” elements, the agency’s head told Reuters on Monday, rejecting criticism from President Donald Trump that staff there were trying to delay a coronavirus vaccine. Dr. Stephen Hahn said he was completely confident that FDA workers were focused solely on the interests of the American people during the coronavirus pandemic. Without evidence, Trump on Saturday accused members of the so-called “deep state” working within the FDA of complicating efforts to test COVID-19 vaccines in order to delay results until after the Nov. 3 presidential election. (Mason, 8/24)

CNN: Fauci Warns Against Premature Authorization Of Coronavirus Vaccine
Dr. Anthony Fauci on Monday warned against the notion of early emergency use authorization for a potential coronavirus vaccine, explaining that such a step could damage efforts to develop other vaccines. His comments come as White House officials have raised the possibility of an early emergency authorization before late-stage trials are finished, two sources have told CNN. Michael Caputo, the assistant secretary for public affairs at the US Department of Health and Human Services, has denied that there was any effort to fast-track vaccine development for political purposes. (LeBlanc, 8/25)

Reuters: Exclusive: Fauci Says Rushing Out A Vaccine Could Jeopardize Testing Of Others
“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci told Reuters in a phone interview. “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci said. (Steenhuysen and O'Donnell, 8/24)

Politico: AstraZeneca Denies White House Is Fast-Tracking Its Covid-19 Vaccine 
AstraZeneca says it hasn’t talked to the U.S. government about an emergency use authorization for its coronavirus vaccine — a day after news reports that the Trump administration may greenlight the vaccine's use before the election. “It would be premature to speculate on that possibility,” the pharmaceutical company said in a statement. (Roubein, 8/24)

Politico: How Trump’s Win-At-All-Costs Vaccine Strategy Could Backfire
President Donald Trump’s blunt demands that the Food and Drug Administration speed the approval of coronavirus vaccines — before it's clear whether any now in development are effective — threaten to undermine the country’s best hope for ending the pandemic. Rushing out a vaccine without solid proof it works could lead many people to refuse to take it, public health experts warn. Worse still would be cutting corners to distribute a shot that then turns out not to work, leaving people unknowingly vulnerable to the deadly virus. (Owermohle, 8/24)

Stat: Political Newcomer Stephen Hahn Struggles To Protect An FDA Under Siege
Stephen Hahn, a political novice who moved here in December to take over the Food and Drug Administration, has found himself steering his agency through the most tumultuous time in its history. But with almost no institutional knowledge behind him, FDA experts worry he’s flying blind, leaving the agency flailing despite its vital role in the effort to control the spread of Covid-19. (Florko and Facher, 8/24)

Scientific American: 'Warp Speed' COVID-19 Vaccine Efforts Aim For Diverse Volunteers And Long-Lasting Protection
Experts say such trials should also include adequate representation from vulnerable subgroups at high risk from COVID-19, including the elderly, minority racial groups and individuals with underlying health problems. Adding to the challenge, a growing number of people have shown skepticism toward an eventual vaccine. And the trials have to answer key questions about how well human immune systems protect against SARS-CoV-2, the novel coronavirus behind the disease. (Schmidt, 8/25)

The Washington Post: These Are The Top Coronavirus Vaccines To Watch
The worldwide effort to create a vaccine for the novel coronavirus kicked off in January, soon after scientists in China posted online the genome of a virus causing a mysterious pneumonia. Vaccine development usually takes years and unfolds step by step. Experimental vaccine candidates are created in the laboratory and tested in animals before moving into progressively larger human clinical trials. These steps are now overlapping in the race to find a vaccine for a global disease that has killed hundreds of thousands of people. Human testing began in some cases before animal studies were finished. As companies launch small Phase 1 trials intended to establish the correct dose, they already are planning the Phase 3 trials that evaluate whether the vaccines are effective and safe. (Steckelberg, Johnson, Florit and Alcantara, 8/24)

Kaiser Health News: Rather Than Give Away Its COVID Vaccine, Oxford Makes A Deal With Drugmaker
In a business driven by profit, vaccines have a problem. They’re not very profitable — at least not without government subsidies. Pharma companies favor expensive medicines that must be taken repeatedly and generate revenue for years or decades. Vaccines are often given only once or twice. In many parts of the world, established vaccines cost a few dollars per dose or less. Last year only four companies were making vaccines for the U.S. market, down from more than 20 in the 1970s. As recently as Feb. 11, Dr. Anthony Fauci, the government’s top infectious disease expert, complained that no major drug company had committed to “step up” to make a coronavirus vaccine, calling the situation “very difficult and frustrating.” (Hancock, 8/25)