•   
  •   
  •   

Politics Meadows to meet with FDA chief as Trump asks about status of vaccine emergency approval

14:15  01 december  2020
14:15  01 december  2020 Source:   cnn.com

Doctors and nurses want more data before championing vaccines to end the pandemic

  Doctors and nurses want more data before championing vaccines to end the pandemic Health-care leaders say they are finding unexpected wariness among medical workers about taking the novel vaccines, based on concerns about President Trump’s politicization of the government’s reviews, their rapid development under Operation Warp Speed, and a lack of information about longer-term safety and effectiveness. Large health systems, medical societies and the federal government are launching an effort to persuade front-line health care providers to take novel vaccines that were developed, and are likely to be granted emergency approval, in record time.

President Trump has called on the Food and Drug Administration to approve a vaccine developed by pharma firm Moderna, after promising In a statement released on Monday, US biotech company Moderna said it would seek American and European emergency approval for its Covid-19 vaccine

Trump also tweeted that many doctors disagree with the FDA ’s decision to revoke its emergency use Sounds familiar: This is the second time in a week that Trump has accused FDA scientists of Despite those efforts, Americans appear wary of a prospective coronavirus vaccine , with nearly 20

White House chief of staff Mark Meadows is scheduled to meet with Food and Drug Administration Commissioner Stephen Hahn in the West Wing Tuesday, as President Donald Trump has privately demanded to know why the agency hasn't granted emergency use for Pfizer's coronavirus vaccine yet, according to two sources.

a man wearing a suit and tie: WASHINGTON, DC - OCTOBER 13: White House Chief of Staff Mark Meadows is seen as Supreme Court nominee Judge Amy Coney Barrett testifies before the Senate Judiciary Committee on the second day of her Supreme Court confirmation hearing on Capitol Hill on October 13, 2020 in Washington, DC. Barrett was nominated by President Donald Trump to fill the vacancy left by Justice Ruth Bader Ginsburg who passed away in September. (Bonnie Cash-Pool/Getty Images) © Bonnie Cash/Pool/Getty Images WASHINGTON, DC - OCTOBER 13: White House Chief of Staff Mark Meadows is seen as Supreme Court nominee Judge Amy Coney Barrett testifies before the Senate Judiciary Committee on the second day of her Supreme Court confirmation hearing on Capitol Hill on October 13, 2020 in Washington, DC. Barrett was nominated by President Donald Trump to fill the vacancy left by Justice Ruth Bader Ginsburg who passed away in September. (Bonnie Cash-Pool/Getty Images)

Meadows summed Hahn for a progress update over the weekend. Hahn requested their meeting happen over the phone, one source said, but was told by the White House that the chief of staff preferred to meet in person. That appears to have led to concern within the FDA that the meeting could become tense, leading Hahn to issue a statement to Axios Monday night defending the FDA's timeline.

Vaccines Won't Stop the Pandemic Unless at Least 50 Million Skeptical Americans Change Their Minds

  Vaccines Won't Stop the Pandemic Unless at Least 50 Million Skeptical Americans Change Their Minds More than four in 10 Americans say they won't get the COVID vaccine when it becomes available. Big problem: Even a highly effective vaccine won't do much to rein in the pandemic if enough people can't be persuaded to get the shot.It would be hard to exaggerate the degree to which experts have been surprised, and relieved, by these preliminary results. Early in the pandemic, conventional wisdom held that the best we could hope for was a slightly better hit rate than seasonal influenza vaccines, which in a good year protect 50 to 60 percent of those inoculated; the Food and Drug Administration set the target for COVID vaccines at a modest 50 percent.

The FDA has used several emergency use authorizations in the pandemic as a way to get many diagnostic tests for Covid-19 more quickly to the market than the agency’s typical approval process. The FDA ’s Hahn reiterated the expectation that any vaccine against the coronavirus strain Covid-19

FDA chief Stephen Hahn is stepping up efforts to convince Americans that his agency won’t sacrifice the safety “ FDA commissioner: No matter what, only a safe, effective vaccine will get our approval ,” read the Asked about the president’s sometimes contradictory statements about the vaccines in

"Let me be clear -- our career scientists have to make the decision and they will take the time that's needed to make the right call on this important decision," Hahn said in the statement.

Pfizer applied for the emergency use authorization November 20. Emergency use authorization from the FDA is not the same as full approval but allows products to be used under particular circumstances before all the evidence is available for approval, according to previous CNN reporting. The FDA has previously said it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech's application for emergency use authorization for a coronavirus vaccine for December 10.

But Trump has become privately frustrated over how long the process is taking, sources told CNN. He has proudly and publicly admitted to pressuring the FDA to move faster.

2021 Pro Football Hall of Fame semifinalists

  2021 Pro Football Hall of Fame semifinalists Take a look at all 25 of the modern-era semifinalists for the Pro Football Hall of Fame class of 2021.

The first potential FDA chief appointee leaked by the Trump transition team is Jim O’Neill. Managing director of Peter Thiel’s Mithril Capital, O’Neill has Instead, he favors “progressive approval ” of drugs and other medical technologies. O’Neill would not be the first FDA head to favor progressive drug

President Trump listens as Stephen Hahn, commissioner of the FDA , speaks during a news briefing Shortly after that, Offit said, Hahn flew back to Washington from Colorado to meet with the president All the vaccine experts Yahoo News spoke with also worried that the public will be wary of a vaccine

"It could have taken four or five years to do this," Trump told reporters about vaccine progress on Thanksgiving. "Normally, it probably would have taken four or five years, just getting it through the FDA. We pushed it very hard."

It's not clear how the meeting between Meadows and Hahn will go until it takes place. A sense of distrust between Trump's closest advisers and career scientists on the FDA already existed before the FDA issued public statements about the meeting Monday night.

"The FDA has been preparing for the review of EUAs for Covid-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted," Hahn said in a statement shortly after Pfizer applied for emergency use authorization for the vaccine in late November. "While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible."

Continuing COVID-19 vaccine trials may put volunteers at unnecessary risk. Is that ethical? .
The success of candidate vaccines by Pfizer/BioNTech and Moderna raises ethical questions about continuing placebo trials in which some may get sick.Is it ethical to give people a placebo when a lifesaving vaccine is available? Should those who received placebos in the first two trials be given preferential access to active vaccine to thank them for their sacrifice?

usr: 0
This is interesting!