White House Objects to FDA Plans on Authorizing Covid-19 Vaccine

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White House Objects to FDA Plans on Authorizing Covid-19 Vaccine

Thomas M. Burton 10 hrs ago

 

 

 

 

 

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White House Objects to FDA Plans on Authorizing Covid-19 Vaccine

 

 

 

 

 

 

© Graeme Jennings - Pool Via Cnp/Zuma Press

Senior White House officials have raised objections to the U.S. Food and Drug Administration’s proposed standards for deciding whether a Covid-19 vaccine should be given widely and don’t appear likely to sign off on the agency’s guidelines, people familiar with the matter said.

In talks with the FDA in recent days, White House officials expressed a number of concerns about the draft guidelines, including a proposal that would require researchers to monitor study subjects for side effects for two months after getting a shot, the people said.

The disagreement could put the administration on a collision course with the FDA over whether and when to authorize use of a Covid-19 vaccine, once the late-stage trials that are testing the shots start providing data—perhaps in as little as a few weeks—on how the injections are performing.

The White House could drop its objections and permit the FDA to publish its guidelines, the people said. Yet so far in talks, administration officials haven’t indicated they would approve the FDA’s proposal or seek to resolve concerns.

A White House spokesperson declined to comment.

 

The White House doesn’t need to approve the guidelines, because they simply indicate the FDA’s thinking, rather than carrying the force of, say, a regulation. Yet the agency often seeks an administration’s stamp of approval so companies and the public will know what goals medicines need to meet in order to be cleared for use. 

The FDA wanted the administration’s blessing in this case to reassure Americans that any vaccines they might be offered would meet high standards, one person familiar with the matter said.

The refusal so far to sign off could reignite concerns that the Trump administration might interfere in science-based decision making at the FDA and pressure the agency to rush out a vaccine for political reasons.

It could also make it harder to persuade many Americans—who polls show are concerned about the safety of the shots—to get one once use is permitted. Health officials say administering safe and effective vaccines widely will be critical to halting the pandemic in the U.S., where nearly 7.3 million have been infected and more than 208,000 people have died from Covid-19.

Companies developing the leading vaccines, seeking to ease public concerns about the shots’ safety, have indicated support for the requirements, saying they wouldn’t seek a shot’s authorization unless it met the kinds of targets that the FDA has laid out. Plans for each of the leading vaccine candidates require they prove at least 50% more effective than placebo during studies, as the agency recommended.

“I’m concerned by the level of micro-management by political forces here. The FDA’s attempt to inform manufacturers and the public should be coming from the scientists at the agency,” said Aaron S. Kesselheim, a Harvard Medical School professor whose research often focuses on the FDA.

At issue in the White House’s dispute with the FDA are the guidelines the agency wants to follow for assessing whether a coronavirus vaccine works safely enough to be widely used.

The FDA typically follows a lengthy approval process for vaccines. But due to the urgent need, the agency sought to establish guidelines that would allow for a much faster review while still ensuring a shot worked safely. Despite that accelerated timetable, the FDA has proposed holding Covid-19 shots to the same rigorous standards it would have used if it conducted a lengthier review, The Wall Street Journal has reported.

The leading vaccine candidates are in the last stage of testing. The trials for shots developed by Moderna Inc. and Pfizer Inc. could start providing some key results by the end of this month or next month, executives at the companies have said.

The administration officials also objected to issuing the guidelines now, since the late-stage trials evaluating whether experimental vaccines work safely could start providing key results in as soon as a few weeks, one of the people said.

Among the White House officials raising concerns were chief of staff Mark Meadows and some high-ranking aides in the Office of Management and Budget, the person said.

Even without the administration’s signoff, the FDA plans to follow its guidelines, the people said. The agency recently sent a letter to major vaccine manufacturers laying out the standards and saying vaccines must meet them in trials to secure authorization, according to the people.

Many of the FDA’s guidelines stuck closely to the requirements the agency planned to follow for a normal review, people familiar with the matter said. For instance, the guidelines call for an experimental vaccine to reduce the rate of infections among people exposed to the coronavirus during a late-stage trial by a statistically significant 50% compared with people getting a placebo, people familiar with the matter said.

The FDA sought to monitor study subjects for side effects for a median of two months following injection because safety issues typically emerge within about six weeks, one of the people familiar with the matter said.

If a vaccine met the standards, the FDA would clear the shot for use during the pandemic through emergency-use authorization, a tool the agency often uses during public-health crises. After the pandemic ended, a vaccine would require a normal approval for continued use.

The agency has followed the emergency authorization process to clear a few Covid-19 therapies, including the antiviral remdesivir. Yet FDA’s the proposed requirements for emergency authorization of a vaccine would make that difficult to issue before Election Day, according to people familiar with the matter.

President Trump has said he would like a vaccine to be available before the election on Nov. 3. He said last month that a shot could be available this fall, hours after the Centers for Disease Control and Prevention Director Robert Redfield said a vaccine might not be widely available until next year.

After details emerged about the FDA’s draft plan for authorizing a vaccine, Mr. Trump said he “may or may not” go along, and said the rigorous standards seemed like “a political move more than anything else.”

He tweeted Sept. 23 about the vaccine process: “@FDA must move quickly.”

In Tuesday’s presidential debate Mr. Trump doubled down on his previous remarks, saying drugmakers had told him vaccines could be widely available before the summer timetable federal health officials had been giving.

 

 

 

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White House gives confusing and incomplete answers about Trump’s health as president says he is ‘feeling well’

Seung Min Kim, Josh Dawsey, Colby Itkowitz 3 hrs ago

 

 

 

 

 

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White House gives confusing and incomplete answers about Trump’s health as president says he is ‘feeling well’

 

 

 

 

 

 

The White House on Saturday created a startling amount of confusion on the status of President Trump’s health and precisely when he contracted covid-19 — issuing conflicting statements and injecting uncertainty into the nation’s understanding of the president’s well-being and whom he and his associates may have exposed to the novel coronavirus.

© Amanda Voisard/for The Washington Post President Trump walks to Marine One on the South Lawn of the White House on Friday en route to Walter Reed Military Medical Center, after testing positive for covid-19.

At a news conference at Walter Reed National Military Medical Center in Bethesda on Saturday morning, Trump’s medical team suggested that the president tested positive for the virus earlier than initially disclosed by the president. Trump’s physician, Sean P. Conley, later issued a “clarification” through the White House on that timeline, as well as the time frame in which the president was administered Regeneron, an antibody cocktail that is part of the complement of drugs Trump has taken to fend off the virus.

Conley also declined to answer specific questions about the president’s health, including how high his fever rose in recent days, when he last tested negative for the virus and whether he was ever administered supplemental oxygen since being diagnosed. A senior administration official later confirmed that Trump was given supplemental oxygen at the White House on Friday before going to Walter Reed.

The questions raised by the news conferences and subsequent comments from White House aides further fueled a credibility problem that has plagued the administration from the start, as the statements only raised more questions about the president’s medical condition.

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For his part, Trump tweeted that he was “feeling well” Saturday afternoon, his first comments of the day hours after his physicians told reporters that the president was in “exceptionally good spirits.” Early Saturday evening, he tweeted out a video where he said that “I came here, wasn’t feeling so well, I feel much better now.” Trump went to Walter Reed on Friday evening, and the White House said he is expected to stay there several days while doctors monitor him.

Saturday evening, a statement from Conley released by the White House press secretary said that Trump has made “substantial progress” since his coronavirus diagnosis and will be closely monitored Sunday in between doses of an experimental drug.

At the Saturday morning news conference, members of Trump’s medical team said the president is now fever-free and that they are “extremely happy” with the progress he has made. But Mark Meadows, the White House chief of staff, then told reporters at the event that Trump went through a “very concerning” period over the past day. Meadows also said the next two days will be key.

“The president’s vitals over the last 24 hours were very concerning and the next 48 hours will be critical in terms of his care,” Meadows said. “We’re still not on a clear path to a full recovery.”

The statement led to confusion, both because of how it was made public and because it seemed to contradict what the president’s doctors said minutes earlier.

The statement from Meadows was originally distributed to the media through a White House pool report and was attributed to “a source familiar with the president’s health.” Two White House officials familiar with the statement, who spoke on the condition of anonymity because they were not authorized to discuss the issue, later said it was Meadows who spoke with reporters. Meadows was also seen on camera pulling reporters aside to talk after the news conference ended. The Associated Press, which had a reporter at the event, also later identified Meadows as the source of the comment.

Meadows, who had stayed with Trump overnight Friday at Walter Reed, did not respond to a request for comment. The chief of staff told other officials on Saturday morning that the president was doing okay, according to White House aides.

Saturday night, in an interview on Fox News, Meadows said that Friday morning, Trump “had a fever and a blood oxygen level that dropped rapidly, and yet, in typical style, this president was up and walking around.”

Trump was angry with Meadows about his Saturday afternoon comments indicating the president was quite sick and has asked aides to reassure the public by offering rosy depictions of his condition, a senior administration official said.

Meadows has been the only White House aide with Trump, giving him almost total control of the message.

[Invincibility punctured by infection: How the coronavirus spread in Trump’s White House]

The comments from the president’s top aide prompted finger-pointing in the West Wing. Some White House officials said they were not pleased with Meadows for briefing reporters anonymously about Trump’s health.

“It was of zero help to us,” said one of them, who, like others, spoke on the condition of anonymity to discuss internal tensions.

A second official said: “We have not communicated with the public well on this.”

Several White House aides also said they also did not have confidence in what they were being told by other officials.

“I can tell you what I am hearing, but I honestly have no idea if it’s right,” said one senior administration official close to the president. “A lot of people aren’t even telling other people in the building the truth.”

Meadows’s stewardship of the White House during the pandemic is also facing some internal criticism after Trump’s diagnosis.

Three different officials said Meadows had not taken the virus seriously enough, not forcing staffers to wear masks and sometimes orchestrating large meetings around the president where officials did not use face coverings.

Inside the building, two of these officials said, he has pushed back against arguments made by doctors and has questioned the science behind masks. He has regularly traveled with extraneous people on Air Force One, the officials said, including his wife and family members.

“He is not someone who preaches that you should be scared of the virus,” one senior administration official said.

The question of transparency surrounding Trump’s health focused on two issues: the public’s right to know about the condition of the commander in chief and to what degree Trump and his aides may have exposed others to the virus who should know so they can tend to their own health.

“Consistency and accuracy on messaging the president’s health condition is important,” said Tom Bossert, the president’s former homeland security adviser. “And we haven’t seen consistency. I can’t speak to accuracy, and neither can you.”

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Trump and his aides traveled frequently during the week and came into contact with many people. Since Tuesday, Trump appeared with thousands at a rally in Minnesota, debated Democratic presidential nominee Joe Biden onstage in Cleveland and met with donors Thursday at his golf club in Bedminster, N.J. He has also interacted with numerous aides, lawmakers and political advisers at the White House and on the road.

These events are potentially venues where the infection could have been spread to others.

“The president should not have attended the fundraiser and placed negligently all the people in attendance at risk of contracting the disease,” Bossert said.

Saturday evening, Trump posted a four-minute video on his Twitter account updating the public on his condition, acknowledging that “we still have steps to go” in his recovery.

Trump said he was given the option to stay at the White House but was told he would be confined to the upstairs presidential residence as he battled the virus — which Trump also referred to as “whatever you want to call it.”

“I can’t do that — I had to be out front,” Trump said. “I can’t be locked up in a room upstairs.”

Meadows’s assessment earlier Saturday of the president’s health was in direct contrast with the evaluation provided by Conley, who said that Trump was doing well, his condition was improving and that his fever had eased. But the doctor wouldn’t provide specific answers about whether Trump has received oxygen, the timeline of the president’s diagnosis or what a lung scan has shown.

Conley was asked several times if and when Trump received supplemental oxygen but provided indirect answers.

“He’s not on oxygen right now,” Conley said. “He’s not needed any this morning. Today at all.”

Conley said the president is receiving daily ultrasounds and lab work, but when asked if scans of his lungs have shown damage, the doctor said he wouldn’t “go into specifics of what the findings are.” The physician also wouldn’t provide an estimated date for the president’s discharge from the hospital.

On a key issue important for determining how many others Trump could have potentially infected, Conley declined to say when the president last tested negative for the virus.

At the beginning of his remarks, Conley said Trump was “just 72 hours into the diagnosis now,” which could mean he was diagnosed as early as Wednesday morning — just 11 hours after he shared a debate stage with Biden, hours before he held a campaign rally in Minnesota and a day before a Thursday fundraiser in New Jersey. Trump revealed his diagnosis at 1 a.m. on Friday only after it was made public that counselor to the president Hope Hicks had contracted the virus.

A “clarification” memo issued under Conley’s name later Saturday said he meant to say Trump was in “day three of his diagnosis,” rather than “72 hours.” Conley also revisited a statement made by another doctor at the Walter Reed news conference, saying the medical team meant “day two” rather than “48 hours” since the administration of a Regeneron antibody cocktail.

In the memo — in which Regeneron was misspelled — Conley said Trump was diagnosed with covid-19 on Thursday evening and received the antibody cocktail on Friday.

The president is receiving remdesivir, an antiviral drug that has shown modest benefits for some people, as well as vitamin D, famotidine, melatonin and aspirin.

The confusion flared as more people close to Trump confirmed over the past two days that they had tested positive for the virus. The latest people infected include Bill Stepien, the president’s campaign manager, and former New Jersey governor Chris Christie, who was closely involved in preparing Trump for the Cleveland debate and was present at the White House over the weekend. Christie said later Saturday that he checked himself into a hospital in northern New Jersey.

Christie adds to the coterie of people known to be diagnosed with the virus who also attended a crowded, celebratory Rose Garden event on Sept. 26 announcing Judge Amy Coney Barrett as Trump’s pick to replace Justice Ruth Bader Ginsburg on the Supreme Court. The others included Trump, first lady Melania Trump, Republican Sens. Thom Tillis (N.C.) and Mike Lee (Utah), and former presidential counselor Kellyanne Conway. University of Notre Dame President John I. Jenkins, and an unidentified member of the White House press corps. Pence and his wife, Karen, tested negative again Saturday for the virus, according to an administration official.

[Rose Garden ceremony attendees who tested positive for coronavirus]

The repercussions of the increasing number of covid-19 cases spread to the Capitol, where Senate Majority Leader Mitch McConnell (R-Ky.) announced Saturday that he was canceling floor votes until Oct. 19 as three GOP senators in recent days announced they had contracted the disease and several others said they would quarantine as a precaution after exposure to people who tested positive.

Aides to Sen. Ron Johnson (R-Wis.) said Saturday that he tested positive for the virus.

Republican leaders emphasized that Barrett’s confirmation hearing will proceed as scheduled on Oct. 12, despite at least two members of the Judiciary Committee testing positive for covid-19 and others quarantining as a precaution. Panel Chairman Lindsey O. Graham (R-S.C.), has said anyone who wants to participate in the confirmation hearing remotely can do so.

Yet Democrats criticized the move and said a position as consequential as an appointment to the Supreme Court deserved a hearing where all senators could be present, and they pressed Graham for a delay.

Elsewhere in Trump’s administration and campaign, it appeared to be business as usual.

The Trump campaign announced that Pence would travel to Arizona, a state that Republicans are scrambling to keep in their column, on Thursday.

The event is scheduled to be held at a facility that makes military tactical gear, and tickets are available to the public. It’s unclear whether the event will be held indoors. The Trump campaign did not immediately respond to several questions about any virus precautions that will be taken, including whether masks or social distancing will be required.

© Amanda Voisard/for The Washington Post President Trump walks to Marine One on the South Lawn of the White House on Friday en route to Walter Reed Military Medical Center, after testing positive for covid-19.

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