Trump puts pressure on FDA for coronavirus silver bullet ahead of Election Day


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In both his public remarks and through private prodding, Trump has pushed for more good news on the pandemic and has insisted that even developments considered minor by health experts be expanded into major announcements for which he can claim credit.

And he’s looking to the Food and Drug Administration for the biggest one.

That’s a distant cry from earlier this year, when Hahn — the man Trump is now pressuring for a solution to the crisis — wasn’t initially included on his coronavirus task force. When Vice President Mike Pence added a second round of officials to the group, Hahn’s name still wasn’t listed. It wasn’t until five weeks after the group was formed that Hahn was named a formal task force member.

Yet if Hahn was once relegated to the periphery, six months later he finds himself squarely at the center of what officials and experts see as a full-on press to deliver a silver bullet that can end the crisis — and rescue the President’s reelection bid.

Speeding up the vaccine timeline

In meetings focused on vaccine development throughout the spring and summer, Trump has consistently pressed officials to speed up their timeline for developing a vaccine, administration officials said, saying the President appeared intent on being able to deliver at least the solid promise of an effective vaccine by the time he faces reelection.

Those efforts have only scaled up as Election Day nears, and Trump has repeatedly complained that some officials at federal health agencies are actively working to stymie his reelection chances by slow-walking announcements that might project forward momentum.

On calendars peppered with early voting deadlines and presidential debates, some of Trump’s advisers have circled another date amid the frenzied final push to Election Day: October 22, when a once obscure panel of academics and researchers convened by the FDA will weigh “the development, authorization and/or licensure” of a coronavirus vaccine.

It’s unlikely the meeting itself will result in a clear directive, officials said, and the board doesn’t have final say on when or how a vaccine is approved. But the public session could prove critical to achieving what some in Trump’s orbit have dubbed the “holy grail” — a Covid vaccine by Election Day.

Administration health officials continue to insist that no vaccine or treatment will be approved for use — either through full authorization or an emergency use designation — unless it is safe and effective. “No one is pressuring the FDA to do anything,” Trump’s press secretary Kayleigh McEnany said on Thursday.

“This President wants to break through regulatory barriers to get a vaccine as safely to the American people as quickly as possible because lives are at stake, but he will not in any way sacrifice safety in making sure that this is 100% airtight before the American people receive it,” McEnany said.

In reality, government officials and others familiar with the matter describe a more complicated situation, where scientific fact is introduced into a fraught political season and where the President likens any effort to slow down or deny approval for his preferred remedies to a personal attack.

The result has created enormous pressure on the agency that will ultimately determine when a vaccine is approved for use. At some point, the FDA will face a decision on authorizing emergency use of a vaccine before it is formally approved — a move Hahn has repeatedly said is on the table. Many health experts, both inside and outside the agency, say they believe it is likely a vaccine will be approved for limited emergency use, potentially for front-line health care workers, some time in the next several months.

Some officials inside the administration are concerned Hahn, who is described by his colleagues as eager to please, could bend to the intense political pressure coming from the West Wing.

While the independent panel of experts who is meeting on October 22 will weigh in on a decision, its advice is not binding. Hahn has said the group “will give us their guidance on any decision that we make” but has not committed to following their lead.

Some health experts fear that leaves open the possibility the White House will pressure Hahn and Health and Human Services secretary Alex Azar to approve use of a vaccine before Election Day.

The White House pushed back on the idea that politics has come before data.

“Every decision the FDA has made during the Trump Administration has maintained the agencies (sic) gold standard for safety and been data-driven to save lives, and this false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” White House spokesman Judd Deere told CNN in a statement. “President Trump believes all Americans should have access to proven, safe, and affordable treatment options and the rapid research, development, trials, and scientific approvals are emblematic of President Trump’s highest priority: the health and safety of the American people.”

Hahn has also denied he’s under pressure. “I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science. I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment,” he wrote in a Washington Post op-ed in August.

The FDA’s awkward reversals

Already, the FDA has found itself making awkward and embarrassing reversals on coronavirus treatments following intense pressure from the President. But its decision on a vaccine will prove to be the highest-stakes move the FDA makes in recent memory.

Earlier this summer, under pressure from Trump and aides like trade adviser Peter Navarro, the FDA approved an emergency use authorization for hydroxychloroquine, only to rescind it less than two months later after a large study showed “no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation.” The President instead used his personal testimony to tout it, even though he had not tested positive for coronavirus.

Then Hahn was forced to apologize after receiving withering criticism from medical experts who said he oversold the lifesaving benefits of convalescent plasma during a briefing with Trump announcing it had been granted emergency approval. Experts said more data was needed to make a determination and even some of Hahn’s colleagues did not agree with granting the emergency authorization. (Hahn said the decision was made based on data, not politics.)

Hahn’s apology became a news cycle that spanned several days and irritated White House officials who had not cleared the mea culpa beforehand. A person close to the situation said Hahn was torn between protecting his reputation among government scientists and West Wing staffers who believed Hahn had nothing to apologize for.

It also resulted in the removal of a spokesperson who had been placed at the agency only days prior. After announcing her arrival in a sunny memo, Hahn removed Emily Miller from her role as chief spokesperson after she played a role in helping him prepare for the briefing. Because she was a political appointee put at the agency by the White House presidential personnel office, led by Trump’s former body man, Hahn couldn’t fire Miller outright. She remains at the agency in an undefined role.

The ultimate ‘October surprise’?

The push for a vaccine has not been limited to the FDA. Pressure is on at every agency to come up with new announcements over the next two months that could signal the pandemic is nearing an end.

Officials say that although there has not been one explicit edict to provide coronavirus deliverables by Election Day, the implications of the administration’s message are clear. Those involved in the various efforts say it is plainly evident that Trump and his advisers hope to convince voters the pandemic is ending by the time ballots are cast in November.

“Everyone wants this to be over by then, or at least to be able to point to a finish line,” one official involved in the federal response said. “They don’t have to spell it out.”

Other officials placed the push for a vaccine within the Trump administration’s larger approach to the coronavirus pandemic, which has been marked by intense pressure from the top to push optimistic assessments and potential cures, even when the science is lacking.

“There’s not any more undue pressure now versus the way things have been working from the get go,” a federal health official told CNN. “There’s an urgency right now to get the vaccination program up and running.”

The Trump administration is planning for a number of vaccine scenarios, according to the official, which include the possibility of a vaccine as early as late November. Other scenarios include a vaccine by early next year or even as late as the back half of 2021, the official said.

Whether the United States will have a Covid-19 vaccine by October remains “unlikely” but “not impossible,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious diseases, told CNN’s Jim Sciutto on Thursday.

“These are all guesstimates,” Fauci said.

Still, it is clear which scenario the President and his team have set their hopes on. In his speech accepting the Republican National Convention, Trump made the development of a vaccine the centerpiece of a short section on the pandemic, vowing his administration “will produce a vaccine before the end of the year, or maybe even sooner.”

Among the President’s political advisers, a vaccine developed in time for use by November 3 has been referred to alternately as the ultimate “October surprise” and the “Holy Grail” for the President’s reelection prospects, which have suffered badly amid the pandemic and ensuing economic contraction.

As far back as the beginning of August, senior leaders at the US Centers for Disease Control and Prevention were instructed to start helping states with vaccine plans, including a plan on how to help schools. CNN previously reported that the agency was expected to come up with a vaccine plan for schools “in at least four states by October,” according to a senior CDC official.

In a letter this week, the CDC told public health officials around the United States to prepare to distribute a potential coronavirus vaccine as soon as late October — days before Election Day.

The documents do not necessarily mean a vaccine will be available in that timeframe, and National Institutes of Health Director Dr. Francis Collins said he did not interpret the letter to mean the CDC was preparing to jump the gun on a vaccine

“The likelihood of that is pretty low,” Collins told CNN. “This is like the Boy Scout motto, Be Prepared.”

Still, the revelation set off another round of worried criticism that the vaccine process may be politicized.

“Too much of the evidence points to the Trump administration pressuring the FDA to approve a vaccine by Election Day to boost the President’s re-election campaign,” Senate Democratic Leader Chuck Schumer said in a statement on Thursday.

The Association of State and Territorial Health Officials on Thursday called on federal leadership to make safety and not politics a priority when considering the timeline of distributing a Covid-19 vaccine in the United States — and to require the completion of Phase 3 clinical trials.

“The safety and efficacy of vaccines is paramount to protecting the health of the American public and to building confidence in our state and territorial immunization programs,” Dr. Rachel Levine, president of ASTHO, said in a statement.

Three vaccine makers have entered phase three clinical trials, and one — Pfizer — said on Thursday it should have enough data to know if its product works by the end of October. The pharmaceutical giant’s Chairman and CEO, Dr. Albert Bourla, said the ongoing clinical trial for a Covid-19 vaccine has enrolled about 23,000 participants, and some are already getting the second dose of the vaccine.

Pfizer “should be able to have enough events to say if the product works or not” by the end of October, Bourla said, speaking to the International Federation of Pharmaceutical Manufacturers and Associations. “We have already worked on the rest of the file,” he said, meaning if the vaccine is effective, “we are going to start submitting to the FDA.”

While Trump has placed phone calls to some drug industry heads for updates on their progress, including the CEO of Regeneron Pharmaceuticals, which is developing an antibody treatment, his current relationship with the pharmaceutical industry is contentious. While he has repeatedly claimed that major drug executives are coming to the White House for a meeting to discuss a drug pricing initiative he has spearheaded, the industry’s chiefs have denied anything is on the books.

Jared Kushner, the President’s son-in-law and senior adviser, has taken an active role in the administration’s vaccine development effort, including in helping select Moncef Slaoui, the former pharmaceutical executive, to lead Operation Warp Speed.

Officials who have participated in Operation Warp Speed meetings, held regularly at the headquarters of the Department of Health and Human Services in Washington, say the election has not been specifically mentioned by representatives from the White House, which have sometimes included Kushner.

But Kushner and his allies have pressed the team to work quickly to develop the vaccine. His message, along with others close to the President, is that the lengthy timeline used to develop previous vaccines is unacceptable this time around given the dire effects the virus has had on Americans’ health and the US economy.

Trump blames a ‘deep state’

Trump has complained this summer that career officials in his own government are working against him, predicting they would purposely avoid announcing a vaccine until after Election Day. Decrying a “deep state” intent on ousting him, Trump has asked officials in the White House to ensure people who are loyal to him are overseeing the vaccine efforts, people familiar with the conversations said. Sources say Trump has at times blamed the FDA commissioner for this and described career health experts like Fauci as people he “inherited.”

Concerned the FDA was being overly cautious in its public messaging, the White House installed Miller as its chief spokesperson. The move, which came as a surprise to many inside the FDA, was viewed by some career employees as an attempt to exert more political control over the administration’s health efforts.

Trump had previously complained bitterly to aides about some of the FDA’s actions during the pandemic, namely its reversal of authorization for hydroxychloroquine, the anti-malarial that is not proven to treat coronavirus.

Inside the West Wing, some officials have claimed that scientists working at the FDA and the National Institutes of Health are actively working to stymie Trump’s efforts toward developing treatments and a vaccine in order to diminish his chances of reelection.

When word arrived at the White House last month that the FDA was preparing to issue an emergency use authorization on convalescent plasma for treating coronavirus, officials quickly decided that Trump himself should announce it rather than issuing a more standard statement from the agency.

That caught some health officials by surprise because they did not view the authorization as a major development. But after a series of phone calls between Trump’s aides and FDA leadership, it was decided that Hahn would come to the White House briefing room to join Trump for the announcement — even though some other administration health officials, including Fauci and his boss at the NIH, Collins — had raised concerns about it.

Generally NIH is not involved in decision-making at the FDA, according to what Dr. Anand Shah, the FDA’s deputy commissioner for medical and scientific affairs, told CNN in mid-August.

What resulted was an embarrassing debacle. Nearly as soon as Trump and Hahn had delivered the announcement during a much-heralded briefing, questions began to emerge about their claims of efficacy. Hahn ultimately apologized for mischaracterizing how effective plasma treatment is known to be. One medical expert in the administration described his comments as “embarrassingly incorrect.” And this week, a panel of NIH experts said in a statement, “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19.”

If the EUA on plasma is ultimately reversed, it would mark another embarrassment for the FDA.

Read more at CNN.com