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The Health 202: Getting a coronavirus vaccine approved before Election Day will be impossible

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with Alexandra Ellerbeck

The door was cracked open — although barely — for the Trump administration to clear a coronavirus vaccine before Election Day.

Now, the Food and Drug Administration appears to be slamming it shut.

The agency is expected to release a tough new standard for granting emergency use authorization of a coronavirus vaccine, my colleagues Laurie McGinley and Carolyn Y. Johnson report. It’s an effort to boost Americans’ trust in the vaccine development process, after President Trump repeatedly linked it with his election prospects and Democratic candidates suggested they wouldn’t trust a vaccine developed under his administration.

The FDA is expected to ask vaccine developers to observe participants for months, not weeks.

Two companies — Pfizer and Moderna — are in the process of giving their final-stage trial participants two vaccine shots each, given three or four weeks apart. They’re expected to finish up that process by early October. Johnson & Johnson announced it has also launched a Phase 3 trial of a single-dose vaccine, for which it is planning to manufacture one billion doses next year.

Previously, the idea had been that companies could apply to the FDA for emergency use after observing participants for just a few weeks, assuming enough participants contracted the virus to allow for comparison between those with the vaccine and those with a placebo. Emergency use authorization, known as EUA, is a quicker way to allow limited use of a drug in a dire situation.

Under the anticipated new guidance, the manufacturers would have to follow participants for a median of at least two months after they received a second vaccine shot. 

That requirement almost certainly means December would be the soonest emergency use could be granted — and renders it impossible for manufacturers to request and receive it before Election Day on Nov. 3.

The guidance is far more rigorous than typical requirements for emergency use authorization.

The FDA is expected to say it will require data for a coronavirus vaccine that is closer to what is required for a full approval.

“That’s a higher bar than is typical for an emergency authorization, which requires only that a product ‘may be effective,’ and the likely benefits outweigh the harms,” Laurie and Carolyn write. “The tougher standard is appropriate, officials have said, because a vaccine is given to healthy people, not to those who are ill.”

Under the potential new guidance, not only would manufacturers have to observe participants longer, but they’d also have to observe at least five severe cases of covid-19 in the placebo group for each trial. The idea would be to provide more solid evidence the vaccine works before it can be widely distributed.

Inspiring confidence in a vaccine is a challenge during the frenzied political season.

Federal agencies have been under intense scrutiny and distrust as Trump has promoted unproven treatments and contradicted vaccine timelines laid out by his own appointees.

The FDA granted – and then revoked -- emergency use clearance for hydroxychloroquine, a drug Trump constantly touted throughout the spring despite a lack of evidence it was effective against covid-19.

Another federal health agency, the Centers for Disease Control and Prevention, has come under fire in recent weeks after it was revealed by Politico that Trump appointees tried to interfere with its reports on the coronavirus. Top health officials have vowed there will be no political interference with vaccine development, but administration critics have been fanning flames of doubt.

Democratic presidential nominee Joe Biden has walked a thin line on the matter, saying he doesn’t trust Trump while still stressing he trusts vaccines and the scientists who develop them.

“I trust vaccines, I trust the scientists, but I don't trust Donald Trump,” Biden said last week in Wilmington, Del.

Democrats said the FDA’s reported changes don't satisfy their concerns.

They’ve intensified their drumbeat that the Trump administration is anti-science, casting doubt on the vaccine development process under his administration.

Sen. Patty Murray (Wash.), the ranking Democrat on the Senate Health Committee, said she’s “glad the FDA is planning to release clear standards for granting vaccines an emergency authorization,” calling it “a necessary step to ensure the FDA isn’t jeopardizing the fight against covid-19 by cutting corners.”

But Murray added that she still has “no confidence that HHS and White House officials won’t continue to intervene with our covid response.” She and 31 other Senate Democrats introduced a measure this week that, if passed, would create a task force to investigate political interference at the Department of Health and Human Services.

Federal health officials probably will tout the stricter guidance in a Senate hearing today.

FDA Commissioner Stephen Hahn is scheduled to testify before the Senate Health Committee, alongside Brett Giroir, assistant secretary for health at DHS, CDC Director Robert Redfield and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Republicans will also praise the administration’s work on vaccine development. Committee Chairman Lamar Alexander (R-Tenn.) will call it an “unprecedented sprint to success” in opening remarks shared with The Health 202.

“The program, called Operation Warp Speed, will save lives without cutting corners on safety and efficacy,” his prepared remarks say. “The covid-19 vaccine development process is likely to produce its first tens of millions of doses within one year. The United States has never developed a vaccine this fast before.”

Ahh, oof and ouch

AHH: The United States has passed a grim milestone of 200,000 coronavirus deaths.

“It’s a shame,” Trump said in response to a reporter’s question about the deaths as he left the White House for Pennsylvania on Tuesday evening.

I think if we didn’t do it properly and do it right, you'd have 2½ million deaths,” the president added. He also blamed China for allowing the virus to spread beyond its border.

Trump, who has consistantly downplayed the virus, said in March that if his administration did a good job, the country would see between 100,000 and 200,000 fatalities. On Monday, the president said the virus only affects the elderly and people with other health problems and has little impact on young people. “It affects virtually nobody. It's an amazing thing,” he said.

Sixty-four children under age 15 have died from covid-19, out of the CDC's current tally of 182,000 deaths. That's 0.03 percent of all deaths. Biden attacked Trump for his comments:

A joint statement by the American Medical Association, the American Hospital Association and the American Nurses Association called 200,000 deaths a “sober milestone” and urged Americans to take further steps to stop the spread of the virus.

“Those lost include mothers and fathers, grandparents, children, teachers, and frontline workers. The steps required to stop the spread of this virus should be well known by now, but with more than 6 million COVID-positive Americans, we say again: wear your mask, wash your hands, and practice physical distancing,” the statement said.

A survey of leading scientists in the early days of the pandemic found that experts on average predicted the coronavirus pandemic would kill about 250,000 Americans by the end of the year. Newer projections, however, suggest that many more could die over the fall and winter.

CNN's Ryan Struyk:

The news comes as observers note worrisome increases in cases and test positivity rates across the country, potentially boding a larger wave in cases even as colder weather makes it harder to socially distance. 

Twenty-seven states and Puerto Rico have seen an increase in their seven-day average of confirmed cases compared to the end of August, Joel Achenbach and Karin Brulliard report. Meanwhile, countries such as France, Spain and Israel that had more success controlling the spread of the virus in the early months of the pandemic are now facing new waves of infection.

“It is too soon to know whether a major autumn surge in infections, something long feared among infectious-disease experts, has started on a broad national scale,” Joel and Karin write. “What is certain is that the United States, like so many other nations, remains in a precarious position amid the most disruptive pandemic in more than a century.”

OOF: The Pentagon diverted money meant for masks and swabs to defense contractors.

“A $1 billion fund Congress gave the Pentagon in March to build up the country’s supplies of medical equipment has instead been mostly funneled to defense contractors and used to make things such as jet engine parts, body armor and dress uniforms,” Aaron Gregg and Yeganeh Torbati report.

The Cares Act gave the Pentagon money to “prevent, prepare for, and respond to coronavirus.” At a time when hospitals lack personal protective equipment and states desperately need billions to support distribution of a coronavirus vaccine, the Defense Department instead redirected the money to defense contractors.

The expenditures, documented in public records, contracts and congressional testimony, constitute “a major departure from Congress’s intent” and illustrate the ways that “bailout cash was — in some cases — redirected to firms that weren’t originally targeted for assistance,” Gregg and Torbati write.

The Defense Department said that it sought to balance boosting the medical industry with support for the defense industry, which they consider critical to national security.

After The Post released its report, Congressional Democrats on Tuesday called for an investigation into how the money was used.

Rep. Barbara Lee (D-Calif.):

OUCH: As Medicare loans come due, rural hospitals could be pushed over financial brink.

Medicare offered rural providers a lifeline with loans meant to help hospitals weather the coronavirus pandemic, Kaiser Health News’s Sarah Jane Tribble reports.

“Yet some hospital administrators have called it a payday loan program that is now, brutally, due for repayment at a time when they still need help,” Tribble writes.

Repayments on the loans are technically due 120 days after they are made. The federal Centers for Medicare & Medicaid Services has not yet started recouping its money, but it also hasn’t told hospital administrators if there are plans to adjust the repayment deadline.

This situation leaves many hospitals in a financial lurch, unable to spend any resources that they have on hand. 

Nearly two-thirds of small rural hospitals, many already operating at a deficit before the pandemic, jumped on the Medicare loans. But as the pandemic rages on, many hospitals say they aren’t able to make the payments. If they don’t the government could stop reimbursing them when they treat Medicare patients.

The House Appropriations Committee on Monday included a proposal to extend the amount of time hospitals have to repay the loans in a new government budget, but the American Hospital Association is calling for full forgiveness of the loans.

Election 2020

The Post compiled the presidential candidates' stances on the issues.

When it comes to the coronavirus response, Trump and Biden agree on the some basic policy positions, even while they may disagree on the emphasis or how to go about implementing a policy. Both support increasing testing, reopening schools and fast-tracking a vaccine.

Biden, however, has expressed reservations about whether a vaccine approved by the Trump administration will be safe. The candidates also differ in their approach to schools: While Trump has suggested withholding funding for school districts that don't reopen, Biden has said that districts should make decisions based on local conditions and has called for emergency funding to help schools purchase personal protective equipment.

The candidates differ on other basic policies. Biden has said that he wants to rejoin the World Health Organization and that he would support a national mask mandate, neither of which Trump supports.

The candidates also differ on other health-care issues, most notably the Affordable Care Act.

Trump's administration is supporting a lawsuit that seeks to overturn the health-care law, while Biden has made strengthening the act and adding a public option a centerpiece of his campaign. Biden also supports lowering the Medicare eligibility age to 60.

Coronavirus latest

  • More than 36,500 Latinos have died of the virus, according to an analysis of government data by The Post. In Latino communities, where many workers are classified as “essential” and where access to health care can be limited, especially for the undocumented, the coronavirus has had a devastating toll, Arelis R. Hernández reports.
  • A new report commissioned by Democratic Sens. Robert P. Casey Jr. (Pa.) and Ron Wyden (Ore.) faults the Trump administration for failing to adequately address the spread of the coronavirus in nursing homes. The report, released Tuesday, finds that shortages of personal protective equipment grew more acute in July and August, many months after the toll of the virus in long-term care facilities was already clear, Will Englund reports.
  • A federal judge in Pennsylvania declined to stay his own ruling that Democratic Gov. Tom Wolf’s limits on crowd size are unconstitutional. The judge ruled that the governor failed to show that “imminent and irreparable” harm will occur if limits restricting indoor gatherings to 25 people and outdoor gatherings 250 people are not in place, the Associated Press reports.
  • The CDC gave states until Oct. 16 to submit plans for distributing a coronavirus vaccine, even as it is still unclear if or when a vaccine will be approved, Reuters’s Julie Steenhuysen and Manojna Maddipatla report.

Daybook

Sugar rush

Finland will launch a coronavirus-sniffing dog pilot program at Helsinki Airport on Sept. 23 to detect if travelers are infected. (Video: The Washington Post)
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