So you’ve got a vaccine. What next? Presented by

With Zachary Brennan, Rachel Roubein and Susannah Luthi

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Quick Fix


— The U.S. remains far from ready for the monumental task of distributing a coronavirus vaccine to hundreds of millions of Americans.

— Rep. Andy Harris is moonlighting as a board member for a coronavirus trial run by NeuroRx, a company whose CEO has ties to the Maryland Republican.

— HHS will roll out several reforms today designed to boost home dialysis and kidney transplants.

WELCOME TO FRIDAY PULSE — where if President Donald Trump is still looking for ideas on that health care plan of his, a certain ex-HHS secretary appears ready and available to help out. Tips to [email protected] and [email protected].

A message from PhRMA: Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives. More.

Driving the Day

SO YOU’VE GOT A VACCINE. WHAT NEXT? — Developing a viable coronavirus vaccine in record time is one thing. But it’s getting that shot into the arms of millions of Americans that could prove a herculean task, POLITICO’s Rachel Roubein and Dan Goldberg report.

States prepping for the biggest vaccine distribution initiative in decades are already running into a series of logistical and supply chain challenges, any of which could derail Trump’s hopes of quickly allocating a vaccine once it’s approved.

— The project’s price tag: $6 billion. That’s what CDC Director Robert Redfield estimates it will cost to cover supplies, distribution and training — a sum that’s been held up for months amid Hill negotiations over a new round of coronavirus aid.

— CDC has issued an interim playbook in the meantime. But there remain a series of “unknowns and unanswered questions,” the agency said, blanks that won’t be filled in until the government determines which vaccines are ready for approval.

The three candidates in late-stage trials, for example, each have different storage requirements — including one that has to be kept to at least -70 degrees Celsius in an ultra-cold freezer.

— What it means for TRUMP: Even if a vaccine is authorized by Election Day, actually getting it out to Americans is still going to take months — and likely stretch well into 2021.

GOP REP. ANDY HARRIS TO SIT ON COVID-19 TRIAL BOARD — Maryland Republican Andy Harris, a doctor who has broken with the scientific mainstream on masks during the pandemic, is now joining the hunt for coronavirus treatments with an unpaid side gig overseeing a drug company trial, POLITICO’s Zachary Brennan scoops.

Harris is one of three members of the data and safety monitoring board for the trial run by NeuroRX, a small Delaware company whose CEO and founder has longstanding ties to the congressman.

— Harris is not being paid by NeuroRx, nor does he own a stake in the company — and the arrangement doesn’t appear to run afoul of House ethics rules. But several bioethicists questioned his lack of experience evaluating drug trials, and said his ties to NeuroRx CEO Jonathan Javitt could complicate matters if the company’s study faces problems.

— The role is still an unusual one. Former FDA Commissioner Scott Gottlieb told POLITICO he’d never heard of a sitting member of Congress serving on a data monitoring committee for any drug.

Walter Shaub, a former Office of Government Ethics director, said it's “concerning” that Harris is involved with an FDA-regulated company, given he sits on the House appropriations subcommittee that controls the agency’s purse strings.

— Harris dismissed suggestions he’s unqualified. The lawmaker said in a statement that he has a Master of Health Science degree, which involves training in biostatistics.

COMING TODAY: KIDNEY CARE MAKEOVER — The health department is unveiling reforms intended to boost home dialysis and kidney transplants, three individuals familiar with the situation told PULSE.

It's part of the Trump administration's ongoing efforts to overhaul kidney care, a presidential mandate that's been somewhat delayed by the ongoing response to Covid-19. But at the same time, the effects of coronavirus have underscored the need for improving kidney care and increasing the number of potential donors, given that many Covid-19 patients have suffered from kidney failure and needed to go on dialysis.

The U.S. kidney transplant system has been long plagued by delays and other problems that have led to some donated organs being lost in transit or otherwise wasted.

— The rules will finalize several kidney-related proposals, including one known as the ESRD Treatment Choices (ETC) model that sought to steer more patients to get dialysis at home rather than in clinics. Another finalized rule would increase financial support for living organ donors, an effort to encourage people who might be dissuaded by the many current logistical and financial barriers, per the proposal last year.

An impact analysis found that the Trump reforms would boost the supply of available donations. The kidney effort is among the most popular public health initiatives by the administration, with some Democrats signaling their support, although some industry groups have intensely pushed back.

— The health department also is moving forward today with a radiation oncology payment model that would test different payment methodologies for radiotherapy episodes of care, with a hope that the model will help save money while preserving quality.

Inside the Humphrey Building

A CAPUTO-LESS HHS BRACES FOR IMPACT — Michael Caputo spent five months working behind the scenes to influence and politicize HHS’ pandemic response. But shortly after Caputo’s abrupt departure, President Donald Trump in just five minutes accomplished the same thing — and he did it from the White House briefing room, POLITICO’s Adam Cancryn reports.

Health officials are anticipating even greater political pressure on the department in the wake of Caputo’s exit, as Trump bets heavily on delivering a vaccine just days before the Nov. 3 election.

— Officials see Trump’s tussle with ROBERT REDFIELD as an omen. Trump twice contradicted his CDC director on public health matters, including on how long it would take to distribute a vaccine to the wider public. And the president’s allies spent Thursday backing him up, casting doubt on CDC’s expertise and teasing the possibility of a vaccine by October.

— ALEX AZAR is back in the spotlight. The HHS secretary has kept a lower profile since facing intense criticism early in the pandemic. But he’ll be expected to take a more prominent role now in mediating between Trump’s political wishes and a health bureaucracy fearful that the White House will rush a vaccine.

— Caputo is unlikely to return. There is little expectation that he'll be back at HHS after the election. But as part of his medical leave, he’ll retain his salary and medical benefits over the next 60 days.

Coronavirus

EX-PENCE AIDE BLASTS TRUMP OVER COVID RESPONSE — Olivia Troye, a former White House coronavirus task force official and adviser to Vice President Mike Pence, sharply criticized Trump for his handling of the pandemic response in a new ad, and accused him of not caring about the crisis.

Troye’s public break with the administration came after months of working on the Covid-19 response, during which she said she was shocked by Trump’s dismissive attitude and vowed to vote for Joe Biden.

In a Washington Post interview, she warned Americans not to take a vaccine that “launches prior to the election” and said that the White House moved far too slowly to contain the virus.

VACCINE FRONTRUNNERS TARGET YEAR-END VERDICTS — New blueprints from the companies leading the Covid-19 vaccine race suggest it will take until at least December to determine whether one of them has a viable vaccine, Zach reports.

Moderna might not have the necessary data to determine whether its shot works until the last days of the year, while Pfizer might not know until January. Both companies will determine whether their vaccines work based on how many people who received the shots in late-stage trials got sick with Covid-19, compared to those in the placebo group.

— The timeline is later than Trump has suggested. The president has repeatedly promised a vaccine by the end of the year, and predicted one could be ready as early as October.

Pfizer’s blueprint also seemed to contradict recent assertions from the company’s CEO, who previously said there might be enough data by October to show whether its vaccine works. Moderna has also suggested it could seek emergency authorization in October or early November.

STUDY: 2 MILLION NEWLY UNINSURED FROM PANDEMIC — An analysis of new data from the U.S. Census Bureau projects roughly 2 million Americans lost health coverage as a result of the pandemic, POLITICO’s Susannah Luthi reports.

The estimate based on household snapshots from April through most of July falls far short of earlier dire forecasts that warned up to 27 million might lose their insurance. But it spotlights the casualties of a health care system tied to employment in a time of twin health and unemployment crises.

— The upheaval didn’t grow the Obamacare markets. Analysts found no significant surge in Obamacare coverage, signaling that Medicaid and other public coverage has served as the main safety net.

— Latinos made up half of adults who lost workplace coverage, a group that doubles as a high-risk demographic for contracting Covid-19. The analysis also found that nearly all the workers who lost their job-based coverage were men, with well over half of those most affected also having not attended college. Nearly half, meanwhile, live in states that didn’t expand Medicaid.

Providers

SEEMA VERMA WANTS MORE NURSING HOME VISITS — CMS issued new guidance Thursday encouraging nursing homes to facilitate safe outdoor visitation, acknowledging the toll that separation from loved ones has taken on nursing home residents, POLITICO’s Tucker Doherty reports.

The announcement follows reports of a summer wave of deaths due to dementia amid the pandemic, and aligns with recommendations recently made by the Trump administration's independent commission on nursing homes.

“While we must remain steadfast in our fight to shield nursing home residents from this virus, it is becoming clear that prolonged isolation and separation from family is also taking a deadly toll on our aging loved ones,” the CMS administrator said.

A message from PhRMA: America’s biopharmaceutical companies are making great progress against a common enemy – COVID-19. They’re learning from successful vaccines for other diseases, developing new treatments and collaborating like never before. Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives. America’s biopharmaceutical companies are working day and night until they defeat COVID-19. Because science is how we get back to normal.

What We're Reading

More Black women are seeking out midwives as a way to avoid Covid-19 and receive better care than in a health system where they are disproportionately more likely to die of childbirth-related causes than white women, Kaiser Health News’ Rachel Scheier reports.

In Vanity Fair, Katherine Eban recounts how Trump senior adviser Jared Kushner’s insistence on private-market solutions to the pandemic set back the coronavirus response.

Controversial federal guidelines recommending against testing asymptomatic people were not written by CDC scientists and were posted over their objections, The New York Times’ Apoorva Mandavilli reports.