HEALTH CARE BRIEFING: Biden Team Crafting Vaccine Logistics Plan

Joe Biden’s advisers are creating plans to distribute a Covid-19 vaccine if he wins on Nov. 3, as his campaign monitors President Donald Trump’s efforts to deliver a drug for signs of political interference, two Biden advisers said.

Biden’s health advisers, many of whom worked under former President Barack Obama, are leveraging longtime relationships with U.S. government officials to keep tabs on Trump’s push to deliver a vaccine in record time, the people said.

The group includes some of the aides who oversaw pandemics and readiness during the Obama administration, many of whom still have contacts within the U.S. government. Among them are Nicole Lurie, the former assistant secretary for preparedness and response under Obama; former Surgeon General Vivek Murthy; and former Food and Drug Administration chief David Kessler.

At the onset of the pandemic in March, Biden assembled a small advisory group of public health and economic experts to keep him up to date on developments and help him craft policy. That group has expanded to dozens as the pandemic persists with the election 49 days away, according to the people.

Developing and distributing a vaccine that could end the coronavirus pandemic and put the world on a path toward economy recovery has emerged as a central issue in the U.S. presidential election. Trump has suggested that a vaccine could be ready before the election, while Democrats including Biden and his running mate Kamala Harris have openly questioned whether Trump intends to meddle in the scientific process.

The Biden aides say distributing a vaccine will be one of the most complicated and challenging tasks the federal government would oversee, and his team is trying to figure out how to get around problems with supply chains that could hamper getting a vaccine to millions of people quickly.

The Biden advisers said they’re talking to as many old colleagues and others as possible who work in career posts at U.S. health and safety agencies who could keep them informed about the government’s push to develop a vaccine, known as Operation Warp Speed. Tyler Pager has more.

Pfizer’s Covid-19 Vaccine Candidate Safe So Far: Also in coronavirus vaccine developments, researchers monitoring Pfizer’s giant trial of its candidate have reported no safety problems even after over 12,000 people received a second dose. “There has been no safety signal reported,” said Mikael Dolsten, Pfizer’s chief scientific officer, in a virtual meeting with investors. Robert Langreth and Riley Griffin have more.

• Meanwhile, AstraZeneca’s vaccine study remains paused in the U.S. pending a regulatory review of an incident in which a U.K. trial participant became ill, U.S. officials said. The British drugmaker and Oxford University put research into the vaccine on hold last week after the volunteer suffered neurological symptoms. Trials resumed in Britain over the weekend and also restarted in South Africa this week. Read more from Riley Griffin.
• Related: Trump Says Coronavirus Vaccine May Be Ready Within Four Weeks

FDA Releases Performance Data on Virus Tests: The U.S. Food and Drug Administration released performance data last night for more than 55 Covid-19 diagnostic tests, in an effort to help doctors, labs and patients evaluate competing products. There are more than 100 tests on the market for Covid-19. Read more from Emma Court.

More on the Pandemic:

• Rewarding Medicaid Doctors for Care a ‘Silver Lining’ of Crisis
• Children of Color, Like Adults, at Higher Risk of Death Due to Virus
• Siemens Healthineers, CDC Developing Covid Antibody Standards
• Nine Out of 10 Teachers Purchased PPE for Themselves, Students
• Abivax Turns Away Suitors as Lead Drug Starts Coronavirus Tests
• BioNTech Gets $445 Million in German Funding for Covid Vaccine
• Carnival’s Ruby Princess Docked, Then Spread Covid to the World

Happening on the Hill

Pelosi, Schumer Seek Probe of ICE’s Alleged Surgical Abuses: Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Chuck Schumer (D-N.Y.) want the inspector general at the Homeland Security Department to investigate a whistle-blower complaint accusing a detention center for U.S. Immigration and Customs Enforcement of performing mass hysterectomies on migrant women. If true, the surgical procedures would amount to a “staggering abuse of human rights,” Pelosi said. Read more from Megan Howard.

Schumer Wants Azar to Resign: Also yesterday, Schumer said that Health and Human Services Secretary Alex Azar should resign following reports that President Donald Trump‘s appointees attempted to interfere with the CDC’s scientific coronavirus reports. Schumer, in opening floor comments yesterday, argued Azar has failed to push back against “outrageous moves” by Trump and has been “almost entirely silent about the chaos and mismanagement” at his agency. Megan Howard has more.

Stimulus Update: Top House Democrats rejected a $1.5 trillion proposal by moderate lawmakers for a coronavirus stimulus package, leaving negotiations stranded again. A proposal by the bipartisan Problem Solvers Caucus wouldn’t do enough to address medical or economic needs, a group of House Democratic committee chairs said in a statement yesterday, Jack Fitpatrick reports. Pelosi said Congress should remain in session until lawmakers and the administration reach an agreement on another coronavirus stimulus package.
Read more: House Moderates Unveil $1.52 Trillion Bipartisan Relief Plan

Hearings:

Oversight Markup: The House Oversight and Reform Committee plans to mark up nine measures, including:

• H.R. 7496, to require federal agencies to submit plans for responding to any resurgence of Covid-19; and
• H.R. 7548, to ensure availability of personal protective equipment during pandemics and other public health emergencies through stockpile requirements and domestic manufacturing incentives.

HHS Coronavirus Response: The Senate Appropriations Labor-HHS-Education Subcommittee will probe the Department of Health and Human Services Covid-19 response at a hearing today. CDC Director Robert Redfield, HHS Assistant Secretary Bob Kadlec and HHS Assistant Secretary for Health Brett Giroir will testify.

VA Medical Supply Chain: The House Veterans’ Affairs Oversight and Investigations Subcommittee scheduled a hearing on changes to the VA medical supply chain in response to Covid-19.

Legislation: The House today is slated to vote on several bills under suspension of the rules, including:

• Child Care Safety During Covid-19: The Health and Human Services Department would have to assist states and tribes with providing child care services safely during the Covid-19 pandemic under a modified version of H.R. 7909. HHS could also make grants to states, territories, and tribes to provide guidance, technical assistance, and support to child care providers. The House Education and Labor Committee hasn’t acted on the bill, which Rep. Abby Finkenauer (D-Iowa) introduced on July 31. For more, see the BGOV Bill Summary by Danielle Parnass.
• Child Care Background Checks: An interagency task force to assist in implementing background check requirements for child care providers would be established under a House-amended version of S. 2683. The Senate passed the bill by voice vote on March 5. For more, see the BGOV Bill Summary by Danielle Parnass.

What Else to Know

Poison Pill Quiets Hospitals on Defying Price Rule: Hospitals that threatened to defy the federal government’s requirement to disclose their negotiated prices with insurers by Jan. 1 are reconsidering after a harsh new penalty—a potential loss of Medicare payments—was buried in a subsequent regulation. Some had considered not complying, protesting that disclosing prices would put some of their business practices in jeopardy. The fine set out by the initial transparency regulation was $300 per day, whereas major hospitals project their initial costs of complying at more than $1,300 a day, the American Hospital Association said.

But a recent yearly payment rule said hospitals that don’t provide their median negotiated rates with Medicare Advantage private insurance plans may also be denied Medicare payments. That would make a rebellion difficult—an analysis from 2019 says about 18% of hospital revenue came from Medicare, according to Definitive Healthcare. Read more from Shira Stein.

Uninsured Numbers Rise as Trump Attacks ACA: Trump seeks a second term as U.S. president, his promise to abolish Obamacare and replace it with a better plan remains unfulfilled. Instead, his actions have boosted the program’s costs for many and the number of uninsured Americans has grown. In 2017, about 28 million Americans were uninsured. In 2019, the figure reached nearly 30 million, according to data from the annual American Community Survey released by the Census Bureau yesterday. Read more from John Tozzi.

Trump Says Obamacare Replacement Is ‘All Ready’ : Trump last night said that his plan to replace Obamacare — which he has repeatedly promised would be introduced in a matter of weeks, only for the deadlines to come and go — is now “all ready.” Read more from Josh Wingrove and Mario Parker.

More Headlines:

• Pilot Program Nears for Insurers of Medicare-Medicaid Patients
• Trump Order Tying Drug Costs to Other Nations Thin on Metrics
• Hospitals Ask Court to Rehear Medicare Drug Pay Rate Cut Case
• Five Facilities Hand Over Medical Records After Scrutiny by HHS
• Tennessee Defends Law on Consent for Pill-Induced Abortions
• Texas, States Want Redo of Obamacare Medicaid Provider Case
• EPA Use of Nerve Cell Data Could Boost Use of Some Pesticides
• Eli Lilly Leukemia Treatment Given Orphan Drug Status by FDA

With assistance from Jack Fitzpatrick

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com