The Covid-19 booster debate begins anew

From: POLITICO Pulse - Thursday Oct 14,2021 02:05 pm
Presented by Surgical Care Coalition: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Oct 14, 2021 View in browser
 
POLITICO's Pulse newsletter logo

By Adam Cancryn and Sarah Owermohle

Presented by

Surgical Care Coalition

Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro.

Quick Fix

— An FDA advisory panel today will be the first to examine Moderna's case for a Covid-19 vaccine booster.

— Moderna is facing rising anger from administration officials and outside activists over its reluctance to further aid the global vaccination effort.

— A Medicare expansion plan championed by progressives is at risk, as Democrats trim their social spending bill.

WELCOME TO THURSDAY PULSE — and for those of you who don’t get enough politics in your real life, this video game could soon provide a virtual fix.

Send real-life tips to acancryn@politico.com and sowermohle@politico.com.

A message from Surgical Care Coalition:

The Surgical Care Coalition is urging Congress to stop impending Medicare cuts of nearly 9% that will threaten patient access to quality surgical care. These cuts are even more concerning considering the ongoing COVID-19 pandemic. Learn more about the Surgical Care Coalition , representing more than 150,000 surgeons across the country, and how you can take action against these devastating cuts.

 
Driving the Day

THE BOOSTER DEBATE BEGINS ANEW — A panel of outside FDA advisers take up Moderna’s case for a vaccine booster today, marking the start of a review process that could soon make millions more Americans eligible for additional Covid-19 shots.

The session follows just a few weeks after the FDA authorized Pfizer and BioNTech’s booster amid a storm of controversy over the White House’s cheerleading of the extra dose and the quality of the data underpinning it.

Yet while Biden officials have tread more carefully this time around, there’s no guarantee the meeting will be drama free.

What to know: Moderna is seeking authorization for a third shot at least six months after people’s initial regimen, though this time the company is proposing they receive just a half-dose. And in a move that could head off significant debate, it’s asking the FDA to greenlight boosters for the same limited portion of the population currently eligible to get Pfizer’s third shot.

The data the company submitted shows that the effectiveness of Moderna’s initial vaccination round wanes over time and a booster enhances recipients’ virus-fighting antibodies.

Still, it’s not a done deal. FDA scientists declined to explicitly support the Moderna booster in the agency’s submissions to the committee, echoing their view toward Pfizer’s booster. They also noted that it remains unclear whether protection against severe disease and death is dropping substantially, and what exactly is driving the reduction in overall efficacy.

The risk of myocarditis associated with the vaccine could also be a variable in the discussion. Though the risk is small, the FDA has linked it to shots in young men in particular — raising the question of whether the panel will endorse giving boosters to younger adults.

The documents and data | The 8:30 a.m. live stream

 

Registration is OPEN for Breakthrough Summit 2021, the most important rare disease conference of the year! On Oct. 18 and 19, the National Organization for Rare Disorders will host the virtual Rare Disease and Orphan Products Breakthrough Summit. The Summit brings together the rare disease community from across the globe, including experts from patient advocacy, government, industry, media and academia, to discuss the current and critical topics in rare diseases. For access to two days of networking and dynamic programming on topics including drug pricing, genetic testing, Covid-19, equity and inclusivity, REGISTER NOW.

 
 

MODERNA TAKES HEAT OVER GLOBAL VAX PLEDGES — A senior Biden health official lit into the vaccine manufacturer Wednesday, urging it to “step up” and commit millions more of its vaccine doses to needy countries abroad.

David Kessler, the chief science officer for the White House’s Covid-19 response, said during a panel discussion that it would be “unconscionable” for Moderna to refuse to further aid the global pandemic fight — disclosing that the White House has pressured it to scale up manufacturing and help close a shortfall in the doses that global vaccine effort COVAX needs to inoculate the world.

“There is very substantial additional capacity at Moderna that has been invested in, and now the question is to get that commitment done at a not-for-profit price in substantial quantities,” he said at the event hosted by the Law and Political Economy Project at Yale Law School. “We don’t have months to wait.”

Kessler’s remarks followed POLITICO’s reporting on rising tensions between Moderna and the White House over the company’s reluctance to commit additional doses globally — a resistance officials believe is driven partly by profit concerns. Kessler alluded to those internal frustrations, saying the administration has used “anything but a light touch” in dealing with its executives.

Yet Moderna still hasn’t budged — and the rest of the panel made sure Kessler knew it. Health Justice Initiative founder Fatima Hassan vented that the administration had allowed the CEOs of Moderna, Pfizer and Johnson & Johnson to become “more powerful than anyone else in the world” based on their ability to pick and choose where doses go.

“We’re stuck because Moderna wants to exercise an enormous amount of control, is really acting in a very greedy way and wants to make a lot of profit,” she said.

A Moderna spokesperson did not respond to questions about the panel discussion.

They also blamed the White House, pressuring Kessler in a series of intense exchanges to explain why Biden wasn’t taking aggressive steps like breaking patents or invoking the Defense Production Act. While Kessler agreed the government had additional options at its disposal, he declined to commit to using them — leaving the panelists and some audience members vocally exasperated.

“At this point, the Covid crisis is no longer a scientific crisis, it is no longer a biomedical crisis,” PrEP4All co-founder James Krellenstein said. “It is a political crisis.”

 

Advertisement Image

 
In Congress

DEMS’ MEDICARE EXPANSION PLAN IS TEETERING — Liberal Democrats are racing to save a major expansion of Medicare benefits from the chopping block, as the party tries to trim more than $1 trillion from its social spending bill.

The effort is the biggest test to date of the influence wielded by the Congressional Progressive Caucus, which is fresh off its successful bid to delay the bipartisan infrastructure bill, POLITICO’s Alice Miranda Ollstein reports.

The 96-member group closed ranks behind Medicare expansion primarily out of the hope it would get a sliver of their long-sought “Medicare for All” vision into law. But in the process, it’s invited various criticisms including the belief that prioritizing Medicare would mean giving benefits to older and wealthy Americans at the expense of a Medicaid plan that would benefit the poor.

The program’s estimated $350 billion price tag over a decade has also made it a prime target for Democratic leaders seeking the cuts needed to win 50 Senate votes.

Add on one more issue: In a letter Wednesday night to committee leaders, centrist Rep. Jared Golden (D-Maine) criticized the Medicare proposal as “underdeveloped” and reliant on “budget gimmicks” to mask its true cost.

Still, leading progressives are already floating the possibility of withholding their support once again to get what they want, with Sen. Bernie Sanders (I-Vt.) earlier this week calling the expansion’s inclusion “not negotiable.”

AND PAID LEAVE IS IN LIMBO — Senate leaders are also considering shrinking paid leave funding under the reconciliation plan to just $300 billion — or 40 percent less than what the House originally approved, POLITICO’s Eleanor Mueller reports.

House and Senate lawmakers have battled over the provision for some time, with the $300 billion level likely to cover three to four weeks of leave. That’s far short of the 12 weeks hat Biden proposed and the House subsequently supported.

Among the options on the table: Democrats could potentially close the gap by reducing the length of the leave benefit, capping how much workers would take home, phasing the program in over time or giving it an expiration date. That could be preferable to risking the entire concept being left out of the final bill.

Yet any of those avenues are sure to limit the impact of a provision Democrats believe will be popular in the pandemic’s wake. Advocates argue that shortening its length would sacrifice the economic and health benefits, especially since most of the evidence they’ve leaned on to push the concept is based on state paid leave programs that are typically three months long.

Capping the benefit could similarly limit the payoff. And phasing in or abruptly ending it at a later date may end up discouraging workers or employers from participating.

FIRST IN PULSE: WARREN, GRASSLEY PRESS FDA ON HEARING AID RULE — Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) want the FDA to immediately issue long-awaited regulations for over-the-counter hearing aids, writing Thursday that they’re critical to making the devices cheaper and more accessible.

The proposed rules governing the direct sale of certain hearing aids cleared OMB review earlier this month, and come after Biden issued an executive order requiring the new regulations by early November.

“We urge your office to finalize the rule without delay to, at a minimum, meet the deadline set forth in the President’s executive order,” the senators wrote to acting FDA Commissioner Janet Woodcock . “Specifically, we hope that the rule does not contain any unnecessary restrictions that hinder access to these devices or their utility.”

Warren and Grassley have advocated for the regulations since 2017, when then-President Donald Trump signed a law based on their proposal to order new regulations making hearing aids available over the counter.

POLL: MOST PARENTS LIKELY TO VACCINATE THEIR YOUNG KIDS — Two-thirds of parents say they’re likely to vaccinate their five-to-11-year-old children against Covid-19 once a shot is authorized, according to a new survey from the National Association of School Nurses and the Covid-19 Vaccine Education and Equity Project.

A majority — 60 percent — also support requiring schools to make the vaccine mandatory for attending in-person classes. Yet that enthusiasm for the shot depended heavily on the parents’ vaccination status, the survey found, with those hesitant about the idea chiefly concerned about potential side effects and long-term risks of the shot.

 

TELL US WHAT YOU THINK: Do you listen to POLITICO podcasts? We want to hear from you! Tell us what you like, what you could do without, and what you want to see in the future from the POLITICO Audio team! Your responses will help us improve our offerings and tailor our podcast content to better fit your needs. Find the survey here.

 
 
What We're Reading

Boeing will be the latest major company to mandate vaccinations for its U.S. employees, The Wall Street Journal’s Doug Cameron reports.

Fewer than half of Republicans now support requiring any childhood vaccines , amid the party’s campaign against Biden’s push to mandate vaccination against Covid-19, The Washington Post’s Aaron Blake writes.

For Vox, Dylan Scott tackles the question at the center of Democrats’ health agenda: Can they cut drug prices without sacrificing medical innovation?

A message from Surgical Care Coalition:

A nearly 9% cut to Medicare could threaten patients’ access to quality surgical care. The Surgical Care Coalition, representing more than 150,000 surgeons across the country, are advocating Congress to stop these harmful cuts to protect patients and ensure access to the care they deserve, especially considering the ongoing COVID-19 pandemic.

Health care systems and providers across the country continue to be strained. And COVID-19 has forced patients to delay routine, preventative care leading to delays in a diagnosis and treatment. The proposed Medicare cuts will weaken the system even further and jeopardize access to care for the most vulnerable.

Learn more about the Surgical Care Coalition and how you can protect patient care by stopping these impending Medicare cuts.

 
 

Follow us on Twitter

Joanne Kenen @joannekenen

Adriel Bettelheim @abettel

Lauren Morello @lmorello_dc

Sara Smith @sarasmarley

Adam Cancryn @adamcancryn

Tucker Doherty @tucker_doherty

Dan Goldberg @dancgoldberg

David Lim @davidalim

Alice Miranda Ollstein @aliceollstein

Sarah Owermohle @owermohle

Carmen Paun @carmenpaun

Rachel Roubein @rachel_roubein

Darius Tahir @dariustahir

Erin Banco @ErinBanco

Lauren Gardner @Gardner_LM

Katherine Ellen Foley @katherineefoley

Ben Leonard @_BenLeonard_

 

Follow us

Follow us on Facebook Follow us on Twitter Follow us on Instagram Listen on Apple Podcast
 

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to .

More emails from POLITICO Pulse

Oct 07,2021 02:02 pm - Thursday

Why the White House is souring on Moderna

Oct 06,2021 02:03 pm - Wednesday

The search is on for the next Francis Collins

Oct 05,2021 02:04 pm - Tuesday

NIH Director Francis Collins to step down

Oct 04,2021 02:05 pm - Monday

Biden’s agenda in limbo