What’s next for vaccine No. 3 — FDA gears up for variant Covid strains — State officials urge providers to burn through vaccine reserves

From: POLITICO Pulse - Friday Feb 05,2021 03:01 pm
Presented by the American Health Care Association and National Center for Assisted Living: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Feb 05, 2021 View in browser
 
POLITICO's Pulse newsletter logo

By Rachel Roubein

Presented by the American Health Care Association and National Center for Assisted Living

With Adam Cancryn and Susannah Luthi

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

— Johnson & Johnson has filed for emergency use authorization of its much-anticipated single-dose vaccine.

— The FDA is readying a battle plan to respond to extra-virulent new coronavirus variants.

— State officials are working with health care providers to quickly distribute their supply of coronavirus shots — even those initially held back in reserve.

WELCOME TO FRIDAY'S PULSE, where we're taking a trip back to 2001, when the Medicare and Medicaid agency needed a new name. One of the names that got nixed: MAMA (as in, the Medicare and Medicaid Administration.) We can’t believe that one didn’t stick…

Send your favorite government acronyms and tips to your regular host, acancryn@politico.com.

A message from the American Health Care Association and National Center for Assisted Living:

While Congress has offered some help during the pandemic, long term care residents and staff need additional resources to make it through this crisis. We’re calling on policymakers to protect our nation’s frontline workers and the vulnerable seniors who depend on them: https://saveourseniors.org

 
Driving the Day

J&J’S SHOT MAY SOON BE HERE. NOW WHAT? The country could soon have a third option in the race to immunize hundreds of millions of Americans, POLITICO’s Sarah Owermohle reports. The Johnson & Johnson vaccine, easier to store and administer, could provide some much-needed logistical simplicity to the complex vaccination campaign.

THE NEXT HURDLE WILL COME ON FEB. 26, when the FDA’s expert panel will review the company’s data. The final decision rests with the agency itself, which could authorize it quickly thereafter.

State health officials are eagerly awaiting more vaccines. The J&J single-dose shot could serve as a critical tool to immunize rural and other hard-to-reach populations, alleviating the logistical hurdles of a second shot.

YET, PUBLIC EDUCATION ON J&J’S VACCINE WILL BE CRITICAL. The company released data last week showing the shot is 66 percent effective against preventing moderate to severe infection, although it is weaker against a more contagious Covid-19 strain first found in South Africa. But it still provides strong protection against hospitalization and death.

Cognizant of the “messaging challenge,” Anthony Fauci, the nation’s top infectious disease expert, stressed that the public shouldn’t be concerned that it’s less effective at stopping infection than the two other vaccines authorized in the U.S.

“There's a lot more to protection than just preventing from getting infected,” he said at a White House briefing earlier this week. “We want to keep people out of the hospital, and we don't want people to die.”

THE NEW STRATEGY TO COMBAT THE VARIANTSThe FDA is quickly crafting new standards for coronavirus booster shots, tests and drugs in an effort to respond to the new, more highly infectious virus variants. That draft guidance could come within two to three weeks, sources tell POLITICO’s Sarah Owermohle and David Lim.

Meanwhile, federal and state officials are scrambling to determine just how widespread those new variants are in the United States.

A road map: The FDA’s top vaccine official has signaled that the agency will draw on its long-held approach to fighting the fast-mutating flu virus. Those shots rely on a base vaccine that is altered annually to target new variants that pop up each season. That method would also mean vaccine manufacturers could skip large-scale, monthslong clinical trials, opting instead to track just a few hundred volunteers for a matter of weeks.

 

TRACK FIRST 100 DAYS OF THE BIDEN ADMINISTRATION: The Biden administration hit the ground running with a series of executive orders his first week in office and continues to outline priorities on key issues. What's coming down the pike? Find out in Transition Playbook, our scoop-filled newsletter tracking the policies, people and emerging power centers of the first 100 days of the new administration. Subscribe today.

 
 


Coronavirus

STATES TO PROVIDERS: WHAT ARE YOU WAITING FOR? — Earlier this week, the Biden administration advised health care providers against unnecessarily holding booster shots in reserve. Now, state officials say they’re passing on that message, POLITICO’s Brianna Ehley reports.

The federal government is still wrestling with significant discrepancies between the number of vaccines distributed and the number of shots in arms. About 35 million doses have been administered, out of the more than 57 million shipped to states, according to federal data.

Flashback: It’s an about-face from the early days of the vaccination effort, when the Trump administration, worried about supply bottlenecks, initially held half the country’s doses back.

FDA LIMITS USE OF CONVALESCENT PLASMAThe agency is limiting use of convalescent plasma treatment for hospitalized Covid-19 patients who are still early in the course of infection or who have impaired immune systems, David reports.

The changes stem from evidence gathered since the agency first authorized the use of convalescent plasma as a coronavirus treatment, under intense pressure from then-President Donald Trump — and despite objections from government scientists that there was not enough evidence backing the treatment.

 

Advertisement Image

 
On the Hill

FIRST IN PULSE: HEALTH EXPERTS WANT QUICK CONFIRMATION FOR TANDEN — More than 100 public health experts have thrown their support behind Biden’s pick to lead the White House budget office and are urging the Senate to speed along her confirmation.

In a letter to the leaders of the Senate Budget and Homeland Security and Government Affairs committees, the group praised Neera Tanden as “a leading voice on public health issues” and stressed the need to have a permanent OMB chief involved in Biden’s Covid-19 response.

Tanden — who heads the left-leaning Center for American Progress — will have her first confirmation hearing next week, where she’s likely to face tough questions from Republicans over her past criticism of the GOP on social media.

 

KEEP UP WITH CONGRESS IN 2021: Get the inside scoop on the Schumer/McConnell dynamic, the debate over the filibuster and increasing tensions in the House. From Schumer to McConnell, Pelosi to McCarthy and everyone in between, new Huddle author Olivia Beavers brings the latest from Capitol Hill with assists from POLITICO's deeply sourced Congress team. Subscribe to Huddle, the indispensable guide to Congress.

 
 


Providers

HOSPITAL LOBBY SEEKS PROBE OF UNITEDHEALTH GROUPThe American Hospital Association is asking acting federal antitrust and health officials to scrutinize some of mega insurer UnitedHealth’s new policies, POLITICO’s Susannah Luthi reports.

What AHA wants probed: The hospital lobby contends some of UnitedHealth’s new practices could stick patients with surprise medical bills, such as the conglomerate’s plan to quit paying for diagnostic tests performed at certain hospital labs.

Hospitals also don’t like a new policy that could hurt their bottom line: UnitedHealth’s decision to use its own specialty pharmacy to dispense some medications that hospitals typically buy, store or administer. Instead, the insurer and its pharmacy would supply the drugs directly to providers and patients. (A spokesperson for UnitedHealth didn’t respond to a request for comment.)

Health insurers have been opened up to new federal antitrust oversight by a bill Congress passed unexpectedly in December. And AHA is on the defensive, too, after the Federal Trade Commission announced a plan to study whether health care industry consolidation has worsened the ballooning cost of care.

A message from the American Health Care Association and National Center for Assisted Living:

We need Congress to step in and protect our nation’s greatest generation by funding long term care providers. Without these facilities, seniors are displaced from their communities and loved ones and left without the quality care they need. We’re calling on policymakers to prioritize our nation’s seniors and the heroic health care workers who protect them: https://saveourseniors.org/

 
What We're Reading

Coronavirus cases, hospitalizations and deaths dropped this week, though the numbers are still astonishingly high, per The Atlantic’s Covid Tracking Project.

Wisconsin Gov. Tony Evers, a Democrat, issued a new mask mandate just an hour after Republicans eliminated the old one, Molly Beck of the Milwaukee Journal Sentinel reports.

Americans are crossing state lines to get the vaccine — and some states are beginning to crack down on the practice, report The New York Times’ Simon Romero, Amy Harmon, Lucy Tompkins and Giulia McDonnell Nieto del Rio.

 

Follow us on Twitter

Joanne Kenen @joannekenen

Adriel Bettelheim @abettel

Jason Millman @jasonmillman

Lauren Morello @lmorello_dc

Sara Smith @sarasmarley

Zach Brennan @ZacharyBrennan

Adam Cancryn @adamcancryn

Tucker Doherty @tucker_doherty

Brianna Ehley @briannaehley

Dan Goldberg @dancgoldberg

David Lim @davidalim

Susannah Luthi @SusannahLuthi

Alice Miranda Ollstein @aliceollstein

Sarah Owermohle @owermohle

Carmen Paun @carmenpaun

Mohana Ravindranath @ravindranize

Rachel Roubein @rachel_roubein

Darius Tahir @dariustahir

 

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