Why full FDA approval of Pfizer’s coronavirus vaccine matters — Biden leans on drug pricing to sell spending bill — Health workforce buckles under Covid resurgence

From: POLITICO Pulse - Monday Aug 23,2021 02:08 pm
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Quick Fix

— The FDA will announce its approval of the Pfizer-BioNTech Covid-19 vaccine as soon as this morning, marking a milestone in the pandemic fight.

— The White House is hoping the appeal of a drug price overhaul will get skeptical House Democrats on board with its $3.5 trillion spending plan.

— Hospitals are short-staffed and struggling to respond to the rise in Delta cases, raising fresh concerns about the quality of patient care.

WELCOME TO MONDAY PULSE — where the FDA was horsin' around this weekend and did a good tweet. Tips to acancryn@politico.com and sowermohle@politico.com.

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Driving the Day

FDA SET TO APPROVE PFIZER’s VACCINEThe agency is poised to announce the full approval of the Pfizer-BioNTech coronavirus vaccine for adults as soon as this morning , in a much-anticipated decision that would make it the first Covid-19 shot to get the federal government’s official stamp, Adam and Erin Banco scooped.

The approval has long been considered a formality, after months of real-world evidence confirmed the vaccine as safe and highly effective. The FDA first authorized it for emergency use last December, and hundreds of millions of shots have since gone out around the world.

But it’s critical to President Joe Biden’s vaccination campaign for two key reasons: First, the full sign-off is expected to prompt a wave of vaccine mandates from major employers, universities and institutions that will help boost the vaccination rate amid the Delta-fueled surge.

And second, a portion of Americans who have held out for months may now have the assurance they need to seek out the vaccine. Polling earlier in the summer has suggested that roughly 30 percent of those who are still unvaccinated would be more likely to get a fully approved shot.

Those could be important developments in beating back Delta’s rapid spread ahead of the colder months. Vaccinations are already accelerating, with the U.S. twice hitting 1 million daily shots last week for the first time since June — a jump that officials have attributed at least in part to Covid-19’s resurgence.

But caseloads are still rising too, hitting levels on par with what the U.S. experienced back in February. And early indications are that infections are spreading rapidly among school-aged children going back to class — jeopardizing Biden’s vow to ensure a full year of in-school learning.

With full approval in hand, more corporations are likely to feel comfortable making vaccination a condition of employment. And it could kick off efforts across the nation to add the Covid-19 shot to the list of vaccines that students must get before they go to school.

Of course, it won’t solve everything. In the least-vaccinated — and often deepest red — parts of the country, there’s likely to be little appetite for anything approaching a vaccine mandate. A chunk of the unvaccinated are also likely to point to the approval as a new excuse not to get the shot, arguing that it happened too fast.

Yet for a Biden administration that’s struggled in recent weeks to contain a virus they’d hoped would be largely defeated by now, the vaccine’s approval offers a bit of good news — and the prime opportunity for a high-profile victory lap.

BIDEN LEANS ON DRUG PRICING TO SELL SPENDING BILL — The White House is trying to build support for its $3.5 trillion spending package by selling skeptical Democrats on the one element that’s projected to save money: a sweeping drug price overhaul.

Administration officials have emphasized the need to slash drug prices during conversations with lawmakers , POLITICO’s Laura Barrón-López reports, pointing in particular to the popularity of permitting Medicare to directly negotiate the cost of medicines.

The provision has consistently won strong support from key voting blocs — evidence that Biden aides say proves passing the spending bill will be crucial to ensuring Democrats keep the House in 2022. Lowering drug costs would counter GOP attacks on Biden’s economic record, the White House believes, and have a more immediate impact than anything in Congress’ bipartisan infrastructure deal.

The new data point: The firm run by Biden campaign pollster Celinda Lake published survey results Friday showing 87 percent of voters over the age of 65 favor Medicare negotiation. The poll also found that 51 percent of seniors were more likely to vote for a Democratic candidate who supported the proposal.

The provision is also key for another reason: It’s projected to create massive savings. When Medicare negotiation language was included in House Democrats’ 2019 drug pricing bill, the Congressional Budget Office said it would save more than $450 billion alone over a decade. Securing that offset is critical for a White House that has vowed to ensure the $3.5 trillion package is paid for in full.

Still, the concept is a hard sell for centrist Democrats. The party only included it in their 2019 bill after extensive negotiations — and with the knowledge it had no chance of becoming law under the Trump administration.

Since then, moderates have clung to concerns it would harm innovation in the drug industry. And the deep-pocketed pharmaceutical lobby has proven willing to amp up the pressure to keep the government from gaining greater leverage over prices.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
Coronavirus

HEALTH WORKFORCE BUCKLES UNDER COVID RESURGENCE — Hospitals are struggling to keep up with a rise in Covid-19 cases that has stretched their workforce and exposed shortages in the pool of available nurses, lab techs and front desk workers, POLITICO’s Dan Goldberg and Alice Miranda Ollstein report.

The depleted ranks of health care workers have raised fresh concerns about the ability to care for the nearly 87,000 people hospitalized with Covid-19, and prompted a scramble to backfill positions by any means necessary.

Some hospitals are now dangling signing bonuses to new hires or rewriting job descriptions so paramedics can treat patients in the emergency room. States including Tennessee and Oregon, meanwhile, are seeking reinforcements from the federal government.

The staffing spread cuts across various specialties, from radiologists and nurses to custodial staff and food-service workers. In many cases, burnout from fighting the pandemic for months on end has resulted in waves of resignations or retirements. Others now need time off to care for family members who are among the hundreds of thousands of newly infected.

As a result, hospitals fear small losses — such as the absence of a runner whose job it is to get supplies from the storage closet — can cascade into major problems, making it more difficult to pay proper attention to patients.

“We’re constantly interrupting the care we are giving to go fetch stuff,” said Marsha Martin, a trauma nurse at University of Florida Shands Hospital. “There are delays in patients getting medicine they need.”

 

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Abortion

DEMS TURN TO ABORTION TO SAVE NEWSOMDemocrats trying to energize voters ahead of California Gov. Gavin Newsom’s recall election are raising alarms over the threat to abortion access if he loses , warning a GOP victory could set back years of reproductive rights work, POLITICO’s Alice Miranda Ollstein and Victoria Guida report.

The push is spearheaded by abortion rights groups like Planned Parenthod and NARAL, which have ramped up their messaging and events supporting Newsom with just weeks until the Sept. 14 election.

Abortion is typically a subject used by conservatives to fire up their base, while Democrats in the past have been more wary of spotlighting such a polarizing issue. But in California, Newsom and his backers are touting his record advancing reproductive rights and accusing Republican challengers of wanting to reverse those policies.

A GOP governor, Democrats say, could cut funding for clinics and appoint anti-abortion officials, while vetoing abortion-rights laws. There’s also the added worry that one of the state’s senators, 88-year-old Dianne Feinstein, could resign before the end of her term – putting Democratic control of the Senate in jeopardy.

So far, Planned Parenthood has contributed more than $12,000 to the race, while NARAL has spent $10,000 defending Newsom.

 

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Medicaid

JUDGE REINSTATES TEXAS MEDICAID WAIVER — A federal judge is blocking the Biden administration from revoking a Trump-era extension of Texas’ Medicaid waiver, calling the decision harmful and “likely unlawful.”

The preliminary injunction temporarily reinstates the 10-year program, which has been at the center of a monthslong dispute between state officials and the federal government. CMS first tried to scrap the waiver in April, arguing that it was approved by the Trump administration without first going through the required public comment period.

Names in the News

Sally Yates, the former U.S. deputy attorney general, is joining the board of mental health nonprofit Project Healthy Minds. Yates is currently a partner at the law firm King & Spalding.

Mahesh Marepalli is the new chief data officer for the Maryland Department of Health. He most recently was a senior vice president at AmerisourceBergen.

A message from the Healthcare Distribution Alliance:

As the backbone of the healthcare ecosystem, HDA members are engaged in COVID-19 response efforts, partnering with the federal, state and local governments to distribute treatments, medical supplies and PPE.

We are the people behind the nation’s largest-ever vaccine rollout, working with the federal government and states to make sure vaccines get where they are needed and supporting our pharmacy and provider partners, so they can put shots in arms.

Our work continues in the fight against COVID-19. Day in and day out, HDA members are leveraging strong relationships at both ends of the supply chain to direct lifesaving medicines to the frontlines, while continuing to meet the daily healthcare needs of all Americans. Distributors are committed to leveraging their logistics expertise and supply chain relationships in the fight against this global pandemic.

Learn more.

 
What We're Reading

Private contractors collected millions of taxpayer dollars helping run state and federal vaccination efforts, but it’s unclear how much value they actually added, The Washington Post’s Isaac Stanley-Becker reports.

For the New Yorker, Atul Gawande investigates why Costa Rica has better health outcomes than the U.S., even as it spends far less per capita on health care.

Records now indicate that the first U.S. Covid-related deaths occurred in January 2020, weeks earlier than originally thought, The Mercury News’ Harriet Blair Rowan and Emily DeRuy report.

 

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