Officials say fourth doses are coming ... if they can buy them

From: POLITICO Pulse - Thursday Mar 24,2022 02:02 pm
Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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By Sarah Owermohle and Katherine Ellen Foley

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PhRMA

With Alice Miranda Ollstein

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QUICK FIX

Officials are preparing for more boosters but warning the funding isn’t there for broader needs.

Moderna plans to ask the FDA to authorize its Covid-19 vaccine for children younger than 6.

Biden officials went to Congress Wednesday to press for more cash in the ongoing coronavirus response.

WELCOME TO THURSDAY PULSE — Names in the news? The administration asked Mehmet Oz to resign from the President’s Council on Sports, Fitness & Nutrition. He refused, and suggested the administration asked Anthony Fauci to resign instead. Send news and tips to sowermohle@politico.com and kfoley@politico.com.

 

A message from PhRMA:

According to a new poll , Americans would like to see Congress focus more on reducing the overall costs of health care coverage such as premiums, deductible, and copays (71%) over reducing the costs of prescription drugs (29%). This extends across party lines; 73% of Democrats and 64% of Republicans would like to see Congress focus on reducing overall costs of coverage. Read more.

 
Driving The Day

THE FOURTH DOSE DEBATE Administration officials are preparing for the likelihood that older people will be advised to get a fourth coronavirus vaccine in a matter of weeks. While many people expect the recommendation is inevitable — particularly as other countries like the United Kingdom start on additional shots — timing and supply are looming questions.

Some health officials, including top Food and Drug Administration vaccine regulator Peter Marks, have advocated expanding those who would be eligible for an additional booster shot by the first week of April, arguing that the vaccination campaign needs to start well ahead of the next surge, Adam Cancryn and Erin Banco reported Wednesday.

Why the rush? Though cases in the U.S. are still dropping, the Biden administration has closely monitored recent Covid spikes in several European countries — where BA.2 is spreading — noting that prior surges there have preceded surges here. The subvariant, which is a more infectious version of Omicron, accounts for roughly 35 percent of all U.S. Covid cases so far, Centers for Disease Control and Prevention data shows, though it is already the majority strain in New England.

But another booster presents some problems. The U.S. has enough vaccine supply now for immunocompromised people to get a fourth dose and, if authorized, a wave of shots for seniors, White House Covid-19 coordinator Jeff Zients said in a press briefing. “However, if the science shows that fourth doses are needed for the general population later this year, we will not have the supply necessary to ensure shots are available, free and easy to access for all Americans,” he added, citing Congress’ deadlock on new coronavirus funding.

“People need to understand the difference between what's being looked at in the next few weeks for the immediate versus the longer range,” Biden’s chief medical adviser, Anthony Fauci, said at the briefing, though he nodded toFDA’s vaccine advisory panel on April 6, when members will wrangle with these issues.

Both Pfizer and Moderna have filed for adding a fourth dose but Pfizer has homed in on the elderly population while Moderna is gunning for another booster for each adult. At the heart of the debate is what limits we can expect from Covid-19 vaccines: Hospitalizations and deaths are down, but cases persist. A new variant surge could change that calculus.

“The somewhat encouraging news is that despite the increase in cases, they are not seeing an increase in [intensive care unit] admissions,” Fauci told POLITICO about Europe’s surge data.

MODERNA TO FILE COVID SHOT FOR YOUNGEST KIDS — Moderna announced Wednesday that its Covid-19 vaccine generated immunity protection for children 6 months to 6 years old comparable to young adults, Katherine reports. However, as the Omicron wave hit the U.S., real-world effectiveness was less robust: Kids 6 months to 2 years were 43.7 percent protected and kids 2 to 6 were 37.5 protected against any form of disease, though no children developed severe disease.

Moderna has started submitting data to the Food and Drug Administration for broader authorization among children 6 to 12 years old, and plans to begin the process for 6 months to under 6 years old in the coming weeks.

Dose dilemma: Moderna also said that it would be studying a booster dose in pediatric populations. Pfizer and BioNTech are also studying the effects of three doses of their vaccine for kids under 5, after the FDA postponed a vaccine advisory committee meeting that would discuss it.

Some vaccine experts believe that Moderna’s pediatric vaccine will need the additional dose from the get-go. “There's a good likelihood this is gonna be a three-dose vaccine,” Peter Hotez, a professor of pediatrics and molecular virology and microbiology at the Baylor College of Medicine, told Katherine.

… Or a sign of the times: “In the era of Omicron, this is actually quite comparable to the efficacy against infection in what we're seeing now with other vaccines,” Anthony Fauci told reporters at a White House press briefing on Wednesday.

ADMIN PUSHES DEMS ON COVID FUNDING IMPASSE — Top Biden administration officials went to Capitol Hill Wednesday night to brief Democratic senators on the need to swiftly approve tens of billions of dollars for the continued Covid response that have been stalled for several weeks as key programs risk running out of money.

Who was there: OMB Director Shalanda Young, outgoing White House Covid-19 response coordinator Jeff Zients and HHS Secretary Xavier Becerra.

What they discussed: Senators and administration officials emerging from the meeting told Alice that no new ideas were discussed and that they merely reiterated the dire need to set aside more funding for vaccines, care for the uninsured, humanitarian aid abroad and more.

Republicans, who were not part of the meeting, have demanded the $22.5 billion the White House is requesting be fully offset with cuts to other government spending.

Asked what they were offering on that front, Becerra quipped: “I’m no longer a member of Congress. Offsets aren’t my lane.”

 

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In Congress

LAWMAKERS COLLATE AROUND UNIVERSAL INSULIN ISSUES — Democrats, who hit a wall on sweeping drug price reforms in a packed year, are pushing a narrower policy fix pre-midterms: Insulin prices.

Senate Majority Leader Chuck Schumer announced a plan on Tuesday to bring legislation to the floor just after Easter that would cap the out-of-pocket cost for insulin products at $35 per month. If that sounds familiar, the Trump administration proposed a similar plan.

But while Democrats are anxious to campaign in the midterms on a tangible win, the plan has drawn criticism from the right and the left, underscoring the challenges that lie ahead, Alice reports.

Advocacy groups and other lawmakers say that an insulin cap alone would do little to solve the underlying problem of high drug prices. Responding to criticism, Schumer said he’d pair the cap with a bipartisan bill from Sen. Jeanne Shaheen (D-N.H.) and Sen. Susan Collins (R-Maine) to target pharmacy benefit managers’ rebates on the century-old treatments. However, the details of that bill are still being negotiated.

Folding the bills together offers a sheen of bipartisanship and addresses some members' concerns about the limited scope of insulin caps. But it also gives more fodder to opponents, including some Republicans and pharmaceutical industry groups, who argue it’s another play at government price controls.

 

SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.

 
 
Around the Nation

HOW THE ABBOTT FORMULA PROBLEM HAPPENED — Abbott Nutrition did not have the proper controls in place to keep dangerous pathogens out of its Sturgis, Mich., plant and the infant formula manufactured there, POLITICO’s Helena Bottemiller Evich reports.

In an update on Tuesday, the agency said it found Cronobacter sakazakii — the bacteria tied to four hospitalizations and two infant deaths in recent months — in numerous places in the formula plant, including on pieces of manufacturing equipment, the floor and a door.

The same inspection found that the plant didn’t ensure that surfaces that would contact infant formula were kept from being contaminated, as well as evidence of standing water, condensation and water leaks in several places. Plant records indicated that Cronobacter had also been found in tested finished product in two instances, one in September 2019 and one in June 2020.

FLORIDA AARP URGES GOV TO VETO NURSING HOME BILL — The Florida AARP launched a campaign on Wednesday urging Gov. Ron DeSantis to veto a bill that would let nursing homes shift some resident care over to lesser-trained employees, POLITICO’s Arek Sarkissan reports. The over-50 interest group argues that the bill, while designed to alleviate staffing shortages in nursing homes, would undo standards set into law in 2001 to protect residents from deplorable conditions.

Names in the News

Kirsten Allen is stepping down from her role as national press secretary for Covid-19 response at the Department of Health and Human Services and taking over as Vice President Kamala Harris’ press secretary.

Roy Baynes, the head of global clinical development and chief medical officer at Merck Research Laboratories, will retire in July. Eliav Barr, a senior vice president of global clinical development, will take his place.

Chris Krepich has joined Nahigian Strategies as director of communications for health care. He most recently worked as communications director for Rep. Brad Wenstrup and the GOP Doctors Caucus, and is an alum of Reps. Jim Sensenbrenner, Keith Rothfus and Sean Duffy.

 

DON’T MISS POLITICO’S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE.

 
 
What We're Reading

For FiveThirtyEight, Betsy Ladyzhets documents all the ways U.S. health officials tried to track Covid-19 over the last few years — and what they need to improve as the pandemic continues.

Michael W. Clune explores the new face of technology attempting to shape our dreams, and what that would mean for the study of our subconscious for Harper’s Magazine.

The narrative of the Great Resignation occludes the fact that the U.S. is going through a dangerous mental health crisis, Annalisa Merelli reports for Quartz.

 

A message from PhRMA:

According to a new poll , voters overwhelmingly support policies that would lower out-of-pocket costs and bring greater transparency and accountability to the health insurance system.

 We need to make the cost of medicine more predictable and affordable. Government price setting is the wrong way. The right way means covering more medicines from day one, making out-of-pocket costs more predictable and sharing negotiated savings with patients at the pharmacy counter.

Learn more.

 
 

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