President Biden is planning to call for a global summit on vaccinations during next week's U.N. General Assembly — and could raise the idea as soon as today, our colleague Dan Diamond reports.

Biden's move comes amid pressure to fulfill his promise to vaccinate the world.

The president plans to propose a “global summit to respond to the coronavirus crisis and boost vaccine supply to the developing world, said three people who spoke on the condition of anonymity to discuss the pending announcement,” Dan and our Post colleagues report.

Mark Dybul, who served as an architect of the President's Emergency Plan for AIDS Relief (PEPFAR), the largest U.S. initiative devoted to a single disease, said he would welcome such an announcement as a step toward a “fully global response.”

“The U.S. can’t be the only one. We need a global effort,” said Dybul, who has called for a global pandemic task force.

A crisis at home has put less-developed countries on the back burner.

Global health advocates hoped this summer would offer the U.S. relief from the pandemic and give the administration time to turn its attention to the global response. But as the delta variant surged, many say they feel the plight of poorer countries was once again relegated to the back burner. 

The announcement that the U.S. would pursue booster shots disappointed some advocates who hoped that the country’s vaccine surplus — including additional deals to purchase 400 million doses this summer — could be directed to global donations. The World Health Organization doubled down yesterday on its call for a moratorium on booster shots until more people around the world have received first doses.

  • While more than half of Americans are fully vaccinated, fewer than 3 percent of people in Africa have been vaccinated.
  • Covax, an initiative backed by the World Health Organization aimed at equitable vaccine access, recently downgraded its projected vaccine supply for 2021 by more than a quarter.

“Unfortunately, it feels like global vaccine access and equity has always been a bit of a back-burner issue for the administration. In June and July, there was a feeling of ‘Mission accomplished. We can start doing vaccines around the world,’ ” said Rachel Silverman, a policy fellow at the Center for Global Development. “Now we’re having a secondary surge at home. There’s this talk about boosters.”

The past few months have seen an increase in U.S. commitments to the global response. 

  • Last month, the U.S. began shipping the first of the 500 million Pfizer doses purchased by the Biden administration as part of its pledge to countries in need. The country has already delivered 130 million donated doses.
  • Last week, the White House promised that it would invest $2.7 billion to ramp up domestic vaccine production, a move which Jeff Zients, Biden’s coronavirus response coordinator, said would help the U.S. “deliver on its commitment to be the arsenal of vaccines for the world.”

The U.S. is also supporting partnerships aimed at ramping up vaccine manufacturing in South Africa and India. Administration officials are quick to point out that they are donating more than any other country in the world. The United Kingdom takes a distant second on that front, committing 100 million doses, according to data from the Duke University's Global Health Innovation Center.

But some advocates argue the U.S. isn't doing enough.

The fact that wealthy countries fought to get in the front of the line for vaccine purchase prevented many poorer countries from buying shots, even as some doses sit unused in freezers. And the U.S. has been reluctant to use its patent on a component of mRNA technology to pressure vaccine makers to share it with manufacturers in other countries.

“We’re patting ourselves on the back for doing the bare minimum and doing more than any other country, but that’s not a great mark,” said Matthew Rose, the head of U.S. policy at the Health Global Access Project. “If everyone’s failing, then we’re all failing together. We’re just the head of the people failing.”

Here’s how lawmakers and advocates want to change that: 

There’s an effort underway to boost funding for global vaccine supply. 

More than 100 members of Congress sent a letter to Biden last month urging his support in securing $34 billion in the massive $3.5 trillion bill moving on Capitol Hill. (Biden has instead called for $15 billion to prepare for future pandemics.)

“Unless we vaccinate the entire population, we are not going to be able to control covid-19 at home,” Rep. Pramila Jayapal (D-Wash.) told The Health 202. 

Global health advocates want the U.S. to spend its money faster.

The nonprofit health advocacy group PrEP4All released a report last month claiming that, of $16 billion authorized in the American Rescue Plan to boost manufacturing of PPE, vaccines and therapeutics, only a small fraction has been spent on boosting vaccine supply. 

A White House official said that close to all of that funding has been designated, including the $2.7 billion announced for vaccine production and another $3 billion aimed at discovering and producing antivirals. Many awards have been finalized or are in the final stages, the official said.

Agency alert

First in The Health 202: The administration wants to put its stamp on the Centers for Medicare and Medicaid Services, a trillion-dollar office overseeing health coverage for more than 150 million people. Today, CMS Administrator Chiquita Brooks-LaSure is releasing six pillars for how she envisions her agency operating — principles that come after Democrats spent four years decrying Trump-era policies on Obamacare and Medicaid. 

She plans to focus on health equity; building on Obamacare; working with partners when crafting and implementing policy; promoting value-based care; keeping health programs afloat by using public funds responsibly; and creating an inclusive workplace. 

The Health 202 caught up with Brooks-LaSure this week. Here are our takeaways:

  • CMS has already thrown out Medicaid work requirements, the Trump administration's biggest legacy in the safety net program, a move that’s angered some Republicans. Brooks-LaSure didn't say whether the agency would roll back other Trump-era policies — like allowing skimpy insurance plans or championing the first-ever block grants in the Medicaid program. But she noted that CMS is “looking at all of the actions of the previous administration.” 
  • The agency could soon be at the center of implementing Biden’s massive social spending bill. The length of time it takes to stand up new programs — such as the Medicare dental benefit Democrats on the Hill are pursuing — “always depends on the details,” she said. (We reported last week that the agency believes it could take three to five years.)
  • Approving Medicaid waivers are a bit of a song and dance between the state and the administration, with both the Obama and Trump administrations declining to approve some proposals. Brooks-LaSure said her agency will evaluate whether states are designing programs so people are getting access to care and supporting safety net providers.

Ahh, oof and ouch

AHH: People who got Johnson & Johnson feel left out of booster plans.

Fourteen million Americans received the Johnson & Johnson vaccine, which isn’t covered under the booster plan announced Aug. 18. Many say they are feeling confused and frustrated by officials’ decision to focus first on recipients of the Pfizer-BioNTech and Moderna shots, The Post’s Derek Hawkins reports.

President Biden said on Aug. 18 that after Sept. 20, vaccinated Americans can get booster shots against coronavirus eight months after their second injection. (The Washington Post)

“I feel like I’m being neglected,” said Janice Higgins, 69, of Hadley, Mass., who got the first vaccine available to her: the one-dose Johnson & Johnson shot. “I’m trying to do the right thing, and I’m being stymied by the health establishment.”

Officials have noted the Johnson & Johnson shot was approved later and said they expect boosters will be needed, but they also have emphasized that for most people the single-dose regimen will be effective at preventing severe disease, hospitalization and death, even from the delta variant.

OOF: Pediatric covid-19 cases are surging in the U.S. as kids return to school.

Weekly pediatric coronavirus cases surpassed 250,000 for the first time since the start of the pandemic, according to data published by the American Academy of Pediatrics.

For the week ending Sept. 2, more than a quarter of confirmed cases in the U.S. were among children, The Post’s Annabelle Timsit reports. Although most pediatric cases are not severe, more than 2,400 children were hospitalized in the seven days ending Tuesday, according to Post data.

The more transmissible delta variant is driving the surge in cases among children, but scientists still don’t know if it is more severe in kids. Experts fear the situation could worsen as kids go back to school, but say it’s not inevitable.

OUCH: Elizabeth Holmes's defense says the collapse of Theranos is a story of failure, not fraud.

Holmes’s defense team argued that her efforts to create a start-up that could run medical tests on just a few drops of blood were motivated by a genuine commitment to improving health, The Post's Rachel Lerman and Gerrit De Vynck report.

“Failure is not a crime. Trying your hardest and coming up short is not a crime,” defense attorney Lance Wade said.

Prosecutors say that it went beyond failure. When Holmes’s business started to falter, they argue, she resorted to outright fraud, misleading investors, business partners and the media about her company’s blood-testing technology. 

Holmes’s company Theranos no longer exists, but its founder's meteoric rise from Stanford dropout to Silicon Valley superstar, and her precipitous fall amid allegations of fraud, has been fodder for a best-selling book, podcasts and an upcoming movie starring Jennifer Lawrence.

Fact check

Is there a back-door way for the government to demand some lower drug prices?

It all comes down to how you interpret a few words in a 40-year-old law.

In a letter to Health and Human Services Secretary Xavier Becerra, Sen. Elizabeth Warren (D-Mass.), Sen. Amy Klobuchar (D-Minn.) and Rep. Lloyd Doggett (D-Tex.) claimed the U.S. government can lower drug prices even without passing a new law. 

“HHS should consider using march-in rights when drugs face limited competition or market practices have failed to ensure an affordable price, ensuring that prescription drugs invented with taxpayer dollars are reasonably priced and affordable,” they write.

The lawmakers were referring to the Bayh-Dole Act of 1980. The act was originally aimed at ensuring that universities and small companies could profit off government-funded research, but it includes a provision saying that, in certain cases, the federal government can “march in” and license patent rights to another manufacturer.

Some advocates say that provision could be used to lower the prices of expensive drugs that were originally created with federal funds. Notably, the two co-sponsors of the bill, former Sens. Birch E. Bayh (D-Ind.) and Robert J. Dole (R-Kan.), declared 19 years ago that was never their intention. 

The Post’s Fact Checker says maybe…but maybe not.

“In the two decades since march-in was identified as a way to control drug prices, advocates of this approach have struck out every time they have sought to advance it,” The Post’s Glenn Kessler writes

But if the Biden administration decides to embrace march-in, it will go to the federal courts. “The lawmakers’ position falls in the realm of opinion. It will be up to the courts to decide whether it is half-baked,” Glenn writes.

Mental health

Coming today: Sens. Michael Bennet (D-Colo.) and John Cornyn (R-Tex.) are releasing a bipartisan white paper on their vision for reforming the country’s mental and behavioral health system, as they seek to hammer out legislation this year. 

The six-page document, shared with The Health 202, argues that anticipated increased demand for services — coupled with the existing unmet need — threatens to overwhelm local systems. The pair’s approach hinges on better integrating mental health care into the broader medical system; collecting better data; improving how federal funds are used; and helping equip the workforce to meet the growing demand for care.

Agency watch

Today is the deadline for the Food and Drug Administration to decide the fate of Juul and other makers of e-cigarettes. Many health groups and Democratic lawmakers have urged the agency to crack down on the products, but the companies and some tobacco-control experts say e-cigarettes help adult smokers quit.

Sugar rush