| Welcome to Tuesday's Health 202 — and to the shortest month of the year. Today we have big news for parents of children under 5: a coronavirus vaccine may be ready by the end of this month. Meanwhile, the health care worker mandate is moving ahead quickly. But first: | In the coronavirus response, Becerra is taking a back seat to Jeff Zients |  Xavier Becerra has led the Department of Health and Human Services since last March. (Shawn Thew/Pool via AP, File) | | | The White House is frustrated with how Health and Human Services Secretary Xavier Becerra is handling the pandemic response. So much so, that officials have openly mused about who might be better in the job, though political considerations have stopped them from taking steps to replace Becerra. That's one of the key takeaways from a deep dive into Becerra's management of the coronavirus from The Post's Dan Diamond, Yasmeen Abutaleb and Tyler Pager. The trio spoke to 28 senior administration officials, health agency officials, outside advisers and experts, most of whom spoke on the condition of anonymity to detail sensitive discussions. Their comments illustrate a new level of frustration over how the nation's top health official has approached the pandemic and its many demands. What they found: Critics blame Becerra — who runs the sprawling, 80,000-person department — for conflicting messaging from the federal health officials he's charged with overseeing. His defenders argue the administration never gave him a clear role. White House and Health and Human Services officials deny the tensions, pointing to the administration's work on vaccines, treatments and tests as proof of a good working relationship. Here's what else their story revealed, and what it means: | | The frustration with Becerra underscores the complex dynamic of how the pandemic response was set up — and several officials described to our colleagues a confusing chain of command. | | From the start, the pandemic response was run out of the White House and led by Jeff Zients, the White House coronavirus response coordinator. He communicates directly with health leaders, like Anthony Fauci, the nation's top infectious-disease expert; Rochelle Walensky, the head of the Centers for Disease Control and Prevention; and Vivek Murthy, the Surgeon General. Those officials technically report to Becerra. The health secretary, who didn't join the administration until late March, wasn't ever given a defined role in the pandemic response, his defenders say. But still, his low profile — which HHS contests — is confounding to some, since a core responsibility of the health secretary job is to coordinate the vast health department. | - Further complicating matters: "The White House has taken a hands-off approach to the CDC and some other health agencies because it is sensitive to charges of political interference after Biden repeatedly criticized the Trump administration's meddling in scientific debates and policies during his campaign," Dan, Yasmeen and Tyler write.
- The result: That has meant it can sometimes be unclear who makes final decisions or is in charge of implementing new initiatives. Zients has faulted Becerra for not doing enough to ensure the White House knows what's coming from its health agencies, especially the CDC — a characterization Zients disputed to our colleagues through a White House official.
| | The view from the administration: White House and HHS spokespeople said Zients and Becerra have a formal check-in and talk throughout the week. | - The "covid response is driven by the science and data," Sarah Lovenheim, HHS's chief spokesperson, wrote in an email to my colleagues, adding that HHS informs the White House of "any high-level actions and decisions."
| | When they don't see eye to eye: White House officials last spring wanted to move forward with a plan to reimburse doctors for encouraging Medicare and Medicaid patients to get vaccinated, given data that skeptics said they would listen to their doctors. | - But the plan was halted after Becerra raised concerns, citing the lack of oversight and potential for fraud, which frustrated officials and advisers trying to win over vaccine holdouts. The administration finally announced a scaled-down version of the plan in December, backed by Becerra and focused on Medicaid.
| | President Biden and his team struggled to pick a health secretary during the transition, as some potential candidates didn't want the job. They landed on Becerra, a former California attorney general and longtime House member. Yet, as one senior administration official put it to my colleagues: The health secretary "is taking too passive a role in what may be the most defining challenge to the administration." (White House spokesperson Kevin Munoz dismissed criticism of Becerra as "anonymous gossip.") | | But don't expect a change in management for several reasons. | - The backlash: Removing Becerra would likely draw the ire of the Congressional Hispanic Caucus and other grass-roots groups that have urged Biden to appoint more Latinos to his Cabinet.
- The Biden factor: "Biden is also averse to firing staffers and unlikely to make major changes unless there are glaring reasons to do so, one senior official said," Dan, Yasmeen and Tyler write.
- A complicated Senate calendar: Democrats already have the thinnest of margins in the Senate and are set to prioritize confirmation of a new Supreme Court justice before the midterms.
| | |  | Coronavirus | | | Is a vaccine for children under 5 coming soon? Coronavirus vaccines for this age group could be available earlier than anticipated, perhaps by the end of February. That would occur under a plan that could lead to the potential authorization of a two-shot regimen in the coming weeks, The Post's Laurie McGinley, Lena H. Sun and Carolyn Y. Johnson scooped last night. As early as Tuesday, Pfizer and its partner, BioNTech, are expected to submit a request to the Food and Drug Administration for the first coronavirus shot for children 6 months to 5 years old. Over the last few months, the companies have been testing a third dose after disappointing results for the two-shot regimen. The data showed two doses were safe, but didn't provide a strong enough immune response in all groups. | - But now: "The idea is, let's go ahead and start the review of two doses," one of the people familiar with the situation told our colleagues. "If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don't do anything until the third-dose data comes in."
- Data on the third shot won't be ready until at least late March. Once it is, regulators are expected to authorize a third dose of the pediatric vaccine.
| | Other vaccine moves to watch … | - The FDA granted Moderna's coronavirus vaccine full approval yesterday. It was previously available under emergency use authorization.
- Maryland-based Novavax filed yesterday for emergency use authorization of its vaccine. The shot was shown to be 90 percent effective in a large clinical trial before the delta and omicron variants became dominant, but manufacturing issues have delayed the shot.
| | |  | Agency alert | | | "Full speed ahead" for health workers' vaccine mandate. That's the message from the Centers for Medicare and Medicaid Services in a letter the agency issued to health-care facilities today and shared with The Health 202. The letter points to guidance on the requirement, as well as best practices for addressing concerns, such as one-on-one conversations. It comes as the vaccine mandate for health facilities receiving Medicare and Medicaid funds began taking effect last week. Health-care workers in roughly half the states had to get their first dose of a coronavirus vaccine, and soon the rest of the country will have to follow. The deadlines were staggered after Republican-led states challenged the rules, leading to differing court rulings before the Supreme Court weighed in. | - One argument for the mandate: "Increasing the uptake of COVID-19 vaccines, including the booster shot, is the most important tool you have against staffing shortages," CMS Administrator Chiquita Brooks-LaSure wrote in the letter.
- Assessing compliance: State survey agencies will help determine whether providers are complying, such as when they investigate a complaint or during the standard recertification process, per a CMS spokesperson.
| | |  | On the Hill | | | Biden's FDA pick makes new ethics pledges for Warren FDA nominee Robert Califf has agreed to new ethics commitments after meeting with Sen. Elizabeth Warren (D-Mass.). The changes, first reported by Politico, come as Califf's nomination has become tighter than originally expected, as some Republicans and a handful of Democrats have signaled opposition. In a letter to Warren, Califf said he would extend the recusal period for companies he previously worked for from two years to four years. He also said he's recusing himself from all matters involving Duke University, which he retired from in 2019. Additionally, he won't seek employment or compensation from any pharmaceutical or medical devices companies he interacts with, if confirmed as head of the agency, for four years after his time in government. Politico reported that Warren would support Califf if the nomination comes to the Senate floor. The view from the White House: An official said the administration has set "the highest ethical standards of any administration" and that Califf has a "strong ethical track record." Warren — who voted for Califf to lead the FDA under President Obama — has asked other nominees to sign on to further ethical standards, and they've obliged. | | |  | From our reporters' notebooks | | | On the move: Alex Azar has a new gig. The former Trump health secretary and self-described architect of Operation Warp Speed has been hired by Foresite Capital, a venture firm investing in coronavirus vaccines and treatments, our colleague Dan Diamond scooped. Azar is "a part time consultant," a Foresite spokesperson texted Dan, though declined to provide further details about Azar's role. Azar also didn't respond to a request for comment. Foresite has invested in dozens of companies, including Novavax, which in 2020 received funding through Operation Warp Speed and on Monday asked FDA to authorize its coronavirus vaccine. | | |  | Sugar rush | | | Thanks for reading! See y'all tomorrow. | |
No comments:
Post a Comment