Overnight Healthcare

Overnight Health Care — FDA vaccine scientists depart amid booster drama

Overnight Health Care — FDA vaccine scientists depart amid booster drama

Welcome to Tuesday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.

The Manhattan DA filed charges against a couple who sold fake vaccine cards on Instagram for $200 each, and charged an extra $250 to enter the cards into New York's centralized database. Also facing charges: the people who bought the cards, many of whom were health workers. COVID-19 vaccines are free. 

Speaking of vaccines, two top vaccine regulators are leaving the FDA as it wrestles with decisions about booster doses, raising a whole new round of questions about varying political pressures on the agency as it navigates the pandemic. 

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For The Hill, we’re Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let’s get started.

Health officials stand by boosters after top FDA scientists announce retirements 

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Top federal health officials on Tuesday defended the Biden administration's approach to coronavirus vaccine booster shots after two senior scientists in the Food and Drug Administration's (FDA) vaccine division announced their intent to leave the agency.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and Phil Krause, the office's deputy director, will retire later this fall, according to an FDA spokeswoman.  

The two scientists are the most senior vaccine regulators at the agency and both helped review the COVID-19 vaccines. Gruber, who has spent 32 years at FDA, will leave at the end of October. Krause, who’s worked at FDA for more than a decade, will leave in November. 

"Stay ahead:" When asked during a press conference whether he thinks the departures would undermine trust in FDA, White House coronavirus response coordinator Jeff ZientsJeff ZientsThe Hill's Morning Report - Presented by Alibaba - Government shutdown fears increase as leaders dig in Travel industry hopes for rebound with loosened COVID-19 restrictions Overnight Defense & National Security — Presented by AM General — Rocky US alliances as Biden heads to UN assembly MORE defended the booster announcement.

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"That decision was made by and announced by the nation's leading public health officials," Zients said, adding that the announcement was made "to stay ahead of the virus" and to give states and pharmacies time to plan.

Context: The announcement comes as FDA is weighing the evidence for coronavirus vaccine booster doses as well as shots for children. It also comes amid fierce debate and criticism over whether the Biden administration is jumping ahead of the scientific review process in announcing boosters for everyone could be available by the week of Sept. 20.

Up next: An agency-wide memo from Acting FDA Commissioner Janet Woodcock said the agency has a plan in place "that will allow us to continue prioritizing science, while meeting timelines that are important to ensuring the end of this devastating pandemic."

Read more here.

 

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FLORIDA WITHHOLDS FUNDING FOR TWO SCHOOL DISTRICTS

The Sunshine State fight over school mask mandates is continuing, even as a lawsuit works its way through the courts. 

Florida Education Commissioner Richard Corcoran announced Monday that the department has withheld funds in the amount of monthly school board member salaries from Alachua and Broward county districts for implementing mask mandates without an opt-out option.

The withholding of funds will continue monthly “until each school board complies with state law and rules,” the statement said.

Florida is one of several Republican-led states that have prohibited mask mandates in schools, yet as of last week 10 districts accounting for more than half of the state’s enrollment have imposed mask mandates.

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Ignores ruling: The announcement came despite a ruling from Leon County Judge John Cooper on Friday that the executive order was “without legal authority.” Cooper issued an injunction stopping the state from withholding funding from districts that institute mask mandates.

The Biden administration has said federal funding can cover the costs of officials that lose pay.

Read more here.

Why the COVID-19 origin report came up inconclusive 

 

The U.S. intelligence community was unable to reach a conclusion about the origins of COVID-19 after a 90-day review of available data and interviews with top health experts and officials.

If anyone was surprised about the inconclusive results, it was not those same health experts and officials. Those with experience hunting viruses in their natural habitats know just how difficult it is to track their origins.

Many had said from the beginning that there is insufficient evidence to pinpoint the moment in which the coronavirus infected its first human victim — and, based on experience with previous novel pathogens, the evidence is almost certain never to be found.

“It was obvious to many of us that based on the information they had, it was going to be incomplete,” said Michael Osterholm, director of the Center for Infectious Disease Research and Prevention at the University of Minnesota. “The level of information you need from the time that a spillover might have occurred or the time a leak might have occurred is in relatively short supply.”

The review by American intelligence agencies will be unsatisfying for everyone, whether they are inclined to believe the virus came from an animal known as a reservoir host and infected the first humans in a natural setting — something most health experts believe is the most likely explanation — or that the global pandemic is the result of a lab leak at a facility in Wuhan, China.

Read more here.

STUDY: MODERNA VACCINE PRODUCES TWICE AS MANY ANTIBODIES AS PFIZER

A study into the immune responses of the two mRNA COVID-19 vaccines found that Moderna’s vaccine created double the amount of antibodies as the Pfizer-BioNTech vaccine.

Researchers analyzed the antibody levels of Belgium health care workers after they received both doses of the vaccines in the study published in the Journal of the American Medical Association on Monday. 

Participants included 688 vaccinated with Moderna and 959 who received the Pfizer shots. 

Results: Among those who had not been previously infected, the Moderna recipients averaged 2,881 units per milliliter, compared to the Pfizer recipients who counted 1,108 units per milliliter.

The antibody levels in those who received Moderna were higher in infected, uninfected and across age categories.

The researchers said the difference in antibody levels could potentially be attributed to the higher mRNA content within the Moderna vaccine and the longer interval between the initial and second shots in the Moderna series.

Read more here.

 

JOHNSON & JOHNSON HIV VACCINE TRIAL FAILS

An HIV vaccine candidate manufactured by Johnson & Johnson failed to provide sufficient protection against infection, the company announced Tuesday, the latest blow to the HIV vaccination effort.

It's yet another example of just how lucky we are that a vaccine to successfully fight the novel coronavirus was manufactured so easily.

The company said its Imbokodo study posed no safety concerns, but will not continue. The study enrolled approximately 2,600 young women across five countries in sub-Saharan Africa, a region where women and girls accounted for 63 percent of all new HIV infections in 2020.

Participants were randomly selected to receive either the vaccine or a placebo, and researchers found the vaccine's efficacy was only about 25 percent, which was not statistically significant. 

The investigational HIV vaccine was manufactured using a strain of common-cold virus engineered to not cause illness, the same basic technology as Johnson & Johnson's coronavirus vaccine. It was administered to participants through four vaccination visits over a year. 

"While we are disappointed that the vaccine candidate did not provide a sufficient level of protection against HIV infection in the Imbokodo trial, the study will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV," Paul Stoffels, chief scientific officer at Johnson & Johnson, said in a statement.

Read more here.


Senate drug pricing bill may not apply to those with job-based insurance

Sen. <span class=Ron WydenRonald (Ron) Lee WydenA Democratic plan to wipe out independent contractors Biden pushes back at Democrats on taxes Want a clean energy future? Look to the tax code MORE (D-Ore.) speaks to reporters as he leaves the Senate Chamber after a cloture vote regarding the bipartisan infrastructure bill on Saturday, August 7, 2021." width="645" height="363" data-delta="9" />

Senate Democrats' bill aimed at lowering prescription drug prices may not apply to the millions of people who get health insurance through their jobs, Senate aides and lobbyists say, prompting alarm from employers and progressive groups.

Democrats' signature drug pricing measure, set to be included in their coming $3.5 trillion package, would allow the secretary of Health and Human Services to negotiate lower drug prices, a long-held Democratic goal. The House measure would apply those lower negotiated prices not only to seniors on Medicare, but also to the roughly 150 million Americans who get health insurance through their employers.

The problem: Byrd rule! In the Senate, the push is running into an obstacle from the complicated rules in the upper chamber. The "Byrd rule" requires that provisions have a sufficient impact on the federal budget. Lowering drug prices for people with private insurance does not have as direct of an impact on the federal budget as lowering prices with Medicare.

Also: Politics. In addition to Senate rules, Senate Finance Committee Chairman Ron Wyden is also navigating delicate politics as he tries to find a balance between moderate and progressive Democrats in a 50-50 Senate — the party cannot lose a single vote on the measure.

Some Democrats, including Sen. Robert MenendezRobert (Bob) MenendezBiden, don't punish India Democrats reject hardball tactics against Senate parliamentarian  Biden threatens more sanctions on Ethiopia, Eritrea over Tigray conflict MORE (D-N.J.), are wary of cracking down too hard on the pharmaceutical industry.

Read more here.

WHAT WE’RE READING

  • Lack of a vaccine mandate becomes competitive advantage in hospital staffing wars (Kaiser Health News)
  • They’re called mild cases. But people with breakthrough covid can still feel pretty sick (The Washington Post)
  • Purdue Pharma scrambles to discourage a Justice Department appeal of bankruptcy deal (NPR)
  • Loopholes leave gaps in mandated coverage for mental health (The New York Times)

 

STATE BY STATE

  • Louisiana hospitals rely on generators, staff lockdowns after Hurricane Ida (The Wall Street Journal)
  • Illinois’ child welfare agency continues to fail Spanish-speaking families (ProPublica)
  • ‘A step in the right direction for national security’: An antibiotic plant reopens in Tennessee to make penicillin (Stat News)
  • Tennessee underreported COVID-19 hospitalizations by about 5,100 (Nashville Tennessean)

 

OP-EDS IN THE HILL

That’s it for today, thanks for reading. Check out The Hill’s healthcare page for the latest news and coverage. We’ll see you Wednesday.