HEALTH CARE BRIEFING: Senate Votes to Block Vaccine Mandate

The U.S. Senate voted last night to block President Joe Biden’s mandate for coronavirus vaccinations or testing for private sector workers in a mostly symbolic defeat for the administration but one that illustrates the nation’s political polarization over dealing with the pandemic.

Two Democrats representing states Biden lost last year— Joe Manchin (W.Va.) and Jon Tester (Mont.)—joined all 50 Republicans to oppose the mandate, which has already been paused by the courts and is not yet being enforced.

The measure passed with a vote of 52 to 48 in the evenly divided chamber.

The Democratic-controlled House, however, is unlikely to take up the resolution of disapproval. In addition, the administration has indicated that Biden would veto any such measure, and there isn’t the two-thirds majority necessary to override him.

Under the mandate, workers at companies with 100 or more employees would have to be vaccinated against Covid-19 or take tests weekly. A federal court has halted the administration’s rule, while another federal court will hear a consolidated case against the mandate.

Manchin has said he supports the mandate for federal workers but not for the private sector, suggesting incentives instead. His state and Tester’s have been hit hard recently with Covid-19 deaths, and both badly lag the nation in vaccination rates.

Vaccine mandates have become a political flashpoint across the country, with Democratic states and cities either considering or enacting their own. Many states and counties won by former President Donald Trump, at the same time, continue to lag in vaccinations. Read more from Steven T. Dennis and Laura Litvan.

GOP Puts Vaccine Mandates on Agenda for Midterm Elections: Fighting federal vaccine mandates is becoming a central pillar of Republicans’ health care agenda, one supporters say could help carry them into power in Congress next year. Apart from yesterday’s resolution, Congressional Republicans are trying to build support for more Congressional Review Act votes around federal vaccine mandates for health care workers and federal contractors. Reps. Jeff Duncan (R-S.C.) and James Comer (R-Ky.) both have resolutions on these mandates.This could be a risky move: voters seem to support at least some vaccine mandates, recent polling shows. Read more from Alex Ruoff.

  • The Biden administration’s Covid-19 shot-or-test rule should remain frozen as litigation proceeds because it’s an unprecedented exercise of power that ultimately will be deemed unlawful, a coalition of Republican attorneys general told a federal appeals court in Cincinnati. The top lawyers of Texas, Florida, and 25 other states asked the U.S. Circuit Court of Appeals for the Sixth Circuit this week to reject the administration’s request to dissolve another circuit’s order blocking the emergency regulation. Read more from Robert Iafolla.

Contractors Scramble After Court Halts Biden’s Shot Mandate: A nationwide block on the Biden administration’s Covid-19 vaccine mandate for millions of federal contractor workers sparked continued confusion for their employers and signals a threat to future executive orders aimed at businesses with government pacts. A Georgia federal judge issued a preliminary injunction on Tuesday against the measure for contractors, which employ roughly a quarter of the U.S. workforce. Read more from Erin Mulvaney and Shira Stein.

Happening on the Hill

Nominations: Biden yesterday announced his intent to nominate January Contreras for assistant secretary for children and families at the Department of Health and Human Services, and Timothy J. Baker as commissioner for the Federal Mine Safety and Health Review Commission, according to a press release.

Senate Floor: The Senate today resumes consideration of the House amendment to S. 610, the Protecting Medicare & American Farmers from Sequester Cuts Act, which would set up a simple-majority process to raise the debt limit and temporarily block cuts to Medicare and other mandatory spending programs. The Senate is scheduled to hold roll call votes on the measure today.

Biomedical Incubator Hearing Planned for 2022, Key Lawmaker Says: House lawmakers plan to hold a hearing next year on Biden’s plan to set up a new biomedical research agency, the head of the House health panel said yesterday. “I don’t know the date. But there’ll be a hearing,” Rep. Anna G. Eshoo (D-Calif.), chair of the House Energy and Commerce health subcommittee, told Bloomberg Law before a hearing on turning biomedical research into personalized health care. The signal of support from Eshoo is critical as she leads the subcommittee with jurisdiction over the Advanced Research Projects Agency for Health, or ARPA-H. And there are two competing proposals in the same committee to set it up. Read more from Jeannie Baumann.

GOP Senators Introduce Fentanyl Bill: Senate Republicans in their effort to address fentanyl-related deaths introduced legislation yesterday that would permanently ban fentanyl analogs while making exceptions for research, Alex Ruoff reports. Senate Health, Education, Labor and Pensions ranking member Richard Burr (R-N.C.) and Sen. Bill Cassidy (R-La.) introduced the Halt Lethal Trafficking (HALT) Fentanyl Act, according to a press release. The Biden administration recently recommended a permanent ban for fentanyl analogs with the ability to make exceptions for research purposes along with changes to sentencing guidelines for some drug traffickers.

  • Rep. Mike Kelly (R-Pa.), along with Rep. Doris Matsui (D-Calif.) and other bipartisan lawmakers, introduced the Access to Rare Indications Act, according to a statement. The legislation aims to ensure insurance, Medicare and Medicaid coverage and support for “evidence-based, medically necessary care” for patients with rare diseases, they said.

The Coronavirus Pandemic

Third Dose of Pfizer-BioNTech Shot Key to Fight Omicron: Pfizer and BioNTech said initial lab studies show a third dose of their Covid-19 vaccine may be needed to neutralize the omicron variant, results that will accelerate booster-shot drives around the world and may lead to use of new strain-specific vaccines.

Company researchers observed a 25-fold reduction in neutralizing antibodies that fight the variant, compared with the original strain of the virus, in people who got just two shots. However, boosting with an additional shot of the vaccine restored protection to a level similar to the initial two-dose regimen, the vaccine partners said in a statement. Along with stimulating the booster push, that may increase the likelihood that an omicron-targeted shot may ultimately be required. Pfizer said this would be ready by March. Read more from Naomi Kresge and Robert Langreth.

  • Biden said new Pfizer data on vaccine effectiveness against omicron is “encouraging.” “This reinforces what my medical advisors have been emphasizing: that boosters give you the highest protection yet,” Biden said in a tweet, Megan Howard reports.
  • Food and Drug Administration authorization of Pfizer booster vaccines for more teens took a step forward when the agency said further study by an advisory committee wasn’t necessary. Third doses for those age 16 and 17 do “not raise questions that would benefit from additional discussion by the members of the committee,” the FDA said in an email. Read more from Fiona Rutherford.
  • New Jersey Governor Phil Murphy (D) said the state is seeing a post-Thanksgiving spike in coronavirus cases and hospitalizations. With only 34% of residents having received a booster shot, the state will open new mass vaccination sites and encourage places to administer shots to walk-ins, he said at a briefing yesterday, Bloomberg News reports.
  • South African excess deaths, a measure of mortality above a historical average, almost doubled in the week ending Nov. 28 from the preceding seven-day period as a new coronavirus variant spread across the country, according to a report from the South African Medical Research Council. The rise, while only reflecting a week of data, contrasts with hospitalization numbers that show that most admissions have mild forms of the coronavirus, spurring hope that the omicron variant is more benign than earlier strains. Read more from Antony Sguazzin.
  • Related: Omicron Symptoms ‘Far Milder,’ S. Africa Hospital CEO Says

Fauci Says Talks Ongoing on Changing Fully-Vaccinated Definition: White House medical adviser Anthony Fauci said conversations are ongoing about changing the definition of fully vaccinated, and that he wouldn’t be surprised if the definition changes within a “reasonable” period of time. While the current definition of fully vaccinated is that of a person with two Pfizer or Moderna shots, or one Johnson & Johnson, there is no question that “to be optimally protected you now have to get third dose” of Pfizer or Moderna or another J&J, he told MSNBC, Daniela Sirtori-Cortina reports.

  • AstraZeneca’s antibody cocktail received emergency use authorization from the Food and Drug Administration, providing another possible weapon in the fight against the pandemic. Results from two trials show the cocktail is highly effective at preventing symptomatic Covid-19 in at-risk people and also halved the risk of developing severe illness or death from mild or moderate Covid-19, Bloomberg News reports.

School Encouragement Linked to More Vaccinations: Schools play an influential role in encouraging Covid-19 vaccinations for kids, according to a Kaiser Family Foundation poll released today. Among parents of 12-17 year olds whose schools encouraged getting the jab, 60% say their child is vaccinated. Slightly over 40% of parents whose schools did not encourage it say that their child is vaccinated. Read more from Jeannie Baumann.

More Headlines:

What Else to Know

Overdose Fight Spurs $30 Million in HHS Grants: The Department of Health and Human Services is offering $30 million in grants for local health providers to fund drug harm reduction services, a move that fits into the agency’s four-pronged plan for combating climbing U.S. overdose rates. The funds will come from the Biden administration’s American Rescue Plan and will target areas suffering most from the addiction epidemic. The HHS’ Substance Abuse and Mental Health Services Administration announced yesterday that it is accepting grant applications, and that funds will go to community programs for syringe services, counseling, and other overdose prevention strategies. Read more from Ian Lopez.

Generics Back Teva as Court Mulls New Redo on Drug-Label Case: Generic drugmakers are lining up behind Teva Pharmaceuticals to tear down a product label ruling they claim jeopardizes their ability to get low-cost drugs to market as the Federal Circuit weighs whether to rehear the case for the third time. A divided U.S. Court of Appeals for the Federal Circuit panel has twice ruled that Teva’s label on a copycat version of GlaxoSmithKline Plc’s Coreg heart drug led doctors to prescribe the generic for an infringing use. The outcome saddles Teva with a $235 million penalty, and case watchers say the latest ruling discourages generic producers from using routine labeling strategies to bring drugs to consumers for fear of massive financial hits—even more so than the first decision. Read more from Ian Lopez.

More Headlines:

To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com

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