HEALTH CARE BRIEFING: Booster Debate to Hinge on Key FDA Meeting

President Joe Biden’s push to begin offering third doses of Pfizer’s coronavirus vaccine faces the first of two crucial tests today when advisers to the Food and Drug Administration meet to weigh whether booster shots should be offered to most Americans.

The meeting will take place as an extraordinary public debate plays out among administration officials, pharmaceutical executives, scientists, public health experts and global activists about whether boosters are even needed—and whether those doses would do more good being sent to poorer nations whose residents haven’t received even a single shot.

The administration’s plan to start offering boosters to almost all vaccinated adults starting next week has raised concerns among health experts that the administration is rushing ahead without enough data and regulatory oversight. The announcement came without the FDA and Centers for Disease Control and Prevention publicly saying they had fully vetted giving a third shot to the 180 million fully vaccinated Americans by year-end.

“If the advisory committee votes not to support boosters, this will put the administration in an awkward position,” Norman Baylor, former director of the FDA’s Office of Vaccines Research and Review and now chief executive officer of Biologics Consulting, said.

The agency isn’t obligated to follow the recommendations of the panel, called the Vaccines and Related Biological Products Advisory Committee, although it typically does. A decision on whether to authorize the supplemental shot could come soon after the meeting concludes later today.

Pfizer and its partner BioNTech will present data that suggest the efficacy of its Covid-19 vaccine wanes over time, and that a booster dose is both safe and effective at warding off the virus and new variants. New data from Israel supports that premise. A third dose of the Pfizer vaccine can dramatically reduce rates of Covid-related illness in people 60 and older, according to a study in Israel released on Wednesday by the New England Journal of Medicine.

But some scientists and even two top FDA officials have questioned evidence supporting the need for a third dose. Covid-19 vaccines work well and governments would be better served to focus on immunizing the unvaccinated, according to a review published in The Lancet this week, authored by an all-star panel of scientists from around the world. Fiona Rutherford and Anushree Dave have more.

More on the Pandemic

Mississippi Becomes Worst State for Covid-19 Deaths: Mississippi has overtaken New Jersey as the state with the highest per-capita death toll from Covid-19. Since the end of June, Mississippi has been among the states hardest-hit by the latest infection surge, fueled by the fast-spreading delta variant. In that period, Mississippi’s cumulative deaths rose by about 22% to 306 per 100,000 residents, the CDC has found. In other words, one in 327 Mississippians have died of Covid-19 since the pandemic began. Jonathan Levin has more.

Arizona AG Admits Suit Over Biden Rule a ‘Long Shot’: Arizona Attorney General Mark Brnovich acknowledged his suit challenging the Biden administration’s announced Covid-19 vaccine requirements for many U.S. workers is unlikely to succeed because the actual rules haven’t yet been finalized. “Is it a long shot? Yeah, I recognize that,” said Brnovich, a Republican running for Senate in 2022. The lawsuit is almost certain to be dismissed because there are no actual mandates yet, making the dispute unripe. Erik Larson has more.

Federal Worker Vaccine Order Gets More Guidance: Federal employees must be fully vaccinated by Nov. 22 or face progressive discipline that can include termination, according to new guidance from the White House on how agencies must implement the president’s Covid-19 inoculation requirement. Additional guidance from the White House’s Safer Federal Workforce Task Force yesterday outlined enforcement of the vaccine requirement, documentation, and “limited exceptions” to the mandate. Read more from Paige Smith.

  • Biden’s call for an employer vaccine mandate has put the federal government’s short-staffed Occupational Safety and Health Administration in a tight spot. In effect, an agency not known for speed is being forced to develop a complex rule under an expedited format in a matter of weeks—with legal challenges all but guaranteed once it takes effect. It will be the second Covid-19 emergency rulemaking for the agency this year. The first one took the agency nearly five months to complete, missing Biden’s initial deadline by more than three months. Read more from Ben Penn.

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Happening on the Hill

Nominations: Biden yesterday announced his intent to nominate Robert Otto Valdez for assistant secretary for planning and evaluation at HHS.

Migrant Care Contracts, Diverted Funds Draw GOP Scrutiny: Republican lawmakers want answers from the Biden administration on how the Department of Health and Human Services is awarding contracts and redirecting money for the care of unaccompanied migrant children. Rep. James Comer (Ky.), the top Republican on the House Oversight and Reform Committee, joined with colleagues in letters demanding HHS explain its management of record numbers of unaccompanied minors.

A spokesperson for HHS defended the agency, saying it prioritizes the care and well-being of minors in its custody. “We act quickly to address any concerns and have proactively closed sites that didn’t meet our standards,” spokesman Jorge Silva said in an email. Ellen M. Gilmer has more.

Patent Tribunal Under Fire in Drug Price Fight: Lawmakers are calling out a U.S. Patent and Trademark Office tribunal favored by generic drugmakers over policy they say blocks pharmaceutical competition, urging the agency to take action amid an ongoing spat to lower prices on prescription drugs. The Patent Trial and Appeal Board has “begun frequently denying petitions” to reconsider the validity of already-granted IP rights “for reasons not based on the merits,” lawmakers from both parties wrote. Ian Lopez has more.

Home Care Plan Could Fail Without $250 Billion: Labor, aging, and disability advocates are fighting to get lawmakers to put at least $250 billion toward their plan to expand home and community-based care for the elderly and disabled and improve conditions for the workers that tend to them. But the plan, which the administration wants funded at $400 billion over eight years, could fail if Congress approves a low amount that spurs states to not to take the money and leave Medicaid programs as is. Shira Stein has more.

Group Targets Democrats Against Drug Pricing Bill: Patients for Affordable Drugs Now launched new ads yesterday targeting Reps. Scott Peters (D-Calif.) and Kathleen Rice (D-N.Y.), both of whom voted against legislation in the House Energy and Commerce Committee to allow the government to negotiate lower drug prices, “for turning their backs on patients.” Each ad includes a six-figure spend and are running in the lawmakers’ districts through the week of Sept. 27, according to a statement from the group, Alex Ruoff reports.

  • Peters, in an interview with Bloomberg Radio, said he opposed the legislation because of “international reference pricing, which imposes a penalty of 95% to anyone who doesn’t agree to the government’s price.” Peters said “with that kind of disincentive at the back end, no one’s going to invest in drug discovery at the front end,” Jack Fitzpatrick reports.

Related:

Democrats Seek Investments for Palliative Care: Sen. Tammy Baldwin (D-Wis.) and Rep. Yvette Clarke (D-N.Y.) called on congressional leaders to secure investments in palliative care and hospice workforces “to keep pace with patient need and to help improve the well-being of Americans with serious illnesses,” according to a statement. The two lawmakers want investments included in the budget reconciliation package carrying major elements of Biden’s economic agenda. Find their letter to leaders here.

Democrats Applaud DOJ Appeal of Purdue Bankruptcy Plan: Rep. Carolyn B. Maloney (D-N.Y.), chair of the Committee on Oversight and Reform, Sen. Elizabeth Warren (D-Mass.), and others applauded a move by the Department of Justice’s U.S. Trustee to appeal the confirmation of Purdue Pharma’s bankruptcy plan, which they said grants too much legal protection to the Sackler family “for their role in fueling an opioid crisis,” according to a release.

What Else to Know Today

Texas Judge Rejects U.S. Bid for Earlier Abortion Hearing: A federal judge in Texas denied a Justice Department request to move up a hearing on whether the state’s restrictive new abortion law should be paused while the federal government challenges the ban in a lawsuit. The White House had argued that an Oct. 1 hearing on its motion for a temporary restraining order against the law should be moved to Sept. 21 because women are already at risk. But U.S. District Judge Robert Pitman denied that request. Erik Larson has more.

Companies Urging Workers to Open Up About Mental Health: The Covid-19 pandemic has led to a surge in mental health claims for employers. Even so, getting workers to acknowledge they’re having a problem and seek help is a major challenge many companies are trying to tackle, both because they want employees to get the care they need and because they are concerned about retaining their workers. Read more from Sara Hansard.

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With assistance from Alex Ruoff and Jack Fitzpatrick

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

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

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