with Alexandra Ellerbeck
“There are a lot of options … and we won’t know until we actually hear the deliberations,” said Walter Orenstein, professor of medicine at Emory University.
Their decision — whatever it is — will hold consequences for the nation’s vaccination effort.
It’s been 10 days since the federal government paused use of the Johnson & Johnson vaccine — over reports of six women developing extremely rare blood clots — and a week since the advisory board for the Centers for Disease Control and Prevention punted a decision on how to proceed.
The decision to pause — while controversial — didn’t have a huge effect on the total availability of vaccines in the United States, considering that far more Pfizer and Moderna shots are being given. But experts have worried about two other potential consequences:
- The Johnson & Johnson vaccine was being particularly targeted at harder-to-reach communities, given the ease of administering it. Unlike with the Pfizer and Moderna vaccines, it doesn’t require ultracold conditions and requires only a single dose.
- News of the rare blood-clotting condition may have increased skepticism among people already concerned about the safety of the vaccines.
So there will be many eyes on today’s meeting of the Advisory Committee on Immunization Practices, starting at 11 a.m., which is the group of outside experts who advise the agency on vaccine safety. Here are several potential outcomes:
They could recommend resuming use of the Johnson & Johnson vaccine, with added warnings.
This is the most likely scenario, according to reporting by our colleagues Laurie McGinley and Lena H. Sun, who interviewed two government officials who spoke on the condition of anonymity. Warnings about the rare complications could be added to the vaccine packaging, and medical professionals could be advised to share the information with potential recipients.
“Federal health authorities are leaning toward recommending that use of the Johnson & Johnson coronavirus vaccine resume, possibly as soon as this weekend — a move that would include a new warning about a rare complication involving blood clots but probably not call for age restrictions,” Laurie and Lena write.
Neither CDC Director Rochelle Walensky nor Janet Woodcock, acting commissioner for the Food and Drug Administration, would say which way federal authorities are leaning. But both offered encouraging news about the incidence of blood clots, telling Laurie and Lena that the government has received only a “handful” of additional cases.
That’s the route Europe took.
Earlier this week, the European Medicines Agency said the Johnson & Johnson vaccine should carry a warning listing the unusual blood clots as “very rare side effects.” But the agency didn’t place any restrictions on who can get the vaccine — and regulators concluded the benefits of the shot are greater than its risks.
“The benefits of the vaccine continue to outweigh these risks, and we now have detailed information in the labeling that alerts to these risks,” said Emer Cooke, the head of the European Medicines Agency. “We’re confident that it can be rolled out appropriately.”
Or the U.S. advisers could recommend resuming use of the vaccine but limiting it to certain populations.
Of the six blood-clotting cases for which details have been revealed, all of the patients were women under age 48. Several vaccine experts said they wouldn’t be surprised if the panel recommends resuming use of the Johnson & Johnson shots, but only for older populations.
Norman Baylor, former director of the FDA’s Office of Vaccines Research and Review, said if that’s the route, he doesn’t expect any gender-based restrictions because of the small number of cases observed.
“I’m going to speculate they’re not going to do it on gender, with those small numbers,” he said.
The panel could also recommend extending the pause.
This decision seems the least likely, given that government officials have said they’ve collected only a “handful” of additional cases beyond the six originally reported.
If the advisers were to abstain yet again from the making a decision — as they did last week — it’s easy to imagine the pause might go on indefinitely.
“The question would be what is the impact on the future of that vaccine if that pause goes on for a very long time,” Baylor said.
Ahh, oof and ouch
AHH: Biden’s next major legislative push does not include health care.
The president’s American Family Plan, which he is expected to roll out next week, raises taxes on the rich to fund universal pre-kindergarten, paid leave and an expanded tax credit for families with children. But the latest version of the plan leaves out proposals to expand health coverage and bring down the price of drugs, the New York Times reports.
“Administration officials had planned to include a health care expansion of up to $700 billion, offset by efforts to reduce government spending on prescription drugs. But they have decided to instead pursue health care as a separate initiative, a move that sidesteps a fight among liberals on Capitol Hill but that risks upsetting some progressive groups that have pushed Mr. Biden to prioritize health issues,” the Times’s Jim Tankersley writes.
Biden is set to outline his plan before his presidential address to a joint session of Congress on Wednesday. Previous versions had called for reducing prescription drug prices to raise revenue that could fund the continued expansion of Obamacare subsidies introduced in last month’s coronavirus relief bill.
- House Speaker Nancy Pelosi (D-Calif.) is digging in over the issue, the Wall Street Journal reports. In a statement released yesterday, she said “lowering health care costs and prescription drug prices will be a top priority for House Democrats to be included in the American Families Plan.”
OOF: Moderate House Democrats have sent Biden their list of health-care priorities.
The 94 lawmakers in the New Democrat Coalition sent Biden a letter calling on him to build on the Affordable Care Act and outlining several proposals they hoped to see included in the administration's agenda.
They want Biden to extend recently introduced subsidies for Obamacare premiums, simplify Medicaid enrollment and add even more incentives to get holdout states to expand the safety-net insurance program. The group also called on the administration to expand telehealth and push for value-based care models, which incentivize providers based on the quality of care they provide.
The changes largely build on initiatives that the Biden administration has already taken and probably would only achieve incremental gains in the number of Americans with health insurance.
Notably absent from the letter: any demand for a public option. Biden campaigned on the idea of a government-run health insurance program, pitching it as a more feasible and moderate alternative to the Medicare-for-all proposals championed by the left wing of his party.
OUCH: The CDC is reassigning prominent respiratory scientist Nancy Messonnier.
Messonnier is said to be moving from her position leading the agency’s coronavirus task force, Politico reports. Messonnier will be absorbed into an incident management response team headed by Walensky, the CDC director.
The CDC said Messonnier retains her position as the agency’s respiratory disease chief, but sources told Politico that she has since taken leave from the CDC, which some of them characterized as an unplanned vacation.
Messonnier rose to prominence in the early days of the Trump administration after her stark warnings about the potential impact of the virus angered top White House officials. After repeated clashes with the administration, Trump officials halted her regular press briefings.
“Messonnier’s long public silence was supposed to end when President Joe Biden assumed office and strove to put more scientists at the forefront of the pandemic response. But she also had differences with Biden officials, according to a person familiar with the discussion,” Politico’s Sarah Owermohle, Erin Banco and Adam Cancryn write.
On the Hill
The Senate Finance Committee deadlocked on its vote to advance Chiquita Brooks-LaSure.
The committee split 14 to 14 in its vote to advance Biden’s nominee to lead the Centers for Medicare and Medicaid Services, MedPage Today's Joyce Frieden reports.
Several Republicans who voted against Brooks-LaSure said that their opposition was not motivated by concern over her qualifications. Instead, they objected to a recent decision by the Biden administration to revoke Texas’s 10-year Medicaid waiver extension.
“She sounds to me like a very qualified person,” said Sen. John Cornyn (R-Tex.), a member of the committee. “And frankly, I was looking forward to voting for her nomination, but this unprecedented action by the administration threatens the security of my state's Medicaid program.”
Senate Majority Leader Chuck Schumer (D-N.Y.) can make a motion for a full Senate vote on the nomination without a recommendation one way or the other from the committee.
In a separate vote of 20 to 8, the committee advanced the nomination of Andrea Palm to serve as deputy health and human services secretary.
At the border
The federal government is paying travel costs for adult sponsors picking up migrant children.
The authorization to provide money for sponsors who are trying to get to the border to pick up kids represents a departure from usual Department of Health and Human Services policy.
“Officials would not provide numbers, but the policy shift underscores the urgency the Biden administration feels to quickly release kids who crossed the U.S.-Mexico border alone and remain in HHS custody,” Axios’s Stef W. Kight and Jonathan Swan report.
Despite efforts to speed up processing, more than 20,000 unaccompanied migrant children are being held in HHS shelters.
On Thursday, a bipartisan group of lawmakers introduced legislation to ramp up staffing at immigration agencies, establish four regional processing centers along the border and streamline court proceedings. The measure was introduced by Cornyn and Kyrsten Sinema (D-Ariz.) in the Senate and in the House by Reps. Henry Cuellar (D) and Tony Gonzales (R), both of Texas.