FDA panel backs Covid vaccines for kids, with caveats

With Lauren Gardner

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— FDA’s panel of outside experts endorses Covid vaccines for younger children but with concerns about broad use.

— Democrats are struggling to solve final issues holding up their social spending bill — including what to do about expanding Medicare and Medicaid.

— A Texas judge dealt the latest blow to opponents of the Biden administration’s vaccine requirements, refusing to halt Southwest Airlines’ Covid-19 mandate.

WELCOME TO WEDNESDAY PULSE — Some companies send emails about open enrollment. Facebook … did this. Send the best enrollment strategies plus news to [email protected] and [email protected].

FDA PANEL RECOMMENDS COVID SHOT FOR KIDS — The FDA’s independent advisory committee on vaccines voted Tuesday to recommend the agency authorize the Pfizer-BioNTech shot for kids ages 5 to 11. The vote puts the vaccine within reach for anxious parents, as FDA is expected to green-light emergency use of the shot this week before the CDC follows suit next week with its deliberative process.

But … just because the vote was overwhelmingly in favor of the recommendation (17–0 with one abstention) doesn’t mean the members were completely gung-ho over the idea of vaccinating kids against Covid, Lauren writes. The safety data, while favorable on its face, is sparse, and some doctors are particularly jumpy given the experience of myocarditis among some teens and young adults after receiving messenger RNA vaccines.

And to some, immunizing kids represents a failure by society’s adults to avail themselves of vaccines and other mitigation measures to a degree that might have stemmed the many Covid waves that have crashed into the U.S. over the last 20 months.

“This vaccine should be available to those parents who are very eager [for their child] to get it, because their child has a comorbidity or because they’re concerned themselves,” said Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, before voting to recommend the shot. “I’m just worried that if we say yes that the states are going to mandate administration of this vaccine to children in order to go to school, and I do not agree with that.”

The counterargument: Doctors routinely vaccinate children against diseases that cause far fewer intensive care unit admissions and deaths, and Covid — namely, severe cases of it — has proven to be a vaccine-preventable disease, said Amanda Cohn, a CDC pediatrician who sits on the FDA panel.

“To me, the benefit is clear,” she said. “We don’t want children to be dying of Covid, even if it is far fewer children than adults.”

DEMS STILL DIVIDED OVER MEDICARE, MEDICAID EXPANSIONS — Top Democrats negotiating the party’s social spending package are still hung up on a series of key issues — including how to handle proposals expanding the nation’s Medicare and Medicaid programs, POLITICO’s Nicholas Wu, Sarah Ferris and Heather Caygle report.

The disagreements stand in the way of the Democrats’ bid to clinch a deal before President Joe Biden leaves the country later this week and have tested party leaders’ ability to keep their narrow majority united.

Among the other remaining hurdles are the size and scope of a paid leave program, the bill’s tax provisions and the fate of a prescription drug plan that was supposed to finance a significant part of the overall package.

The White House met with several groups of lawmakers Tuesday in an effort to bridge the gap, with Biden joining top advisers, including Susan Rice and Brian Deese. House Speaker Nancy Pelosi also signaled optimism, saying at one point the bill was 90 percent complete.

Yet that final 10 percent is critical — and has yet to be solved. Senate centrist holdouts Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.) remain roadblocks to a final deal, with Manchin particularly skeptical of the Medicare expansion. Meanwhile, Sen. Bernie Sanders (I-Vt.) and other progressives insist the major health provision must remain in the bill.

As for Medicaid: Democrats are mulling a new plan that would offer a few years of subsidized private insurance to those in the coverage gap in states that haven’t expanded Medicaid, POLITICO’s Alice Miranda Ollstein reports.

The concept is a response to concerns from Manchin and others who say holdout states shouldn’t be rewarded by having the federal government pay for coverage they’ve declined to provide.

It’s also likely to be more appealing to the insurance industry, since the government would directly subsidize Obamacare plans without creating a federal alternative.

JUDGE UPHOLDS SOUTHWEST AIRLINES’ VAX MANDATE — A Texas judge rejected a pilots’ union’s challenge to Southwest Airlines’ Covid-19 vaccine mandate in the latest legal loss for those opposed to the Biden administration’s vaccination requirements, POLITICO’s Oriana Pawlyk reports.

The Southwest Airlines Pilots Association’s case came after they had unsuccessfully sought exemptions to a federal mandate covering government workers and contractors — an umbrella that includes major U.S. commercial airlines. When that attempt failed, the union filed for an injunction in Dallas federal court.

But Texas District Judge Barbara M. G. Lynn denied the request, calling it premature and dismissing the union’s argument that the vaccines have potential side effects that could end a pilot’s career.

“Requiring Southwest employees to be vaccinated against COVID-19 will likewise improve the safety of air transportation,” she wrote.

Texas Gov. Greg Abbott has separately sought to ban vaccine mandates for private businesses in the state. But Southwest is still requiring its employees to be vaccinated by Dec. 8.

HEALTH GROUPS PLEAD FOR PAID LEAVE PROGRAM — Nineteen health and medical organizations are making a late push for preserving paid leave in Democrats’ social spending bill, calling universal medical and family leave “fundamentally an access to care issue.”

“The status quo forces many patients and caregivers to choose between treating their illness and having enough income to survive — while also exacerbating health inequities,” the groups, which include AARP, March of Dimes and the American Heart Association, wrote to HHS Secretary Xavier Becerra. “A universal paid leave program will help eliminate those tough choices.”

The letter comes as Democrats are still haggling over the specifics of a paid leave program and whether it will survive as part of a reconciliation package that could be finalized as soon as this week.

TODAY: HHS ROLLS OUT OVERDOSE PREVENTION STRATEGY — Becerra will be in Baltimore to debut a new federal overdose prevention strategy alongside Rep. David Trone (D-Md.), Maryland Attorney General Brian Frosh and Baltimore Mayor Brandon Scott.

The 10 a.m. ET announcement will be staged at a health center for the homeless that provides a syringe exchange program and other addiction services.

HEALTH ADVOCATES PRESS FOR SURPRISE BILLING GUARDRAILS — More than 30 employer, union and health plan groups sent a letter to top Biden officials Tuesday urging the administration to formalize an arbitration process that would protect consumers with large hospital bills.

The letter from the Coalition Against Surprise Medical Billing — sent to Becerra, Treasury Sec. Janet Yellen and Labor Sec. Martin Walsh — cited research from states like New Jersey, New York and Texas where the approaches to resolve costly bills “provide a cautionary warning about the consequences of a more expansive arbitration process.”

Background: The administration issued an interim final rule (Requirements Related to Surprise Billing; Parts I and II) that groups across the provider, insurer and employer networks are commenting on. “By reinforcing the importance of a predictable and limited arbitration process, the latest rule helps achieve a critical goal of improved access to affordable, in-network care,” the coalition wrote.

Neil Trautwein is the new executive director at the Partnership for Employer-Sponsored Coverage. He’s principal at Trautwein & Associates and a longtime health care lobbyist.

Facebook was slow to crack down on anti-vaccine posts even after employees and researchers found ways to slow the spread of conspiracy theories surrounding Covid-19, The Associated Press’ David Klepper and Amanda Seitz report.

Florida’s new surgeon general is dismissing criticism over his refusal to wear a mask, contending he can’t “communicate clearly” while wearing a face covering, the Tampa Bay Times’ Mary Ellen Klas writes.

In California, a medical clinic is testing a new model that combines concierge care for well-off patients with free services for the uninsured, Kaiser Health News’ Bernard Wolfson reports.

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