With Covid-19, there’s no such thing as a sure thing – POLITICO

ON THE REBOUND — CDC Director Rochelle Walensky has a rebound Covid-19 infection, the agency said in a statement Monday, a development that underscores — for the dwindling number of people paying attention — this is, once again, a Confusing Pandemic Moment.

After testing positive for Covid-19 last week, Walensky took the antiviral treatment Paxlovid, tested negative and then tested positive again after experiencing more mild symptoms. The director is fully boosted and has received the updated bivalent booster that targets the Omicron variants dominant in the U.S. right now.

As we know, rebounds after Paxlovid aren’t uncommon. Both President Joe Biden and First Lady Jill Biden have had rebound infections after taking the antiviral pill. A June CDC study found that rebound cases were unlikely to lead to hospitalization and generally milder than the first infections.

That’s blunted some people’s interest in the treatment, but a study published in JAMA Network Open last week suggests rebound infections aren’t limited to people treated with Paxlovid. Researchers from the University of California, San Diego, and Harvard found that nearly a third of the patients they studied experienced symptoms after being symptom-free for two days. In those cases, most symptoms were mild.

Adding to the uncertainty: Two separate studies from Harvard and Columbia found that the new bivalent boosters may not be any more effective than the first-generation shots. Peter Marks, the FDA’s director of the Center for Biologics Evaluation and Research, was quick to throw cold water on the studies, saying they were too small and limited to be conclusive. He said better data about the new boosters would be coming soon.

Will anyone be paying attention when it does? Only 22.8 million Americans — just 7.3 percent of the eligible population — have received a bivalent booster shot, despite the Biden administration’s ongoing push to encourage people to get it ahead of the winter.

Walensky’s breakthrough and rebound infections are unlikely to hurt that campaign or stop anyone from saying no to treatment if they get Covid-19. Millions have already tuned the CDC out. But for those who haven’t, her case is a potent reminder that after nearly three years of living with this virus, there’s still no such thing as a sure thing.

WELCOME TO TUESDAY PULSE — So it turns out there is a “planet killer” asteroid out there that’s been hiding behind the sun’s glare. It’s just really, really far away. I hope that’s all any of us ever need to know. Send your news and tips to [email protected] and [email protected].

TODAY ON OUR PULSE CHECK PODCAST, Lauren Gardner talks with Alice Miranda Ollstein about how the increase in RSV cases casts attention on a handful of drugmakers with vaccines in the pipeline. Plus, Alice’s dispatch from Michigan where Gov. Gretchen Whitmer is trying to make an economic case for abortion rights.

WAITING ON THE RSV VACCINE — The sudden surge in respiratory syncytial virus cases among children across the nation has put fresh attention on the handful of drugmakers with vaccines and therapies in development, POLITICO’s Lauren Gardner and Katherine Ellen Foley report.

But it’s doubtful that RSV vaccines for children will be available in the near term. The first ones likely to become available will be for the elderly and pregnant people. Pfizer has said it plans to file an application to the FDA in the fall, and GSK expects to file for approvals by the end of the year.

Backstory: Pandemic-associated lockdowns in 2020 disrupted the normal circulation of viruses in the population, and flu and RSV rates plummeted that winter. Since then, respiratory diseases have peaked at unusual times, with RSV cases rising in the spring and summer of 2021 and beginning to spike this year as early as August.

More than 6,000 cases of RSV were PCR- or antigen-confirmed across all age groups during the week of Oct. 22, according to the CDC, compared with fewer than 30 recorded RSV cases during the last week of October 2020.

The vaccine: National Institutes of Health researchers have worked on developing an RSV vaccine since the 1960s. One potential vaccine candidate worsened the disease in babies who were inoculated and later exposed to RSV. Roughly 80 percent of the children in the trial who contracted RSV later were hospitalized and two died.

After “decades of frustration,” NIH scientists made a breakthrough in 2013 that paved the way for two vaccine options closest to seeking regulatory approval. But they’re geared toward older individuals, not children.

“It probably will be the next great pediatric vaccine,” said Paul Offit, director of the Vaccine Education Center and a doctor at the Children’s Hospital of Philadelphia. But “it hasn’t been an easy vaccine to make.”

SCATHING FEEDBACK ON FDA’S TOBACCO PROGRAM — Legal, industry and public health experts told the outside panel reviewing the FDA’s tobacco regulatory decision-making that the agency’s process is so slow and opaque that it’s ineffective, POLITICO’s Katherine Ellen Foley reports.

As part of the process, anonymous FDA staffers have also said the Center for Tobacco Products’ regulation is driven by politics instead of the science behind the impact of new tobacco products on the agency’s mission to reduce any harm to adult consumers or youth.

Last week, the five-person panel, organized by the Reagan-Udall Foundation and led by former FDA chief of staff Lauren Silvis, heard comments from the public and some FDA staffers in addition to the experts on how the agency’s Center for Tobacco Products could more effectively execute its mission. An online comment portal is open through Nov. 7.

WHY ISN’T WEED ON THE AGENDA? More than two-thirds of American voters say they support marijuana legalization, but fewer than 1 in 5 congressional candidates in the 2022 primaries staked out clear positions on cannabis policy, POLITICO’s Natalie Fertig and Holly Otterbein report.

One month before Election Day, Biden — who has been notoriously wary of legalizationannounced a series of executive actions aimed at federal drug reform: He pardoned more than 6,500 people with federal convictions for marijuana possession and began a review process that could federally decriminalize weed.

But few candidates in next week’s midterms are following his lead. In 2020, criminal justice reform was a major issue for voters in the wake of the murder of George Floyd, and cannabis policy received a boost in attention because of that. But in 2022, the focus has primarily been on democracy, crime, abortion and the economy. That, some strategists say, has kept candidates from discussing cannabis.

Without clear evidence that cannabis support moves the needle positively in their races, candidates are wary of deviating from the status quo, experts say.

OBAMACARE CALL CENTER WORKERS TO STRIKE — Hundreds of call center workers at the nation’s largest federal call-center contractor plan to strike today, the first day of Affordable Care Act open enrollment.

The workers at Maximus, the contractor in Tysons Corner, Virginia, staff call centers that handle Medicare and ACA Federally Facilitated Marketplace calls. During open enrollment, call volume dramatically increases and workers are pushed to their limits and expected to answer back-to-back calls about complex issues, workers say.

The workers want a minimum wage of $25 an hour, at least 30 minutes per shift of non-call time and policies protecting them from abusive calls, which worsened during the pandemic, including the ability to hang up or escalate calls.

Maximus said in a comment to POLITICO that only 1 percent of its 11,000 call center workers were involved in the strike today.

The company also disputed the workers’ characterization of its break policy and policies protecting them from abusive calls, saying it provides “reasonable and flexible break policies” and that “employees can request bathroom breaks at any time and employees who work 8 hours can take two 15-minute rest breaks in addition to their half hour lunch break.”

“Maximus respects the dignity and well-being of our employees,” Eileen Cassidy Rivera, vice president of public relations and communications said in a comment. “While we haven’t seen evidence of a growing trend in abusive or obscene calls, we have a very clear Standard Operating Procedure to protect our employees when we occasionally receive such calls. If a caller is persistently inappropriate or obscene, or uses derogatory or disrespectful language, our employees are empowered to immediately end the call. They are not required to warn the abusive caller that the call is being terminated and are not required to ask their supervisor for permission to disconnect a call.”

GROUPS CALL ON CONGRESS TO ACT ON HOME INFUSION — Patient groups, providers and pharmacists are calling on lawmakers to pass new legislation that seeks to make it easier for patients on Medicare to get infusion therapy at home.

In a letter sent Monday to Congressional leadership, the 30 signatory organizations say the way that the Centers for Medicare and Medicaid Services is implementing a dedicated Medicare home-infusion therapy benefit is so restrictive that it’s standing in the way of patient access.

They say the Preserving Patient Access to Home Infusion Act (S. 2652 (117)) would ensure Medicare beneficiaries’ access to home care as their counterparts with private insurance do. The letter follows a similar effort from dozens of health systems and hospitals that have already called on Congress to advance the bill in August.

“With every commercial health plan in the country providing robust coverage for home infusion therapy, it’s confounding that Medicare hasn’t been able to get this benefit right,” said Shea McCarthy, director of legislative affairs at the National Home Infusion Association.

AND A NEW LAWMAKER SCORECARD — Patients Rising Now, the advocacy group for patients with chronic illness, releases its scorecard today of lawmakers based on their votes, co-sponsorship and other actions that support the chronic disease community.

Takeaway: The report’s authors say it shows that while healthcare issues are largely bipartisan, the trend in Congress of sweeping legislative packages is preventing specific, targeted bills from making it to the floor for a vote.

Lauren Lyles-Stolz has joined the National Association of Chain Drug Stores as senior director of reimbursement, innovation and advocacy. Most recently, she served as health legislative assistant for Rep. Brad Schneider (D-Ill.).

The Washington Post reports on the deadly mechanics of crowd events like the tragedy in Seoul.

In South Sudan, which has one of the world’s worst maternal mortality rates, a U.N.-supported maternal clinic is about to close due to lack of funding, The Associated Press reports.

Fentanyl is now behind 1 in 5 youth deaths in California, the San Jose Mercury News reports.

CLARIFICATION: Pulse has been updated to include comments from Maximus.