Public health officials are hammering out plans to vaccinate children. CDC advisers are set to debate who should get Moderna and Johnson & Johnson’s booster shots. And federal regulators are strongly considering greenlighting extra doses for people as young as 40.
Vaccine providers may once again see more people clamoring to get shots all at once. The simultaneous efforts come as the pace of immunization has slowed in recent months, with just over 57 percent of Americans fully vaccinated. But now, beleaguered public health officials are in planning mode again, as experts hash out thorny questions about who should get the shots.
AP's Jonathan Lemire
Here’s what you need to know:
1.The stage is set for a coronavirus vaccine for kids.
For some parents, federal health officials can’t greenlight the shot soon enough.
Yesterday, the White House unveiled its plans to roll out vaccines for the 28 million children ages 5 to 11. The massive effort is set to begin when federal health officials authorize the reduced doses of Pfizer’s shot, which could come early next month.
- A head start: The White House says it has already acquired enough doses to vaccinate every child in that age group, Lena H. Sun, Frances Stead Sellers and Amy B Wang report.
- Behind the scenes: The plan is to make the kids’ vaccine available to over 25,000 pediatricians and doctors’ offices, in addition to pharmacies, school-based sites and more.
- The packaging: Vaccinators will receive packages of 10 vials, each containing 10 doses. Doses must be used within six hours once a vial is cracked open, according to a CDC planning document obtained by The Health 202.
- Allocating the doses: States received estimates this week of how many shots they’ll get in their first shipments, according to two people familiar with the plans. Roughly 10 million doses will get sent to states and 5 million will go to pharmacies in the first week, a CDC spokesperson confirmed.
But yet, officials know some parents won’t be rushing to vaccinate their kids. The administration is planning a national public education campaign to try to combat hesitancy.
The Post's Laurie McGinley
2.Today: CDC advisers will debate boosters (again).
Yesterday, the Food and Drug Administration authorized booster shots for Moderna and Johnson & Johnson. The agency also said people can get any type of vaccine for their booster regardless of the first dose they received.
Who can get it? Moderna’s authorization lets Americans 65 and older, as well as those at risk due to an illness or their workplace, get a booster after six months. Johnson & Johnson’s is much broader, allowing anyone 18 and older to get the extra dose after just two months.
All day: The CDC’s outside advisers will meet to recommend the use of booster shots, which will then require sign off from the agency’s director.
- “The CDC’s immunization advisers are likely to recommend that people try to get a booster of the same vaccine as their initial series, but allow for mixing and matching,” my colleagues Carolyn Y. Johnson, Laurie McGinley and Lena H. Sun report.
An NIH study showed mixing and matching coronavirus vaccines increased virus-fighting antibodies, though the study’s sample size was small. Even so, two members of the CDC’s advisory committee told The Health 202 they were comfortable with the practice, since it would provide more flexibility to clinicians.
Looming over the meeting is a decision from CDC Director Rochelle Walensky to partially overrule her advisers last month. She recommended the Pfizer booster for those at risk from their jobs after the committee decided against doing so in a contentious 9-to-6 vote.
- The Health 202 spoke with panel members Kevin Ault, a professor at the University of Kansas School of Medicine, and Wilbur Chen, a professor of medicine at the University of Maryland School of Medicine. They took opposing positions on the issue, but both said they understood Walensky’s call.
3. Even more Americans may be able to get boosters — at least pretty soon.
The FDA is seriously considering allowing coronavirus boosters for everyone age 40 and older, a move that would drastically increase the number of people who can get the extra shot.
- “Senior federal health officials have been eager to lower the eligibility age for booster shots because of concerns that some middle-aged people are becoming ill with covid-19 despite being fully vaccinated,” Laurie writes.
But don’t expect a decision until at least next month. The FDA still needs to authorize covid shots for kids first (see No. 2 on the list).
White House prescriptions
President Biden is getting into the nitty-gritty details of negotiations over his agenda
President Biden is taking a more active role in negotiations over Democrats’ signature social-spending package, The Post’s Annie Linskey, Sean Sullivan and Matt Viser report.
After weeks in which the president revealed few of his own opinions on how to slim down the package, he has started to dive into specific details, telling lawmakers what elements of the package he thinks are essential and what can be cut. He’s told lawmakers, for instance, that he prefers universal pre-kindergarten to free community college.
The president has also weighed in on health-care priorities. He's floated the idea of giving seniors a debit card loaded with $800 to spend on dental benefits as part of an expansion of Medicare.
Biden has signaled money for programs for in-home care for seniors and the disabled and extending Medicaid to 2.2 million people in non-expansion states remain in the mix, our colleagues report.
- A possible timeline? “House Speaker Nancy Pelosi told her top lieutenants at a meeting Tuesday that she was aiming to finalize the outline of the package by Thursday night, people with knowledge of the conversation said. The speaker has also said she wants to hold House votes on the package by Oct. 31, or a week from Sunday," Annie, Sean and Matt write.
CNN's Manu Raju
The president is set to appear at a town hall in Baltimore tonight.
- Biden has been hitting the road to sell his sweeping economic vision to the public. Appearing in his childhood hometown of Scranton, Pa., Biden promised his agenda would spark “a fundamental shift in how our economy works.” (Read the full story from The Post’s Tony Romm, Seung Min Kim, Marianna Sotomayor and Jeff Stein.)
Aduhelm's launch flopped
Sales of Aduhelm, Biogen's controversial and expensive new Alzheimer's drug, came in well below expectations, Axios's Bob Herman reports.
The company sold $300,000 worth of Aduhelm in the third quarter, which prompted analysts at Raymond James to call the Alzheimer's drug “potentially the worst drug launch of all time,” Bob writes.
“Aduhelm's controversial approval and high price tag have shaped the market reaction. Health insurers are hesitant to cover Aduhelm until Medicare makes a decision next year, and doctors aren't embracing the drug either,” he writes.
Biogen CEO Michel Vounatsos said the main reason there has been almost no uptake of Aduhelm is the “lack of clarity on reimbursement” – something Medicare will weigh in on next year. But Vounatsos said Biogen doesn't plan to immediately lower the price of the drug, which costs on average $4,300 for a monthly infusion.
Some nursing homes have been slow to vaccinate their staff
A federal nursing home mandate is looming. But only 69 percent of nursing home staff have been vaccinated, according to federal data.
The low vaccination rates among nursing home workers are a cause for concern because many residents are older and suffer from medical conditions that make them particularly susceptible to breakthrough infections, The New York Times’s Reed Abelson reports.
- Federal health officials are in the throes of crafting vaccination requirements for staff in health facilities and nursing homes, which may boost immunizations. The Centers for Medicare and Medicaid Services anticipates issuing the rule in mid-to-late October, a spokesperson told The Health 202 earlier this month.
Some states, like New York and Maryland, and many individual facilities and nursing home chains have imposed mandates. Other facilities are holding off on a mandate until the federal government forces their hand.
- In at least 10 states, the staff vaccination rate is less than 60 percent. Oklahoma and Missouri have the lowest rates, with less than 55 percent of staff vaccinated per facility on average.
- Staff vaccination rates are over 90 percent in five states, including California, Hawaii and Massachusetts.
Here's what else we're watching:
- New York Mayor Bill de Blasio (D) announced that all city workers will need to show proof of at least one vaccine dose by Oct. 29. Those who meet the deadline will get $500. Those who don’t could find themselves on unpaid leave.
- Novavax is claiming that its vaccine will be ready for global use this year, saying it plans to file for emergency use in the United States by the end of 2021, Politico’s Sarah Owermohle, Erin Banco and Adam Cancryn report. The statement comes after Politico reported that manufacturing issues with the vaccine, including impurities in its production, would delay its global campaign.
From our notebook
The pressure is on…
As Democrats debate what’s in and out of their economic package, advocates are jockeying to get buy in on their priorities. Here are two new efforts shared with The Health 202:
Protect Our Care, a Democrat-connected health-care advocacy organization, is ratcheting up the pressure on Sen. Kyrsten Sinema (D-Ariz.) to support drug pricing reforms. A new ad released today will air in Phoenix, part of a six-figure media blitz in her home state. Sinema has reportedly expressed concerns over Democratic efforts to give the federal government the power to negotiate with drug companies for lower prices.
More than two dozen addiction treatment and recovery groups sent a letter to Congress urging Democrats to keep a national paid leave program. The organizations — which include the National Association for Addiction Treatment Providers and the American Psychiatric Association — argue that many people are unable to take time off work to receive addiction treatment. A paid leave program, they write, would help remove that critical roadblock.
Thanks for reading! See y'all tomorrow.