| Good morning! I'm the researcher for Health 202 and will be giving you the run-down on what you need to know about today's highly anticipated FDA advisory meeting on boosters. Below, we'll also get into the latest on legal battles over masking and vaccines. | Today's debate: Booster shots for the Pfizer vaccine |  Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, stands at the center of important decisions on coronavirus vaccines. (Amanda Andrade-Rhoades for The Washington Post) | | | When the FDA's outside vaccine advisers meet today, it could be their most contentious discussion since the start of the pandemic. They will need to decide whether to recommend a third, booster shot for the Pfizer vaccine. What they're staring down: A scientific community divided over whether now is the time to widely greenlight booster shots for all Americans. A Food and Drug Administration publicly sparring over the question of whether to recommend them. And a broader public taking matters into their own hands, as some seek a third shot even before the agency has formally authorized one. "This issue of boosters seems to be controversy on steroids," Cody Meissner, an infectious-disease specialist at Tufts and a member of the advisory committee, told The Health 202. | | Proponents of booster shots point to evidence that the effectiveness of vaccines may wane over time, leading to more breakthrough infections. Skeptics say the vaccines continue to prevent severe illness. The booster debate has sparked infighting between the White House and the CDC and may have contributed to the retirement plans of two top FDA vaccine regulators. | | Here's what you need to know ahead of today's meeting. | | The players: Nineteen voting members are set to attend today's meeting. These members bring expertise in vaccines, infectious diseases and biostatistics. The FDA is sending at least nine participants who will provide the agency with perspective but won't vote. | - Among them: two top FDA vaccine regulators, Marion Gruber and Philip Krause, who were co-authors of a Lancet article this week that argued forcefully against booster shots. Those same officials announced late last month that they would soon leave the agency — a departure that was, in part, because of the push for boosters, one former official told our colleagues at The Post.
- But not all of the officials are in lockstep: Also speaking is Peter Marks, the FDA official overseeing coronavirus vaccines who has said he thinks that data out of Israel makes a compelling case for boosters.
| | Speaking of Israel, expect proponents of booster shots to lean heavily on data from that country to make the case for boosters. | - Sharon Alroy-Preis, a top official from Israel's Ministry of Health will speak at the meeting, and is expected to attribute a sharp decline in delta variant cases to Israel's decision to authorize shots for everyone over 12. One study from Israel, published Wednesday in the New England Journal of Medicine, found that boosters reduced the risk of infection and severe illness in adults over 60.
- But some scientists say the data from Israel is not definitive: It covers a limited time period and relies on real-world studies, in which it can be hard to control for all the variables.
| | The key issues: The FDA's advisory committee is charged with determining whether booster shots are safe and whether they are effective. Pfizer will present findings from a clinical trial of around 300 people who received booster shots. That may seem like a pretty small group, but the advisers will also likely take into account the strong safety record of the initial two-shot series of the Pfizer vaccine. "I want to be pretty convinced that there is no harm. We don't want adverse reactions which will discourage people who are unvaccinated [from getting the initial shots]," Meissner said. | | Advisers will want to know how quickly vaccine protection is waning, the durability of the boosters' effect and whether the shots are safe and reduce viral transmission, our colleagues Laurie McGinley, Carolyn Y. Johnson and Lena H. Sun report. Issues of process could also come up. Jesse Goodman, a former chief scientist at the FDA, told The Health 202 that he thought the White House got ahead of itself when it announced a plan to make boosters available to the general public, beginning the week of Sept. 20. "A major policy decision and initiative was put out as a done deal prior to a discussion of the evidence," he said. Meanwhile, White House officials have defended their decision, saying it was crucial to give states the heads up so that they could craft their distribution plans. What happens next: | - The FDA's advisory opinion is just that, advisory. It'll be up to the agency to decide whether to go along with it.
- The FDA decides whether shots are safe and effective, but it's generally up to the CDC's Advisory Committee on Immunization Practices to recommend who should get them. They are set to meet next week.
| | |  | Coronavirus | | Battles over masking are playing out in court |  Florida Gov. Ron DeSantis has said the state will withhold money from school districts that require masks. (Joe Skipper/Reuters) | | | Some school districts have defied state bans on mask mandates. Now, that conflict is playing out in the courts, with mixed results. | | Cases have centered on questions of state power — whether governors have the power to ban mask mandates — and federal disability protections — whether preventing schools from requiring masks disadvantages the medically vulnerable and violates their rights. The court decisions so far are not final, but instead on whether to allow states to enforce the bans while litigation continues. | - Judges in Arkansas, Oklahoma and Iowa have blocked efforts to enforce the bans on mask mandates. A judge in Tennessee also issued a temporary restraining order on the state's ban, although the ruling applied to only one county.
- But other courts have allowed state prohibitions on mask mandates to stand. In Florida, an appeals court backed Gov. Ron DeSantis's ban on masks in schools, overturning a lower-court decision that put the ban on hold. The State Supreme Court in Texas has also sided with Texas's Republican governor, Greg Abbott.
- Meanwhile, the feds are getting involved. The U.S. Department of Education is investigating Iowa, Oklahoma, South Carolina, Tennessee, Utah and Florida to see if restrictions on mask requirements prevented kids with disabilities from returning to in-person school.
| The next legal battle: Republicans are threatening to sue over Biden's push for vaccine mandates |  Texas Gov. Greg Abbott said his state will win a "constitutional showdown" over a federal push for vaccine mandates. (Eric Gay/AP) | | | Republican Attorneys General from 24 states threatened to use every legal option to combat the Biden administration's vaccine mandate plans, calling the president's push to require vaccine for every federal worker and much of the private sector workforce a "threat to individual liberty." Yesterday President Biden accused some Republican governors of "the worst kind of politics," accusing the governors of Florida and Texas of "doing everything they can to undermine the lifesaving requirements that I proposed." | Here's what else you need to know | - Hospitals around Idaho are now allowed to ration care as covid cases overwhelm capacity. Meanwhile, a doctor who spread misinformation about vaccines has been elevated to the regional public health board in Ada County, which oversees the state capital of Boise, The Post's Hannah Knowles reports.
- New York officials want world leaders arriving for the United Nations General Assembly to be vaccinated, and now they have the backing of General Assembly President Abdulla Shahid, The Post's Ellen Francis and Adam Taylor report. But the measure has sparked confusion, especially over what vaccines will qualify. Russian U.N. Ambassador Vasily Nebenzya called it a "a clearly discriminatory measure."
- Nursing home aides were the least likely among nursing home staff to have received a coronavirus vaccination, according to a research letter in JAMA Internal Medicine.
- In a forthcoming book, former FDA commissioner Scott Gottlieb blames the CDC for hampering the U.S. response to the pandemic. Gottlieb argues intelligence agencies should have more of a role in pandemic preparedness, Axios's Tina Reed reports. The book, "Uncontrolled Spread," is set to come out Sept. 21.
- The White House confirmed that it offered to set up a call with rapper Nicki Minaj after the pop star wrote about her cousin's hesitancy to get a coronavirus vaccine. Minaj's tweet suggesting the vaccine can make people impotent "highlighted the Biden administration's ongoing struggles against coronavirus misinformation," The Post's Felicia Sonmez reports.
| | |  | State scan | | The leader of California's insurance exchange to depart after a decade | | Peter Lee helped launch Covered California, the state's Obamacare exchange, and has served as the only executive director since it began in 2012. He plans to leave his post in early 2022 after overseeing the effort to help get millions of Californians covered. | | |  | White House prescriptions | | Biden is making a fresh pitch for his massive social spending plan |  Biden delivers remarks regarding the economy. (Demetrius Freeman/The Washington Post) | | | The push marks a pivot away from emergency spending to deal with the pandemic to advancing a long-term liberal vision of government. In the White House's East Room on Thursday, Biden praised recent economic gains, attributing the advances to federal coronavirus relief aid and effective vaccines. But he stressed the need for lasting policy changes to ease the hardships of the pandemic, our colleagues Tyler Pager and Tony Romm report. His remarks come at a critical moment. The House took a first step in translating Biden's blueprints into a $3.5 trillion piece of legislation. But it's already under threat from Democrats who oppose a drug pricing provision key to offsetting the cost of a major health-care expansion and from centrists wary of the price tag. | | |  | Quote of the week | | | Welcome to our new Quote of the Week section! Here you'll find a quote that caught our eye — whether newsy, amusing or just a really good summary. (Submissions are always welcome.) | | A friend of Peter Marks texted the FDA official overseeing coronavirus vaccines | "Oh, my God, it never stops!" | | | | | | | | |  | Sugar rush | | | Thanks for reading! Have a good weekend! | |
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