What A Day: The Food and Drug Administration

Friday, September 17, 2021
BY SARAH LAZARUS & CROOKED MEDIA

 -Justice Clarence Thomas, not in any way a partisan hack

As a scientific debate rages on over the Biden administration’s plan to begin rolling out coronavirus-vaccine booster shots next week, the FDA’s vaccine advisory committee has recommended a middle road: Booster just the Boomers, for now.
 

  • The committee voted decisively against recommending that the agency authorize Pfizer booster shots for all Americans ages 16 and older, in a 16-3 vote that followed a public debate over whether boosters are necessary to combat waning immunity. “It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Michael Kurilla, a committee member and NIH official. Accordingly, the panel took a second vote and endorsed boosters for people over 65 and high-risk groups.
     
  • Pfizer has made the case for booster shots based on data from Israel showing that severe cases went up sharply from July to August, despite the country’s high vaccination rate. But the CDC published new data on Friday showing that all three shots available in the U.S. continue to provide strong protection against severe disease, even as overall effectiveness declines over time. (Moderna held up slightly better than the others, remaining 93 percent effective at keeping folks out of the hospital. Hats off to Dolly Parton.) One key nuance here: We’re not all on the same page about what a “severe case” means. In Israel, it’s defined by low oxygen levels and an elevated respiratory rate. In the U.S., it means hospitalization and/or death.
     
  • The advisory committee’s debate was strictly focused on whether data indicated that booster shots were safe, effective, and necessary, divorced from the question of what U.S. boosters might mean for global vaccine equity. Last week, the WHO reiterated its call for a moratorium on third shots in rich countries; the Biden administration says it can triple-jab Americans and keep up its global distribution efforts at the same time. The administration is set to announce next week that it will buy another 500 million Pfizer doses to donate around the world.

Meanwhile, a less-scientific debate over the next frontier of vaccine mandates has been picking up steam: Should unvaccinated people be allowed to infect everybody on the Acela? Or no?
 

  • Earlier this month, Rep. Don Beyer (D-VA) introduced the Safe Travel Act, which would require anyone traveling domestically by air or Amtrak to show proof of vaccination or a negative COVID test. Anthony Fauci endorsed a travel mandate this week, as did former Transportation Secretary Ray LaHood. Airlines have made it clear that they’re in favor of the idea—rampant plague hasn’t actually been great for business—but feel they can’t afford to issue their own requirements without a directive from either Congress or the White House. Your move, Congress or the White House!
     
  • In addition to helping the U.S. get the Delta surge under control, vaccine requirements for travel might limit further incidents like this one: A group of tourists from Texas assaulted a hostess at a Manhattan restaurant after she asked them to show proof of vaccination, as mandated for indoor dining in the city. “Unvaccinated red-state residents bringing COVID across the country and punching anybody who tries to stop them” feels like something to maybe nip in the bud before Gov. Greg Abbott (R-TX) giddily endorses it.
 

For all of the tension and disagreement around booster shots, the most pressing problem hasn’t changed: Over 1,900 Americans are dying each day because not enough people have received a first dose. We’ve already seen that workplace vaccine requirements effectively raise vaccination rates and aren’t nearly as controversial as the GOP would like them to be; moving quickly to protect travelers from the unvaccinated would seem to be the logical next step.

Lovett or Leave It: Live Or Else is back in Los Angeles! Vaxx up and mask up to join Jon Lovett and friends every week at Arena Cinelounge — Outdoors.  In his first show back, Lovett will be joined by friend of the pod Emily Heller. Tickets are on sale now for weekly shows starting on September 23rd. For updates, check out Crooked.com/events.

The Pentagon has acknowledged that a U.S. drone strike in Kabul on August 29 was a horrific mistake, as a New York Times investigation concluded last week. The strike killed 10 civilians, including seven children, and the targeted car that the military thought was loaded with explosives and bound for the Kabul airport in fact posed no threat at all. The driver was Zemari Ahmadi, a worker for a U.S. aid group who had nothing to do with ISIS, and the “explosives” in his car were most likely water bottles. “This strike was taken in the earnest belief that it would prevent an imminent threat to our forces and the evacuees at the airport, but it was a mistake and I offer my sincere apology,” Gen. Kenneth McKenzie said on Friday. McKenzie said the U.S. was “exploring the possibility” of making reparations payments to the victims' families.

In the latest edition of the Facebook Files investigation, Facebook’s internal research shows that it knew that anti-vaxxers were flooding the platform to discourage vaccinations, undercutting Mark Zuckerberg’s own goal of protecting the vaccine rollout. While Zuckerberg was bragging that his company had “already connected more than 2 billion people to authoritative COVID-19 information,” Facebook researchers were warning that anti-vax users were flooding the comment sections of vaccine-related posts, sowing doubt about authoritative sources. “That’s a huge problem and we need to fix it,” the staffers wrote. Facebook was scrambling to get anti-vax content under control behind the scenes while playing the problem down in public, demonstrating that even on the rare issue where Zuckerberg decides to take a stand, the company doesn’t have the wherewithal to prevent Facebook from causing harm.

In 2021 mental health is finally a thing, especially as people are not feeling like their normal selves. Let’s support one another and talk openly. Whether or not therapy is your thing, knowing it’s available and affordable is important, for you or perhaps a loved one.  

Millions of people are trying and loving online therapy. It doesn’t have to be sitting around just talking about your feelings.

So, what is therapy, exactly? It’s whatever you want it to be.

You can privately talk to someone if your stress is too much to manage, you’re battling a temper, having relationship issues, anxiety, depression, etc… Whatever you need, there’s no more shame in these normal human struggles. We take care of our bodies, why not our minds, too? Without a healthy mind, being truly happy and at peace is HARD.

BetterHelp is customized online therapy that offers video, phone and even live chat sessions with your therapist, so you don’t have to see anyone on camera if you don’t want to. It’s much more affordable than in-person therapy and you can start communicating with your therapist in under 48 hours.

It’s always a good time to invest in yourself, because you are your greatest asset. See if online therapy is for you by heading to BetterHelp.com/crooked for 10% off your first month.

North Carolina judges have struck down the state’s voter ID law as unconstitutional. 

Gov. Kathy Hochul (D-NY) has signed a bill into law that will keep people with minor parole violations out of jail.

Voters of all persuasions support the Build Back Better Plan by a 32 point margin, according to a new Data For Progress Poll. 

Gov. Jared Polis (D-CO) has married his longtime partner Marlon Reis in the first same-sex marriage for a sitting governor.

. . . . . .


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