THE MORNING DISPATCH

The Morning Dispatch: What’s Taking the FDA So Long on Vaccine Approval?

Plus: How the Delta variant is affecting school reopening plans, and some more movement on Capitol Hill on infrastructure.

The Dispatch Staff 32 min ago
(Photograph by Al Drago/CQ-Roll Call/Getty Images.)

Happy Thursday! The Dispatch’s softball team is getting up off the mat and taking on the U.S. Agency for International Development tonight. They better hope they’ve developed some defense—we’re bringing out the big bats.

Quick Hits: Today’s Top Stories

  • The Senate voted 67-32 on Wednesday to open debate on a bipartisan infrastructure package that would allocate approximately $550 billion in new federal spending toward roads, bridges, waterways, airports, internet, and more. The full text of the bill is still being written, and final passage is not yet guaranteed.
  • United Kingdom officials announced yesterday that fully vaccinated travelers from the United States and European Union will no longer need to quarantine upon arrival to the country, starting August 2. The White House has not reciprocated, keeping in place its ban on most British people entering the United States.
  • In an effort to “promote accountability for entities and individuals that have perpetuated the suffering of the Syrian people,” the State Department on Wednesday announced the imposition of sanctions on a handful of Syrian prisons, Assad regime officials, and militia groups/leaders. They are the first new sanctions the Biden administration has imposed on the country.
  • A group of bipartisan House lawmakers announced Wednesday that they were forming a new caucus aimed at holding the Chinese government accountable for the genocide it is allegedly perpetrating against the Uyghur people.

The Mystifying Wait for Full Vaccine Approval

We wrote to you yesterday about the growing prevalence of COVID vaccine mandates, a discussion that’s gained steam as the Delta variant rips through the population. Some employers are beginning to require certain workers to get shots, but many institutions are waiting on the Food and Drug Administration to grant the vaccines full approval—rather than the current emergency use authorizations—before doing so. The longer the pandemic lingers, the more public health officials wonder: What the heck is taking so long?

“I can’t explain it,” Dr. Monica Gandhi, an infectious disease expert at the University of California San Francisco, told The Dispatch. “It doesn’t even seem like there’s a story that can be written about the reason for the delay, because I don’t think there are any reasons for it.”

To get full authorization from the FDA, Gandhi explained, companies are typically required to show clinical trial data—usually published in a peer reviewed journal—and submit six months of data showing the ongoing effects of their vaccines. When Pfizer and Moderna received emergency approval from the FDA in December 2020—the first time new vaccines had received such an authorization—the second criterion had not yet been met.

“When we went to emergency approval of these vaccines, they had only released their results in November and had only two weeks’ worth of data for some of the participants in their Phase 3 trials,” Gandhi said. “But now we’re past the six months—quite a bit past the six months—for some of those participants, because they started enrolling in July [2020].”

Both Pfizer and Moderna requested full authorization from the FDA earlier this summer. And in a recent essay for the New York Times, Eric Topol, a professor of molecular medicine at The Scripps Research Institute and a former FDA advisor, noted that 180 million doses of the Pfizer vaccine and 133 million of Moderna’s have been administered in the United States.

“In the history of medicine, few if any biologics (vaccines, antibodies, molecules) have had their safety and efficacy scrutinized to this degree,” he wrote. “It’s frankly unfathomable that mRNA vaccines have been proved safe and effective in hundreds of millions of people and yet still have a scarlet ‘E.’”

Delta Disrupts Back-to-School

It’s hard to believe, but the end of the summer is quickly approaching. For your Morning Dispatchers, that will mean welcome relief from the D.C. heat and humidity and a fond farewell to our intrepid interns. For more than 50 million kids across the United States, it will mean going back to school in an educational system that has been profoundly disrupted by the COVID-19 pandemic.

A report released Tuesday by the consulting firm McKinsey & Company underscores the negative effects of “unfinished learning” caused by the pandemic. By the end of the 2020-2021 school year, elementary school kids in grades one through six were “five months behind in mathematics and four months behind in reading” on average, with a disproportionate impact falling on poorer, majority-minority, and urban schools. These setbacks could be permanent, leading to depressed economic productivity and other ill effects years down the road.

Chris Marsicano, an education policy professor at Davidson College who helped develop the  Return to Learn tracker at the American Enterprise Institute, told The Dispatch that despite years of research showing that in-person learning is better for students, the “transitions from online K-12 education to hybrid or in-person systems” that happened across the country this past spring still showed “negative trends … relative to previous years in terms of student outcomes, whether they be test scores or grades or what have you.”

Marsicano’s colleague Nat Malkus, an AEI scholar, said “the return to normal school operations will be the best way to get kids sort of back on track—not necessarily caught up, but back on track.”

Unfortunately, normal operations may be further off for many than many had hoped. Earlier this month, the American Academy of Pediatrics updated its COVID-19 guidance for schools, urging universal masking while also “strongly advocating” for in-person learning. This week, the CDC followed suit.

Lucy Lets Charlie Brown Kick the Football on Infrastructure

If you follow politics and Congress closely, you know that accomplishing anything ambitious related to infrastructure has been the source of jokes on Capitol Hill for several years. Many elected officials across the political spectrum have promised to fix roads and bridges, saying it is a topic where Republicans and Democrats hold common ground.

During the Trump years, Democrats repeatedly pointed to infrastructure as a potential area for collaboration with Republicans—only for the two parties to differ dramatically on how much money to spend and how to finance that new spending. Many of those disagreements remained coming into the Biden administration, but a group of bipartisan senators has sought a deal for several months to address traditional infrastructure items including airports, highways, and rail.

After weeks of negotiations with their Democratic colleagues and the White House—and several false starts—a handful of Republicans led by Sen. Rob Portman of Ohio announced outside of Minority Leader Mitch McConnell’s office that an agreement had finally been reached.

Republicans weren’t the only ones taking a victory lap. “This deal signals to the world that our democracy can function, deliver, and do big things,” President Biden said in a statement. “As we did with the transcontinental railroad and the interstate highway, we will once again transform America and propel us into the future.”

Worth Your Time

  • If you enjoy good faith debate and discussion between two people who legitimately disagree, you’ll love this podcast featuring Ross Douthat and Ezra Klein. In it, the pair discuss how serious current threats to the democratic process actually are, how we should think about teaching American history, and why certain populations harbor such distrust for the medical establishment.
  • Vladimir Putin’s “regime is growing stronger, despite social discontent over the economy and Western sanctions for its alleged transgressions,” writes Ann Simmons in the Wall Street Journal. The West has exerted some pressure, but Alexei Navalny—the Russian opposition leader who survived an alleged assassination attempt—remains in jail, a sign of the invincibility Putin currently feels. “He doesn’t appear to feel threatened by the opposition or pressure from the U.S. and cares little about appeasing the public,” Simmons notes. “Authorities instead appear willing to use a range of tools to quash any space for organizing street protests or investigating the financial affairs of Mr. Putin and his inner circle.”

Presented Without Comment

Twitter avatar for @BencjacobsBen Jacobs @Bencjacobs

Trump starts to tell @jonathanvswan that he lost in #TX06 but then corrects himself axios.com/trump-team-bla…Image

July 28th 2021

12 Retweets

Toeing the Company Line

  • The Wednesday G-File (🔒) is back, and Jonah is angry—at those minimizing the events of January 6, at the CDC’s mask guidance about-face, at the framing of vaccine hesitancy, at anti-vaxxers, at House GOP leadership. “Whether it’s masks or vaccines, people can’t see past their partisan blinders,” he writes. “It’s all so incandescently stupid.”
  • On this week’s Dispatch Podcast, the gang breaks down the start of the January 6 select committee—both the substance and the politics—before turning to the CDC’s new masking guidance and Simone Biles’ decision to withdraw from competition at the Olympics.
  • Scott Lincicome’s latest Capitolism (🔒) explores the state of economic inequality, why it drives so much of the policy debate in Washington, and how three variables—omitted income, pre-tax/transfer income, and demographics—distort some of the statistics you might have seen. “American income inequality basically disappears when you consider government policies and the actual financial resources (post-tax/transfer) available to the poor and middle class, instead of just the top line of their paychecks,” he writes.

Reporting by Declan Garvey (@declanpgarvey), Andrew Egger (@EggerDC), Charlotte Lawson (@charlotteUVA), Ryan Brown (@RyanP_Brown), Harvest Prude (@HarvestPrude), Tripp Grebe (@tripper_grebe), Emma Rogers (@emw_96), Price St. Clair (@PriceStClair1), Jonathan Chew (@JonathanChew19), and Steve Hayes (@stephenfhayes).
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