The Morning Dispatch: Hello, Comirnaty

Plus: Polls remain close as California barrels toward its recall election for Gov. Gavin Newsom.

Happy Tuesday! A quick correction before we get started. In yesterday’s Quick Hits, we wrote this: “Eighteen commercial aircraft will arrive in Kabul in the coming days to aid in the evacuation effort, the Pentagon said Sunday.” Commercial aircraft are assisting with the evacuation, but as the Pentagon statement we linked made clear, those planes are not flying into Kabul itself; rather, they are being used “for the onward movement of passengers from temporary safe havens and interim staging bases.” We apologize for the error.

Quick Hits: Today’s Top Stories

  • The Food and Drug Administration formally approved the Pfizer-BioNTech COVID-19 vaccine for those 16 and over on Monday, making it the first COVID-19 vaccine to advance past the emergency use authorization in the United States. Regulators granted full approval to the vaccine after reviewing updated clinical trial data from Pfizer showing it to be 91 percent effective at preventing COVID-19 disease.
  • Shortly after full FDA approval was granted, several institutions implemented new—or stricter—vaccine mandates. New York City will now require every Department of Education employee in the city—from principals to custodians—to have at least one COVID-19 vaccine dose by September 27, and the Pentagon reaffirmed Defense Secretary Lloyd Austin’s earlier promise to mandate vaccines for service members “immediately upon” FDA licensure. Pentagon spokesman John Kirby said the Department will provide an updated timeline “in the coming days.”
  • One day after President Joe Biden floated the possibility of extending his administration’s self-imposed August 31 deadline for completing evacuations out of Afghanistan, a Taliban spokesman told Sky News there “would be consequences” for doing so. “If they are intent on continuing the occupation it will provoke a reaction,” he added. The Pentagon said Monday morning the U.S. military had transported just under 11,000 out of Afghanistan over the past 24 hours.
  • German, American, and Afghan troops were involved in a brief firefight at the Kabul Airport on Monday morning that resulted in one Afghan soldier dead and three injured, according to German military officials. Navy Capt. William Urban—spokesman for U.S. Central Command—said an “unknown hostile actor” shot an Afghan soldier, leading Afghan, American, and German forces to return fire in “keeping with their right of self-defense.”
  • new U.S. Army report released Monday found that the Chinese military has significantly improved its ballistic missile force’s range and accuracy in recent years, with new versions of China’s DF-11 short-range ballistic missile more than doubling their range to beyond 700 kilometers while improving accuracy to within a 30 meter circular error.
  • California Superior Court Judge Frank Roesch ruled over the weekend that Proposition 22—the ballot measure California voters approved last November allowing companies such as Uber, Lyft, and DoorDash to continue classifying their drivers as independent contractors—is unconstitutional. The companies plan to appeal the ruling.
  • The United States Capitol Police announced Monday it had completed an internal investigation into the fatal shooting of January 6 rioter Ashli Babbitt, determining that the conduct of the officer involved was “lawful” and “within Department policy.” The officer will not face internal discipline.

FDA Gives Full Approval to Pfizer Vaccine

(Photo by Suzanne Kreiter/Boston Globe/Getty Images.)

Eight months and hundreds of millions of administered doses after the Food and Drug Administration first granted an emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine, the regulating body announced Monday that it had at last granted the pharmaceutical giant’s mRNA shot full approval for Americans 16 and older.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA commissioner Janet Woodcock said in a statement. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

The vaccine will remain available under EUA for kids ages 12 through 15, as it has been since May.

Critics of the FDA have decried its approval process as dangerously slow, but the less than four months between Pfizer’s formal application in May and final sign off is actually the quickest turnaround in the agency’s history. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

On the consumer end, there isn’t a great deal of difference between EUA and full approval for a vaccine like Pfizer’s. But full approval gives the company the assurance it will be able to continue marketing the drug even after the COVID public health emergency has ended. It also frees Pfizer to begin to promote the vaccine itself using its own brand name—which, to your Morning Dispatchers’ dismay, turns out to be the word “Comirnaty.”

California Governor’s Recall Election Looms

When we last wrote to you about the ongoing effort to remove Gov. Gavin Newsom from his post, California Republicans had just clinched the 1.5 million signatures required to trigger a recall election. In the six months since, an organized opposition has fielded candidates, mobilized the conservative base, and funneled cash into attack ads targeting the state’s Democratic leadership.

California election officials began sending mail-in ballots to all registered voters in the state on August 16, and Californians have until the official day of the election—September 14—to return them. On the ballot itself, voters will be faced with two questions: Do you want to recall Gov. Newsom, and, if the governor is recalled, with whom do you want to replace him?

A recall is triggered if a majority of voters answer yes to the first question. At that point, whichever candidate receives a plurality of support on the second would assume the governorship. The method lends itself to a situation wherein California’s next governor could be selected by fewer than half the election’s voters, which—given the strange, off-year timing—will likely be an exceedingly slim fraction of the overall electorate. If Newsom is recalled, California’s secretary of state will certify the results on October 22 and the new governor will serve out the remainder of Newsom’s term, which is set to expire on January 2, 2023.

“Republicans are motivated, they’re aware of the election, they have a smaller universe to turn out than Democrats,” said Rob Stutzman, a Republican consultant in California who worked on Arnold Schwarzenegger’s 2003 bid—the only successful recall campaign in California history. “It’s essentially why this election, in a 2:1 Democratic state, is polling so closely. There’s going to be a huge inequity in turnout.”

Worth Your Time

  • Much has been written already about JD Vance’s quixotic bid to represent Ohio in the U.S. Senate next year, but this piece—from James Pogue in The American Conservative—might be the best. Pogue is on the political left, but he’s also from the same kind of down-on-its-luck rural Ohio town that Vance detailed in his bestselling book Hillbilly Elegy—and in theory is someone Vance would want to represent. “I asked him if there was some version of his project that didn’t have to be exclusionary,” Pogue writes. “I was surprised when he used the word right back at me. ‘I think that any national project has to be on some level exclusionary,’ [Vance] said. He talked about it as a foregone conclusion that the only way left to have a sense of cultural grounding in America was to wear it as an oppositional identity, against an elite that I still wasn’t sure the makeup of.”
  • Two years ago last month, Los Angeles Angels pitcher Tyler Skaggs died in his hotel room after choking on his own vomit with a mix of alcohol, fentanyl, and oxycodone in his system. One year later, erstwhile Angels media relations staffer Eric Kay was arrested and charged with distributing the fentanyl that killed the 27-year-old pitcher. In a piece for League of Justice—a publication that covers the intersection of sports and the law—Amy Dash reports that prosecutors have evidence showing a drug dealer delivered the fatal pills to Angels Stadium the same day of Skaggs’ overdose, and that Kay was “running a drug distribution operation within the Angels organization” that provided illegal opioids to “at least six” Angels players. Tens of millions of dollars are at stake, as Skaggs’ family seeks to hold the organization civilly liable for the pitcher’s death. “The family says the Angels are aware of the ‘rigors of a 162 -game schedule and are aware that players are at risk of turning to medication to assist with pain management,’” Dash writes. “The Skaggs’ suit accuses the Angels of creating ‘the perfect storm,’ by employing an alleged drug addict and distributor.”
  • The FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine on Monday, but Conor Friedersdorf argues in The Atlantic that U.S. regulators’ overly cautious approach to risk during the pandemic has cost far more lives than it’s saved. “Each time a new weapon emerges in the fight against a deadly disease, the bureaucrats charged with judging its safety and efficacy face a trade-off: Proceed too quickly and a dangerous or useless drug or medical device might be granted approval; proceed too slowly and the sick and dying might be denied a lifesaving intervention,” he writes. “But public-health officials operate under incentives that distort their judgment. If they approve a drug or medical device that hurts even a tiny number of people, or that proves ineffective, the harms are clear, and those responsible may be pilloried in the press as negligent or corrupt. When the bureaucracy moves too slowly, the harms are harder to see. As the economist Alex Tabarrok put it in 2015, people still die, but ‘the bodies are buried in an invisible graveyard.’”

Presented Without Comment

Also Presented Without Comment

Toeing the Company Line

  • On Monday’s Advisory Opinions, Sarah and David are joined by University of Pennsylvania law professor Mitchell Berman for a discussion of the jurisprudence of sports. How are unwritten rules baked into athletics? Are robot umpires coming? And is anything about the Olympics legal?

Reporting by Declan Garvey (@declanpgarvey), Andrew Egger (@EggerDC), Charlotte Lawson (@charlotteUVA), Ryan Brown (@RyanP_Brown), Harvest Prude (@HarvestPrude), and Steve Hayes (@stephenfhayes).