The Morning Dispatch: FDA Postpones Decision on COVID Vaccines for Young Children

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Quick Hits: Today’s Top Stories

• In a televised meeting with President Vladimir Putin on Monday, Russian Foreign Minister Sergei Lavrov said he believes diplomatic negotiations with the West over the Ukraine situation “are far from exhausted,” adding he would “propose continuing and building them up.” In a potential sign of de-escalation early Tuesday morning, Russia’s Defense Ministry said some troops currently deployed near the Ukraine border would return to their bases. It’s unclear how many soldiers are covered by the order, and other Russian military exercises remain ongoing.

• Secretary of State Antony Blinken announced Monday the United States was “in the process” of temporarily relocating its embassy operations in Ukraine from Kyiv to the western city of Lviv due to “the dramatic acceleration in the buildup of Russian forces.”

• German Chancellor Olaf Scholz sought to downplay the likelihood of Ukraine joining NATO after meeting with Ukrainian President Volodymyr Zelensky on Monday. “The question of [Ukrainian] membership in alliances is practically not on the agenda,” he told reporters. “And that is why it is strange to observe that the Russian government is making something that is practically not on the agenda the subject of major political problems.” Zelensky called NATO membership a distant “dream” for Ukraine, but “not the absolute goal.” Scholz is scheduled to meet with Putin today.

• Prime Minister Justin Trudeau announced yesterday he will invoke the sweeping powers afforded him in the 1988 Emergencies Act to break up the protests against Canada’s COVID-19 restrictions that have disrupted commerce and traffic in cities across the country. Using the Act—a version of which was last invoked more than 50 years ago—the government will give police “more tools” to move the protesters and their trucks, allow financial institutions to freeze accounts of those participating in the blockade, and subject crowdfunding sites like GoFundMe and GiveSendGo to the country’s laws against money laundering and terrorism financing. “The act is to be used sparingly and as a last resort,” Trudeau said. “Right now, the situation requires additional tools not held by any other federal, provincial or territorial law.” The declaration went into effect immediately, but it must be approved by Parliament within seven days.

• Royal Canadian Mounted Police (RCMP) announced they arrested 13 people on Monday after discovering a small group of heavily armed individuals within the broader protest against COVID-19 measures in Coutts, near Alberta’s border with Montana. Authorities said they seized 13 long guns, a machete, several handguns and sets of body armor, and a large amount of ammunition.

• Citing the trajectory of the Omicron wave, Ontario Premier Doug Ford announced Monday the province will “fast track” its reopening plan by increasing various capacity limits later this week and doing away with all vaccine requirements on March 1.

• U.S. District Court Judge Jed Rakoff held on Monday that former Alaska Gov. Sarah Palin did not meet the “very high” legal standard for libel in her case against The New York Times. Rakoff is allowing the jury to continue their deliberations, but their verdict will be set aside if they find in favor of Palin. Regardless, Palin’s team is expected to appeal.

COVID Vaccines for Young Children? Not Yet

With the back half of the Omicron wave nearing the end of its precipitous decline, more and more Democratic governors and mayors around the country are loosening COVID-19 restrictions and arriving—at least implicitly—at the position Gov. Jared Polis of Colorado staked out months ago: “At this point, if you haven’t been vaccinated, it’s really your own darn fault,” he told Colorado Public Radio in early December, defending his refusal to reimpose a statewide mask mandate.

For the most part, Polis is right. There was a time when the vaccines were scarce, but those days are long gone. According to Centers for Disease Control (CDC) data, the United States has administered nearly 550 million vaccine doses thus far, and delivered another 125 million to pharmacies, clinics, and other vaccination centers. White House officials say the administration has shipped 400 million doses to more than 100 countries around the globe. If you still aren’t vaccinated more than nine months after the last states removed eligibility requirements, it’s because you don’t want to be—not because you weren’t able to be.

Unless, of course, you were born after February 16, 2017. (And if you were, we admire your commitment to keeping up with the news via TMD!) Ever since the Food and Drug Administration (FDA) and CDC authorized and recommended Pfizer and BioNTech’s shot for five- to 11-year-olds last fall, the only Americans ineligible for the vaccine have been the approximately 19 million children in the country four years old and younger. On Friday, they learned—well, their parents learned—they’d be waiting at least a couple more months.

“The FDA is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15,” read an afternoon statement from Acting Commissioner Dr. Janet Woodcock. “This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”

Less than two weeks earlier, FDA officials were anonymously leaking to media outlets that authorization for this age group could come before the end of February. Now, it’s looking like mid-April at the earliest. What happened?

Pfizer and BioNTech began testing a two-dose vaccine for children under five years old months ago, but the companies announced in mid-December they were amending the clinical trial to add a third dose that would be administered at least two months after the second. The size of the doses themselves had been reduced to 3 micrograms for this youngest cohort—compared to 10 micrograms for older children and 30 micrograms for recipients ages 12 and above—and two shots at that level just weren’t generating enough of an immune response in toddlers ages two to four. (Two shots did, however, seem to be sufficient for the six- to 24-month-olds in the study.)

To expedite the authorization process, Pfizer and BioNTech hatched a plan: They would apply to receive emergency use authorization (EUA) for the two-dose regimen for which they had data, and then circle back with additional information several weeks later asking the FDA to amend the EUA and include a third dose. Because the vaccination series takes nearly three months to complete—three weeks between doses one and two, eight weeks between doses two and three—staggered authorizations would allow parents to get the ball rolling and protect their children as quickly as possible.

The FDA appeared interested in the idea—until late last week, when it suddenly wasn’t. A new tranche of two-dose Pfizer-BioNTech data had reportedly just come in reaffirming the vaccine’s safety for children, but its efficacy—particularly against the Omicron variant—simply wasn’t where it needed to be.

“Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group. Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness.”

Dr. Paul Offit—a vaccine expert at the Children’s Hospital of Philadelphia (CHOP) and member of the FDA advisory committee that would have been meeting today to discuss and vote on the Pfizer-BioNTech data—was grateful the agency reversed course. “To come to our committee with data on two doses for safety and efficacy, knowing that it was going to be a three-dose vaccine, was, I think, asking a lot,” he told The Dispatch, noting it’s no guarantee the third dose solves the efficacy issues. “I just am glad that they didn’t put us in a position to do that, because I think it’s very possible that that vote could have been no—which sends a bad message out there to parents.”

Pfizer and BioNTech said they expect to have a more complete dataset in “early April.” If a three-dose regimen is found to be safe and effective at that point—and the authorization process follows a timeline similar to earlier COVID-19 vaccine EUA applications—it could receive full regulatory signoff within two weeks.

To some parents ready to move on to post-pandemic life, however, Friday’s decision was yet another example of FDA bureaucracy standing in the way. “Why not let parents who want to vaccinate their children, start vaccinating their children?” asked New York Times columnist Ezra Klein. “Instead of having the option to get started on a vaccine protocol that takes weeks to build antibodies, we’re just going to wait for the Omicron wave to infect kids everywhere and then give this authorization to start vaccinations.”

Individual parents have their own risk tolerance, of course, but on a macro level, the stakes of this debate are much less high. According to Centers for Disease Control data, children younger than age 18 account for just 795 of the 898,699 deaths (0.088 percent) attributed to COVID-19 since the outset of the pandemic, and the virus was responsible for just 1.1 percent of the 70,082 all-cause deaths among children over that span. Although more children overall were hospitalized with COVID-19 during the Omicron surge because more children were contracting the virus, studies found it somewhere between one-third and two-thirds less likely that any given child would be hospitalized with the latest variant when compared to Delta.

Parents seem to have internalized these figures, because uptake on even the authorized childhood COVID-19 vaccines has been slow. According to the Kaiser Family Foundation, just 28 percent of children ages five to 11 had received at least one dose as of January 18, 2022, and 19 percent had received two. After an initial rush from eager parents to get the process started in early- to mid-November, the number of doses administered to that age group daily plummeted, and has remained low since. 

One possible reason: Teenage boys have been found to be at a slightly elevated risk for myocarditis—or heart inflammation—after receiving a COVID-19 vaccine. But myocarditis is a side effect of COVID-19, as well. “Children are much more likely to develop heart issues after COVID-19 infection than after the vaccine,” said Dr. Matthew Elias, a cardiologist at CHOP. “When children develop myocarditis after COVID-19 infection, it’s typically much more severe than when it occurs post-vaccine.”

In a call with reporters, Marks expressed hope that the FDA’s decision to slow down the process will build trust with those who have reasonable concerns. “I think parents can feel reassured that we have set a standard by which we feel that if something does not meet that standard, we can’t proceed forward,” he said.

Whenever the vaccines are available, Offit—who’s seen the rare but debilitating instances of child COVID-19 hospitalization up close—encourages parents to make sure their kids receive them. “It’s certainly true that children, especially young children, get infected less frequently, and that when they’re infected, they’re infected less severely,” he said. “The fact of the matter is that they can be infected severely, and they can suffer, and they can, rarely, die. So if you can make a vaccine that can prevent that and prevent it safely, then it’s a value.”

“We still immunize children every year in this country for polio, [even though] we haven’t had polio in this country since the ‘70s,” he continued. “The reason that we do it is because polio still exists in the world. I think we’re going to need to have a highly protected population for years, if not longer. And children grow up. If this vaccine’s protection lasts against moderate to severe disease—which I think is very likely—then it makes sense to vaccinate children anyway, for what may ultimately become a routine childhood vaccine.”

Worth Your Time

• It takes about 12 years and $400,000 worth of schooling to become a doctor in the United States, a huge investment relative to most other countries in the world. Perhaps unsurprisingly, the U.S. ranks near the bottom in physicians per capita. “As a matter of basic economics, fewer doctors means less care and more expensive services,” Derek Thompson writes in The Atlantic. “Naturally, some doctors might object to more competition for the same reason that some homeowners object to more local construction: They’re afraid that abundance will eat their wealth. But they should consider the other side of the coin, which is that having more doctors might make life better for doctors, who work much longer hours than their European peers. Doctor burnout and brutal 16-hour shifts for residents and M.D.s aren’t necessary tests of willpower; they’re just the inevitable result of not having enough people to do the work that today’s hospitals demand. The most obvious reason America needs an abundance of medical practitioners is … just look around.”

• With the Omicron wave nearing its end, Democratic governors in states around the country have finally begun relaxing statewide vaccine and masking mandates. As noted, Colorado’s Jared Polis, a Democrat, has been there for months. “In Polis’s calculus, the advent of vaccination changed everything, including citizens’ moral responsibilities to one another, and he has been unwilling to let his state’s unvaccinated minority keep the rest of the population on an indefinite emergency footing,” New York Magazine’s Gabriel Debenedetti writes of the 46-year-old governor. “He believes that every governor will have to adapt to endemic circumstances eventually, that there’s only so much he can do for the persistently unvaxxed, and that COVID lifestyle restrictions have been costlier than other Democrats have acknowledged.”

• In an essay for American Purpose, Andrew Wood laments what has become of Vladimir Putin’s Russia. “A country that cannot face its past remains its victim,” he writes. “A different, obligatory, censored, and reimagined version of Soviet and Russian history, with Stalin as its hero, has been promoted since Putin’s inauguration as president in 2000. Its essential elements reflect Soviet-era beliefs about the achievements and international status of the USSR from 1945 until 1985, the year now seen by Russia’s present-day rulers as having led to the USSR’s destruction under Western pressure. It reflects an instinct that remains important: to deny that Russia’s own actions are responsible for unwelcome consequences. Everything the regime dislikes is always someone else’s fault.”

Presented Without Comment

Also Presented Without Comment

Toeing the Company Line

• For a piece on the site today, Audrey talked to several Democratic senators who are caught in a messaging bind between their states’ Democratic governors, who are scaling back pandemic restrictions, and President Biden, whose CDC continues to urge maximum caution with measures like indoor masking.

• On Monday’s episode of Advisory Opinions, David and Sarah discuss the latest John Durham filing, Trump and his top secret documents, the latest on the Electoral Count Act, and a very strange letter. Plus: More Olympics nonsense with the Russians.

Let Us Know

Does the FDA’s decision to slow down the authorization process with respect to COVID-19 vaccines for young children increase or decrease the amount of trust you have in the agency’s evaluation process?

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