FDA panel backs Moderna COVID booster shot for high-risk Americans, clearing the way for a 3rd jab

A key federal advisory committee voted unanimously Thursday to recommend emergency authorization of a booster shot for older and more vulnerable recipients of Moderna’s COVID-19 vaccine, a sign that millions of Americans who received their second Moderna dose at least six months ago will likely be cleared for a third jab as soon as next weekend.

The Food and Drug Administration panel also expressed openness to eventually greenlighting boosters for younger and less vulnerable recipients of both the Pfizer-BioNTech and Moderna vaccines — a crucial Biden administration goal.

For months, the White House has cited data from Israel, the first nation to offer third shots to all residents over the age of 12, to argue that boosters are necessary to bolster waning vaccine protection, combat breakthrough infections and slow transmission of the hypercontagious Delta variant.

Some panel members agreed. “I am of the opinion that we need boosters,” said infectious disease specialist Mark Sawyer, even as he stressed that he was “not wild about a bunch of 20-year-olds running around getting a booster.”

Joe Biden
President Biden at the White House on Thursday. (Drew Angerer/Getty Images)

“I find the Israeli data compelling, as well as the breakthrough cases we’re finding in the United States,” Sawyer added.

In the near term, Moderna’s boosters are likely to follow the same path as Pfizer’s, which were authorized last month for Americans 65 and older, as well as for younger adults at “high risk of serious complications” from COVID-19. The criteria for the latter group include those exposed to certain work environments (e.g., nurses and teachers), those in unsafe living arrangements (e.g., the homeless and incarcerated) and those with underlying health issues — the same groups the FDA advisory committee said Thursday should now be eligible for a third Moderna shot.

In the next few days, acting FDA Commissioner Janet Woodcock will deliver the agency’s final determination on whether to authorize the Moderna boosters and for whom. At the end of next week, the Centers for Disease Control and Prevention will engage in a similar process to review the FDA’s decision and issue its own guidance, which state health departments almost always implement.

Meanwhile, the FDA advisory panel will vote Friday on boosters for recipients of the one-dose Johnson & Johnson vaccine. Preliminary data from a federal clinical trial published Wednesday found that J&J recipients may be better off with a booster shot from Moderna or Pfizer-BioNTech.

Thursday’s Moderna vote was not a foregone conclusion. Some studies have shown that the Moderna vaccine has so far provided more durable protection against infection than its Pfizer counterpart, perhaps because Moderna opted for a larger dose and spaced its initial shots four weeks apart instead of three. Moderna’s potency against hospitalization has also held up better over time than Pfizer’s, according to a recent CDC study. In an assessment of Moderna’s data published before Thursday’s meeting, FDA scientists seemed unconvinced.

“Some real-world effectiveness studies have suggested declining efficacy of Moderna COVID-19 vaccine over time against symptomatic infection or against the Delta variant, while others have not,” the FDA scientists said in the briefing document.

Janet Woodcock
Janet Woodcock, acting commissioner of the FDA. (Stefani Reynolds/AFP via Getty Images)

In addition, the World Health Organization has asked wealthy countries to make more vaccine available to developing nations before boosting their own populations — and Moderna in particular has faced heated criticism for “supplying its shots almost exclusively to wealthy nations, keeping poorer countries waiting while earning billions in profit,” as the New York Times recently reported.

But these concerns took a backseat Thursday to updated data from Israel showing dramatic reductions in “severe disease” among Israelis of all ages who received a third dose of Pfizer as well as much lower rates of infection than those who received only two doses. As a result, said Sharon Alroy-Preis, director of public health services at Israel’s Ministry of Health, “there is no question in my mind that the break of the curve” — the country’s recent Delta wave is now in sharp retreat — “was due to the booster dose.”

Data from Moderna pointed in a similar direction, showing that the rate of severe COVID cases among trial participants who were vaccinated with two Moderna doses an average of 13 months ago was 46 percent higher than the rate among participants who were vaccinated with two Moderna doses an average of 8 months ago. Among participants 65 or older, the rate of severe cases was 64 percent higher.

“The data are not perfect,” said Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, noting the small size of the Moderna study. “But these are extraordinary times, and we have to work with imperfect data.”

Given the early indications of waning Moderna efficacy and the evidence from Israel about the impact of Pfizer boosters, the panel ultimately decided to “harmonize” its recommendations for the two mRNA vaccines.

A vial of the Moderna COVID-19 vaccine
A vial of the Moderna COVID-19 vaccine. (Mike Segar/Reuters)

“From a pragmatic point of view ... I support this EUA [emergency use authorization] because we’ve already approved it for Pfizer, and I don’t see how we can possibly not approve it for Moderna and not have most U.S. folks be completely confused,” said Dr. Stanley Perlman, a professor of microbiology and immunology at the University of Iowa.

“I have a little bit of trouble with saying [you can get a booster if] you got Pfizer … for the primary series, but you can’t get it if you got Moderna,” added Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital. “I don’t think that’s fair.”

After the committee voted 19-0 to recommend Moderna boosters for seniors and other high-risk Americans, it proceeded to a less formal discussion of whether to “support use of a mRNA COVID-19 vaccine … in the general population of adults.”

The FDA’s expert panel had earlier seemed unified in its opposition to the Biden administration’s push for boosters for all, and many of those objections remained.

“I just worry that we haven’t clearly defined what the goal is,” said Dr. Paul Offit, an infectious disease expert with the Children’s Hospital of Philadelphia. Offit described a decline in neutralizing antibodies and an erosion of protection against mild or asymptomatic infection as “inevitable,” adding that preventing such infections — as opposed to severe illness, hospitalization and death — is “a high bar to which we hold no other vaccine.”

Others questioned whether boosters had really caused Israel’s downturn in cases, given that earlier, pre-booster waves had also receded in time. Some wondered whether scientists would see the “same drop-off” in antibodies after a booster, meaning vaccine recipients would have to “come back in another six months, needing to boost again.”

But several panel members signaled that they would consider recommending boosters for younger and less vulnerable adults if new data warranted it.

Hattie Pierce, right, and Tiffany Taliaferro
Hattie Pierce receives a vaccine booster shot from Dr. Tiffany Taliaferro in Washington, D.C. (Tom Williams/CQ-Roll Call via Getty Images)

“Could it be that boosters inhibit transmission and break that cycle?” Rubin asked. “That could be one factor to consider.”

“Is it possible that boosters in the right context could help us get to herd immunity? That’s intriguing,” Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children's Hospital, added. He also mentioned “long COVID in children,” saying the current literature was “muddled” but that additional information could tip the scales in favor of a broader booster rollout.

Citing declining case counts in the U.S. — and models predicting a possible winter resurgence — Dr. Peter Marks, the FDA’s highest-ranking vaccine regulator, warned, “We can’t simply look at what’s going on right now with the pandemic curve and call it a day. We have to be prepared for what might happen next.”

Dr. Arnold Monto, the panel’s acting chair, concurred. “The concern that I have is that we don’t want to wait until we see more severe infections in the under-65 general population, because getting this vaccine out takes time and requires extreme logistic efforts,” he said.

Monto suggested that going forward, the FDA not “think about this as one enormous population group down to age 18,” but rather break the general population into smaller categories, “down to age 40,” perhaps, and then down to “18-year-olds.”

“We are seeing breakthrough infections with hospitalization in those age groups,” Monto continued. “We need to develop some rationale for going down in age groups as we gain experience with booster doses. … Then we can revisit the topic and try to refine it.”

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