The FDA reportedly plans to approve COVID boosters for all this week. Why experts say that’s the right call.

·West Coast Correspondent
·12 min read

Last Thursday, Colorado became the first state in the U.S. to approve COVID-19 boosters for all residents over 18 who were initially vaccinated at least six months ago — breaking with federal officials, who at the time had authorized the shots only for seniors and others at high risk of serious illness because of living arrangements, working conditions or medical issues.

Then California did the same thing. And New Mexico. And New York City. And Arkansas. And Rhode Island.

“If you’re interested in getting a booster, go ahead and get one,” said Dr. Mark Ghaly, California’s secretary of health and human services.

Now the U.S. Food and Drug Administration is following suit and aiming to authorize booster doses of Pfizer’s vaccine for all adults as early as Thursday, according to a report in the New York Times.

It’s unprecedented for individual states and cities to get ahead of the FDA and the Centers for Disease Control and Prevention, both of which had resisted the Biden administration’s boosters-for-all push amid concerns about global equity and debate over whether younger people really need them. FDA and CDC advisers had also expressed worries about undermining confidence in the vaccines — which still provide significant protection — at a time when millions of Americans have yet to receive their first jab.

A woman walks past a sign reading
A woman heads for a COVID-19 vaccination in Denver in February. (David Zalubowski/AP)

But as federal officials saw states and cities opening up eligibility on their own — and absorbed new information about the waning durability of the original two-dose vaccine regimen — they reportedly decided to reconvene and reconsider this Thursday (for the FDA) and Friday (for the CDC).

“Infections are starting to rise,” Dr. Ashish K. Jha, dean of the Brown University School of Public Health, tweeted. “Hospitalizations are inching up. The holidays are approaching. The data is becoming increasingly clear. It is time for every adult 6 months out to get a booster.”

There are three reasons why federal officials are now planning to join states like Colorado and approve boosters for all.

1. Two vaccine shots aren’t as effective as they used to be.

Jha was right when he wrote that “the data is becoming increasingly clear.” Seemingly every day, more studies show that the Pfizer and Moderna vaccines’ original 90-plus percent effectiveness against COVID infection and hospitalization has worn off over time and in the face of the hypercontagious Delta variant — but that it can be restored, almost instantly, with a third shot.

The latest proof comes from the U.K. On Monday, government researchers there released their first real-world study on the subject. They found that in the absence of a booster, the Pfizer vaccine had become just 62.5 percent effective against symptomatic infection in those 50 or older; for the AstraZeneca vaccine the corresponding number had fallen even further, to 44 percent. Yet boosters increased protection to 94 percent for Pfizer and 93 percent for AstraZeneca after two weeks.

As a result, the U.K. immediately broadened booster eligibility to everyone 40 and older.

A nurse draws a dose of the Pfizer COVID-19 vaccine.
A nurse draws a dose of the Pfizer COVID-19 vaccine at Park Avenue Health Center in Arlington, Mass. (Jessica Rinaldi/Boston Globe via Getty Images)

Other research shows the same effect. Late last month, Pfizer announced the results of its randomized, placebo-controlled booster trial — the gold standard for assessing vaccine efficacy. Previously, there had only been “vaccine effectiveness reports without randomization, without a placebo control group and [with] multiple potential confounding factors,” according to Dr. Eric Topol, head of the Scripps Research Translational Institute. 

Among the 5,000 or so original Pfizer recipients who received a booster, just five developed symptomatic COVID over the next two months. Of the 5,000 vaccinated people who received a placebo booster instead, however, 109 got COVID — 22 times as many. The researchers concluded that the booster had restored the vaccine’s efficacy rate to 95.6 percent, which was consistent regardless of age, sex, race, ethnicity or chronic medical conditions. Last week, Pfizer asked the FDA to authorize its boosters for all U.S. adults.

FDA advisers had previously acknowledged that effectiveness against infection has waned and that boosters revive it. But they questioned whether full protection against infection should be the goal, especially among younger, healthier Americans, or whether immunization efforts should focus instead on shielding the most vulnerable from severe outcomes.

The problem is that recent data from the Israeli Ministry of Health, which approved boosters for all vaccine recipients 12 or older this summer, found that severe disease was about 20 times more common in adults over 40 who were vaccinated but had not received a booster than in adults of the same age who did get a booster. As the researchers put it: “Across all age groups, rates of confirmed infection and severe illness” — emphasis added — “were substantially lower among those who received a booster dose of the Pfizer vaccine” than those who did not.

Likewise, a subsequent observational study of more than 1.4 million Israelis published in the Lancet found that — compared with two doses of Pfizer administered at least five months before — “adding a third dose was estimated to be 93% effective in preventing COVID-19-related admission to hospital, 92% in preventing severe disease, and 81% in preventing COVID-19-related death, as of 7 or more days after the third dose.”

A woman receives the COVID-19 vaccine in the Israeli city of Modi'in.
A woman receives the COVID-19 vaccine in the Israeli city of Modi'in on Oct. 19. (Gil Cohen Magen/Xinhua via Getty Images)

“Back in April I was totally against booster shots due to lack of evidence of attrition of effectiveness and obvious interest of the companies to promote them,” Scripps's Topol explained in response. “Now the data are abundant and [in my opinion] definitive for their benefit.”

And by analyzing antibody levels, Israeli researchers have reportedly concluded that the third shot "offers different, apparently improved, protection from the first two doses" and could be effective for nine to 10 months, "or even longer," according to The Times of Israel

None of which is to say the first two doses no longer work. A CDC study from September found that unvaccinated Americans remain 11 times more likely than their vaccinated peers to die of COVID; a more recent Texas study found that unvaccinated Texans are 20 times more likely to die of the disease. Even as nearly 70 percent of the U.S. population has received at least one vaccine dose, the unvaccinated continue to account for approximately three-quarters of confirmed COVID cases in states that index positive tests to vaccination status. Despite the threat of their waning effectiveness, the vaccines are preventing millions of infections and tens (perhaps even hundreds) of thousands of hospitalizations and deaths.

Yet as the weather cools and holiday celebrations lure Americans indoors, COVID rates are starting to climb in several states with relatively high vaccination rates that were spared the worst of Delta’s summer surge — signaling a potential seasonal spike partially driven by fading immunity.

2. Winter is coming.

Last winter was the worst phase of the U.S. pandemic — a time when more than 3,000 Americans were dying of COVID each day and more than 250,000 were testing positive.

Medical staff move a COVID-19 patient who died onto a gurney.
Medical staff move a COVID-19 patient who died onto a gurney at Willis-Knighton Medical Center in Shreveport, La., in August. (Gerald Herbert/AP)

Thanks to the vaccines, this winter is almost certain to be less tragic. But waning effectiveness against both infection and severe illness could make it a lot worse than it has to be.

Currently, fewer than 1 in 3 U.S. seniors — by far the most vulnerable age group, and the one that federal officials are most eager to reach — have received booster shots. That number plummets even further, to fewer than 1 in 7, among all Americans who got their second dose at least six months ago.

Other countries are doing much better. Roughly 80 percent of eligible Israelis have already received boosters. The same goes for approximately 70 percent of eligible Belgians, more than 60 percent of Britons, about half of French residents, more than 40 percent of Germans and about 35 percent of Italians.

Another looming wave of infection throws the benefits of boosters into sharp relief. Not only can they restore full protection against hospitalization and deaths among the otherwise vulnerable, limiting the ultimate toll of such a surge, but they can also reduce the size of the surge itself — and further shield the vulnerable — by reducing the number of people who get infected and spread the virus to others.

The latest Israeli data, for instance, shows that during that country’s Delta wave earlier this year, cases began to decline in each respective age group shortly after boosters were made available to them — even as cases continued to rise in younger age groups that weren’t eligible yet. Today, cases have fallen in Israel from a summer peak of more than 11,000 a day to just a few dozen, and unvaccinated people again account for nearly all hospitalizations after rates had started to tick up among vaccinated Israelis whose immunity had waned.

A girl in class is seen through a door, behind a sign in the hallway that says
A girl takes notes in class on the first day of school at College des Freres in Jerusalem on Sept. 1, amid an uptick in coronavirus infections. (Maya Alleruzzo/AP)

“I just don't get [the] ‘vaccine wasn't designed to prevent infections’ line,” Dr. Bob Wachter, chair of the Department of Medicine at the University of California, San Francisco, tweeted Sunday. “If vax used to prevent 95% of infections, then wanes, but protection can be restored via safe/cheap boost — which not only prevents cases [and] Long Covid [but] also keeps [the] community safer — why NOT do that?”

Indeed, the collective upside of encouraging boosters for all — curbing community spread during the holidays — has been as much a part of the rationale in Colorado and elsewhere as the renewed individual protection they provide.

“Case counts are significant, spread rates are far too high, and the Delta variant is far more transmissible than previous variants. In addition, our hospitals are well beyond capacity, and several have declared Crisis Standards of Care,” David Scrase, New Mexico’s acting health secretary, said in a statement. “Providing boosters for adults will significantly increase levels of immunity protection across our state — and that’s essential for all of us. COVID-19 is incredibly opportunistic — and it’s our job to ensure that the virus has fewer and fewer opportunities to spread.”

3. The vast majority of U.S. adults are already eligible anyway. They just don’t realize it because of mixed messaging from Washington, D.C.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention.
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention. (Stefani Reynolds/Pool via Reuters)

“I’ve been very frustrated with the convoluted messaging out of the CDC and the FDA,” Colorado Gov. Jared Polis said Sunday on CBS’s “Face the Nation.”

A few minutes later, Dr. Scott Gottlieb, a former head of the FDA who now sits on Pfizer’s board, echoed Polis’s criticism. “I think the confusing message around the boosters may end up being one of the biggest missed opportunities in this pandemic,” Gottlieb said. “Anyone who’s eligible for a booster — and most Americans probably are eligible at this point — should be going out and seeking it.”

In October, advisory panels for the FDA and CDC debated — and disagreed — about booster criteria before CDC Director Rochelle Walensky settled on a somewhat byzantine formula: Anyone who initially received Johnson & Johnson’s one-dose vaccine would be eligible for a second dose of the vaccine of their choice, as would anyone 65 or older who initially received either Pfizer or Moderna. But Pfizer or Moderna recipients ages 18 to 64 would have to “self-attest” to being at high risk because of where they live (such as a long-term-care facility) or work (such as a school) or because of a preexisting medical condition (such as asthma).

In effect, this made at least 89 percent of U.S. adults eligible for boosters six months after their previous dose, according to an analysis by the Computational Epidemiology Lab at Boston Children's Hospital, which is affiliated with Harvard Medical School.

A person walks past a sign that says
A person walks past a COVID-19 vaccination sign at a pharmacy in New York in August. (Wang Ying/Xinhua via Getty Images)

That’s largely because 75 percent of U.S. adults have a body-mass index of 25 or more, which the CDC considers “obese” — and obesity is a qualifying medical condition. Other qualifying conditions include depression, a current or former smoking habit, high blood pressure and a recent pregnancy. Combine all those risk factors with qualifying jobs — first responders, educators, food and agriculture workers, manufacturing workers, corrections workers, public transit employees and others — and you get to about 9 in 10 U.S. adults.

Then consider that pharmacies and other providers aren’t even checking qualifications, and the fact is that every single U.S. adult can already get a booster if he or she wants one.

The problem is that almost no U.S. adults know that, and they don’t know it because the CDC had not made it clear. 

In recent days, leaders in Colorado, California, New Mexico, New York City, Arkansas and Rhode Island have broken with federal officials in an attempt to make the booster situation as clear as they possibly can, arguing there’s no point to a rule that stops far more eligible than ineligible Americans from getting vaccinated. 

“What we’re finding is that we want more people to get their booster shot and that this is somewhat confusing and limiting as to the eligibility,” Arkansas Gov. Asa Hutchinson said Monday. “We’re changing that.”

Now it looks like regulators in Washington, D.C. have gotten the message.

This story has been updated throughout to reflect the FDA's reported plans to approve broad use of the boosters.

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