Tracking the rollout of the COVID-19 vaccines as the United States emerges from the pandemic.
With the rollout this month of a new coronavirus booster, U.S. public health leaders once more face the challenge of persuading Americans that they should roll up their sleeves and get another, possibly better, shot targeted at the omicron strain.
This has become tougher with each successive vaccination campaign.
About 68% of the U.S. population has received either two doses of the Pfizer-BioNTech or Moderna vaccines or one dose of Johnson & Johnson, but only one-third has chosen to get a booster. In Canada, much of Europe, Japan and South Korea, people have chosen to get additional doses at far higher rates.
This summer, when COVID-19 vaccines were finally authorized in the U.S. for children under 5, they met with low demand. By mid-August, just under 5% of kids under 5 had received their first shots and only about 1% were fully vaccinated.
Several have said there’s inadequate proof that the reformulated booster shot will provide better protection than the original or that it’s been rushed out after being tested only on animals, not people. Centers for Disease Control and Prevention Director Rochelle Walensky and other proponents of the new booster have countered that waiting for more evidence would have left the U.S. using a potentially outdated vaccine if, as expected, COVID-19 surges this fall and winter.
Among the most notable of the objectors is Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the Food and Drug Administration advisory committee that recommends whether to authorize vaccines and for whom. Offit has pristine pro-vaccine credentials: He’s the author of “Deadly Choices: How the Anti-Vaccine Movement Threatens Us All” and has been one of the nation’s most vocal advocates for childhood vaccination.
We spoke to Offit about where he thinks the public messaging about the COVID-19 vaccine and boosters has broken down. The key group for health officials to reach, he said, isn’t those adamantly opposed to getting the vaccine or those who’d happily line up for 10 doses. It’s everyone else, he said, the ones thinking: “Do I really need another dose? How badly do I need this dose?”
In an emailed statement, a spokesperson for the U.S. Department of Health and Human Services defended the CDC’s and FDA’s messaging on vaccines and promoted the new booster: “We know we can save tens of thousands of lives if we can encourage the public to get their updated booster vaccine.” (See full statement here)
The stakes go beyond whether Americans will embrace each new COVID-19 shot, holding the potential to damage public confidence in all vaccines, Offit said. He pointed to four moments when leaders at the CDC, the FDA or in the Biden administration failed to communicate clearly what to expect from the COVID-19 vaccine and when and for whom extra shots could make a critical difference:
1. Vaccine meets world
When the Pfizer and Moderna vaccines were authorized in December 2020 and became available to an eager public, their makers and public health officials touted them as having efficacy rates of over 90% against mild, moderate and severe illness.
That was true, but temporary. What got lost in the messaging was that the shots’ protection against mild illness was bound to decline over time, Offit said. Public health officials should have made clearer that the principal goal was to prevent disease severe enough to lead to hospitalization or death. That’s what the vaccines delivered:
“If I could go back in time, right then when our committee was presented with those data in December , I think we should have stood up or people should have stood up and said: ‘Realize that this protection is great. And we hope this protection holds up against severe illness and keeps you out of the hospital and keeps you out of the ICU and keeps you from dying. But this protection against mildly symptomatic illness is not going to hold up over time.’ And that’s what happened. Six months later, protection faded. Instead of offering a reasonable explanation for that, we did the opposite.”
By mid-2021, there was a flurry of stories about so-called breakthrough infections — cases of COVID-19 among Americans who were fully vaccinated. At the time, they were considered rare. Perhaps the most memorable: an outbreak in Provincetown, Massachusetts, that began over the July 4 weekend and infected 469 people, including 346 who’d had the requisite vaccine doses.
Here, Offit said, was an opportunity to remind people that the vaccine’s protection against serious disease remained. Labeling mild cases or asymptomatic infections as “breakthroughs” was an avoidable error, he said:
“Four of the 346 were hospitalized. That’s a hospitalization rate of 1.2%. That is a vaccine that is working well. We should have stood up and said this is what you want from this vaccine. And the other 342 had a mild or asymptomatic infection, which we labeled ‘breakthrough’ infection. And that’s the CDC’s word, I mean, in their Morbidity and Mortality Weekly Report, that was the headline in that report of that outbreak, when it should have been the opposite. It should have been, ‘This vaccine is doing just what you expected it to do.’”
The fallout from not framing breakthrough infections this way continues to this day. A July survey of vaccinated adults conducted by Kaiser Family Foundation found that almost half, 48%, said they didn’t think boosters are effective because some vaccinated people are still getting infected.
3. Boosters for all?
In August 2021, the Biden administration announced plans to begin offering boosters to most fully vaccinated adults starting the following month.
The announcement was unusual, in part because the advisory panels that typically guide the CDC and FDA on vaccine decisions hadn’t yet weighed in on the booster question. Scientists who were convinced the data backed another shot quickly began debating those who thought that, at least for younger, healthier people, the first two were still plenty effective.
That September, the panel on which Offit sits, the FDA’s Vaccines and Related Biological Products Advisory Committee, rejected the notion that most adults needed a third dose, endorsing boosters only for those 65 and older or at high risk because of underlying health conditions.
“I mean, the most recent data, the data that were generated just a month before that, showed protection against severe disease was holding up. So what was [Biden] trying to do? Was he trying to protect against mild disease? Because that’s not doable. And so that came to our committee, and we voted no. We unanimously voted no.”
A CDC advisory panel came to a similar conclusion, recommending boosters only for limited groups. Ultimately, though, both agencies went beyond their advisers’ guidance. The FDA authorized boosters for any adult whose work or living conditions put them at higher risk of exposure. The CDC expanded its recommendations to match.
Said Offit: “So now you’re additionally confused. Should we get a booster dose or not?”
The landscape shifted again with the arrival in late 2021 of the omicron variant. Omicron was sufficiently genetically different from earlier versions of COVID-19 to spark worries about how well the vaccine’s protection would hold up.
Many public health experts who’d questioned the push to boost all adults became converts. CDC studies showed that fully vaccinated people who got boosters were less likely to end up in the hospital with COVID-19 than those who’d had only the first two doses of vaccine.
But certain subsets of people gained far more protection against serious illness from boosters, while others gained far less, Offit said. Public health officials should have articulated this more clearly:
“The question was, who was benefiting from that third dose or that fourth dose? Was it everybody? Was it a healthy 25-year-old? Or were there just certain select groups that were benefiting from that additional dose? And the answer is, just certain select groups. No. 1, far and away, older people. And by that, I mean really older people. People over 75. The other group was people who had the kind of serious health problems where even if they had a mild illness, they could still end up in the hospital. And then the third group, to a lesser extent, were people who were immunocompromised. That’s who was benefiting from that third or fourth dose.”
4. Omicron booster
Conveying a clear message about the benefits of the newest boosters has been more challenging than for previous shots, Offit said. “Even if you’ve been paying attention and reading everything you can, it’s been confusing,” he said.
As omicron became the dominant strain of COVID-19 worldwide, manufacturers began work on reformulated vaccines designed to provide better protection against it.
Some were what’s called bivalent, containing both the mRNA codes for the spike protein in the original virus strain that emerged in China and the spike protein in a strain of omicron.
In June, Pfizer-BioNTech and Moderna presented data from small-scale human trials to the FDA advisory committee on which Offit sits. The data showed that people who received a bivalent booster targeting the omicron BA.1 strain made somewhat more antibodies in response to Omicron BA.1 than people who received the original booster. (For all subjects, the boosters were their fourth shots overall.)
From Offit’s perspective, though, the increase in antibodies “did not translate to a clinically significant difference” in protection from severe disease. Other experts have expressed similar concerns.
Since the BA.1 strain of omicron is no longer circulating, the FDA asked manufacturers to develop boosters tailored to fight the now-prevalent BA.4 and BA.5 strains. The companies provided data from animal tests for this booster, showing it triggered a strong immune response to all omicron variants.
Ultimately, Offit voted against switching to an omicron-matched booster, but almost all his fellow panelists recommended that the FDA move ahead with these shots.
Though its counterparts in Europe, the United Kingdom and Canada have authorized the booster targeting BA.1, for which there was some human data, the FDA authorized a booster matched to BA.4 and BA.5.
The Biden administration has bought 171 million doses — possibly the last free doses of COVID-19 boosters Americans will get, as Congress has blocked the administration’s requests for more funding.
At this stage in the pandemic, after so many cases and so many shots, the HHS spokesperson acknowledged that “our communications strategy is different.” Still, the administration’s statement set a high bar for what the new shot would deliver, saying it’s “expected to not only improve protection against serious disease, but may also restore protection against symptomatic disease.”
Offit expects that by mid-October, additional data will become available on how people’s immune systems respond to the new U.S. booster, answering at least some of the lingering questions about the shots.
“We’ll see whether or not they were right,” he said of the booster’s advocates.
Offit fears that the federal government’s mistakes in explaining the purpose of the COVID-19 shots and boosters have the potential to undermine public confidence in other vaccines, engendering pushback even against those with decadeslong track records. That, in turn, could bring the return of devastating infectious diseases once thought vanquished.
He pointed to a recent case of paralytic polio in Rockland County, New York, the first in the U.S. in almost a decade. Rockland County’s vaccination rates, which have long lagged those of the state and the nation, dropped even further during the pandemic. Offit worries the rest of the nation could travel down a similar path.
“You’ll see these diseases come back,” Offit warned. “And believe me, that’s not a disease you want to see come back. I was in a polio ward when I was 5 years old. ... I didn’t have polio. I had a failed operation on my right foot. But that landed me in a polio ward for six weeks. And I remember those children. I remember iron lungs. ... I was in hell for six weeks. Nobody wants to go back there.”