WASHINGTON — Federal health officials are starting to push new, variant-targeting vaccines that they say will curb a winter coronavirus wave and protect America’s most medically vulnerable people. The question is whether Americans feel any urgency to get them.
The updated vaccines from Moderna and Pfizer and BioNTech, authorized Wednesday by the Food and Drug Administration, are tailored to fighting back the dominant BA.4 and BA.5 strains. Biden officials hope the fresh doses can push down coronavirus case rates that have plateaued at roughly 400 deaths and more than 5,000 hospitalizations a day — and then stave off an all-but-assured case surge in the coming months.
The administration is “planning a robust public education campaign, building on lessons we’ve learned, and focusing on those most at-risk,” a White House official told STAT. Those efforts include a weekly survey of at least 1,500 people on the fence about getting a booster, outreach to community leaders and text alerts from pharmacies to encourage boosters, they added. The Centers for Disease Control and Prevention will convene an expert panel Thursday to discuss recommending the vaccines to the broader U.S. population, which they are expected to do.
However, vaccine experts are already split about the benefits of offering the doses broadly. And their debate is playing out publicly, even as coronavirus fatigue sets in among many Americans who have already snubbed existing boosters.
The Health and Human Services Department initially ordered 175 million doses of the new vaccines, enough to cover nearly half of Americans. But just a third of eligible people, about 100 million, have followed nearly year-old guidance to get one additional booster of the original shots. Younger people, especially, have faltered at getting extra doses as the pandemic drags into a third year and severe cases decline.
That’s left the administration in a quandary: Most Americans might not get, or even particularly need, another booster right now. But plenty of people still do.
“No one’s under any illusion that the demand is going to be what it was in 2020,” a senior Biden official told STAT. “But it’s absolutely critical that we focus on those who are at risk.”
Complicating the matter, Biden officials are tiptoeing around messaging on what the updated shots can do, and what they can’t, stymied in part by the fact that there is not yet solid human data. Officials and outside allies described to STAT a need to temper expectations that this booster will protect against future variants, or to dispel notions that this booster might be the last one a person needs.
Infectious disease experts say the administration is also bruised from earlier missteps, such as describing breakthrough cases as exceedingly rare or not stressing enough that while vaccines vastly curb severe infection, mild cases will still happen.
“Very early on, we never quite had explained to the American public what are reasonable expectations for protection against this kind of virus,” said outside FDA adviser Paul Offit, a pediatrician with the Children’s Hospital of Philadelphia, who is critical of the strategy to boost nearly all American people.
The “horrible public messaging” started early, says Eric Topol, founder and director of the Scripps Research Translational Institute.
“The unwillingness to accept boosters was because of mass confusion, starting in August of 2021, that’s never been cleared off,” he said, referring to the first reports of breakthrough cases. “Then [there was] this unrealistic expectation about vaccine preventing infection and transmission, which was true, with a booster, all the way through until we got to Omicron.”
The FDA authorized Pfizer and BioNTech’s shot as a booster for people 12 and older, and Moderna’s for people 18 and older.
Administration officials admit that they are not sure how long the new vaccine’s protection will last, a foggy question that shifts with each new variant’s lessons. They also are careful not to promise reduced transmission, particularly without solid human data for the new vaccines on the table. But they are confident that the updated vaccines are safe since they are edits on already-vetted shots.
“This will hopefully give us the kind of immunity we need right now,” FDA vaccine chief Peter Marks said during a Wednesday press briefing about the authorizations.
Marks and FDA Commissioner Robert Califf have already wrestled with some scientists’ complaints, including Offit’s, that the agency is moving too fast to authorize the vaccines on limited data. The two point to annual updates to influenza vaccines, which rely on small updates to original formulations and skip large-scale human studies to deliver seasonal vaccines quickly.
“We want to make sure that when we make data available publicly, that we’re confident in those data because a couple of times during this pandemic I personally have experienced where we went forward too quickly, and had to double back,” Marks told reporters.
That means data could take “one to two months” to land, he added.
In the meantime, public health experts question how many people will be in line for new shots as they roll out in the coming weeks, dampened both by data questions and the public’s growing complacency towards pandemic measures.
“This one is gonna be the toughest sell yet,” said Richard Besser, CEO of the Robert Wood Johnson Foundation and a former acting director of the Centers for Disease Control and Prevention. “For some people who’ve been willing to roll up their sleeve for other boosters, they may say, ‘I want to wait.’”
The question is what they are waiting for. More human data may assuage some peoples’ concerns, but public health experts say a broader conversation about who needs boosters and when they should be administered is on the horizon.
Offit, for instance, wants to see the country move to an annual booster schedule that focuses on medically vulnerable populations.
Topol argues that the government needs to focus on a so-called universal coronavirus vaccine that would ideally battle multiple incoming strains. Biden officials say that is months if not years away, and they need more funding, which has stalled in Congress.
Those experts acknowledge that the real concern in the looming booster campaign is older and immuno-compromised people, and that they are struggling to maintain the urgency that fueled earlier scrambles to get vaccinated.
“I’m not sure how you break through,” said Besser. “You want people to get on with their lives, and you want people who are at increased risk of severe disease to remain protected. You don’t want to lead with fear as a nation.”
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