The Food and Drug Administration is poised to dramatically expand the use of Covid-19 booster shots as soon as this week, after weeks of public debate over who needs the shots — and when.
POLITICO breaks down the U.S. booster rollout and the big remaining questions, including how long the shots’ protection lasts and whether the Biden administration will authorize “mix and match” boosters.
So, who can get a booster?
FDA has authorized Pfizer’s shot for some groups and is likely to authorize boosters from Moderna and Johnson & Johnson in the coming days.
The Pfizer shot is cleared for people 65 and older or those ages 18-64 with underlying health conditions or who work in jobs — like health care or corrections — that put them at greater risk of contracting the virus. FDA advisers recommended Moderna boosters for the same groups, whereas they endorsed J&J boosters for everyone 18 and older who originally got the J&J shot.
(People with severely weakened immune systems have been eligible for a third initial shot of the Moderna or Pfizer vaccines since August, but those are considered extra doses rather than boosters).
That sounds … pretty wide open.
FDA has decided that people can “self attest” to their eligibility for boosters — which means you won’t be asked to prove that you qualify.
And as many experts have pointed out, a majority of Americans likely qualify as “high risk” based on guidance from the Centers for Disease Control and Prevention. That includes the 42.4 percent of U.S. adults who are considered obese, and those with other relatively common conditions like diabetes and moderate to severe asthma.
The only real booster barrier now is for teens 12-17, who are eligible for vaccination with the Pfizer shot but are not yet cleared for any brand of booster. FDA declined to authorize the Pfizer booster for 16- to 17-year-olds over concerns about a rare side effect — the heart inflammation myocarditis — that is more common in teens and young adults.
I got J&J or Moderna — can I get a Pfizer booster?
Not yet. (Sorry!)
Moderna and J&J boosters will likely be authorized soon, perhaps as early as the end of the week. But federal regulators are still studying the safety and efficacy of so-called “mix and match boosters,” when someone receives a booster shot of a Covid vaccine made by a company different from their initial series.
Is mixing and matching better?
Preliminary results from a federally funded mix-and-match study suggest Pfizer and Moderna’s boosters are the most effective, especially for those who received a single dose of J&J’s shot. The practice also appeared to be just as safe as giving the same vaccine initially and as a booster.
But the study size was small, the results haven’t been peer-reviewed, and the FDA does not seem ready to authorize that approach. There’s one more route that could be in play, though: CDC’s vaccine advisory committee, which helps determine who should get particular shots, could use its authority to allow mix-and-match boosters.
“I think, from a public health perspective, there’s a clear need in some situations for individuals to receive a different vaccine,” said Amanda Cohn, the CDC’s representative to the FDA advisory committee.
Why not just give boosters to everyone now?
For most people under 65 or so, available data suggests that vaccines still provide strong protection against severe illness and death. Some studies show they’ve become less effective over time at preventing mild or moderate infections.
But because vaccines seem to be holding up for most adults, a booster might only provide marginal benefit for those groups, many health experts have argued.
Panel member Patrick Moore, a professor at the University of Pittsburgh Cancer Institute, said he had some “real issues” with recommending the Moderna booster, in part because data did not show a major drop in vaccine protection.
“It is more gut feeling rather than based on really truly serious data,” he said, adding: “The data itself is not strong, but it is certainly going in a direction that is supportive of this.”
There’s also the slight — but noteworthy — potential for harm from administering unnecessary boosters. FDA advisers have been especially concerned about giving boosters to young adults and teens, particularly boys and men, who may be at greater risk for side effects like myocarditis when their protection from initial vaccination is likely quite strong.
I thought boosters were supposed to stop infection.
When the first Covid-19 shots rolled out last year, scientists were optimistic that the shots could prevent or at least sharply reduce transmission of the virus. Real-world data collected since then suggests that may not be the case.
Many researchers now argue the biggest benefits will come from vaccinating people in the U.S. and elsewhere who haven’t had their first Covid-19 shots.
Still, the Biden administration has advocated for wide use of boosters to tamp down Covid transmission as much as possible.
“We don’t want to have a wave of severe Covid-19 before we give boosters,” Peter Marks, FDA’s top vaccine regulator, said during the meeting last week.
Are we going to do this every year?
Maybe. Many vaccines require periodic boosters, including shots for tetanus and whooping cough.
Countries only began to roll out Covid boosters this summer, so we don’t know how long protection lasts. That’s a good reminder that science is happening in real time to an unusual degree during the pandemic. Two years ago, we didn’t know this virus existed.