Biden administration plans to offer second booster shots to those 50 and older
By Sharon LaFraniere
The Biden administration is planning to give Americans age 50 or older the option of a second booster of the Pfizer or Moderna coronavirus vaccine without recommending outright that they get one, according to several people familiar with the plan.
Major uncertainties have complicated the decision, including how long the protection from a second booster would last, how to explain the plan to the public and even whether the overall goal is to shield Americans from severe disease or from less serious infections as well, since they could lead to long COVID.
Much depends on when the next wave of COVID infections will hit, and how hard. Should the nation be hit by a virulent surge in the next few months, offering a second booster now for older Americans could arguably save thousands of lives and prevent tens of thousands of hospitalizations.
But if no major wave hits until the fall, extra shots now could turn out to be a questionable intervention that wastes vaccine doses, deepens vaccination fatigue and sows doubt about the government’s strategy. The highly contagious omicron subvariant BA.2 is helping to drive another surge of coronavirus cases in Europe and is responsible for about one-third of new cases in the United States, but health officials have said they do not anticipate a major surge caused by the subvariant.
Federal health officials have hotly debated the way forward, with some strongly in favor of a second booster now and others skeptical. But they have apparently coalesced around a plan to give everyone age 50 and up the option of an additional shot, in case infections surge again before the fall. In the fall, officials say, Americans of all ages, including anyone who gets a booster this spring, should get another shot.
The Food and Drug Administration could authorize a second booster early next week, according to multiple people familiar with the deliberations. The Centers for Disease Control and Prevention would then follow with its own advice.
A second booster is at best a stopgap measure. Many experts argue that the existing coronavirus vaccines need to be modified because the virus’ variants are diminishing their power; the question is how to reconfigure them. A surge in the fall is considered highly likely, whether it comes in the form of the omicron variant, a subvariant like BA.2 or a new lineage entirely.
More than a dozen studies are underway to find the next generation of vaccines, with the first results expected in May or June. If all goes well, that would allow enough time to produce new doses before the fall. One major hitch is that the Biden administration says it does not have the money it needs to reserve its place in line by paying vaccine manufacturers for doses in advance.
On the plus side, data from the CDC indicates that four to five months after a third shot, the Pfizer and Moderna vaccines remain about 78% effective against hospitalization due to COVID-19. That might even be an underestimate, given the study’s limitations.
On the other hand, 78% is still a drop from the 91% effectiveness that was found after two months, and the vaccines’ potency may fall further with more time. If a new wave hits in the coming months, even a somewhat modest decline in protection against hospitalization could have a huge impact, especially among the roughly 55 million Americans 65 or older, who have borne the brunt of the pandemic so far. Pfizer and its German partner BioNTech have said that emerging data, including from Kaiser Permanente, shows that the potency of its booster dose against severe disease wanes in three to six months.
Already, 1 in 75 Americans 65 or older has died of COVID-19, making up three-fourths of the nation’s deaths from the virus, according to the CDC’s data. More than 33 million people in that age group, or more than two-thirds, have received a first booster and would be eligible for a second.
For some officials, the bottom-line question is this: How much must effectiveness against hospitalization drop before a second booster is justified?
As it was in the fall, when boosters were first rolled out, the broader scientific community is divided over what to do. “I am not persuaded there is substantial waning of protection against severe disease after the third dose,” Dr. Philip Krause, a former senior regulator at the FDA, said in an interview.
But Dr. Monica Gandhi, an infectious disease doctor and medical professor at the University of California, San Francisco, said that while healthy younger people with one booster were fine at this point, older people “should probably start receiving fourth shots now.”
There may be somewhat less resistance among scientists now than there was to the first booster shots, since evidence has emerged that those doses saved lives during the winter’s omicron wave.
Given the limited nature of data supporting a second round of booster shots, some federal officials say that some sort of neutral advice is as far as the Biden administration can go. But in general, wishy-washy regulatory advice is not popular, as people and doctors often want concrete advice more than options.
Dr. Judith A. Aberg, chief of the division of infectious diseases at Mount Sinai Health System, said the public could be frustrated with mere permission for a second booster.
Unlike with the first round of regulatory decisions on booster shots, no meetings of the advisory committees of either the FDA or the CDC are planned before the decision on second boosters. The panels’ recommendations are nonbinding but are usually followed. Bypassing those committees will draw criticism.
“This is a complex decision that involves a pretty deep dive, and I think it would really benefit from public discussion,” said Dr. Jesse L. Goodman, a former chief scientist at the FDA. “I would not want to see an advisory committee skipped on this.”
The supply appears to be there: States have 131 million doses of the Pfizer and Moderna vaccines on hand. Many experts say there is no evidence that an additional shot could hurt people’s immunity by habituating them to coronavirus vaccines.
The biggest downside may be more vaccine fatigue and skepticism that the vaccines work and that the nation’s vaccine policy is really driven by data. With each successive shot that becomes available, fewer Americans get it.