The Biden administration is planning to give Americans age 50 or older the option of a second booster of the Pfizer-BioNTech or Moderna coronaviruses vaccine without telling them to get one, according to several people familiar with the plan.
Major uncertainties include how long the protection from a second booster would last, how to explain the plan to the public, and whether the overall goal is to shield Americans from severe disease or from less serious infections, since they could lead to long Covid.
It depends on when the next wave of Covid infections will hit and how hard it will be. If the nation is hit by a surge in the next few months, offering a second booster for older Americans could potentially save thousands of lives and prevent tens of thousands of hospitalizations.
If no major wave hits until the fall, extra shots could turn out to be a questionable intervention that will waste vaccine doses, deepens vaccination fatigue and sows doubt about the government's strategy. The Omicron subvariant BA.2 is responsible for about a third of new cases in the United States and is helping to drive another surge of coronaviruses in Europe, but health officials have said they do not anticipate a major surge caused by the subvariant.
Federal health officials have debated the way forward, with some in favor of a second booster and others not so sure. They have come up with a plan to give everyone age 50 and up the option of an additional shot in case infections surge again before the fall. Americans of all ages should get another shot in the fall, according to officials.
Multiple people familiar with the deliberations say the FDA could authorize a second booster early next week. The Centers for Disease Control and Prevention had its own advice.
A second booster is not enough. The question is how to modify the existing coronaviruses vaccines because of their diminishing power. A surge in the fall is considered highly likely if it comes in the form of the Omicron variant, a subvariant like BA.2 or a new lineage entirely.
The first results of more than a dozen studies are expected in May or June. It would allow enough time for new doses to be produced before the fall. The Biden administration doesn't have the money to reserve its place in line by paying vaccine manufacturers in advance.
According to the C.D.C., the Pfizer-BioNTech and Moderna vaccines are effective against hospitalization for four to five months after a third shot. That might be an underestimate, given the study's limitations.
78 percent is still a drop from the effectiveness that was found after two months, and the vaccines may fall further with more time. If a new wave hits in the coming months, even a small decline in protection against hospitalization could have a huge impact, especially among the 55 million Americans 65 or older who have been hardest hit by the Pandemic so far. According to Pfizer and BioNTech, data shows that the effectiveness of the booster dose fades in three to six months.
According to the C.D.C., one in 75 Americans 65 or older has died of Covid, making up three-fourths of the nation's deaths from the virus. More than two-thirds of the people in that age group have received a first booster.
The bottom-line question for some officials is how much effectiveness against hospitalization must drop before a second booster is justified.
The scientific community is divided over what to do with boosters, as it was in the fall.
Some federal officials say that neutral advice is as far as the Biden administration can go given the limited nature of data. In general, people and doctors prefer concrete advice over options, which is why regulatory advice is not popular.
The public could be frustrated with just permission for a second booster, said Dr. Judith Aberg, chief of the division of infectious diseases at Mount Sinai Health System.
The advisory committees of both the F.D.A. and the C.D.C. do not have meetings planned before the decision on second boosters. Recommendations are not binding but are usually followed. Critics will criticize skirting those committees.
This is a complex decision that involves a deep dive, and I think it would benefit from public discussion.
Administration officials seem willing to listen to complaints. The F.D.A. has scheduled an April 6 meeting of its advisory committee to discuss what the administration's overall vaccine strategy should be moving forward.
Federal officials seem to be making their best guess on timing. If people get a second booster now and the virus comes back in July, their protection may have already fallen off. If the administration waits until a Covid wave hits, it will be too late to protect tens of millions of people.
States have 131 million doses of the Pfizer-BioNTech and Moderna vaccines on hand. There is no evidence that an additional shot could hurt people's immunity.
More vaccine fatigue and skepticism that the vaccines work may be the biggest downside. Fewer Americans get it with each successive shot.
Britain and Israel have put out data on the effectiveness of booster shots. According to the latest report by Britain's health security agency, the effectiveness of a booster dose of either Pfizer or Moderna drops to between 25 percent and 40 percent after 15 weeks.
The British health agency said it was difficult to measure how well boosters protect against hospitalization. More hospitalized patients tested positive for Covid but had been admitted for other reasons since Omicron typically caused milder illness.
The agency estimated that vaccine effectiveness against hospitalization for those 65 or older dropped to 85 percent 15 weeks or more after the booster, compared with 91 percent right after the shot. Britain is offering a second booster this spring to older people and others at high risk.
Israel's data shows that a second booster shot raises protection twofold. No one knows how long. Israel only recently began its second booster campaign and has only a few months of data. Dr. Aberg said that the data set had limitations.
More than half a million Israelis age 60 or older were found to have a reduction in mortality if they received a second booster. Some vaccine experts are interested in that research but it has not been peer-reviewed.
Pfizer and Moderna do not seem to have much of their own data to back up their requests for emergency authorization; Pfizer is seeking second boosters for those 65 and older, while Moderna wants to give second booster shots to all adults. The gold standard of scientific evidence on how well a dose works is not available.
The decision will be made on the basis of incomplete information, according to Dr. Peter J. Hotez, a vaccine expert.
They contributed research.
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