WASHINGTON — The Biden administration plans to give Americans age 50 and older the option of a second booster shot of the Pfizer-BioNTech or Moderna coronavirus vaccine without outright recommending that they get one, according to several people familiar with the plan.
Major uncertainties have complicated the decision, including how long protection from a second booster shot would last, how the plan will be explained to the public, and whether the overarching goal is to only protect those deemed appropriate from a severe one To protect against illness or less severe infections well, they could lead to long covid.
Much depends on when and how severe the next wave of Covid infections will hit. Should a virulent wave sweep the nation in the next few months, offering older Americans a second booster shot now could save thousands of lives and prevent tens of thousands of hospitalizations.
But unless a major wave hits by the fall, extra shots now could prove a questionable intervention that wastes vaccine doses and could deepen vaccine fatigue and cast doubt on the government’s strategy. The highly contagious omicron subvariant BA.2 is contributing to a further surge in coronavirus cases in Europe and is responsible for about a third of new cases in the United States, but health officials have said they are not associated with a larger spike from the Calculate subvariant .
Federal health officials have heatedly debated how to proceed, with some now strongly in favor of a second refresher and others skeptical. But they have apparently banded together on a plan to give everyone aged 50 and over the option of an extra shot in case infections pick up again before the autumn. In the fall, officials say, Americans of all ages, including anyone getting a booster shot this spring, should get another shot.
The Food and Drug Administration could approve a second booster early next week, according to several people familiar with the deliberations. The Centers for Disease Control and Prevention could then advise those eligible to consider further vaccination, rather than recommending it.
A second booster is at best an emergency solution. Many experts argue that the existing coronavirus vaccines need to be modified because the variants of the virus reduce their potency; The question is how to reconfigure them. An autumn surge is considered very likely, whether in the form of the Omicron variant, a subvariant such as BA.2, or an entirely new lineage.
More than a dozen trials are underway to find the next generation of vaccines, with the first results expected in May or June. If all goes well, that would leave plenty of time to start making new cans before fall. A big catch is that the Biden administration says it doesn’t have the money it needs to reserve its spot in line by paying vaccine makers upfront for doses.
On the plus side, data from the CDC indicates that the Pfizer-BioNTech and Moderna vaccines remain about 78 percent effective against hospitalizations due to Covid-19 four to five months after a third vaccination. Given the limitations of the study, this might even be an underestimate.
On the other hand, 78 percent is still a drop from the 91 percent effectiveness seen at two months, and the effectiveness of the vaccines may continue to decline over time. If a new wave strikes in the coming months, even a somewhat modest drop in protections from hospitalization could have a huge impact, especially among the roughly 55 million Americans aged 65 and over who have borne the brunt of the pandemic so far. Pfizer and BioNTech have said new data, including from Kaiser Permanente, shows the effectiveness of its booster dose against serious illnesses wears off in three to six months.
Already one in 75 Americans age 65 and older has died from Covid, accounting for three-quarters of the country’s deaths from the virus, according to the CDC. More than 33 million people in this age group, or more than two-thirds, have received a first booster shot and would be eligible for a second one.
For some officials, the key question is: How much does the effectiveness against hospitalization have to drop before a second booster dose is warranted?
As in the fall when the first boosters were introduced, the broader scientific community is divided on what to do. “I’m not convinced that there is a significant drop in protection from serious disease after the third dose,” said Dr. Philip Krause, a former chief regulator at the FDA, in an interview.
But dr Monica Gandhi, an infectious disease physician and professor of medicine at the University of California, San Francisco, said while healthy younger people are fine with a booster shot at this point, older people “should probably start their fourth shot now.”
There may be a little less resistance among scientists now than there was when the first boosters were given, as those doses were found to have saved lives during the winter’s Omicron surge.
Given the limited data supporting a second round of booster shots, some federal officials say the Biden administration can only go with some sort of neutral advice. But in general, wishy-washy regulatory advice isn’t popular, as people and doctors often want more specific advice than options.
dr Judith A. Aberg, chief of the infectious diseases unit at Mount Sinai Health System, said the public could be frustrated by just allowing a second booster shot.
Unlike the first round of booster vaccination approval decisions, no meetings of the FDA or CDC advisory committees are scheduled prior to the decision on second booster vaccinations. The recommendations of the committees are non-binding, but are generally followed. Bypassing these committees will draw criticism.
“This is a complex decision that requires quite a deep dive, and I think it would really benefit from a public discussion,” said Dr. Jesse L. Goodman, a former chief scientist at the FDA. “I wouldn’t want to see an advisory committee skipped.”
But administration officials seem willing to accept complaints about the process. The FDA has scheduled an April 6 meeting of its Advisory Committee to discuss how to move the administration’s overall vaccine strategy forward.
As for the timing, federal officials appear to be simply guessing to the best of their ability. If people get a second booster shot now and the virus resurfaces in July, their protection may already be gone. On the other hand, if the administration waits until a Covid wave arrives, it will be too late to vaccinate tens of millions of people.
The supply appears to be there: States have 131 million doses of the Pfizer-BioNTech and Moderna vaccines in stock. Many experts say there is no evidence that additional vaccination could affect people’s immunity by making them accustomed to coronavirus vaccines.
The biggest downside may be greater vaccine fatigue and skepticism that the vaccines are working and that the nation’s immunization policy is truly being driven by data. With each successive shot that becomes available, fewer Americans get it.
In addition to the CDC, the UK and Israel have released data on the declining effectiveness of booster shots. The UK Health Authority’s latest report states that effectiveness against symptomatic infections drops to 25 to 40 percent 15 weeks or more after a booster dose of either Pfizer or Moderna.
The UK Health Authority said how well booster vaccines protect against hospitalization is harder to measure. Because Omicron typically caused milder disease than previous variants, more hospitalized patients tested positive for Covid but had been admitted for other reasons.
Looking only at patients admitted for respiratory illness, the agency estimated that vaccine effectiveness against hospitalizations in people 65 years and older fell to 85 percent 15 weeks or more after the booster shot, compared with 91 percent in the weeks immediately after vaccination . Like a few other countries, the UK is offering a second boost to the elderly and other high-risk individuals this spring.
Israel’s data suggests that a second booster dose increases protection from hospitalization four-fold and from infection two-fold. But nobody knows for how long. Having only recently launched its second booster campaign, Israel has only two months or less of data. Other Israeli data suggests that a second booster dose brings antibody levels back to their peak after the first booster dose, but Dr. Aberg said the dataset also had limitations.
A study of more than half a million Israelis aged 60 and older, released Thursday, found a notable reduction in mortality among those who received a second booster shot compared to those who only received a first. This research has generated a great deal of interest from some vaccine experts, but has not been peer-reviewed.
Pfizer and Moderna don’t appear to have much of their own data to support their emergency permit requests; Pfizer is seeking second booster shots for people 65 and older, while Moderna made a sweeping request to offer all adults second booster shots. There’s also no data from a randomized, placebo-controlled trial — considered the gold standard for scientific evidence — on how well the dose would work.
“We have to make this decision based on incomplete information,” said Dr. Peter J. Hotez, vaccines expert at Baylor College of Medicine in Houston.
Sheelagh McNeill and Kitty Bennett contributed research.