WASHINGTON — The Biden administration is pushing ahead with a plan to give at least everyone 65 and older — and possibly some younger adults — the option of a second booster of the Pfizer-BioNTech or Moderna coronavirus vaccine without outright recommend that they get one, according to several people familiar with the schedule.
Major uncertainties have complicated the decision, including how long the protection against a second booster would last, how to explain the plan to the public, and even whether the overall goal is to protect everyone who is only eligible from serious illness or from minor illnesses. serious infections as well, as they can lead to long-term Covid.
Much depends on when the next wave of Covid infections will strike, and how hard. Should a powerful wave hit the country in the coming months, offering a second booster now could arguably save thousands of lives for older Americans and prevent tens of thousands of hospitalizations.
But if a big wave doesn’t hit until the fall, additional injections now could prove to be a questionable intervention that wastes vaccine doses and could increase vaccine fatigue and cast doubt on the government’s strategy. The highly contagious Omicron subvariant BA.2 is fueling a new wave of coronavirus cases in Europe and is responsible for about a third of new cases in the United States, but health officials have said they don’t expect a major increase caused by the sub variant .
Federal health officials have hotly debated the way forward, with some now strongly in favor of a second booster and others skeptical. But they seem to have banded together around a plan to give at least older Americans the option of an extra shot, in case the infections pick up again before the fall. It was unclear how broad the eligible group would be. In the fall, officials say, Americans of all ages, including anyone getting a booster this spring, should get another chance.
A decision by the Food and Drug Administration to approve a second booster could come early next week, according to multiple people familiar with the deliberations. The Centers for Disease Control and Prevention can then advise those who qualify to take another shot, rather than recommending that they do so.
A second booster would at most be an emergency measure. 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. A peak in the fall 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 studies are underway to find the next generation of vaccines, with first results expected in May or June. If all goes well, that should give enough time to produce new doses before the fall. One big problem is that the Biden administration says it doesn’t have the money it needs to reserve its place in the queue by pre-paying vaccine manufacturers for doses.
On the positive side, data from the CDC indicates that four to five months after a third injection, the Pfizer-BioNTech and Moderna vaccines remain about 78 percent effective against hospitalization due to Covid-19. That could even be an underestimate, given the limitations of the study.
On the other hand, 78 percent is still a 91 percent drop in effectiveness found after two months, and the potency of the vaccines may further decline with time. If another wave hits in May or summer, even a somewhat modest decline in hospitalization protections could have a huge impact on the roughly 55 million Americans, age 65 or older, who have been most affected by the pandemic. . Pfizer and BioNTech have said new data, including that from Kaiser Permanente, show that the booster dose’s potency against serious diseases wanes within three to six months.
According to CDC data, one in 75 Americans age 65 or older has already died from Covid, accounting for three-quarters of the country’s deaths from the virus. More than 33 million people in that age group, or more than two-thirds, have received a first booster and would qualify for a second.
For some officials, the key question is this: How much does the effectiveness against hospitalization need to decline before a second booster is warranted?
As in the fall, when boosters were first rolled out, the wider scientific community is divided on what to do next. “I am not convinced that protection against serious disease decreases significantly after the third dose,” said Dr. Philip Krause, a former senior FDA supervisor, in an interview.
dr. Monica Gandhi, an infectious disease physician and medical professor at the University of California, San Francisco, said healthy younger people with one booster were OK at this point, but older people “should probably be getting fourth injections now.”
There may be less resistance among scientists now than there was to the first booster shots, as evidence suggests those doses saved lives during the winter’s Omicron wave.
Given the limited nature of the data supporting a second round of booster shots, some federal officials say some sort of neutral advice could go down the Biden administration. But in general, slack advice on regulation is unpopular, as people and doctors often want more concrete advice than options.
dr. Judith A. Aberg, chief of infectious diseases at the Mount Sinai Health System, said the public could be frustrated with mere approval for a second booster.
Unlike the first round of regulatory decisions on booster shots, no FDA or CDC advisory committee meetings are scheduled prior to the decision on second boosters. The recommendations of the panels are not binding, but are usually followed. Bypassing those commissions will be criticized.
“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 wouldn’t want to see an advisory committee skipped on this.”
But government officials seem willing to accept complaints about the process. The FDA has scheduled a meeting of its advisory committee on April 6 to discuss what the administration’s overall vaccine strategy should be.
As for the timing, federal officials just seem to be making their best guess. If people get a second booster now and the virus revives in July, their protection may already have fallen away. On the other hand, if the administration waits for a Covid wave to hit, it will be too late to vaccinate tens of millions of people.
The supply is there, at least for older folks: States have 131 million doses of the Pfizer-BioNTech and Moderna vaccines on hand. Many experts also say there’s no evidence that an extra shot could harm people’s immunity by getting them used to coronavirus vaccines.
Perhaps the biggest downside is more vaccine fatigue and skepticism that the vaccines work and that the country’s vaccine policies are really data-driven. With each subsequent shot that becomes available, fewer Americans are getting it.
In addition to the CDC, Britain and Israel have published data on the declining effectiveness of booster shots. The latest report from the UK Health Service states that effectiveness against symptomatic infection drops to 25 to 40 percent 15 weeks or more after a booster dose of Pfizer or Moderna.
But the UK health service said how well boosters protect against hospitalization was harder to measure. Because Omicron tended to cause milder disease than previous variants, more hospitalized patients tested positive for Covid but were admitted for other reasons.
Looking only at patients admitted for respiratory disease, the agency estimated that the vaccine’s effectiveness against hospitalization for people over 65 fell to 85 percent 15 weeks or more after the booster, compared with 91 percent in the weeks immediately following the injection. Like a few other countries, Britain is offering a second booster this spring for the elderly and others at high risk.
Data from Israel suggest that a second booster injection increases protection fourfold against hospitalization and twofold against infection. But no one knows for how long. Since Israel has only recently started its second booster campaign, it only has two months or less of data. Other Israeli data suggests that a second booster restores antibody levels to their peak levels after the first booster, but Dr. Aberg said that dataset also had limitations.
Pfizer and Moderna don’t seem to have much of their own data to support their emergency consent requests; Pfizer is looking for second boosters for the over-65s, while Moderna made a sweeping request to offer second booster shots to all adults. Neither has submitted data from a randomized, placebo-controlled trial — considered the gold standard of scientific evidence — on how well the dose would work.
“We will have to make this decision based on incomplete information,” said Dr. Peter J. Hotez, a vaccine expert at Baylor College of Medicine in Houston.
Sheelagh McNeill and Kitty Bennett research contributed.
