Biden administration plans to offer second booster for people 50 and older

WASHINGTON — The Biden administration plans to give Americans 50 or older the option of a second booster 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 complicated the decision, including how long to protect against a second recall, how to explain the plan to the public, and even whether the overall goal is to protect Americans from serious illness or less serious infections. also, because they could lead to a long Covid.

It all depends on when the next wave of Covid infections will hit and how intense. If the nation were to be hit by a virulent surge in the coming months, offering a second booster now to older Americans could arguably save thousands of lives and avert tens of thousands of hospitalizations.

But if no major wave hits before the fall, additional injections could now prove to be a questionable intervention that wastes vaccine doses, deepens vaccination fatigue and casts doubt on the government’s strategy. The very contagious Omicron BA.2 sub-variant is helping drive 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 do not anticipate a sharp increase 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 over the age of 50 the option of an additional vaccine, in case infections rise again before the fall. Come fall, officials say, Americans of all ages, including anyone who gets a booster this spring, should get their shots again.

The Food and Drug Administration could authorize a second recall early next week, according to several people familiar with the deliberations. The Centers for Disease Control and Prevention would then follow up with their own advice.

A second reminder is at best a stopgap measure. Many experts say existing coronavirus vaccines need to be modified because variants of the virus decrease their potency; the question is how to reconfigure them. A surge in the fall is considered very likely, whether it comes in the form of the Omicron variant, a sub-variant like BA.2, or an entirely new lineage.

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. A major snag is that the Biden administration says it doesn’t have the money it needs to reserve its place online by paying vaccine makers for doses in advance.

On the positive side, CDC data indicates that four to five months after a third injection, the Pfizer-BioNTech and Moderna vaccines remain approximately 78% effective against hospitalization due to Covid-19. This might even be an underestimate, given the limitations of the study.

On the other hand, 78% is still a drop from the 91% effectiveness seen after two months, and the potency of vaccines could still decline over time. If a new wave hits in the coming months, even a somewhat modest drop in hospitalization protection could have a huge impact, especially among the roughly 55 million Americans age 65 or older, who have up to now borne the brunt of the pandemic. Pfizer and BioNTech said emerging data, including from Kaiser Permanente, shows that the potency of its booster dose against severe disease declines within three to six months.

Already, one in 75 Americans age 65 or older has died from Covid, accounting for three-quarters of virus deaths in the country, CDC data shows. More than 33 million people in this age group, more than two-thirds, have received a first booster and would be eligible for a second.

For some managers, the key question is: how much should the effectiveness against hospitalization drop before a second booster is warranted?

As it was in the fall, when the recalls were first issued, the wider scientific community is divided on what to do. “I am not convinced that there is a substantial decrease in protection against serious illness after the third dose,” said Dr. Philip Krause, former senior 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 that while healthy young people with recall are fine at this stage, older people “probably should start receiving a fourth vaccine now.”

There may be a little less resistance among scientists today than there was for the first booster shots, as evidence has emerged that these doses saved lives during the winter surge of Omicron.

Given the limited nature of the data supporting a second round of recalls, some federal officials say some sort of neutral advice is as far as the Biden administration can go. But in general, wishy-washy regulatory advice isn’t popular, because people and doctors often want concrete advice more than options.

Dr. Judith A. Aberg, chief of the Mount Sinai Health System’s division of infectious diseases, said the public might be frustrated by just allowing a second recall.

Unlike the first round of regulatory decisions on the recalls, no FDA or CDC advisory committee meetings are scheduled before the decision on the second recalls. The recommendations of the panels are not binding but are generally followed. Bypassing these committees will attract criticism.

“It’s a complex decision that involves a pretty deep dive, and I think it would really benefit from public debate,” said Dr. Jesse L. Goodman, former chief scientist at the FDA. see an advisory board jumped on it.

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 what the administration’s overall vaccine strategy should move forward.

When it comes to timing, federal officials just seem to be making their best guess. If people get a second reminder now and the virus reappears in July, their protection may have already fallen again. By contrast, if the administration waits for a wave of Covid to hit, it will be too late to vaccinate tens of millions of people.

The supply seems to be there: States have 131 million doses of the Pfizer-BioNTech and Moderna vaccines. Many experts say there is no evidence that an extra injection can harm people’s immunity by getting them used to coronavirus vaccines.

The biggest downside could be more vaccine fatigue and skepticism about vaccine effectiveness and that national vaccine policy is truly data-driven. With each successive shot that becomes available, fewer Americans get it.

Besides the CDC, Britain and Israel have published data on the diminishing effectiveness of booster shots. The latest report from the UK Health Security Agency indicates that efficacy against symptomatic infections drops between 25% and 40% 15 weeks or more after a booster dose of Pfizer or Moderna.

The UK health agency said it was more difficult to measure how well reminders protected against hospitalization. Because Omicron generally caused milder disease than previous variants, more hospital patients tested positive for Covid but were admitted for other reasons.

Considering only patients admitted with a respiratory illness, the agency estimated that the vaccine’s effectiveness against hospitalization of people aged 65 or older fell to 85% 15 weeks or more after the booster, from 91% in the weeks following the vaccine. Like a handful of other countries, Britain is offering a second booster this spring for the elderly and other high-risk people.

Data from Israel suggests that a second booster injection quadruples the protection against hospitalization and doubles against infection. But no one knows for how long. As Israel only recently started its second recall campaign, it only has data for two months or less. Other Israeli data suggests that a second booster restores antibody levels to their peak after the first booster, but Dr. Aberg said this dataset also has limitations.

A study published Thursday on more than half a million Israelis aged 60 or older found a noticeable reduction in mortality among those who received a second booster compared to those who received only a first. This research has generated strong interest among some vaccine experts, but has not been peer-reviewed.

Pfizer and Moderna don’t appear to have much of their own data to back up their emergency clearance requests; Pfizer is seeking second boosters for those 65 and older, while Moderna has filed a sweeping request to offer second boosters to all adults. There is also no data from a randomized, placebo-controlled study – considered the gold standard of scientific evidence – on the effectiveness of the dose.

“We’re going to 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 contributed to the research.