Biden Administration Could Give Older Americans Second Support

WASHINGTON — The Biden administration is moving forward with a plan to give at least anyone aged 65 and over — and possibly some young adults as well — a second booster option of the Pfizer-BioNTech or Moderna coronavirus vaccine without recommending that they get one. , according to a few people familiar with planning.

Great uncertainties complicated the decision, including how long the protection from a second booster would last, how the plan would be made public, and even whether the overall goal was to protect eligible individuals only from severe illness or less serious infections. good, because they can lead to long Covid.

Much depends on when the next wave of Covid infection hits and how harsh it will be. If the nation suffers a severe surge in the next few months, offering a second booster for older Americans now could possibly save thousands of lives and prevent hundreds of thousands of hospitalizations.

But if a big wave doesn’t come until the decline, now the extra shots could become a dubious intervention that wastes doses of vaccines and could deepen vaccine fatigue and cast doubt on government strategy. highly contagious Omicron subvariable BA.2 A new coronavirus is helping to drive the case increase in Europe and is responsible for about a third of new cases in the United States, but health officials said. I don’t expect a big fluctuation originates from the sub-variant.

Federal health officials have hotly debated the way forward, with some now in favor of a second booster and others skeptical. But they seem to converge around a plan to at least give older Americans a choice should infections rise again before the decline. It was unclear how large the group would be. Officials say Americans of all ages should be given another chance this fall.

A decision on whether to allow a second booster from the Food and Drug Administration could come early next week, according to many familiar with the negotiations. The Centers for Disease Control and Prevention may then advise those who are eligible to consider getting another vaccine rather than recommending it.

Giving some people a second booster option would be a temporary measure at best. Many experts argue that existing coronavirus vaccines should be modified as variants of the virus reduce their potency; The question is how to reconstruct them. Whether in the form of the Omicron variant, a sub-variant like the BA.2, or an entirely new generation, a bearish fluctuation is considered quite likely.

More than a dozen studies are underway to find next-generation vaccines, and the first results are expected in May or June. If all goes well, this will provide ample time to produce new doses before they drop. One major setback is that the Biden administration has told vaccine manufacturers that it doesn’t have the money it needs to reserve its next spot, by paying vaccine manufacturers upfront for doses.

On the plus side, Data from CDC Four to five months after the third shot, the Pfizer-BioNTech and Moderna vaccines show about 78 percent effectiveness against hospitalizations due to Covid-19. This may even be an underestimated estimate, because the study may have included a disproportionate number of people who are immunocompromised, making them more likely to become seriously ill.

On the other hand, 78 percent is still a decline from the 91 percent effectiveness found two months later, and the potency of the vaccines may decline further over time. If a new wave hits in May or during the summer, even a modest drop in protection against hospitalization could have a huge impact on the nation’s nearly 55 million Americans aged 65 and over who are burdened by the pandemic. Pfizer and BioNTech said emerging data, including Kaiser Permanente, show that the effect of the booster dose against severe disease diminishes within three to six months.

One in 75 Americans aged 65 and over has already died from Covid, accounting for three-quarters of the nation’s deaths from the virus, according to data from the CDC. More than 33 million people in this age group, or more than two-thirds, received first aid and were eligible for second aid.

For some officials, the real question is: How much should efficacy fall against hospitalization before a second supplement can be justified for those most at risk?

As boosters were first introduced in the fall, the broader scientific community is split over policy. A former senior regulator of the FDA, Dr. “I am not convinced that there is a significant reduction in protection against serious illness after the third dose,” Philip Krause said in an interview.

D., an infectious disease physician and professor of medicine at the University of California at San Francisco. Monica Gandhi said that healthy young people are fine at this point with a booster, but older people “probably should start getting the fourth vaccine.”

As evidence emerges that these doses save lives during the winter Omicron wave, there may be slightly less resistance among scientists than there was to the first booster shots.

Some federal officials say some sort of neutral advice is as far as the Biden administration can go, given the limited nature of data supporting the runoff. But in general, arbitrary regulatory advice is not popular, as people and doctors often want concrete advice rather than options.

Chief of the infectious diseases division at Mount Sinai Health System, Dr. Judith A. Aberg said the public may be disappointed with just permission for a second boost.

Unlike initial regulatory decisions on booster vaccines, neither FDA nor CDC advisory committee meetings are scheduled prior to the second booster decision. The recommendations of the panels are not binding, but are generally followed. Bypassing these committees will lead to criticism.

Former chief scientist of the FDA, Dr. “This is a complex decision that involves some pretty deep scrutiny and I think it will really benefit from public discussion,” said Jesse L. Goodman. “I wouldn’t want to see an advisory committee jump in on it.”

However, management officials seem willing to accept complaints about the process. The FDA scheduled an advisory committee meeting on April 6 to discuss where the administration’s overall vaccine strategy should go.

As for timing, federal officials seem to be making their best guess. If people get a second booster now and the virus resurrects in July, their protection may already be down again. 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.

At least there is supply for older people: States have 131 million doses of Pfizer-BioNTech and Moderna vaccines.

Many experts say there is no evidence that a supplemental vaccine can harm their immunity by acclimatizing people to coronavirus vaccines.

The biggest downside may be greater vaccine fatigue and skepticism that vaccines work and that the country’s vaccine policy is really data driven. With each successive shot that becomes available, fewer Americans get it. From Mount Sinai, Dr. On the other hand, delegating a second booster could result in more people getting the first one, Aberg said.

The CDC, as well as the UK and Israel, have released data on the declining effectiveness of booster shots. The latest report by the UK’s health safety agency states that effectiveness against symptomatic infection drops by between 25 and 40 percent 15 weeks or longer after a booster dose of Pfizer or Moderna.

But the British health agency said it was more difficult to measure how well the promoters protected against hospitalizations. Because Omicron typically causes milder disease than previous variants, more hospitalized patients tested positive for Covid but were admitted for other reasons.

Looking at patients admitted only for respiratory illness, the agency estimates that vaccine efficacy against hospitalization for people 65 and older drops from 91 percent to 85 percent 15 weeks or more after supplementation. Like some of the other countries, the UK is offering a second boost this spring to older people and others at high risk.

Israeli data shows that a second booster shot increases the protection against hospitalization by fourfold and against infection by twofold. But for how long no one knows. Since Israel has just launched its second support campaign, it only has data for two months or less. Other Israeli data suggest that a second booster restores antibody levels to their peak after the first booster, but Dr. Aberg said the dataset also has limitations.

Neither Pfizer nor Moderna seem to have much data to support emergency authorization requests; While Pfizer is looking for second-boosters for those 65 and older, Moderna has made an extensive request to offer second-booster shots to all adults. None provided data from a randomized, placebo-controlled study—considered the gold standard of scientific evidence—on how well the dose would work.

D., a vaccine specialist at Baylor College of Medicine in Houston. “We will have to make this decision based on incomplete information,” said Peter J. Hotez.

Sheelagh McNeill and kitty bennett contributed to research.