WASHINGTON — With a supply of at least 100 million doses at the ready, officials in the Biden administration are developing a plan to offer coronavirus booster shots to some Americans as early as this fall, even as researchers continue to fiercely debate whether additional shots are needed. according to those familiar with the effort.
The first boosters are likely to go to nursing home residents and health professionals, followed by other seniors who were at the front of the line when vaccinations began at the end of last year. Officials are imagining giving people the same vaccine they were originally given. They have discussed the start of the effort in October but have not agreed on a timetable.
While many outside experts claim there is no evidence yet that vaccine protection against serious illness and hospitalization is declining in the United States, government officials say they cannot afford to delay the logistics of providing boosters to millions of people. until that tip point is reached. The spotty nature of the national disease reporting network further complicates the issue of timing.
The effort comes as a new wave of coronavirus grips the nation, undoing much of the progress the government had made. Hospitals in states like Texas, Louisiana and Mississippi are once again overrun with patients, the vast majority of them unvaccinated.
Among other indicators, officials say, the government is closely monitoring Israel, where some data points to an increase in serious illness among older adults who received that country’s Pfizer-BioNTech vaccine early in that country’s campaign, according to people who have it. assessed. Some officials are concerned that even if a decrease in protection leads to only mild or asymptomatic infections, those infected people could still spread the virus and prolong the pandemic.
Any decision for a booster policy is fraught, officials said, as the government does not want to undermine public confidence in what have been proven to be powerfully effective vaccines. Nor does it want to over-vaccinate Americans when many other countries have yet to get serious with vaccination campaigns, raising the threat of dangerous new variants that could spread to the United States and evade the vaccines.
The World Health Organization has called for a moratorium on booster shots until the end of September, saying the available doses should be used to help countries that are lagging far behind on vaccinations.
Regulators for the European Union said this month there was not yet enough data to justify boosters. Germany and France nevertheless announced plans to give booster shots to the elderly and other vulnerable populations next month.
Israel, which already administers booster shots to people over 60, announced on Thursday that it would also offer them to people over 50. Britain is pending so far, but already has a detailed plan to distribute boosters to people over 50.
More than a million Americans have already managed to get booster shots, though the Food and Drug Administration hasn’t even been asked to decide whether they’re safe or effective.
They represent less than 1 percent of those who are fully vaccinated. But more people could try to follow suit once regulators fully approve the Pfizer-BioNTech vaccine, a move expected early next month. Although the regimen requires two injections, doctors could at that point prescribe a third for patients without fear of violating FDA rules.
Late this week, the FDA approved third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, and the CDC recommended them. Authorities decided that those individuals, who make up less than 3 percent of Americans, deserved additional injections because many failed to respond to the standard dosage.
Government officials continued to insist that boosters were not needed for the general population for the time being. Determining where that change is is difficult because administration experts have no current data on so-called breakthrough infections in vaccinated people, including their prevalence, when these people were vaccinated, and what vaccine they received.
Instead, officials are analyzing a complex set of information from a variety of sources, including from vaccine manufacturers Moderna and Pfizer-BioNTech, which have an agreement with the Israeli government to review its data. Other sources of information include a variety of foreign governments and the Centers for Disease Control and Prevention, which collect data from states and hospitals. All that data is subject to interpretation and can be used to support arguments for or against boosters.
“It’s a bit chaotic, everyone is doing their own thing,” said Dr. Jesse L. Goodman, a former chief scientist at the FDA and now a medical professor at Georgetown University. “We need a system to monitor the effectiveness of vaccines in practice in near real-world time.”
He added: “If something comes up like the Pfizer report on Israel, we should be able to say, ‘Do we see that here?’ I am very disappointed that we are not there yet.”
Some federal officials referred to the booster discussions as emergency planning; others suggested that boosters for the general population were very likely and the questions were how to give it to them and when.
dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases and a top White House adviser, said on Thursday that officials were busy planning because “sooner or later you need a booster.”
Jeff Zies, the White House coronavirus coordinator, said that if and when additional shots were needed, they would be rolled out “in a quick and efficient manner.”
Vaccine makers, which run billions of dollars, have been among the most vocal proponents of boosters.
“Countries will have to decide whether to be two months early or two months late,” Moderna CEO Stéphane Bancel said in an interview on Monday. While the decision is up to public health authorities, he said, “Our recommendation would be to arrive two months early as we can save lives and avoid hospitalization.”
On the other hand, there are some influential scientists who say booster shots are premature at best and unethical at worst, with no convincing real-world evidence showing the vaccines’ effectiveness against serious illness and hospitalization is declining.
“Vaccinate the unvaccinated, vaccinate the world, then talk about boosters,” said Dr. Luciana L. Borio, a former acting chief scientist at the Food and Drug Administration.
According to the CDC, only a small fraction of the more than 166 million fully vaccinated Americans have been hospitalized for Covid-19 or have died. Of that number – 8,054 on August 9 – three quarters were 65 years of age or older. But the agency says the actual total is likely greater because the data relies on voluntary reporting from the states.
Data from Israel is of growing concern. With only 8.7 million inhabitants, Israel has surpassed the United States in vaccinating its population. It has relied almost exclusively on the Pfizer-BioNTech vaccine and has a nationalized health care system that allows it to monitor patients systematically.
Researchers from Israel’s Ministry of Health have said the effectiveness of the Pfizer vaccine in preventing infection fell from 95 percent at the beginning of the year to 39 percent from late June to mid-July. However, the overall efficacy of the vaccine against serious diseases remained high at 91.4 percent.
More recent Israeli data points to ongoing erosion. One person who reviewed it said it showed that the effectiveness of the Pfizer vaccine against serious illnesses was significantly reduced for people over 65 who received their first injections in January or February.
Moderna officials reported in a profit call last week that six months after a person received their second dose, the strength of their antibodies to variants was found to have decreased significantly. But many scientists say that declining antibodies are expected and should not be seen as a sign that a vaccine is less effective.
In general, American scientists are frustrated with the way bits and pieces of often conflicting data trickle out in company press releases and studies that have not been peer-reviewed or published in scientific journals.
The CDC has said it is tracking breakthrough infections in specific population segments, including health professionals, medical workers and nursing home residents. But the reports posted to its website are based on data from months ago, before the Delta variant became dominant.
“Everyone is confused because there isn’t a lot of published data,” said Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine in Houston. “The question is how vulnerable we are, and the numbers are kind of all over the map.”
While some federal officials have argued that each booster should be matched to the Delta variant, the administration is expected to use the same vaccines already manufactured and studies indicate they work well against the Delta variant.
Mr Bancel, the CEO of Moderna, said his company would not have a vaccine specifically targeting the Delta variant until the end of the year. Pfizer is on a similar track.
Both companies are expected to soon file with the FDA for authorization of a third injection of their existing two-dose vaccines. Moderna is studying the effectiveness of both full-dose and half-dose boosters.
NIH researchers are conducting trials to determine whether giving them a booster injection of a vaccine other than the one they originally received provides better protection. While a mix-and-match effort can be difficult to organize, officials want to see that data.
“It’s a bit compressed from what you’d normally want,” said Dr. John Beigel, who leads the study. “But we want to make sure we have data this fall to make decisions.”
Benjamin Mueller contributed reporting from London, and Noah Weiland from Washington. Kitty Bennett research contributed.
