Federal regulators plan to authorize an additional dose for seniors and immunocompromised people in the coming weeks, ahead of the introduction of a newly formulated booster later in the year.WASHINGTON — The Food and Drug Administration plans to allow older and immunocompromised Americans to get a second updated coronavirus booster shot in the near future, an acknowledgment of the virus’s continuing risks to vulnerable people whose immunity might be sagging months after a previous inoculation.Federal regulators are expected to authorize the additional dose in the next few weeks, according to people familiar with the agency’s planning. Those 65 and older would be able to receive the vaccine free of charge at least four months after their previous updated shot. Those with immune deficiencies would also be eligible.Regulators are expected to authorize the additional dose without explicitly recommending it for those groups, a stance that emphasizes the discretion of patients and their health providers. Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, is expected to sign off on the decision — a customary step in the regulatory process.Michael Felberbaum, an F.D.A. spokesman, said in a statement that the agency was monitoring data on the virus and would “base any decision on additional updated boosters upon those data.”The decision reflects the Biden administration’s ongoing concerns about the durability of protection against the virus for those Americans most at risk, even as the pandemic’s threat to younger, healthier Americans has receded. About 1,600 deaths from Covid-19 were reported for the week ending March 29, according to the most recent federal data. Those who are dying from Covid-19 are overwhelmingly 65 and older.Looking to blunt the effects of a potential winter Covid surge, the F.D.A. authorized the retooled booster shots, which are aimed at Omicron subvariants, at the end of August. But only about 55 million Americans — less than 17 percent of the population — have received an updated booster, according to the C.D.C. Among those 65 and older, 42 percent have received one of the shots.The Washington Post earlier reported the coming authorization.The Biden administration is planning to roll out another reformulated booster late in the summer or early in the fall, a schedule that would align with the annual flu vaccine. In the coming months, regulators plan to select the version of the virus they want to target with that retooled booster.In the meantime, a second booster for some groups would be in line with a proposal that regulators made at a January meeting of an independent group of vaccine advisers, at which the panel discussed offering vulnerable Americans more than one annual coronavirus shot.At that meeting, federal health officials pointed to research that showed the reformulated boosters were still working to protect Americans against newer versions of the virus that circulated deeper into the winter.The Biden administration has a substantial stockpile of the updated booster shots, and many of those doses could end up going to waste once a new booster is rolled out later this year. Federal health officials purchased more than 170 million doses of the updated shots last year. A senior Department of Health and Human Services official said recently that the administration was considering donating some of the vaccine.

The agency cleared booster doses targeting Omicron subvariants, hoping to curtail a fall or winter surge.WASHINGTON — The Food and Drug Administration on Wednesday authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.The agency cleared two options aimed at the BA.5 variant of Omicron that is now dominant: one made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older.Biden administration officials have argued that even as researchers work to understand how protective the new shots might be, inoculating Americans again in the coming weeks could help curb the persistently high number of infections and deaths. They have said that retooling the vaccine is likely to provide better protection against highly contagious Omicron subvariants heading into winter.An average of about 90,000 infections and 475 deaths are recorded every day around the United States, almost three years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy.But there are also hopeful signs. Even with high case counts, fewer than 40,000 people are currently hospitalized with the virus, a decrease of 10 percent since early August and far fewer than during the Delta-driven surge last summer or the Omicron-fueled wave last winter. Deaths have also remained somewhat flat in recent weeks, a sign that vaccines are helping to prevent the worst outcomes of Covid-19.Read More on the Coronavirus PandemicBoosters: Updated coronavirus vaccines are expected soon after Labor Day. But money to distribute the shots has dried up, as America’s vaccination program is feeling the effects of a long period of retreat.Moderna’s Lawsuits: The vaccine manufacturer sued Pfizer and BioNTech, claiming that its rivals’ Covid-19 shot copied groundbreaking technology that Moderna had developed before the pandemic.Fauci to Step Down: Dr. Anthony S. Fauci, President Biden’s top medical adviser who was catapulted into the spotlight at the start of the pandemic, said he would leave government service by the end of the year.New C.D.C. Guidelines: The agency loosened its Covid-19 guidance, saying those exposed to the virus no longer need to quarantine.Ample evidence suggests that many Americans will hold back from getting the updated boosters, either because they are weary of the pandemic or may not feel urgency about an additional dose. With each new shot offered, there are fewer takers.As more companies bring workers back to offices and students return to campuses this fall, persuading Americans to get the updated booster shots will be a major challenge for the administration.The companies produced the retooled booster shots with extraordinary speed, a testament to the mRNA technology that Pfizer and Moderna have harnessed since the early months of the coronavirus outbreak. The F.D.A. advised companies just two months ago on the formulation that they should adopt for the new vaccines. By later this week, millions of those doses will be delivered to states.The tight timeline meant that the companies came to federal regulators this summer with more limited data on the redesigned boosters than a traditional review process would call for, generating some controversy. Regulators authorized the vaccine without results from human trials, which have just started.Federal officials argue that because the coronavirus is evolving so quickly, human trials would be out of date before they could deliver results that could be used in the F.D.A.’s authorization decision. Instead, they are relying on the results of mouse trials and earlier human trials by Pfizer and Moderna of reformulations aimed at previous versions of the virus. The Biden administration is casting the shots as a standard upgrade that Americans should embrace ahead of potential surges in cases this winter, just like the flu shot, which is reconfigured every year to target more current versions of the influenza virus.The new shots are arriving during a period when the White House has been largely quiet on the pandemic. President Biden has rarely commented on the virus in recent months, even after he fell ill with Covid-19 in July. The White House no longer holds regular news briefings on the federal pandemic response, like it did in the first year of the administration, a reflection of the weariness many Americans have in keeping up with Covid precautions.“Covid-19 is the third leading cause of death in the United States. And it’s as if we’ve just accepted that that is going to be the case,” said Mercedes Carnethon, an epidemiologist at Northwestern University’s Feinberg School of Medicine. “I really hope as many people as possible will seek the updated booster so we can protect those who will have a terrible outcome.”Vaccinations remain the cornerstone of the federal government’s Covid strategy, even with tests and treatments widely available. The Biden administration has ordered over 170 million doses for the fall campaign, and officials do not expect shortages in supply when the doses are rolled out.“If it’s freezing cold out and you have children, you’re going to dress them warmly. This is the concept here,” said Dr. Paul G. Auwaerter, the clinical director in the infectious diseases division at the Johns Hopkins University School of Medicine. “You’ll want to head into the respiratory season with a virus that we know has surprised us with a booster.”Exactly how protective the shots might be is still unknown, Dr. Auwaerter said. He pointed to the modest increases in neutralizing antibodies that the companies found in vaccines they tested earlier this year targeting the original form of Omicron. How antibody levels would translate to protection with the new vaccines was unclear, he added.Experts warned against trying to choose Moderna’s shot over Pfizer’s or vice versa; with research in humans just beginning, scientists are months from knowing whether one brand offers better protection than the other.Many Americans have recently been infected by variants in the Omicron family and have some protection from their bouts with the virus, a development that federal agencies may take into account when recommending how the new shots get used. An advisory committee to the Centers for Disease Control and Prevention is scheduled to meet later this week to make recommendations.“For most people the risk of death is so low at this point, because they’ve gotten infected or vaccinated, or more likely both,” said Dr. Gregory Poland, professor of medicine and infectious diseases and director of the Vaccine Research Group at the Mayo Clinic.Dr. Poland, who has advised Moderna, Pfizer and White House officials on Covid-19 vaccines, said updating booster shots the way the F.D.A. did on Tuesday amounted to a “chase your tail” strategy, tweaking the design incrementally to try to keep up with the fast-changing virus. The new boosters, he said, could potentially save some lives among the elderly and those with immune deficiencies, but were unlikely to make as substantial an impact with the rest of the population.

Lawmakers accused top Biden administration health officials of neglecting virus testing and mangling key messaging around the pandemic.WASHINGTON — Top federal health officials on Tuesday defended the Biden administration’s efforts to protect Americans from the highly contagious Omicron variant, facing withering accusations from senators about the scarcity of coronavirus tests and confusing guidance on how soon people who test positive for the virus can return to normal life.In a nearly four-hour hearing, lawmakers charged that the administration remained woefully unable to meet the demand for at-home tests, noting that the White House would fulfill its pledge to send 500 million of them to American households for free only after the current surge had peaked.The health officials testified before the Senate Committee on Health, Education, Labor and Pensions during one of the most trying weeks yet in the administration’s struggle with the pandemic. Infection rates are skyrocketing nationwide, and hospitals set a single-day record on Sunday for the number of patients with the virus, surpassing last winter’s peak.While Democratic senators offered only gentle criticism, Republicans were unsparing, claiming that President Biden and his pandemic response team had mangled public health strategy and messaging.“Most Americans can’t make heads or tails of anything coming out of this administration,” Senator Tommy Tuberville, Republican of Alabama, said. “I’m getting texts as we speak, sitting here, asking, ‘Where do I get the test?’ We spent billions on this.”The officials who testified said they had mounted an all-out effort to test, treat and vaccinate Americans in the middle of a shape-shifting pandemic that had suddenly reached a new inflection point with the Omicron variant.“It’s hard to process what’s actually happening right now, which is, most people are going to get Covid,” said Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, offering one of the federal government’s most pointed acknowledgments of Omicron’s impact since the variant arrived in the United States.“What we need to do is make sure the hospitals can still function, transportation, you know, other essential services are not disrupted while this happens,” she added.Dr. Anthony S. Fauci, Mr. Biden’s chief medical adviser, said the virus had “fooled everybody all the time, from the time it first came in, to Delta, to now Omicron,” adding, “We’re doing the best we possibly can.”Dr. Anthony S. Fauci, President Biden’s chief medical adviser, said the virus had “fooled everybody all the time, from the time it first came in, to Delta, to now Omicron.”Pool photo by Greg NashThe hearing came as the Omicron variant, coupled with the Delta variant, has strained hospital systems and caused businesses to struggle to stay open because of staff shortages. An average of more than 735,000 infections are being reported in the United States each day, according to a New York Times database.On average over the last seven days, more than 135,000 people were hospitalized with the virus, an 83 percent increase from two weeks ago. The hospitalization totals include people who test positive for the virus incidentally after being admitted for conditions unrelated to Covid-19, but there is no national data showing how many people are in that category.Modeling scenarios cited in an internal government document dated Jan. 5 and obtained by The New York Times suggest there will be more than a million confirmed infections per day by the end of the month.That number is widely viewed as a vast undercount because of the scarcity of tests and the widespread failure of people to report positive results from at-home tests to government authorities. The Institute for Health Metrics and Evaluation, an independent health research center at the University of Washington, estimated last week that daily infections had already risen to six million, and it predicted that more than half of Americans would be infected by the Omicron variant over the next six weeks. Public health experts have said that many cases will be mild or asymptomatic.Senior Biden administration officials said in interviews on Monday that infections and hospitalizations were expected to peak nationwide by the end of January and then plummet sharply. But Dr. Fauci warned on Tuesday that peaks and valleys would not look the same across the United States.The hearing took a detour early on with a fierce back-and-forth between Dr. Fauci and Senator Rand Paul, Republican of Kentucky. The senator accused Dr. Fauci of working to undermine scientists with opposing views on the virus, something Dr. Fauci strongly denied.His voice raised, Dr. Fauci said personal attacks from Republicans had put his safety and his family’s safety at risk. He held up a copy of a fund-raising webpage for Mr. Paul that featured a “Fire Dr. Fauci” graphic, and he said the senator had targeted him to score points with conservatives.After nearly a year of concerted effort to tame the pandemic, Mr. Biden is facing an exhausted public and a new burst of alarming headlines. Asked by reporters on Tuesday whether he was worried about the nation’s fight against the virus, the president said that he was “concerned about the pandemic, just because worldwide it’s not slowing up very much.” He added that federal officials were working to help states and hospitals.Hospitals set a single-day record on Sunday for the number of patients with the virus, surpassing last winter’s peak.Dave Sanders for The New York TimesLast week, a group of former pandemic advisers to Mr. Biden published a series of articles calling on the administration to reset its response to Covid in a way that would acknowledge the “new normal” of living with the virus indefinitely.Federal officials on Tuesday also hinted at that. Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, told lawmakers that it was more important for Americans to use rapid tests to guide their behavior than to report every positive result to government agencies.The Coronavirus Pandemic: Key Things to KnowCard 1 of 5The latest Covid data in the U.S.

Regulators are also expected to allow even younger children with immune deficiencies to get an extra shot.WASHINGTON — The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster shots on Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.Regulators are also expected to authorize an extra shot of Pfizer’s vaccine for both adolescents and adults five months after receiving a second dose, instead of the current interval of six months. Younger children, ages 5 to 11, with immune deficiencies would be able to receive booster shots as well.The decision to expand the use of the shots would come just as schools begin to reopen after the holiday break, and as governments around the world try to respond to the fast-spreading Omicron variant. Israel on Thursday approved a fourth dose of vaccine for people with weakened immune systems, and Britain’s National Health Service said its hospitals would erect field wards to help deal with the surge in coronavirus cases.Several U.S. states hit their all-time case records for the coronavirus this week, disrupting the lives of millions of Americans. New York’s mayor-elect, Eric Adams, vowed to keep the city’s vaccine mandate for private-sector employees in place, and the C.D.C. issued a blunt warning to potential travelers: “Avoid cruise travel regardless of vaccination status.”Health officials are trying to encourage more Americans to get a booster shot — just over a third of fully vaccinated adults have received one — and warn that the unvaccinated face the greatest risk of severe illness and death from Omicron.“Our C.D.C. guidance has been very clear that people should get their boost when they are eligible,” Dr. Rochelle P. Walensky, the C.D.C. director, told reporters this week. “That is both for — because of waning immunity and because we need more protection against Omicron.”Dr. Walensky said on Wednesday that even as daily case counts had climbed by roughly 60 percent in the past week, hospitalizations and deaths were still relatively low, a suggestion that Omicron might be less lethal. She and Dr. Anthony S. Fauci, President Biden’s chief medical adviser, cited international research hinting at the same conclusion.Studies have shown that while two doses of the Pfizer-BioNTech vaccine have provided strong protection as the Delta variant swarmed the country, Omicron can evade the defenses of fully vaccinated people, heightening fears about the risks for young people.More than 70 percent of people 12 and older in the United States are fully vaccinated, according to the C.D.C. Around a quarter of children between 5 and 11 have received at least one dose. Children under 5 are still not eligible for a vaccine.The latest surge has caused a concerning rise in hospitalizations among children. But early data suggests that Omicron appears to be causing milder illness for children, similar to findings for adults. And hospital officials and physicians have said that nearly all children hospitalized with Covid-19 were unvaccinated or partially vaccinated.Children can better withstand coronavirus infections, but in rare instances can still become very sick and even die. At least 1.8 million adolescents between 12 and 15 years old have tested positive for the virus, according to the C.D.C.A series of studies published on Thursday by the agency underscored how important vaccination can be for children and adolescents. In one study spanning July through early December that examined hundreds of adolescents in Arizona, researchers said two doses of the vaccine reduced the risk of infection by 92 percent.Two other C.D.C. studies showed that there were few serious side effects reported among 5- to 11-year-olds who had received the Pfizer-BioNTech vaccine, and that pediatric hospitalizations occurred mostly among children who had not been fully vaccinated.One recent South African study showed that the effectiveness of Pfizer’s vaccine against severe illness and hospitalization was about 70 percent after two doses, against Omicron in particular.Pfizer-BioNTech’s vaccine is the only of the three federally authorized coronavirus shots that is approved for use in people under 18.The Centers for Disease Control and Prevention’s vaccine advisory committee is planning to meet by the middle of next week to weigh in on whether to recommend the changes in the F.D.A.’s booster policy. If the committee agrees with the F.D.A.’s authorizations, Dr. Walensky is expected to promptly endorse the revisions.Dr. Kathryn M. Edwards, a vaccine expert and professor of pediatrics at Vanderbilt University School of Medicine, said the F.D.A.’s expected decision was justified.“We’re having a lot of suggestions and a lot of experience with Omicron that it’s infecting people that have been boosted. But fortunately, we’re not seeing a lot of severe disease,” she said. “So I think if you look at the immune responses, at least in adults, you’ll see that this booster dose does enhance your neutralization capacity against Omicron.”Other vaccine experts said the administration’s continued attention to offering boosters to younger, healthier people was misguided.Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the F.D.A.’s vaccine advisory committee, said research on vaccine effectiveness, including against Omicron, had revealed substantial and durable protection from two doses against severe disease, including in adolescents — the purpose of vaccination, he said.A booster dose could increase one’s protection for several months, he said, but delivering extra shots to young Americans was “focusing on the people who are already protected.”The Coronavirus Pandemic: Key Things to KnowCard 1 of 4The global surge.

Regulators are set to clear extra doses of Pfizer-BioNTech’s vaccine as soon as Thursday, after states began expanding eligibility on their own.WASHINGTON — The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans.The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The F.D.A. is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.The broad booster authorization has been viewed as something of a fait accompli for weeks. Some state and local officials have begun rolling out similar policies ahead of F.D.A. action — responding to persistent virus case counts, including some breakthrough cases, and the eagerness of many Americans to seek additional protection ahead of holiday gatherings.New York City health officials on Monday encouraged all adults who want boosters to seek them out. Arkansas, California, Colorado and New Mexico have also moved to expand access.Many Americans, regardless of where they live, have taken the matter into their own hands and sought out extra doses even if they did not yet officially qualify.The F.D.A. in September downsized an initial request from Pfizer-BioNTech’s to fully approve booster doses for all adults. Instead, it made a more limited population eligible, including those 65 and older, as well as adults with underlying medical conditions or those at risk because of their jobs.At least 30 to 40 percent of vaccinated adults are still excluded from booster eligibility, according to some estimates.More than 30 million people have already gotten additional shots, with the daily number often outpacing that of first shots given around the country. Booster doses were also authorized in October for everyone who received the single-dose Johnson & Johnson vaccine, and for vulnerable groups who received Moderna’s two-dose shot.The C.D.C.’s gathering on Friday is scheduled to be briefer than recent meetings about Covid vaccines — just three hours. It is expected to be straightforward, one federal official familiar with the planning said, in part because of how far the nation’s booster campaign has already come. That would suggest a significant softening of opposition among public health experts since President Biden announced in August that he hoped to offer booster doses to all adults.Mr. Biden wanted to start the campaign in late September, but his announcement was heavily criticized by public health experts, who said he was rushing the federal scientists and regulators responsible for deciding whether the data supported such a move. Some key regulators and outside advisers had argued that the effectiveness of the two-dose regimen, especially in preventing hospitalization and death, has held up strongly. One large study in New York of nearly nine million people has shown remarkable durability in the protection gained from all three federally authorized vaccines.But more recently, federal regulators and scientists have said the evidence is increasingly clear that a reduction in vaccine efficacy against milder Covid cases, and in protective antibodies, has put Americans — especially seniors and those with medical conditions — at risk of harmful breakthrough infections as the Delta variant of the virus only gradually loosens its grip.Pfizer and BioNTech said last week that their request is based on data from a clinical trial in the United States and elsewhere that included more than 10,000 volunteers. After a third dose, the vaccine’s efficacy rate against symptomatic disease had been restored to about 95 percent, they said. It remains unclear, however, how long the protection from a booster shot will last..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-1kpebx{margin:0 auto;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-1kpebx{font-size:1.25rem;line-height:1.4375rem;}}.css-1gtxqqv{margin-bottom:0;}.css-19zsuqr{display:block;margin-bottom:0.9375rem;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}Moderna is expected to soon submit its own request for the F.D.A. to broaden eligibility for its booster. But for now, every adult can get the Pfizer booster if it is broadly authorized, according to people familiar with the planning.Top federal health officials, including Dr. Anthony S. Fauci, have argued for months — often pointing to Israel, which started its booster campaign in late July and now offers extra shots to everyone 12 and older — that the case for boosting widely in the United States is clear. Dr. Fauci said at an event sponsored by Reuters on Tuesday that the virus could potentially be brought under control in the U.S. by the spring if boosters were available for everyone.Vaccine experts have said that antibody protection is just one measure of how a vaccine confers protection, and that in the case of Covid vaccines, it was always expected to fade. Some have warned that keeping antibody levels high would possibly require regular booster shots — a standard that would be difficult to sustain.While the F.D.A.’s expert committee is not expected to weigh in before the agency’s ruling, several members said last month at a meeting discussing booster shots that the agency should go ahead and lower the age eligibility.An Israeli study published in the scientific journal The Lancet in late October compared about 730,000 people who had received a booster dose in August or September with individuals who had received only two doses of the Pfizer-BioNTech vaccine at least five months earlier, finding that boosted recipients had a lower risk of hospitalization and severe disease. Those with booster shots were evaluated between one week and nearly two months after their third dose.Israeli officials reported at an F.D.A. meeting last month that third doses had not caused any significant safety concerns, a finding that Pfizer was expected to present to the F.D.A. in its request to expand eligibility. Friday’s meeting of the C.D.C. panel will likely examine data the company provides on side effects. Regulators have been particularly concerned about links between the Pfizer-BioNTech and Moderna vaccines and myocarditis, inflammation of the heart muscle, which has been observed especially in younger men who received two doses of those vaccines.A. Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan and a member of the F.D.A. committee, said that while she was at first skeptical about clearing booster shots for so many adults based heavily on data from Israel, she was more convinced now that millions of Americans have received the extra shots.“Caution is always better,” she said. Clearing more adults to get boosters, she added, would help make the messaging around booster shots more manageable.

Experts said the shot could bring relief to parents anxious about their children getting sick, though some worry that those most at risk may slip through the cracks.WASHINGTON — The Food and Drug Administration is expected to authorize Pfizer-BioNTech’s coronavirus vaccine for emergency use in children 5 to 11 on Friday, people familiar with the agency’s planning said, a move eagerly anticipated by millions of families looking to protect some of the only remaining Americans left out of the vaccination campaign.About 28 million children in the group would be eligible to receive one-third of the adult dose, with two injections three weeks apart. If the Centers for Disease Control and Prevention signs off, as is expected, they could start getting shots as early as Wednesday.The Biden administration has promised that children’s shots will be easily accessible at pediatrician offices, community health centers, children’s hospitals and pharmacies, with 15 million doses ready to ship immediately. States started ordering doses last week, under a formula based on how many children they have in the age group. While the school year is already well underway, the pediatric dose is arriving in time for the holidays, giving more comfort to families looking to gather older and younger people together for the first time since the early months of 2020.“It’s an incredibly important tool in the return to normalcy,” said Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and a leader of the Covid-19 Prevention Network. “To be able to know that your child is protected and not going to get severely ill by going to school is an incredible psychological relief.”In a clinical trial, the vaccine was shown to generate significant protection in children against the virus. But whether it will help substantially to curb the pandemic is unclear. As of this week, 8,300 children ages 5 to 11 have been hospitalized with Covid-19 and at least 94 have died, out of more than 3.2 million hospitalizations and 740,000 deaths overall, according to the C.D.C.The biggest determinant of how much more sickness and death lies ahead is whether the more than 60 million adolescents and adults who are already eligible for shots get vaccinated, said Dr. Jennifer Nuzzo, an epidemiologist at Johns Hopkins Coronavirus Resource Center.Some vaccine experts warn that the same inequities that plagued the vaccine rollout for adults earlier this year could hinder the one for children.“We cannot see what we saw in the earliest stages of rolling out the vaccines for adults, in which advantaged persons and persons of means figure out a way to be first in line,” said Dr. James E.K. Hildreth, the president of Meharry Medical College, a historically Black institution.He said that school nurses, churches and local health officials would be key in reaching some children and families who might not have insurance or access to pediatricians. The vaccinations are free to everyone.While the pandemic has generally hit people of color hardest, the racial disparities are especially stark among children.Black and Hispanic children are less likely to be tested for the virus but more likely to be infected, get hospitalized and die from Covid-19 than white children, according to the Kaiser Family Foundation. Hospitalization rates in the 5 to 11 age group are three times as high for Black, Hispanic and Native American children as for white children, according to the C.D.C.In the 5-11 age group, more than half are children of color and nearly four in 10 come from households with incomes below 200 percent of the federal poverty level, according to Kaiser.At Children’s National Hospital in Washington, officials have devised a plan to make sure families and children at greater risk have immediate access to shots, said Dr. Lee Ann Savio Beers, the hospital’s medical director for community health and advocacy and the president of the American Academy of Pediatrics.Marisol Gerardo, 9, getting a dose of the Pfizer-BioNTech coronavirus vaccine during a clinical trial for children at Duke Health in Durham, N.C., in April.Shawn Rocco/Duke Health, via ReutersThe hospital plans to notify its most at-risk patients, based on medical diagnosis and the neighborhood where they reside, about the shots by directly contacting parents, she said.A survey from the Kaiser Family Foundation released on Thursday found 27 percent of parents of 5- to 11-year-olds were eager to vaccinate their children right away, while a third said they would wait and see how the vaccine rollout went. The uptake among adolescents has been slower than public health experts hoped: Pfizer’s vaccine became available to children 12 to 15 in May, but only roughly 40 percent of that age group is now fully vaccinated, compared to 69 percent of adults.State and local health officials are girding not just for more vaccine hesitancy, but for possible fights over vaccine mandates in schools.“I think the contention we have seen over the mask issue is likely to pale in comparison to what we’re going to see over the idea of a vaccine mandate” for school children, Dr. Jessica Snowden, chief of the infectious disease division at Arkansas Children’s Hospital, said. At a meeting this week of the F.D.A.’s expert advisory panel on vaccines, several members came out strongly against school vaccine mandates..css-1kpebx{margin:0 auto;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-1kpebx{font-size:1.25rem;line-height:1.4375rem;}}.css-1gtxqqv{margin-bottom:0;}.css-k59gj9{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;width:100%;}.css-1e2usoh{font-family:inherit;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;border-top:1px solid #ccc;padding:10px 0px 10px 0px;background-color:#fff;}.css-1jz6h6z{font-family:inherit;font-weight:bold;font-size:1rem;line-height:1.5rem;text-align:left;}.css-1t412wb{box-sizing:border-box;margin:8px 15px 0px 15px;cursor:pointer;}.css-hhzar2{-webkit-transition:-webkit-transform ease 0.5s;-webkit-transition:transform ease 0.5s;transition:transform ease 0.5s;}.css-t54hv4{-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-1r2j9qz{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-e1ipqs{font-size:1rem;line-height:1.5rem;padding:0px 30px 0px 0px;}.css-e1ipqs a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;}.css-e1ipqs a:hover{-webkit-text-decoration:none;text-decoration:none;}.css-1o76pdf{visibility:show;height:100%;padding-bottom:20px;}.css-1sw9s96{visibility:hidden;height:0px;}.css-1in8jot{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;font-family:’nyt-franklin’,arial,helvetica,sans-serif;text-align:left;}@media (min-width:740px){.css-1in8jot{padding:20px;width:100%;}}.css-1in8jot:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1in8jot{border:none;padding:10px 0 0;border-top:2px solid #121212;}What to Know About Covid-19 Booster ShotsThe F.D.A. has authorized booster shots for millions of recipients of the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines. Pfizer and Moderna recipients who are eligible for a booster include people 65 and older, and younger adults at high risk of severe Covid-19 because of medical conditions or where they work. Eligible Pfizer and Moderna recipients can get a booster at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second shot at least two months after the first.Yes. The F.D.A. has updated its authorizations to allow medical providers to boost people with a different vaccine than the one they initially received, a strategy known as “mix and match.” Whether you received Moderna, Johnson & Johnson or Pfizer-BioNTech, you may receive a booster of any other vaccine. Regulators have not recommended any one vaccine over another as a booster. They have also remained silent on whether it is preferable to stick with the same vaccine when possible.The C.D.C. has said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney or liver disease; dementia and certain disabilities. Pregnant women and current and former smokers are also eligible.The F.D.A. authorized boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The C.D.C. says that group includes: emergency medical workers; education workers; food and agriculture workers; manufacturing workers; corrections workers; U.S. Postal Service workers; public transit workers; grocery store workers.Yes. The C.D.C. says the Covid vaccine may be administered without regard to the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.A C.D.C. study suggests that 42 percent of children aged 5 to 11 have coronavirus antibodies from prior infection, prompting some F.D.A. advisers to ask if one dose would be sufficient for children. Use of that study has been questioned by some scientists. F.D.A. panelists also asked whether only those with high-risk medical conditions, such as obesity, should get the vaccine, since it is clear they are most vulnerable to getting very ill with Covid-19.But C.D.C. officials said it would be hard to narrow eligibility, and the F.D.A.’s advisory panel endorsed offering the pediatric dose to the entire age group by a 17-0 vote, with one abstention.Dr. Snowden said the Delta variant wiped out any notion that children are impervious to the virus. At the height of the most recent surge, she said, the Arkansas Children’s Hospital was treating as many as 30 children a day for Covid, including some with fully vaccinated parents. While that number has shrunk, “it is still not back to where we were before Delta,” she said.Much of the burden of the rollout of children’s shots is expected to fall on pediatricians and family physicians, many of whom are strained by staffing shortages and pent-up demand for care at this point in the pandemic but have deep relationships with parents and children. Dr. Sterling Ransone, the president of the American Academy of Family Physicians and a physician in rural Deltaville, Va., said that he would keep his office open later on weekdays and on Saturdays to accommodate demand for pediatric shots.“We know who to prioritize — asthmatics, those with heart disease, people who are obese,” he said.Dr. Victor Peralta, a pediatrician in the racially diverse neighborhood of Jackson Heights, Queens, said uptake might be a bit slower at first among his patients, most of whom are poor enough to have Medicaid coverage. But he predicted the pediatric dose would catch on and ultimately help slow transmission of the virus. “I have no doubt that this will make a difference beyond just the worried well,” he said.Dr. Kathryn M. Edwards, a professor of pediatrics at Vanderbilt University School of Medicine, said pediatricians will help public health officials monitor side effects, such as myocarditis, or inflammation of the heart muscle. Regulators have been carefully watching the higher incidence of that condition in young males who are vaccinated.“Doctors and pediatricians know myocarditis,” Dr. Edwards said. “We give a lot of vaccines, and know how to report adverse events.”Another challenge will be ensuring that parents have time and transportation to get their children to vaccine providers. Dr. Beers said that the pediatric academy was already consulting with business groups about giving employees, especially those on hourly schedules, paid time off so they do not lose income taking their children to get a shot.In Vermont, which has one of the highest adult vaccination rates in the country, health officials may “barnstorm” rural and more isolated regions of the state that had lower uptake of shots in earlier stages of the vaccination campaign, hoping to get 80 percent of children between 5 and 11 vaccinated, said Kelly Dougherty, the state’s deputy health commissioner.Pediatric vaccines will be incorporated at community sites already doing first and second doses and booster shots, she said. Vaccinations at school-based clinics are set to begin in the state in the second week of November.Kitty Bennett

The agency will also allow vaccine recipients to pick which vaccine they want as a booster, endorsing a mix-and-match approach.WASHINGTON — The Food and Drug Administration authorized booster shots on Wednesday for tens of millions of recipients of Moderna’s two-dose coronavirus vaccine and Johnson & Johnson’s single-dose shot, significantly expanding efforts to bolster protection for vulnerable Americans.The agency also authorized medical providers to give people a booster shot of a different Covid-19 vaccine, a strategy known as “mix and match.”That decision may dampen interest in the United States in Johnson & Johnson’s vaccine, which studies have found provides less protection than the other two. Recipients of that vaccine will have the option of seeking a Moderna or Pfizer-BioNTech booster, which could prompt a more substantial jump in protective antibodies. Recipients of the other two vaccines will have the same leeway to choose a different vaccine for a booster shot.The regulators, who authorized boosters for high-risk recipients of the Pfizer-BioNTech vaccine last month, did not recommend any one vaccine over another as a booster.“We do not have preferential recommendations,” Dr. Janet Woodcock, the F.D.A.’s acting commissioner, said at an evening news briefing. “We feel that if patients have questions, they should consult with perhaps their physician or another provider.”The latest authorizations arrived amid what is shaping up to be a busy stretch of major regulatory decisions on vaccines. The F.D.A. is expected to decide in the coming weeks whether Pfizer-BioNTech’s vaccine should be authorized for children 5 to 11. The agency’s independent vaccine advisory committee is set to consider the matter on Tuesday and make a recommendation.Regulators may also decide as early as November whether to allow even more people to obtain booster shots, including younger adult recipients of the Pfizer or Moderna vaccines who are not yet eligible. While many vaccine experts have questioned whether healthy younger people need booster shots at this time, some members of the advisory committee urged the agency last week to expand eligibility. Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said the agency could be “nimble” in including more younger adults. “It is something that can happen as soon as we see and feel that we need to take that action,” he said.One key question before regulators was whether to authorize a full or a half-dose of Moderna’s vaccine as a booster shot. Data from a federally funded study suggested a full-strength dose of Moderna could hugely boost the antibody levels of Johnson & Johnson recipients and increase the antibody levels of Pfizer recipients better than an additional shot of the same vaccine.But Moderna only sought permission for a half-dose as a booster shot, submitting data in support of that. In the end, the F.D.A. decided to authorize the half-dose Moderna booster for recipients of all three vaccines, at least in part, Dr. Marks suggested, in order to limit confusion among providers.The move on Wednesday to make a much larger swath of Americans eligible for boosters followed unanimous votes last week from the F.D.A.’s advisory committee to recommend the authorizations. A separate committee advising the Centers for Disease Control and Prevention is scheduled to vote on Thursday on its own recommendations for the Moderna and Johnson & Johnson boosters.The panel will also consider whether people need more guidance about when and whether to switch vaccines for a booster shot. C.D.C. officials are expected to argue for flexibility.Given the existing data, “we have to be noncommittal about what is the best,” Dr. Marks said. “We have to simply say that any one of these combinations is reasonable.”The C.D.C.’s director typically endorses that panel’s recommendations as a final step before vaccines are put into use. If the agency agrees with the F.D.A., those booster shots could be available to the public as soon as this weekend.The eligibility requirements for a booster differ depending on vaccine. Pfizer and Moderna recipients will be able to get an extra shot six months after their second injection if they are at least 65 years old or at high risk of severe Covid-19 complications because of medical conditions or where they work. Johnson & Johnson recipients — all of whom are 18 and older — will be eligible for a second shot at least two months after the first.The decision to allow recipients to switch to a different vaccine as a booster adds yet another layer of complexity. “Although it is not simple,” Dr. Marks said, “it’s not utterly hopelessly complex.”Even as the F.D.A.’s advisory panel last week unanimously supported Moderna and Johnson & Johnson boosters last week, its experts raised concerns that the data in the companies’ applications was limited and, in the case of Johnson & Johnson’s, not independently verified.Moderna argued to the committee that a third shot of its vaccine would bolster protection against infection and more moderate disease. There appeared to be little evidence that the vaccine’s robust protection had waned significantly.In contrast, some F.D.A. experts and committee members argued that Johnson & Johnson recipients needed an additional shot to better bolster them against severe Covid-19, since that vaccine was less effective than those of Moderna and Pfizer-BioNTech.The F.D.A. discussed data with the committee showing that Johnson & Johnson’s vaccine was only roughly 70 percent effective against hospitalization, compared with around 90 percent for Moderna and Pfizer.But other data, including from a study of nearly nine million people in New York State, found better results from a single dose of Johnson & Johnson, including for older Americans, with durable protection..css-1kpebx{margin:0 auto;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-1kpebx{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-1kpebx{font-size:1.25rem;line-height:1.4375rem;}}.css-1gtxqqv{margin-bottom:0;}.css-k59gj9{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;width:100%;}.css-1e2usoh{font-family:inherit;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;border-top:1px solid #ccc;padding:10px 0px 10px 0px;background-color:#fff;}.css-1jz6h6z{font-family:inherit;font-weight:bold;font-size:1rem;line-height:1.5rem;text-align:left;}.css-1t412wb{box-sizing:border-box;margin:8px 15px 0px 15px;cursor:pointer;}.css-hhzar2{-webkit-transition:-webkit-transform ease 0.5s;-webkit-transition:transform ease 0.5s;transition:transform ease 0.5s;}.css-t54hv4{-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-1r2j9qz{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-e1ipqs{font-size:1rem;line-height:1.5rem;padding:0px 30px 0px 0px;}.css-e1ipqs a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;}.css-e1ipqs a:hover{-webkit-text-decoration:none;text-decoration:none;}.css-1o76pdf{visibility:show;height:100%;padding-bottom:20px;}.css-1sw9s96{visibility:hidden;height:0px;}.css-1in8jot{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;font-family:’nyt-franklin’,arial,helvetica,sans-serif;text-align:left;}@media (min-width:740px){.css-1in8jot{padding:20px;width:100%;}}.css-1in8jot:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1in8jot{border:none;padding:10px 0 0;border-top:2px solid #121212;}What to Know About Covid-19 Booster ShotsThe F.D.A. has authorized booster shots for millions of recipients of the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines. Pfizer and Moderna recipients who are eligible for a booster include people 65 and older, and younger adults at high risk of severe Covid-19 because of medical conditions or where they work. Eligible Pfizer and Moderna recipients can get a booster at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second shot at least two months after the first.Yes. The F.D.A. has updated its authorizations to allow medical providers to boost people with a different vaccine than the one they initially received, a strategy known as “mix and match.” Whether you received Moderna, Johnson & Johnson or Pfizer-BioNTech, you may receive a booster of any other vaccine. Regulators have not recommended any one vaccine over another as a booster. They have also remained silent on whether it is preferable to stick with the same vaccine when possible.The C.D.C. has said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney or liver disease; dementia and certain disabilities. Pregnant women and current and former smokers are also eligible.The F.D.A. authorized boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The C.D.C. says that group includes: emergency medical workers; education workers; food and agriculture workers; manufacturing workers; corrections workers; U.S. Postal Service workers; public transit workers; grocery store workers.Yes. The C.D.C. says the Covid vaccine may be administered without regard to the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.The experts appeared swayed by the idea that a single shot of Johnson & Johnson’s vaccine never offered as much protection as the vaccines made by Moderna and Pfizer-BioNTech, and thus needed to be shored up. They also argued that Moderna recipients should be eligible for booster shots, at least partly because Pfizer recipients already were. Pfizer won authorization for a booster shot last month, after it argued that the potency of its vaccine had waned against severe disease.“We’ve already approved it for Pfizer, and I don’t see how we can possibly not approve it for Moderna” without sowing confusion, said Dr. Stanley Perlman, an infectious disease expert at the University of Iowa and an F.D.A. committee member.The Food and Drug Administration’s decision to make recipients of the Moderna and Johnson & Johnson vaccines eligible for booster shots followed unanimous votes in favor of authorization by its advisory committee. Bess Adler for The New York TimesNorman W. Baylor, the former director of the F.D.A.’s vaccines office, said that the lack of substantiated data for Johnson & Johnson’s vaccine was highly unusual, calling into question why the F.D.A. had pushed to gather its expert committee for a vote on booster shots.“It’s obvious F.D.A. was not as prepared,” he said. “The F.D.A. appears to be, from what we’ve seen, rushed to make a decision on these boosters.”After the Biden administration began pushing for a broad booster rollout in August, top officials said that streamlining booster recommendations could help avert public confusion. Dr. Marks has said the goal was to reach a “harmonized” approach toward booster recommendations for the general population.For at least some of the roughly 15 million people who chose the Johnson & Johnson vaccine, the debate over the company’s data may not matter. The F.D.A.’s decision to allow flexibility to providers and patients in booster shots could lead many of them to choose a Moderna or Pfizer-BioNTech booster instead.Regulators were influenced by preliminary data from a federally funded study that measured antibody levels in people who received a different vaccine as a booster, comparing nine groups of 50 volunteers each. Those getting another dose of Johnson & Johnson saw antibodies go up just fourfold, the study found. Switching to a Pfizer-BioNTech booster raised antibody levels by a factor of 35. A full-dose Moderna booster raised them 76-fold.Dr. Kirsten E. Lyke of the University of Maryland School of Medicine, who presented the findings at the F.D.A. meeting last week, cautioned in an interview against drawing hasty conclusions from their results. By next month, the researchers hope to know how well the different boosters increase virus-attacking T cells. It is possible that Johnson & Johnson’s vaccine could do well in those results, she said, adding, “We’ll get a more rounded picture.”Since the Pfizer-BioNTech vaccine was authorized as a booster shot last month, some state health officials have clamored for mix-and-match flexibility, saying it would help them reach older and at-risk residents in cases where they did not have a supply of the same vaccine that people initially received.Top C.D.C. officials suggested last week that the mix-and-match rules would also leave room for those concerned about side effects — for example, younger women worried about the Johnson & Johnson vaccine’s ties to a rare blood clotting condition — to switch brands. Some may be interested in switching to Johnson & Johnson, on the other hand, if they have concerns about rare heart-related side effects linked to the Moderna and Pfizer-BioNTech vaccines.“We would expect many people will continue to get the same series that they had already received,” Dr. Woodcock said. But she added: “We wanted to provide a lot of flexibility.”Carl Zimmer

Regulators said that people over 65 or at high risk of severe Covid-19 were eligible for an extra shot, setting up a staggered national booster campaign.WASHINGTON — After weeks of internal strife at the Food and Drug Administration, the agency on Wednesday authorized people over 65 who had received Pfizer-BioNTech’s coronavirus vaccine to get a booster shot at least six months after their second injection.The F.D.A. also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming severely ill with Covid-19 or are at risk of serious complications from the disease due to frequent exposure to the coronavirus at their jobs.The authorization sets up what is likely to be a staggered campaign to deliver the shots, starting with the most vulnerable Americans. It opens the way for possibly tens of millions of vaccinated people to receive boosters at pharmacies, health clinics, doctors’ offices and elsewhere.Roughly 22 million Americans are at least six months past their second dose of the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention. About half of them are 65 and older. Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to learn whether they, too, can get boosters.The F.D.A.’s decision will be followed as soon as Thursday by a recommendation from the C.D.C., which issues guidance on vaccine policy for clinicians and public health officials throughout the United States. An advisory committee of the C.D.C. is now in the midst of a two-day meeting on the issue. But even if the C.D.C. takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the F.D.A.’s eligibility criteria.The ruling followed weeks of internal disagreement at the F.D.A., where some vaccine regulators openly challenged the idea of offering booster shots to the general population. Public health experts and state officials have criticized what they said were confusing public messages from the Biden administration about who should be eligible for a booster shot and when.Regulators have significantly slowed the booster rollout that top federal health officials drafted and President Biden announced in mid-August. At the time, Mr. Biden said that pending regulatory approval, he wanted to offer third shots to every American adult who had been fully vaccinated with the Pfizer-BioNTech or Moderna vaccine at least eight months earlier, starting this week.But so far the F.D.A. has cleared booster shots only for Pfizer-BioNTech recipients, and not all of them. Regulators are expected to take up whether to authorize the shots for recipients of the Moderna and Johnson & Johnson vaccines in short order.Wednesday’s authorization made the United States the most recent wealthy nation to offer people booster doses, joining a list that includes Germany, France, Israel and Britain. Some public health experts say those doses should instead be directed to countries that have vaccinated far fewer of their residents.At a virtual Covid-19 summit on Wednesday, Mr. Biden pledged an additional 500 million doses of Pfizer-BioNTech’s vaccine to countries that need them.The F.D.A.’s ruling could set off a spirited debate about who falls into the eligible subgroups, especially those who are considered at special risk because of their jobs.At a meeting last Friday, members of the agency’s advisory committee of experts said that health care workers should be eligible for boosters because of their work, and a senior F.D.A. regulator said that teachers fit in the same category. There was also a push to include some inmates and staff at jails and prisons because of risks tied to incarceration. Those specific recommendations will be left to the C.D.C.The F.D.A.’s decision to include those who are at high risk of severe Covid-19 captures another significant swath of the population. An estimated 60 percent of Americans suffer from obesity or other chronic medical conditions that heighten their risk of suffering from severe Covid-19, but not all of them might be included.Pfizer had asked the F.D.A. to approve a third shot for all recipients of its vaccine who were 16 and older, six months or more after their second injection. Regulators scrambled to collect and review safety and efficacy data fast enough to meet the administration’s goal of offering shots this week.At a dramatic meeting last week, members of the F.D.A.’s outside advisory committee said the available data was too limited to justify additional injections for so many people and voted 16 to 2 against approving Pfizer’s request. Some of the committee’s experts were concerned that Pfizer’s clinical trial results on boosters included only about 300 volunteers, a point that was brought up repeatedly by the C.D.C.’s experts.But the advisory committee voted unanimously for the narrower option reflected in the regulatory decision.President Biden attends a virtual global Covid-19 summit on Wednesday from New York. He had hoped to offer a third shot more broadly to adults who had received the Pfizer or Moderna vaccines. Doug Mills/The New York TimesThe F.D.A. not only narrowed Pfizer’s request, but authorized the third shot on an emergency basis instead of fully approving it..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}As a practical matter, since the F.D.A. fully approved the Pfizer-BioNTech vaccine as a two-dose regimen last month, physicians have had broad latitude to prescribe a third dose to people they deemed in need of one. Many Americans have already sought extra shots on their own, typically by finding a cooperative pharmacist or pretending to be unvaccinated.“There’s anxiety about this public expectation that everyone should go get a booster,” said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which represents state health agencies. “If we pull back on that, then states are going to get left holding the bag.”Dr. Jesse L. Goodman, a former chief scientist at the F.D.A., said that because of some uncertainty around the benefits of boosters, regulators were right to grant only an emergency clearance for the shots while continuing to study their safety and performance.“A stepwise approach is very judicious,” he said. Some state health officials greeted the F.D.A.’s move enthusiastically. Dr. Clay Marsh, West Virginia’s Covid-19 czar, said that his state’s success vaccinating older residents early meant that they were overdue for extra protection.He also said that strained hospitals in the state could not afford to lose more staff, and that booster doses could protect frontline workers from milder infections that would require them to stay at home.“Anxious would be an understatement,” he said of those waiting for extra shots. “We’ve asked them to be patient with us. We’ve gotten texts and emails from people saying they’re living like hermits again with Delta variant, asking when is it going to be safe.”The decision is the latest in a series of important ones that the F.D.A. is expected to make in the next few weeks. Ahead lie complex decisions on whether to authorize booster shots for recipients of the Johnson & Johnson and Moderna vaccines, whether to authorize the use of Moderna’s vaccine for children ages 12 to 17, and whether to authorize Pfizer-BioNTech’s vaccine for children between the ages of 5 and 11.Top federal health officials have said they needed to publicly announce plans for a booster campaign so that states could prepare for a rollout. But some state officials said it was a challenge to sort out conflicting messages from federal officials.For instance, the president said people should be eligible for a booster eight months after their second shot, but the F.D.A. set the interval at six months. Patrick Allen, the director of the Oregon Health Authority, said that the switch has thrown off the state’s planning and caused officials there to “scramble” to prepare for many more residents who now could be eligible.“We thought at an eight month window we were going to be OK with supply and demand, with our core infrastructure being clinics and pharmacies. But if we have 350,000 people eligible at the beginning, we’re going to have some challenges,” he said, referencing estimates the state has made. At least one county is now preparing to reopen a fairgrounds site for booster doses, he said.

WASHINGTON — A scientific advisory committee to the Food and Drug Administration on Friday overwhelmingly recommended against approving a booster shot of the Pfizer-BioNTech coronavirus vaccine for people 16 and older.The panel agreed to discuss later Friday afternoon whether Pfizer vaccine recipients who are 65 or older, or at higher risk because of their jobs or underlying health conditions, should be given a third shot.The committee voted 16 to 2 against a broader recommendation after an intense daylong public discussion on whether booster shots are necessary and if so, for whom. The Biden administration had been hoping the F.D.A. and the Centers for Disease Control and Prevention would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.Although the F.D.A. is not obliged to follow its advisory committee’s recommendations, it typically does. The agency will likely make a decision by early next week.The vote came after a sharp debate in which many of the panel’s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified extra shots for so much of the population when the vaccines appear to still offer robust protection against severe Covid-19 disease and hospitalization, at least in the United States.“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.The negative vote was the latest in a series of setbacks for President Biden’s booster plan since he first announced it a month ago. Mr. Biden said at the time that he wanted most adults who had gotten a second Pfizer or Moderna vaccine at least eight months ago to start receiving booster shots the week of Sept. 20.But two weeks after his announcement, leaders of the F.D.A. and the C.D.C. told the White House that it would be impossible to authorize booster shots for recipients of the Moderna vaccine that soon. It is now unclear whether extra injections will be offered to Pfizer recipients, and if so, to how many.In a remarkable public display of internal dissension, two F.D.A. scientists co-authored a medical journal article earlier this week arguing that there was no credible evidence yet in support of booster shots for the general population. Those officials, who are leaving the agency this fall, joined outside experts and other federal health officials who cast doubt at the meeting on whether Pfizer’s request should be approved.On the other hand, Dr. Peter Marks, their superior and the official who oversees the F.D.A.’s vaccine division, noted that many well-known vaccines require booster shots and urged the committee to consider the importance of not just of preventing severe disease but of curbing the spread of infection.After the F.D.A. rules on Pfizer’s request, an advisory committee to the C.D.C. will meet to recommend how exactly the extra doses should be used. Earlier public discussions suggest the C.D.C. committee may be leaning toward tailoring booster shots toward the elderly and others particularly vulnerable to worse outcomes from Covid-19, instead of to all those who received their second injection eight months earlier.The F.D.A. committee’s vote followed hours of presentations by officials from Pfizer, the C.D.C., the Israeli government and independent experts on the complex array of data they have collected up until now about the waning effectiveness of Pfizer and other vaccines over time.Dr. Sara Oliver of the C.D.C. presented data showing that vaccines continue to strongly protect against severe forms of Covid-19 in the United States, even in people 75 and older.Jonathan Sterne, a professor of medical statistics and epidemiology in the United Kingdom, said he had analyzed 76 different studies on the vaccines’ real world effectiveness and found that multiple factors can skew the results, including how many unvaccinated people in a study have natural immunity from prior Covid-19 disease. He also warned against drawing conclusions from short-term results from booster shots; data from Israel, for example, only included a follow-up period of several weeks for older adults.Israeli experts made a different argument, telling the committee that they believed third Pfizer shots helped dampen a fourth wave of transmission as the Delta variant swept the nation this summer. The Israeli government, which has relied almost entirely on the Pfizer vaccine, began offering booster shots in late July, starting with the elderly..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}Dr. Sharon Alroy-Preis, Israel’s head of public health services said the summer’s rise in the number of hospitalized patients who had been fully vaccinated with Pfizer’s vaccine was “scary.” She said 60 percent of severely or critically ill patients and 45 percent of those who died during what she called the fourth surge had received two injections of Pfizer’s vaccine.After offering boosters to the general population, she said, Israel is now averaging about half as many severe or critically ill patients as anticipated. She said boosters not only helped curb the spread of infection, but “actually saved lives.”Another Israeli scientist walked the panel through a new study of health records of more than 1.1. million people over age 60. It found that at least 12 days after the booster, the rates of severe disease were nearly twenty-fold lower among those who received a third Pfizer shot compared to those who did not.Dr. William C. Gruber, a senior Pfizer vice president in charge of vaccine development, suggested that if the United States does not follow Israel’s lead, it could potentially face more than five million more infections a year among people who received their second dose 10 months earlier, compared to those who got the second shot five months earlier.“Israel could portend the U.S. Covid-19 future, and soon,” he said.He said Pfizer’s data shows a third shot elicits a robust antibody immune response that equals or greatly exceeds the response after the second dose. Data also show, he argued, that breakthrough infections among vaccinated Americans are linked more to the ebbing power of the vaccine over time instead than to the Delta variant.But committee members, including some government officials, appeared deeply skeptical of the Pfizer’s data and Israel’s analyses. Dr. Philip Krause, one of the F.D.A. vaccine experts who authored the medical journal review, criticized Pfizer’s presentation of data that had not been peer-reviewed or evaluated by the F.D.A., arguing that possible problems in the modeling within could understate the vaccine’s efficacy.Dr. Oliver, the C.D.C. official, questioned attempts to draw a parallel between the United States and Israel, noting that Israel has only nine million residents and is less diverse than the United States. Notably, she also said that Israel defines a severe case of Covid-19 more broadly than the United States does, which might help explain why Israel reports more serious breakthrough infections among its vaccinated.Another C.D.C. official, Dr. Amanda Cohn, asked Israeli officials why the spread of the virus there had recently intensified, despite a broad rollout of boosters. Dr. Alroy-Preis said that the Jewish holidays, together with the start of the school year, had contributed to what she suggested would be a temporary surge in cases.Committee members also said they were concerned about a paucity of safety data in younger recipients of a booster dose, since studies have shown a higher risk of the heart condition myocarditis in young men who received Pfizer-BioNTech’s vaccine. Several of them asked whether it would be better to wait for a booster vaccine designed specifically to fend off the Delta variant of the virus.Apoorva Mandavilli and Sheryl Gay Stolberg contributed reporting.

The announcement that Dr. Marion Gruber and Dr. Philip Krause will leave this fall comes as the agency conducts sensitive reviews of coronavirus vaccines for children and booster shots.WASHINGTON — Two of the Food and Drug Administration’s top vaccine regulators will leave the agency this fall, a development that could disrupt its work on deciding whether to recommend coronavirus vaccines for children under 12 and booster shots for the general population.Dr. Marion Gruber, the director of the F.D.A.’s vaccines office, will retire at the end of October, and her deputy, Dr. Philip Krause, will leave in November, according to an email that Dr. Peter Marks, the agency’s top vaccine regulator, sent to staff members on Tuesday morning. One reason is that Dr. Gruber and Dr. Krause were upset about the Biden administration’s recent announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot, according to people familiar with their thinking.Neither believed there was enough data to justify offering booster shots yet, the people said, and both viewed the announcement, amplified by President Biden, as pressure on the F.D.A. to quickly authorize them.Dr. Marks said he would serve as the acting director of the vaccines office while the agency searched for its next leader. Stephanie Caccomo, a spokeswoman for the agency, said it was “confident in the expertise and ability of our staff to continue our critical public health work.”Some public health experts have said the administration’s booster shot announcement, which did include a caveat that the F.D.A. would first have to authorize such shots, undermined the agency’s responsibility to make that assessment on its own schedule, led by career scientists. Since Mr. Biden took office in January, the White House has made a point of saying it would not influence the F.D.A.’s work.Some outside experts have also challenged the booster plan as premature, saying the available data shows that the Pfizer-BioNTech and Moderna vaccines are holding up well against severe disease and hospitalization, including against the Delta variant. Extra shots would be warranted only if the vaccines failed to meet that standard, some have said.White House officials have stressed that the plan for Americans to start receiving boosters next month was uniformly endorsed by the most senior federal health officials, including Dr. Janet Woodcock, the acting F.D.A. commissioner. They have described the need to develop a booster plan as urgent in light of growing evidence that the vaccines lose potency over time — a trend that they fear suggests the vaccines’ protection against severe disease and hospitalization will also soon weaken..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}Officials have singled out data from Israel as a particularly worrisome sign, especially for older adults and other vulnerable groups. Data from abroad “actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease and death,” Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention, said at a White House briefing on the pandemic Tuesday.Asked about reports that Dr. Gruber and Dr. Krause were unhappy with what they viewed as pressure on the agency, Jeffrey D. Zients, the White House’s Covid-19 response coordinator, reiterated that the booster strategy had always been contingent on F.D.A. review.“As our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” he said at the briefing. “We announced our approach in order to stay ahead of the virus, give states and pharmacies time to plan, and to be transparent with the American people.”But some critics have said that explanation falls short, because F.D.A. regulators are in the position of trying to determine whether booster shots are safe and effective after the White House — and their own agency head, Dr. Woodcock — already endorsed administering them.Dr. Marion Gruber and Dr. Philip Krause viewed the announcement on booster shots, amplified by President Biden, as pressure on the F.D.A. to quickly authorize them, people familiar with their thinking said.Doug Mills/The New York Times“This process has been the reverse of what we would normally expect in vaccine policy,” with the administration announcing plans based on a certain outcome before regulators can complete their review, said Jason L. Schwartz, an associate professor of health policy at the Yale School of Public Health. “That has made it even more complicated and confusing for the public.”The announcement of the departures comes at a critical time for the F.D.A. The agency is in the midst of a marathon push to decide several important questions about the three coronavirus vaccines it authorized on an emergency basis over the past year. It is facing public pressure from some quarters to speed up, and from others to slow down. Mr. Biden still has not nominated someone to permanently lead the agency, a post that requires Senate confirmation.Only about three weeks remain before the Biden administration wants to begin offering boosters to recipients of the Pfizer-BioNTech and Moderna vaccines, starting with nursing home residents, health care workers and others who were inoculated early in the vaccination campaign..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-3btd0c{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:1rem;line-height:1.375rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-3btd0c{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-3btd0c strong{font-weight:600;}.css-3btd0c em{font-style:italic;}.css-w739ur{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-family:nyt-cheltenham,georgia,’times new roman’,times,serif;font-weight:700;font-size:1.375rem;line-height:1.625rem;}@media (min-width:740px){#NYT_BELOW_MAIN_CONTENT_REGION .css-w739ur{font-size:1.6875rem;line-height:1.875rem;}}@media (min-width:740px){.css-w739ur{font-size:1.25rem;line-height:1.4375rem;}}.css-9s9ecg{margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}.css-uf1ume{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-box-pack:justify;-webkit-justify-content:space-between;-ms-flex-pack:justify;justify-content:space-between;}.css-wxi1cx{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:column;-ms-flex-direction:column;flex-direction:column;-webkit-align-self:flex-end;-ms-flex-item-align:end;align-self:flex-end;}.css-12vbvwq{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-12vbvwq{padding:20px;width:100%;}}.css-12vbvwq:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-12vbvwq{border:none;padding:10px 0 0;border-top:2px solid #121212;}.css-12vbvwq[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-12vbvwq[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-12vbvwq[data-truncated] .css-5gimkt:after{content:’See more’;}.css-12vbvwq[data-truncated] .css-6mllg9{opacity:1;}.css-qjk116{margin:0 auto;overflow:hidden;}.css-qjk116 strong{font-weight:700;}.css-qjk116 em{font-style:italic;}.css-qjk116 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:visited{color:#326891;-webkit-text-decoration-color:#326891;text-decoration-color:#326891;}.css-qjk116 a:hover{-webkit-text-decoration:none;text-decoration:none;}The F.D.A. is currently trying to schedule a meeting of its panel of independent experts, the Vaccines and Related Biological Products Advisory Committee, to discuss booster shots, according to people familiar with the agency’s planning. That meeting would be public, and could potentially reveal concerns among regulators and the F.D.A.’s outside experts about the administration’s strategy.The F.D.A. is also expected soon to tackle the question of whether to authorize coronavirus vaccines on an emergency basis for children under 12.Last week, the agency fully approved the Pfizer-BioNTech vaccine for people 16 and older, a major decision that spurred a series of vaccine mandates at corporations, universities, hospitals and elsewhere.That decision and a host of others fell to teams led by Dr. Gruber and Dr. Krause, working under Dr. Marks.The F.D.A. reviews data from vaccine manufacturers on safety and efficacy, and sometimes makes decisions with input from the outside advisory committee of vaccine experts. The agency’s decisions are followed by recommendations from the Centers for Disease Control and Prevention, after it hears from its own outside panel of experts.Both Dr. Gruber and Dr. Krause have been at the agency for 30 years and have long experience reviewing vaccines, including for Ebola. The office they lead evaluates annual flu vaccines, including which strains each year’s version targets, and it had a central role in the F.D.A.’s authorization of three coronavirus vaccines, which also include a single-dose shot from Johnson & Johnson.Their office also guides manufacturers on what kinds of studies they need to conduct to evaluate new vaccines, then reviews the data on them. The F.D.A. came under enormous pressure last fall by Trump administration officials to water down or scuttle standards it had set for vaccine emergency use authorizations, but prevailed in publishing the guidelines. Dr. Stephen M. Hahn, the F.D.A. commissioner under President Donald J. Trump, said on Tuesday that Dr. Gruber and Dr. Krause “stuck together and marshaled amazing resources and got the authorizations done in record time.”“They set the gold standard” for vaccine reviews, said Dr. Luciana Borio, the former acting chief scientist at the agency under President Barack Obama. During the pandemic, she added, “they put their heads down and organized their team to do this work under tremendous pressure, but do it in a rigorous, expedited and flexible form.”