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U.S. to Advise Boosters for Most Americans 8 Months After Vaccination U.S. to Advise Boosters for Most Americans 8 Months After Vaccination
(about 13 hours later)
WASHINGTON — The Biden administration has decided that most Americans should get a coronavirus booster vaccination eight months after they received their second shot, and could begin offering third shots as early as mid-September, according to administration officials familiar with the discussions. The Biden administration has decided that most Americans should get a coronavirus booster vaccination eight months after they received their second shot, and could begin offering third shots as early as the third week of September, according to administration officials familiar with the discussions.
Officials are planning to announce the decision as early as this week. Their goal is to let Americans who received the Pfizer-BioNTech or Moderna vaccines know now that they will need additional protection against the Delta variant that is causing caseloads to surge across much of the nation. The new policy will depend on the Food and Drug Administration’s authorization of additional shots. Officials are planning to announce the decision on Wednesday at the White House. Their goal is to let Americans who received the Pfizer-BioNTech or Moderna vaccines know now that they will need additional protection against the Delta variant, which is causing caseloads to surge across much of the nation. But the new policy will depend on the Food and Drug Administration authorizing additional shots.
Officials said they expect that recipients of the Johnson & Johnson vaccine, which was authorized as a one-dose regimen, will also require an additional dose. But they are waiting for the results of that firm’s two-dose clinical trial, expected later this month. Recipients of the Johnson & Johnson vaccine, which was authorized as a one-dose regimen, will also most likely require an additional dose, the officials said. But they are waiting for results, expected this month, from a clinical trial that provided participants with two doses. So far, only about 14 million people in the United States have gotten the Johnson & Johnson shot, which the government began offering in March. The first Pfizer and Moderna vaccines were given in December.
The first boosters are likely to go to nursing home residents, health care workers and emergency workers. They would probably be followed by other older people who were near the front of the line when vaccinations began late last year, then by the general population. Officials envision giving people the same vaccine they originally received. The first boosters would probably go to nursing home residents, health care workers and emergency workers, who were the first to be vaccinated last winter. They would likely be followed by other older people, then by the general population. Officials envision giving people the same vaccine they originally received.
The decision comes as the Biden administration is struggling to regain control of a pandemic that it had claimed to have tamed little more than a month ago. President Biden had declared the nation reopened for normal life for the July 4 holiday, but the wildfire spread of the Delta variant has thwarted that. Covid-19 patients are again overwhelming hospitals in some states, and federal officials are worried about an increase in the number of children hospitalized just as the school year is set to begin. Some five million people in the United States — everyone who got two doses of Pfizer or Moderna vaccine by the end of January — would be eligible for boosters by late September under the plan. In all, more than 90 million people in the country have been fully vaccinated with Pfizer’s product, and more than 64 million with Moderna’s. But about 40 percent of the population has still not gotten even a first dose, a problem the administration will need to stay focused on even as it turns to providing boosters.
For weeks, Biden administration officials have been analyzing the rise in Covid-19 cases, trying to figure out if the Delta variant is better able to evade the vaccines or if the vaccines have waned in strength over time. According to some administration experts, both could be true, a distressing combination that is re-energizing a pandemic that the nation fervently hoped had been curbed. Administration officials are expected to make the case Wednesday that even if the booster plan shifts based on new data, it is prudent to have a strategy in place now.
Dr. Francis S. Collins, the director of the National Institutes of Health, told “Fox News Sunday” that “there is a concern that the vaccine may start to wane.” That, combined with the Delta variant’s ferocity, could dictate boosters, he said. White House officials are expected to present data showing that the vaccines’ protection against Covid-19 infections is declining — a trend they attribute to a combination of the Delta variant and a degree of waning in the vaccines’ protection. Unvaccinated people still make up the vast majority of those who become seriously ill or are hospitalized with Covid-19.
The announcement comes as the Biden administration is struggling to regain control of a pandemic that it had claimed to have tamed little more than a month ago. President Biden had declared the nation reopened for normal life for the July 4 holiday, but the wildfire spread of the Delta variant has thwarted that. Covid-19 patients are again overwhelming hospitals in some states, and federal officials are worried about an increase in the number of children hospitalized just as the school year is set to begin.
For hospitals and state and local governments, having to manage a new round of vaccinations amid the Delta surge adds another layer of complication to the response, said Dr. Janis M. Orlowski, chief health officer of the Association of American Medical Colleges, which represents 400 of the nation’s largest teaching hospitals.
Before vaccinating health care workers, Dr. Orlowski said, hospitals will want data about side effects from booster shots, so they can know how to stagger vaccinations among their staff without hurting their ability to care for patients. “You can’t do the whole I.C.U. at the same time,” she said, “because you don’t want everyone getting fever and chills.”
In interviews on Tuesday, hospital officials and doctors generally supported the push for booster shots. Unlike the vaccination campaign that began last winter, they said, this time there will be enough doses to go around, which should make things move more smoothly.
“I think we’re running out of second chances,” said Dr. Matthew Harris, the medical director of the coronavirus vaccination program at Northwell Health, New York’s largest hospital system. “What keeps me up at night is the inevitability of a variant that is not responsive to the vaccine, so if this is how we stay ahead of it, I fully support it.”
Dr. Danny Avula, Virginia’s vaccine coordinator, said his state has thousands of vaccine providers in place and can likely manage boosters without much change. “What caused so much of the urgency and frenzy of January through April was the limitations in supply,” he said. “I think it will be a very different rollout for booster than it was for the initial shots.”
The booster strategy has been under discussion for several weeks, but a consensus about how to proceed was reached in meetings only this weekend. Officials said senior health officials all endorsed it, including the surgeon general, Dr. Vivek H. Murthy, and the leaders of the National Institutes of Health, the Food and Drug Administration and the Centers for Disease Control and Prevention.
The administration has more than 100 million doses stockpiled that could be used for boosters, plus the tens of millions more in freezers at pharmacies and other locations. The administration has purchased still more supply scheduled for delivery this fall, and officials say they are not worried about running out.
Federal health officials have been particularly concerned about data from Israel suggesting that the Pfizer-BioNTech vaccine’s protection against severe disease has fallen significantly for elderly people who got their second shot in January or February.Federal health officials have been particularly concerned about data from Israel suggesting that the Pfizer-BioNTech vaccine’s protection against severe disease has fallen significantly for elderly people who got their second shot in January or February.
Israel can in some ways be viewed as a template for the United States because it vaccinated more of its population faster and has almost exclusively used the Pfizer-BioNTech vaccine that made up much of the U.S. stock. Unlike the United States, though, Israel has a nationalized health care system that allows it to systematically track patients.Israel can in some ways be viewed as a template for the United States because it vaccinated more of its population faster and has almost exclusively used the Pfizer-BioNTech vaccine that made up much of the U.S. stock. Unlike the United States, though, Israel has a nationalized health care system that allows it to systematically track patients.
The latest Israeli data, posted on the government’s website on Monday, shows what some experts described as continued erosion of the efficacy of the Pfizer vaccine against mild or asymptomatic Covid-19 infections in general and against severe disease among the elderly who were vaccinated early in the year. The latest Israeli data, posted on the government’s website, shows what some experts described as continued erosion of the efficacy of the Pfizer vaccine against mild or asymptomatic Covid-19 infections in general and against severe disease among the elderly who were vaccinated early in the year.
One slide suggests that for those 65 years or older who got their second shots in January, the vaccine is now only about 55 percent effective against severe disease. But researchers noted that the data has a wide margin of error, and some said other Israeli government data suggested the decline in efficacy was less severe. One slide suggests that for those age 65 or older who got their second shots in January, the vaccine is now only about 55 percent effective against severe disease. But researchers noted that the data has a wide margin of error, and some said other Israeli government data suggested the decline was less severe.
“It shows a pretty steep decline in effectiveness against infection, but it’s still a bit murky about protection against severe disease,” said Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine in Houston, who reviewed the data at the request of The New York Times.“It shows a pretty steep decline in effectiveness against infection, but it’s still a bit murky about protection against severe disease,” said Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine in Houston, who reviewed the data at the request of The New York Times.
Dr. Jesse L. Goodman, a former chief scientist with the Food and Drug Administration who also reviewed the data, said it suggests “worrisome trends” that could signal waning of vaccine effectiveness. But he said he would like to see further detail from Israel and, more important, data indicating whether the United States is headed in the same direction. Federal officials said the booster program would most likely follow much the same scenario as the initial vaccination program. The first shots for the general public in the United States were administered on Dec. 14, days after the F.D.A. authorized the Pfizer shot for emergency use. People started receiving the Moderna vaccine a week later.
Federal officials said the booster program will most likely follow much the same scenario as the initial vaccination program. The first shots for the general public in the United States were administered on Dec. 14, days after the F.D.A. authorized the Pfizer shot for emergency use. People started receiving the Moderna vaccine a week later. It is not clear how quickly the F.D.A. could rule on booster shots.
While frontline health care workers and nursing home residents were among the first to get inoculated nationwide, states followed their own plans for who else was eligible for shots in the early weeks and months of the vaccination campaign. Pfizer is further along in submitting data to the F.D.A. that it says supports the use of extra doses. Moderna and the National Institutes of Health are still studying whether a half-dose or a full dose would work better for a third shot but expect results soon. Both companies expect to complete their submissions of booster data soon.
But almost everyone 65 and older qualified for vaccination by late February, as did many police officers, teachers, grocery store employees and other people at risk of being exposed to the virus on the job. An advisory committee on vaccines for the Centers for Disease Control and Prevention would need to review the data on boosters before the C.D.C. can recommend them.
The regulatory path for additional shots is not entirely clear. Pfizer-BioNTech filed data to the F.D.A. on Monday that it said showed the safety and effectiveness of a booster shot. But the data was preliminary, from Phase 1 of a clinical trial. Moderna is on a similar track, exploring the safety and efficacy of both a half-dose and a full dose as a third shot.
The World Health Organization has called for a moratorium on booster shots until the end of September, saying available doses should be used to help countries that are far behind in vaccinations. But Israel is already offering third shots to those at least 50 years old. Germany and France have said they plan to offer additional shots to vulnerable segments of their populations next month. Britain has a plan to do so, but is holding off for now.The World Health Organization has called for a moratorium on booster shots until the end of September, saying available doses should be used to help countries that are far behind in vaccinations. But Israel is already offering third shots to those at least 50 years old. Germany and France have said they plan to offer additional shots to vulnerable segments of their populations next month. Britain has a plan to do so, but is holding off for now.
Late last week, the F.D.A. authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, and the Centers for Disease Control and Prevention recommended them. The authorities decided those individuals, who make up fewer than 3 percent of Americans, merited extra shots because many fail to respond to the standard dosage. The agency has not yet authorized any of the vaccines for children younger than 12. Late last week, the F.D.A. authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, and the C.D.C. recommended them. The authorities decided those individuals, who make up fewer than 3 percent of Americans, merited extra shots because many fail to respond to the standard dosage. The agency has not yet authorized any of the vaccines for children younger than 12.
Noah Weiland contributed reporting.Noah Weiland contributed reporting.