Here’s what you need to know about booster shots and the United States’ plans.
Frequently Asked Questions
Why is the U.S. planning to offer booster shots?
Booster shots are extra doses of vaccine beyond a normal regimen. For the two-dose Moderna and Pfizer-BioNTech vaccines, that means a third shot. Health officials say a growing body of data suggests the boosters will counteract waning immunity. But officials said that administering of boosters won’t go forward without the approval of the Food and Drug Administration and the Centers for Disease Control and Prevention.
Top U.S. health officials on Wednesday attributed drops in vaccine effectiveness to the passage of time as well as the virulence of the delta variant that quickly outcompeted other strains of the coronavirus. The delta variant now accounts for an estimated 98.8 percent of new U.S. infections.
They also said they want to stave off any potential decline in the vaccines’ ability to prevent hospitalizations and deaths. “You want to stay ahead of the virus. … You don’t want to find yourself behind, playing catch-up,” said White House medical adviser Anthony S. Fauci.
Officials said they were also persuaded by evidence that boosters can significantly increase people’s immunity after it declines. The results were “striking,” Fauci said.
Until just recently, evaluations of vaccine effectiveness amid the rise of the delta variant largely relied on observations from outside the United States. A recent New England Journal of Medicine study concluded that the Pfizer-BioNTech vaccine was 88 percent effective against symptomatic infections in England.
Others, such as a study in Israel, found larger declines in protection against infection. One U.S. report, which collected data from Mayo Clinic Health System facilities in five states and has not yet gone through peer review, found a drop in the Pfizer-BioNTech vaccine’s effectiveness against delta infections to 42 percent. Moderna’s vaccine was 76 percent effective.
A study from New York is the first to assess vaccine protection against coronavirus infection across the entirety of a U.S. state after the emergence of the delta variant. The study authors found a modest drop in vaccine effectiveness: It declined from 92 percent in May to 80 percent in late July.
Who qualifies for a booster shot in the U.S., and when?
If the Biden administration’s plan is approved, Americans will be eligible for a third dose eight months after the date on which they received their second dose, officials said. That means that while the broad booster rollout begins the week of Sept. 20, the first people to get the extra doses will be the first populations that were vaccinated — higher-risk groups such as health-care workers, residents of long-term-care facilities and the elderly.
Those who got the Johnson & Johnson vaccine probably will also need a booster, officials said, but they are awaiting more data. Use of the J&J shots in the United States did not begin until March, they noted.
Immunocompromised people are immediately eligible for booster shots. Multiple studies show third shots improved immune defenses in organ-transplant recipients and others with compromised immune systems.
Why are booster shots recommended after eight months?
There is “nothing magical” about the eight-month mark, Surgeon General Vivek H. Murthy said Wednesday. But that is what health experts landed on after observing increases in infection over time among the vaccinated.
“Around the six-month mark in the data, you start to see increases in mild to moderate infection,” Murthy said Wednesday.
Health officials emphasized that vaccines remain highly protective. Murthy said that “the most important purpose of the vaccine is to keep us out of the hospital and to save our life. … And, fortunately, we are seeing that still holding at a high level, which is good news.”
“But our anticipation is that if the trajectory that we are seeing continues … we will likely see in the future an increase in breakthrough hospitalizations and breakthrough deaths” without boosters, Murthy said.
How will booster shots be distributed in the U.S.?
White House coronavirus coordinator Jeff Zients promised Wednesday that it will be “just as easy and convenient to get a booster shot as it is to get a first shot.” About 80,000 sites nationwide, including 40,000 local pharmacies, will offer third doses, he said.
Boosters will be free to everyone regardless of their health insurance or immigration status, he said, adding: “No ID or insurance required.”
“The bottom line is that we are prepared for boosters and we will hit the ground running in the weeks ahead,” Zients said.
What other countries are offering boosters?
Israel started offering a third dose of the Pfizer-BioNTech vaccine last month to people older than 60 and to severely immunocompromised adults.
Germany will start offering extra shots to immunocompromised people in September and to the very elderly, nursing home residents and people who have received the AstraZeneca or Johnson & Johnson vaccines, its health ministry has said.
France also plans to make certain groups — residents of nursing homes, those over age 75 and people with severe health conditions — eligible for boosters in September.
Hungarian Prime Minister Viktor Orban has announced plans to offer third doses widely, and officials in Spain and Italy have suggested that boosters are likely to be needed. British health officials also are preparing to administer booster shots, starting in September.
What about approval by health agencies?
Standard practice is for the Food and Drug Administration to assess the safety and efficacy of vaccines and for the Centers for Disease Control and Prevention’s outside advisers — the Advisory Committee on Immunization Practices (ACIP) — to recommend what vaccines Americans should get and when. After ACIP makes its recommendations, the CDC director decides whether to accept them.
Administration officials stressed in Wednesday’s coronavirus briefing and in subsequent interviews that a booster-shot campaign will not proceed without a go-ahead from the FDA and the ACIP. One official conceded that the process is “going to be a little messy” for a while but added that the administration has little choice but to act, given the fast spread of the delta variant.
“We are not skipping the very important FDA and ACIP process here,” Murthy said at Wednesday’s briefing. “They have an incredibly important role to play in evaluating safety and making recommendations for vaccines.”
Asked why the Biden administration is announcing its intentions before those groups weigh in, Murthy said leaders want to be transparent and give the public as well as state and local governments time to plan.
“We have told the public [that] when we see a signal in the data, we will tell them when we are concerned.” he said.
“We are fulfilling that promise today,” Murthy said.
Jesse Goodman, a former chief scientist at the FDA and now a professor of medicine and infectious diseases at Georgetown University School of Medicine, said he thinks that boosters will be needed. “Being prepared for a booster campaign makes sense,” he added.
But Goodman also said it was important for the Biden administration to avoid putting “the cart before the horse.”
He added that it was repeatedly said in the coronavirus briefing that normal processes would prevail, “but I think it puts that process under a date-certain kind of pressure.”
Why are plans for booster shots controversial?
Some in the global public health community have criticized wealthy countries’ moves to offer booster shots while poorer nations struggle to provide even their most vulnerable citizens with first vaccine doses.
At a news briefing Wednesday held just before the United States announced its booster plans, scientists at the World Health Organization said the unvaccinated should get priority for the limited lifesaving resources. The WHO has urged a moratorium on booster shots while the rest of the world catches up on initial vaccinations, calling the decision to offer widespread extra doses immoral.
On Wednesday, WHO officials decried “vaccine nationalism” and said that allowing the virus to spread among unvaccinated populations also could lead to the emergence of dangerous new variants.
Mike Ryan, executive director of the WHO’s Health Emergencies Program, likened booster shots to giving out extra life jackets to people who already have them. Joachim Hombach, executive secretary of the WHO’s Strategic Advisory Group of Experts on Immunization, said that vaccines may become less protective over time but that scientists have not seen a decline in protection against severe disease.
Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, also questioned a premise of the U.S. decision on booster shots — that an already occurring decline in vaccine immunity against mild or moderate illness was likely to be followed by a decline in protection against severe disease and hospitalization. He says he thinks protection against serious disease might last a few years.
Wednesday, Biden administration officials said the United States remains committed to distributing vaccine doses around the globe and noted that the United States has donated more vaccine than all other nations combined.
Frances Stead Sellers, Brittany Shammas, Adela Suliman and Bryan Pietsch contributed to this report.