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. Top U.S. health officials 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 more than 99 percent of new U.S. infections, the CDC estimates. The health officials 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. A trio of studies published this month by the CDC echoed past findings on vaccines’ effectiveness over time and against the delta variant. They found that the shots continued to provide strong protection against hospitalization and death due to covid-19 but were less effective at protecting the elderly, especially those with underlying medical conditions. One study found that the Moderna vaccine was better at preventing hospitalization, with 95 percent protection compared to 80 percent for Pfizer-BioNTech’s shots and 60 percent for Johnson & Johnson’s. It also showed diminishing effectiveness against hospitalization for people 75 and older, suggesting the cause could be both waning immunity and the contagiousness of the delta variant. Another CDC analysis of more than half a million coronavirus cases from early April to mid-July showed that vaccine effectiveness against infection dipped from 90 percent early on in that window to less than 80 percent as the delta variant began to dominate. But protection against hospitalization and death hardly declined, the study said. People who were not fully vaccinated this spring and summer were more than 10 times more likely to be hospitalized, and 11 times more likely to die of covid-19, researchers recently found.

Who qualifies for a booster shot in the U.S., and when?

Certain Pfizer-BioNTech vaccine recipients will be eligible for a third dose six months after the date on which they received their second dose, officials said. For now, the extra dose is available only for people 65 and older, long-term care facility residents, and individuals aged 18-64 who either have underlying medical conditions or are at an increased risk for covid-19 because of occupational or institutional setting. The latter group includes first responders, education staff and workers in the agriculture, manufacturing, grocery store and public transit industries and Postal Service. The federal health agencies did not endorse a “mix-and-match” approach to vaccine boosters, citing a lack of evidence on the potential effects of using two different shots. Those who were immunized with Moderna’s or Johnson & Johnson’s vaccines will have to wait. Moderna submitted an emergency-use authorization application for its booster earlier this month and is waiting for the Food and Drug Administration to review the data. While Johnson & Johnson released data from a Phase 3 clinical trial for its booster — showing positive results — the company has not yet applied for emergency use authorization. Immunocompromised people are already eligible for a third shot of the Pfizer-BioNTech and Moderna vaccines. Multiple studies show third shots improved immune defenses in organ-transplant recipients and others with compromised immune systems.

Why are booster shots recommended after six months?

Health experts recommended administering a third dose after six months, based on observations of increased infections among the vaccinated. “Around the six-month mark in the data, you start to see increases in mild to moderate infection,” Surgeon General Vivek H. Murthy said last month. 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.?

President Biden said that the doses will be delivered to a wide range of facilities across the country — drawing on the existing infrastructure established by former president Donald Trump’s Operation Warp Speed. Following the CDC’s new guidance, appointments can be scheduled at national pharmacies such as CVS and Walgreens . Consumers are not required to get a prescription or a letter from their doctor. About 70 percent of vaccine doses are being given at pharmacies, and boosters will not require additional documentation, CDC officials said. On Aug. 18, White House coronavirus coordinator Jeff Zients promised 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.

What other countries are offering boosters?

Israel started offering a third dose of the Pfizer-BioNTech vaccine in midsummer to people older than 60 and to severely immunocompromised adults. Many European countries have followed in the months since. France made certain groups — people over the age of 65 as well as those with underlying health conditions — eligible for boosters in September. Britain just started a massive booster rollout offering extra shots to 30 million people who are front-line health care workers, older than 50 or otherwise medically vulnerable. Other European countries such as Germany and the Czech Republic have also embraced boosters for the more vulnerable, and a health official recently said that all Italians will likely become eligible for a third dose in 2022.

How were boosters approved?

Standard practice is for the FDA to assess the safety and efficacy of vaccines and for the CDC’s outside advisers — the Advisory Committee on Immunization Practices (ACIP) — to recommend what vaccines Americans should get and when. The CDC director then decides whether to accept those recommendations. On Wednesday, the FDA authorized booster shots for Americans over 65, adults at heightened risk of severe illness and certain front line workers. A day later, the CDC’s advisory panel largely mirrored this decision by recommending a third shot of the Pfizer-BioNTech vaccine for people 65 and older, nursing home residents and people 50 to 64 with underlying medical conditions. The committee stopped short of endorsing booster shots for people whose jobs put them at risk of infection, voting 9 to 6 to not expand the vaccination regimen. In a rare move, CDC Director Rochelle Walensky late Thursday overruled the panel’s decision and added a recommendation for boosters for front line workers — an effort “to recognize where our actions can have the greatest impact,” she said in a statement. Walensky’s endorsement officially authorizes booster shots, which are expected to be available immediately at locations where the Pfizer vaccine is already being administered, including pharmacies, health departments, clinics and some doctor’s offices. Yet, the decision did not come without controversy — including backlash from within the medical community.

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 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. 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. In a virtual summit last Wednesday, President Biden announced the United States will buy an additional 500 million doses of the Pfizer-BioNTech coronavirus vaccine to donate to countries in need, raising the number to 1.1 billion doses. Another point of contention with booster shots is who is authorized to receive them. As seen in last week’s heated debate within the CDC’s advisory panel, some experts do not believe the three-shot regimen should be expanded to the majority of Americans at the moment. Joel Achenbach, Ben Guarino, Brittany Shammas and Frances Stead Sellers contributed to this report.

What to know about coronavirus booster shots in the U.S.

By Hannah Knowles

Laurie McGinley

María Luisa Paúl

and

Lena H. Sun

September 27, 2021 at 3:52 p.m. EDT

A health-care worker fills a syringe with the Pfizer-BioNTech coronavirus vaccine at the American Museum of Natural History in New York on July 22. (Mary Altaffer/AP)

The Biden administration is rolling out coronavirus vaccine booster shots for certain groups after the Centers for Disease Control and Prevention endorsed a third dose of the Pfizer-BioNTech vaccine for Americans over 65 and adults at heightened risk of severe illness.

The administration had announced plans to make booster shots available to all Americans, citing concerns about people’s immunity from shots waning over time. The decision comes amid a surge in infections from the delta variant across the country, all while vaccinations rates have slowed.

Qualifying Pfizer-BioNTech vaccine recipients can get a booster six months after the date of their second dose. Officials said they will address recommendations for the Moderna and Johnson & Johnson vaccines after reviewing relevant data.

Here’s what you need to know about booster shots and their rollout.

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