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U.S. Expands Booster Shots to All American Adults to Head Off Delta Variant

By Josh Wingrove and Fiona Rutherford

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What You Need to Know

  • Elderly people and health-care workers who got their shots at the beginning of the year will become eligible for the boosters first.
  • The CDC published three studies showing that messenger RNA vaccines continue to provide strong protection against hospitalization from the virus.
  • Nearly 170 million people in the U.S. have been fully vaccinated, though only some would become eligible in the next few months for a booster.

The Biden administration will start offering booster shots on Sept. 20 to all vaccinated U.S. adults — a massive expansion to a program previously limited to those with weakened immune systems — as the coronavirus delta variant continues its spread.

Top U.S. public health officials said Wednesday in a joint statement that a third dose of Pfizer Inc. and Moderna Inc. shots “will be needed to maximize vaccine-induced protection and prolong its durability.”

Health-care workers and elderly people who got their shots at the beginning of the year will become eligible for the boosters first.

The move is a sharp shift in policy for Biden, and one the administration acknowledges is made more out of an abundance of caution than pressing need. Officials cited a series of warning signs and data points about the declining efficacy of the vaccines over time, and acknowledged unknowns, such as whether boosters would help stem transmission of delta.

The warning signs and the vaccine efficacy data were enough to trigger the move, which until last week the officials had indicated was premature.

“You want to stay ahead of the virus,” infectious disease expert Anthony Fauci said Wednesday during a briefing.

J&J Under Study

Earlier Wednesday, U.S. health officials including Fauci, Centers for Disease Control and Prevention Director Rochelle Walensky, Food and Drug Administration Acting Commissioner Janet Woodcock and Surgeon General Vivek Murthy issued a joint statement about the decision.

“Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout,” they said in the statement.

The U.S. will begin issuing the boosters to fully vaccinated adults who received their second shot at least eight months earlier, Murthy said.

The plan, which doesn’t include vaccinated people between the ages of 12 and 17, is still subject to an independent evaluation and clearance by the FDA. It will be up to the FDA to guide a decision on minors, Murthy said.

Zients said the boosters will be free, regardless of health insurance status, and there will be roughly 80,000 sites in the U.S. providing the shots.

President Joe Biden will speak about the expanded program later Wednesday. Shares of Pfizer rose 1.1% as of 1:43 p.m. in New York. Moderna fell 2.2% and BioNTech’s American depositary receipts lost 2.8%.

Health officials are still studying a possible booster for the roughly 14 million Americans who received the Johnson & Johnson single-dose vaccine, which didn’t use the same mRNA technology as Pfizer and Moderna. But the officials said they anticipate boosters for the J&J shot “likely will be needed.”

The U.S. is facing a new wave of Covid infection, primarily among the unvaccinated and driven by the delta variant, which has fueled concern over breakthrough infections that occur in vaccinated people. Deaths have been rising again, too, including 1,002 recorded on Tuesday.

Still, the medical community remains divided over the efficacy of widespread booster shots, though studies continue to roll in on breakthrough infections and whether vaccine efficacy wanes over time, in particular for older or more vulnerable people.

The White House has said the expansion won’t hinder its plan to donate shots to other nations.

“Look, to end this pandemic, we have to protect the American people and we have to continue to do more and more to vaccinate the world,” Jeff Zients, the head of Biden’s Covid response team, said Wednesday in a briefing. “Both are critical. And we’re already proving that we can protect our own people here at home while we help others.”

Fauci, speaking at the same briefing, emphasized that the U.S. needed “to stay ahead of the virus.”

“You don’t want to find yourself behind, playing catch-up,” Fauci said.

New Studies

The CDC published three studies showing that messenger RNA vaccines continue to provide strong protection against hospitalization from the virus, even as efficacy at preventing infections has waned somewhat in the face of the highly infectious delta variant.

In one study, published Wednesday in CDC’s Morbidity and Mortality Weekly Report, researchers found that the vaccines remained 95% effective at preventing hospitalization in New York at the end of July, after delta had taken over, compared to the same rate of effectiveness against hospitalization in early May.

A second study in the same journal found the shots’ ability to prevent hospitalizations held up well from March through July, with no statistical lowering of efficacy in the second half of the period compared to the first.

There was also no statistically meaningful drop-off in efficacy in preventing hospitalizations in the elderly, those with multiple chronic medical conditions, or other subgroups of patients, the real-world study found.

In a third report, researchers found that vaccine efficacy in preventing infections in nursing homes dropped from 74.7% before delta took over in the spring to 53.1% after delta became predominant in June and July.

The study could not distinguish between symptomatic and asymptomatic infections. But the authors concluded that “additional doses might be considered” in nursing home residents.

Walensky also pointed to a pre-print Mayo Clinic study showing protection against infection declined over time, particularly for people who got Pfizer’s shot, and cited other unpublished data showing waning effectiveness against delta, regardless of whether time had passed.

“Given this body of evidence, we are concerned that the current strong protection against severe infection, hospitalization and death could decrease in the months ahead, especially among those who are at higher risk or who were vaccinated earlier,” she said. “Our plan is to protect the American people and to stay ahead of this virus.”

Just last week, Walensky had stressed that it wasn’t time for boosters for anyone other than severely immunocompromised people.

The officials emphasized that the efficacy is falling in particular against infection, but that vaccines still are effective against serious cases, hospitalization and death.

Fauci said it wasn’t clear whether booster shots would curb transmission of the virus among the vaccinated. “With full transparency, we don’t know that right now,” he said.

Nearly 170 million people in the U.S. have been fully vaccinated, though only some would become eligible in the next few months for a booster. Zients estimated there’d be 100 million boosters given out by the end of 2021.

Officials said they have enough supply to continue donations and exports to other nations still struggling to procure vaccines. Still they’ve faced criticism for stoking inequities by handing out third shots while vast majorities of people in many countries haven’t had their first.

WHO Reaction

The World Health Organization has called for a moratorium on booster shots through September to enable poorer countries to catch up on vaccination rates. A spokesperson for Gavi, the Vaccine Alliance, which co-leads the Covax sharing program, said that rich countries giving boosters will only exacerbate inequities and called on countries to share all excess doses with Covax.

“The divide between the haves and have-nots will only grow larger if manufacturers and leaders prioritize booster shots over supply to low and middle income countries,” WHO Director-General Tedros Adhanom Ghebreyesus said in a press briefing in Geneva.

Tedros pressed for Johnson & Johnson, which is manufacturing some vaccines in Africa, to distribute doses there before sending them to Western countries that have already immunized large portions of their populations.

Sarah Swinehart, Senior Director of Communications for North America at The ONE Campaign said the decision to authorize booster shots for all Americans threatens to further exacerbate global vaccine inequities and prolong the pandemic in the U.S. and abroad.

“It’s outrageous that a healthy, vaccinated individual will be able to get a third shot before the elderly and health workers in low-income countries can get a single dose,” Swinehart said.

The CDC said separately that it will launch a new outbreak analysis and forecast center, picking a group of outsiders from academia and the private sector to lead the new initiative.

(Image: lakshmiprasada S/Shutterstock)

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