Biden Maps Huge Booster Push, Urges School Masks to Blunt Delta Variant

(Bloomberg) -- President Joe Biden beefed up his administration’s response to a nationwide surge in coronavirus infections on Wednesday, laying out a series of actions including vaccination boosters and possible legal action against governors who have blocked mask requirements in schools.

“The threat of the delta virus remains real but we are prepared,” Biden said Wednesday at the White House. “This is no time to let our guard down.”

The U.S. is facing a new wave of Covid-19 infections, primarily among the unvaccinated and driven by the delta variant. Deaths have been rising again with 1,002 recorded on Tuesday.

The plan to start offering booster shots on Sept. 20 to all vaccinated U.S. adults marks a massive expansion to a program previously limited to those with weakened immune systems. 

He also announced a new requirement that nursing homes ensure their staff are vaccinated in order to receive federal funding. And he directed Education Secretary Miguel Cardona to take steps such as exercising oversight authorities and taking legal action to counter governors who have prevented schools from requiring children to wear masks.

Texas Governor Greg Abbott and Florida Governor Ron DeSantis are working to block local school districts from imposing mask mandates in their states. Several districts have taken the state to court so that they can require children wear masks in class.

“If you visit, live, and work in a nursing home you should not be at a high risk from contracting Covid from unvaccinated employees,” Biden said.

Health-care workers and elderly people who got their shots at the beginning of the year will become eligible for the boosters first. The U.S. will begin issuing the boosters to fully vaccinated adults who received their second shot at least eight months earlier.

The booster 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. 

Top U.S. public health officials said earlier 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.” 

The 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.

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.

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.

White House adviser Jeffrey 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.

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.”

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.

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