Biden officials to begin COVID-19 booster vaccine program on Sept. 20

The Biden administration said Wednesday it is ready to begin offering booster COVID-19 shots on Sept. 20 to Americans who completed their vaccination course at least eight months ago, citing clear evidence that immunity against infection and mild and moderate disease from the delta variant wanes over that interval.

Top health officials characterized the decision, which is subject to final clearance from regulators, as a move to get ahead of the crisis as the delta variant romps through the nation.

They said the current vaccines remain effective at preventing severe disease, hospitalization or death but they didn’t want to be caught flat-footed if vaccinated people start to see worse outcomes later in the year.

“The available data make very clear that protection against [coronavirus] infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” Centers for Disease Control and Prevention Director Rochelle Walensky, acting Food and Drug Commissioner Janet Woodcock, National Institute of Health Director Francis Collins and his infectious diseases chief, Dr. Anthony Fauci, said in a joint statement with the White House COVID-19 team.

“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. “For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

A New York state study showed a decrease in protection against infection from 92% in May — relatively early in the rollout — to 80% in July.

A national study of 14,000 nursing homes found protection against infection dropped from 75% in March, the pre-delta era, to 53% by Aug. 1.

“This represents a substantial decline in vaccine effectiveness against infection among those who are most vulnerable, including during months where delta was the predominant circulating variant,” Dr. Walensky said.

About 51% of the U.S. population has completed an initial round of vaccination against COVID-19, though rates vary widely from state to state.

Officials said the good news is that for now, the vaccines are maintain protecting against hospitalization. For instance, the New York State study found 95% protection against hospitalization in both May and July.

“Protection against severe disease and hospitalization is currently holding up pretty well,” Dr. Walensky said. “In areas with low vaccination coverage, we continue to hear far too many heartbreaking stories of people who do not get vaccinated, only then to get severe COVID-19.”

Dr. Fauci displayed charts that showed antibody levels gradually waning in studied vaccinated persons. He said a booster shot can elevate antibody levels by 10-fold, giving recipients better protection against the aggressive delta strain.

“You get a dramatic increase in antibody titers when you do a third immunization dose,” he said.

White House COVID-19 Coordinator Jeff Zients said the U.S. has enough vaccine supply for every American to get their initial shots or boosters. The boosters will be available at roughly 80,000 sites, including 40,000 local pharmacies, and they will remain free, with no proof of insurance required.

The plan applies to persons 18 and older but U.S. Surgeon General Vivek Murthy said the CDC and FDA will work to update its guidance for those ages 12 to 17 who are eligible for initial courses of the vaccine now.

The rollout will follow the sequence that unfolded at the start of the vaccine campaign, with health workers, nursing home residents and older populations who received the shots as early as December eligible to get their booster shots first.

Officials said they wanted to be ready before the FDA and the CDC’s Advisory Committee on Immunization Practices (ACIP) sign off on the plan in the coming weeks. The rollout will center on third shots from the so-called “messenger-RNA” vaccines from Pfizer-BioNTech and Moderna.

People who received the one-shot Johnson & Johnson version will need boosters but they got a later start and the booster hasn’t been fully tested.

“Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks,” officials said. “With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

The plan is a turnabout from earlier in the year when officials said they saw no immediate need for booster shots. The fast-moving, more contagious delta variant scrambled those plans, however.

“We have a responsibility to give the maximum about of protection,” President Biden said at the White House.

Experts say unvaccinated people remain the lion’s share of hospitalized patients and nearly all deaths. But a trickle of data from highly vaccinated countries like Israel and increasing reports of breakthrough infections in the vaccinated — Sen. Lindsey Graham of South Carolina and Texas Gov. Greg Abbott among them —renewed the focus on boosters.

“There does seem to be growing data from the U.S. and Israel showing some reduction in vaccine effectiveness to infections after 6 months or so, though the protection against hospitalization and death seems to hold up relatively well,” said Krishna Udayakumar, the founding director of the Duke Global Health Innovation Center. “Boosters are really a temporizing measure – the real solution would be to vaccinate as much of the world’s population as possible. We will continue to see new variants emerge while the virus rages in many parts of the world.”

The World Health Organization has criticized wealthy nations for rolling out booster shots while many countries struggle to get their initial vaccination programs off the ground. The organization says health workers and vulnerable persons around the world should get vaccinated before the booster programs begin.

“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.

WHO’s emergencies chief, Mike Ryan, was more pointed, comparing booster plans to giving out “extra life jackets to people who already have life jackets, while we’re leaving other people to drown without a single life jacket.”

Mr. Biden rejected the idea the U.S. cannot help itself and others at the same time, citing its donation of tens of millions of doses to countries around the world and pledge to donate 500 million doses through 2022.

“We can take care of America and help the world at the same time,” Mr. Biden said. “America’s donated more vaccine to others countries than every other country in the world combined.”