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. 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.”
Federal officials were slated to outline data that support the decision on Wednesday ahead of a White House address by President Biden.
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. 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.
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 Wednesday.