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.
