CDC Director Rochelle Walensky, MD, and acting FDA Commissioner Janet Woodcock, MD, recommended the U.S. delay its COVID-19 booster rollout during a Sept. 2 meeting with Jeff Zients, White House COVID-19 response coordinator, according to The Wall Street Journal.
The recommendation was made because the FDA needs more time to collect and review the data on COVID-19 booster's safety and efficacy, people familiar with the discussions said.
On Aug. 18, the U.S. said it is prepared to offer booster shots for all Americans who received two doses of Pfizer or Moderna's COVID-19 vaccine beginning the week of Sept. 20 and starting eight months after an individual's second dose. On Aug. 25, people familiar with the planning process told The Wall Street Journal the country will likely offer booster shots for fully vaccinated Americans six months after their last COVID-19 vaccine was administered, instead of the eight-month gap that had been previously announced.
HHS said its plan is contingent upon FDA approval for COVID-19 boosters, which hasn't been granted yet. The agency amended the emergency use authorizations for Pfizer's and Moderna's COVID-19 vaccines Aug. 12, allowing for a third dose in immunocompromised people, but not yet for the rest of the population.
Drs. Woodcock and Walensky told Mr. Zients the FDA may only be able to approve and recommend booster doses for people who received Pfizer's vaccine in time for the country's planned rollout, according to The Washington Post.
Pfizer began submitting data to the FDA for its booster dose's approval Aug. 25. Moderna did the same Sept. 1. Johnson & Johnson announced a booster dose of its vaccine increases antibody levels nine-fold Aug. 25, and the drugmaker said it will submit this new data to the FDA.
"We always said we would follow the science, and this is all part of a process that is now underway,” Chris Meagher, a White House spokesperson told The Wall Street Journal. "When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus."