US vaccine booster plan faces complications

WASHINGTON (AP) — President Joe Biden's plans to start delivery of booster shots by September 20 for most Americans who received the COVID-19 vaccines are facing new complications that could delay the availability of third doses for those who received the Moderna vaccine, administration officials said Friday.

Biden announced last month that his administration was planning for boosters to be available for all Americans who received the mRNA vaccines in an effort to provide more enduring protection against the coronavirus, pending approvals from the Centers for Disease Control and Prevention and the Food and Drug Administration.

Those agencies, though, are awaiting critical data before signing off on the third dose, with Moderna's vaccine increasingly seen as unlikely to make the September 20 milestone.

According to one official, Moderna produced inadequate data for the FDA and CDC to recommend the third dose of its vaccine and the FDA has requested additional data that is likely to delay those boosters into October.

Pfizer, which is further along in the review process, in part because of data collected from the vaccine's use in Israel, is still expected to be approved for a third dose for all by September 20.

A key FDA panel is to review Pfizer's data on boosters on September 17.

Data for boosters on Johnson & Johnson's single-dose vaccine won't be available for months, since that shot wasn't approved until February, officials said.

Dr Janet Woodcock, the acting FDA commissioner, and CDC Director Dr Rochelle Walensky briefed White House COVID-19 coordinator Jeff Zients and other officials about the expected Moderna delay on Thursday, officials said.

Most of the 206 million Americans at least partially vaccinated against COVID-19 received the Pfizer shot, but about 80 million received the Moderna vaccine, according to CDC data.

The administration's public pronouncement about booster availability, a break from the more deliberate and behind-the-scenes planning that defined its early vaccination campaign, sparked concerns from some that the White House was getting ahead of the science on boosters.

The White House said it was merely preparing for the boosters' eventual approval, and that the reviews were “all part of a process that is now underway.”

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