Moderna Booster Dose Likely to Miss Biden's Sept. 20 Target as It Awaits FDA Approval

Booster shots for the Moderna vaccine will likely miss President Joe Biden's target date of Sept. 20 to start delivery of booster shots for most Americans who have already received the COVID-19 vaccine as the Moderna booster is still awaiting approval.

The Centers for Disease Control and Prevention and the Food and Drug Administration have not yet signed off on approval for the Moderna vaccine, as they are still awaiting critical data and will likely not meet the target date.

Moderna did not provide adequate data for the FDA and CDC to recommend the booster shot, according to one Biden administration official. The FDA requested additional data which will likely delay the third dose until October.

For more reporting from the Associated Press, see below.

Moderna Vaccine
FDA and CDC recommendation for a third shot of the Moderna vaccine is not expected until October. A nurse draws a vaccine dose from a vial as residents receive their second dose of the Moderna coronavirus vaccine at the Cameron Grove Community Center on March 25, 2021 in Bowie, Md. Win McNamee/Getty Images

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 CDC and FDA.

Pfizer, which is further along in the review process than Moderna, 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 Sept. 20. A key FDA panel is to review Pfizer's data on boosters on Sept. 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."

"We are awaiting a full review and approval by the FDA and a recommendation by the ACIP," said White House spokesman Chris Meagher, referencing the CDC's Advisory Committee on Immunization Practices. "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."

Even before Biden's announcement last month, his administration had been preparing for months for the possibility that boosters would be required, maintaining America's supply of doses and devising promotion plans with the same "intensity" that it brought to the initial vaccination campaign, Zients told reporters Thursday.

Biden on Aug. 18 touted boosters as a protection against the more transmissible delta variant of the virus, which is raging across the country and slowing the economic recovery from the pandemic, as well as potential variants to come.

"Just remember, as a simple rule — rule: Eight months after your second shot, get a booster shot," he said then, adding that health experts were aiming to be ready to administer them by Sept. 20, pending approval by the regulatory agencies.

Dr. Anthony Fauci, the nation's top infectious disease expert, has become an outspoke champion of the booster campaign, as the Biden administration looks to curtail the delta variant.

He told reporters on Thursday he believes it is likely that Americans will all need to get a third dose of the mRNA vaccines to be considered fully vaccinated against COVID-19.

"From my own experience as an immunologist, I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses," he said.

A formal determination that the third dose is required for "full vaccination" would have broad implications for schools, businesses and other entities that have implemented vaccination mandates.

Booster Shot
Biden's plans to start delivering booster shots by Sept. 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, Sept. 3. In this April 26, 2021 file photo, a nursing student administers the Moderna COVID-19 vaccine at a vaccination center at UNLV, in Las Vegas. John Locher, File/AP Photo