The Biden administration plans to offer updated versions of coronavirus boosters targeting highly transmissible omicron subvariants shortly after Labor Day, according to several media reports.
The new shots would be offered to all Americans 12 and older, and officials hope they will quell an expected winter surge in COVID-19 cases, The New York Times reported.
Dr. Peter Marks, the top vaccine regulator at the Food and Drug Administration, told the Times that, although the new formulations haven’t been tested in humans, he was “extremely confident” in data showing they are safe and effective. Marks added the FDA was close to authorizing the new vaccine boosters, saying they would target the omicron subvariants BA.4 and BA.5 that account for almost all of the new cases of COVID-19 in the United States.
Both Pfizer and Moderna have asked the FDA to authorize updated versions of their coronavirus boosters. Pfizer has asked regulators to approve its shots for those 12 and older, while Moderna has applied for use only in adults 18 and older.
Data from trials of the new formulations in mice have shown positive results. Some experts have cautioned vaccine makers to wait to put the new formulations into production until clinical trials are completed later this year. But Dr. Anthony Fauci, the nation’s top infectious disease expert, stressed to the Times that officials would move forward safely with the “totality of the evidence that we have.”
Fauci added that the flu vaccine is updated each year in a similar fashion. Moderna began a human trial this month, and Pfizer will follow suit in the coming days, with initial results expected later in 2022.
The Biden administration in June asked vaccine makers to tweak their inoculations to address the omicron strain, which has led to yet another massive surge in coronavirus cases nationwide. The White House has reportedly planned to focus its COVID-19 booster campaign on the retooled vaccines when they are available, rather than those already in circulation, to help combat Americans’ fatigue with round after round of shots and the pandemic writ large.
About 450 people are dying in the U.S. each day of COVID-19, many who remain unvaccinated or have serious underlying health conditions.
Fauci told the Times on Tuesday that the death toll was still deeply troubling considering the now widespread access is to vaccines and antivirals to treat the coronavirus.
“We have really got to do better to protect the American public,” Fauci told the publication. “We are in the middle of a BA.5 outbreak here, and we are nowhere near where we want to be.”
The Centers for Disease Control and Prevention will meet on Sept. 1 and 2 with its advisory panel of experts to decide if and when to roll out the new doses.