Democrat President Joe Biden’s chief medical advisor Dr. Anthony Fauci has claimed that federal health officials “don’t have time” to complete clinical trials before approving the latest COVID-19 booster shots for public use.
“We don’t have time to do a clinical trial because we need to get the vaccine out now,” Fauci said during an appearance on CBC this week.
Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID), argues that 400 Americans are dying per day from COVID-19 and thousands of others are in hospitals with the disease.
The updated boosters, produced by pharmaceutical giants Pfizer and Moderna, were authorized for public use by the U.S. Food and Drug Administration (FDA) on August 31.
Following FDA authorization, the shots were subsequently recommended for virtually all Americans 12 and older by the U.S. Centers for Disease Control and Prevention (CDC).
Both booster shots contain elements of the BA.4 and BA.5 virus variants.
There is no human data available for the formulations.
Pfizer and Moderna presented data on preclinical testing.
This testing was only done on mice.
They also referenced human data for a different formulation, based on different strains of the virus.
Since BA.5 is the dominant variant in the United States, “you have every reason to believe that [the updated formulation] is going to be better than having a vaccine that isn’t highly specific to the circulating strain,” Fauci insists.
“That hasn’t been proven in a clinical trial,” he admitted.
Fauci isn’t part of the U.S. regulatory or recommendation process on vaccines but his comments are followed closely by millions of Americans, who see him as the vaccine “czar.”
The institute he heads runs clinical trials and does other work.
Fauci’s comments echo those of other top U.S. officials, including CDC Director Dr. Rochelle Walensky.
During an appearance on “Conversations on Health Care” broadcast on August 29, Walensky warned that waiting for human data would leave the boosters outdated.
“If we wait for those data to emerge in human data, not just mice data, we will be using what I would consider to be a potentially outdated vaccine,” she said.
However, Officials have been hedging on how well they think the boosters will work.
“The idea here is not just to increase the antibodies right now, but also to hopefully give us a longer duration of protection because the hope here is not to have to give lots of vaccines each year,” Dr. Peter Marks, a top FDA vaccine official, told reporters in a call after the agency authorized the boosters.
Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health, blasted Fauci’s remarks.
Risch warned that Fauci’s comments were “reckless” in light of the fact that regulators didn’t rush to have vaccine companies update the vaccines during previous periods, such as when the Delta variant was dominant in 2021.
He also criticized Walensky’s remarks.
Risch points to how the CDC’s variant monitoring shows that BA.4.6, which is not part of the updated boosters, is growing in proportion in recent weeks.
“By the time that a supposed new winter wave of infections would occur in late November or December, it will likely be BA.4.6 and the new booster will be outdated anyway,” Risch said.
Even if BA.5 were still dominant in the future, the duration of benefit will likely not be much better than the current booster, which only provides an increase in protection for several weeks, Risch added, referencing a study published in the New England Journal of Medicine.
Data the CDC presented during a recent meeting also showed that vaccine effectiveness is down significantly against Omicron and its subvariants, which include BA.4.6 and BA.5, including against severe disease.
While some experts have said they support how the United States authorized the new boosters with a dearth of data, others have said that the decision wasn’t warranted.
“Basically, we’re playing in a sandbox of unknown benefits and unknown risks, because they don’t have clinical trials,” Dr. Vinay Prasad, an epidemiologist at the University of California, San Francisco, said in a video.
The United States should have required randomized, controlled trials before clearing the boosters, he added.