Dr. Anthony Fauci is claiming that there wasn’t enough time to wait for clinical trial data before clearing updated COVID-19 booster shots.
“We don’t have time to do a clinical trial because we need to get the vaccine out now,” Fauci said on the Canadian Broadcasting Corp. last week, pointing to how about 400 Americans are dying per day with COVID-19 and thousands of others are hospitalized with the disease.
The updated boosters, made by Pfizer and Moderna, were authorized by the U.S. Food and Drug Administration on Aug. 31 and subsequently recommended for virtually all Americans 12 and older by the U.S. Centers for Disease Control and Prevention (CDC).
Both shots contain elements of the Wuhan, BA.4, and BA.5 virus variants. No human data was or is available for the formulations. Pfizer and Moderna presented data on preclinical testing, done on mice. They also referenced human data for a different formulation, combinations of the Wuhan and BA.1 strains.
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 said. “That hasn’t been proven in a clinical trial.”
Fauci, the director of the National Institute of Allergy and Infectious Diseases and the White House’s chief medical adviser, isn’t part of the U.S. regulatory or recommendation process on vaccines but his comments are followed closely by millions of Americans. The institute he heads runs clinical trials and does other work.
Fauci was echoing other top U.S. officials, including CDC Director Dr. Rochelle Walensky.
Walensky said on “Conversations on Health Care” during a segment broadcast on Aug. 29 that waiting for human data would leave the boosters outdated.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for those data to emerge in human data, not just mice data, we will be using what I would consider to be a potentially outdated vaccine,” she said.
Officials have been hedging, though, 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 emeritus of epidemiology at the Yale School of Public Health, said that Fauci’s comments were hypocritical because randomized, controlled trials (RCTs) were required for the original vaccines, when the mortality of the virus was much higher.
“That is, he demanded RCTs when viral mortality was high, i.e., big emergency need, but didn’t require RCTs when [there was] little emergency need,” Risch told The Epoch Times in an email.
He also criticized Walensky’s remarks, pointing to how the CDC’s variant monitoring shows that BA.4.6, which isn’t 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 presented by the CDC 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.