The Lancet paper argues that vaccine-based protection against severe covid is still strong, while evidence is lacking that booster shots will be safe and effective. University of Florida biostatistician Ira Longini, a co-author on the Lancet paper, said it would be “immoral” to begin widespread boosters before the rest of the world was better vaccinated. As the disease continues its global spread, he noted, it is likely to develop deadlier and more vaccine-evasive mutants.
Longini was also skeptical of an August study, which Israeli scientists are to present to the FDA on Friday, that NIH officials had touted as strong evidence in support of boosters. On an Aug. 24 call with Israeli officials, Fauci urged them to publish that data, and a version appeared in the New England Journal of Medicine on Wednesday.
That study found that people receiving a third dose of the Pfizer-BioNTech vaccine were 11 times more likely to be protected from covid infection than those who had gotten only two doses. But the study observed people for less than two weeks after their booster vaccinations kicked in. Biostatisticians felt it had irregularities that raised questions about its worth.
“I don’t want to say the study isn’t correct, but it hasn’t been reviewed and there are possible biases,” said Longini, who helped design the 2015 trial that resulted in a successful Ebola vaccine and now works on global covid vaccine trials.
Fauci emphasized that no single study or piece of data led Biden or the members of the White House covid response team to conclude that boosting was necessary. The compilation of evidence of waning immunity combined with reams of research was a factor. Now the crucial decisions are in the hands of the regulators, awaiting the FDA and CDC’s judgment on how the nation should proceed.
“It isn’t as if,” Fauci said, “one day we’re sitting in the Oval Office saying, ‘You know, Mr. President, I think we need to boost.’ And he says, ‘Tony, go ahead and do it.’ You can’t do it that way. You’ve got to go through the process.”
Journalist Nathan Guttman contributed to this report.
This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
[Update: This story was revised at 12:30 p.m. ET on Sept. 16, 2021, to add comments from Dr. Robert Seder, a senior investigator for the National Institutes of Health.]
