Dr. Marion Gruber and Dr. Philip Krause are apparently resigning from the Food and Drug Administration in protest over the Biden administration’s push for a COVID-19 vaccine booster.
Gruber is the director, and Krause the deputy director of the FDA’s Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research. In a recent article in the British medical journal the Lancet, they write, “Current evidence does not … appear to show a need for boosting in the general population.”
They are far from alone. Many scientists who have looked at the research conclude that at this point, there is little evidence supporting the need for a booster other than for the immunocompromised and possibly the elderly population.
Studies from Israel, Qatar, Pfizer, and the Centers for Disease Control and Prevention have found that the effectiveness of the initial two doses of the COVID-19 vaccines do wane over time. However, the effectiveness wanes against infection and not necessarily against severe COVID-19, which can lead to hospitalization and death.
Of course, one can reasonably ask why the U.S. shouldn’t administer third vaccine doses to increase protection against infection.
But Jeffery Morris, professor of biostatistics at the University of Pennsylvania, notes that the testing conducted in much of the research is on people who have no COVID-19 symptoms. So, the tests are picking up a lot of asymptomatic infections.
“There are studies that have shown that asymptomatic disease does not transmit as much as symptomatic,” said Morris. “So, if what boosters are primarily doing is preventing a bunch of asymptomatic infections, they might not be doing much good at all.”
Koen Pouwels, a researcher at Oxford who was the lead author on a paper that found vaccines were less effective against the delta variant, mentioned another important reason why protecting against infections was not an adequate reason to support boosters.
“Booster policy shouldn’t be based on declining antibodies or reductions in protection against infection,” Pouwels said. “Protection against severe disease should drive that decision, especially given that there is a limited stock of vaccines and several low-income countries have many people who didn’t have the opportunity to get vaccinated yet.”
Every booster given in the U.S. or any other nation delays vaccines going to people in other areas of the world who have not yet been vaccinated. Since the virus can move globally, getting as many people vaccinated worldwide will be key to getting the pandemic under control.
A much better case for boosters rests on whether vaccine effectiveness against severe COVID-19 wanes. The research on that is, thus far, mixed. Research from the CDC found that vaccines were 86% effective against protecting hospitalizations at three months and 84% effective at about six months, an insignificant difference. A paper from Israel found that effectiveness against severe COVID-19 dropped among those who had received their second dose in January compared to those who had received it in March.
Another paper using data from Israel, where the government has initiated a booster campaign, found that booster shots substantially increased protection against severe illness.
Morris took a deep dive into booster data from Israel and initially found that booster shots provided no added protection against serious disease or death when compared to those who had been vaccinated but received no booster. Yet, when he broke down the data by age, he discovered that boosters provided no added protection for people under age 60 but did provide added protection for those over age 60.
At present, Morris doesn’t see much evidence to support a booster for most people, although he added a caveat.
“It depends on what your health objective is,” he said. “But it might make sense with a delta surge, where the variant carries a high viral load and moves quickly.”
Since a booster will increase the antibodies that fight infection, boosters might be worth doing during a surge.
Otherwise, he’s not yet convinced it is a good idea beyond helping the immunocompromised and possibly the elderly.
“But as a long-term strategy, does it really make sense to try and keep the levels of antibodies super high in everybody’s blood all the time, indefinitely? That makes no sense.”
