FDA Panel’s Endorsement of COVID-19 Vaccine Boosters Makes Sense, Experts Say

Vials of Johnson & Johnson's COVID-19 vaccine are seen in Culver City, Calif., on Aug. 5, 2021. (Patrick T. Fallon/AFP via Getty Images)

The recent advisory panel endorsement of boosters of the Moderna and Johnson & Johnson COVID-19 vaccines was a good decision, experts told The Epoch Times.

“The recommendations are following the evidence that we have and I’m pretty comfortable with what they’re moving forward with. It makes sense,” said Dr. Michael Saag, professor of medicine and infectious diseases at the University of Alabama Birmingham.

“For the most part, I think their recommendations are reasonable,” added Dr. Tom Russo, professor and chief of infectious disease at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences. “The boosters are going to be beneficial.”

The Vaccines and Related Biological Products Advisory Committee, which advises the Food and Drug Administration (FDA), last week recommended the agency allow tens of millions of Americans to get a Moderna booster and approximately 15 million others get a second shot of the Johnson & Johnson vaccine.

Both votes were unanimous.

They came after the same panel advised the FDA to widen the emergency use authorization (EUA) for Pfizer’s vaccine to allow more people to get a booster. The agency took up that recommendation. When the Centers for Disease Control and Prevention (CDC) on Sept. 24 agreed, some 20 million Americans could get a booster if they received a primary Pfizer regimen and at least six months had elapsed.

Some panel members expressed concern about the scant data presented by FDA scientists and the vaccine makers and the fact that much of the Johnson & Johnson data was not independently analyzed by the FDA.

But even they ultimately said it was sufficient to signal a need for boosters, particularly since the pandemic has not ended.

“The data itself is not strong but it is certainly going in a direction that is supportable of this vote,” said Dr. Patrick Moore, a temporary voting member and a professor at the University of Pittsburgh Cancer Institute.

“The data are not perfect but these are extraordinary times and we have to work with imperfect data,” said Dr. Eric Rubin, a temporary voting member who is the editor-in-chief of the New England Journal of Medicine.

Booster supporters point to evidence showing waning protection among many against infection by the CCP (Chinese Communist Party) virus, which causes COVID-19, and waning protection against hospitalization among the elderly. The FDA says that drop in protection could portend a similar drop in younger people.

The agency authorized Pfizer and Moderna boosters for the immunocompromised, or about 2.7 percent of U.S. adults, in August and such boosters are now recommended by the CDC. That population largely did not see a detectable antibody response to two doses, according to some studies.

For the wider EUA, Pfizer presented data on just 318 booster recipients while Moderna’s data centered on just 171 participants. Johnson & Johnson shared data primarily from one clinical trial, which saw over 8,500 participants get a booster dose and about 6,000 monitored more closely for safety effects.

Vials of the Pfizer and Moderna COVID-19 vaccines are seen in Jackson, Miss., on Sept. 21, 2021. (Rogelio V. Solis/AP Photo)

Moderna and Pfizer boosters are now authorized or set to be authorized for everybody over age 65 and people between the ages of 18 and 64 who are deemed “at high risk of severe COVID-19” or whose “frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19.”

A second dose of Johnson & Johnson’s vaccine should be made available to anybody, regardless of age or underlying conditions, who got or gets an initial dose, the panel said.

“I think there’s clear evidence that that will boost the immune response and provide better protection against infection, and probably serious COVID-19 infections, with acceptable risks,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, told The Epoch Times.

The data generated in trials was somewhat limited and likely not sufficient for approval but was sufficient for a wider emergency use authorization, Carome added. “That’s the nature of emergency authorizations,” he said. “We do ultimately think it’s going to be important to collect more safety information.”

Carome’s group was against allowing anybody to get a Pfizer booster, which was pushed for by top Biden administration officials before the panel rejected the proposal, leading to the more narrow set of recommendations.

Whether everybody should get a third dose of a Pfizer or Moderna vaccine remains unclear, Dr. Peter Gulick, an associate professor of Medicine at the College of Osteopathic Medicine at Michigan State University, told The Epoch Times.

“That’s a good question. I don’t have any real answer for that,” Gulick said.

Many experts say that while boosters may be beneficial in select cases, what remains most important is getting COVID-19 vaccines to people who are still unvaccinated. Although there are experts who argue that includes people with prior infection—that group enjoys some immunity against the CCP virus—others don’t agree and point to studies that indicate natural immunity often provides protection similar to or better than vaccination.

Moving forward, there remains a strong possibility that COVID-19 shots will become annual, similar to the influenza vaccines.

“Boosters are going to become the norm,” Saag said, “and we'll probably be dealing with this for the next five to 10 years.”