Increasing vaccination rates
There was broad consensus about the need to boost public support for COVID-19 vaccinations. While about 81% of the U.S. population has had at least one dose of this vaccine, only 15.3% have had an updated bivalent booster dose, according to the CDC.
“Anything that results in better public communication would be extremely valuable,” said committee member Henry H. Bernstein, DO, MHCM, of the Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, N.Y.
But it’s unclear what expectations will be prioritized for the COVID vaccine program, he said.
“Realistically, I don’t think we can have it all – less infection, less transmission, less severe disease, and less long COVID,” Dr. Bernstein said. “And that seems to be a major challenge for public messaging.”
Panelists press for more data
Other committee members also pressed for clearer targets in evaluating the goals for COVID vaccines, and for more robust data.
Like his fellow VRBPAC members, Cody Meissner, MD, of Dartmouth’s Geisel School of Medicine, Hanover, N.H., supported a move toward harmonizing the strains used in different companies’ vaccines. But he added that it wasn’t clear yet how frequently they should be administered.
“We need to see what happens with disease burden,” Dr. Meissner said. “We may or may not need annual vaccination. It’s just awfully early, it seems to me, in this process to answer that question.”
Among those serving on VRBPAC was one of the FDA’s more vocal critics on these points, Paul A. Offit, MD, a vaccine expert from Children’s Hospital of Philadelphia. Dr. Offit, for example, joined former FDA officials in writing a November opinion article for the Washington Post, arguing that the evidence for boosters for healthy younger adults was not strong.
At the Jan. 26 meeting, he supported the drive toward simplification of COVID vaccine schedules, while arguing for more data about how well these products are working.
“This virus is going to be with us for years, if not decades, and there will always be vulnerable groups who are going to be hospitalized and killed by the virus,” Dr. Offit said.
The CDC needs to provide more information about the characteristics of people being hospitalized with COVID infections, including their ages and comorbidities as well as details about their vaccine history, he said. In addition, academic researchers should provide a clearer picture of what immunological predictors are at play in increasing people’s risk from COVID.
“Then and only then can we really best make the decision about who gets vaccinated with what and when,” Dr. Offit said.
VRBPAC member Ofer Levy, MD, PhD, also urged the FDA to press for a collection of more robust and detailed information about the immune response to COVID-19 vaccinations, such as a deeper look at what’s happening with antibodies.
“I hope FDA will continue to reflect on how to best take this information forward, and encourage – or require – sponsors to gather more information in a standardized way across these different arms of the human immune system,” Dr. Levy said. “So we keep learning and keep doing this better.”
In recapping the panel’s suggestions at the end of the meeting, Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research, addressed the requests made during the day’s meeting about better data on how the vaccines work.
“We heard loud and clear that we need to use a data-driven approach to get to the simplest possible scheme that we can for vaccination,” Dr. Marks said. “And it should be as simple as possible but not oversimplified, a little bit like they say about Mozart’s music.”
A version of this article first appeared on WebMD.com.