An FDA advisory panel meeting tomorrow could start a reset of how the U.S. approaches its COVID-19 vaccine strategy. Driving the news: Agency officials have sent signs they want to move from the on-the-fly response that's, at times, left the public confused to an annual vaccination schedule that more closely mirrors flu vaccines. - They will also consider the process for determining when it makes sense to update the vaccines against emerging variants, per an FDA briefing document.
"It signals an idea of thinking for a longer-term horizon," Jason Schwartz, an associate professor at the Yale School of Public Health, who is not on the panel, told Axios. Yes, but: Experts on the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, have serious questions about the reboot — and whether they have sufficient data to support it. - "I'd like to see some data on the effect of dosing interval, at least observational data," Eric Rubin, editor in chief of the New England Journal of Medicine and a committee member, told the New York Times. "And going forward, I'd like to see data collected to try to tell if we're doing the right thing."
- Previous recommendations may have been too broad and didn't sufficiently focus on on high-risk individuals, such as the elderly or those with pre-existing health conditions, committee member Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told Axios.
- "I think by giving a blanket recommendation for everyone over six months of age, we diluted that message," Offit said.
The big picture: CDC and FDA officials will present an update on the effectiveness and safety of the original and booster versions of the approved COVID vaccines. What to watch: A key question is whether the committee continues backing bivalent booster doses, which are based on the original COVID strain and a later variant — or if the shots should only match the latest strain in circulation. Go deeper. |
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