THURSDAY, April 7, 2022 – Outlining a daunting timeline for development of any updated coronavirus vaccine for next fall, federal health officials told an expert advisory panel on Wednesday that clinical trials of potential candidates would have to begin by next month, and a final formula chosen by June, to meet that tight deadline.
The assessment came during a daylong meeting of outside advisers to the U.S. Food and Drug Administration, who met to discuss what the nation’s COVID vaccine policy should look like moving forward.
But time is of the essence.
While numerous clinical studies of retooled shots are ongoing from vaccine manufacturers and the U.S. National Institutes of Health (NIH), they are too small to provide the kind of efficacy data that were produced for earlier vaccines, The New York Times reported.
Once larger trials are completed, vaccine manufacturers would need several months to produce hundreds of millions of doses of a reconfigured vaccine, Robert Johnson, director of an infectious disease division within the U.S. Department of Health and Human Services, told the panel.
“If you’re not on your way to that clinical trial by the beginning of May, it is very difficult to have collectively across manufacturers enough product to meet that demand,” Johnson said, the Times reported.
Dr. Peter Marks, who oversees vaccine regulation for the FDA, agreed that decision on a fall vaccine was needed by May or June.
But vaccine experts are still guessing at what the ever-changing pandemic will bring.
Questions include whether new variants will emerge and, if so, whether they will change the virus substantially. Many experts think another surge is likely this fall. Another question is how to modify existing vaccines so they work better.
Trevor Bedford, a biostatistician at the Fred Hutchinson Cancer Research Center, said during the meeting that the coronavirus has been mutating far faster than the flu virus, which has a redesigned vaccine every year, the Times reported.
Booster shots were also discussed during the gathering: Sharon Alroy-Preis, director of public health services for Israel’s Health Ministry, described Israel’s experience with a second booster shot for people ages 60 and older.
Last week, the United States followed suit and authorized a second booster for Americans ages 50 and older. The CDC recommended the second booster for anyone 65 and older and people ages 50 to 64 with underlying health conditions.
While Marks said the FDA did not consider the second booster to “be a major expansion or change,” Dr. James Hildreth, president of the Meharry Medical College in Tennessee, asked why the FDA did not seek the advice of a panel it had convened to discuss future vaccine policy, the Times reported.
Jerry Weir, a senior FDA official, said the agency expects to ask the advisory panel to review any reconfiguration of existing vaccines before a future emergency authorization.
The meeting also included Dr. John Beigel, a clinical research director at the NIH, who described a new study designed to compare how well Moderna’s existing vaccine works when stacked against modified versions meant to target known variants, either on their own or in combination, the Times reported.
The study will include enrolling 600 volunteers who have received their vaccines and a booster. Some will be given a dose of the existing vaccine. Others will get experimental vaccines that target the Omicron variant, Omicron plus the Beta variant, the Delta variant and a prototype virus that emerged first in the pandemic. Results may be ready by mid-summer, Beigel said.
- The New York Times
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Posted April 2022