The next generation of COVID-19 boosters is being evaluated by the FDA.
As the agency works to make new, improved, boosters available in September to help prevent severe disease and save lives in the fall and winter, the approach is stirring debate.
The FDA is going to base its decision on whether to authorize new boosters on studies involving mice instead of humans.
"For the FDA to rely on mouse data is just weird, in my opinion," says John Moore. Mouse data can't be used to predict what humans will see.
Others argue that there's not enough time to wait for data from human studies and that the country has had enough experience with the vaccine to be confident that it's safe.
500 people die of coronaviruses every day. In the fall and winter, those numbers may rise. "Can we do something better?" is the question being asked by Dr. Levy. By implementing this approach, we can.
A new booster that targets both the original strain of the virus and the original omicron variant was approved by the UK.
The FDA did not approve of BA.1 bivalent boosters. Moderna, Pfizer and BioNTech were told by the FDA to develop bivalent vaccines that target the BA.4 and BA.5 subvariants in order to offer stronger, longer- lasting protection.
The FDA used a new strategy for testing the new boosters. Only the results of tests on mice will be submitted by the companies. The results will be used by regulators to decide whether to authorize the boosters.
Results from human studies will probably not be available until late October or early November.
The worry is that the boosters may not work as well as the data suggests. Experiments done on mice are unreliable.
With the government telling people not to get the old boosters now and rejecting the first bivalent vaccines, the FDA really needs good evidence that the BA.4/5 boosters are actually better.
The University of Pennsylvania's Paul Offit is an advisor to the FDA. Anything less than that is not acceptable.
The approach may further erode the efforts to convince people to get boosted.
Monica Gandhi is a researcher at the University of California, San Francisco. extrapolation may be considered too great if it isn't done otherwise.
The country can't wait for more evidence, according to others. Billions of people who have gotten Moderna and Pfizer-BioNTech are shown to be safe.
The new booster won't be the same as the original vaccine because it will contain genetic coding for two different versions of the vaccine's main component.
The flu vaccines are changed every year to try to match whatever strains are likely to be circulating but aren't routinely tested again every year.
"We're going to use all of these data that we've learned through not only this vaccine but decades of viral immunology to say that we're going to do those animal studies." We aren't going out too far on a limb here.
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