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Makary told CNBC on Wednesday that he’s “hopeful and optimistic” about the platform but would also “like to see the data.”
“We’re not going to get ahead of the game,” he said. “We’re going to basically say, we’d like to see the data, how far mRNA technology can be applied is a question where we’d love to see it applied, as far as it can be applied, but it’s got to meet our scientific standards, so we’ll see what it gets with cancer, with other infectious diseases. ...”
Reading the news, it seems that both FDA and Moderna/MRNA should share the blame (BTW, its ticker symbol matches mRNA).
Moderna may have become overconfident because of speedy emergency approvals of its Covid vaccines during the pandemic.
So, this time, it compared its mRNA flu vaccines only with the standard doses of the current flu vaccines. It sort of assumed that at higher senior doses (4x), it will also be effective for 65+. For Moderna, the mRNA flu vaccine is just a stepping stone for possibly its blockbuster combo flu + Covid vaccine.
In pharma, this practice seems common. So, a basic assumption is that most drugs will also work for kids at doses adjusted for weight and no new tests are required for kids.
FDA said, nothing doing, Moderna must also present separate data for 4x senior doses by comparing with existing 4x senior doses. And that seems to have developed as the face-saving compromise for both FDA and Moderna.
Remember how NIH had to fight to get patent co-rights with Moderna for its Covid vaccines.
I think it is more complicated than that because the Guardian reported that the FDA was aware and had no problem with using standard vaccine for the over 65 Control.
After all only 65 % of seniors get any flu shot and only half of those get the high dose.
So while the high dose is more effective than the standard in seniors, if you use standard care as the control you should pick some combination of "none" (but you could not randomly assign subjects to no flu shot) or standard.
An alternative design would be to mimic what happens in real life- randomly assign folks to new shot or "which one of the old shots do you want standard or high dose".
But with two comparison groups you would need more subjects to have a powerful enough study.
the real advantage to mRNA is not that it is necessarily more effective, but that it can be produced much faster and can combine several flu strain protein in to one shot more easily.
This looks like it was a bridge too far even for RFK, especially given the data that an mRNA cancer vaccine may be coming
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Moderna may have become overconfident because of speedy emergency approvals of its Covid vaccines during the pandemic.
So, this time, it compared its mRNA flu vaccines only with the standard doses of the current flu vaccines. It sort of assumed that at higher senior doses (4x), it will also be effective for 65+. For Moderna, the mRNA flu vaccine is just a stepping stone for possibly its blockbuster combo flu + Covid vaccine.
In pharma, this practice seems common. So, a basic assumption is that most drugs will also work for kids at doses adjusted for weight and no new tests are required for kids.
FDA said, nothing doing, Moderna must also present separate data for 4x senior doses by comparing with existing 4x senior doses. And that seems to have developed as the face-saving compromise for both FDA and Moderna.
Remember how NIH had to fight to get patent co-rights with Moderna for its Covid vaccines.
After all only 65 % of seniors get any flu shot and only half of those get the high dose.
So while the high dose is more effective than the standard in seniors, if you use standard care as the control you should pick some combination of "none" (but you could not randomly assign subjects to no flu shot) or standard.
An alternative design would be to mimic what happens in real life- randomly assign folks to new shot or "which one of the old shots do you want standard or high dose".
But with two comparison groups you would need more subjects to have a powerful enough study.
the real advantage to mRNA is not that it is necessarily more effective, but that it can be produced much faster and can combine several flu strain protein in to one shot more easily.
This looks like it was a bridge too far even for RFK, especially given the data that an mRNA cancer vaccine may be coming