Or “phase III with Taiwanese characteristics” (and sorry if we forget to supply all of the technical documents, but there’s so many!).
I’m not even confident that immunobridging would count as phase II according to the standard definition…
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I’d like to know of a similarly sharp decrease anywhere else on the planet. If anyone knows of any, please share.
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Is that New Zealand?
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Some time after Taiwan’s outbreak I encountered that graph on the 'net, and I thought, They had a tough time at first, but it looks like they got a handle on things. And I thought, Maybe Taiwan can, too.
Singapore
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So I have to apologize to Medigen, it turns out they were upfront with their phase III trial being an immunobridging trial and not a typical blinded comparative phase III trial like I had assumed.
“And Medigen says the test will be carried out through immunobridging to compare the vaccine’s overall level of protection with that of the AstraZeneca vaccine.”
If anyone is interested, I did a little digging to find out what current views are on Phase III trials now that vaccines are available. This article while a little dated is pretty detailed and goes over many options, but does not include immunobridging.
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But isn’t this by definition counter to what the industry considers a “Phase III trial” to be?
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Nice one!
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Yes, but the statement they released was not misleading, it clearly stated that it was an immunobridging study.
I made an assumption when they said they were conducting a Phase III that they were conducting a blind comparative study, since that is what has been done in the past when a blind, placebo trial has been considered unethical or impractical.
A blind comparative study gives two different vaccines to two different groups and then monitors each groups outcomes, then compares how many people contracted the virus in group A versus group B to determine which is more effective.
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I guess the question is: has an immunobridging study ever before been considered a “Phase III trial” that was used to approve a vaccine for use (full or emergency use) in a developed country?
4 posts were merged into an existing topic: Questions and Answers about how to get the Coronavirus Vaccine
Don’t get into experimental design nuances. It’ll make his head ‘esplode.’
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My vaccine card doesn’t have the batch number for my first dose
It’s it possible to get this batch number added retroactively, for travel in Europe?
LOL “experimental design nuances.”
Name a single vaccine that that has been approved for use (emergency or full) in a developed nation based on a “Phase III” trial that was based exclusively on immunobridging when it’s in a class of vaccine for which there isn’t already an approved vaccine.
You won’t find one.
No subunit protein vaccines have been approved yet for COVID, so seeking approval on the basis of a bridge to vaccines in other classes is not legitimate.
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Good work, Taiwan. Crushing the curve on one hand, vaccinating ASAP in spite of political obstacles on the other.
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