Page 2 - Being Proactive News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Data will be available to the public as well. but what the fda did proactively is they asked the company to look at the data and here's why they did that. here's what changed between december and now, john. we had the omicron wave and that meant we had millions more children who were infected and many who ended up in the hospital, it turns out that also generated new clinical data in the trial, the fda wants to look at that data and to understand does that mean this vaccine, two doses, is safe and effective for kids. if it is not, they're not going to recommend it for children yet. if it is, t...

That comes in, but the fda was not saying what the conclusion would be. they wanted the opportunity to look at the data and to make an assessment. and when they looked at that, the data, their assessment was that, we need to wait and get more data to feel confident that this is -- meets the standards for authorization. so that's what happened. and it's actually an example of the fda being proactive, which is what you want the fda to do during a pandemic, but it's also an example of the fda not compromising on its standards. it knows it's the gold standard for safety and efficacy, and until tha...

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