Because in US, the @US_FDA is THE gatekeeper making sure the drugs we take & tests we use DO work & are safe
FDA makes decisions based on data PROVIDED TO THEM
As far as safety goes, FDA is the BEST DEFENSE the population has against dangerous biological products.
2/
There are a few things to consider:
If the FDA IS endorsing something w an EUA or an approval, you can be pretty darn sure it works AND is safe when used as intended.
FDA is THE REASON ppl in US can go to CVS, pick something up, read the label & safely use the product.
3/
This added safety comes at a cost. And that cost is Time
It is time to collect sufficient data, get it to FDA & allow FDA to make a determination
In the middle of a pandemic, when time is a deadly enemy, it can be easy to be angry every time FDA doesn’t turn on a dime
4/
There is definitely a period over which the FDA MUST be allowed to do it’s job & maintain the safety of our tools
Certainly when time is deadly bc a raging new pandemic, and data is abundant, fast work at FDA is needed
But now Omicron is v new! FDA doesn’t have data yet.
5/
Believe me - you do NOT want the processes of the FDA eroded.
Yes the FDA should be more nimble. Absolutely. Not disagreeing at all.
But you DO want the FDA to be bolstered - to be offered more resources during the pandemic. @POTUS and @NIH are doing this Right now.
6/
Telling US public not to go against directions is the *right* thing to do
We don’t want to erode trust in the FDA and FDA wants to maintain trust in safety.
Is it always biologically optimal? No. Testing is center of that story!
But in exchange we get long term safety
7/
So I am in absolute full agreement with @US_FDA on this message
This is the right call. FDA doesn’t have the data to support any change and their responsibility is the safety of Americans
FDA is accelerating collection of new data on swabs w NIH. This is huge progress.
8/
This is new. Its not time to be angry but to recognize that in return for time, FDA is staying off a slippery slope of eroding safety of all that has been authorized
We have good tests. Can they be better? Maybe, but not at expense of getting on slippery slopes around safety
9/
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@phil_luttazi The global exit strategy from this pandemic is/always has been the building up of immunity
This virus will never disappear and herd immunity to eliminate is not a thing for a virus like this
So we are stuck with effectively one option (with multiple paths to get there)
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@phil_luttazi We must build up a sufficiently robust and diverse immune response so that the importance that this virus has in our lives falls lower and lower.
As adults we are on the same steep learning curve that babies are on in early life. But doing this as adults is risky business
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@phil_luttazi However, we have no choice. The virus is with us and just like the other viruses we contend with as babies, it’s not going away.
So it would be foolish to assume that vaccination is our only approach to building immunity when we have a virus that will cycle for our lifetimes
3/
My family is spread across the US - In past few weeks, every single house has had multiple people w COVID
It's a bumpy road and we're taking a particularly rough path with a lot of casualties
But we are building up the layers of immunity to grow out of this virus' grip on us.
Regarding building "Layers of Immunity"
Think about immunity like studying for a test
Read a textbook. Each time, you reinforce formed memory & you see something new too! Some small but useful detail
Immune memory can be considered simply - very much like regular memory
Even though the vaccines aren't stopping transmission (they were never meant to. Herd immunity shouldn't have been seen as an option) the vaccines ARE working to do EXACTLY what they were meant to do - stop disease
@awyllie13 Numerous reports show saliva comes up earlier and w Omicron there have been MANY anecdotes that throat swabs (which interact with saliva!) are turning positive BEFORE nasal swabs
And this pre-print suggests people are infectious when saliva turns positive
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Importantly, people are becoming symptomatic really fast too! As this study suggests
So we can use this to our GREAT advantage...
If beginning to feel Symptomatic - ASSUME positive, ASSUME infectious