When will covid vaccines be done with the EMERGENCY approval status?

[Anonymous]

Bumping this to see if there's any news about full approval. I found an article online (can't link) which said Pfizer submitted for full approval in the beginning of May. The article also said that full approval could take up to 10 months to complete. I understand the EUA was enacted because it was an emergency. Many states are lifting their state of emergency orders. What happens if covid no longer qualifies as an emergency before full approval is granted?

[Anonymous]

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Anonymous wrote:So what’s the difference between “approval” and “authorization”, as far as vaccines are concerned?

emergency use authorization is granted when certain criteria are met, including there are no adequate, approved, and available alternatives. In this case, 2 months of data was required along with the fact that there was no adequate approved alternative.

approval requires 6 months of data

Tick tock. It's been 6 months. Should be approved any day no?

Yes, maybe by this afternoon.

So when the FDA waves its magic wand, will we see a jump in vaccination rate?

They will find something else...maybe they can start saying vaccines cause autism again.

Out of my family and circle of friends I was the first to line up for every other vaccine, flu, Tdap, hepatitis vaccines. I am not getting this one though, at least not until it has been approved for a year or so. Call me all the names you want, it’s help turning me off to the vaccines even more.

It’s totally true that the onslaught of threats and shaming in this country, is only making people more suspicious of the real agenda here.

The fing real agenda is to end the pandemic, which requires us all working together and shouldering the vaccine risk. We only get community spread down by vaccination or real lockdowns, and we already learned Americans can’t lock down to save their mother.

Until all the kids can be vaccinated that isn’t going to happen. I will wait until it’s approved for children since I am smaller than many children.

Me too. Does that matter? Do you mean approved for emergency use or full approval?

No. Vaccine dosing is based on the maturity of the immune system (roughly), not body weight or height.

[Anonymous]

Anonymous wrote:Bumping this to see if there's any news about full approval. I found an article online (can't link) which said Pfizer submitted for full approval in the beginning of May. The article also said that full approval could take up to 10 months to complete. I understand the EUA was enacted because it was an emergency. Many states are lifting their state of emergency orders. What happens if covid no longer qualifies as an emergency before full approval is granted?

Nothing. The FDA's emergency use authorization was not based on any particular state's declaration. It's based on HHS's declarations, and HHS isn't going to yank approval while Pfizer and Moderna's applications are pending. Becerra just renewed the COVID-19 public health emergency declaration in April, and I'd be shocked if he doesn't sign the next one in July, and then October (at least if the vaccine hasn't been formally approved).

[Anonymous]

Anonymous wrote:

Anonymous wrote:Bumping this to see if there's any news about full approval. I found an article online (can't link) which said Pfizer submitted for full approval in the beginning of May. The article also said that full approval could take up to 10 months to complete. I understand the EUA was enacted because it was an emergency. Many states are lifting their state of emergency orders. What happens if covid no longer qualifies as an emergency before full approval is granted?

Nothing. The FDA's emergency use authorization was not based on any particular state's declaration. It's based on HHS's declarations, and HHS isn't going to yank approval while Pfizer and Moderna's applications are pending. Becerra just renewed the COVID-19 public health emergency declaration in April, and I'd be shocked if he doesn't sign the next one in July, and then October (at least if the vaccine hasn't been formally approved).

What is the criteria for a national emergency? Things are improving rapidly here in the US.

[Anonymous]

It takes six months after applying under pressing conditions.
Otherwise it takes up to a year.
The trials will be done in 2023 but I think the placebo group has been allowed to get the vaccine, so I’m not sure how much it matters at this point.
I got the vaccine though. I’m not worried about vaccines - drugs are riskier.

[Anonymous]

Good grief! Now your angle is that you want to yank the vaccine because case counts have gone down.

Man up and go get your shot. You’ll likely get a free doughnut and other goodies. Join the rest of the normal population.

[Anonymous]

Anonymous wrote:Good grief! Now your angle is that you want to yank the vaccine because case counts have gone down.

Man up and go get your shot. You’ll likely get a free doughnut and other goodies. Join the rest of the normal population.

It's not that, just my mind wandering on this rainy afternoon.

[Anonymous]

I was told it may not be approved but they worry about mass panic. Not sure if that's true

[Anonymous]

Anonymous wrote:I was told it may not be approved but they worry about mass panic. Not sure if that's true

Come again?

[Anonymous]

Anonymous wrote:

Anonymous wrote:I was told it may not be approved but they worry about mass panic. Not sure if that's true

Come again?

Who told you this nonsense? The vaccines are almost certain to be approved. They are incredibly effective, and they have real-world data from millions and millions of people. Stop getting your news from randos on the internet.

[Anonymous]

They need to review the safety data for real now. And the number of adverse events is astronomical. So it will be a long time (if ever) it's approved. So much data and backlogged.

[Anonymous]

Anonymous wrote:I was told it may not be approved but they worry about mass panic. Not sure if that's true

Go take your medicine and get some rest. Tonight is pudding night, and we can give you chocolate if you're a good girl!

[Anonymous]

Anonymous wrote:They need to review the safety data for real now. And the number of adverse events is astronomical. So it will be a long time (if ever) it's approved. So much data and backlogged.

Astronomical? Under what metric? Did you do a sophisticated analysis comparing data to background rates as well?

[Anonymous]

It's up in the air, but delayed. I wouldn't hold your breath. And why does anyone care at this point? If you got it under EUA then you're done. If you didn't you can either wait for possible approval or not.

[Anonymous]

Anonymous wrote:

Anonymous wrote:They need to review the safety data for real now. And the number of adverse events is astronomical. So it will be a long time (if ever) it's approved. So much data and backlogged.

Astronomical? Under what metric? Did you do a sophisticated analysis comparing data to background rates as well?

No I didn't do a study. It's public knowledge. Have you been under a rock? You didn't think there have been adverse events? Probably because millions of people vaccinated at once but regardless they need to study each and every event which is in the thousands.