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

[Anonymous]

My friends want the vaccine when it gets the normal approval. Presumably higher safety standards must FIRST be proven.

[Anonymous]

Anonymous wrote:My friends want the vaccine when it gets the normal approval. Presumably higher safety standards must FIRST be proven.

It will be eventually. There are literally hundreds of millions of doses administered and the problems are almost nil.

Full approval is a formality at this point. Get your shot early, if you can.

[Anonymous]

To get full approval, known as a Biologics License, companies will need to submit six months of data. Both Pfizer and Moderna say they now have six months of data. Approval is a much faster process than Authorization.

So

1) it will happen very soon
2) you need new friends

[Anonymous]

PP here I should also clarify

3) It does not require higher safety standards must first be proven, just more data
4) you need new 'friends'

[Anonymous]

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

[Anonymous]

Anonymous wrote:To get full approval, known as a Biologics License, companies will need to submit six months of data. Both Pfizer and Moderna say they now have six months of data. Approval is a much faster process than Authorization.

So

1) it will happen very soon
2) you need new friends

m



Very wrong on #2 and can't wait to see it approved.

[Anonymous]

Anonymous wrote:PP here I should also clarify

3) It does not require higher safety standards must first be proven, just more data
4) you need new 'friends'

5) perhaps you need to not live in fear and think for yourself

[Anonymous]

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

[Anonymous]

Anonymous wrote:

Anonymous wrote:To get full approval, known as a Biologics License, companies will need to submit six months of data. Both Pfizer and Moderna say they now have six months of data. Approval is a much faster process than Authorization.

So

1) it will happen very soon
2) you need new friends

m



Very wrong on #2 and can't wait to see it approved.

IF? Nothing has changed significantly in terms of the efficacy or the side effects over the last 4 months. Its not an if question. Perhaps your ignorance shows that I am wrong on #2, it just means we won't ever be friends

[Anonymous]

Anonymous wrote:

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

So it isn't good if there are treatments for Covid? Hmmm that's weird.

[Anonymous]

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

"Approval" = we do not yet have the timeline's worth of data we determined should be done in typical times

Emergency Use "Authorization" = this is an emergency and we have sufficient information to allow use while we continue to gather data along the typical timeline that we set outside of emergencies

Note that with a pandemic, you can gather large N numbers in a highly accelerated way, because so many people are being exposed at once and are willing to join trials. However, although you can look at tens of thousands of people more quickly, you can't look at them for 6 months until 6 months has passed. it also doesn't speed up other aspects of full approval, such as detailed examination of manufacturing plants -- there are only so many people trained to do the inspections, and there are physical limitations to how fast you can accurately assess things.

[Anonymous]

Anonymous wrote:

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?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

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

So it isn't good if there are treatments for Covid? Hmmm that's weird.

?? Treatment isn't an adequate alternative to a vaccine if there is documented reinfection (there was, genotyped) and significant morbidity associated with the illness despite treatment (this, too).

This isn't finger warts, PP.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

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?

it should and it will. Pfizer and Moderna both just crossed that threshold. What will your excuse be once they are approved?

[Anonymous]

Anonymous wrote:

Anonymous wrote:

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?

How long do you think it takes to analyze that much data and pull together an analysis with full discussion section? Honest question.