Why is the USA dominating the vaccine race? (1 Viewer)

[the rover]

Obviously most of it was sarcasm, but you did say we have known the vaccine was safe and then criticized the federal response and we should have thought outside the box and mentioned millions of people signing up. 

I made an assumption you thought we should have given the vaccine to millions of people much earlier. 

Such a thing would have had a massive negative response from the public, media, and politicians all over. An even more negative response than the one we are already fighting to overcome. 

Do you think that there would be less of a negative response if Trump and his administration hadn't downplayed the virus, called it a hoax, eroded confidence in our own experts, the CDC and the NIH?   Do you think the negative perception of the vaccine may skew by party affiliation?

 

[IvanKaramazov]

This is another friendly reminder that people in the UK are currently the vaccine that our own FDA just can't be bothered to approve without an additional time for grandstanding.  

 

[IvanKaramazov]

Here's a good explainer if you don't understand why the FDA's foot-dragging is literally killing people.

Two to three thousand people a day are dying from COVID. Thus anything that delays rolling out a vaccine has a very high cost in human lives. People want to deny this, perhaps because it is so horrifying. I get a lot of pushback when I say that FDA delay is deadly. Let’s dispense with a few objections. It is true, of course, that the people who are dying today can’t literally be saved by a vaccine today but they could have been saved had they been vaccinated four or five weeks ago and similarly projecting forward.

Another response that many smart people tell me is that a vaccine can’t be rolled out immediately so even under the best scenarios you couldn’t save that many people immediately. That’s true but irrelevant. Since a lot of people are getting this wrong, I want to show this in a simple model using pictures. . . . 

 

[SoBeDad]

This is another friendly reminder that people in the UK are currently the vaccine that our own FDA just can't be bothered to approve without an additional time for grandstanding.  

I think the grandstanding is coming from some politicians, who didn't even promote social distancing or wearing masks a few months ago. After a concern about rare anaphylactic reactions in the UK, I've heard from some doctors that the info sheet given with the vaccine needs to be clarified and Pfizer needs to review it. Final approval is gonna happen tonight, and political pressure just erodes confidence. 

 

[IvanKaramazov]

I think the grandstanding is coming from some politicians, who didn't even promote social distancing or wearing masks a few months ago. After a concern about rare anaphylactic reactions in the UK, I've heard from some doctors that the info sheet given with the vaccine needs to be clarified and Pfizer needs to review it. Final approval is gonna happen tonight, and political pressure just erodes confidence. 

Counterpoint: Some politicians have spent the last several months screaming at people for visiting deserted beaches, taking their kids to playgrounds, and visiting their families during the holidays.  But the idea that maybe we might act with a sense of urgency in getting a vaccine approved is apparently a bridge too far.  

Again, the vaccine that we're talking about was developed over the course of two days in January.  About a quarter million Americans have died since then who likely would be alive today if there had able to take this vaccine.  If you're in favor of "let's take our time and not release this thing until we're absolutely positively sure that we've dotted every i and crossed every t," you are arguing that it was worth a quarter million lives to . . . do whatever it is we accomplished over the course of the last eleven months.  I respectfully disagree. 

 

[Shula-holic]

This is another friendly reminder that people in the UK are currently the vaccine that our own FDA just can't be bothered to approve without an additional time for grandstanding.  

Exactly.  Every day we wait, there will be thousands on the back end that will die.

 

[The Z Machine]

The issue for me, @IvanKaramazov, is that i don't have anywhere near the expertise needed to evaluate if the FDA is taking an unreasonably long time to approve drugs.

 

[parasaurolophus]

The issue for me, @IvanKaramazov, is that i don't have anywhere near the expertise needed to evaluate if the FDA is taking an unreasonably long time to approve drugs.

I am old enough to remember this FDA receiving lots of criticism for approving too many drugs too fast. 

If you look at the last several years approvals went up quite a bit.

I am also old enough to remember even Fauci in April saying 18 months would be optimistic for a vaccine. 

Were ANY articles written prior to us knowing it was 95% effective that things should be sped up? Like a single one?

 

[IvanKaramazov]

I am old enough to remember this FDA receiving lots of criticism for approving too many drugs too fast. 

I've literally never seen the FDA criticized for moving too fast.  I do remember reading articles 20 years ago about how the FDA is way too conservative relative to its counterparts in other developed nations.

 

[parasaurolophus]

I've literally never seen the FDA criticized for moving too fast.  I do remember reading articles 20 years ago about how the FDA is way too conservative relative to its counterparts in other developed nations.

Just do some searching for it they are there. Then look at the number of drugs approved annually and how many more in recent years are being approved. 

20 years ago was very different. 

And obviously the FDA isnt perfect. They have lots of problems. I try to think of ways to improve it and it gets real murky. We have a system in place where the FDA doesnt do the actual work for approvals. They have to comb through piles of data presented to them by outside parties that are super biased and want approval. 

They also need cooperation from the medical community at every turn. And if you think the FDA is stuck in molasses, you should hear some of the doctors that are on these adcomm panels. 

I will never forget when a discussion broke out during one of them because a doctor asked if the company had done any research on what would happen if somebody swallowed the whole blister pack. The company reps were like how tf are we supposed to handle that question?  

But a simple look at the number of biotech firms with drugs in development shows how impossible it would be to expand the FDA enough to be super involved at every level. 

So what do we do? How do we fix it? How do we make them less skeptical but ensure that they cant be defrauded? How do we keep the doctors and hospitals involved with the studies shielded from liability, bought in to the process, and unimpeachable by the companies wanting approval? It is really complicated. And it all naturally leads to delay. Why? Because time is essentially the one way to ensure all of it is as legit as possible. It is the one sure fire way that warts get uncovered. 

I wish the search function was working properly right now because I am pretty sure I mentioned the blister pack guy in the stock thread and I know I mentioned in one of the covid threads very early that this version of the FDA was the best we have ever had for approving something fast.

So much of the criticism right now just seems so revisionist history and 20/20 hindsight because we are pretty sure it is effective and safe. If people were banging the drum of feet dragging back in september it would be fairer. 

I would take this vaccine today in a heartbeat. I know millions of others would too. If they would pay me I would let them put me in a lab and throw creme filled coronavirus pies in my face to see if it works. 

I think that should be allowed. But I think that is a totally separate debate and one that would cause levels of outrage from the medical community. 

 

[Maurile Tremblay]

The founder of Moderna is an Armenian who was born in Lebanon and immigrated to the US via Canada.

Moderna's Chief Medical Officer is an Israeli living in the US.

The BioNTech/Pfizer vaccine developers are Turkish Muslim immigrants to Germany.

Pfizer's CEO is a Greek Jew.

Link.

"Immigrants, we get the job done!"