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Tue May 4, 2021, 08:23 AM

The FDA must give full approval on the vaccines.

It is making vax hesitant people think there could be something wrong.

Not that there is. But Jesussum chrissum, 200million people in US alone have taken the vaccines.

What is the hold up?

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Arrow 34 replies Author Time Post
Reply The FDA must give full approval on the vaccines. (Original post)
boston bean Tuesday OP
LisaL Tuesday #1
boston bean Tuesday #2
Ms. Toad Tuesday #19
Hortensis Tuesday #20
boston bean Tuesday #24
Ms. Toad Tuesday #25
boston bean Tuesday #26
Ms. Toad Tuesday #29
boston bean Tuesday #31
Ms. Toad Tuesday #32
boston bean Tuesday #33
Ms. Toad Tuesday #34
dsc Tuesday #3
RegularJam Tuesday #4
Elessar Zappa Tuesday #8
RegularJam Tuesday #16
tymorial Tuesday #5
BoringUsername Tuesday #9
RegularJam Tuesday #17
Claire Oh Nette Tuesday #21
RegularJam Tuesday #22
Claire Oh Nette Tuesday #27
RegularJam Tuesday #28
OneGrassRoot Tuesday #6
Orrex Tuesday #7
boston bean Tuesday #10
Orrex Tuesday #12
boston bean Tuesday #14
Orrex Tuesday #15
Claire Oh Nette Tuesday #30
mainer Tuesday #11
TraceNC Tuesday #13
former9thward Tuesday #18
forthemiddle Tuesday #23

Response to boston bean (Original post)

Tue May 4, 2021, 08:26 AM

1. It's a process.

Companies have to ask first. I am not even sure they asked for a full approval at this point.

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Response to LisaL (Reply #1)

Tue May 4, 2021, 08:27 AM

2. Yeah well, this is a problem.

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Response to boston bean (Reply #2)

Tue May 4, 2021, 12:25 PM

19. Science is not a problem.

There is a science-based process vaccines, medicines, etc. go through to minimize the risk that we don't encounter another DES, Thalidomide, routine annual X-rays (just to name a few).

We can't let policy or uninformed impressions dictate scientific outcomes.

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Response to Ms. Toad (Reply #19)

Tue May 4, 2021, 12:36 PM

20. This. Of course.

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Response to Ms. Toad (Reply #19)

Tue May 4, 2021, 02:44 PM

24. That is all good. 200 million americans s have received the vaccine including myself.

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Response to boston bean (Reply #24)

Tue May 4, 2021, 03:04 PM

25. And you (and I) chose to take part in a great science experiment.

I happen to think the benefits outweigh the risks.

But it is still, by the criteria we use to permit unfettered use - and in some instances mandated use - it is still an experiment.

Moving from experiment to approved is a science-based process. It should not be dictated by the whims of politics - because that requires us to trust the good intentions of whoever is holding political office. Pretty sure you would have been screaming bloody murder had Trump just mandated in approval of hydroxochloroquin, or even of vaccines.

As to the millions who have received the vaccine - that's all well and good, but we didn't receive the vaccine under controlled settings and not everyone's outcome was tracked. So while it seems logical that it should be safe, there is a large leap between putting shots in arms and proving that there aren't intermediate-term consequences. That data has to be gathered scientifically (not just by counting shots).

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Response to Ms. Toad (Reply #25)

Tue May 4, 2021, 03:07 PM

26. So, this reason for hesitancy is well founded.

Pfizer will be asking for full auth at the end of this month, I just read.

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Response to boston bean (Reply #26)

Tue May 4, 2021, 03:24 PM

29. For anyone paying attention to the science - there is reason

for a thorough evaluation (which I did before I chose to have the vaccine)

Both Pfizer and Moderna use technologies that are relatively new. There were (as of sometime in 2020) zero fully approved uses of mRNA in the US. (I am not aware of any currently approved uses, but once I found 2020 in response to a friend who asserted mRNA has been used as a delivery vector for medicnes decades I figured 2020 was close enough) Although there have been clinical trials, none were far enough along for FDA approval yet.

So we really don't know the long-term impact of using mRNA to trigger our bodies to create immunity (or even of just injecting mRNA into our bodies).

I am not aware of anyone who studies these things who expects there to be long-term consequences. But my guess is that people didn't expect annual X-rays (which my mother had growing up to have the long-term consequence of increased chest cancer risk {she has two breast cancers}, or that DES would create increased risk of cancer in the second generation, or that thalidomide would create children with no or severely deformed limbs).

We can only know what we can know - and the reality is that no one is far enough out from having mRNA injected (for any reason) to know beyond theoretical best guesses. I'm sure we still won't know by the time the FDA gives formal approval - but we'll have much more data about immediate side effects and mid-term side effects (6-ish months)

So we all have to make decisions based on our comfort with risks we have to balance - and our assessment of whether the known risks of COVID are greater than the unknown long-term risks (which are predicted to be zero).

I would be skeptical of anyone expressing hesitancy based on short-term effects. There is plenty of formal (and even more informal) data on that - but not if they are expressing hesitancy because of the unknown long-term effects.

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Response to Ms. Toad (Reply #29)

Tue May 4, 2021, 03:28 PM

31. It is long term effects they are saying is a concern. As the FDA has not approved fully.

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Response to boston bean (Reply #31)

Tue May 4, 2021, 03:40 PM

32. You don't need to tell them

that we still won't know long term effects for quite a few years (if there are any). If FDA approval convinces them, that's more vaccines in arms.

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Response to Ms. Toad (Reply #32)

Tue May 4, 2021, 03:41 PM

33. That is what I am saying. We need FDA full approval as soon as possible.

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Response to boston bean (Reply #33)

Tue May 4, 2021, 03:44 PM

34. Patence.

I doubt it will take much longer. We're in uncharted territory - but assuming they did it right this very large experimental use should give them data enough to gain full approval earlier than usual.

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Response to boston bean (Original post)

Tue May 4, 2021, 08:32 AM

3. Medium term studies need to be conducted that

test both safety and effectiveness in the future. I am not sure how long the time frame is, but I would imagine it is at least 6 months.

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Response to boston bean (Original post)

Tue May 4, 2021, 08:40 AM

4. Pfizer hasn't even filed for full approval.

They are expected to do so by the end of the month. I guarantee they are working as quickly as possible to do so as being granted approval will allow them to market directly to consumers. They authorized it for emergency use in very short order. Additionally, I do not see full approval as something that is going to shape hearts and minds when it comes to taking it. There is a lot of quality data out there right now competing with the conspiracy theories. That will not change once fully approved. What will change is how the vaccines are marketed, distributed, and pricing. Pfizers shot isn't even currently approved under the emergency order for all Americans.

I also don't think this is something that is going to be clear cut when it comes to messaging. Pfizer will most likely be applying for emergency acceptance of boosters at the same time they apply for full approval.

People will muddy the waters no matter the situation.

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Response to RegularJam (Reply #4)

Tue May 4, 2021, 10:01 AM

8. At least the military

and other organizations could make vaccines required if full approval is given.

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Response to Elessar Zappa (Reply #8)

Tue May 4, 2021, 12:06 PM

16. That is true. It could.

Considering the number of people currently unwilling to get vaccinated I don't see that as something that will be picked up in the private sector.

There is the possibility it might be required for the military, but that is not a given. It is probably a given that they will at least have targeted requirements.

It will help but will have almost zero impact on those being referenced by the op.

There are too many variables right now to understand how this will all work out. We just need people to get the shot right away. If for nothing else it will slow the potential for other variants.

Schools would be major if the vaccine has staying power. We are uncertain of that. It's probably going to take longer for younger age groups to be approved as just today upper middle and high school students were approved under the emergency order.

I do think Pfizer and the others being able to market it directly to the public might help. That can only happen with full approval.

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Response to boston bean (Original post)

Tue May 4, 2021, 09:07 AM

5. Full approval won't change anything.

It will happen but you won't see an uptick in rates nor will it convince skeptics. They don't believe the FDA plain and simple. They believe in conspiracy theory like shedding and other ridiculous anti-vax propaganda. They will not change unless they make a conscious decision to educate themselves with an open mind.

The only way to help convince them is for community and political leaders they trust help to convince them to overcome their skepticism and preconceived notions.

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Response to tymorial (Reply #5)

Tue May 4, 2021, 10:13 AM

9. Well, it will allow the military to force their people to take it

As someone else mentioned... and that's significant.

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Response to BoringUsername (Reply #9)

Tue May 4, 2021, 12:08 PM

17. That is a very small number of people, overall.

Almost statistically insignificant.

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Response to RegularJam (Reply #17)

Tue May 4, 2021, 01:47 PM

21. Full approval means lots of places can mandate the vaccine

Pfizer and Moderna are conducting Phase 4 studies now on long term efficacy and safety. These studies will add to their filing with the FDA.

Once the vaccines have full approval, then Hospitals, private industries, schools, and the military can require vaccination. THe morons who have zero clinical trial pharma research experience who are waiting for additional data will have it. Businesses can demand vaccine passports whatever form they take. The fools who bitched about herd immunity and wanted us to get back to normal are now preventing us from achieving herd immunity to get back to normal.

Shame them. Ask about their elderly parents and grandparents, why they risk their loved ones.

Pfizer was approved for 12 and up. that Phase 4 data will help push full approval as well.

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Response to Claire Oh Nette (Reply #21)

Tue May 4, 2021, 02:12 PM

22. "Can"

Pfizer will get full approval. Nothing in the data shows it won't. So will others.

This idea that corporate America is going to mandate vaccinations to do business with them or for employment isn't going to be borne out in reality.

That leaves the rest you mentioned. Statistically insignificant with respect to who the unvaccinated population overall is going to be. I don't think people are thinking that part through.

Under a one and done vaccine the school system would be huge. I don't think the schools will have a mandate and at this point the vaccine is looking more like a flu type vaccine. We just don't know.

I'm not saying it isn't a big deal. Pfizer will begin manufacturing, distributing, and pricing the vaccine on their own. That will be the biggest change.

The country is heading back to normal. Some places, like where I live(high population center), we are just about back to normal. Nothing is going to stop it.

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Response to RegularJam (Reply #22)

Tue May 4, 2021, 03:18 PM

27. ALready happeneing

Houston Methodist Hospital gave their employees eight weeks to get either vaccines or submit their resignations. They are mandating it.

Full approval means private businesses and Federal workers, including the military, will require.

Immunity for Insurance liability, which Mitch wanted, never passed. Insurance companies will put economic pressure on businesses, and the non vaccinated will be barred from hotels, airplanes, cruise ships. The push for proof of vaccine is coming from the private sector.

Universities are requiring students in the dorms to have the vaccine. More people are vaccinated and want vaccine passports than don't.

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Response to Claire Oh Nette (Reply #27)

Tue May 4, 2021, 03:24 PM

28. I didn't argue to the contrary about it currently happening on a small scale.

The whole idea of a vaccine passport that will have any real world impact will be gone in six months.

Making a claim at a single point in time, when we know decisions won't be made for some time, does not lead one to real world prognostications.

Additionally, lets take your hospital example. How many more Americans will that policy impact over that of the population as a whole. That's called statistical insignificance. Even if mandated by every hospital.

The below statement is false. There is no legal or factual basis for such a statement.

"Full approval means private businesses and Federal workers, including the military, will require."

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Response to boston bean (Original post)

Tue May 4, 2021, 09:12 AM

6. "Some people say..."

The Robert Kennedy Jrs driving the anti-vaxx conspiracy theories should have a campaign mounted against all of them, most if not all of whom have profited immensely since the arrival of COVID. Joseph Mercola especially, but so have many other "influencers" in the woo/wellness/anti-vaxx circles.

Just as conspiracies originate with unfounded rumors, the same should be applied to the charlatans.

"It has been reported that RFJ, Jr., Joseph Mercola, Christine Northrup and others who have led the anti-vaxx, anti-mask charge have all been secretly fully vaccinated against COVID while they continue to warn their followers to avoid the vaccine and other health measures."

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Response to boston bean (Original post)

Tue May 4, 2021, 09:41 AM

7. FDA approval is irrelevant to Reich-wing antivaxers

Once the approval happens, they’ll immediately declare that it was the result of bribes or the evil machinations of the imaginary Deep State. Then they’ll refuse the vaccine for that reason.

Because they’re a cult of ignorant racist fuckheads, especially the silent lurkers here who’ve oozed out of their various online Conservative circle jerk forums.

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Response to Orrex (Reply #7)

Tue May 4, 2021, 10:32 AM

10. That is why I specifically said hesitant. Not anti vax, agreed they are hopeless

I have spoken to many who point to this as a reason for hesitancy.

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Response to boston bean (Reply #10)

Tue May 4, 2021, 10:37 AM

12. Oh, my bad.

I confess that I don’t know many COVID vaccine-hesitant people who aren’t full-blown Trumpers, so my sample pool is skewed.

However, when Gardisil was approved years back, quite a few people on DU still expressed hesitancy, mostly for reasons gleaned from YouTube and a host of “alternative” “medicine” websites. I suspect that something similar would apply to the current vaccine.

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Response to Orrex (Reply #12)

Tue May 4, 2021, 10:50 AM

14. It,does exist in the left too. But for covid mostly in the right.

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Response to boston bean (Reply #14)

Tue May 4, 2021, 10:53 AM

15. Very true. (nt)

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Response to boston bean (Reply #10)

Tue May 4, 2021, 03:25 PM

30. Vaccine hesitant for just this vaccine

means they've allowed politics to interfere with their understanding, or lack there of of science.

If they are hesitant, then 6 blood clot cases out of 7 million before those vaccines were halted and the safety protocols worked. There is now a warning for premenopausal women.

There are not piles of bodies from vaccination. There aren't. There are piles of bodies from victims of actual COVID.

Vaccine safety and efficacy standards are significantly higher than they are for viagra (a Pfizer block buster drug that Pfizer is not about to risk profits from by pushing a dangerous or unsafe vaccine.) or rogaine, or chemotherapy drugs.

While there are a few people with serious health issues that preclude them from vaccines or severe allergic reactions, and some people who can't face needles, it boils down to ignornance, selfishness, NIMBY, laws for thee and not for me, entitlement or cowardly fear of needles

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Response to boston bean (Original post)

Tue May 4, 2021, 10:34 AM

11. Absolutely agree

I have a vaccine-hesitant member of my family who's just waiting for FDA approval.

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Response to boston bean (Original post)

Tue May 4, 2021, 10:42 AM

13. Agreed. I don't think we're going to get where

we need to be. President Biden came in with a great plan and a top-notch team, and he’s done everything he could, but it still might not work due to these anti-vax sociopaths. Thankfully we’re not still stuck with “the former guy” because then we’d really be screwed.

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Response to boston bean (Original post)

Tue May 4, 2021, 12:19 PM

18. These things can take the FDA years.

If they rush it, then it will look more suspicious. If you remember Dr. Fauci said a year ago it would take 2-3 years just to get a vaccine.
It was going into people's arms 7 months later in December. Many people thought that was suspicious including many who post here.

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Response to former9thward (Reply #18)

Tue May 4, 2021, 02:20 PM

23. I can guarantee if Trump had won

Many here would absolutely not believe the FDA.
We just have to look back to October to see this.

I am thrilled that the vaccine is working as promised, but to say that we should curtail full study is very scary. We can’t rush science. Honestly, although I think it was worth the risk, what will happen if one year from now we start seeing horrific side effects?

I’m fully vaccinated, and I don’t fear the future, but honestly we are rushing a new technology, this isn’t the regular tried and true vaccine, so I hope the studies continue.

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