General Discussion
Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsThe 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?
LisaL
(44,973 posts)Companies have to ask first. I am not even sure they asked for a full approval at this point.
boston bean
(36,221 posts)Ms. Toad
(34,069 posts)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.
Hortensis
(58,785 posts)boston bean
(36,221 posts)Ms. Toad
(34,069 posts)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).
boston bean
(36,221 posts)Pfizer will be asking for full auth at the end of this month, I just read.
Ms. Toad
(34,069 posts)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.
boston bean
(36,221 posts)Ms. Toad
(34,069 posts)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.
boston bean
(36,221 posts)Ms. Toad
(34,069 posts)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.
dsc
(52,160 posts)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.
RegularJam
(914 posts)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.
Elessar Zappa
(13,975 posts)and other organizations could make vaccines required if full approval is given.
RegularJam
(914 posts)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.
tymorial
(3,433 posts)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.
BoringUsername
(142 posts)As someone else mentioned... and that's significant.
RegularJam
(914 posts)Almost statistically insignificant.
Claire Oh Nette
(2,636 posts)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.
RegularJam
(914 posts)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.
Claire Oh Nette
(2,636 posts)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.
RegularJam
(914 posts)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."
OneGrassRoot
(22,920 posts)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."
Orrex
(63,208 posts)Once the approval happens, theyll immediately declare that it was the result of bribes or the evil machinations of the imaginary Deep State. Then theyll refuse the vaccine for that reason.
Because theyre a cult of ignorant racist fuckheads, especially the silent lurkers here whove oozed out of their various online Conservative circle jerk forums.
boston bean
(36,221 posts)I have spoken to many who point to this as a reason for hesitancy.
Orrex
(63,208 posts)I confess that I dont know many COVID vaccine-hesitant people who arent 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.
boston bean
(36,221 posts)Orrex
(63,208 posts)Claire Oh Nette
(2,636 posts)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
mainer
(12,022 posts)I have a vaccine-hesitant member of my family who's just waiting for FDA approval.
TraceNC
(254 posts)we need to be. President Biden came in with a great plan and a top-notch team, and hes done everything he could, but it still might not work due to these anti-vax sociopaths. Thankfully were not still stuck with the former guy because then wed really be screwed.
former9thward
(31,997 posts)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.
forthemiddle
(1,379 posts)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 cant 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?
Im fully vaccinated, and I dont fear the future, but honestly we are rushing a new technology, this isnt the regular tried and true vaccine, so I hope the studies continue.