Covid: the shape of things to come

[Barmoley]

First FDA needs to approve covid vaccines. Not just emergency use, but formal approval. It is pretty ridiculous that this hasn't happened yet.

 

[ian]

First FDA needs to approve covid vaccines. Not just emergency use, but formal approval. It is pretty ridiculous that this hasn't happen yet.

Yea, that would help! I heard somewhere that the things they’re evaluating now are technical things like how well the vaccine can be transported and stored, etc, not like how safe or effective it is. Wonder if that’s true. Certainly seems strange that they haven’t lit a fire under the formal approval process, since so many people are using the emergency approval as an excuse. But I guess if they hurry it, maybe it won’t seem credible to those people? Idk. I feel like there are always going to be people saying “this was approved in a year, which is four times faster than any other vaccine approval, and is therefore suspicious”, nevermind the fact that we’ve never had the urgency of a global pandemic behind vaccine authorizations.

 

[MarcelNL]

normally validation of production, shipping and storage happens in parallel with the studies, so that is likely lagging behind.

 

[Barmoley]

I am sure there are many "good" reasons, but surely transportation, storage, production have been sorted out at this point, given how many vaccines have been delivered. The approval will help a lot and not having it casts a weird light on the issue. There will still be people that will refuse to vaccinate, but at least there will be less reason for them to do so. At the moment it is difficult to argue for the safety of the vaccine when FDA doesn't have it approved. Not to mention that it is not easy to require people to vaccinate with something not having full FDA approval. General public doesn't care about the technicalities of the FDA approval process. For decades we've been fed the "fact" that if it is not FDA approved it is not safe and should not be used. Most know this is not technically true, but under the circumstances not having FDA approval is a very good argument against the vaccines.

 

[Keith Sinclair]

One of my sister's is a holdout rest of siblings
have shots. I told her virus does not care about
your beliefs or politics. Less than 60% not enough to make anti vaxers safe. Cases are going up in Hawaii. With highly contagious strains pretty much all non vaccinated by own
choice. Hospital beds are filling up again.

All I could tell my sister is love her like to have her around many more years she is 74.

 

[user 16756]

I am sure there are many "good" reasons, but surely transportation, storage, production have been sorted out at this point, given how many vaccines have been delivered. The approval will help a lot and not having it casts a weird light on the issue. There will still be people that will refuse to vaccinate, but at least there will be less reason for them to do so. At the moment it is difficult to argue for the safety of the vaccine when FDA doesn't have it approved. Not to mention that it is not easy to require people to vaccinate with something not having full FDA approval. General public doesn't care about the technicalities of the FDA approval process. For decades we've been fed the "fact" that if it is not FDA approved it is not safe and should not be used. Most know this is not technically true, but under the circumstances not having FDA approval is a very good argument against the vaccines.

my friend this is a very logical, measured approach.

unfortunately our world has somehow gotten to a place where we do not all live with the same shared set of facts that existed at least through the end of the 70s. the people who are using FDA status as an excuse will simply find another one. they probably wont even have to look very far.

additionally several decades of the thrust towards this has resulted in a country where we can look at the two largest sources of news and one runs stories about Delta cases and the other about Cathode Ray Tubes. I suspect most vaccine holdouts would not even see a story about FDA approval as it would be significantly down the page from all the culture war stuff that is all anyone seems to care about anymore.

 

[MarcelNL]

At some point ANY excuse is valid, and that goes for both groups.

I find it a bit funny (but understandable) that everyone wants drugs to be as safe as possible, yet now we're in a pandemic shortcuts seem acceptable. I'm definitely not a fan of the FDA, yet it's pretty sure they have good reasons to follow the procedures they have (if ultimately perhaps only legal, as what they do is probably all acc. to CFR).

EMA as far as I know has fully approved the Pfizer for all EU countries, yes there are more regulators in the world, and the vaccination rate is also not anywhere near 80% in ANY EU country. COVID-19 Vaccine Tracker | European Centre for Disease Prevention and Control
In France the govt is now enticing the population to get vaccinated (low 50%) by promising preferential treatment in bars restaurants etc, and it works, at the same time the threat is that non vaccinated people will have more difficulty to some things.

'sorting' something out works for building something, not so for drugs where every step of the process from bulk materials to final drug delivered needs to be traceable, every process validated, all contaminants, degradation processes and effects of packaging charted and investigated.....in short, you don't want to know how much stuff needs to be researched, documented, validated, verified, certified, submitted, verified, approved.

 

[VICTOR J CREAZZI]

I have some people I used to like that i dont talk to anymore because we are not on the same page.

Fixed that for me.

 

[mpier]

I try to look at things with an open mind, being that I am older. I have seen a lot of products of all kinds that have been approved for use in my life time as good for use by the general population turn into a very bad thing in the long run. Only long term studies can really determine the overall safety of a product. With that being said today’s technology is much improved. But would still understand if there are skeptics who want to wait for awhile. I just got stabbed for my family’s sake, but I may have held out longer just to see how things shake out with the different drugs being used.

 

[spaceconvoy]

What incentive would the FDA have to dilute its own power? It would be a tacit admission that many of their regulations are burdensome, and typically cause more harm than they prevent (in the current century). Why stop with covid? Are all deaths that could have been prevented with an experimental drug not equally tragic? The FDA is institutionally opposed to these arguments because they threaten its very existence.

 

[Barmoley]

FDA approval doesn't guarantee that there are no long term problems. There are plenty of examples of approved medicines turning out to be bad down the road. There is a disconnect though with FDA recommending the vaccines, that the organization hasn't itself fully approved. Claiming that this is due to their rigorous process is laughable. Either don't push the vaccines that haven't passed your process or approve them. They look like buffoon that don't believe in their own message. They are basically saying use these vaccines because this is the best tool we have at this time to stop this disease, but let us cover our ass just in case. Of course the situation is not as black and white as I make it out to be, but the message needs to be clear if we want it to work and it is not at this time. It is understandable why many are confused, on the fence or otherwise don't want to "experiment" with the vaccine.

 

[AT5760]

There's exactly .0001125% of the population that is objectively looking at the FDA emergency authorization vs. approval process and making decisions based on scientific concerns about the safety of vaccines.

From a non-scientific standpoint, I haven't talked to or observed anyone expressing vaccine reservations based on anything other than "freedom" or regurgitation of amorphous talking points.

People can and will make their own choices, but I don't think that the admittedly muddy narratives that the FDA and CDV have caused are impacting a lot of rational actors.

 

[Barmoley]

There's exactly .0001125% of the population that is objectively looking at the FDA emergency authorization vs. approval process and making decisions based on scientific concerns about the safety of vaccines.

From a non-scientific standpoint, I haven't talked to or observed anyone expressing vaccine reservations based on anything other than "freedom" or regurgitation of amorphous talking points.

People can and will make their own choices, but I don't think that the admittedly muddy narratives that the FDA and CDV have caused are impacting a lot of rational actors.

I disagree, most of the people I've talked to that haven't vaccinated yet bring up lack of full FDA approval as the main reason. All are rational, educated and smart people. So I'd say exactly 73.93421% of the still unvaccinated population of educated and rational actors are affected.

Jokes aside it is very difficult to argue with people not wanting to vaccinate when the government agencies that we supposed to listen to send mixed messages.

 

[DitmasPork]

Late to the party of this thread!

I'm of the belief that the US government needs to be more aggressive in getting the entire population vaccinated—ideally to make it a requirement to get vaccinated. I'd love to see both public and private sector jobs require all employees to be vaccinated; schools to do the same with students; no driver's license or government benefits unless proof of vaccination; etc.

Sure there're risks, a relatively small risk—but it's the same with any vaccination. I've a few relatives who're anti-vacc, their views for the most part shaped by the pervasive misinformation from "alternative press" and other questionable sources. Sad to see so many people resistant to vaccination—just foolish and not cool IMO.

It's certainly a new reality upon us. I hate wearing masks, but do so out of respect and safety for others, as well as my own protection. It is simply the responsible thing to do. I kick people out of my business of they refuse to wear a mask.

I'm quite passionate about my views, perhaps because I live in one of the covid hot zones of NYC, and remember vividly how covid ravaged the city.

 

[ian]

Jokes aside it is very difficult to argue with people not wanting to vaccinate when the government agencies that we supposed to listen to send mixed messages.

I don't find it that difficult, really. I'm happy saying that there are various hoops and such that the FDA has to jump through that haven't been done yet, but that the basically unanimous consensus of the FDA, the CDC, and the overall scientific community is that these vaccines are safe, effective, and essential to combating the pandemic, unless we all want to shelter in place for the next however many years. That's not to say that they'll believe this argument, but I don't find it hard to say.

 

[mpier]

I see and hear so many passionate statements about this conversation, and passion is such a great emotion that drives us in many positive directions. But when I hear people say they want to take away the fundamental rights of others because they do not believe as they do that becomes persecution and persecution as history has taught us is EVIL. We need to have understanding and compassion for what others may be going through, you don’t know what goes on in another’s mind so why paint them with such a flawed brush. I got vaccinated for my family not necessarily for myself, but I have other health issues with multiple medications so I was very hesitant as I should be and my family was very supportive of all my decisions. A lot of my overall decision to get vaccinated was being more educated on which vaccines would be best and safest. So now with
options out there why do we need to shut down again it may just come down to it is your decision to get vaccinated or not and you must live with the consequences.

 

[CA_cook]

It is ridiculous that FDA has not granted full approval for the COVID vaccine yet. Given how many doses have been administered they have safety data worth decades of normal clinical trials. Surely antivaxxers will come up with a different canard, butt that would rob them off their biggest weapon. The more people get pissed off at antivaxxers the more support there would be for vaccine mandates. And unfortunately that what we need now to crush this pandemic. We had a change to do it with voluntary vaccinations, but we missed it because of vaccine hesitancy and disinformation. Mandates are the next logical step. If you don't want to get the vaccine, fine, work remotely, don't go to restaurants, buses, planes, bar and concerts. Public health has the word "public" for a reason. It's not just about you.

 

[spaceconvoy]

It is ridiculous that FDA has not granted full approval for the COVID vaccine yet. Given how many doses have been administered they have safety data worth decades of normal clinical trials.

This is wishful thinking. You're saying that having more doses administered speeds up the passage of time somehow?

AT5760 has it right.. the distinction between only matters to people looking for an excuse to refuse the vaccines. It's a moving target, and granting full approval won't lead to widespread vaccination. They'll just find another complaint to latch onto.

 

[Barmoley]

This is wishful thinking. You're saying that having more doses administered speeds up the passage of time somehow?

View attachment 135777

AT5760 has it right.. the distinction between only matters to people looking for an excuse to refuse the vaccines. It's a moving target, and granting full approval won't lead to widespread vaccination. They'll just find another complaint to latch onto.

As true as that might be. Not having full approval is a solid reason not to trust the vaccine or FDA message. Yes some people will find another reason not to get vaccinated, but some will just get vaccinated, I personally know a few. We can argue percentages and all that, but the message would be clearer. Right now to a lay person like myself that doesn't know all the intricacies of FDA approval process it just seems like they are not sure of long term effects, so they don't give full approval. This might not be true, but in this situation perception is more important than reality. There is absolutely no reasonable downside for them giving full approval at this point. If down the road it turns out that there are long term effects FDA will be blamed regardless, since they are pushing the vaccines hard.

 

[MarcelNL]

The problem IMO lies in the mindset of blaming someone to begin with, I don't know who will be blaming FDA and for what but everyone can make their own decision...to get informed, to get vaccinated, or not.

BTW: point folks to this, Opinion: Don't wait for full FDA approval to get your Covid shot. Here's why

 

[DitmasPork]

In the US, I think attitudes towards vaccinations are influenced be whatever city or state one lives in.

The way things are shaping up, unvaccinated people will just have to accept that they don't have the same rights as vaccinated people. Their choice.

For instance, a bunch of the top restaurants in NYC—Danny Meyer, et al—are now mandating that all their workers and restaurant customers must be vaccinated. No shirt, no shoes, no covid vacc, no service.

How it should be IMO.

 

[CA_cook]

This is wishful thinking. You're saying that having more doses administered speeds up the passage of time somehow?

Not really. What I am saying is that FDA has a lot more data that with a normal compound to evaluate safety. If you are looking for rare side effects, they would been recorded, given how many people got the vaccine already. Very large sample size a huge advantage when you evaluate safety.

It still does not tell you about long-term side effects, thats correct, but there are few or no cases of long term side effects with any vaccine so it is highly unlikely to see that with these ones. mRNA also stays in the organism for a day or less before it is degraded, which again puts long-term side effects in the improbable category. AT this point the benefit of a real approval vastly outweighs the risks.

 

[ian]

The problem IMO lies in the mindset of blaming someone to begin with, I don't know who will be blaming FDA and for what but everyone can make their own decision...to get informed, to get vaccinated, or not.

BTW: point folks to this, Opinion: Don't wait for full FDA approval to get your Covid shot. Here's why

Nice piece. It’s also nice to be reminded that I have no idea what goes into FDA approval, so I probably shouldn’t comment on whether it’s too fast or too slow. Presumably there’s a reason it’s taking this long.

 

[chiffonodd]

 

[Luftmensch]

I have no idea what goes into FDA approval, so I probably shouldn’t comment on whether it’s too fast or too slow.

I have no horse in this race... the FDA only indirectly affects me. The conversation interested me so I wanted to know what the fuss was about. I did 15 minutes of reading and found some logical sounding answers. There are plenty of articles written by credible sources. The FDA offers a lot of information. I am not going to pretend 15 minutes of reading will make anybody an expert on the approval process but finding some credible high-level explanations is possible! The probable answer is: "it is taking exactly as long as it needs to"

The fact that the vaccines have emergency use authorisation (EUA) means they are demonstrably safe and effective. This was done using trial data from 10,000's patients. Drug companies need to apply to the FDA for full approval. For example; in early May, Pfizer submitted a rolling application for their vaccine's full authorisation. The FDA granted priority review in the middle of July [see Pfizer-BioNTech announcement]. Note that [ref]:

Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.

Priority review was only granted two weeks ago!! A lot of this has to do with the manufacturers assembling all the correct data and applying. After an application checks all the boxes, the FDA needs to review all the submitted material to ensure the safety and efficacy of the vaccines. The FDA also has to validate that the vaccine can be manufactured safely and consistency at scale. Their process has a lot of checks, at multiple levels. This is purposely done to catch mistakes but it does put the brake on speed. I doubt full approval will take the 6 month period. But even with FDA employees working weekends and overtime, it is not going to happen in two weeks!

The FDA are damned if they do; and damned if they dont. If somebody thinks the FDA is moving too slowly - we have never had a safe vaccine for corona viruses before. Similarly EUA has never been granted to a vaccine in America before. We are breaking speed records for medical development. These are all unprecedented. If somebody thinks the FDA is moving too fast - the FDA and government recognise the urgency and have invested a whole lot of resources in prioritising critical solutions. Of course the process is moving as quickly as it can... but not because anybody is cutting corners!

I share the same view as many here. For certain vocal parties, it doesn't matter whether the vaccines reach full FDA approval or not. Approval is a red herring. This group of people has made their decision and are using post-hoc reasoning to justify their prior world view. Those against the vaccine will just find a way to shift the goal posts once approval has been given.

A full FDA approval will be useful in giving institutions the confidence (maybe authority) to require the vaccine (e.g. schools/universities/military). It would likely fast track new boosters... and good or bad... it will likely change the EUA ecosystem. New and effective vaccines may not be granted EUA status if approved vaccine already exist.

My guess (for the zero weight it holds) is September

 

[Luftmensch]

Given how many doses have been administered they have safety data worth decades of normal clinical trials

Yes/no... clinical trials are done in phases. You might not know it, but the last phase is done after market release. It can be really hard to catch the 1 in 100,000 events, even with large scale pre-market trials.

But you are right. The vaccines have been given to millions of patients. This is like a phase-IV trial. The major vaccines have confirmed their efficacy and safety. BUT! In some cases they have also revealed rare and serious side effects - such as the AstraZeneca blood clots.

 

[MarcelNL]

Submission of study data is a whole different can of worms, first it needs to be cleaned, adverse events coded (translated into a uniform system), signed by the investigators, databases locked, adverse event narratives written, analysis done, digested discussed, results written up (most of that work usually is describing adverse events in narratives).

After submission of the package FDA validates the package to ensure they have all that is expected and required (checking for empty files etc). There is only so much you can do in parallel as there are some clear dependencies. Believe me when I say that companies are as efficient as can be in that process, time to registration matters big time $$...

Enough work to keep large teams in various disciplines very busy. ALL original data gets transferred -in contrary to EMA)- FDA does their own little analysis on the data that was submitted, panels of experts are consulted, meetings held, clarifications asked and sent.... quite an intense process.
After approval a similar process runs for the safety surveillance data, periodically and incrementally all safety data gets chewed on, reports written and submitted, and if you think there is one uniform system across the world- NO.

 

[spaceconvoy]

https://www.nature.com/articles/s41598-021-95025-3
"... the highest risk of resistant strain establishment occurs when a large fraction of the population has already been vaccinated but the transmission is not controlled."

Back to the original topic; the future of covid will be forever. Because vaccines do not prevent asymptomatic transmission, and a widely vaccinated population creates selection pressure favoring vaccine-resistant strains, this thing will never go away. Unless everyone embraces masks as a way of life so yeah, I'd place good money on the emergence of a vaccine-resistant strain by the end of this year.

 

[MarcelNL]

not sure about the vaccine resistant strain, modelling mutations is one thing, what those mutations end up like is another and to me that is for the virologists to answer, what I read and heard so far makes me think they expect that the vaccines are likely still efficacious in protecting us from getting seriously ill.

https://www.nature.com/articles/d41586-021-00031-0

 

[Keith Sinclair]

Masks have been used by some Asian countries by person's in crowded conditions for
many years. Covid first time I've worn them still
mandate to go anywhere. Was thinking they
work because keeps you hands off you face.

I haven't even had a cold in over 3 years.
Certainly in part to having mask since covid
& sanitizer in the car when take mask off.

Used to catch colds after going to grocery store.