coronavirus discussion

[welfare]

Originally Posted by CRS

Ok I see where you drew that.
But the fact still remains.
Underscore asked what the options were. And the truth is, aside from implementing heavy restrictions, there really doesn't seem to be much else on the horizon so far to stop/contain the spread.
I just don't really see what the alternatives are at this point in time.

[twitchyzero]

Originally Posted by stewie

Can't remember if it was a picture somewhere in this thread of a mall food court with no masks and everyone eating with a safe space of an entire empty table beside them which is safe whereas dinner with 2 family members who you trust with your life is waaaaay to dangerous. Pretty much sums up my thoughts on this.

i mean, how do you eat with masks on?

if youre eating for only 20 minutes distanced not letting your guard down and not doing any social acitivities before and after with good ventilation, yeah it's probably safe...but lets be real that's not happening around people you 'trust with your life'

[Hondaracer]

Originally Posted by CivicBlues

Look I'm not a doctor, epidemiologist, or even a biomedical engineer. But I would think Vaccine trials are structured a little differently than medical equipment testing. My understanding is that COVID vaccine trial phases weren't shortened or abrogated but instead run in parallel. Regular vaccines run phases in a series due to budgetary/funding concerns and regulatory approval delays - there simply is no sense of urgency for other vaccines. With this vaccine the entire might of the world economy and political will is behind it so that's why they were able to do more phases at once, without sacrificing due diligence.

Then again, if explanations like this won't convince you, let me ask what will? How long will you wait before you take the vaccine to see if "all is clear"? How many long term longitudinal studies must be done first? Or will you just refuse to get it no matter what because it's somehow been "tainted" politically?

I’ll start this by saying I am not against the vaccine at all, and if I come off that way it’s my bad. if there was one for me tomorrow maybe I’d take it. I’m not overly concerned regarding the safety either. Nor do I think there is any sort of conspiracy etc. Much like yourself, If having the vaccine means I can travel abroad, sign me up.

In regards to the trials, I will try and regurgitate what my wife has explained to me regarding getting things certified. Basically the FDA, Europe, and Asia all have different standards to getting things approved. Some companies use Europe or Asia as a “back door” to getting FDA approval because it is much easier to get approval is another governing body has already approved your product.

Proving efficacy of your product depends on who it is serving, how many people it is serving, and how effective it has to be. Then the safety of course.

I’m no expert in vaccines I’m not an epidemiologist, however, for somthing that will undoubtedly be available to the entire world, a 44,000 test group seems incredibly small to prove efficacy and safety. As well, oral medications and injections generally have a much higher standard of testing than say, a medical device which you use in a hospital to monitor somthing, or administer somthing, etc. Because it has direct health implications. Even things like knee replacements etc which are inside you are far less scrutinized than somthing you take orally or intravenously.

I’m just asking questions, I’m not saying it’s some conspiracy or that I won’t take it. .

[Hondaracer]

Originally Posted by westopher

From the CDC. Probably where the "mainstream media" is getting that information.



Of course they can't accurately document how common it is, how severe it is, and how long term it is. The long term doesn't exist yet.

So where are the numbers? How many people are effected by these conditions?

That information may be out there but when I looked before it was incredibly vague. I’d say if the more serious long term effects only a effect single digit portions of people who have been infected, that isn’t that big of a deal

[whitev70r]

Yah, I don't get that if you ask questions about the effectiveness, the validity of the trials, possible side effects of the vaccine - you're automatically a Trump supporter, anti-vaxxer. C'mon man, this has got to stop.

I mean the logistics of the Pfizer one is in and of itself complicated. It has to be kept at like -70C, if you take it out of that temp, you have 6 hrs to use it before it is ruined. Just think about that complex process from Belgium, where it is manufactured, to the chain of places where it is stored, to where you are going to receive it.

[stewie]

Originally Posted by twitchyzero

i mean, how do you eat with masks on?

if youre eating for only 20 minutes distanced not letting your guard down and not doing any social acitivities before and after with good ventilation, yeah it's probably safe...but lets be real that's not happening around people you 'trust with your life'

Regarding the picture - In the span of 20 minutes how many people have passed by you? How does one not let their guard down? Do they take a bite and put a mask back on while they chew until ready for the next bite?
The problem with this is that I don't know where any of those people have been over the past several days, where they're coming from, or where they're going. Later in the week you see the news report that there was a corona virus positive person in the mall on Saturday. Cool. that was now 3 days ago and there's 0 contact tracing available unless it was an employee of a store and you may have entered the store while they were there.
Your family is a bit of a different story in my view. I know what they do on a daily basis... I should never of taught them how to text or what facebook was...

Lastly, I'm sorry but I do trust my parents with my life. They've looked out for my best interest since the day I was born. I know it's hard to believe but some people actually do have happy little families.

[Manic!]

Originally Posted by whitev70r

Yah, I don't get that if you ask questions about the effectiveness, the validity of the trials, possible side effects of the vaccine - you're automatically a Trump supporter, anti-vaxxer. C'mon man, this has got to stop.

I mean the logistics of the Pfizer one is in and of itself complicated. It has to be kept at like -70C, if you take it out of that temp, you have 6 hrs to use it before it is ruined. Just think about that complex process from Belgium, where it is manufactured, to the chain of places where it is stored, to where you are going to receive it.

https://www.pfizer.com/news/hot-topi...ion_fact_sheet

We also have developed packaging and storage innovations to be fit for purpose for the range of locations where we believe vaccinations will take place. We have specially designed,temperature-controlled thermal shippers utilizing dry ice to maintain recommended storage temperature conditions of -70°C±10°C for up to 10 days unopened. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations.
We will utilize GPS-enabled thermal sensors with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes, 24 hours a day, seven days a week. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen.

- The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice every five days for up to 30 days of storage.
- Refrigeration units that are commonly available in hospitals. The vaccine can be stored for five days at refrigerated 2-8°C conditions.

[Hondaracer]

Originally Posted by stylez2k4

This doesn't sound right to me. I had a look at the package insert for Shingrix that was approved in 2017:



and MenQuadfi (2020):



and DENGVAXIA (2019):





What certification are you talking about? Are you referring to approval?



Well yeah the disease has only been around 1 year. I'm not sure what long term date you are expecting...

In regards to the Dengvaxia vaccine, their trials used basically half of the amount of people the Pfizer vaccine did with an incredibly small, specific test group, as it looks like the vaccine can only be provided to people who have clinically tested for Dengue in the past.

Every approval varries greatly, obviously, and your shinrex comparison is apt. However they are obviously addressing completely different things which have completely different circumstances and potential outcomes.

As I said in the other post, certification and approval is based on what you are claiming your product does.

[stylez2k4]

Originally Posted by Hondaracer

In regards to the trials, I will try and regurgitate what my wife has explained to me regarding getting things certified.

Drugs don’t get certified. They get approved.

Originally Posted by Hondaracer

Basically the FDA, Europe, and Asia all have different standards to getting things approved. Some companies use Europe or Asia as a “back door” to getting FDA approval because it is much easier to get approval is another governing body has already approved your product.

This is a poor understanding of the approval process. There is no backdoor. You are seeing correlation not causation. If a drug gets approved by a regulatory body, it is because they have a solid NDA. If you have a solid NDA, you are of course more likely to get approved by another regulatory body.

FDA is also regulatory body not a governing body.

Originally Posted by Hondaracer

I’m no expert in vaccines I’m not an epidemiologist, however, for somthing that will undoubtedly be available to the entire world, a 44,000 test group seems incredibly small to prove efficacy and safety.

If you are not an expert, why do you think 44,00 test group is small? What are you basing that determination on?

[stylez2k4]

Originally Posted by Hondaracer

In regards to the Dengvaxia vaccine, their trials used basically half of the amount of people the Pfizer vaccine did with an incredibly small, specific test group, as it looks like the vaccine can only be provided to people who have clinically tested for Dengue in the past.

Every approval varries greatly, obviously, and your shinrex comparison is apt. However they are obviously addressing completely different things which have completely different circumstances and potential outcomes.

I don't think you understand how evaluating drug effectiveness work and how statistical power is derived based on sample size and the effectiveness.

As I said in the other post, certification and approval is based on what you are claiming your product does.

I've never seen any drug be certified. Please refer me to drug that is certified for a use.

[CivicBlues]

Originally Posted by Hondaracer

I’ll start this by saying I am not against the vaccine at all, and if I come off that way it’s my bad. if there was one for me tomorrow maybe I’d take it. I’m not overly concerned regarding the safety either. Nor do I think there is any sort of conspiracy etc. Much like yourself, If having the vaccine means I can travel abroad, sign me up.

In regards to the trials, I will try and regurgitate what my wife has explained to me regarding getting things certified. Basically the FDA, Europe, and Asia all have different standards to getting things approved. Some companies use Europe or Asia as a “back door” to getting FDA approval because it is much easier to get approval is another governing body has already approved your product.

Proving efficacy of your product depends on who it is serving, how many people it is serving, and how effective it has to be. Then the safety of course.

I’m no expert in vaccines I’m not an epidemiologist, however, for somthing that will undoubtedly be available to the entire world, a 44,000 test group seems incredibly small to prove efficacy and safety. As well, oral medications and injections generally have a much higher standard of testing than say, a medical device which you use in a hospital to monitor somthing, or administer somthing, etc. Because it has direct health implications. Even things like knee replacements etc which are inside you are far less scrutinized than somthing you take orally or intravenously.

I’m just asking questions, I’m not saying it’s some conspiracy or that I won’t take it. .

Well, first of all there's no "Asian FDA", it's every country for itself and as far as I can tell no Asian countries have approved Pfizer's vaccine. The first one was the UK, which as a unintended consequence of Brexit, no longer has to wait for EU Health approval on top of that. The next was Health Canada which was a day after. The FDA still hasn't approved it yet (as of 11:25am 12/11/2020 but they've been greenlit by the advisory board. In any case, if you don't trust the FDA, then you trust the UK MHRA or Health Canada even less then? There's no indication of any back-door approval shenanigans as your wife seems to imply.

44,000 is a good size for phase 3 vaccine trials from what I understand. What number are you looking for? 100,000? a million? The Moderna vaccine only has 30,000. At what point is the size of a trial becomes large enough that tracking becomes problematic. Again, I'm not an expert but I would assume pharmaceutical companies that have been in business for decades as well as the regulatory bodies that approve them know what they're doing.

[westopher]

Originally Posted by Hondaracer

So where are the numbers? How many people are effected by these conditions?

That information may be out there but when I looked before it was incredibly vague. I’d say if the more serious long term effects only a effect single digit portions of people who have been infected, that isn’t that big of a deal

Single digit percentages are massive on this scale. We are talking about a 1% death rate that has killed 1.5 million people worldwide. I’m not saying there’s a massive percentage of people with long term health effects. I’m asking why a single digit % of negative health effects of the vaccine is being said to be more dangerous, or as dangerous as the disease? How are the unknowns of the vaccine being considered as large of a threat by some people as known health effects of the disease it’s been engineered to fight?

[Hondaracer]

Originally Posted by stylez2k4

Drugs don’t get certified. They get approved.



This is a poor understanding of the approval process. There is no backdoor. You are seeing correlation not causation. If a drug gets approved by a regulatory body, it is because they have a solid NDA. If you have a solid NDA, you are of course more likely to get approved by another regulatory body.

FDA is also regulatory body not a governing body.



If you are not an expert, why do you think 44,00 test group is small? What are you basing that determination on?

I’m using certification as the medical device term, if you want to get hung up on that go ahead.

I’m basing 44,000 being “small” based on the resulting groups it will be distributed to and other vaccines and treatments which had a similar sized test group which do not apply to nearly the amount of people the Pfizer covid vaccine will. I do agree though that the statistical analysis based on this test group will scale to the general population.

[Hondaracer]

Originally Posted by CivicBlues

Well, first of all there's no "Asian FDA", it's every country for itself and as far as I can tell no Asian countries have approved Pfizer's vaccine. The first one was the UK, which as a unintended consequence of Brexit, no longer has to wait for EU Health approval on top of that. The next was Health Canada which was a day after. The FDA still hasn't approved it yet (as of 11:25am 12/11/2020 but they've been greenlit by the advisory board. In any case, if you don't trust the FDA, then you trust the UK MHRA or Health Canada even less then? There's no indication of any back-door approval shenanigans as your wife seems to imply.

44,000 is a good size for phase 3 vaccine trials from what I understand. What number are you looking for? 100,000? a million? The Moderna vaccine only has 30,000. At what point is the size of a trial becomes large enough that tracking becomes problematic. Again, I'm not an expert but I would assume pharmaceutical companies that have been in business for decades as well as the regulatory bodies that approve them know what they're doing.

She didn’t imply anything she just has explained in the past that approval for (mostly medical devices) so sorry for using that analogy with the vaccine, that say you build a knee replacement and get the approval for this product, if you create a new product that is based on the old product, this product can see approval in a round about way even if does not do the exact same thing as the original product.

Not exactly applicable here, I’m just spitballing in terms of approval for things in the medical field with my limited understanding.

The questions regarding the efficacy of preventing transmission and deaths are still very valid though imo.

[stylez2k4]

Originally Posted by Hondaracer

I’m using certification as the medical device term, if you want to get hung up on that go ahead.

As far as I know regulatory bodies such as FDA and Health Canada do not certify medical devices. They get approved.

Medical devices can be certified by organizations like CSA and UL, but those are not the same.

I’m basing 44,000 being “small” based on the resulting groups it will be distributed to. I do agree though that the statistical analysis based on this test group will scale to the general population.

In that case you are not using a evidence based evaluation process. You are basing it on your instinct, which is wrong.

[CivicBlues]

Originally Posted by Hondaracer

The questions regarding the efficacy of preventing transmission and deaths are still very valid though imo.

Agreed. We're all waiting on this...and the best way to get data on this? Mass adoption of the vaccine

[Bouncing Bettys]

Originally Posted by mikemhg

This, entirely. This is why I abrogate myself from COVID debates with people. The reality is, there's a lot of people out there with mental health issues, that aren't happy with their lives, with the world, and thus are looking for a reason to be angry about government, etc.

I even called a buddy of mine out about it, as he's one of those anti-covid, conspiracy, conservative types that thinks the world is going to end.

I asked him bluntly, "Let's be real here, you're not happy with your life, you somewhat wish that there was a societal collapse, am I not right?". He paused, and said, "You're right".

There's a lot of that going on here with these people.

Twitter

[CivicBlues]

Lol, as if Very Conservative Men would even go to a doctor to get diagnosed. It's not part of their cultural coda "man-up, don't be a pussy".

[underscore]

^ they should really overlay the percentage that actually go see the medical professionals that could make the diagnosis. You also have to factor in how the survey was done, age groups, etc.

Originally Posted by Hondaracer

I’m no expert in vaccines I’m not an epidemiologist, however, for somthing that will undoubtedly be available to the entire world, a 44,000 test group seems incredibly small to prove efficacy and safety.

Well it's not going straight from a 44k test group to the rest of the world instantly. So there's effectively going to be many test groups, increasing in size, starting with older people and working younger, before it reaches you or I.

[Hondaracer]

Fair enough, the nature of the roll-out itself will be a test group.

[Bouncing Bettys]

Originally Posted by CivicBlues

Lol, as if Very Conservative Men would even go to a doctor to get diagnosed. It's not part of their cultural coda "man-up, don't be a pussy".

Originally Posted by underscore

^ they should really overlay the percentage that actually go see the medical professionals that could make the diagnosis. You also have to factor in how the survey was done, age groups, etc.

This is all addressed in the tweet thread.

[JDMDreams]

They should just give the super med that they gave Trump, and Rudy

[CivicBlues]

Originally Posted by Bouncing Bettys

This is all addressed in the tweet thread.

You mean this? It doesn't seem to address it at all just acknowledge it.
It's possible that the disparities in self-reported diagnosis are simply or partly a function of white liberals being more likely to seek mental health evaluations. I don't have the data to answer this question. But given that they also tend to score higher on neuroticism..

Ah yes, who would question such a nuanced interpretation from someone who proclaims themselves to be a "Wokeness Studies scholar researching the 'Great Awokening'"

[welfare]

Originally Posted by Bouncing Bettys

This is all addressed in the tweet thread.

[CivicBlues]

Oh so when it comes to differing political views you want to "cure" the opposite side, but with an actual disease you're ok with just letting it run it's course?

Yeah Liberalism, what a twisted ideology. Forcing people to confront and seek help for physical and mental ailments.

Much better to just bottle it up and carry on as if nothing's wrong.