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Covid vaccine makers commit to not seek approval until complete Phase III trials

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Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#321

Earlier quoted context omitted.

And what basis do you have to believe such treasonous claims? CNN told you so? What motivation could they possibly have? Oh yeah, to get you to vote democrat. Don’t be naive.

Cool your jets man. If you are an American you should be aware that criticizing the President is patriotic, not treasonous. It was patriotic to criticize Obama, just as it is patriotic to criticize the current president.

The entire arguments of the left can be summarized as Orange Man Bad despite having no new wars, record 401ks, tax breaks for the middle class (I got one), the first president to openly support gay marriage upon taking office. (none of that obama 6 year in change of mind bullshit because midterms are over), Passed the first step act that freed people incacerated by Joe Biden's crime bill, etc.

The reason why the democrats are going to lose in November is because they cried wolf too many times. Charlottesville is a perfect example. Anyone who listen to the full transcript can tell clear as day what Trump said vs what people tried to allege. The mocking of the crippled guy was another one. You can tell the left is panicking too. They are shutting down comments, censoring ideas, intimidating naysayers, and basically devolving into the fascists they say they hate. Don't believe me? I'll pay you $1000 to wear a BLM hat to a Trump rally, and a MAGA hat to a BLM rally and you tell me which one was more accepting.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#322

Earlier quoted context omitted.

> That's the "herd immunity" fraction for a disease with a growth rate of 3. Only if you assume (1) perfectly homogeneous mixing and (2) nobody is naturally immune (either due to cross-reactivity with immune responses to other coronaviruses or for any other reason).

To add to this, the effective reproduction number (what I think the GP is referring to?) varies not just with the prevalence of immunity, but also with the contact network of the population in question. Currently the effective reproduction number is not 3, in most places, because we're avoiding large gatherings and, depending on the region, wearing masks and avoiding indoor gatherings. If many more people were immune…

> Despite this marked difference in virus replication in the lungs, reduction in viral shedding from the nose was not observed.

So vaccinated people will not get too sick, not self-isolate, but will still shed the virus? That sounds concerning for the non-vaccinated.

[] ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia in rhesus macaques

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#323

Earlier quoted context omitted.

Let's quantify "a lot of people". Out of 45 million vaccinated, 450 got Guillain-Barré Syndrome. I couldn't find info on if any of them died. That would have been acceptable if it had stopped a disaster, but as it turned out the 1976 Swine Flu epidemic never really materialized as expected. With Covid killing 1000 Americans per day, I think we should happily accept those odds of side effects or worse.

If a few hundred people get a brutal side-effect, that's enough ammo for anti-vaxers to severely cripple the general public's trust in our public health systems. Somewhat frustratingly, this vaccine needs to be held to the same standards of safety & efficacy as any other vaccine, but I do wish they'd let immunocompromised people get access to the thing a notch earlier than they would otherwise.

I think a lot of ammo for anti-vaxers comes from the government and media not being completely honest about vaccine side-effects. That's because it is difficult for an individualist or a socialist to separate public health from individual health. The CDC is not your personal physician. The CDC worries when newspapers publish facts about vaccines, such that some vaccines can cause severe and traumatic side effects, while being 52% effective, because they worry about obtaining herd immunity and need people to accept the vaccine for that. They want you to go through weird little side-effects, like not enjoying alcohol for months, so you don't infect a senior they count in the flu statistics. It's when "do no harm" means sacrificing the lives of a few to save the many.

Then there are political and funding concerns. If your own government funds your research to investigate if Agent Orange is harmful to the point of culpability costing billions, you are very careful and delicate with your conclusions. If your vaccination tests show that black Africans show more severe adverse effects, or that, maybe yes, the connection between vaccination and (worsening of) autism is both plausible and understudied, what do you do? For them its a single kid, maybe 2-3 in 100.000 which will start to suffer from autism years earlier, and a disease eradicated. For anti-vaxers, it is their kid.

Essential workers and at-risk people are first in line to receive the vaccine. The hope was availability in September, and public rollout in the beginning of 2021.

The anti-vax conspiracy mud has completely destroyed online information about this subject. There are more such subjects, where it is very difficult to find what the anti-activists are freaking out about. For instance, my gut tells me that physical and mental torture can be effective to obtain useful information. That that's why the mob, military, and police mainly use it for. But, online, nothing: torture is completely ineffective for the first 10 pages of Google. The Holocaust is another obvious one. 5G rollout ("completely safe, maybe, we don't know for sure. Improved Youtube streaming is important tho!"). Or try to find information on how the riots created a spike in infections. All news sites report on the same non-peer reviewed non-scientific institute paper, saying the riots caused spikes is a lie, yet the paper clearly postulates that riots increased infection for black participants and their families, but taken on the whole, they likely caused non-protestors to stay at home more for fear of violence and this reduced virus spread.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#324

Earlier quoted context omitted.

If the vaccine confers only limited immunity - but the users run off and act like they are immune for life - we could pretty quickly end up in a situation where giving a vaccine could result in 5 deaths where 1 only would have happened without it because people would have been more careful. This is why it is important to understand not only that it doesn't kill people, but how much immunity it provides.

That's what they said about masks, and that turned out to be wrong too. Assuming that people are idiots never helps

"they" (who?) said that ppe was in short supply and should be reserved for medical personnel.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#325
post #227
post #216

Earlier quoted context omitted.

Sure, that makes sense. My comment was based on Fauci's recent comments saying approval could happen as soon as next month if there are enough infections in the control group. It seems to me that what he is implying is that the risk of long-term side effects would not be worth blocking approval of a vaccine if the vaccine proved to be effective in preventing the virus.

Gotcha. Yeah, that timeline seemed really aggressive, but I would hope that the FDA uses it's standard set of evaluating criteria for any new vaccine. Even though the phase 3 might only have a few months of data, you can pool phase 1 + 2 data as well, which would give you a bit more confidence as to potential long term side effects. It would also depend on what they approve it for. You could see them restricting it t…

The FDA has published a detailed guideline on how to handle vaccines against the SARS-CoV-2. Among these, the minimum requirement of a 50% efficacy and mandatory monitoring of the trial participants for at least one year after the trial end (which will not be when authorization requests will be made, in case it works, but later on).

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#326
post #76

Earlier quoted context omitted.

especially right now, a failure when so many are paying attention (and large part of population is now anti-vaxers) could actually ruin the company.

should have added that that the vaccine has very limited $$ potential (can't charge a gazillion for it due to bad PR and competition) and most makers have hundred billion brands that can be ruined by this. So they aren't going to risk their company for this. Lastly, suppose Acme Pharma released it against all common sense, all over the media scientists would talk against it, so lose-lose.

However, these companies got a lot of money to ramp up production ahead of approval ("at-risk manufacturing") often by governments. If the vaccine is a fluke, they might be in trouble.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#327

So, correct me if I'm wrong, but a) current hypothesis is people with prior exposure to common-cold non-COVID-19 coronaviruses are by and large either asymptomatic or have milder symptoms than those without such exposure b) presumably it should be possible to test people for these antibodies much as we can test people for COVID antibodies If people would volunteer for the b) anti-body test in reasonable numbers, and…

Coronaviruses are called so because they look a certain way under an electron microscope. They don't necessarily have common proteins. So you point a does not stand. As for point b,due to the fact that antibodies are specialized and there are tons of viruses that cause the common cold, I wouldn't expect them to match or even exist at any given time in the bloodstream since they only last ~6m and after that memory tak…

There is documented cross-reactivity in T-cell responses: individuals who had not come in contact with SARS-CoV-2 developed an immune reaction (T-cell based) against it.

Whether this prevents infection (unlikely) or lessens the symptoms is still an open question. But the phenomenon exists.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#328
post #149

Earlier quoted context omitted.

Maybe we should first distribute the vaccine to the elderly, then? It sounds like the trade-off benefits and risk would be different there.

Maybe. You still have to be careful, though: your prior assumption is that older/sicker people are more likely to have side-effects from anything . It's also hard to find big enough groups of old/sick people to do sensitive statistical experiments. Vaccine development is hard.

On top of that, there are cases of many vaccines which are much less effective in the elderly.

While secondary causes are likely causing much of the higher mortality in the elderly, sometimes the immune system is just... not as strong. And yes, that does mean something other than COVID-19 could come along an 'get that person', but... here's my point:

https://www.cda-adc.ca/jcda/vol-66/issue-10/551.html

Hepatitis B surface antigen (HBsAg) induces neutralizing antibodies (anti-HBs) that protect against HBV infection. ... Response to vaccine following a 3-dose series is typically greater than 95% in young, healthy people, although it decreases with age (Quite a few vaccines are like this. Less effective on the elderly. So we could end up with an even larger horror show, with some COVID-19 vaccines.

Such as, it has some bad side effects, AND, doesn't really help the most-at-risk group as much as desired!

What really bugs me is, there are what? Greater than 70 vaccines in development?

Some governments have pre-picked supposed winners. On top of all the other political bull going on, are they going to stick with those winners, regardless of outcome? Or have preferentiality to those specific vaccines?

Because I can imagine some being highly effective and safe, and others being the reverse.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#329

Earlier quoted context omitted.

That's what they said about masks, and that turned out to be wrong too. Assuming that people are idiots never helps

"they" (who?) said that ppe was in short supply and should be reserved for medical personnel.

Well obviously this depends on what you mean by "they". But a leading narrative during the early part of the pandemic was that masks were not good, for various reasons, one of which was that they didn't actually offer protection, but people think that they do, so people will be less careful.

This was so much part of the narrative that there were later pieces about how bad this narrative ended up being, e.g. in the NYTimes.

So for sure, it was a real thing.

Re: Covid vaccine makers commit to not seek approval until complete Phase III trials

#330
post #280
post #278

Earlier quoted context omitted.

Are you arguing that the 1976 Swine Flue vaccine incident is the worst possible case or the worst possible case on record? If the former, then what is your evidence or reasoning for that? If the latter, how do we know that this is the worst case we can expect?

Well, the worst case is that the vaccine is actually a highly contagious world ending bioweapon that causes the extinction of humanity, so the latter. How do you know that the current death rate for COVID19 won't eventually be much higher for those who have "recovered"? Maybe all those asymptomatic youngsters are actually going to develop horrible debilitating lung and blood disorders? We work with the data we have,…

>How do you know that the current death rate for COVID19 won't eventually be much higher for those who have "recovered"? Maybe all those asymptomatic youngsters are actually going to develop horrible debilitating lung and blood disorders?

The same could be said about the vaccine since we will have no long term studies.

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