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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

#111

Post by adamnemecek »

chrisco255 wrote: post #108

The vaccine hail Mary is weird to me. We've seen that herd immunity can be achieved (see Sweden). People under 65 with sufficient levels of vitamin D have extremely low odds of dying from this disease, less than even the flu. The CDC reported that less than 10% of deaths reported were from Covid alone. We're probably already near herd immunity with hospitalizations plummeting everywhere. Why are we still pinning ever…

No, we are not at herd immunity. Because if uncontrolled, in US alone 3 million (probably more) would die.

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

#112

Post by SpicyLemonZest »

shajznnckfke wrote: post #92
spamizbad wrote: post #71

Earlier quoted context omitted.

The 1976 swine flu outbreak is one example of what can go wrong if you rush a vaccine: https://en.wikipedia.org/wiki/1976_swine_flu_outbreak It was rushed by the Ford administration for political reasons and got a lot of people very sick.

Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19. My concern is that there’s an agency whose job is to minimize the risk of harm from a covid-19 vaccine, but not an agency whose job is to balance the risk of harm from a vaccine with the ongoing harm from not having a vaccine.

It's not the worst case, just the worst one that's happened in a vaccine deployed at scale. The dengue vaccine is a famous example of why careful research and approval processes are required; it's effective and not too inherently dangerous, but was found to actually make the disease worse for people who haven't been infected in the past.

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

#113

Post by ibejoeb »

Tarq0n wrote: post #88
onetimemanytime wrote: post #47

Earlier quoted context omitted.

>> I don’t feel reassured that those won’t be rushed. actually I am. Vaccine makers don't gain much by doing something risky (considering the negatives) so they'll check the ones seeking election at all costs.

They probably could get some countries to indemnify them, they'd probably survive the damage to their reputation.

Countries including the USA, under the VICP. Vaccine makers are at very limited liability.

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

#114

Post by gizmo686 »

ssully wrote: post #62
gizmo686 wrote: post #23

Earlier quoted context omitted.

It doesn't even have to be a "bad" vaccine. The FDA has already said that 50% effectiveness would be sufficient, which would put it about on par with the seasonal flu vaccine. Combined with a high baseline infection rate, and an aggressive testing regime (at least compared to flu/other non-pandemic diseases), there will be a lot of people who get vaccinated and proceed to get sick and test positive. The real evidence…

My understanding is that while prevent infection using the vaccine is a big goal, the other more important goal is that it triggers a better response in people when they do get sick. Specifically, if you get the vaccine and then go on to catch the virus, your body will fight it better and you will have minor symptoms (and hopefully don't go to the ICU). I will say that everything I've said is just from what I read. I…

That is my understanding as well, but it is entirely irrelevant to the point being made. If someone on the anti-vax margins get the vaccine and proceeds to get sick and test positive, the are more likely to say "the vaccine doesn't work" compared with "I would have gotten more sick if I wasn't vaccinated". You also wont here all the stories of people who got the vaccine and proceeded to not get sick; so there is a sampling bias to hearing about cases where the vaccine doesn't work as well.

The concern here is about the longterm PR of vaccinations, not the technical benefits of the vaccine.

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

#115

Post by anonu »

Does anyone know the dangers of a "bad batch" of vaccines, specifically with Covid?

Here's a bit of digging on some of the dangers of smallpox[1]. Apparently, you can get something called progressive vaccinia which eats away at your skin.[2]

[1] https://www.cbsnews.com/news/the-most-dangerous-vaccine/

[2] https://en.wikipedia.org/wiki/Progressive_vaccinia

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

#116

Post by refurb »

wearhere wrote: post #5

What’s the timeline for Phase III trials? The article doesn’t seem to say. I don’t feel reassured that those won’t be rushed.

You can look up those details on clinicaltrials.gov. They will list the timeline for the primary endpoint. That doesn't include recruitment delays though.

Here are the details for the Oxford/Astrazeneca vaccine.[1] It's a 1 year trial. From what I've seen, they vary in length, but have interim analyses scheduled on a regular basis (3-6 months). If they see a strong signal, they can seek approval based off that interim data.

[1]https://clinicaltrials.gov/ct2/show/NCT04536051?term=ChAdOx1...

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

#117

Post by Vysero »

hn_throwaway_99 wrote: post #78
Vysero wrote: post #49

Earlier quoted context omitted.

No it wouldn't be consistent with that. That would be consistent with not thinking critically. The hypocrisy of quoting a politician in order to reinforce your narrative whilst simultaneous talking about how the narrative your trying to reinforce is being driven by political motivations is... well it's sad really.

Such a bizarre argument. Direct quote from your comment: > Tell me again why I should care what Kamala Harris opinion on the matter is? Literally no one else is telling you that you should care what Kamala Harris' opinion on the matter is. You are the only one that seems to care what her opinion on the matter is.

By including the quote from a political candidate the author is saying (without words) that her opinion on the mater matters. Therefore, the AUTHOR is telling me that I should care what Kamala Harris' opinion on the matter is. How can you not see that?

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

#118

Post by GavinB »

Given that a vaccine may not provide total protection, they should consider how to sell a potential early, safe but only moderately effective vaccination. For instance, calling it a "COVID-19 Immune Booster Shot," and be very transparent that it reduces your protection against the virus but is not total immunity. Then the world won't lose faith in science and medicine when folks who had the shot are testing positive and even dying.

Hopefully either way the amount of news coverage will be enough that most people will get informed about it, in a way that they don't for most issues.

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

#120

Post by garmaine »

apocalyptic0n3 wrote: post #93
calvinmorrison wrote: post #65

Earlier quoted context omitted.

How about "rushing" the vaccine to you know... end the pandemic? Or would you rather more people die "from covid" to hurt Trumps chances of winning?

The bigger issue is if they rush a drug that does long term harm to people, it could destroy the company. This is a drug that they will be giving out to 300+ million people in the US along. Screwing it up would result in a massive amounts of lawsuits that they may not recover from. They don't want to risk that just for some political capital with a person who may not be in power in a few months.

The fix for that is easy: have the FDA authorization grant them immunity from vaccine safety or efficacy liability.
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