Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

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

statnews.com

Post reply on HN
Print view View original

171–180 of 344 posts

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

#171

Post by treeman79 »

gilbetron wrote: post #95
treeman79 wrote: post #38

Earlier quoted context omitted.

It is a political decision. The kind leaders are supposed to make, the kind they don’t like making. A leader has to decide on either pushing early and either saving/condemning hundreds of thousand of lives. Or playing it safe and condemning/saving hundreds of thousands to death while we complete years worth of trials. Oh because that’s not enough pressure the economy is burning, which will cost many lives as well. It…

"political decision" in this context is making a decision to approve something to increase the odds of one candidate winning. It is not "a decision by a politician" but rather "a decision with the primary motivation being political gains only".

In part.

Politicians pander to their people. Most often by promising take stuff from group A and give it to group B

Killing off your constituents is usually bad for re-election. So mutual self interest.

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

#172

Post by shajznnckfke »

DoreenMichele wrote: post #169
shajznnckfke wrote: post #156

Earlier quoted context omitted.

I do think there will be a permanent adjustment in society to deal with the risks created by this type of virus in the future. Tell everyone to start wearing masks as soon as the outbreak starts, instead of telling them that masks are only for idiots and healthcare workers. Isolate travelers from affected areas before it has a chance to spread, and so on. But I also expect that just about every occupation from indust…

Well, I didn't say anything about eliminating jobs. Just that I, personally, see no reason to tie the idea of going back to work to a vaccine. I think we would do better to look for germ control solutions that are already proven and available currently. As one example, ordering online or calling ahead and picking up is a way to support local eateries while minimizing the spread of germs. I'm a big fan of Little Caesa…

I agree that we should try to adjust to the world we find ourselves in, but there’s only so much problem-solving effort to go around, and I think most people are already trying to do what they can. It’s tough to reshape society on a dime.

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

#173

Post by SpicyLemonZest »

gniv wrote: post #164
SpicyLemonZest wrote: post #70

Earlier quoted context omitted.

I think you're misunderstanding the problem space here. We don't expect a coronavirus vaccine to prevent close to 100% of infections, so it's not a binary question of working vs. not working. The question is, how strong of an effect at what level of confidence is required to conclude that it's working well enough?

> We don't expect a coronavirus vaccine to prevent close to 100% of infections Why not? I would have thought we do. Most vaccines do (flu notwithstanding).

I don't know the biological reasons behind it (I don't even know if the reasons are known, or if it's just based on early results), but Dr. Fauci's said that scientists are hoping for 75% effectiveness and 50-60% effectiveness would be acceptable. (https://www.cnbc.com/2020/08/07/coronavirus-vaccine-dr-fauci...)

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

#174

Post by RangerScience »

mumblemumble wrote: post #130
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.

According to FDA, phase III trials typically take 1-4 years. It's worth noting that, if there are any adverse effects that take a while to become apparent, the trial will need at least that long to be able to detect them. To my knowledge, severe vaccine reactions usually happen fairly soon, but a year before onset isn't necessarily unheard of for some vaccines. Also, that's just for vaccines that got approved; there…

If the vaccine only confers a few months of immunity, like the yearly flu vaccine, how long does it take to develop, produce and distribute the update?

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

#175

Post by adrianb »

loeg wrote: post #94
takeda wrote: post #61

Earlier quoted context omitted.

I heard somewhere that we should be prepared for middle of next year. They don't want politics to influence the safety of it. Releasing a vaccine that would cause damage would be devastating for the company. I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?

> I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them? No, and this is why Phase III trials take a long time, potentially a very long time if we actually get a handle on the virus with measures like masking and social distancing. Here's the protocol: 1. Volunte…

> This process can take years if the background rate of infection is low enough.

This is why the phase 3 trials tend to be organised in countries with high rates of infection, such as Brazil, South Africa or India. In locations with low rates of infection it's too likely that the people in the experimental group don't get infected simply because they don't get exposed to the virus.

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

#176

Post by whyleyc »

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…

Not sure where to start with these statements, but they aren't helpful.

    "We've seen that herd immunity can be achieved (see Sweden)."
No it can't. By the end of July 2020 only 6% of the population was known to have antibodies, according to the Swedish Public Health Agency[1]. It is estimated that 70% to 90% of a population needs such antibodies to achieve herd immunity[2]

    "People under 65 with sufficient levels of vitamin D have extremely low odds of dying from this disease."
Vitamin D has not been scientifically proven as a preventative treatment for COVID-19. The UK National Institute for Health and Care Excellence published a report summarising the research studies on Vitamin D for COVID-19 and found that 'no causal relationship between vitamin D status and COVID‑19 was found after adjustment for confounders such as comorbidity, socio-demographics, ethnicity, BMI and other baseline factors.' [3]

    "We're probably already near herd immunity"
If you are referring to the USA here this is likely not true. No one knows the "true" infection rate, but even if you use the upper estimates of Imperial College modelling[4] this figure is 72 million, or 22% of the population.

    "... less than even the flu"
Again not true. Every age group has worse outcomes from COVID-19 than the flu. If you are 50-64 you are almost 5 times as likely to die[5]

    "... hospitalizations plummeting everywhere"
The hospitalisation rate is down, but not "plummeting". There are still 32,000 people hopsitalised in the U.S. [6] and a number of forecasters predicting a rise over the next 4 weeks[7].

[1] https://bbc.co.uk/news/world-europe-53498133

[2] https://www.jhsph.edu/covid-19/articles/achieving-herd-immun...

[3] https://www.nice.org.uk/advice/es28/chapter/Factors-for-deci...

[4] https://ourworldindata.org/covid-models

[5] businessinsider.com/coronavirus-death-rate-us-compared-to-flu-by-age-2020-6?r=US&IR=T

[6] https://covidtracking.com/data/national/hospitalization

[7] https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/hosp...

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

#177

Post by hackyhacky »

blackflame7000 wrote: post #73
Tepix wrote: post #20

Earlier quoted context omitted.

Why do people care about what medical advice Trump has to offer? We don't really need a vaccine, we can just drink bleach!

I think Trump’s sarcasm is lost on some people and thats why they dislike him so passionately.

In the incident alluded to by the above comment, there was no sarcasm. It was pure, honest ignorance.

If you ask people why they hate Trump, "sarcasm" will probably not come up too much.

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

#178

Post by nouveaux »

anonu wrote: post #115

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

"After the program began, the vaccine was associated with an increase in reports of Guillain-Barré Syndrome, which can cause paralysis, respiratory arrest, and death."

This vaccine was rushed which had deadly results.

https://en.wikipedia.org/wiki/1976_swine_flu_outbreak

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

#179

Post by nfw2 »

loeg wrote: post #94
takeda wrote: post #61

Earlier quoted context omitted.

I heard somewhere that we should be prepared for middle of next year. They don't want politics to influence the safety of it. Releasing a vaccine that would cause damage would be devastating for the company. I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them?

> I'm wondering how do they test it, do they inject volunteers with the vacine, and they tell them to go infect themselves with a virus that 1 time out of 100 will kill them and an unknown percentage disable them? No, and this is why Phase III trials take a long time, potentially a very long time if we actually get a handle on the virus with measures like masking and social distancing. Here's the protocol: 1. Volunte…

I can see why it may take years to determine if the infection rate has been significantly lowered.

But what is the timeline for determining if there are serious deleterious symptoms?

If we get to the point where we know a bunch of vaccines are safe, but not necessarily effective, could these be approved for anyone who understands the risks?

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

#180

Post by 411111111111111 »

DavidSJ wrote: post #137
bglusman wrote: post #132

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…

What’s your source for (a)? I think virtually every human being on the planet has been infected with some coronavirus common cold strain in the past.

It would also be inversely correlated with age, as the likelihood of having contracted the common cold increases with the amount spend interacting with people throughout your life.

This doesn't reflect reality, as its correlation isnt inverted.

Post reply on HN