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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

#261

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.

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.

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

#262
post #251

Earlier quoted context omitted.

> It would be tragic, for example, to see any serious side-effects from a vaccine in people under the age of 20, who have essentially no risk from infection. They have little risk of death if they have no comorbidities, but even for a 20 year old, just getting COVID-19 is likely gonna be worse than the side effects from almost any vaccine imaginable. I've had vaccine side effects and I've had COVID and I'd take ten m…

"I've had vaccine side effects and I've had COVID and I'd take ten more vaccine side effects over one COVID, please." I don't know what side-effects you've had from vaccines, but when I talk about risks, I'm not talking about headaches...people actually died from from the 1976 H1N1 vaccine.

... yeah, and way more people are dying from COVID than have ever died from all vaccines put together.

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

#263

Earlier quoted context omitted.

Given the way this story is going, I’m somewhat expecting a future where right-wingers refuse to wear masks but happily take the vaccine, while the left goes antivax and refuses to take it (because it was “rushed by Trump”) but continues to wear masks. Perhaps by our powers combined, we’ll defeat the virus!

Why would the people who refuse to wear masks take a vaccine? They think the virus is a hoax.

They think whatever Trump tells them to think. So if Trump tells them to take a shot, they will take the shot (FOR FREEDOM!).

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

#264

The New York Times has a chart, updated daily, of all the vaccines in development.[1] This is worldwide, not US. Phase I: 24 Phase 2: 14 Phase 3: 9 Limited approval: 3 (CanSinoBio, Gamaleya Research Institute (Russia), Sinovac) Full approval: 0 That's not even including the hundred or so still in lab or animal testing. It's encouraging; something is likely to work. The real question is, how effective are the ones tha…

If multiple vaccines are ready at the same time, who will decide which vaccine is distributed to which people? Would it be regional? Random?

I imagine it would be constrained on shipping logistics, initially. Vaccines require temp. controlled shipping.

Effectively random.

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

#265
post #252

The question of whether the virus or vaccine poses a greater risk seems like a controversial one. I (28, no health conditions) personally would be willing to take the vaccines that have gone through stage 2 trials. I registered myself as a willing volunteer but have not been selected. It seems to me that there is a middle ground between approving and recommending a vaccine to all Americans and completely blocking acc…

> have open phase 3 trials that accept anyone willing to waive the risks

If we can quickly train up musicians and waitresses to do the data collection, sure.

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

#266

Earlier quoted context omitted.

The virus is pretty bad, right? Ought we be making a cost-benefit analysis where we compare the risks of side effects from the vaccine to the risks of the spread of the virus? In comparison to a vaccine like Gardisil, which surely prevents far fewer deaths than a covid-19 vaccine will, wouldn’t such an analysis actually indicate that the trials be rushed to some extent? I’m feeling anxious that the current political…

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.

You don’t need to go so far back. The 2009 swine flu pandemic vaccine caused Narcolepsy in about 10 / 100 000 vaccinated, all of which were children aged 12-16 (which is not a group included in trials, by the way).

https://en.wikipedia.org/wiki/Pandemrix

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

#267

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

In UI design, I've found that "idiot" is not that useful a concept. I think its more useful to think through particular thought processes.

A mask is

1. A constant reminder of the presence of the pandemic.

2. Fallible in ways that humans can easily visualise.

Vaccines on the other hand are indistinguishable from magic.

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

#268
post #259

Earlier quoted context omitted.

Do you just want to do more research, or are you contending that you think the harm from COVID-19 is actually less than the harm from the most severe side effects of a vaccine we've ever seen?

In what age group? The 1976 vaccine actually killed people and gave Guillain Barré to many more, so that's your worst-case outcome. So far, under 20 years of age, the fatality rate for Covid is measured in low-single-digit thousandths of a percent (i.e. under a thousand in the US). https://www.medrxiv.org/content/10.1101/2020.08.24.20180851v...

Yeah, the worst vaccine mortality rate ever was still not remotely as bad as that, and you're not considering that a vaccine given to a 20 year old is helping to protect all the other people said 20 year old comes into contact with, who will have substantially higher mortality rates from COVID.

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

#269

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

But you have some broad idea if a mask is having some effect (e.g. if your mouth and nose are tightly covered). With a vaccine, the protection or lack thereof is invisible to you and others.

Anyone who's been getting flu vaccines surely has a pretty good idea how ineffective they can be.

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

#270

Earlier quoted context omitted.

top-down rules to micromanage I don't operate that way. Generally speaking, that's antithetical to how I operate in life. I think if we have more support for remote work for people who want/need it and more support for options like Little Caesar's pizza portal which allows for contactless take-out, that helps make life possible for the most vulnerable people. Given how long people are living and our success in keepin…

Maybe I misunderstood, because I'm on board with everything you're describing here. Most people I've seen who say they don't want to return to "business as usual" mean that we should just have restrictions in place forever, but if we're just talking about additive changes to let people avoid diseases if they'd like, I'm all in favor.

Back in March, I had extra money for some reason and the pandemic was hitting my small town in terms of things closing and hours being limited, etc. I made a point of going every single day to get pizza from the Little Caesar's.

When I began going, the staff was standing around with nothing to do and they were scared the location was going to permanently close. They didn't have enough business to survive.

I walk everywhere, so when I get pizza, it's very visible. People see me carrying a pizza box down the street and at least once someone asked me "Oh, is the Little Caesar's open?" and I was able to say "Yes! It is!" without violating social distancing.

I began using the pizza portal, which had been there for some time but never got used. One of the early times I used it, someone stared at me the entire time and now mine is not the only order in it.

The Little Caesar's removed the two chairs from their lobby and added hand sanitizer and made some other changes, but the big change is that -- at least in part because of me modeling it -- locals began calling ahead or ordering online instead of walking in and ordering. Even when they walk in, they frequently go sit in their car to wait for their order instead of standing in the Little Caesar's to wait.

They are busier than I have ever seen them in the three years I have lived here and they were hiring new employees during the pandemic. I always have to wait for my order now because they are always busy, yet it is safer than it has ever been for me to get food from there -- which is a constant concern for me because of my incurable medical condition.

Meanwhile, in recent months I have seen multiple local eateries advertised as for sale, presumably because the pandemic is negatively impacting the restaurant business generally.

Ordering online or by phone and getting takeout is a best practice for germ control and it's available right now and we can improve on that model with relatively small tweaks, like making hand sanitizer standard at all businesses, and larger tweaks, like making pizza portal style pick up options available at other eateries. And it in no way requires any government rules trying to micromanage your behavior.

It's about opening up options that actually work and promoting things that are already proven to work and are already available so the economy doesn't have to be strangled by this pandemic. It's an approach that doesn't require us to choose between economic health and physical health. It's an approach that works because it respects the need for both and does so without asking anyone to jump through giant hoops now in hopes of some potential, but not guaranteed, payoff somewhere down the road after x, y or z happens.

Thank you for engaging me.

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