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

211–220 of 344 posts

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

#211

Post by Animats »

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 that make through the safety tests? Nobody really knows yet. The FDA (pre-Trump push) announced that their minimal effectiveness for approval was 50%, which is low for a vaccine. Moderna is aiming for 60%. Effectiveness times fraction of population getting it has to be > 70% or so to stop the epidemic with a vaccine alone. That's the "herd immunity" fraction for a disease with a growth rate of 3.

Useful questions:

- If a vaccine is only partially effective, will an antibody test tell if it worked?

- Will taking one vaccine limit the effectiveness of another vaccine taken later? That's happened for a few vaccines.[2] It's usually more of a timing thing; some vaccines should not be given within a few weeks of other vaccines.[3]

- Could widespread use of a moderately effective vaccine cause people to abandon mask-type precautions and cause an epidemic spike in the unprotected part of the population?

Is someone working those issues effectively?

[1] https://www.nytimes.com/interactive/2020/science/coronavirus...

[2] https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.10...

[3] https://www.ok.gov/health2/documents/IMM_PRG_5-20_Intervals_...

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

#212

Post by SpicyLemonZest »

DoreenMichele wrote: post #201
SpicyLemonZest wrote: post #197

Earlier quoted context omitted.

It just seems terribly dismissive of all the people who want and demand a return to business as usual. A plan for handling the coronavirus that doesn't include "here's when we'll open the bars" is missing a huge piece of the problem.

I honestly fail to see a connection between your statement and mine. I don't generally drink alcohol and I have a permanently compromised immune system, so hanging out at bars isn't some normal part of my life. So I don't understand what you feel is so essential to "here's when we'll open the bars." Also, a bar up the street from me has already re-opened and (when they were just doing take-out beer) I posted a photo…

I guess I'm not sure how to respond. It's not about bars specifically; it's about returning to an environment where people are free to crowd about if they'd like. As long as there are top-down rules to micromanage where I can go and how many others I can go with, the problem isn't solved. "Maybe we should just get used to those rules" isn't a solution - in all but the hardest-hit areas, the rules are most of the problem!

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

#213

Post by ISL »

jrochkind1 wrote: post #208

Sure, who even needs a regulator if pharmaceutical companies will just promise not to bring products to market unless they are "safe and effective".

Looming in the background are torts. If vaccine makers are forced to race ahead of safety in order to get to market and one turns out to be insufficiently safe, the manufacturer may get sued into the ground.

By agreeing not to jump the safety protocol, they are continuing to both limit their liability directly (by ensuring a safer product) and adhere to best-practices (which might help in a future court case).

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

#215

Post by orwin »

nradov wrote: post #102
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?

No one will be told to go intentionally infect themselves. There will be no human virus challenge trials in the US as that would obviously never pass a review board. Instead they will vaccinate a study group and then compare infections, symptoms, and deaths versus a control group. The best estimate of infection fatality rate is 0.65%, not 1%. https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scena...

I think this is the right IFR for the US, maybe a confidence interval is necessary however. In early April, data scientists paid by ARSGE calculated the IFR in france based on the diamond princess and found .7%, +- .2%, and estimated the high early IFR in spain and Italy was due to missing asymptomatic people and mismanagement. This pdf should still be available.

US having a relatively younger population, .65% seems correct.

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

#216

Post by nfw2 »

refurb wrote: post #204
nfw2 wrote: post #179

Earlier quoted context omitted.

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?

Adverse events are monitored continuously as long as the patient is still a part of the trial (which often extends past approval). Once the product is approved, the FDA has an adverse event monitoring system that collects reports and analyzes them for signals that might imply a previously-unknown adverse event. Of course it take more than just one case to for a new signal to be identified (unless it's really obvious…

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.

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

#217

Post by garmaine »

ethanbond wrote: post #154
garmaine wrote: post #120

Earlier quoted context omitted.

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

Man that is a good solution. That way we get a vaccine immediately! Who cares if it’s saline. Or arsenic.

The way these things are worded only protect from unintentional damage.

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

#218

Post by jrochkind1 »

ISL wrote: post #213
jrochkind1 wrote: post #208

Sure, who even needs a regulator if pharmaceutical companies will just promise not to bring products to market unless they are "safe and effective".

Looming in the background are torts. If vaccine makers are forced to race ahead of safety in order to get to market and one turns out to be insufficiently safe, the manufacturer may get sued into the ground. By agreeing not to jump the safety protocol, they are continuing to both limit their liability directly (by ensuring a safer product) and adhere to best-practices (which might help in a future court case).

Shh, if you say that too loud, the presidential administration will just indemnify them.

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

#219

Post by CydeWeys »

RangerScience wrote: post #174
mumblemumble wrote: post #130

Earlier quoted context omitted.

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?

Good news is that COVID (and coronaviruses in general) don't seem to have the same kind of mutation potential to bypass immune system responses like influenza does. So our best guess is that a COVID vaccine will be like Tdap or MMR, i.e. after the initial course you maybe only need occasional booster shots (if even that), vs influenza where it mutates enough that a new vaccine must be developed and administered every year.

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

#220

Post by aphextron »

RangerScience wrote: post #174
mumblemumble wrote: post #130

Earlier quoted context omitted.

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?

>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?

The Pfizer and Moderna vaccines are mRNA based, which means the iteration time is measured in weeks. The production process is massively simplified; it's just a chemical process like any other drug, rather than needing to be incubated in chicken eggs like a flu vaccine. The first mRNA vaccines for SARS-CoV-2 were being administered within 2 months of the outbreak. If these things work (and they do; phase 2 trials have shown immunogenicity 3-4 times higher than COVID convalescent plasma [0]), and they are proven to be safe in widespread usage, it will potentially revolutionize vaccine development. COVID could end up saving lives in the long run for the fact that it sped up the timeline on mRNA vaccines by a decade.

[0] https://www.medrxiv.org/content/10.1101/2020.08.17.20176651v...

Post reply on HN