19 ms·

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

190 points by sethbannon 6y ago

ars 6y ago
"82% of Democrats and 72% of Republicans expressed concern that the Covid-19 vaccine approval process would be driven more by politics than by science. More than 80% of independents, Republicans, and Democrats said they would worry about the safety of a vaccine that was approved quickly." Wow. And lest you think this is a Trump thing, the figures are similar in European countries. A bad COVID vaccine (one that doesn't work), or heaven help us, one that causes harm, could set public healthcare back decades.
- gizmo686 6y ago
  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 of the vaccine working would be by the herd immunity it creates. But that is a population level effect, and people are terrible at understanding population level effects.
  - lettergram 6y ago
    > The FDA has already said that 50% effectiveness would be sufficient, which would put it about on par with the seasonal flu vaccine. I think it’s difficult to quantify how successful the flu vaccine is. I’ve reviewed the numbers and it’s not clear the general flu vaccine does anything. That being said, targeting specific strains can help (problem with flu is the various strains and ability to mutate so easily).
    - liability 6y ago
      They make a new flu vaccine twice a year and effectiveness is quantified each time. https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.html https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates...
      - lettergram 6y ago
        The problem is correlations. The flu naturally varies in severity by region, age, time, etc. Even the studies you linked, anything prior to 2010 is suspect by participant counts being way too low. More recent studies appear better, BUT we don’t have anything prior to when vaccines started to compare. I’m not saying the evidence isn’t there, I am arguing it’s circumstantial - aka not definitive how much it helps. Flu itself varies in severity widely. I’m honestly convinced the entire flu vaccine program / push is to keep the industry active. This is similar to the DOD spending money on new weapons they don’t need to keep manufacturing going
      - nradov 6y ago
        The NIH is attempting to develop a universal influenza vaccine. A clinical trial is currently underway. https://www.niaid.nih.gov/diseases-conditions/universal-influenza-vaccine-research https://www.niaid.nih.gov/diseases-conditions/universal-infl...
  - ssully 6y ago
    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. If someone with an actual medical background knows more, I would love to hear it.
    - gizmo686 6y ago
      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.
- polote 6y ago
  > the figures are similar in European countries. Do you have a source ?
- treeman79 6y ago
  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’s a horrible decision to make anyway you slice it. Politician is going to be hated no matter what. If it works, they are bad for taking so long, taking risk. If it goes south...
  - ip26 6y ago
    I think the common understanding of a decision 'driven by politics instead of science' is making the choice in the way that most advantages your own political career, instead of the way that saves lives or the economy.
    - tux1968 6y ago
      Aren't those two things essentially the same thing? The best way to advance your career is to make choices that benefit the most people. You're not going to get ahead if your decision fails to save lives or the economy.
      - ip26 6y ago
        The best way to advance your career is to make choices that benefit the most people. You're not going to get ahead if your decision fails to save lives or the economy. Is this satire, or simply your first brush with politics? The subject of the vaccine is a tidy hypothetical example. Approve vaccine (with no actual regard to efficacy or safety). Bolster confidence in the status quo, reopen economy. People feel hopeful, things look up, re-elect current administration. Whoops, turns out the vaccine is actually poison. But it's too late to elect the other guy now, and the administration retains power four more years.
      - junipertea 6y ago
        You are, if you manage to blame the other party for sabotaging you.
- blackflame7000 6y ago
  Do you really believe polls like this are accurate?
  - jdhbbbhb 6y ago
    No. It's all propaganda
- eanzenberg 6y ago
  Not sure how this is an ‘only’ Trump thing. Republicans believe D-politics will delay the vaccine so it doesn’t come out before Nov 3rd, and Democrats believe R-politics will prematurely release a vaccine before Nov 3rd. This country has become so politically cancerous that I wonder if a WW2 style event were to happen (as if Covid isn’t one already) if the country could unite around it, today. And before you question the thesis, I’ve had the pleasure of listening to a few doctors lament the possibility of having life-saving therapies or vaccines if it helped Trump get re-elected.
  - deleted 6y ago
    [deleted]
- sugarpile 6y ago
  “A bad COVID vaccine (one that doesn't work), or heaven help us, one that causes harm, could set public healthcare back decades.” I see this a lot (and am not jumping on you), do you mind explaining why you feel this way? To me one of the few things that could restore my faith in public health after how this pandemic has been handled is allowing widespread early access to the vaccine with full access to whatever data has been gathered. In flight is fine. This “hur dur the masses can’t be trusted to make their own decisions” shit has got to stop. It has become clear public health in the US is more politics than health so any sort of management on an individual level gets zero trust from me.
Vysero 6y ago
"Sen. Kamala Harris of California, the Democratic vice presidential nominee, hinted that she would not take a Covid-19 vaccine if one were approved and distributed before the election. “I would not trust Donald Trump,” she said in a CNN interview. “I will not take his word for it.”" Tell me again why I should care what Kamala Harris opinion on the matter is? It must be her infinite knowledge and experience as a trained virologist...
- anamexis 6y ago
  It sounds like her opinion is that she will defer to trained virologists.
  - Vysero 6y ago
    That's completely beside the point. What I asked is, why should I care what her opinion on the mater is? Why was this quote included in this article? Also it doesn't "sound like" that at all. You could not possibly make that judgment based on the two sentences included in the quote.
    - hn_check 6y ago
      She was asked by CNN, given that she's running on the Biden-Harris ticket. No one particularly cares whether you care or not, but she is clearly a rather important person right now and was asked this question given that public health has marched to political drums rather than safety drums lately.
      - Vysero 6y ago
        Really? Considering the article is talking about how these things could be politically motivated I find it pretty dang odd to then go on by quoting a politicians opinion on the mater...
        hackyhacky 6y ago
        Who better to ask about politics than a politician?
wearhere 6y ago
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.
- deelowe 6y ago
  It's a moving target, so it's hard to say. Phase 3 trials depend entirely on the number of infected in the control group. Current estimates seem to indicate we may start seeing preliminary results in early Q4 with vaccines on target for an early 2021 date for implementation. These are the most aggressive schedules of course. Few are giving conservatives estimates right now, but I've seen June floated for more reasonable timelines.
- dmarchand90 6y ago
  My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any security beyond that
  - saiya-jin 6y ago
    Any increase in testing time will give some, albeit hard to measure, improvement in safety of the vaccine. Or am I missing something?
    - marcosdumay 6y ago
      Trump has made some very worrisome statements intended on either rushing a vaccine or placing the blame for the lack of it into whoever refuses to rush it. Then the FDA answered with a non-statement that said basically "there's no conspiracy, we are fully invested into doing our job". And, of course, that gave a clear signal that the FDA felt pressured and was reported worldwide with that bias. So, I read the GP saying that the manufacturers are telling the FDA "we know better than you" in an attempt to conserve their own credibility. Notice that this is a very bad message to pass into their own regulator, and worrisome for different reasons. But as long as it's only PR, it's not a real problem.
  - 6y ago
Invictus0 6y ago
Without fast track approval, in the best case scenario, approximately how long would it take for any of these vaccine candidates to go through phase 3 trials?
kippinitreal 6y ago
Seems like a smart decision by those businesses to team up (collude?) here both for business and public health reasons. If they all agree to wait post election there will be a higher rate of vaccinations which will benefit everyone (sales and progress towards herd immunity). I'm not sure if this would put them into any odd legal situations for playing politics.
- creaghpatr 6y ago
  There's no collusion or team up here, the pledge in question carries no obligations and is not legally binding. So this is more of a PR play. Possibly in response to politicians sowing doubt on the efficacy of a vaccine.
astrophysician 6y ago
Question: is it not a standard procedure to stop a Phase III trial early when the statistics warrant it? Isn't this a pretty cut-and-dried statistical question? Naively I would think that there's nothing controversial about ending a trial early, isn't that the ethical thing to do? I guess the political maneuvering angle before the election complicates all of that, but if the Trump administration is really willing to actually fabricate Phase III trial data, then why trust anything regardless of whether or not the Phase III trial "completes" or not?
- chundicus 6y ago
  My understanding is that the data has to be overwhelmingly good to stop the trial early. I suspect the Trump administration's ability to actually fabricate trial data would be pretty limited without collateral damage (i.e. whistleblowing). Their ability to push it out of Phase III prematurely however is more debatable.
  - mikeyouse 6y ago
    I don't think they typically stop the trial as much as they go to the FDA for emergency authorization with data from their midpoints showing overwhelmingly positive effects to get approval to proceed to Phase 4, while still finishing Phase 3. It's meant to compress the timeline, not to skip steps.
- vikramkr 6y ago
  If the statistics warrant it then yes, but for a vaccine, even waiting to finish these trials is an incredibly rushed schedule. This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it. I don't think the concern is about fabricating phase III data. The concern is that extreme political pressures mean no matter what the interim results say, the FDA may feel inclined to approve the vaccine. Considering that we need healthy people to willingly take these vaccines to end the pandemic, losing that trust in the process would be devastating. People need to believe that the FDA approved it because the evidence shows the vaccine is most likely effective without safety concerns. If they don't, then they won't take it, and if the vaccine then fails phase III, its not clear how you regain that trust as a regulatory agency.
jwieczorek 6y ago
Meanwhile, Russia just today announced it is starting the release of the first batch of its own vaccine to the public. https://www.aljazeera.com/news/2020/08/sputnik-russia-coronavirus-vaccine-200813070859021.html https://www.aljazeera.com/news/2020/08/sputnik-russia-corona...
- samatman 6y ago
  Correct, and this announcement is, among other things, a response to that.
- ConsiderCrying 6y ago
  Not sure why this got downvoted, it's not like the person is endorsing Russia's decision. I'm highly skeptical a country that refused to go on lockdown and underreported cases would make a safe vaccine faster than the rest of the world.
  - DenisM 6y ago
    > country that refused to go on lockdown What? Moscow lockdowns were some of the harshest outside East Asia.
    - orwin 6y ago
      I think grandparent meant "refused to go on lockdown on time". I have contacts in khazan ( not sure if orthographied correctly), the harsh lockdowns were due to a miscomprehension of the word "exponential growth" and overused hospitals.
      - c6401 6y ago
        >refused to go on lockdown on time Not sure if there was a definitive understanding when it was on time. As far as I remember, lockdown in Moscow started on March 23.
- deleted 6y ago
  [deleted]
woke_neolib 6y ago
They did not actually commit to finishing the clinical trials. > The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration. https://www.nytimes.com/2020/09/08/world/covid-19-coronavirus.html#link-679303d7 https://www.nytimes.com/2020/09/08/world/covid-19-coronaviru...
deleted 6y ago
[deleted]
BurningFrog 6y ago
There are 170+ covid vaccines being developed, 7 of which are in stage 3 trials: https://www.washingtonpost.com/graphics/2020/health/covid-vaccine-update-coronavirus/ https://www.washingtonpost.com/graphics/2020/health/covid-va... So it's a bit misleading to talk about "the vaccine".
warent 6y ago
I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds somewhat convincing enough to be concerning. EDIT: Downvoting someone for asking questions, even if based on a false premise, is completely shameful, especially when there's no claim to fact and it's clearly not made to be inflammatory. This community should encourage asking questions. Think carefully before throwing around a downvote as a marker of disagreement.
- airza 6y ago
  I think ruling that out is the point of a phase 3 trial.
  - newacct583 6y ago
    Exactly. Realistically vaccines are very safe, very occasionally they aren't. So you start small and increase the sample size gradually to manage that risk until you have enough data to show both efficacy and safety. To be fair: it's also a global pandemic, and one very poorly controlled in the US. So there is real and quantifiable risk to being "too slow", also. Balancing between the two extremes isn't well-served by a static protocol, you'd do something different for a vaccine against ebola (where you want to take your time because there are very few cases) than you would for covid (more urgent, low thousands of people dying every day) than you would have in the 50's for polio (an ongoing global catastrophe). So... sure. It's not at all unreasonable that an "emergency" vaccine approval might happen. Which is why it's such a disaster that the FDA has given the appearance of being politicized (c.f. the plasma nonsense announcement, the right wing journalist hired as a press manager by the white house and then fired from within the bureaucracy). There is real concern that this administration really would "cheat" with a vaccine announcement in a way unsupported by the science. So now worry about blowback is forcing the pharma companies to, perhaps, err in the opposite direction by ruling out an emergency approval. I'm not sure that's right either. (Or maybe they all know there's no way they'll have valid data before November and are just trying to shut the debate down early.)
credit_guy 6y ago
The actual pledge is here [1]. There are 4 bullet points, 3 of them are quite generic; the one that made all the waves is: "[we pledge to] Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA." I feel there's some weasel wording going on here. They don't pledge to ask for approval after the completion of Phase 3. Instead they use a very convoluted phrasing, that's designed to make people think it's after Phase 3 is completed, but if you read more closely says something quite different. When is the Phase 3 for Moderna expected to be completed anyway? This is readily available information at clinicaltrials.gov [2]. The estimated study completion date is October 27, 2022. Is the CEO of Moderna saying he will not seek approval prior to that date? Pfizer's estimated study completion date is November 14, 2022 [3]. Two years from now doesn't sound quite "warp speed" to me. Did they take billions of dollars of public money to deliver a vaccine in 2 years? [1] https://www.businesswire.com/news/home/20200908005282/en/Biopharma-Leaders-Unite-Stand-Science https://www.businesswire.com/news/home/20200908005282/en/Bio... [2] https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 [3] https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728
- darkerside 6y ago
  I agree. They are only saying they will demonstrate safety and efficacy through the trials, not that the trials will be technically completed. And, I think that's fine. I'm not taking a politician's word for whether that has been achieved, but I agree with it in concept.
- maxerickson 6y ago
  'after demonstrating safety and efficacy' is not weasel wording though, it's just a different benchmark than 'completing the study'. The headline is inaccurate, but that's on Statnews. When studies go really well, doctors consider themselves ethically obligated to end them early, so that the placebo group can receive the treatment. That these studies have planned end dates well into the future doesn't mean that they must run that long (or that it will take that long to collect sufficient safety data).
blumomo 6y ago
Here in Europe they are freed from legal consequences should the vaccine harm someone. Instead our countries are to pay any occurring damaging. So I don’t quiet get what motivated the vaccine makers to await the approval given that they are practically free from prosecution anyway.
- snowwrestler 6y ago
  The U.S. has a similar regulatory regime to manage vaccine liability. But it's not a free-for-all; vaccines need to meet certain criteria before they qualify for this program. This is a huge reason that these companies are concerned. If they are pushed to release a vaccine too early, and it harms a bunch of people, any evidence they bent the rules at all will be used to try to break their immunity from civil liability. It would be a field day for personal injury lawyers.
- eCa 6y ago
  It should be in everyone's (and certainly the manufacturers') interest that the vaccines actually are safe.
  - blumomo 6y ago
    Past has shown that it wasn’t. See swine flu vaccinations.
    - refurb 6y ago
      No vaccine is 100% safe. That doesn't exist. The real question is the risk/benefit profile. Does the benefit of the vaccine outweigh the risks. That was a "no" for the swine flu vaccine since the outbreak fizzled out quickly. If tens of thousands were dying every month from the swine flu, then the vaccine may have still be worth it even with the GBS side effect.
mola 6y ago
What exactly is this news source doing here? Just repackaging a press release? There are very important questions being asked here about the wording. Journalists should be the one thinking up these questions and asking them. They shouldn't publish these kinds of statements without doing this. Otherwise they are no more than propaganda machines. Fake news is not only out-right lying, it's journalists not doing their jobs of asking the hard questions.
chrisco255 6y ago
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 everything on hopes for a vaccine?
- adamnemecek 6y ago
  No, we are not at herd immunity. Because if uncontrolled, in US alone 3 million (probably more) would die.
- noodlenotes 6y ago
  The problem is that the people who back reopening are also against precautions that would make reopening safer. If I could trust the random people I'll encounter to wear their masks correctly and stay home if they're sick, maybe I would feel safe going out again. But instead politics has emboldened these people to behave in ways that put the people around them at more risk than necessary.
- whyleyc 6y ago
  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 https://bbc.co.uk/news/world-europe-53498133 [2] https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-with-covid19.html https://www.jhsph.edu/covid-19/articles/achieving-herd-immun... [3] https://www.nice.org.uk/advice/es28/chapter/Factors-for-decision-making https://www.nice.org.uk/advice/es28/chapter/Factors-for-deci... [4] https://ourworldindata.org/covid-models 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 https://covidtracking.com/data/national/hospitalization [7] https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/hospitalizations-forecasts.html https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/hosp...
garmaine 6y ago
WTF. This is going to kill people. A lot of people. Look, the usual situation with vaccines is that we are weighing (1) the danger posed to the few people who get sick while the trials are going on; vs. (2) the risks taken on by everybody who gets the vaccine. The vaccine might have a small likelihood of triggering reactions or otherwise having adverse effects, and spread over the entire population these edge cases can add up to do more damage than the disease itself. Again, that is for typical vaccine situations. A pandemic is totally different--the number of cases is exponentially increasing and ripping through the entire population. So our options are: 1. Wait the additional 6-12 months it would take (even accounting for the immense investments that have been made) to get a vaccine to go through all the normal regulatory hoops we would demand of vaccine development outside of a pandemic. During which time COVID-19 rips through the population leaving potentially millions dead and hundreds of millions of recovered with disease-related tissue damage. 2. Wait, but stay in lockdown to keep the disease at bay, but in the process massively drive up suicide, domestic violence, and divorce rates, wreck the economy, and force people to spend their savings and/or trigger massive inflation through pandemic relief. 3. Some horrible compromise between the above two extremes. 4. Roll out the vaccines as quickly as they can be manufactured, starting now. Don't wait for Phase III results. The Phase I and Phase II trials tell us that the vaccine successfully generates antibodies. The group sizes so far have been large enough to know that the risk of fatal interactions is less than the risk of dying from COVID-19 itself--indeed, for the most part there haven't been ANY severe reactions, at least in the major vaccines. This "wait until the vaccine is proven safe!" is politically generated nonsense. There is no data-driven argument supporting it. Ideologues on the left assume that Trump wants a vaccine ASAP to win reelection, don't trust is understanding of the science, and therefore assume that early administration of a vaccine would be some sort of unsafe political compromise. Ideologues on the right believe COVID-19 is a hoax anyway. But even a broken clock is right twice a day, and the fact that Trump wants a quick vaccine approval has no bearing on whether it is a good idea or not; and in this case it very clearly IS beneficial to distribute a vaccine as quickly as it can be manufactured.
- deleted 6y ago
  [deleted]
anonu 6y ago
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/ https://www.cbsnews.com/news/the-most-dangerous-vaccine/ [2] https://en.wikipedia.org/wiki/Progressive_vaccinia https://en.wikipedia.org/wiki/Progressive_vaccinia
- nouveaux 6y ago
  "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 https://en.wikipedia.org/wiki/1976_swine_flu_outbreak
  - hedgew 6y ago
    > "There is not even complete agreement about the causal relationship between the swine flu vaccine and Guillain-Barré syndrome" > "Studies suggest that it is more likely that a person will get GBS after getting the flu than after vaccination" In the worst case, about 450 people got Guillain-Barre due to the vaccine. Counterfactually, some thousands or even a million Americans might have died from the swine flu itself.
- grillvogel 6y ago
  the Cutter Incident comes to mind. https://en.wikipedia.org/wiki/Cutter_Laboratories#Cutter_incident https://en.wikipedia.org/wiki/Cutter_Laboratories#Cutter_inc...
GavinB 6y ago
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.
bglusman 6y ago
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 a subset of them who have them would volunteer for a modified trial, we could possibly do a double-blind intentional-exposure test on people to confirm that the vaccine confers BETTER immunity than the existing similar antibodies do, right? Would it be possible to ethically and realistically use that strategy to accelerate effectiveness testing (if not safety testing) of any vaccine candidates? or would the smaller scale of that have only made sense for something more like Phase 2 trials? Arguably, as long as safety is near perfect, we should be willing to tolerate only moderate (say, 90%) effectiveness (and I'd read one of the vaccines took two doses to get 100% effectiveness but was 90% after a single dose), but I don't know how safety is evaluated and obviously long-term safety and short-term safety are pretty different/I imagine a lot of people will be more concerned about long term safety and I don't know how you can reassure them on that on any kind of accelerated schedule.
- DavidSJ 6y ago
  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.
  - 411111111111111 6y ago
    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.
    - nomel 6y ago
      > inversely correlated with age To some degree. Immunity fades, which is the whole concept of booster shots.
nfw2 6y ago
After hearing Fauci's recent comments on the matter, my understanding is that the phase III trials can be considered for approval once there are enough infections in the control group to do a comparative analysis. Since the events now needed to confirm the vaccine are in the control group, not the experimental group, it seems that the blocker for approval now isn't SAFETY, as it has been continually suggested, but EFFICACY. If that is indeed the case, what makes the most sense to me would be to allow an early approval of any vaccine that meets reasonable safety requirement (some x months in stage 3 trial), but the patient must sign a waiver saying that they understand there may be rare side effects and there is no guaranteed immunity.
- maxerickson 6y ago
  No, phase III is still examining safety. For example, they document how a larger number of vaccinated individuals react to infection. A phase II trial might not track any infections.
  - nfw2 6y ago
    Phase III examines both the efficacy and safety of the vaccine. These are independent questions. Just because a trial takes x years to determine efficacy, it doesn't necessarily take the same amount of time to determine safety. Fauci said certain vaccines could be approved as soon as there were enough events in the control group. Any dangerous side effects would only be in the experimental group and not dependent on events in the control group. If the only blocking factor is number of events in the control group, that to me suggest that the question of safety has already be sufficiently resolved for some of the candidate vaccines.
    - maxerickson 6y ago
      Yes, I directly addressed that. A potential safety issue with vaccines is making the course of the infection worse. So you have to look at vaccinated people that get infected (an 'event') to check on that. Phase II checks if the vaccines directly causes problems, but doesn't look at a lot of events.
mumblemumble 6y ago
Meta observation: The sheer volume of downvoting of reasonable comments in here really speaks volumes about the extent to which the SARS-CoV-2 pandemic is at least as much a political subject as it is a scientific one.
- trhway 6y ago
  "El sueño de la razón produce monstruos" (The Sleep of Reason Produces Monsters).
jrochkind1 6y ago
Sure, who even needs a regulator if pharmaceutical companies will just promise not to bring products to market unless they are "safe and effective".
- ISL 6y ago
  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).
  - jrochkind1 6y ago
    Shh, if you say that too loud, the presidential administration will just indemnify them.
  - ralph84 6y ago
    It's been decades since vaccine makers had any liability for their products in the US. That hasn't changed with COVID-19. https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Injury_Act https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...
    - ISL 6y ago
      I signed a waiver for a non-approved yellow-fever vaccine in the US recently (supply of the approved vaccine is either non-existent or very limited); there must be some level of testing/certification required before reaching that threshold?
Animats 6y ago
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-vaccine-tracker.html https://www.nytimes.com/interactive/2020/science/coronavirus... [2] https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.1091908 https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.10... [3] https://www.ok.gov/health2/documents/IMM_PRG_5-20_Intervals_Live_Vaccines&Other_Rules.pdf https://www.ok.gov/health2/documents/IMM_PRG_5-20_Intervals_...
- umanwizard 6y ago
  > 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).
  - brian_cloutier 6y ago
    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, even if we hadn't reached herd immunity, we could safely relax restrictions on gatherings without causing another wave. Concerts would still be out of the question, but dinner parties and hair salons would no longer be so concerning.
mensetmanusman 6y ago
We should have had a serious national discussion about letting low risk volunteers be exposed to the virus to rapidly progress through Phase 3, right? https://www.nature.com/articles/d41586-020-01179-x https://www.nature.com/articles/d41586-020-01179-x
mchusma 6y ago
I hope that the benchmark for approval is "for a given group, the risk of the vaccine is lower than the risk of COVID". This has some good commentary: https://marginalrevolution.com/marginalrevolution/2020/09/on-vaccine-timing-from-the-comments.html https://marginalrevolution.com/marginalrevolution/2020/09/on... some thoughtful commentary. I believe that for at risk populations it is very likely that taking a phase III vaccine candidate is the safer option right now, let alone after another month of data. I think let anyone who wants to volunteer to take it make their own risk assessment but be required to send data back. The only real arguments I have seen against this are political or paternalistic. But I also think people should be allowed to run human challenge studies on volunteers, which is also an ethical no brainier. But that doesn't seem to be happening either. It basically feel like the world in 2020 decided the answer to the "trolley car problem" https://en.wikipedia.org/wiki/Trolley_problem https://en.wikipedia.org/wiki/Trolley_problem. 2020 society's action seems to be: "inaction causing 5 deaths is better than action causing 1 death".
- outside1234 6y ago
  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.
  - cultureulterior 6y ago
    That's what they said about masks, and that turned out to be wrong too. Assuming that people are idiots never helps
    - meowface 6y ago
      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.
nfw2 6y ago
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 access to vaccines that have been through some baseline safety testing. What seems like a good solution to me is to have open phase 3 trials that accept anyone willing to waive the risks. This would also accelerate us towards to a point where we are ready to approve a vaccine for everyone.
- afarrell 6y ago
  > 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.
rsynnott 6y ago
Timely: https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/ https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vac... (This may be nothing, of course, but it's a decent illustration that some caution is warranted)

190 points by sethbannon 6y ago

ars 6y ago

"82% of Democrats and 72% of Republicans expressed concern that the Covid-19 vaccine approval process would be driven more by politics than by science. More than 80% of independents, Republicans, and Democrats said they would worry about the safety of a vaccine that was approved quickly." Wow. And lest you think this is a Trump thing, the figures are similar in European countries. A bad COVID vaccine (one that doesn't work), or heaven help us, one that causes harm, could set public healthcare back decades.

gizmo686 6y ago
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 of the vaccine working would be by the herd immunity it creates. But that is a population level effect, and people are terrible at understanding population level effects.
- lettergram 6y ago
  > The FDA has already said that 50% effectiveness would be sufficient, which would put it about on par with the seasonal flu vaccine. I think it’s difficult to quantify how successful the flu vaccine is. I’ve reviewed the numbers and it’s not clear the general flu vaccine does anything. That being said, targeting specific strains can help (problem with flu is the various strains and ability to mutate so easily).
  - liability 6y ago
    They make a new flu vaccine twice a year and effectiveness is quantified each time. https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.html https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates...
    - lettergram 6y ago
      The problem is correlations. The flu naturally varies in severity by region, age, time, etc. Even the studies you linked, anything prior to 2010 is suspect by participant counts being way too low. More recent studies appear better, BUT we don’t have anything prior to when vaccines started to compare. I’m not saying the evidence isn’t there, I am arguing it’s circumstantial - aka not definitive how much it helps. Flu itself varies in severity widely. I’m honestly convinced the entire flu vaccine program / push is to keep the industry active. This is similar to the DOD spending money on new weapons they don’t need to keep manufacturing going
    - nradov 6y ago
      The NIH is attempting to develop a universal influenza vaccine. A clinical trial is currently underway. https://www.niaid.nih.gov/diseases-conditions/universal-influenza-vaccine-research https://www.niaid.nih.gov/diseases-conditions/universal-infl...
- ssully 6y ago
  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. If someone with an actual medical background knows more, I would love to hear it.
  - gizmo686 6y ago
    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.
polote 6y ago
> the figures are similar in European countries. Do you have a source ?
treeman79 6y ago
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’s a horrible decision to make anyway you slice it. Politician is going to be hated no matter what. If it works, they are bad for taking so long, taking risk. If it goes south...
- ip26 6y ago
  I think the common understanding of a decision 'driven by politics instead of science' is making the choice in the way that most advantages your own political career, instead of the way that saves lives or the economy.
  - tux1968 6y ago
    Aren't those two things essentially the same thing? The best way to advance your career is to make choices that benefit the most people. You're not going to get ahead if your decision fails to save lives or the economy.
    - ip26 6y ago
      The best way to advance your career is to make choices that benefit the most people. You're not going to get ahead if your decision fails to save lives or the economy. Is this satire, or simply your first brush with politics? The subject of the vaccine is a tidy hypothetical example. Approve vaccine (with no actual regard to efficacy or safety). Bolster confidence in the status quo, reopen economy. People feel hopeful, things look up, re-elect current administration. Whoops, turns out the vaccine is actually poison. But it's too late to elect the other guy now, and the administration retains power four more years.
    - junipertea 6y ago
      You are, if you manage to blame the other party for sabotaging you.
blackflame7000 6y ago
Do you really believe polls like this are accurate?
- jdhbbbhb 6y ago
  No. It's all propaganda
eanzenberg 6y ago
Not sure how this is an ‘only’ Trump thing. Republicans believe D-politics will delay the vaccine so it doesn’t come out before Nov 3rd, and Democrats believe R-politics will prematurely release a vaccine before Nov 3rd. This country has become so politically cancerous that I wonder if a WW2 style event were to happen (as if Covid isn’t one already) if the country could unite around it, today. And before you question the thesis, I’ve had the pleasure of listening to a few doctors lament the possibility of having life-saving therapies or vaccines if it helped Trump get re-elected.
- deleted 6y ago
  [deleted]
sugarpile 6y ago
“A bad COVID vaccine (one that doesn't work), or heaven help us, one that causes harm, could set public healthcare back decades.” I see this a lot (and am not jumping on you), do you mind explaining why you feel this way? To me one of the few things that could restore my faith in public health after how this pandemic has been handled is allowing widespread early access to the vaccine with full access to whatever data has been gathered. In flight is fine. This “hur dur the masses can’t be trusted to make their own decisions” shit has got to stop. It has become clear public health in the US is more politics than health so any sort of management on an individual level gets zero trust from me.

Vysero 6y ago

"Sen. Kamala Harris of California, the Democratic vice presidential nominee, hinted that she would not take a Covid-19 vaccine if one were approved and distributed before the election. “I would not trust Donald Trump,” she said in a CNN interview. “I will not take his word for it.”" Tell me again why I should care what Kamala Harris opinion on the matter is? It must be her infinite knowledge and experience as a trained virologist...

anamexis 6y ago
It sounds like her opinion is that she will defer to trained virologists.
- Vysero 6y ago
  That's completely beside the point. What I asked is, why should I care what her opinion on the mater is? Why was this quote included in this article? Also it doesn't "sound like" that at all. You could not possibly make that judgment based on the two sentences included in the quote.
  - hn_check 6y ago
    She was asked by CNN, given that she's running on the Biden-Harris ticket. No one particularly cares whether you care or not, but she is clearly a rather important person right now and was asked this question given that public health has marched to political drums rather than safety drums lately.
    - Vysero 6y ago
      Really? Considering the article is talking about how these things could be politically motivated I find it pretty dang odd to then go on by quoting a politicians opinion on the mater...
      - hackyhacky 6y ago
        Who better to ask about politics than a politician?

wearhere 6y ago

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.

deelowe 6y ago
It's a moving target, so it's hard to say. Phase 3 trials depend entirely on the number of infected in the control group. Current estimates seem to indicate we may start seeing preliminary results in early Q4 with vaccines on target for an early 2021 date for implementation. These are the most aggressive schedules of course. Few are giving conservatives estimates right now, but I've seen June floated for more reasonable timelines.
dmarchand90 6y ago
My impression is that this was done to specifically counter Donald Trump rushing a vaccine prior to the election. I don't think it was really made to give any security beyond that
- saiya-jin 6y ago
  Any increase in testing time will give some, albeit hard to measure, improvement in safety of the vaccine. Or am I missing something?
  - marcosdumay 6y ago
    Trump has made some very worrisome statements intended on either rushing a vaccine or placing the blame for the lack of it into whoever refuses to rush it. Then the FDA answered with a non-statement that said basically "there's no conspiracy, we are fully invested into doing our job". And, of course, that gave a clear signal that the FDA felt pressured and was reported worldwide with that bias. So, I read the GP saying that the manufacturers are telling the FDA "we know better than you" in an attempt to conserve their own credibility. Notice that this is a very bad message to pass into their own regulator, and worrisome for different reasons. But as long as it's only PR, it's not a real problem.
- 6y ago

Invictus0 6y ago

Without fast track approval, in the best case scenario, approximately how long would it take for any of these vaccine candidates to go through phase 3 trials?

kippinitreal 6y ago

Seems like a smart decision by those businesses to team up (collude?) here both for business and public health reasons. If they all agree to wait post election there will be a higher rate of vaccinations which will benefit everyone (sales and progress towards herd immunity). I'm not sure if this would put them into any odd legal situations for playing politics.

creaghpatr 6y ago
There's no collusion or team up here, the pledge in question carries no obligations and is not legally binding. So this is more of a PR play. Possibly in response to politicians sowing doubt on the efficacy of a vaccine.

astrophysician 6y ago

Question: is it not a standard procedure to stop a Phase III trial early when the statistics warrant it? Isn't this a pretty cut-and-dried statistical question? Naively I would think that there's nothing controversial about ending a trial early, isn't that the ethical thing to do? I guess the political maneuvering angle before the election complicates all of that, but if the Trump administration is really willing to actually fabricate Phase III trial data, then why trust anything regardless of whether or not the Phase III trial "completes" or not?

chundicus 6y ago
My understanding is that the data has to be overwhelmingly good to stop the trial early. I suspect the Trump administration's ability to actually fabricate trial data would be pretty limited without collateral damage (i.e. whistleblowing). Their ability to push it out of Phase III prematurely however is more debatable.
- mikeyouse 6y ago
  I don't think they typically stop the trial as much as they go to the FDA for emergency authorization with data from their midpoints showing overwhelmingly positive effects to get approval to proceed to Phase 4, while still finishing Phase 3. It's meant to compress the timeline, not to skip steps.
vikramkr 6y ago
If the statistics warrant it then yes, but for a vaccine, even waiting to finish these trials is an incredibly rushed schedule. This isn't even about stopping the trial early - this is about approving it conditionally before the trial is done and then waiting for the trial to end to really approve it. I don't think the concern is about fabricating phase III data. The concern is that extreme political pressures mean no matter what the interim results say, the FDA may feel inclined to approve the vaccine. Considering that we need healthy people to willingly take these vaccines to end the pandemic, losing that trust in the process would be devastating. People need to believe that the FDA approved it because the evidence shows the vaccine is most likely effective without safety concerns. If they don't, then they won't take it, and if the vaccine then fails phase III, its not clear how you regain that trust as a regulatory agency.

jwieczorek 6y ago

Meanwhile, Russia just today announced it is starting the release of the first batch of its own vaccine to the public. https://www.aljazeera.com/news/2020/08/sputnik-russia-coronavirus-vaccine-200813070859021.html https://www.aljazeera.com/news/2020/08/sputnik-russia-corona...

samatman 6y ago
Correct, and this announcement is, among other things, a response to that.
ConsiderCrying 6y ago
Not sure why this got downvoted, it's not like the person is endorsing Russia's decision. I'm highly skeptical a country that refused to go on lockdown and underreported cases would make a safe vaccine faster than the rest of the world.
- DenisM 6y ago
  > country that refused to go on lockdown What? Moscow lockdowns were some of the harshest outside East Asia.
  - orwin 6y ago
    I think grandparent meant "refused to go on lockdown on time". I have contacts in khazan ( not sure if orthographied correctly), the harsh lockdowns were due to a miscomprehension of the word "exponential growth" and overused hospitals.
    - c6401 6y ago
      >refused to go on lockdown on time Not sure if there was a definitive understanding when it was on time. As far as I remember, lockdown in Moscow started on March 23.
deleted 6y ago
[deleted]

woke_neolib 6y ago

They did not actually commit to finishing the clinical trials. > The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration. https://www.nytimes.com/2020/09/08/world/covid-19-coronavirus.html#link-679303d7 https://www.nytimes.com/2020/09/08/world/covid-19-coronaviru...

deleted 6y ago

[deleted]

BurningFrog 6y ago

There are 170+ covid vaccines being developed, 7 of which are in stage 3 trials: https://www.washingtonpost.com/graphics/2020/health/covid-vaccine-update-coronavirus/ https://www.washingtonpost.com/graphics/2020/health/covid-va... So it's a bit misleading to talk about "the vaccine".

warent 6y ago

I've recently heard an argument that the probability of being injured/killed by a vaccine (e.g. due to complications, allergies, etc.) is on average greater than the probability of covid causing damage/fatality to an individual, therefore if people are administered these vaccines then we'll actually see an increase in mortality/illness. Can anyone speak to this? I'm not sure how legitimate this is, but it sounds somewhat convincing enough to be concerning. EDIT: Downvoting someone for asking questions, even if based on a false premise, is completely shameful, especially when there's no claim to fact and it's clearly not made to be inflammatory. This community should encourage asking questions. Think carefully before throwing around a downvote as a marker of disagreement.

airza 6y ago
I think ruling that out is the point of a phase 3 trial.
- newacct583 6y ago
  Exactly. Realistically vaccines are very safe, very occasionally they aren't. So you start small and increase the sample size gradually to manage that risk until you have enough data to show both efficacy and safety. To be fair: it's also a global pandemic, and one very poorly controlled in the US. So there is real and quantifiable risk to being "too slow", also. Balancing between the two extremes isn't well-served by a static protocol, you'd do something different for a vaccine against ebola (where you want to take your time because there are very few cases) than you would for covid (more urgent, low thousands of people dying every day) than you would have in the 50's for polio (an ongoing global catastrophe). So... sure. It's not at all unreasonable that an "emergency" vaccine approval might happen. Which is why it's such a disaster that the FDA has given the appearance of being politicized (c.f. the plasma nonsense announcement, the right wing journalist hired as a press manager by the white house and then fired from within the bureaucracy). There is real concern that this administration really would "cheat" with a vaccine announcement in a way unsupported by the science. So now worry about blowback is forcing the pharma companies to, perhaps, err in the opposite direction by ruling out an emergency approval. I'm not sure that's right either. (Or maybe they all know there's no way they'll have valid data before November and are just trying to shut the debate down early.)

credit_guy 6y ago

The actual pledge is here [1]. There are 4 bullet points, 3 of them are quite generic; the one that made all the waves is: "[we pledge to] Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA." I feel there's some weasel wording going on here. They don't pledge to ask for approval after the completion of Phase 3. Instead they use a very convoluted phrasing, that's designed to make people think it's after Phase 3 is completed, but if you read more closely says something quite different. When is the Phase 3 for Moderna expected to be completed anyway? This is readily available information at clinicaltrials.gov [2]. The estimated study completion date is October 27, 2022. Is the CEO of Moderna saying he will not seek approval prior to that date? Pfizer's estimated study completion date is November 14, 2022 [3]. Two years from now doesn't sound quite "warp speed" to me. Did they take billions of dollars of public money to deliver a vaccine in 2 years? [1] https://www.businesswire.com/news/home/20200908005282/en/Biopharma-Leaders-Unite-Stand-Science https://www.businesswire.com/news/home/20200908005282/en/Bio... [2] https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 [3] https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728

darkerside 6y ago
I agree. They are only saying they will demonstrate safety and efficacy through the trials, not that the trials will be technically completed. And, I think that's fine. I'm not taking a politician's word for whether that has been achieved, but I agree with it in concept.
maxerickson 6y ago
'after demonstrating safety and efficacy' is not weasel wording though, it's just a different benchmark than 'completing the study'. The headline is inaccurate, but that's on Statnews. When studies go really well, doctors consider themselves ethically obligated to end them early, so that the placebo group can receive the treatment. That these studies have planned end dates well into the future doesn't mean that they must run that long (or that it will take that long to collect sufficient safety data).

blumomo 6y ago

Here in Europe they are freed from legal consequences should the vaccine harm someone. Instead our countries are to pay any occurring damaging. So I don’t quiet get what motivated the vaccine makers to await the approval given that they are practically free from prosecution anyway.

snowwrestler 6y ago
The U.S. has a similar regulatory regime to manage vaccine liability. But it's not a free-for-all; vaccines need to meet certain criteria before they qualify for this program. This is a huge reason that these companies are concerned. If they are pushed to release a vaccine too early, and it harms a bunch of people, any evidence they bent the rules at all will be used to try to break their immunity from civil liability. It would be a field day for personal injury lawyers.
eCa 6y ago
It should be in everyone's (and certainly the manufacturers') interest that the vaccines actually are safe.
- blumomo 6y ago
  Past has shown that it wasn’t. See swine flu vaccinations.
  - refurb 6y ago
    No vaccine is 100% safe. That doesn't exist. The real question is the risk/benefit profile. Does the benefit of the vaccine outweigh the risks. That was a "no" for the swine flu vaccine since the outbreak fizzled out quickly. If tens of thousands were dying every month from the swine flu, then the vaccine may have still be worth it even with the GBS side effect.

mola 6y ago

What exactly is this news source doing here? Just repackaging a press release? There are very important questions being asked here about the wording. Journalists should be the one thinking up these questions and asking them. They shouldn't publish these kinds of statements without doing this. Otherwise they are no more than propaganda machines. Fake news is not only out-right lying, it's journalists not doing their jobs of asking the hard questions.

chrisco255 6y ago

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 everything on hopes for a vaccine?

adamnemecek 6y ago
No, we are not at herd immunity. Because if uncontrolled, in US alone 3 million (probably more) would die.
noodlenotes 6y ago
The problem is that the people who back reopening are also against precautions that would make reopening safer. If I could trust the random people I'll encounter to wear their masks correctly and stay home if they're sick, maybe I would feel safe going out again. But instead politics has emboldened these people to behave in ways that put the people around them at more risk than necessary.
whyleyc 6y ago
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 https://bbc.co.uk/news/world-europe-53498133 [2] https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-with-covid19.html https://www.jhsph.edu/covid-19/articles/achieving-herd-immun... [3] https://www.nice.org.uk/advice/es28/chapter/Factors-for-decision-making https://www.nice.org.uk/advice/es28/chapter/Factors-for-deci... [4] https://ourworldindata.org/covid-models 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 https://covidtracking.com/data/national/hospitalization [7] https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/hospitalizations-forecasts.html https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/hosp...

garmaine 6y ago

WTF. This is going to kill people. A lot of people. Look, the usual situation with vaccines is that we are weighing (1) the danger posed to the few people who get sick while the trials are going on; vs. (2) the risks taken on by everybody who gets the vaccine. The vaccine might have a small likelihood of triggering reactions or otherwise having adverse effects, and spread over the entire population these edge cases can add up to do more damage than the disease itself. Again, that is for typical vaccine situations. A pandemic is totally different--the number of cases is exponentially increasing and ripping through the entire population. So our options are: 1. Wait the additional 6-12 months it would take (even accounting for the immense investments that have been made) to get a vaccine to go through all the normal regulatory hoops we would demand of vaccine development outside of a pandemic. During which time COVID-19 rips through the population leaving potentially millions dead and hundreds of millions of recovered with disease-related tissue damage. 2. Wait, but stay in lockdown to keep the disease at bay, but in the process massively drive up suicide, domestic violence, and divorce rates, wreck the economy, and force people to spend their savings and/or trigger massive inflation through pandemic relief. 3. Some horrible compromise between the above two extremes. 4. Roll out the vaccines as quickly as they can be manufactured, starting now. Don't wait for Phase III results. The Phase I and Phase II trials tell us that the vaccine successfully generates antibodies. The group sizes so far have been large enough to know that the risk of fatal interactions is less than the risk of dying from COVID-19 itself--indeed, for the most part there haven't been ANY severe reactions, at least in the major vaccines. This "wait until the vaccine is proven safe!" is politically generated nonsense. There is no data-driven argument supporting it. Ideologues on the left assume that Trump wants a vaccine ASAP to win reelection, don't trust is understanding of the science, and therefore assume that early administration of a vaccine would be some sort of unsafe political compromise. Ideologues on the right believe COVID-19 is a hoax anyway. But even a broken clock is right twice a day, and the fact that Trump wants a quick vaccine approval has no bearing on whether it is a good idea or not; and in this case it very clearly IS beneficial to distribute a vaccine as quickly as it can be manufactured.

deleted 6y ago
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anonu 6y ago

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/ https://www.cbsnews.com/news/the-most-dangerous-vaccine/ [2] https://en.wikipedia.org/wiki/Progressive_vaccinia https://en.wikipedia.org/wiki/Progressive_vaccinia

nouveaux 6y ago
"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 https://en.wikipedia.org/wiki/1976_swine_flu_outbreak
- hedgew 6y ago
  > "There is not even complete agreement about the causal relationship between the swine flu vaccine and Guillain-Barré syndrome" > "Studies suggest that it is more likely that a person will get GBS after getting the flu than after vaccination" In the worst case, about 450 people got Guillain-Barre due to the vaccine. Counterfactually, some thousands or even a million Americans might have died from the swine flu itself.
grillvogel 6y ago
the Cutter Incident comes to mind. https://en.wikipedia.org/wiki/Cutter_Laboratories#Cutter_incident https://en.wikipedia.org/wiki/Cutter_Laboratories#Cutter_inc...

GavinB 6y ago

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.

bglusman 6y ago

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 a subset of them who have them would volunteer for a modified trial, we could possibly do a double-blind intentional-exposure test on people to confirm that the vaccine confers BETTER immunity than the existing similar antibodies do, right? Would it be possible to ethically and realistically use that strategy to accelerate effectiveness testing (if not safety testing) of any vaccine candidates? or would the smaller scale of that have only made sense for something more like Phase 2 trials? Arguably, as long as safety is near perfect, we should be willing to tolerate only moderate (say, 90%) effectiveness (and I'd read one of the vaccines took two doses to get 100% effectiveness but was 90% after a single dose), but I don't know how safety is evaluated and obviously long-term safety and short-term safety are pretty different/I imagine a lot of people will be more concerned about long term safety and I don't know how you can reassure them on that on any kind of accelerated schedule.

DavidSJ 6y ago
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.
- 411111111111111 6y ago
  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.
  - nomel 6y ago
    > inversely correlated with age To some degree. Immunity fades, which is the whole concept of booster shots.

nfw2 6y ago

After hearing Fauci's recent comments on the matter, my understanding is that the phase III trials can be considered for approval once there are enough infections in the control group to do a comparative analysis. Since the events now needed to confirm the vaccine are in the control group, not the experimental group, it seems that the blocker for approval now isn't SAFETY, as it has been continually suggested, but EFFICACY. If that is indeed the case, what makes the most sense to me would be to allow an early approval of any vaccine that meets reasonable safety requirement (some x months in stage 3 trial), but the patient must sign a waiver saying that they understand there may be rare side effects and there is no guaranteed immunity.

maxerickson 6y ago
No, phase III is still examining safety. For example, they document how a larger number of vaccinated individuals react to infection. A phase II trial might not track any infections.
- nfw2 6y ago
  Phase III examines both the efficacy and safety of the vaccine. These are independent questions. Just because a trial takes x years to determine efficacy, it doesn't necessarily take the same amount of time to determine safety. Fauci said certain vaccines could be approved as soon as there were enough events in the control group. Any dangerous side effects would only be in the experimental group and not dependent on events in the control group. If the only blocking factor is number of events in the control group, that to me suggest that the question of safety has already be sufficiently resolved for some of the candidate vaccines.
  - maxerickson 6y ago
    Yes, I directly addressed that. A potential safety issue with vaccines is making the course of the infection worse. So you have to look at vaccinated people that get infected (an 'event') to check on that. Phase II checks if the vaccines directly causes problems, but doesn't look at a lot of events.

mumblemumble 6y ago

Meta observation: The sheer volume of downvoting of reasonable comments in here really speaks volumes about the extent to which the SARS-CoV-2 pandemic is at least as much a political subject as it is a scientific one.

trhway 6y ago
"El sueño de la razón produce monstruos" (The Sleep of Reason Produces Monsters).

jrochkind1 6y ago

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

ISL 6y ago
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).
- jrochkind1 6y ago
  Shh, if you say that too loud, the presidential administration will just indemnify them.
- ralph84 6y ago
  It's been decades since vaccine makers had any liability for their products in the US. That hasn't changed with COVID-19. https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Injury_Act https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...
  - ISL 6y ago
    I signed a waiver for a non-approved yellow-fever vaccine in the US recently (supply of the approved vaccine is either non-existent or very limited); there must be some level of testing/certification required before reaching that threshold?

Animats 6y ago

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-vaccine-tracker.html https://www.nytimes.com/interactive/2020/science/coronavirus... [2] https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.1091908 https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.10... [3] https://www.ok.gov/health2/documents/IMM_PRG_5-20_Intervals_Live_Vaccines&Other_Rules.pdf https://www.ok.gov/health2/documents/IMM_PRG_5-20_Intervals_...

umanwizard 6y ago
> 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).
- brian_cloutier 6y ago
  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, even if we hadn't reached herd immunity, we could safely relax restrictions on gatherings without causing another wave. Concerts would still be out of the question, but dinner parties and hair salons would no longer be so concerning.

mensetmanusman 6y ago

We should have had a serious national discussion about letting low risk volunteers be exposed to the virus to rapidly progress through Phase 3, right? https://www.nature.com/articles/d41586-020-01179-x https://www.nature.com/articles/d41586-020-01179-x

mchusma 6y ago

I hope that the benchmark for approval is "for a given group, the risk of the vaccine is lower than the risk of COVID". This has some good commentary: https://marginalrevolution.com/marginalrevolution/2020/09/on-vaccine-timing-from-the-comments.html https://marginalrevolution.com/marginalrevolution/2020/09/on... some thoughtful commentary. I believe that for at risk populations it is very likely that taking a phase III vaccine candidate is the safer option right now, let alone after another month of data. I think let anyone who wants to volunteer to take it make their own risk assessment but be required to send data back. The only real arguments I have seen against this are political or paternalistic. But I also think people should be allowed to run human challenge studies on volunteers, which is also an ethical no brainier. But that doesn't seem to be happening either. It basically feel like the world in 2020 decided the answer to the "trolley car problem" https://en.wikipedia.org/wiki/Trolley_problem https://en.wikipedia.org/wiki/Trolley_problem. 2020 society's action seems to be: "inaction causing 5 deaths is better than action causing 1 death".

outside1234 6y ago
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.
- cultureulterior 6y ago
  That's what they said about masks, and that turned out to be wrong too. Assuming that people are idiots never helps
  - meowface 6y ago
    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.

nfw2 6y ago

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 access to vaccines that have been through some baseline safety testing. What seems like a good solution to me is to have open phase 3 trials that accept anyone willing to waive the risks. This would also accelerate us towards to a point where we are ready to approve a vaccine for everyone.

afarrell 6y ago
> 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.

rsynnott 6y ago

Timely: https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/ https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vac... (This may be nothing, of course, but it's a decent illustration that some caution is warranted)