If a few hundred people get a brutal side-effect, that's enough ammo for anti-vaxers to severely cripple the general public's trust in our public health systems.
Somewhat frustratingly, this vaccine needs to be held to the same standards of safety & efficacy as any other vaccine, but I do wish they'd let immunocompromised people get access to the thing a notch earlier than they would otherwise.
I think a lot of ammo for anti-vaxers comes from the government and media not being completely honest about vaccine side-effects. That's because it is difficult for an individualist or a socialist to separate public health from individual health. The CDC is not your personal physician. The CDC worries when newspapers publish facts about vaccines, such that some vaccines can cause severe and traumatic side effects, while being 52% effective, because they worry about obtaining herd immunity and need people to accept the vaccine for that. They want you to go through weird little side-effects, like not enjoying alcohol for months, so you don't infect a senior they count in the flu statistics. It's when "do no harm" means sacrificing the lives of a few to save the many.
Then there are political and funding concerns. If your own government funds your research to investigate if Agent Orange is harmful to the point of culpability costing billions, you are very careful and delicate with your conclusions. If your vaccination tests show that black Africans show more severe adverse effects, or that, maybe yes, the connection between vaccination and (worsening of) autism is both plausible and understudied, what do you do? For them its a single kid, maybe 2-3 in 100.000 which will start to suffer from autism years earlier, and a disease eradicated. For anti-vaxers, it is their kid.
Essential workers and at-risk people are first in line to receive the vaccine. The hope was availability in September, and public rollout in the beginning of 2021.
The anti-vax conspiracy mud has completely destroyed online information about this subject. There are more such subjects, where it is very difficult to find what the anti-activists are freaking out about. For instance, my gut tells me that physical and mental torture can be effective to obtain useful information. That that's why the mob, military, and police mainly use it for. But, online, nothing: torture is completely ineffective for the first 10 pages of Google. The Holocaust is another obvious one. 5G rollout ("completely safe, maybe, we don't know for sure. Improved Youtube streaming is important tho!"). Or try to find information on how the riots created a spike in infections. All news sites report on the same non-peer reviewed non-scientific institute paper, saying the riots caused spikes is a lie, yet the paper clearly postulates that riots increased infection for black participants and their families, but taken on the whole, they likely caused non-protestors to stay at home more for fear of violence and this reduced virus spread.
There’s no hard line where we need to test for t months, and then we will find out if the vaccine is safe. There is no magic threshold where suddenly we know the answer for sure. It’s more like: the size of the error bars on our estimate of the harm y in quality-adjusted-life-years (QALY) is constrained by some function on the time t, where there is diminishing returns as t increases. It’s always going to be possible that there’s some side-effect that doesn’t show up until t+1 months.
Further, we could build an expression of our estimate z of the total harm caused by the virus (including downstream harms like “deaths of despair” from economic damage). By minimizing y-z over t, we can find out the best time to release the vaccine (maybe to the most at-risk populations first).
I don’t think anyone at the FDA is doing this calculation. I think they are just trying to get y below some threshold, which is probably quite low compared to z. My goal in this conversation is to advocate for the people who will suffer and die because of that gap - and hope there is someone better qualified than me that fills that role in the government helping decide what to do. My fear is that the FDA is a highly conservative institution using processes that aren’t well-adapted to the current epidemic.
To add more color, I think if the vaccine comes out with unexpected side-effects, heads will roll at the FDA. But no heads will roll at the FDA over the many thousands who could have been saved by releasing a vaccine sooner.
I don’t think your fear is well founded. The fact that these vaccines are already in phase 3 trials, despite being developed earlier this year, is a testament to how much the FDA understands the current situation. Look up how long it usually takes a vaccine to get from development to phase three trials, I can guarantee you it’s not six months. People in this thread are quite alarmist. Vaccine trials usually take a long time, because whatever is trying to be cured isn’t a pandemic. In a pandemic you can run trials and get results quickly in a large area. Any side effects of these vaccines are going to show up quickly, it runs through your bloodstream and then your immune system takes care of it. We’re running large phase three trials and we’ll have a sense of effectiveness and general safety in a few months.
Fauci spoke on this matter recently. He said that phase 3 completion is not dependent on time, but rather dependent on the number of events (infections) in the control group.
This to me suggests the main blocker for approval now is proving efficacy, and that we already have enough data to conduct the time-based safety analysis you described with reasonable confidence.
There is another potential safety concern that the vaccine could exacerbate COVID infections. I don't know how critical this concern is, but it would also be constrained by number of infection events, not time.
They can’t easily be “much, much, much” worse for a vaccine that has already been through orders of magnitude more screening than the Swine Flu vaccine.
The Precautionary Principle cuts both ways, and I think this breaks peoples’ brains.
You don’t need to go so far back. The 2009 swine flu pandemic vaccine caused Narcolepsy in about 10 / 100 000 vaccinated, all of which were children aged 12-16 (which is not a group included in trials, by the way).
Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19.
My concern is that there’s an agency whose job is to minimize the risk of harm from a covid-19 vaccine, but not an agency whose job is to balance the risk of harm from a vaccine with the ongoing harm from not having a vaccine.
"Is this the worst-case scenario? It doesn’t sound nearly as bad as covid-19."
This is a case where the media hysteria surrounding the risks of Covid isn't helping anyone. If polling is to be believed, the general public significantly overestimates their personal risk of mortality from the virus:
As noted by the link above, the vast majority of that risk is concentrated in the oldest/sickest people. If everyone in the population is given a vaccine with even a fraction of a percent mortality, it could vastly exceed the risk posed by the virus to younger people.
It would be tragic, for example, to see any serious side-effects from a vaccine in people under the age of 20, who have essentially no risk from infection.
> It would be tragic, for example, to see any serious side-effects from a vaccine in people under the age of 20, who have essentially no risk from infection.
They have little risk of death if they have no comorbidities, but even for a 20 year old, just getting COVID-19 is likely gonna be worse than the side effects from almost any vaccine imaginable. I've had vaccine side effects and I've had COVID and I'd take ten more vaccine side effects over one COVID, please.
There's also the fact that vaccines are never 100% effective and that herd immunity is important, so the 20 year old still needs the vaccine to protect the older people they may run across. So even if the 20 year old is personally somehow guaranteed an asymptomatic, no-damage infection from COVID, they still need the vaccine. Vaccines don't just protect you, they protect everyone else, and a large part of their efficacy in reducing total population mortality is through these herd immunity effects, not just from protecting the individual people who've been vaccinated.
"I've had vaccine side effects and I've had COVID and I'd take ten more vaccine side effects over one COVID, please."
I don't know what side-effects you've had from vaccines, but when I talk about risks, I'm not talking about headaches...people actually died from from the 1976 H1N1 vaccine.
Do you just want to do more research, or are you contending that you think the harm from COVID-19 is actually less than the harm from the most severe side effects of a vaccine we've ever seen?
In what age group? The 1976 vaccine actually killed people and gave Guillain Barré to many more, so that's your worst-case outcome. So far, under 20 years of age, the fatality rate for Covid is measured in low-single-digit thousandths of a percent (i.e. under a thousand in the US).
Not necessarily. Yes, the risk from Covid-19 is larger. But you do not know how well the vaccine works for elderly people. If the protection of the vaccine is relatively low, just vacinating elderly people does not make a huge difference in the outcome, if the general population has a lot of infected people. Vaccination is only partly about protecting the individual and a lot about preventing the spread of disease.
Take Rubella. If you are not pregnat, which means every male, you are at no risk by the disease. But Rubella gets vaccinated against these days as a standard vaccination, as the best way to preent pregnant women to get infected is, to prevent the spread in the population. And it is really nastily infective. When I was in the last year of high school, we had a breakout and to my knowledge, every single pupil in that year got infected.
Maybe. You still have to be careful, though: your prior assumption is that older/sicker people are more likely to have side-effects from anything. It's also hard to find big enough groups of old/sick people to do sensitive statistical experiments.
On top of that, there are cases of many vaccines which are much less effective in the elderly.
While secondary causes are likely causing much of the higher mortality in the elderly, sometimes the immune system is just... not as strong. And yes, that does mean something other than COVID-19 could come along an 'get that person', but... here's my point:
Hepatitis B surface antigen (HBsAg) induces neutralizing antibodies
(anti-HBs) that protect against HBV infection.
...
Response to vaccine following a 3-dose series is typically greater than
95% in young, healthy people, although it decreases with age (< 90%
response at age 40 and only 75% response at age 60). Other factors such
as smoking, obesity and chronic disease decrease vaccine efficacy and may
be used to predict risk of nonresponse.6 Adverse events are minimal,
although mild injection-site reactions may occur in 20% of recipients.
Quite a few vaccines are like this. Less effective on the elderly. So we could end up with an even larger horror show, with some COVID-19 vaccines.
Such as, it has some bad side effects, AND, doesn't really help the most-at-risk group as much as desired!
What really bugs me is, there are what? Greater than 70 vaccines in development?
Some governments have pre-picked supposed winners. On top of all the other political bull going on, are they going to stick with those winners, regardless of outcome? Or have preferentiality to those specific vaccines?
Because I can imagine some being highly effective and safe, and others being the reverse.
Absolutely. Prioritize those at highest risk of Covid complications (elderly, comorbidities) or those at high risk of exposure (front line healthcare workers).
It will be interesting once vaccines become available. Vaccinating several billion people will have a lot of operational challenges and will likely take upwards of a year to complete.
It's not the worst case, just the worst one that's happened in a vaccine deployed at scale. The dengue vaccine is a famous example of why careful research and approval processes are required; it's effective and not too inherently dangerous, but was found to actually make the disease worse for people who haven't been infected in the past.
Yep, I think everyone from my parents generation in morocco have a very distinguishable, large round scar that resembles a burn scar. Not only does it look painful, but it also looks like an absolutely perfect way to spread diseases. They were lucky AIDs wasn't really around at the time!
Out of 45 million vaccinated, 450 got Guillain-Barré Syndrome. I couldn't find info on if any of them died.
That would have been acceptable if it had stopped a disaster, but as it turned out the 1976 Swine Flu epidemic never really materialized as expected.
With Covid killing 1000 Americans per day, I think we should happily accept those odds of side effects or worse.