The 1976 swine flu outbreak is one example of what can go wrong if you rush a vaccine: https://en.wikipedia.org/wiki/1976_swine_flu_outbreak
It was rushed by the Ford administration for political reasons and got a lot of people very sick.
It was rushed by the Ford administration for political reasons and got a lot of people very sick.
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.
They can easily be much, much, much worse.
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.
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.
The Precautionary Principle cuts both ways, and I think this breaks peoples’ brains.
https://en.wikipedia.org/wiki/Guillain%E2%80%93Barr%C3%A9_sy...
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.
- Lowers the public’s chance of contracting COVID by 50%
- Causes 0.001% of the public to get seriously ill.
...then withholding that vaccine from everyone because some people who don’t understand probability may have a temper-tantrum would be deeply immoral.
None of this contradicts your point per se, but I don’t know what to do about it.
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.
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.
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:
https://us.beyondbullsandbears.com/2020/07/28/on-my-mind-the...
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.
Vaccine development is hard.
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:
https://www.cda-adc.ca/jcda/vol-66/issue-10/551.html
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.
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.
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.
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.
Do you have any non-anecdotal articles that quantify this?
https://www.medrxiv.org/content/10.1101/2020.08.24.20180851v...
Citation required.
I'll leave the math as an exercise for the reader, but that's a really low mortality rate, orders of magnitude less than even young healthy people who've gotten COVID-19.
And despite your comment on other subthreads, we don't make these decisions by directly comparing naïve mortality counts. It's not like it's acceptable to hurt N-1 people, just because the virus hurt N people. If a vaccine kills / cripples hundreds of young people, nobody is going to take the vaccine. It's pointless to debate this.
Even with experimental concerns like the small sample size, 55% incidence of long-term neurological effects is pretty alarming
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.