All this to say that for the pivotal phase 3 trials submitted to FDA for approval, I would suppose almost all existing drugs had much fewer than 40k participants.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ev...
It looks like the initial approval of Lipitor was in the hundreds of patients. Now, statins were brand new and not used really broadly. Pfizer did a ton of follow up studies, but looking at the most current label.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/02...
The two biggest trials, ASCOT and CARDS, which measured improvements in mortality (needed to be big trials to measure any difference), they were ~10,000 and ~2,000 patients each.
So suffice to say, Lipitor, which is used in a massive population, has probably been tested, in clinical trials, on a total number of patients comparable to the Pfizer Covid vaccine trial. Obviously the duration of the Lipitor trials were much longer and there a massive body of clinical data from actual use, but it at least gives you some perspective on numbers.
Vaccine trials tend to be larger because you have to account for the fact that only a small number of people will get infected.
And I can remember getting my tetanus booster in secondary school and when I rolled over in my sleep waking up because my shoulder was so swollen and painful.
I'm not dismissing the fact that the vaccines might cause serious side effects. In fact, it's expected that some very small percentage will. But for the vast majority of patients, the Pfizer vaccine has a similar safety profile to other approved vaccines.
Indeed! And I'll be going with the adenoviral route which has been used for more than fifty years, rather than the brand new, first time ever mRNA product.
Interesting, I feel the exact opposite. I can't wait to take a mRNA vaccine, but the adenovirus ones seem sketchy given that Sinovac, J&J, and AstraZeneca have all seen serious adverse events in their trials, while Pfizer and Moderna have seen none, along with much higher efficacy.
I wasn't aware there were any adenoviral vaccinations approved for human use? What are you referring to?
Yes, I do have some concerns regarding long term effects of mRNA based vaccines. As you said, I would also like to see some deeper thinking about this. I feel that other delivery vectors may be better known and have an existing track record.
I also understand that mRNA treatments have had some excellent outcomes in cancer patients. However, these treatments have been highly personalised, based on the patient's own DNA. Therefore, I also wonder about the general medium and longer term effectiveness of mRNA for coronavirus vaccination.
I'm in no way an anti-vaxer. I'm completely vaccinated for all the common things (MMR etc). As is my child. No problems with something that's been around for a long time and is well known.
I would just like to make my own choice regarding which brand new, accelerated testing regime, vaccine I decide to inject.
One interesting thing is that I was quite worried that in April/May all these experimental treatments have been stopped, because all the most interesting companies were forced to redirect their focus to COVID (the only reason you could use a lab). I'm relieved, that at least we got something in return: derisking mRNA as a delivery method, and showing that it's far superior to older ones. You're right that we don't have medium / long term data yet, but this article is quite relevant:
https://www.jpost.com/health-science/could-an-mrna-vaccine-b...
Linial explained that “mRNA is a very fragile molecule, meaning it can be destroyed very easily... If you put mRNA on the table, for example, in a minute there will not be any mRNA leftover. This is as opposed to DNA, which is as stable as you get.” She said that this fragility is true of the mRNA of any living thing, whether it belongs to a plant, bacteria, virus or human. As such, she said the worry should not be that the mRNA won’t get into the cells and instead will stay outside, floating in the body and causing some kind of reaction. Rather the concern should be that if it doesn’t enter the cells, it will disintegrate and therefore be ineffective.
The idea that COVID-19 is somehow less dangerous than having some RNA in your blood for a few hours (remember, it disintegrates fast when above -70C) is completely insane.
If you compare the frequency of those side effects alone vs. the rarity of side effects we've seen in historical "bad" vaccines, you still end up with a pretty obvious cost-benefit in favor of taking it. From that point of view, "even smaller chance of dying" becomes just a perk.
https://jamanetwork.com/journals/jamacardiology/fullarticle/...
Mental illness: 20% within 5 weeks
https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0...
Chronic Fatigue: 50% at 10 weeks
https://www.medrxiv.org/content/10.1101/2020.07.29.20164293v...
Not downplaying, I've had bad episodes of flu that left me low on energy for weeks, want to see how that compares and if it's been looked into (I expect not given recency).
My recovery from Covid in March was about on par with a bad flu, was late April until I felt good again and was back to normal on a physical level.
Well, in the 20,000 dosages in the pfizer vaccines, I believe there was no autoimmune conditions found. I think Moderna was the same. If that's your concern, maybe steer clear of the AstraZeneca/ChAdOx1 vaccine.
There are two main components to the vaccine, the RNA itself, and the proteins it causes the cell to make. Both naturally break down and are removed from the body very quickly--in hours to days from my understanding, so one could use that to conjecture that longer term effects are perhaps less likely in this case and something like that would show up sooner.
We're not really comparing flu stats vs. covid stats. I'd argue these things are not good whether they come from a severe flu or covid, so that seems like a red herring? Here our choice is "what is more likely to mess me up badly, a vaccine designed, tested and peer reviewed with a do-no-harm mindset, or the virus behind a pandemic that has killed more than a million people worldwide."
Do you get a flu vaccine each year?
covid can do/does plenty of nasty things to "non vulnerable" people besides kill them
Note that the clinical trials for this vaccine 100% excluded pregnant women, and required males to agree to use two forms of contraception. IIUC they also excluded people with prior exposure to COVID-19.
I'd take it if I were 60, certainly 70 - an 80 year old with pre-existing conditions has a shockingly high 20% infection fatality rate(1). But at 35 and in decent health, with little exposure to at risk people around me? Better off to wait.
For healthy children and teens, it's going to take far more data to know if the vaccines are safer than COVID-19. For them it's about a 1 in 1 million fatality rate per infection(1). And we've screwed up before: one of the H1N1 vaccines turned out to occasionally cause narcolepsy, and that wasn't even novel vaccine technology.
Is there zero risk of serious side effects? Of course not, there never is. But the trial gives enough data to say the risk is worth the benefit.
Edit: The FDA has already hinted that their initial approval (EUA) may be restricted to certain populations where the risk-benefit is justified. In other words, they may not approve it for healthy, young adults where the risk of serious Covid complications is low. That "full" approval could come later after additional clinical experience is gained.