Well, yeah, we don't want a drug that kills more people than it saves, right?
> we want you to rush your testing
That's not happening, what will be accelerated will be regulatory approvals and reviews, not clinical trials.
Regulators can decide they're uneasy about potential for birth defects, or side effects with particular other drugs you never tested, or any number of issues. Sometimes a pharmaceutical company just hoped not to be asked, and other times the concern comes out of the blue.
But if we're fast-tracking approval, anything that isn't a red flag won't get in the way. That unavoidably means higher risk to patients overall. Since the virus kills a lot of people every day everywhere it hasn't been eliminated it makes sense to take that risk, but governments (accountable to their citizens) get to decide that, not drug companies.
The trials are most certainly accelerated. Take a look at Moderna's trial of their RNA vaccine.[1]
It's a 2 year trial, but data is collected on a rolling basis. They aren't waiting 2 years for final results, I'm guessing they do a few interim analyses until they see the two arms split in terms of infection rate. Then they'll go to the FDA and see if that's sufficient for approval.
And look at the N-size. 30,000 people for a drug that will be given (potentially) to billions of people. To make a comparison, Gardasil, the HPV vaccine was tested in ~28,000 individuals over 3-4 years.[2] And Gardasil is used in a much more limited population than the Covid vaccine will be.
[1]https://clinicaltrials.gov/ct2/show/NCT04470427?term=mRNA-12... [2]https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/...
(It wouldn't be HN without a splash of pedantry; apologies in advance.)
I'm curious what you mean by this. Women constitute slightly more than half of the population, no? There are probably billions of women at this point who have had Gardisil administered.
https://www.cancer.org/cancer/cancer-causes/infectious-agent...
And it's not limited to women now. Different countries have it approved/covered for men of different ages. I (as a man) recently finished the full course, though I had to pay for it out of pocket.
So Gardasil is only approved for "girls and women 9 through 26 years of age". Plus there wasn't much expectation of use outside of Western countries initially since it's not cheap and there are likely higher priority vaccines in developing countries (i.e. do you spend dollars on this or meningitis vaccines?). Use is probably pretty broad now, ~10 years post-launch.
Eventually they expanded the label to include "boys and men 9 through 26 years of age".
So all in all, a relatively small slice of the population, where for the Covid vaccine, they're trying to get it approved for pretty much everybody.
This! The public are acutely aware of the predicament that governments have created and most will be very skeptical of a vaccine that's been rushed through like this especially if a regulator says 'sure its totally safe' when we can all see the data to determine that cannot possibly exist in the near future.
However today there are ready armies of lawyers to sue for those very rare side effects that have a much lower fatality rate than the disease itself.
Are pharmaceutical companies the pinnacle of honesty and ethics? Of course not. Would it be worthy pulling a covid vaccine out of shelves if it caused a 1 in 1Mi serious side effect? No way.
Sure, you can try to identify and quantify the risk so maybe don't give this vaccine to people who might have a worse outcome, still, nothing is perfect.
What predicament? The gov't didn't create covid.
> especially if a regulator says 'sure its totally safe'
To my knowledge (and I did work in this area) no regulator will ever declare a drug 'totally safe'.
> most will be very skeptical of a vaccine that's been rushed through like this
Yeah well, you're speaking for a rather large population whose minds you don't know so please don't. Also covid is dangerous so people may be skeptical but still take it.
1. We want you to sell us the drug at cost with no profit margin
2. We want you to be responsible for unlimited liability for whatever the drug might eventually do
Oh, and by the way, we want you to rush your testing so you don't have the normal time to verify its safety!