Normally one of the possibilities of regulatory oversight is that you go into a meeting hoping your drug is approved, but the regulators are concerned about X. "Go away and check X" says the regulator, "this isn't a No, but it also isn't a Yes, we want to understand X before we decide". Maybe it'll take 12-18 months to set up and run experiments to answer X.
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.
That's not happening, what will be accelerated will be regulatory approvals and reviews, not clinical trials.
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.
> And Gardasil is used in a much more limited population than the Covid vaccine will be.
(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.
270 million doses worldwide to date, of those 100 million are in the USA. The full course is two or three doses depending on age, so that's somewhere between 90-135 million people fully covered.
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.
The FDA doesn't do clinical trials for vaccines. This is unique to vaccines in US drug regulation. Vaccine manufacturers self-certify and send a report to the FDA, who signs off on it. They can certainly choose to rush clinical trials in the current environment and probably still have their report signed off on by the FDA.
> Oh, and by the way, we want you to rush your testing so you don't have the normal time to verify its safety!
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.
Depends on the relative risks. I can imagine an 80 year old in a US nursing home jumping on the barely tested vaccine while a 23-year-old New Zealander waits for more information.
The problem is that others will have to take the vaccine as well. Not to protect themselves, but to protect others. It would be nice if they could do that without (fear of) risking their personal safety.
Every vaccine/drug can have potential side effects, possibly in the 1 case to millions of doses. There's no such thing as a non-side-effect product.
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.
> The public are acutely aware of the predicament that governments have created
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!