Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?


Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. Secondly, I don't believe it's a valid analogy because the process of reviewing clinical trial evidence is not similar to the process of reviewing executable code. Thirdly, there is no amount of review that guarantees a lack of mistakes, so it's simply a question of risk tolerance which you have to balance against the harm of delay.


> Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done.

I imagine the expedited process also means summaries and overviews that would normally be presented were skipped--detailed documentation if we're continuing the source code metaphor.


They started rolling review back in October:

https://www.pharmamanufacturing.com/industrynews/2020/uk-reg...


That's good (though it should have been earlier) but makes the approval delay even less acceptable.

Edit: Actually FDA Fast Track was approved in July. There should be no surprises for the FDA in this submission. https://www.pfizer.com/news/press-release/press-release-deta...


Add to that the fact that the whole world is watching, and hundreds of thousands of lives are at stake


If a team from the UK had already done it, I would just go ahead and accept their analysis. The US should give emergency approval now, based on the UK approval.


I’d prefer to see multiple agencies independently evaluating this.

Swiss cheese model. Each agency is going to have holes, and many previously unknown ones could be exposed given the unusual time and societal pressures they’re working under.

If the UK approves something and everyone goes “eh, good enough” that’s significantly riskier than if we wait the extra week or two and get consensus from the UK, EU, US, etc. The chances of large holes showing up in the processes of all of those agencies that align to miss something is much less.

We’re talking about things we’re going to be injecting into literally hundreds of millions of people very quickly. The risks of a fuckup here are pretty severe and it’s quite likely a severe mistake would cause more harm than delaying another week or two.


That's a reasonable position, but if I were making a list of American government pandemic mistakes, this honestly wouldn't even crack the top hundred.


And if it turns out the UK approval process, like so much else of its bureaucracy because of years of austerity cuts, has been under-staffed, under-funded and simply bowed to political pressure?

I wouldn't be so quick to trust anything British right now. We're in a bit of a state.

The only reason we're not the laughing stock of the world right now is because the Americans managed to fuck up even more than us.




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: