12 ms·
What was the point in waiting? What was under the consideration for so long that the FDA needed to wait weeks or months after all of the data has been released?
by ipnon 6y ago
What was the point in waiting? What was under the consideration for so long that the FDA needed to wait weeks or months after all of the data has been released?
- Fjolsvith 6y agoElection related.
- rantwasp 6y agoi enjoy a conspiracy theory as much as the average joe, but this stuff is getting out if hand
- Karupan 6y agoI used to enjoy harmless ones like aliens or flat earthers, but the ones in 2020 are just outright dangerous.
- rantwasp 6y agoflat earthers were funny until we needed their help to flatten the curve
- creddit 6y agoI highly doubt it's related to the election, but there is a "conspiracy theory" that is entirely plausible to me which is that the paternalistic leaders of the FDA/CDC believe that by taking longer to "validate" the data they are going to be better at convincing anti-vaxxers of the safety of the vaccine. The data analysis here is comically straightforward! This doesn't take 3wks! There's a reason the UK has already approved it! https://marginalrevolution.com/marginalrevolution/2020/12/how-badly-has-the-fda-been-lagging.html https://marginalrevolution.com/marginalrevolution/2020/12/ho...
- DonHopkins 6y agoThat's what people who don't believe in science and disdain listening to scientists claim.
- tehjoker 6y agoTrump threatened to fire the FDA administrator unless he authorized it today. That's not the hallmark of a careful analysis. https://www.washingtonpost.com/health/2020/12/11/trump-stephen-hahn-fda-covid-vaccine/ https://www.washingtonpost.com/health/2020/12/11/trump-steph... From a personal perspective, I want a safe and effective vaccine as soon as anyone would. I do not want to be propagandized into taking something potentially dangerous just because it lets the business community make money. What I want is a careful, rigorous, and non-politicized decision making process before I can trust the output of an experimental process. This has clearly not happened.
- ummonk 6y agoI hate Trump's bullying tactics as much as the next person, but let's be clear - the FDA had completed its data analysis and released it a few days ago, and then the advisory panel yesterday supported its endorsement. At this point it was clear the vaccine was safe and effective, and an EUA should be rapidly announced by the FDA, whether the Trump would pressure them or not.
- aaomidi 6y agoWith more platforms taking an anti misinformation stance I wonder if HN is planning to do the same? Even though we have a smaller reach.
- ummonk 6y agoThey only released the data 3 days ago. Or are you talking about the marketing release of data, which needed to be properly analyzed?
- ardit33 6y agoThe application and data was submitted 3 weeks ago... it took 3 weeks for the FDA to drag their feet and just say the obvious... It is like the titanic is burning and these guys are playing violin...
- roseway4 6y agoThe FDA reran, in a matter of weeks, the entire analysis undertaken by Pfizer’s pharmacologists and statisticians over a series of months.
- zaroth 6y agoTo be fair, this was an extremely basic analysis on a relatively minuscule amount of data, where the form and format of data and the method of analysis has been prescribed months ago. There was no decision that shouldn’t have been made ahead of time. Either it met the predefined criteria or it didn’t.
- Retric 6y agoRegulators need to independently verify more than just raw calculations. The incentives to hide or falsify data can be enormous.
- zaroth 6y agoThe only thing that couldn’t be verified until the last minute was the unblinded results. Everything else should have been a continuous process of pre-verification up to the point the 128 positive confirmed COVID cases were unblinded. Assume the unblinded results will be good enough, and verify everything else you would normally verify ahead of time. The only thing that remains is to verify the unblinded cases the day they are announced. And not just that but your approval thresholds should already be preset and preregistered, the doses already distributed to point-of-care, and nurses start administering shots the very next day. Yes it’s a big waste of money if it turns out not to work. That’s the whole point. Turns out the vaccine is highly effective 10 days after the first dose. We could have been doing at least a million doses a day since November 19th. Realistically even long before then.
- starpilot 6y agoThey needed to wait months to see if the people who received vaccine did not get the virus, and that they also were not harmed by the vaccine. This isn't some binary instantaneous outcome.
- koolba 6y agoThey’re arguing about analyzing the data more quickly rather than spending three weeks analyzing it. There’s no additional data gleamed in that time period.
- ardit33 6y agoI was wondering as well... the data was submitted about 3 weeks ago... I understand that it is extensive data (for about 44,000 patients), but taking 3 weeks to compile/analyze seems excessive. They should have put in an army of analyzers into it... There are about 3,000 people dying every day.... it is like 9/11 every day, or 9 jumbo jets falling.... The FDA should be treating this as a war effort, and not drag their feet into pointless bureaucratic 'safety' theater.
- baskire 6y agosadly those extra days gained would do little to even put a dent in that figure.
- xyzzyz 6y agoAlas, UK managed to approve the same vaccine a week ago. A week of delay means extra 15-20 thousands of lives lost.
- bigyikes 6y agoAlso the sooner a vaccine is released, the sooner you can dampen the exponential growth, potentially compounding the lives saved. Not sure how significant of an effect this might be, though.
- addicted 6y agoI’d question what was the point of rushing this out? The vaccines are gonna be supply constrained for a while. The same number of people will be vaccinated on Jan 31 (or the day before the next batch of vaccines become available) whether we start today or a few weeks from now. At this point the more important consideration should be not doing anything that might even slightly reduce public faith in the vaccine.
- maxerickson 6y agoThe first batch of Pfizer vaccine is enough to vaccinate a substantial portion of the vulnerable elderly (after vaccinating healthcare workers). Given that they are the ones that are dying at the highest rates, getting it deployed as fast as possible is likely to extend quite a few lives. It's not like they've executed well on your last point in the meantime.
- nsgi 6y ago> The same number of people will be vaccinated on Jan 31 That could still mean a big difference in the number of deaths. Some of those people may die/become seriously ill before Jan 31 before the vaccine gets to them
- lupire 6y agoNot a big difference. A few thousand. A drop in the bucket compared to the 250K and any more ahead killed because many Americans are making a religion of intentionally refusing to limit their spreading of the virus.
- scoopertrooper 6y agoWhat's the point in rushing? Production is already going at full speed and they're not yet ready to begin the vaccination programme. Rolling this thing out is going to be a massive operation given the delicate conditions it must be stored under and the coordination across thousands of health systems required. All the preparation work is well under way and the timing of this approval doesn't impact it in the slightest.
- creddit 6y agoYeah who cares about the lives being lost in the meantime?
- scoopertrooper 6y agoMy point was that none of the work required to prepare to begin the vaccinations was held up by the work of reviewing the studies and granting approval. Furthermore, how many lives would be lost if society didn't have confidence in the approval process and declined vaccination? Russia is suffering this exact problem at the moment. https://www.washingtonpost.com/world/europe/rusisia-vaccine-sputnik-interest/2020/12/10/005917fa-3702-11eb-9699-00d311f13d2d_story.html https://www.washingtonpost.com/world/europe/rusisia-vaccine-...
- _Microft 6y agoThey did not 'wait'. The FDA needed the time to do their job. Contrary to what some people would like to believe government agencies are not rubber-stamping factories.
- nottrobin 6y agoI know nothing about what goes into approving a vaccine, but I am genuinely curious how come the US FDA was a whole 10 days behind the UK in approving this, and were also beaten by Bahrain and Canada. Is it because they're genuinely more careful? Or is it just bureaucracy?
- makomk 6y agoThe UK was unusually aggressive in getting everything in place to roll out this vaccine early - not just the approval process, but other logistics as well. The FDA, on the other hand, was under pressure to delay approval for partisan election-related reasons; the press created the perception that approving the vaccine early would be an evil plot by Trump to win the election. If the trials had reached enough cases to return results earlier, the difference could've been really dramatic because those delaying tactics essentially imposed a minimum length of time the trial had to run for in a slightly stupid way.