FDA willing to fast track coronavirus vaccine before phase three trials end
Source: CNBC
The chief of the U.S. Food and Drug Administration is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible, according to an interview in The Financial Times.
Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Stephen Hahn told the publication that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
"It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," Hahn told The Financial Times. "If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination."
The comments come a week after the FDA granted emergency authorization of convalescent plasma to treat hospitalized Covid-19 patients, despite concerns among some health officials that data from clinical trials is too weak to support widespread application of the treatment yet. That announcement was on the heels of President Trump accusing the FDA, without any evidence, of trying to hurt him politically by dragging its feet in approving new coronavirus vaccines and treatments.
Read more: https://www.msn.com/en-us/money/markets/fda-willing-to-fast-track-coronavirus-vaccine-before-phase-three-trials-end/ar-BB18wcVF?li=BBnba9O&ocid=DELLDHP
What could go wrong?
still_one
(92,187 posts)takers regardless of which side of the aisle
I suspect there probably won't be major safety issues, but the problem will be determining how effective the vaccine is.
Giving someone a vaccine that is not very effective is extremely dangerous because it leads to a false sense of security, and they take unnecessary risks
BKDem
(1,733 posts)Why would you even think that?
Uh, maybe because its total bullshit?
Mr.Bill
(24,284 posts)He may be the first person in history to make a vaccine responsible for more deaths than the disease.
napi21
(45,806 posts)people does he think will accept this vaccine? People aren't stupid! They know the phase 3 testing is where they confirm no lasting problems from the vaccine in any age group of our population, & that it has the desired immunity in everyone as well.
progressive nobody
(816 posts)Phrase 3 is the most critical and important.
dalton99a
(81,475 posts)SergeStorms
(19,200 posts)have not been kind to Donald Trump's beautiful, youthful face, have they? It looks like the entire White House staff has been using his face for a dart board.
karin_sj
(808 posts)He is sickening
Response to dalton99a (Reply #5)
llashram This message was self-deleted by its author.
yaesu
(8,020 posts)suspect while tRump is dictator, I won't be taking it if they do.
bluestarone
(16,926 posts)The WHOLE FDA. panel GOES FIRST!!
SergeStorms
(19,200 posts)They'd just lie and give them saline solution anyway.
bluestarone
(16,926 posts)BadgerKid
(4,552 posts)Still, youve got to wonder what if anything gets overlooked.
Igel
(35,300 posts)Part of the push for fast-tracking dates to Act Up! and the push for AIDS drugs to hit the market as quickly as possible.
It's a question of how many people are hurt by the drugs (and in what ways) versus how many people are hurt by postponing the drugs (and in what ways)--multiplied by some assessment of the likelihood that the drug is useful or not. It's the same for drugs that do pass the full battery of tests.
Once authorization is granted, the usual testing regime continues in any event. And sometimes the final results get the drug pulled from the market. Or regs involving its use get nudged.
A number of the early AIDS drugs were finally taken off the market or drastically restricted. They were bad. On the other hand, that typically happened when something better came along.
I had a nasty allergic reaction to a drug once and was prescribed Seldane to squash the reaction. Throat was swelling shut, bad bruising just from looking at part of my body. Six months later the FDA yanked Seldane's approval. It was killing too many people--stopping their hearts. (Men, mostly, if I remember correctly.) It's an on-going process.
It would be the same with this. If 1000 people are dying per day, but the vaccine only kills 10 per day, which is better? (It's the same calculus we use with other vaccines. They all have some risk. But the benefits outweigh the risk.)
roamer65
(36,745 posts)Then every Repuke Congress critter.
warmfeet
(3,321 posts)I am on board then.
sure why not
(39 posts)What could possibly go wrong?
SergeStorms
(19,200 posts)And Donald Trump had absolutely nothing to do with this, right? I'm not putting anything in my body unless it goes through the full federal approval process, and I'm considered an "at risk" individual.
JustABozoOnThisBus
(23,339 posts)It's a gamble, but if we start production on a few promising vaccines and stockpile them, we might be in a better position to distribute the vaccine when/if the phase 3 trials prove it's good.
It's a venture with some risk, but it's also risky to wait until all tests are done before starting production.
It's a bet, and if we back the "right horses", lives are saved.
No way I'd distribute the vaccine to the market before trials are done and results published/accepted.
calclar
(55 posts)...or is that only taking place with a few of the largest manufacturers??
Seems so long ago (!) when that was announced, I just can't remember.
JustABozoOnThisBus
(23,339 posts)As opposed to pre-test approval for general distribution.
Steelrolled
(2,022 posts)to start early manufacturing, and receiving guarantees for "N" hundred million vaccine kits. For sure they have done this for Moderna and the Oxford vaccine.
Response to JustABozoOnThisBus (Reply #12)
calclar This message was self-deleted by its author.
Midnight Writer
(21,753 posts)It would put millions of Americans at risk if there was widespread mistrust of vaccines.
How could he do that? By having the US Government put out a dangerous untested vaccine.
His overall goal is to destroy trust in American institutions, not only domestically but abroad.
lonely bird
(1,685 posts)Yes, that is opinion. But developing vaccines takes a long damn time. There is no vaccine for the first SARS. No AIDS vaccine. There was an Ebola vaccine released in 2019.
How many people will get sick from reactions to this vaccine? How many will get the disease anyway despite the vaccine?
Steelrolled
(2,022 posts)The initial (small scale) safety and effectiveness trials (phases 1 and 2) were good.
If the large scale trial (phase 3) shows very good effectiveness, and no safety issues, and the pandemic is still harming many, the FDA will consider whether the effectiveness results (so far) outweigh the safety risks (so far). If so, they could give limited approval. The FDA will continue monitoring the 30000 Phase 3 participants, as well as the deployment to the general public after approval (known as phase 4).
I'm excited about the results so far.
NickB79
(19,236 posts)To convince tens of millions to avoid the vaccine. If that happens, it could be worse than waiting the extra few months to see which are the safest.
Steelrolled
(2,022 posts)I volunteered for the trial but haven't been called. If the numbers are good, I'll be first in line to get it early.
kacekwl
(7,016 posts)No other experts or scientists who know the crap going on at the agencies will to speak up ? Is everyone going to shut up and let the chips fall where they may ? I find that hard to believe and truly sad if correct.
Steelrolled
(2,022 posts)I would hope they focus on that and not politics-driven speculation in the news. If and when the FDA gives approval would be the time for a whistle-blower to speak up.
Rebl2
(13,498 posts)getting it then. No way they should be doing this.
Dios Mio
(429 posts)the results wouldnt be known until after the election. He is going to force the FDA to make a mess of this but thats okay as long as it makes him look like a real leader.
Rebl2
(13,498 posts)not. He doesnt care if it makes people sick or kill them.
Lonestarblue
(9,981 posts)I hate having to stay home most of the time, but I would hate being on a ventilator struggling to breathe even more.
kimbutgar
(21,137 posts)Because there is no fricking way I would take a vaccine for that administration of fraudsters.
The Magistrate
(95,247 posts)Liability could prove a wipe-out....
PSPS
(13,594 posts)truthisfreedom
(23,146 posts)And the anti-vaxxers win a huge new following. Nothing is accomplished, and covid-19 drags out for another 5 years.
radius777
(3,635 posts)Trump would do anything to win including twisting the arms of the FDA.
The worst would be if Fauci stands up there and endorses it.
If we don't get ahead of this, it could be like another Comey type event that shifts independents.