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Because the best way to gain broad acceptance of something that only works if everyone does it is to give them something unproven?
Yeah, but it’s a dry plague.
Eric Feigl-Ding
@DrEricDing
Sad day: ARIZONA has crossed the rubicon… its epidemic now exceeds Brazil and Peru to be one of the hardest hit regions in the world. Exceeding all European countries as well. Today: Record cases, record positivity %, record ER, record hospitalizations, record ICU. #COVID19
“I moved to Arizona for my health.”
This is beyond tragic and shameful. If I think about it too much I become enraged and don’t know what to do with myself. Raining here and I’m waiting for a book to arrive so I guess I’ll go scrub my clean kitchen floor.
Mrs. VH and I are considering a long visit to one of our daughters (Santa Fe, Seattle) if things go further south here. At this point, we continue to hunker down, wear our masks, and only go out when necessary.
The other thing about Phase III trials is that they often reveal side effects or other dangers that weren’t apparent in smaller trials. There was one big study that was stopped, IIRC, because all-cause mortality in the active-agent group was significantly larger than in the controls. (Or that might have been for something that was already approved?) This can be especially the case because it’s not until Phase III that you start recruiting people who are at more risk for weird interactions (because it would be unethical to do that when you don’t know that the drug works at all) Phase I safety testing is (as I understand it) more about whether it harms average patients.
So, for example, it likely wouldn’t be until phase III of something that you started recruiting lots of older people with multiple comorbidities…
Would you fly to Seattle? Planes are packed I hear.
No, we’d drive. It’s a 3 day, 2 night trip in a Subaru Forester with two Miniature Pinschers. There’s plenty of risk in taking a trip too.
Can anything coming out of the FDA be trusted at this point when Getting a Vaccine by October is openly being touted by the Trump campaign to reassure nervous Republicans?
OT/ GOP always looking for an angle or a con instead of helping citizens who are all reeling from the effects of SARS-COV-2 pandemic.
TALLAHASSEE — As Florida reels from an economic collapse and double-digit unemployment, Republicans are looking to avoid a return to the state capital until after the November elections.
This strategy is a political move designed to duck public scrutiny of what one Republican legislator called the “firestorm” of Covid-19, police brutality and the state’s troubled unemployment system. With President Donald Trump and dozens of state lawmakers on the November ballot, waiting until after campaign season to address the state’s mounting fiscal crisis might make political sense but lawmakers risk sending the state into a deficit.
Tax collections in April alone plunged nearly $900 million below forecasts after Florida shut down offices, restaurants and retailers to limit the spread of the virus. At the same time, state spending has accelerated to pay for the emergency response. Medicaid enrollment is rising.
“They would rather pretend everything is OK and let the state burn,” said state Rep. Evan Jenne, a Dania Beach Democrat. “They are playing with people’s lives rather than [taking] the time to fix what’s broken and go into full ostrich mode.”
I’m not sure why everyone thinks a (real) vaccine will be available anytime soon. This 1-1.5 years is polyana bullshit. It usually takes the better part of a decade to develop an effective vaccine. Anything they push at the public this year is an election year stunt. Sorry.
And let us not forget manufacturing is hard. 300+ million doses for the USA, if it is a one shot vaccine. And then the rest of the world.
Not easy.
More proof it’s only about the power for them, not about policy or governance.
That’s right; phase I trials are with otherwise healthy people, so the signal-to-noise ratio of an adverse effect is much clearer (e.g. good luck observing that a vaccine reaction causes breathing trouble if the trial participant has COPD). They’re also small, pretty much by definition. Phase III is the real proof that a vaccine or drug is clinically useful.
What the Pfizer VP is proposing is not crazy — he’s not saying there should be no clinical trial, but is proposing something like an early-adopter deployment, based on a measurable marker corresponding to how their particular vaccine works. Given the prevalence of Covid and the fact it will not be difficult to observe efficacy of a vaccine “in the wild”, I personally don’t think their proposal is worthwhile. It’s also predictably self-serving. What they’re not mentioning is there are more than a hundred vaccines in development worldwide, and the first one across the line is certain to receive extra attention and orders from governments desperate to show they’re taking action. Beating another vaccine to positive “vaccine found!” headlines will be worth billions, even if the time difference is measured in days.
Agreed, insofar as a vaccine being available this calendar year. The optimism for 1-1.5 years is because of the sheer scale of the global effort. As of today there are over 150 vaccines in different stages of development, so even a 2% success rate would result in two or three viable vaccines, statistically speaking, and that’s why even realists like Fauci now believe 1-1.5 years is reasonable. A phase 3 trial is also, frankly, easier in a pandemic. If one creates a new vaccine for hepatitis C (say), then a successful phase 3 trial has to run for years to observe a meaningful difference in infection rates, since the number of folks coming down with hep C on a daily basis even without the vaccine is low. Sadly we don’t have the same “problem” with Covid.
Basically the odds of an individual vaccine succeeding are as low as they ever were… but with basically every large immunology outfit globally working on one, the overall odds have changed. It’s the first time in history this has happened
We could work with the WHO and do the Phase III trial in a place where the virus is prevalent, like Brazil. Oh, wait, we don’t work with the WHO, do we?
Trump wants it done at warp speed, so he can say it’s been “cured” by October. There’s no guarantee that the first one will be safe and effective if produced at warp speed.There was a batch of polio vaccine in 1955 that turned out to be defective and actually caused the patients to contract polio
I heard it would take 8,000 747s to distribute vaccine worldwide.
I’m morbidly curious what Trump will say when there is no deployable, re-opening worthy vaccine by October. Hard to blame that one on illegal immigrants! Maybe he’ll blame the WHO? He can blame China for spying, I guess, but that wouldn’t explain why they don’t have a vaccine either. It’s also hard to say thousands upon thousands of scientists worldwide are all “losers” and “dummies”.
Then again, when he’s really in a pickle he’s known to drop a subject entirely. Like when he said his investigators in Hawaii were uncovering things “you wouldn’t believe” on Obama’s birth and it was literally never mentioned again.