Needed: A Faster Way to Test Vaccines
Reading Nicholas Christakis’s book Apollo’s Arrow: The Profound and Enduring Impact of Coronavirus on the Way We Live (affiliate link), I ran across an interesting fact I had missed in the coverage of the Moderna COVID vaccine: it was developed in February 2020 — before many of us had even heard of the new coronavirus.
That testing has been accomplished this quickly is a miracle. But what if there had been some way to accelerate the testing? I’m not talking about stripping away currently necessary protocols, but a sea change in the way testing is done. Christakis mentions the use of genetically modified animals whose immune reactions are engineered to resemble that of humans. But the real advance, I think, is yet to be discovered: some form of rapid testing on cells that is proved to have similar outcomes to lengthy months- and years-long testing protocols.
It may be unachievable. But imagine if we could have started administering a vaccine for COVID-19 in late February or early March.
If the vaccine had come out earlier, Trump would have been re-elected. Nearly any favorable change in America’s fortunes before the election would have help him, and he didn’t need much help.
Trump claimed that there was foot-dragging, just for this reason, and the vaccine news from 3 companies coming out 1, 2 and now 3 weeks after the election may mean there was some truth to Trump’s complaints.
Kevin M (ab1c11) — 11/23/2020 @ 8:52 amBut imagine if we could have started administering a vaccine for COVID-19 in late February or early March.
I doubt that any regime could have got such quick results But the situation in prisons was such that maybe some aggressive human testing there might have been of mutual benefit.
Kevin M (ab1c11) — 11/23/2020 @ 8:57 amI can only imagine immunologists are sounding like Scotty from Star Trek right now.
Hoi Polloi (66077a) — 11/23/2020 @ 9:19 amTrump claimed that there was foot-dragging, just for this reason, and the vaccine news from 3 companies coming out 1, 2 and now 3 weeks after the election may mean there was some truth to Trump’s complaints.
Over at Powerline, Steven Hayward reminds us that “the experts” assured us that having a vaccine ready by the end of this year was a pipe dream and that it would at least June 2021 before we could count on it. That doesn’t necessarily mean that there was a conspiracy against Donald Trump by the media and scientific establishment, but it does suggest what a lot of us have been arguing all along: that where coronavirus is concerned a lot of the “experts” are just spit-balling their guesses and are unwilling to admit that they lack the data to make informed estimates.
JVW (ee64e4) — 11/23/2020 @ 9:20 amFascinating stuff:
What if the key to understanding the COVID-19 virus (and perhaps many other coronaviruses) is not biochemistry, but biomechanics?
JVW (ee64e4) — 11/23/2020 @ 9:30 amA vaccine is available in Texas next month. It will first go to healthcare and frontline workers. They are our guinea pigs for the vaccine, but they are also at highest risk for Covid.
DRJ (aede82) — 11/23/2020 @ 10:03 amI think it would be very cool if that kind of biotech were discovered. I’d like to believe that someone at some pharmaceutical company was already working on it, but IDK, it wouldn’t be a sexy development or one they could sell for much and I don’t know if the need for a new vaccine comes along often enough that being first to the vaccine would be profitable enough to fund development of such a thing simply on speculation.
Nic (896fdf) — 11/23/2020 @ 11:51 amVaccine development is one thing; testing and clearing it for safe distribution is another. Abbreviate the protocols and you raise the risks. Case in point- swine flu vaccine produced back in the mid-70s. The gov’t rushed it out w/ all good intent but bad batches reached the public and people got sick from it. Saw it first hand; half the guys got the free shots and became ill- those of us who declined the freebee did not.
DCSCA (797bc0) — 11/23/2020 @ 12:08 pmLet’s tell the truth: the FDA normally requires years of testing before approving a new medicine. This is being rushed out at high speed because of the politics.
The Dana in Kentucky (facd7c) — 11/23/2020 @ 2:27 pmThe rushed vaccine didn’t work out well in 1976. 60 Minutes.
https://youtu.be/4bOHYZhL0WQ
Efficacy of flu vaccines. 40 to 60% at best even though pre-release percentages were much higher.
https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm
Even the polio vaccine is not 100%.
https://www.cdc.gov/vaccines/vpd/polio/hcp/effectiveness-duration-protection.html
I’m not against vaccines. I personally would wait to see how these new COVID-19 vaccines work before taking them. I have now had 5 PCR tests for COVID-19 and all of them have come out negative. I figure if I continue my current behavior and wait to see how the vaccines turn out, I’ll be OK.
Tanny O'Haley (8a06bc) — 11/26/2020 @ 3:10 pmThere is, of course, and the current protocols for evidence based medicine is not itself…evidence based.
But…you gotta believe. Actually, I mean you have to subject everything to the common sense test.
https://www.wsj.com/articles/too-much-caution-is-killing-covid-patients-11606238928
They’re never going to change things by themselves.
You gotta believe. There needs to be political overriding of the “science.”
More political interference than Donald Trump dared to give.
Sammy Finkelman (e5fb44) — 11/26/2020 @ 3:29 pmTrump says a vaccine could be distributed next week. He’s right. All that it is waiting for is for the FDA to certify it – and it about as sure as the results of the election.
Sammy Finkelman (e5fb44) — 11/26/2020 @ 3:32 pmThis has been one of my deepest frustrations. I didn’t vote for Trump, but if hiring him was supposed to be good for anything, cutting through inflexible, devoid-of-common-sense institutional thinking that gave us this delay should have been it. The FDA is set up to approve things only after you demonstrate that if you give the drug to 500 million people, you won’t kill anyone. You also have to prove safety and effectiveness in a randomized placebo controlled trial that takes 6 months.
In a pandemic, these are both entirely the wrong calculations, for one simple reason: if you deliver a perfect, safe vaccine after the virus has already swept through the population, it’s too late. If the disease will kill hundreds of thousands if not stopped, and proving vaccine safety on a 500-million level means those hundreds of thousands will die because of the delay in reaching that level of certainty, then your insistence on that level of certainty about safety is killing people.
Prove, instead, that the vaccine would kill or debilitate no more than 1 in 10,000 persons. If I’m in the high risk category and there’s a 10% chance the disease will kill me, when I weigh that against the 0.01% chance the early vaccine will kill me, taking the vaccine is a no brainer. It should be a no-brainer to the FDA.
Again, the FDA required a randomized controlled trial involving tens of thousands that took almost 6 months. No. You solicit volunteers, and you conduct your controlled trial by deliberately exposing the volunteers. You’d be done in 6 weeks, not 6 months. There were literally thousands of volunteers that offered themselves for this purpose. If they weren’t enough, the President could have offered commutations as an inducement. As to liability, he could have badgered Congress into passing a federal liability waiver for any professional involved in the process and generous compensation for anyone injured, or for their families in the event of death. If the choice is a vaccine in June or a vaccine in December, that’s an argument he would have won.
A vaccine should have been available by late June – at least to those most vulnerable. The only limiting factor should have been production capacity.
Public figures who have suggested things like this, or who suggested making the vaccine available to the most vulnerable after the phase 1 trials, have all been swarmed into recanting. The big fear is that if a vaccine kills someone, the public will never take it. That’s top-down nonsense. People get skittish about a vaccine when they don’t perceive the disease as a risk. People felt able to decline the MMR because those diseases are so rare nobody worries about them. But COVID-19 is obviously killing thousands, and if the vaccine is visibly effective, people will, largely, see it as clearly the better bet. At the very least, those most vulnerable will see it as the better bet.
So what if, when the prevalence of the disease diminishes, you get a lower ultimate vaccination rate among those least vulnerable than you would have if the early vaccine had not killed a handful of people? If so, then you get a handful more people dying of it each year after the pandemic is over. -That’s a problem you can address with a refined vaccine put through the full trials and the kind of inducements we presently use for most childhood vaccinations. Weighed against saving hundreds of thousands who will certainly die due to the delay – the fear of a lower ultimate vaccination rate is no excuse.
We could and should have had a vaccine five months ago.
Nathan Wagner (98260f) — 11/26/2020 @ 8:30 pm13. Nathan Wagner (98260f) — 11/26/2020 @ 8:30 pm
And , more important, a cure. And temporary immunity through easy application of neutralizing antibodies.
Because a vaccine is thw wrong thing to look for in a hurry.
And the problem is demands, not for safety, but for efficacy, to be proven beyond a reasonable doubt complete with exclusionary rules of evidence.
It was not possible to prove that, without letting the epidemic spread – mathematically impossible, under FDA guidelines which the the Trump Administration partially opposed until the companies gave in, almost certainly because there was a very probably Democratic Party engineered attack on the idea of anything that would come out before the election.
Sammy Finkelman (9966eb) — 11/27/2020 @ 5:36 am