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Stay tuned for an informative covid disinformation thread tag team with my brother Jules (aka @JamesMWilliam18 ) to my Vincent.
Okay, it took a while but I'm finally following up on this. Thanks to @JamesMWilliam18 for the continued motivation and inspiration!
tl;dr right here: https://www.baltimoresun.com/maryland/carroll/opinion/cc-op-community-voices-wack-122020-20201220-qdthn6a74zbvrfqd2lcljqphsm-story.html
tl;dr right here: https://www.baltimoresun.com/maryland/carroll/opinion/cc-op-community-voices-wack-122020-20201220-qdthn6a74zbvrfqd2lcljqphsm-story.html
Vaccine development is usually a long, tedious, very detailed process, taking years to decades.
The FDA has a robust, comprehensive process to vet new vaccines.
Just because Operation Warp Speed accelerated the process doesn't mean we can't/shouldn't trust the new covid vaccines.
The FDA has a robust, comprehensive process to vet new vaccines.
Just because Operation Warp Speed accelerated the process doesn't mean we can't/shouldn't trust the new covid vaccines.
The first step is the vaccine concept development: what disease, what technology, how big a market, etc.
It's important to be clear up front that this is a collaboration between medical researchers and industry.
Medical researchers are trying to solve health problems.
Pharma? $$
It's important to be clear up front that this is a collaboration between medical researchers and industry.
Medical researchers are trying to solve health problems.
Pharma? $$
Not necessarily a bad thing. Where those two agendas intersect, amazing things can happen.
FDA oversees the process and serves are referee, mediator, planner, etc.
FDA oversees the process and serves are referee, mediator, planner, etc.
That first step usually occurs in the background, without much FDA involvement.
All the R&D is funded by grants at academic research centers, or through pharma corporate $.
If a viable concept emerges from simulations, modelling, cell culture, and animal testing, on to trials!
All the R&D is funded by grants at academic research centers, or through pharma corporate $.
If a viable concept emerges from simulations, modelling, cell culture, and animal testing, on to trials!
FDA supervised human clinical trials have roughly 4 phases (oversimplification).
The two major elements of review at every stage are safety and efficacy.
Safety: does anyone die? Severe reactions? Any long term problems?
Efficacy: does it stimulate the immune system? How much?
The two major elements of review at every stage are safety and efficacy.
Safety: does anyone die? Severe reactions? Any long term problems?
Efficacy: does it stimulate the immune system? How much?
Most importantly, does the level of antibody measured after the vaccine result in *effective* immunity, actually preventing symptomatic disease? Even better, preventing asymptomatic disease, so you can stop the spread?
How long does that effective immunity last?
How long does that effective immunity last?
If a candidate vaccine passes Phase I (no one dies, seems to stimulate an immune response), it's on to Phase II, which is just like Phase I but bigger, more subjects, more data, now looking more closely at efficacy.
At every phase, reviewers at the FDA closely scrutinize.
At every phase, reviewers at the FDA closely scrutinize.
This can usually take months to years. Ordinarily, the pharma company is allowed to structure the trial themselves, based on their estimates of success, cost, risk, etc. This is a challenge for reviewers because they have to make sure the trial is properly structured.
If the trial is correctly structured (# patients, lab techniques, blinding, etc.) AND the data looks promising (no major problems AND stimulates immune response), it's on to the next Phase.
Phase III trials are even larger, hundreds to 1000's of patients. By now, there haven't been any serious problems, and there's enough evidence of positive effect that pharma companies will invest large sums of money in these trials. Each patient must be compensated, lab time....
..equipment, reagents, lab workers, software, etc. Then all that data goes to the FDA for ANOTHER review. A lot of up front money at risk for the pharma company, all of which could go down the toilet at any time if something weird crops up.
If Phase III is successful, the company applies for permission to release the vaccine. But it's not over yet: Phase IV is post-release surveillance, through the Vaccine Adverse Events Reporting System (VAERS).
Anyone can report to VAERS: researchers, health providers, the public
Anyone can report to VAERS: researchers, health providers, the public
All vaccines are continuously monitored through VAERS. If a pattern of infrequent but serious reactions starts to accumulate, the FDA can pull the vaccine. This happens infrequently, but it does happen. An example is the early version of the rotavirus vaccine. Pulled, improved.
Operation Warp Speed (OWS) - what OWS did very successfully was accelerate all these steps, without compromising the safety and efficacy reviews.
There were multiple facets of the effort.
There were multiple facets of the effort.
First, the usual cast of characters in vaccine development on the Federal side is wide ranging: HHS, NIH, CDC, DoD, and BARDA (Biomedical Advanced Research and Development Agency). Under OWS, all these groups came together, coordinated, shared data and oversight.
This group took control of all covid research efforts, specified standard testing protocols, unified all review efforts, and combined resources to accelerate review.
By necessity, most other efforts were sidelined at these agencies, which will take a toll later.
By necessity, most other efforts were sidelined at these agencies, which will take a toll later.
Next, and of critical importance, OWS fronted billions of dollars to the pharma companies to start building production capacity BEFORE the vaccine trials were finished.
Doing this in parallel was unprecedented. Usually, because of the enormous financial risk, ...
Doing this in parallel was unprecedented. Usually, because of the enormous financial risk, ...
...those investments wouldn't be made until AFTER successful completion of later phases of human trials.
OWS massively accelerated production capacity building.
Lots of negotiations involved, and some companies took a pass, relying on their own resources (e.g. Pfizer).
OWS massively accelerated production capacity building.
Lots of negotiations involved, and some companies took a pass, relying on their own resources (e.g. Pfizer).
Nice work if you can get it, because I'm sure it gives Pfizer more leverage for a better deal now that they've got a good vaccine.
As we discussed in the beginning, for pharma, it's all about $$$$$$.
As we discussed in the beginning, for pharma, it's all about $$$$$$.
Last, OWS picked winners and losers, fast-tracking and forward funding ones that the expert panel of research agency reps and health experts thought were most promising. This is usually a pretty laissez-faire process, where industry picks and chooses, except in unusual cases.
To their credit, the OWS team fast-tracked the RNA vaccines, which will likely have a massive payoff in coming years. That's another thread.
Summary: OWS was a massive success of big government management of a crisis, using three main tools:
1) heavy handed coordination by multiple govt. agencies;
2) dumping billions into vaccine R&D and production, mitigating industry risk;
3) picking winners and losers.
1) heavy handed coordination by multiple govt. agencies;
2) dumping billions into vaccine R&D and production, mitigating industry risk;
3) picking winners and losers.
All while maintaining oversight of safety and efficacy through the usual (although expedited) review process the FDA has done successfully for decades.
Big government: IT WORKS!
Get your covid vaccine as soon as you can.
/end
Big government: IT WORKS!
Get your covid vaccine as soon as you can.
/end
