In terms of just geometric-mean concentration of antibodies, the levels achieved after the first dose were 1.8x and 2.8x (in the 10µg and 30µg patients, respectively) the levels seen in the convalescent serum panel. The question is why? Pfizer Inc. is a research-based, global biopharmaceutical company. Pfizer Inc. is dedicated to discovering, developing, manufacturing, and selling healthcare products internationally. Seems like the Pharma establishment is against challenge trials. The devil is in the mathematical details and the quality of the assumptions used for them.What actually costs these deaths are people believing there will be a vaccine very soon, and not trying to get rid of COVID-19 without a vaccine immediately instead. It will be interesting to see how their patient responses compare to these data. This is actually the first real data set on any of the genetic vaccines, since Moderna’s paper on their Phase I trial has not yet appeared (all we had was a brief press release) and a brief press release is all we got from Inovio’s DNA vaccine work as well. Yet, research approaches with a high risk of failure (not of the vaccine, but the study itself) are considered the “prudent, ethical course” while the pandemic rages. If your participants happen to be careful about their social distancing or transmission goes down in the area, the trial is screwed. Is it really that difficult to follow up on patients and analyze their antibodies?Sorry, but it isn’t that simple! The company sells its products in more than 125 countries globally. The federal government of Angela Merkel cannot temporarily close businesses or mandate a 14 day quarantine for travelers from abroad. Germany has.Challenge testing will be completely unnecessary if things don’t change. Male/female almost 50/50, ages from 19 to 54, mean 35 years old.
Unlike current therapies for RA, tofacitinib takes a novel approach, targeting the intracellular signaling pathways that operate as hubs in the inflammatory cytokine network. (until we get a vaccine)Fortunately, there are good answers to both of those (which are questions that others have as well). We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development, manufacture and distribution of healthcare products…
It’s an expensive enough (and risky enough) proposition, and the safety standards would be so high for a nonfatal “disease of inconvenience”, that no one really has wanted to touch it. Fiddling while lungs burn in my opinion.Moral: Statistical testing of clinical data is difficult and way beyond high school (or even college) math. Pretty much everyone reported it after the second, which is to be expected. I think the US is more individualistic and internally complex than even NZ/Australia, for that matter.The US has unique advantages and disadvantages that make it not really remotely comparable to any other place on Earth. If you think about it, a phase 3 trial is just a passive-aggressive challenge trial…hope transmission stays high where you are testing …wink, wink…hope participants are sloppy about masking and social distancing…wink wink…then hope you get enough exposure in the pool to be able to show a response…wink wink. They are small studies so I would think it would be very feasible to collect such data. Yes, it leaves a scar.New Zealand probably can’t sustain its economy with indefinite quarantine from the rest of the world, but if a vaccine comes along early next year, their plan will have worked great.Maybe logistical wasn’t the right wordIf you add funny animals, a queen and a horrible accent to the US you get Australia – I am not sure the lack of a king/queen is the radically different governmental structure you had in mind.One thing that caught my eye in this post was the comment about measuring neutralizing antibodies from patient samples. while Pharma gets support for accelerating technologies they will be able to a patent for more profitable uses down the road. Get the full spectrum immunity of natural infection in all its glory.