Re: Farmas USA
NVAX
Sigo subiendo más información. Esta del grupo de FB. El primer mensaje es de Mark Reddish (lo ha nombrado framus más de una vez). Parece que comparte mis sospechas de que la vacuna de este año tiene algo diferente de la del pasado que hace que no funcione. Con lo que si esto es así, lo mejor que podría pasar es que dijeran en la conferencia que han descubierto de qué se trata:
While the suggestion that vax vax were 'given RSV' this is ludicrous as written. The disease data is way too small to suggest these Pts were at any greater risk. And of course the vaccine does not contain any RSV and can not transmit infection. In some instances certain antibodies have been shown to increase infectivity (notably for HIV and other viruses) but even that is not suggested in this data. What is suggested in this data is that the year 2 vaccine did not provide a protective antibody response. This has been my predicted outcome here, that an attribute of the vaccine from ph2 was not seen in the ph3 lot of vaccine. Studies of monoclonal inhibition are needed to understand if this theory may be correct. While a low attack rate can skew a trials outcome, I find the disease data disturbing with respect to functional antibodies that do not appear to be working
Estos son de Casey Crooks, que trabaja en el sector seguro:
Had the vax worked in P3 then one would have thousands of antibody points to correlate to who got or didn't get sick and develop a benchmark for what level of immunogenicity is protective. THEN one looks at the P2 rollover data with that information. But, the P3 didn't work. One doesn't have the benchmarks. Trying to pull efficacy data out of the P2 is grasping, it was never designed for that, breaking the P2 resolve into 4 arms just drops the numbers too low for even a glimpse of efficacy (IMO). P2 rollover was really always all about immungenicity, not efficacy. But I understand that is all there is to work with for the moment as well.
-
the PCA assay is a competitive monoclonal antibody binding study, serum from trial participants is used to see if it can compete away the binding of the mAB palivizumab, a mAb that is known to provide protection from RSV. Regarding "an attribute" (and not to say this is what Mark is saying) but attributes of the P2 included generating serum that 1) produced anti-F IgG. This is antibodies that will bind the F protein anywhere, some binding which may be protective some which certainly is not and 2) serum that could compete away palivizumab binding, this would be a subset of the anti-F IgG population, indicative of antibodies that bind at or near the site that is known to be protective. This will be done with both the rollover and the P3, it is part of the P3 protocol. Were time it would be being done now. Plenty of folks want to see the PCA result. If the PCA result falls flat then it is game on and the property is once again valuable to BP. Falling flat would mean the P3 batch had issues, but since they did it in P2 it means they can do it, and they jsut need to figure out production. On scalability that folks mention ... this is a no competition high margin product, they'll build it if it works.