Los datos están en esta presentación:
http://novavax.com/download/files/presentation/Novavax_Sept2017_InvestorPresentation.pdf
Por qué se estudia en hurones:
As described in this Primer article, the ferret is an excellent small mammalian model that can recapitulate many of the hallmarks of human influenza virus infection. Given the wealth of information that can be generated while studying respiratory virus infection in this model, ferrets offer numerous advantages over other small mammalian models and are an ideal laboratory species to measure the most crucial aspects of influenza virus infection in the context of improving public health.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3180220/
-
La ventaja que se mostró en el anterior resultado es que protegía ante una gran variedad de cepas y mejoraba lo actual. Además de que se ha comprobado hace poco que la mayoría de vacunas no protegen ante algunas cepas por su método de producción. Este es un resumen que hicieron en IV. Como siempre, son muy optimistas:
https://seekingalpha.com/article/4125607-novavax-nvax-presents-stifel-2017-healthcare-conference-slideshow
Slide 17 (Ferrets Rule)
Most all of the new influenza vaccines are not approved based on human efficacy, either. They are approved through immunogenicity data, and for animals, ferrets are the Gold Standard.
“That’s why people are excited. Because with the gold standard animal, NanoFlu results crushed the current products on the market. Human immunogenicity data is next.....” MOMONEY77
“That the vax shows HAI and MN responses against a broad collection of historical H3N2 strains is certainly very cool, but not only that, but in antigen-matched/strain-matched responses (say A/HK or B/BR) Nanoflu appears to give FZ-HD a bit of a beat down. And then the A/CA result (strain matched for FZ-HD where FZ-HD should really outperform) Nanoflu beats it soundly with both HAI and MN (FZ-HD has home field advantage with A/CA, and loses).The results are staggering.” MUDDY
This H3N2 flu season will hit late & very hard, and NanoFlu will be a very HOT topic. Here's why...
Flu, although always evolving, follows patterns. Every year we learn more about the flu and the effectiveness of the commercial vaccines.
Here's what we know as FACT:
- Australia just suffered one of the worst (H3N2) flu seasons on record.
- The (egg-based) vaccines failed to protect. Many people suffered & died.
- We know that there was NOT ONLY a mismatch of the circulating H3N2 in the seed virus for the vaccine, but we now know that there was also a critical mutation that occurred in the egg-based production system. Scientific FACT. Double whammy...
- Basically, you have a highly flawed vaccine that offers very little protection. (10%)
- H3N2 is already starting to hit the US & Canada (and the UK), and we aren't even into December. H3N2 has started early, even though it's usually most prevalent late in the flu season.
- Articles are coming out, left & right about egg-based mutations leading to ineffective vaccines.
- More articles will come about this and ALSO, the fact the vaccine seed strain was mis-targeted. (Trying to fit a round peg into a square hole.)
- China will start reporting H7N9 cases & H5N6 cases sparking pandemic concerns. (Human H7N9 cases usually start ramping up in December and the virus has evolved.)
- NanoFlu Ph 1/2 data will be released and it will be "staggering." (December 2017)
- BARDA will jump on board with funding BEFORE Q2 18. (Likely, Q1, early March 2018).
NanoFlu... The new paradigm of flu vaccine coupled with the next generation adjuvant, Matrix-M. Exactly what Hana Golding and the FDA have been talking about & dreaming of.
And as Dr Glenn stated during the last conference call when discussing the NanuFlu program : " Also these data suggest that NanoFlu has the potential to address the problem of annual strain mismatch due to its ability to induce highly neutralizing antibodies against a broad range of influenza strains."
--
Sobre el retraso, la compañía dijo que no les dieron los virus para poder hacer el estudio y los han tenido que cultivar ellos. Para mí este retraso tiene lógica y sentido. Ahora bien, sabiendo cómo son, cualquier cosa es posible.