That said this has been a seat of the pants operation through no fault of Merck. They have data, good data in fact. The trial was however a mess, do how useful it is towards claims of efficacy can be debated. If the epidemic was still full blown it may be sufficient for EA. as is now, likely not. More data will be required for a standard approval route
I've been invested in both for the last few years. Bought NVAX at 2.
The news for them that is meaningful is their RSV vaccine that will change the landscape and may be one of the largest opportunities in vaccines that remain unaddressed.
There will not be an approval of RSV without a large ph3 study that merest efficacy endpoints. The hope is to define the site 2 antibodies as a surrogate, but that is not a validated marker/surrogate. It is arguable if this is actually an unmet need as there are treatments. As to being eligible for a PRV, it is not on the list.
So the st risk population won't be vaccinated and there will insides remain a need for a therapeutic. If you think your answer suggests otherwise we are right back to the delusional fool you are every day.
Perhaps you can tell us how when and where the one billion at risk people were successfully vaccinated. Since measles is an appropriate 'model'. When does that happen over how many decades and who pays.
We done with this lunacy
Again the quotes support only the notion of seeking approval via human Giles studies, and not via the animal rule. That said clearly the route to approval for NVAX is by the animal rule as they did not get into the field studies. I did not say nor did I imply they had sufficient data for approval via the field studies reported, only that this is CLEARLY the path they are pushing. Suggesting otherwise is 'all yours' good for you. It's bull.
With regard to the discussion bout significance of immunity or duration, they made an honest comment about what they don't know, and key to that is the durability of the apparent protection they saw. Despite 'tweaks' in the trial a field study showing 16 vs 0 in a controlled study would be quite good data. I expect other professionals in the industry agree. Is the trial perfect? Absolutely not and again I think professionals in the field will all agree. But will they be able to pyrsue emergency authorization for use and perhaps conditional approval? My guess is that they try. They will include animal challenge date and immunogenicity from primates and humans and they will try.
Back to fishing
What he is saying is that it is not known how long the apparent protection will last. Always true for a study like this. A six month field study can't tell you what 1 years immunity will look like. He is being honest not mysterious.
Second for the second comment on the animal rule, this is a human study and they do not say anything to suggest they are headed to an animal rule based approval. To the contrary they are suggesting the human studies are supportive.
It aint Merck that bs tting here.
Yes there were injection site reactions and flu like symptoms. Duh. It's a vaccine.
Might want wait on this claim and wait for details from this trial. For now the news is that it met the HAI targets, and it is only HAI that matter when it comes to approval on the surrogate marker.
The process moves in steps, once you get to a specific step there is no reason why the next step would be delayed.
Nothing but data is more like it
There are in fact few real risks as the basic method has been around for twenty plus years. Believe it or not it isn't really hard. There are some limitations to what can be accomplished however as mechanism of immunity/protection is not always best achieved by generating antibodies. So not all diseases can be addressed. However for disease targets such as flu or RSV or Ebola this approach is rock solid and has little technology risk. Nothing is perfect but this method is well understood and offers a commercially scalable and reliable method for production that has fewer downside risks than current egg based processes.
Bottom line is this. Very low technical risk but some limitations that cannot do everything. That limitation is a function of how the immune system works and perceives particulates.
yes I would worry about execution and the ability to manage 'burn'. Technology for all sorts of things fail all the time due to failed execution. Management matters at least as much as technology.
You are correct, this has nothing to do with egg based production. The Merick vaccine is a live attenuated virus strain that replicates and can in theory (but never in 40 years of use) generate a new non attenuated vaccine. Flu vaccines are not live they are detergent extracted soups of proteins. Extrapolating isn't the correct word here. Try dead wrong.