Larry Corey Currently presenting
Listening in to a Fred Hutchison in house presentation on CoViD vaccine with Larry Corey and John Mascola discussing the structure of ph 2/3 studies. Extensive details on companies and technologies and timelines. So some excellent Questions/comments.
First question was What companies-technologies are coming as Along And first company mentioned in the presentation was Novavax. First. Detailed discussions following were suggesting multiple technologies are needed to deliver seven billion doses. But he mentioned protein vaccines several times and adjuvant/proteins to target populations. He indicated children, pregnant woman and elderly are most likely targeted best By adjuvant/protein formulations.
Next
‘what are the five? Answer is that there are in fact a named five, but more are coming soon. And ‘expected BARDA Funding others as soon as they reach a certain stage. (Sounds like post ph1).
Timelines
First ph3 starts in a month, others follow, suggested protein vaccines come a few months after MRNA, and specifically mentioned protein vaccine into efficacy ph3 ‘by fall/September. He then gave timelines on potential first efficacy read out by Year end. Doubted potential for a true efficacy read out. Second ph3 (adeno) reads out next and then protein after that ( 3 months staggered finish line). But the hope is to see surrogates of immunity (antibody titer) from the sum of each study. If the MRNA trial shows immunity is seen at or above a neutralizing titer of X, then When later trials to come along like protein based Vaccines (his words) then approval could be based by immunogenicity testing. Bingo right there is the bingo.
So protein adjuvant based formulations were mentioned many many times. Including ‘we know how to make these in large quantities and they can Definitely be used in campaigns like this.’we don’t know yet if these earlier technologies will do this.
So Larry is leading the network (It is worldwide not just US) just like he did the HTVN. The group there from infectious diseases, HTVN, the statistics group are leading the study design and data collection. really great hour of detailed discussions that made me believe the right product wins in the end
Y una explicación más extensa de otro forero:
RedPlate gave you a great explanation. I know you're capable of understanding his reply, but allow me to provide some details in a language easily understood by people unfamiliar with technical jargon.
The vaccine must induce a certain amount/quality of antibodies for the vaccinated person to be protected against COVID. This amount/quality is loosely called Surrogate Of Immunity (SOI). We don't know the SOI yet because COVID is brand new.
Moderna is going to do phase II/III, in which people are vaccinated, a bunch of days later blood is tested to determine the amount of antibodies induced by the vaccine, and then the people who got later infected are identified to see who was adequately protected by the antibodies and who wasn't.
If all the protected people had antibodies above a certain level, and all the unprotected people had antibodies below that (same) certain level, and if on top of that the number of protected people is NOT ridiculously too small compared to the number of unprotected people, then we could conclude that this certain level of antibodies is the SOI (the amount/quality of antibodies required to protect against COVID).
Then, when Novavax does its phase II/III, they won't have to go to the same length Moderna will have to go through to prove efficacy. After vaccinating people and testing their blood a bunch of days later to determine the antibody levels, Moderna will have to wait several days and weeks until people are infected before efficacy can be determined.
Whereas, Novavax would only need to vaccinate and check the antibodies a bunch of days later. That's it. If the antibodies of a participant are above the SOI determined by Moderna's study, then this person is deemed protected.
However, if in Moderna's study only a tiny insignificant number of people were protected from infections, then the study would be useless, and any calculated SOI would be dismissed. Obviously, NVAX would have no SOI value to use. In that case, perhaps AstraZeneca/Oxford could come up with a valid SOI when they do their phase II/III shortly after Moderna. Then, Novavax could use the SOI determined by them. Otherwise, Novavax will have to do a longer study to determine efficacy.
