Here are my notes from the RA Capital Covid discussion two days ago for those who have not listened: (NVAX stuff is highlighted):
This is our 24th episode covering covid
None of this should be taken as investment advice
Delta variant thinking: vaccines generally effective but spiking in US.
Lots of medical discussion including “Do we need to wear masks?”
Length of time since vaccinated; over time waning esp. older people. Boosters likely for everyone 12-18 months.
Data on specific vaccines: JnJ modest reduction on Wuhan. Worse with SA and Brazil. MRNA larger reduction but same as SA and Brazil. PFE more data. Israel, where they do more testing, 64% infection protection on Delta strain; 93% serious disease. Variation in other places.
Still not robust data. Delta variant unknown maybe more data from unapproved vaccine.
Hospitalization rate Delta and Wuhan the same in one UK study.
NVAX data, when fully released, may provide more insight.
NVAX Prevent 19: very high efficacy.
In line with what we knew from previous studies. Safety profile good too. Looking like they should have some EUAs in the next couple of months.
Likely to start in UK, Canada, EU, Korea; FDA may be on tail end of Q3.
Manufacturing on track for 100M end of Q3; 150M end of Q4.
Where does NVAX fit in with all the others approved. Global need; 200 countries still with very few vaccines at all. Developing world, boosters. Existing contracts.
Shrinking market in developing world for the first set of vaccines.
Very good data coming (Oxford trial) to compare vaccines as boosters. Expect some results in July.
Really good head to head with Oxford study; immune response and tolerability. So far, it seems to favor protein vaccines like NVAX because of their tolerability.
Any problems expected with mixing vaccines? Some mixed data; interim, separate modality as booster but might be worse tolerability or another study the same.
Re-dosing adenovirus vaccines is challenging.
Curevac: Bottom line world is lucky to have MRNA and PFE early on after CVAC results. Results not surprising to us based on prelim results.
Why lousy results? Variants acc. to company. Modified mRNA used in PFE and MRNA. And dose much lower with CVAC and tolerability worse on first dose and about same on second dose.
Supply deal with EU, 400M doses; bar is only 50%; still not sure if final analysis will get it there. EU contract may be in jeopardy. More effective against severe disease could help CVAC. Working with GSK on 2nd generation that has worked better with monkeys. Trials next 4 months. Quite delayed.
Curevac fail follows a lot of other failures. NVAX an exception despite disappointment of how fast it is coming out.
NVAX should come on line pretty soon and be the booster of choice moving forward.
Major limitation on other protein vaccines coming online. Adjuvant many use AS03 (very powerful immune booster; but tolerability not as good like used in Shingrix which can be bought to take).
Martrix-M; powerful and more tolerable.
Protein vaccines seem to be the best choice in boosting market; and NVAX appears to be first choice of protein vaccines.
MRNA quadrivalent flu vaccine, announced today, a big question mark is tolerability.
CDC guidance on mRNA and myocarditis; 1 for 250k.
Very mild and treatable. Everyone 12 and older should get vaccine. Not on same level as blood clots (AZ), since it is largely treatable.
Myocarditis is more associated with mRNA vaccines, not with JnJ or with NVAX based on initial data.
MRNA flu vaccine on a yearly basis will need to be monitored for myocarditis since this will have a higher dose.
In a world where there is a much safer protein vaccine, why would you want to use an mRNA vaccine? Perhaps if it has superior efficacy, but otherwise not. Flu vaccines have not tended to be very efficacious so maybe room for mRNA flu vaccine.
Therapeutic anti-virals: Merck drug, Molnupiravir; oral. P3 study underway. P2 study data increases probability; P3 data expected Sept./Oct. Increases possibility of success. Viral load decreases over time as would be expected. But drug seems to decrease viral load faster than placebo. Mixed results. But so far, there seems to be no difference in duration and symptom severity. Maybe P2 too small a study.