Valneva SE (VALN)

Here's the deal... The CNBC article only looks at antibodies against the spike protein. Valneva's vaccine is the entire virus, which unlike any of the other vaccines tested, facilitates the production of antibodies against other viral antigens aside from the spike protein. For all we know Valneva's vaccine is ideal because the immune system can generate a humoral and T-cell response against far more than just the spike protein. Indeed, with the spike protein mutating at such a high frequency the key might reside in the broad immune response the Valneva vaccine potentially provides. This may be the primary differentiator for Valneva over any other available vaccine pertaining to variants of the virus, including Omicron. Indeed, nobody knows if antibody production is the primary determinant of immunity. It's likely the T-cell response induced by the vaccine, as opposed to the antibody production, that wins the day. It's the very reason Valneva is potentially the best vaccine out there, despite the Lancet article regarding boosters. Nonetheless, that article definitely didn't help matters for the stock.

(Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT
Biologika today announced their collaboration for the production of
Valneva’s inactivated COVID-19 vaccine candidate VLA2001. This follows last
week’s announcement that Valneva signed an Advance Purchase Agreement with
the European Commission to supply up to 60 million doses of VLA2001, over two
years.

Under the collaboration, IDT Biologika will produce VLA2001’s drug substance
at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, in addition to
Valneva’s manufacturing site in Livingston, Scotland.

What we know:
1) VLA 2001 out performed AZN's viral vectored vaccine in a P3 study for peak anti-spike protein titers. It also showed robust T-cell responses and antibody responses directed against proteins other than the spike. No one experienced serious illness who got either the VALN or AZN vaccine (AZN is highly effective at preventing serious illness).
2) mRNA vaccines can produce very high antibodies directed against spike proteins but these fall off rapidly, at least following the second dose, given a few weeks from the first. We don't know if the post booster (3rd injection) titers will fall rapidly.
3) mRNA vaccines are associated with myocarditis and very recently reported to produce a sustained elevation of ACS risk parameters. AZN vaccine is associated with thrombotic side effects. So far, no serious, side effects are confirmed to be VLA2001 related.
4) A VLA2001 booster given 2-3 months after the Pfizer mRNA did not raise titers significantly but after the AZN vaccine it did. The VALN CEO has stated that optimal timing was not used for boosting in this trial.

My take is: 1) VLA2001 will likely be approved but not for boosting after mRNA vaccines until more data is available 2) So far, VLA2001 is shaping up to be the safest choice but more data is needed and there are theoretical reasons that should be so 3) Vaccine resistant may be more amenable to VLA 2001. 4) It remains to be proven if VLA2001 is the most durable vaccine relative to the 'spike only' vaccines

Steven, take this for what it is worth for my opinions are worth little. I’m wrong more than I’m right, and I take large positions so I am not really a great hedge fund manager, way too much volatility for the average shareholder.

That being said, I outperform just about all of them with triple digit returns for a few years annualized.

NVAX is my 4th largest long and has been since the beginning of the pandemic - VALN , EBS, DVAX or VIR now, so NVAX is in there. It’s obvious that We are running a highly concentrated Covid fund with nat gas and semis following. The common is either a dream or a nightmare depending on cost basis. The management is controversial. The scientists that work there are very competent. The vaccine is excellent. It will work against the variants and without the mRNA risk, which we know is cardiac inflammation in the long term and will increase ACS in a future.population . mRNAhas also saved many lives so don’t get me wrong but the day will come when the facts of rushing these vax will be undeniable. JNJ is a little different but not the best

My son works for NVAX so I can tell you without anything specific NVAX is getting it together. The adjuvant is difficult to source and manufacturing is or was chaos. This is why the DVAX adjuvant is probably the better ticket but if I had my choice I’d say the Matrix M is better for your body to get your immune system to respond. Nevertheless, both are better than what is out there.

regarding market action, there is extreme manipulation countervailing forces to drive the price up or down. What happened today is talked about on that board but it shows what rumors can do without contracts and real earnings. Go to the charts and it is the middle of a base from the 130s to 250s. Until EUA from Europe or the UK happens, There will be every conceivable manipulative gyration.

I posed the question to this board a few months ago about NVAX because I really feel it is the largest competitor to VALN and the other DVAX adjuvants whole virus vaccines. Accordingly, I’m not playing favorites. So, I’m bullish until the market turns on Covid stocks. This hasn’t happened yet but it will.

There are several points, Valneva has to execute on in the upcoming future:
1. Most important (near-term), receive approval by EMA (and MHRA (UK)) - basis for bringing the vaccine to the EU
2. Show data, that VLA2001 is safe and effective in elderly and adolescents
3. Show data, that VLA2001 is equal effective as booster vs mRNA-based vaccines
4. Demonstrate that long-term safety is much better than mRNA
5. Demonstrate that protection of VLA2001 lasts longer than with mRNA
6. Provide more deals with other countries, in near-term with high-price Asian countries
7. in 2022 show strategy for USA (and) Canada
8. Last but not least, provide final manufacturing strategy (expansion in Scotland has been suspended after UK deal termination)

Moderna will use a higher booster dose to fight omicron. The question is will that raise the cardiac risk, as more of the mRNA ends up in the heart. May not be the best option.
I think VLA2001 will gain ground as people take a closer look. I would prefer a non mRNA booster rather than repeatedly raising or boosting my cardiac ACS risk parameters. This is simply an ongoing experiment with billions of subjects. I hope politics doest restrict availability in the US. Moderna seems to have an inside track with the government having a big stake in the patents. Fortunately we have a free press and if they get wind of any favoritism the message will get out.

THIS is from 2 days ago;

Johnson told lawmakers on Wednesday he was "personally very disappointed when we couldn't get approval for the Valneva vaccine in the way that we had hoped".

"What we are doing is investing massively in this country's vaccine capability across the country so that we are prepared for the next pandemic and I very much hope that Valneva will be part of that," he said.

Before cancelling the supply deal in September, Britain had secured options for hundreds of millions of doses of the vaccine and earlier this month, Valneva secured a 60 million dose supply deal with the European Commission.

Looks like the mRNA companies will be playing 'whack a variant', trying to rapidly adapt to each new iteration of COVID, and governments are on board. What's clearly needed is broader antigen coverage and more robust T cell immunity which VLA2001 promises. This can obviously also be adapted to new variants and deployed quickly around the world with less cold chain issue. The other issue with the mRNA vaccines is long term unknown effect on vasculature. It would seem VALN vaccines should at least be an option if not first choice.
https://www.thecardiologyadvisor.com/home/topics/acs/acute-coronary-syndrome-acs-biomarkers-mrna-covid19-vaccine/