If none of Moderna's competitors announce the performance of their own omicron specific vaccine this pre-market and that at AH today the FDA releases the meeting materials for June 28, Moderna will effectively be the only company with solid omicron-specific vaccine data entering the VRBPAC meeting come next Tuesday.
T
This is located on the footnote of page 13 of the FDA documents for Tuesday's meeting: "Novavax will be presenting data on the use of their Novavax COVID-19 Vaccine, Adjuvated as a booster to address SARS-CoV-2 variants. THIS VACCINE was developed against the PROTOTYPE VIRUS." Reading that they will be relying on their prototype vaccine data for upcoming meeting, I suspect that the odds that Novavax is successful on their omicron vaccine effort is not looking very good. I'm also finding it hard to accept the narrative that NVAX is just not yet ready with their data as I observed that their clinical trial was hastily planned in such a way to get that their data ready by June 28. Recall how they started on May 31 and set their primary outcome at 14 days later (around June 14) as opposed to the usual 30 days set by other vaccine makers. A neutralization study should then just take 2-3 days max if everything else was nicely prepared beforehand. This time frame would then easily bring them to a comfortable June 17. It's of course still possible that they are just slow or they have some other strategical considerations related to the finance rather than the science. But I increasingly confident that Moderna will dominate the omicron specific vaccine market. My two cents. GL all.
T
The FDA materials for June 28 are now available. As expected, Novavax missed to include their data for the meeting and we now get to see the absolute GMT value between Moderna and Biontech (see below).
The need for the Novavax vaccine is greater than ever.
What does the data really show for the updated mRNA vaccines?
To me what was expected and certainly both Pfizer’s and Moderna bi-valent vaccine will be approved. Yet the flaw with mRNA is as glaring and enormous as ever. Proves that they are continuously playing catch up and mRNA has failed as a platform. Basically 1.5 times the antibody response at 1 month for Ba1 . Much less for the newer sub variants. What variants will be circulating in the fall? The dead of winter? What will be the level of antibodies for those variants at 3 months 4 months.? Most likely the same pattern of rapid waning and minimal protection. What if a really virulent variant arrives . This is a stop gap and the need for a more durable vaccine exists and is needed. Multiple reasons for an alternative to mRNA .
The future is a pan -coronavirus universal vaccine and Novavax has the best path forward because it’s dosage independent. Remember and think about this, Pfizer raising the dosage to try and get a better immune response in adults. So a 50 year old 100 pound women should get 60 mcg? YET let’s say a 17 year old male 200 pounds going away to a infested college dorm this fall only gets 10 mcg? How absurd! The Novavax vaccine is dosage independent using the same dosage in all age groups.
Sure Novavax will introduce a bi-valent vaccine soon, however it’s a 6- valent, maybe 8-valent vaccine that targets all parts of the spike including the non mutating areas.
We have a seat at the table , hoping for a FDA approval on Monday. At the meeeting we can acknowledge the need for a bi-valent Omicron enhanced vaccine . Im sure the FDA will be interested in hearing the progress of our vaccine as well.
Novavax is the future and will be the ultimate winner in the control of this plague.
W
Think about yesterdays trading: 6 Million shares bought 2 Million shares sold Strange
W
What is the 50 average stock price ? once moderna closes above it, the bull run will start
R
So BetaTech chief didn’t think Omicron variants warranted an updated vaccine now he is arguing with regulators that human trial is not needed since they are late for the fall booster with no data to submit? This guy was supposed to be a scientist while Bancel caught heat for merely communicating what the data and epidemiologists were saying. Let’s see which mrna bivalent vaccine will launch first. MRNA science 🧬 🧪
P
Where are all the memesters?
T
In a couple of weeks we will see $300 levels.
B
Buy to $200.
M
I’m holding this stock for 15 years minimum no matter what. I don’t care if it goes to $5,000 a share. I am not selling.
N
U.S. CDC advisers back Moderna COVID vaccine for teens, older children REUTERS 11:49 AM ET 6/23/2022
H
Can't wait till $MRNA comes out with another drug using their technology.
T
FYI, Pfizer/Biontech have now released their positive result. So it turns out that at least 2 companies, not just 1 will enter the VRBPAC meeting with positive data supporting variant adjustment. Now, we'll have to wait for Novavax's data. It'll be interesting to see how the events unfold.
P
Back to $200 then $300 then 400$ then $500 ......................
A
news out: MODERNA ANNOUNCES BIVALENT BOOSTER MRNA-1273.214 DEMONSTRATES POTENT NEUTRALIZING ANTIBODY RESPONSE AGAINST OMICRON SUBVARIANTS BA.4 AND BA.5
One month after administration in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 in all participants regardless of prior infection.
T
Excellent article by the Daily Telegraph: "Moderna's omicron jab ready for Australia by August 1". It's about the omicron vaccine in Australia but it's more than that. It's also about how Moderna's platform narrative is playing out. GL all.
D
Man, when does this take off to 200 again? Nothing but good news smh...
Reading that they will be relying on their prototype vaccine data for upcoming meeting, I suspect that the odds that Novavax is successful on their omicron vaccine effort is not looking very good. I'm also finding it hard to accept the narrative that NVAX is just not yet ready with their data as I observed that their clinical trial was hastily planned in such a way to get that their data ready by June 28. Recall how they started on May 31 and set their primary outcome at 14 days later (around June 14) as opposed to the usual 30 days set by other vaccine makers. A neutralization study should then just take 2-3 days max if everything else was nicely prepared beforehand. This time frame would then easily bring them to a comfortable June 17. It's of course still possible that they are just slow or they have some other strategical considerations related to the finance rather than the science. But I increasingly confident that Moderna will dominate the omicron specific vaccine market. My two cents. GL all.
Neutralization GMT gainst the omicron variant.
MRNA prototype: 1473
MRNA bivalent: 2372 (HIGHEST VALUE)
BNTX prototype (age 18-55): 1100
BNTX omicron (age 18-55): 1929
BNTX prototype (age above 55): 456 (for 30 ug)
BNTX omicron (age above 55): 1015 (for 30 ug), 1435 (for 60 ug)
BNTX bivalent (age above 55): 711 (for 30 ug), 900 (for 60 ug)
Neutralization GMT against the ancestral variant.
MRNA prototype (age above 18): 5649
MRNA bivalent (age above 18): 5977
BNTX prototype (age 18-55): 12009
BNTX omicron (age 18-55): 11997
I may mistype or miss some important nuance, so please read the original FDA materials. Please do your own DD. GL all.
The need for the Novavax vaccine is greater than ever.
What does the data really show for the updated mRNA vaccines?
To me what was expected and certainly both Pfizer’s and Moderna bi-valent vaccine will be approved. Yet the flaw with mRNA is as glaring and enormous as ever. Proves that they are continuously playing catch up and mRNA has failed as a platform. Basically 1.5 times the antibody response at 1 month for Ba1 . Much less for the newer sub variants. What variants will be circulating in the fall? The dead of winter? What will be the level of antibodies for those variants at 3 months 4 months.? Most likely the same pattern of rapid waning and minimal protection.
What if a really virulent variant arrives . This is a stop gap and the need for a more durable vaccine exists and is needed.
Multiple reasons for an alternative to mRNA .
The future is a pan -coronavirus universal vaccine and Novavax has the best path forward because it’s dosage independent. Remember and think about this, Pfizer raising the dosage to try and get a better immune response in adults. So a 50 year old 100 pound women should get 60 mcg? YET let’s say a 17 year old male 200 pounds going away to a infested college dorm this fall only gets 10 mcg? How absurd!
The Novavax vaccine is dosage independent using the same dosage in all age groups.
Sure Novavax will introduce a bi-valent vaccine soon, however it’s a 6- valent, maybe 8-valent vaccine that targets all parts of the spike including the non mutating areas.
We have a seat at the table , hoping for a FDA approval on Monday.
At the meeeting we can acknowledge the need for a bi-valent Omicron enhanced vaccine . Im sure the FDA will be interested in hearing the progress of our vaccine as well.
Novavax is the future and will be the ultimate winner in the control of this plague.
6 Million shares bought
2 Million shares sold
Strange
REUTERS 11:49 AM ET 6/23/2022
One month after administration in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 in all participants regardless of prior infection.