#26716
Re: Novavax (NVAX): Un Nuevo Comienzo
Este mensaje y los 2 siguientes tienen bastante información:
https://www.rankia.com/foros/bolsa/temas/3387826-novavax-nvax-nuevo-comienzo?page=1743#respuesta_5452468
Luego otras cosas que he ido recogiendo (un poco de todo y seguro que en lo de hoy del CDC hay cosas interesantes):
Also clear is that a bivalent NVAX will better prepare us for future variants in the omicron branch of the tree. Personally I fear different branches evolving beyond omicron. Recall that omicron diverged into mice and came back into humans with 39 mutations after 6 plus months passing in mice. This will happen again either from mice or bats or deer perhaps where long term mutations are now accumulating. It won’t be the predictable that comes next. In fact there are now BA2 sub variants accumulating mutations in the S2 or an terminal domain, the region of spike that gives NVAX its advantage over mRNA.
https://www.investorvillage.com/smbd.asp?mb=193&mn=185053&pt=msg&mid=23360368
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https://www.investorvillage.com/smbd.asp?mb=193&mn=184324&pt=msg&mid=23345802
> UK Cov-Boost trial already showed that 2373 on top of mRNA shots performs worse than MRNA or even PFE/BNTX shots (except for durability).
(red) First off the CD4 T cell responses were good. And yes the NA titers were lower as the restricted number of epitopes were not boosted as well as was seen when boosting either AZ or NVAX boosting of NVAX that present wider numbers of epitopes. This is why the two booster trial is being run. The addition of a broader number of epitopes requires boosting as these S2 domain epitopes are still naive and like all antigens require a boost. However perhaps most important now is the effects of boosting people with prior infections, now a very very large segment of the population. For anybody previously vaccinated with mRNA and subsequently infected NVAX will be a superior booster
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Right the COV-BOOST study showed RNA as dose 3 was better than Novavax against original strain. But now that we see Novavax seems to do better against Omicron, and everyone's immunity is now maxed out after 3 shots, the rec for shot 4 would be Novavax now or wait for BA5 boosters
https://twitter.com/michaelzlin/status/1547453294708080642?s=20&t=i1DYFxmX5iW-vjy2scHj6A
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https://ir.novavax.com/2022-02-28-Novavax-Announces-Extended-Durability-of-Protection-Against-Infection-and-Disease-in-United-Kingdom-COVID-19-Vaccine-Phase-3-Clinical-Trial
First off the notion of sterilizing immunity was only back in the Wuhan days. That is no where near the case any time after the beta variant. (60% efficacy in SA study) Now that more extensive N terminal domain mutations are coming out the advantage NVAX has had is fading as well . Yes I listened and watched and read the data in quite extensive detail. There are dramatic drops in titer for BA1, 2,4, and now 5. And even though there are still ‘decent’ titers they will fade quickly as all titers always do. Better? Yes. Some sort of Christmas miracle? Nope. Let’s be real ok.
Personally I would advocate for a BA5 (large cross reaction with 4) and add in BA2.75as the next generation variant that WILL dominate by late fall. It is distinct from the BA4/5 lineage and in particular offers the newer N terminal domain mutations. The importance of this can’t be overstated as much of the T cell mediated durability of protection comes from CD4 T cells specific to the S2 (NTD) region of spike that until now has not been highly mutated. Let’s try like hell to get a step ahead instead of a step behind. And for gods sake use 5ug of each and be better than others instead of matching them. I hate to put it this way but ‘be best’ comes to mind
--
Importancia boosters aunque disminuya la protección a infección rápido:
Aumento de supervivencia con 4 dosis frente a 3 (mRNA)
https://twitter.com/Biomaven/status/1547979592807223297?s=20&t=i1DYFxmX5iW-vjy2scHj6A
And also we have observational studies confirming that 3rd and 4rd doses improve outcomes against hospitalizations and death (some months):
https://www.nejm.org/doi/full/10.1056/NEJMoa2201688
https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e3.htm
--
Pretty disappointing results here from $MRNA booster trials (including arms with original vaccine, omicron BA.1 specific, combo). BA.1 arms do better against BA.1 than original, but by less than one might have expected - only factor of 2 better.
vs. BA.5 all lose potency by 3x
https://twitter.com/Biomaven/status/1548014346675965954?s=20&t=i1DYFxmX5iW-vjy2scHj6A
(esto puede ser un arma de doble filo si al final NVAX tiene un resultado similar como parece)
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Re: EMA comparison of the side-effects for NVAX, Pfizer, and Moderna --> Novavax is by far the safest!
EU Nordic Study;
Data on time to discharge and death after myocarditis was included in supplementary analyses. For male and females combined (all ages), 49.5% (95% CI 26.0 – 73.3) were discharged on day 4 or later following the second dose of Spikevax, while 53.7% (95% CI 39.4 – 67.4) were discharged on day 4 or later in the unvaccinated. For Comirnaty, a similar pattern was observed. Following the second dose of Spikevax, 4.5% of patients died within 28 days (95% CI 0.0 – 13.2) versus 1.2% (95% CI 0.5 – 2.7) among unvaccinated.
https://www.ema.europa.eu/en/documents/prac-recommendation/signal-assessment-report-myocarditis-pericarditis-spikevax-previously-covid-19-vaccine-moderna-covid_en.pdf
https://www.investorvillage.com/smbd.asp?mb=193&mn=186009&pt=msg&mid=23377620
Korea
Seguro que hay por ahí algo más reciente
https://twitter.com/M96191366/status/1538886336270241792?s=20&t=Sns5E7vCrzgdGfXtaAKnZQ
--
https://www.rankia.com/foros/bolsa/temas/3387826-novavax-nvax-nuevo-comienzo?page=1743#respuesta_5452468
Luego otras cosas que he ido recogiendo (un poco de todo y seguro que en lo de hoy del CDC hay cosas interesantes):
Also clear is that a bivalent NVAX will better prepare us for future variants in the omicron branch of the tree. Personally I fear different branches evolving beyond omicron. Recall that omicron diverged into mice and came back into humans with 39 mutations after 6 plus months passing in mice. This will happen again either from mice or bats or deer perhaps where long term mutations are now accumulating. It won’t be the predictable that comes next. In fact there are now BA2 sub variants accumulating mutations in the S2 or an terminal domain, the region of spike that gives NVAX its advantage over mRNA.
https://www.investorvillage.com/smbd.asp?mb=193&mn=185053&pt=msg&mid=23360368
--
https://www.investorvillage.com/smbd.asp?mb=193&mn=184324&pt=msg&mid=23345802
> UK Cov-Boost trial already showed that 2373 on top of mRNA shots performs worse than MRNA or even PFE/BNTX shots (except for durability).
(red) First off the CD4 T cell responses were good. And yes the NA titers were lower as the restricted number of epitopes were not boosted as well as was seen when boosting either AZ or NVAX boosting of NVAX that present wider numbers of epitopes. This is why the two booster trial is being run. The addition of a broader number of epitopes requires boosting as these S2 domain epitopes are still naive and like all antigens require a boost. However perhaps most important now is the effects of boosting people with prior infections, now a very very large segment of the population. For anybody previously vaccinated with mRNA and subsequently infected NVAX will be a superior booster
-
Right the COV-BOOST study showed RNA as dose 3 was better than Novavax against original strain. But now that we see Novavax seems to do better against Omicron, and everyone's immunity is now maxed out after 3 shots, the rec for shot 4 would be Novavax now or wait for BA5 boosters
https://twitter.com/michaelzlin/status/1547453294708080642?s=20&t=i1DYFxmX5iW-vjy2scHj6A
--
https://ir.novavax.com/2022-02-28-Novavax-Announces-Extended-Durability-of-Protection-Against-Infection-and-Disease-in-United-Kingdom-COVID-19-Vaccine-Phase-3-Clinical-Trial
First off the notion of sterilizing immunity was only back in the Wuhan days. That is no where near the case any time after the beta variant. (60% efficacy in SA study) Now that more extensive N terminal domain mutations are coming out the advantage NVAX has had is fading as well . Yes I listened and watched and read the data in quite extensive detail. There are dramatic drops in titer for BA1, 2,4, and now 5. And even though there are still ‘decent’ titers they will fade quickly as all titers always do. Better? Yes. Some sort of Christmas miracle? Nope. Let’s be real ok.
Personally I would advocate for a BA5 (large cross reaction with 4) and add in BA2.75as the next generation variant that WILL dominate by late fall. It is distinct from the BA4/5 lineage and in particular offers the newer N terminal domain mutations. The importance of this can’t be overstated as much of the T cell mediated durability of protection comes from CD4 T cells specific to the S2 (NTD) region of spike that until now has not been highly mutated. Let’s try like hell to get a step ahead instead of a step behind. And for gods sake use 5ug of each and be better than others instead of matching them. I hate to put it this way but ‘be best’ comes to mind
--
Importancia boosters aunque disminuya la protección a infección rápido:
Aumento de supervivencia con 4 dosis frente a 3 (mRNA)
https://twitter.com/Biomaven/status/1547979592807223297?s=20&t=i1DYFxmX5iW-vjy2scHj6A
And also we have observational studies confirming that 3rd and 4rd doses improve outcomes against hospitalizations and death (some months):
https://www.nejm.org/doi/full/10.1056/NEJMoa2201688
https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e3.htm
--
Pretty disappointing results here from $MRNA booster trials (including arms with original vaccine, omicron BA.1 specific, combo). BA.1 arms do better against BA.1 than original, but by less than one might have expected - only factor of 2 better.
vs. BA.5 all lose potency by 3x
https://twitter.com/Biomaven/status/1548014346675965954?s=20&t=i1DYFxmX5iW-vjy2scHj6A
(esto puede ser un arma de doble filo si al final NVAX tiene un resultado similar como parece)
--
Re: EMA comparison of the side-effects for NVAX, Pfizer, and Moderna --> Novavax is by far the safest!
EU Nordic Study;
Data on time to discharge and death after myocarditis was included in supplementary analyses. For male and females combined (all ages), 49.5% (95% CI 26.0 – 73.3) were discharged on day 4 or later following the second dose of Spikevax, while 53.7% (95% CI 39.4 – 67.4) were discharged on day 4 or later in the unvaccinated. For Comirnaty, a similar pattern was observed. Following the second dose of Spikevax, 4.5% of patients died within 28 days (95% CI 0.0 – 13.2) versus 1.2% (95% CI 0.5 – 2.7) among unvaccinated.
https://www.ema.europa.eu/en/documents/prac-recommendation/signal-assessment-report-myocarditis-pericarditis-spikevax-previously-covid-19-vaccine-moderna-covid_en.pdf
https://www.investorvillage.com/smbd.asp?mb=193&mn=186009&pt=msg&mid=23377620
Korea
Seguro que hay por ahí algo más reciente
https://twitter.com/M96191366/status/1538886336270241792?s=20&t=Sns5E7vCrzgdGfXtaAKnZQ
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A ‘breadth of protection’: Novavax’s newly approved COVID vaccine arms the U.S. with a new weapon against Omicron BA.5 subvariant
https://fortune.com/2022/07/14/novavax-covid-vaccine-approved-fda-omicron-ba-5-subvariant/
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https://www.investorvillage.com/smbd.asp?mb=193&mn=186083&pt=msg&mid=23379151
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Seguimiento de hoy del CDC:
1321 cases of myocarditis/pericarditis after 491million doses of mRNA
Incidence of myocarditis/pericarditis is 2-6 times more frequent with CoViD disease in varied age groups. Even in highest risk young males (2x)
After 7 days the incidence returns to baseline level.
Median hospital stay one day
100% of cases resolved. 81% reporting no long term consequences, 19% still in follow up.
Cases tend higher with MRNA vs PFE.
https://twitter.com/HelenBranswell/status/1549378688881393665
