Coronavirus

[bkp_duke]

Would include this in the above message but no idea how to add quotes into messages that I've already posted anymore...not the same as before. I'm surprised they're just looking at antibody neutralizing responses. I thought clinical results were the golden metric still? I mean, it's probably fine (personally it looks to me like the quality titers correlate pretty well with real-world results), but I'm going to guess that if there is any question about the results, we're going to wish we had a larger N. We're now in a vaccinated situation, and events are even more rare.

But I guess you're saying it is phase 1. I guess it's not clear to me why they don't go straight to phase 3. Is there really that much doubt about antibody responses and safety? They really don't take any chances!

So I guess you're saying we'll get the large N later? Or they'll just skip that step instead? I guess I'm on board with that as well. I guess from the press release it's technically an amendment to a phase 2 trial. So hopefully skip phase 1 and phase 3, then start vaccinating.

It's a "new drug" according to the FDA. So it must go through Phase 1, although it can be expedited.

Plus, phases 2 and 3 are EXPENSIVE to run. If the new sequence doesn't have higher levels of neutralizing antibodies, they probably won't pursue Phases 2/3.

 

[AlanSubie4Life]

It's a "new drug" according to the FDA. So it must go through Phase 1, although it can be expedited.

Plus, phases 2 and 3 are EXPENSIVE to run. If the new sequence doesn't have higher levels of neutralizing antibodies, they probably won't pursue Phases 2/3.

Technically amendment phase 2, but semantics.
I would think an antibody response was a given at this point.

 

[Jeff N]

New Helix sequencing update:

https://twitter.com/x/status/1369793371280089090

 

[AlanSubie4Life]

New Helix sequencing update:

https://twitter.com/x/status/1369793371280089090

Looks like it's a little ahead of schedule.

Fortunately cases continue to decline, albeit slowly. If we can just avoid lighting a match, everything will probably be fine. Just a few more weeks before the tide of vaccinations should be overwhelming.

 

[bkp_duke]

Technically amendment phase 2, but semantics.
I would think an antibody response was a given at this point.

AN Ab response, yes. HIGH enough, not necessarily. This is one of those things the FDA will not allow it to proceed further without the Ab data. There are many more variables than just mRNA sequence that determine if a robust Ab response is stimulated.

Basically, it's one of those "must go through the motions" things.

 

[AlanSubie4Life]

AN Ab response, yes. HIGH enough, not necessarily. This is one of those things the FDA will not allow it to proceed further without the Ab data. There are many more variables than just mRNA sequence that determine if a robust Ab response is stimulated.

Basically, it's one of those "must go through the motions" things.

Yeah, I understand that. Just seems strange given the proven methodology, that given the urgency, they wouldn't move straight to a more robust trial. I would be shocked, completely shocked, if the antibody response to B.1.351 was not robust and more neutralizing to B.1.351 than the existing vaccine. But maybe there are other ethical considerations...like does this vaccine provide good cross protection to B.1.1.7 (which is way more prevalent!)? Which would mean that the isolated trial of just 1273.351 would potentially put people at risk... So I can certainly see it is complicated.

Perhaps this is all that will be required (it's still really unclear to me how the process will work exactly to approve these boosters) - then it would make a lot of sense to just do a small quick trial to test AB response (and cross-reactivity of course), and then roll it out, as a booster.

Fortunately the data so far (from sera of infected individuals) suggests that B.1.351 vaccines will have good cross-reactivity (backwards compatibility) with other variants. Of course it'll just be 25µg or so in the mixed version, so there's a question of exactly how strong a response that will generate, but maybe as a very similar booster it will be very strong.

The good news is that, as far as I can tell, the existing vaccines in use in the US are highly effective, even against the variants. The data is a bit mixed and limited and lacking, but that existing limited data still suggests that fairly strongly, FWIW. So maybe not so urgent after all.

 

[Jeff N]

The companies also said the latest analysis of the Israeli data shows the vaccine was 97% effective in preventing symptomatic disease, severe disease and death.

Pfizer/BioNTech say data suggests vaccine 94% effective in preventing asymptomatic infection

Pfizer Inc and BioNTech SE said on Thursday that real-world data from Israel suggests their COVID-19 vaccine is 94% effective in preventing asymptomatic infections, meaning it could significantly reduce transmission.

www.reuters.com

 

[AlanSubie4Life]

The companies also said the latest analysis of the Israeli data shows the vaccine was 97% effective in preventing symptomatic disease, severe disease and death.

Pfizer/BioNTech say data suggests vaccine 94% effective in preventing asymptomatic infection

Pfizer Inc and BioNTech SE said on Thursday that real-world data from Israel suggests their COVID-19 vaccine is 94% effective in preventing asymptomatic infections, meaning it could significantly reduce transmission.

www.reuters.com

It's wonderful news. They've tried to get rid of confounders in their analysis but probably not perfect. But in any case still a great result. Still no information on B.1.351, unfortunately. Hopefully soon, from somewhere!

Here's the associated press release.

Real-World Evidence Confirms High Effectiveness of Pfizer-BioNTech COVID-19 Vaccine and Profound Public Health Impact of Vaccination One Year After Pandemic Declared | Pfizer

Dramatically lower COVID-19 disease incidence rates observed in individuals fully vaccinated with the Pfizer-BioNTech vaccine, based on real-world data gathered by the Israel Ministry of Health Data suggest Pfizer-BioNTech vaccine prevents asymptomatic SARS-CoV-2 infection Latest data analysis...

www.pfizer.com

 

[TespaceX]

By just going off the headlines that Pfizer's vaccine is 97% effective in preventing any symptoms, it sounds like it's the magic cure (for the population's variants being studied against). Just get everyone a shot there and this virus is pretty much done there. Sounds too good to be true, no?

 

[AlanSubie4Life]

Sounds too good to be true, no?

It‘s great, but not that surprising for a virus like this. Some viruses are very amenable to vaccination! Having a new and sophisticated way to generate a strong and targeted immune response made success more likely.

But really glad the stars aligned like this.

Remember none of this is long-term results - aside from variants, we don’t know about longevity of the sterilizing response. That will affect the final trajectory here.

There is a reason that the Biden administration is ordering hundreds of millions more vaccines than we apparently need! Be prepared!

 

[nwdiver]

It‘s great, but not that surprising for a virus like this. Some viruses are very amenable to vaccination! Having a new and sophisticated way to generate a strong and targeted immune response made success more likely.

But really glad the stars aligned like this.

Remember none of this is long-term results - aside from variants, we don’t know about longevity of the sterilizing response. That will affect the final trajectory here.

There is a reason that the Biden administration is ordering hundreds of millions more vaccines than we apparently need! Be prepared!

Wonder when we'll see a mRNA flu vaccine.

 

[EVNow]

By just going off the headlines that Pfizer's vaccine is 97% effective in preventing any symptoms, it sounds like it's the magic cure (for the population's variants being studied against). Just get everyone a shot there and this virus is pretty much done there. Sounds too good to be true, no?

How are you going to get "everyone" vaccinated - when half the people don't even want to wear a mask ?

 

[bkp_duke]

How are you going to get "everyone" vaccinated - when half the people don't even want to wear a mask ?

Tell them they can't have it. No joke, reverse psychology works wonders on idiots.

 

[AlanSubie4Life]

How are you going to get "everyone" vaccinated - when half the people don't even want to wear a mask ?

66% or so of people want to get vaccinated, and 10% aren't sure. When combined with natural infection (much of which has already occurred and I would expect is more heavily weighted in the 24% "No" group), should be enough. That should get us to 75% immune (not quite since the vaccines aren't 100% effective...) which would require a R0 of 4 or whatever.

Peer pressure will probably help too at some point. Once people start seeing life is back to normal and get back into the presence of peers I'd imagine many of the holdouts will just fold.

 

[bkp_duke]

66% or so of people want to get vaccinated, and 10% aren't sure. When combined with natural infection (much of which has already occurred and I would expect is more heavily weighted in the 24% "No" group), should be enough. That should get us to 75% immune (not quite since the vaccines aren't 100% effective...) which would require a R0 of 4 or whatever.

Peer pressure will probably help too at some point. Once people start seeing life is back to normal and get back into the presence of peers I'd imagine many of the holdouts will just fold.

Passports should require vaccination. Don't get vaccinated, cannot leave the country, go on a cruise, etc. etc.

 

[AlanSubie4Life]

Sounds like vaccine open season begins May 1st. I expect it will be earlier than that in most states. Can't wait. Straight into my veins (or muscle since that's preferred in this case)!

 

[byeLT4]

Tell them they can't have it. No joke, reverse psychology works wonders on idiots.

OMG LOL! I was literally thinking about this earlier as we are on Tues-Saturday shifts at work and my coworker wants to miss every Saturday... I was thinking of telling the bosses just make it a Mon-Fri position and she'll be begging to come in

Keeping on topic my parents were vaccinated today!

 

[TespaceX]

How are you going to get "everyone" vaccinated - when half the people don't even want to wear a mask ?

You don’t need 100% participation as mentioned.

Maybe you’ve realized by now (or, maybe it’s not the case in your area), the percentage of population voluntarily willing to get a shot is much greater than the percentage voluntarily willing to wear a mask. All around me, people who have been critical of mask-wearing and the various restrictions to daily life from the beginning are shaming those who are against getting the vaccine. It’s really stupid all around.

 

[nwdiver]

It’s really stupid all around.

 

[AlanSubie4Life]

Passports should require vaccination. Don't get vaccinated, cannot leave the country, go on a cruise, etc. etc.

Seems a little extreme to me. I don't know what is the solution, though.

Maybe they could require vaccination for re-entry, lol.