Vaccine/Antibody updates

[Skatastrophy]

I'm not over estimating, much like Hards alluded to, I'm trying to figure out what a word with a vaccine, even early stages or initial roll outs would look like for people and their risk management.

Yep, that's what the "2.5 years to rollout a vaccine" was referring to. That's after the vaccine was created and in production.

Getting a vaccination machinations in place worldwide is quite the ordeal. The timeline to the vaccine is probably 6 months to a year, but we may have a long time to go with social distancing and mask wearing guidelines.

[Jockey]

Another question.

How long will be necessary to determine both dosage amounts and whether a booster will be needed? I'm guessing that would be the next step after determining whether a vaccine is effective.

[JWags85]

Yep, that's what the "2.5 years to rollout a vaccine" was referring to. That's after the vaccine was created and in production.

Getting a vaccination machinations in place worldwide is quite the ordeal. The timeline to the vaccine is probably 6 months to a year, but we may have a long time to go with social distancing and mask wearing guidelines.

Understood. As I mention, if this is indeed the case, the economic disaster is only beginning.

[forgetful]

Yep, that's what the "2.5 years to rollout a vaccine" was referring to. That's after the vaccine was created and in production.

Getting a vaccination machinations in place worldwide is quite the ordeal. The timeline to the vaccine is probably 6 months to a year, but we may have a long time to go with social distancing and mask wearing guidelines.

The time to rollout a vaccine also depends on the platform it is based off of. I believe that the technology that the leading vaccine candidates are built on can scale faster and should lead to a shorter time period for rollout.

The limiting factor may actually end up being delivery devices, not the vaccine itself.

[The Sultan]

Understood. As I mention, if this is indeed the case, the economic disaster is only beginning.

The economic disaster is going to get worse before it gets better.  With the virus not being managed well, there will continue to be higher unemployment and lower levels of economic activity.

Furthermore, while K-12 and higher education institutions WANT to start in person, it is looking increasingly unlikely that many districts will last through the fall in person.  I think the psychological impact of this will be huge.  And will significantly impact the holiday season. 

[JWags85]

The economic disaster is going to get worse before it gets better.  With the virus not being managed well, there will continue to be higher unemployment and lower levels of economic activity.

Furthermore, while K-12 and higher education institutions WANT to start in person, it is looking increasingly unlikely that many districts will last through the fall in person.  I think the psychological impact of this will be huge.  And will significantly impact the holiday season.

Yep, that's my biggest concern.  I think the psychology of everything is starting to take a life of its own, beyond treatment options or numbers specific to a persons geography.   And that's very bad for things that rely on positive consumer sentiment

[GooooMarquette]

The economic disaster is going to get worse before it gets better.  With the virus not being managed well, there will continue to be higher unemployment and lower levels of economic activity.

Furthermore, while K-12 and higher education institutions WANT to start in person, it is looking increasingly unlikely that many districts will last through the fall in person.  I think the psychological impact of this will be huge.  And will significantly impact the holiday season.

Agreed on all levels.

Regarding the psychological impact, I suspect the mental trauma of prolonged uncertainty and isolation will long outlive the pandemic. And the quandary about reopening schools with the very real possibility that they might need to be shut down again begs an interesting question: Which is worse for kids - the isolation of being away from their friends and teachers for prolonged periods, or the uncertainty of repeatedly switching back and forth between open and closed schools. I don't know the answer to this question, but hopefully school districts are getting the input of psychiatrists and psychologists to consider this factor.

[GBPhoenix1993]

Treatments are just as important.  Treatments that decrease deaths and need for ventilators and need for hospitalization in combination with a vaccine will be the key.  Lots of good info on treatments starting to come out.

I totally agree that better immediate treatments upon diagnosis may turn out to be the faster and better way to deal with this.  A combination of both better treatments plus vaccines would be ideal.  Right now certain steroids and Remdesivir are the only semi-effective treatments, but they aren't great, and hopefully some of the other ones in testing right now will be significantly better. 

I want to see this disease get managed to the point that the deaths, hospitalizations, and serious side effects are down to a bad flu level or something better.  We never shut things down for the 2017-2018 flu and that's the benchmark I want to see before we can consider this thing "controlled".  Right now, it's way worse than that 2017-18 flu, but if enough treatments and vaccines are created to get this down to that level or better, at that point we go back to "business as usual".  Business as usual to me means nothing shutdown and large gatherings allowed without worry. 

My optimistic hope is that we get there by March 2021.  Maybe I'm crazy for being that optimistic, but I see enough promise in treatments being developed that maybe by then this thing is under control.

[Jockey]

I think there will be a big effect on adults as well. And that certainly relates to the economy. Too many families were caught cash-short when the shutdown started. I think getting a nest egg will become priority for many families over short term spending.

I stand by my 2-3 year prediction for the economy to get back to some sort is pre-pandemic levels.

But a bad 2nd wave could increase the time. That is a very real possibility considering this is America. Even in states like California and Ohio that did a great job early, things are getting really bad.

The mitigating factor is a vaccine. It's effectiveness will determine whether we slowly start moving to normal or do a 180 toward a major depression.

[rocky_warrior]

Looks like the front-runner vaccines will include a few days of feeling pretty crappy.  Not the worst trade-off, but might deter folks too (ignore the headline, it's a fairly balanced writeup):

https://www.wired.com/story/covid-19-vaccines-with-minor-side-effects-could-still-be-pretty-bad/

[Jockey]

Looks like the front-runner vaccines will include a few days of feeling pretty crappy.  Not the worst trade-off, but might deter folks too (ignore the headline, it's a fairly balanced writeup):

https://www.wired.com/story/covid-19-vaccines-with-minor-side-effects-could-still-be-pretty-bad/

Honesty.

It's what was lacking from our leaders. Let's hope the creators of the vaccines are more open. If they aren't and stories get out about side effects, we'd be lucky to get 50% participation.

Side effects + no long term testing could prolong the pandemic. More honesty = greater participation.

[shoothoops]

U.S. paying Pfizer $1.95 billion for 100 million doses of their vaccine. May buy up to 600 million doses.

https://www.bloomberg.com/amp/news/articles/2020-07-22/pfizer-in-pact-with-u-s-for-100-million-covid-19-vaccine-doses-kcx9x3ww?__twitter_impression=true

https://www.bloomberg.com/amp/news/articles/2020-07-22/pfizer-in-pact-with-u-s-for-100-million-covid-19-vaccine-doses-kcx9x3ww?__twitter_impression=true

It's being manufactured at the Pfizer St. Louis facility. SLU appears to be testing Moderna's vaccine. Not sure about Wash U. You can go to clinicaltrials.gov

https://www.stltoday.com/business/local/washu-and-slu-announce-covid-19-vaccine-trials-in-st-louis/article_86b4031d-274a-53e3-8995-146bc3bc8418.html

[pbiflyer]

Not a good sign for herd immunity

Rapid Decay of Anti–SARS-CoV-2 Antibodies in Persons with Mild Covid-1

https://www.nejm.org/doi/full/10.1056/NEJMc2025179

Our findings raise concern that humoral immunity against SARS-CoV-2 may not be long lasting in persons with mild illness, who compose the majority of persons with Covid-19. It is difficult to extrapolate beyond our observation period of approximately 90 days because it is likely that the decay will decelerate.3 Still, the results call for caution regarding antibody-based "immunity passports," herd immunity, and perhaps vaccine durability, especially in light of short-lived immunity against common human coronaviruses. Further studies will be needed to define a quantitative protection threshold and rate of decline of antiviral antibodies beyond 90 days.

[Frenns Liquor Depot]

I would be cautious with running with these anti-body studies from what I have read - at least extrapolate it to 'how long immunity lasts'. 

The answer from what I gather is that no one knows yet and the fact that anti-bodies decay does not answer that question yet...despite many headlines trying to take it there.

[Frenns Liquor Depot]

By the way if anyone wants to claim they stayed in a holiday Inn last night re: immunology.  Here is a great thread and short video. 

https://twitter.com/virusesimmunity/status/1285944893085491204?s=21

[forgetful]

For those possibly interested in getting in on a trial.

https://www.niaid.nih.gov/clinical-trials/vaccine-research-center-clinical-studies

Sign up.

I would possibly consider it, if I knew I would get the vaccine and not a placebo.

[Jockey]

I would be cautious with running with these anti-body studies from what I have read - at least extrapolate it to 'how long immunity lasts'. 

The answer from what I gather is that no one knows yet and the fact that anti-bodies decay does not answer that question yet...despite many headlines trying to take it there.

Exactly. This is one more reason that vaccines take so long to develop and test in normal circumstances.

[TSmith34, Inc.]

For those possibly interested in getting in on a trial.

https://www.niaid.nih.gov/clinical-trials/vaccine-research-center-clinical-studies

Sign up.

I would possibly consider it, if I knew I would get the vaccine and not a placebo.

Hey fortgetful, what is the status of your friend who was working on creating antibodies in volume?

[TSmith34, Inc.]

Pfizer hopes to get emergency approval by October

https://www.usatoday.com/story/news/2020/07/22/coronavirus-covid-19-and-vaccines-trump-masks-and-ex-cdc-director/5484636002/

"Pfizer and BioNTech announced a deal with the federal government for 100 million doses of their vaccine candidate once the companies obtain approval or emergency use authorization from U.S. Food and Drug Administration. Americans will receive the vaccine for free, the firms said. If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October."

[GooooMarquette]

Pfizer hopes to get emergency approval by October

https://www.usatoday.com/story/news/2020/07/22/coronavirus-covid-19-and-vaccines-trump-masks-and-ex-cdc-director/5484636002/

"Pfizer and BioNTech announced a deal with the federal government for 100 million doses of their vaccine candidate once the companies obtain approval or emergency use authorization from U.S. Food and Drug Administration. Americans will receive the vaccine for free, the firms said. If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October."

For what it's worth, I would not be confident getting a vaccine that has been approved through the EUA process. It was created by FDA to grant expedited 'approval' for products that might save the lives of people who are critically ill. As such, the approval criteria are more vague and lax than the 'safe and effective' standard required for standard approval.

I think EUA was totally appropriate for Remdesovir, because that is now used in patients who are already critically ill with COVID, and as such are willing to face some additional risk.

I don't think the same can be said for a vaccine, which by definition is given to healthy individuals.

[Frenns Liquor Depot]

Pfizer hopes to get emergency approval by October

https://www.usatoday.com/story/news/2020/07/22/coronavirus-covid-19-and-vaccines-trump-masks-and-ex-cdc-director/5484636002/

"Pfizer and BioNTech announced a deal with the federal government for 100 million doses of their vaccine candidate once the companies obtain approval or emergency use authorization from U.S. Food and Drug Administration. Americans will receive the vaccine for free, the firms said. If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October."

This seems to fall clearly into what Rocky was calling out earlier.  It would be interesting analysis to find out if rushed approval results in more immunizations over a 6-9 month period vs. getting the 30K plus through a phase 3 trial and then starting.

[TSmith34, Inc.]

This seems to fall clearly into what Rocky was calling out earlier.  It would be interesting analysis to find out if rushed approval results in more immunizations over a 6-9 month period vs. getting the 30K plus through a phase 3 trial and then starting.

Yeah, I personally am going to be pretty cautious with a vaccine that was rushed, unless like the Oxford one it had preciously been deemed safe long term.

[forgetful]

Hey fortgetful, what is the status of your friend who was working on creating antibodies in volume?

It'll come down to two things.

1. Are these antibodies being used as treatments (less needed) or prophylactic. If we are using these in lieu of a vaccine as a protection before being infected, they probably can't handle the scale. The vaccines, depending on which is the winner, are going to be much easier to produce on scale. If we are only using them as treatments, they should be able to handle the scales needed.

2. Results from the antibody trials. We have to hope that the antibodies that have been selected as either monoclonals, or cocktails, are the best/right antibodies. There are reasonable ways to produce the antibodies on scale now, but the problem is there is a bit of a lead time to get to industrial scale. Those "lead times" phases are in progress, so if they are right on the antibody treatments, we should be good to go on scale. My personal preference for methods are using tobacco to produce antibodies on scale. Much cheaper than alternative methods.

There are potential efficacy problems with using plant derived antibodies though. So again, needs to be resolved in testing first. Good news is there are several different platforms in testing around the world, so let's just hope that whichever is most effective is also ready to go in terms of scaling.

[forgetful]

Hey fortgetful, what is the status of your friend who was working on creating antibodies in volume?

An additional aspect of this. He was pretty certain that China would be ahead of the game here, for various reasons. That may not necessarily be the case, as China seems to be pivoting to a vaccine emphasis. They are already inoculating their military with their top vaccine candidate.

That may slow their development/emphasis in the antibody market.

[shoothoops]

Next phase of Moderna study begins today, 30,000 patients for the next several months...followed by Oxford's study in August, then J&J and Pfizer by Sept and Oct.

https://apnews.com/d9150647d677cd036c03b8d0ab52358b?utm_campaign=SocialFlow&utm_source=Twitter&utm_medium=AP