Vaccines and Therapeutics 2.0 & 3.0 Merge

[Jersey Girl]

One thing I want to add: don't just hold on. Redouble your efforts to stay health and keep those with whom you come in contact healthy. I'll do a state of the COVID post tonight. But the TL/DR is that we are right now in worse shape than at any time during the pandemic. When the cases were concentrated in the metropolitan areas of New York and New Jersey, they were visible and obvious. Because the effects are spread out over mostly rural areas of the country, it's hard to see them. But we're in the worst exponential spread of the virus we've experienced to date.

If you trust infection disease experts, increase your vigilance. Wash your hands regular and thoroughly. Limit trips outside your home. Do not attend indoor gatherings. If you are going to be in contact with anyone outside of your home, wear a face covering. If you have to cough or sneeze, do it into the crook of your arm. If you feel sick, stay home and isolate yourself from the others in your household. Try not to touch your face. All that stuff.

We can see some light at the end of the tunnel. What a tragic waste to get hit by a train.

Yes, that is a timely reminder, RI. Our country had a record breaking 504 new cases yesterday. I still follow this like it's my job. Because I believe it is.

With regard to indoor gatherings. We had a discussion here Sunday with a small faction of the tribe. Everyone seems willing to separate for the holidays (for the good of the whole) except for one lone dissenter who is fixated on the upcoming holiday but isn't following anything and only learns the stats when I mention them---which is what I've been doing every single day for the past 2 weeks.

Anyone can check into a Covid Tracker. There are several out there. The refusal to do so amounts to neglect in my mind. But that's not on me. I've been doing what I believe is my due diligence regarding the virus this whole entire time. My bases are as covered as they possibly can be. After that it's in God's or fate's hands.

I trust that new information will arise (I have some thoughts about what that might be--gigantic spike in cases, stay-the-hell-home orders, or possibly a school related quarantine) and the matter will be settled without our saying another single word about it.

I suppose we could still manage a modified gathering of some sort, but I am ready to go it alone which is what I would be doing. I dislike Thanksgiving to start with but I do have all the fixin's and a Barbie turkey in the freezer so there it is. I am happy to dig in my own heels to reap what I think will be the blessings and rewards later on in this pandemic as vaccines with good efficacy and safety profiles begin to emerge.

I want to add something to this that I mentioned in another post on this or the old board.

Wash your hands regular and thoroughly. Limit trips outside your home. Do not attend indoor gatherings. If you are going to be in contact with anyone outside of your home, wear a face covering. If you have to cough or sneeze, do it into the crook of your arm. If you feel sick, stay home and isolate yourself from the others in your household. Try not to touch your face. All that stuff.


Use your coat, sweater, or shirt sleeves to cover your hands when you open doors. Just flop that sleeve out over your hand and use it as if it were a glove. I do it automatically having done that for decades in classrooms. Anyone would be hard pressed to find an instance of Miss Jersey actually touching a classroom interior or exterior door handle. I don't do it. Same thing with store doors.

And don't be shy about using latex, vinyl or even woolen gloves for the same thing when you go out. Just remember that gloves are only a barrier and should be treated as the mask--single use and throw away, throw them on the floor of your car and leave them there for a day or so, or you can just wash them as needed depending on what type you used. The outside of gloves are where the covey critters are. Learn to remove gloves properly (even your woolen gloves) so that your bare hand never touches the outside surface of the glove and the glove is left turned inside out. I am sure there are youtube videos that demonstrate this practice.

In early childhood...we remove latex/vinyl gloves the same exact way and can even manage to stash and cover a soiled disposable diaper inside the discarded gloves--without anything ever touching our bare hands. But still...we wash our hands afterwards as an extra precaution.

Scrub those covey critters off your hands like your life depends on it. And don't forget to keep those door knobs, latches, knobs, and even the toilet lever covey free! Get those darn things off there!

Covey is not your friend boys and girls. Don't play with it!

[Gunnar]

The fact that the new Pfizer vaccines needs to be stored at a temperature of -103° Fahrenheit gives me a bit of a pause. This is bound to make it both expensive to use and administer and hard to keep in storage. I hope that other vaccines that are both reliable and less easily perishable soon become available. I'm still rooting for the University of Pittsburg's PittCoVaccine to pass clinical trials and become viable, because it reportedly can easily be quickly scaled up to mass production and distribution, and, perhaps even more important and appealing , it can both be transported and stored indefinitely at room temperature with no need for refrigeration. Just think what that will mean for both affordability and ease of administering.

[Jersey Girl]

The fact that the new Pfizer vaccines needs to be stored at a temperature of -103° Fahrenheit gives me a bit of a pause. This is bound to make it both expensive to use and administer and hard to keep in storage. I hope that other vaccines that are both reliable and less easily perishable soon become available. I'm still rooting for the University of Pittsburg's PittCoVaccine to pass clinical trials and become viable, because it reportedly can easily be quickly scaled up to mass production and distribution, and, perhaps even more important and appealing , it can both be transported and stored indefinitely at room temperature with no need for refrigeration. Just think what that will mean for both affordability and ease of administering.

They will come, Gunnar. This looks to be just the first one out of the gate. I think the PittCoVaccine and it's method of delivery would be invaluable to a planet-wide pandemic. If the vaccine itself doesn't prove a good candidate, I wonder if another vaccine could be delivered via a patch method????

There are SO many meds that have been transferable to a patch system.

As for me, I'll watch these mRNA vaccine reports. If all looks good and when my turn comes...shoot me up!

I'm not afraid of these vaccines so long as they perform well in terms of efficacy (remember experts were saying we'd be doing good with a 54% effective rate?) and safety profiles.

You know I'm very thankful for my living conditions. We have what we need and the setting is very nice. I miss my people who are a plane ride away.

[Res Ipsa]

The fact that the new Pfizer vaccines needs to be stored at a temperature of -103° Fahrenheit gives me a bit of a pause. This is bound to make it both expensive to use and administer and hard to keep in storage. I hope that other vaccines that are both reliable and less easily perishable soon become available. I'm still rooting for the University of Pittsburg's PittCoVaccine to pass clinical trials and become viable, because it reportedly can easily be quickly scaled up to mass production and distribution, and, perhaps even more important and appealing , it can both be transported and stored indefinitely at room temperature with no need for refrigeration. Just think what that will mean for both affordability and ease of administering.

They will come, Gunnar. This looks to be just the first one out of the gate. I think the PittCoVaccine and it's method of delivery would be invaluable to a planet-wide pandemic. If the vaccine itself doesn't prove a good candidate, I wonder if another vaccine could be delivered via a patch method????

There are SO many meds that have been transferable to a patch system.

As for me, I'll watch these mRNA vaccine reports. If all looks good and when my turn comes...shoot me up!

I'm not afraid of these vaccines so long as they perform well in terms of efficacy (remember experts were saying we'd be doing good with a 54% effective rate?) and safety profiles.

You know I'm very thankful for my living conditions. We have what we need and the setting is very nice. I miss my people who are a plane ride away.

There was some controversy earlier in the process because Pfizer had planned to take a preliminary look after 32 diagnosed cases among the study participants (44K I think). They scrapped that early look and planned to look at 62 cases. While they made up their minds, their diagnostic samples were in the freezer. By the time they settled on 64 cases, it turned out they had 94 positive cases. That's what this announcement is based on. However, it is a press release -- no paper or peer review involved. Another interim look is planned at 120 cases, with the endpoint being at 164 cases. So there's room for the efficacy number to change, but the minimum set by agreement with the FDA is 50%. The interim reviews are not conducted by Pfizer, but by an independent expert team. The final results will be published in a peer-reviewed paper.

Another note of caution. Pfizer expects to manufacture 50 million doses this year, with 2 doses used per person. The U.S. contracted to buy 100 million doses if the vaccine proved safe and effective (payable on delivery). But Pfizer also has purchase contracts with several other countries, and I don't think we know who gets dibs.

As for distribution plans, Trump has said "the military." Does the military have plans? Dunno. Trump is busy trying to steal an election and Pence is going on vacation. If anyone can find a real distribution plan, let me know.

[Jersey Girl]

As for distribution plans, Trump has said "the military." Does the military have plans? Dunno. Trump is busy trying to steal an election and Pence is going on vacation. If anyone can find a real distribution plan, let me know.

Trump? Trump don't care. Trump don't give a crap. He's fixated on himself not American citizens.

I read that he's planning to do more rallies, this time with election fraud being the emphasis. So yeah. He apparently will be out re-crisscrossing the country instead of doing his damn job.

What else is new.

[Gunnar]

The fact that the new Pfizer vaccines needs to be stored at a temperature of -103° Fahrenheit gives me a bit of a pause. This is bound to make it both expensive to use and administer and hard to keep in storage. I hope that other vaccines that are both reliable and less easily perishable soon become available. I'm still rooting for the University of Pittsburg's PittCoVaccine to pass clinical trials and become viable, because it reportedly can easily be quickly scaled up to mass production and distribution, and, perhaps even more important and appealing , it can both be transported and stored indefinitely at room temperature with no need for refrigeration. Just think what that will mean for both affordability and ease of administering.

They will come, Gunnar. This looks to be just the first one out of the gate. I think the PittCoVaccine and it's method of delivery would be invaluable to a planet-wide pandemic. If the vaccine itself doesn't prove a good candidate, I wonder if another vaccine could be delivered via a patch method????

There are SO many meds that have been transferable to a patch system.

As for me, I'll watch these mRNA vaccine reports. If all looks good and when my turn comes...shoot me up!

I'm not afraid of these vaccines so long as they perform well in terms of efficacy (remember experts were saying we'd be doing good with a 54% effective rate?) and safety profiles.

You know I'm very thankful for my living conditions. We have what we need and the setting is very nice. I miss my people who are a plane ride away.

Sure, I'll rejoice in the fact that the new Pfizer vaccine promises to be a safe and effective vaccine, but I still hope that effective alternatives soon become available, especially if they prove to be less perishable and cheaper and easier to stockpile and administer.

[Moksha]

LONDON (Reuters) - Many COVID-19 survivors are likely to be at greater risk of developing mental illness, psychiatrists said on Monday, after a large study found 20% of those infected with the coronavirus are diagnosed with a psychiatric disorder within 90 days.

https://www.reuters.com/article/health- ... SKBN27P35N

It might be well to bear this in mind with friends, family, and elected leaders. Let's wish them the best.

[Jersey Girl]

LONDON (Reuters) - Many COVID-19 survivors are likely to be at greater risk of developing mental illness, psychiatrists said on Monday, after a large study found 20% of those infected with the coronavirus are diagnosed with a psychiatric disorder within 90 days.

https://www.reuters.com/article/health- ... SKBN27P35N

It might be well to bear this in mind with friends, family, and elected leaders. Let's wish them the best.

I saw that when scrolling on my phone last night. Depression, anxiety and insomnia, as I recall. It must be our bodies reacting to trauma.

[MeDotOrg]

E.I. Lilly has just been given emergency use authorization for its new theraputic called...are you ready....

Bamlanivimab

I'm not sure the boys in Marketing were given enough time with the name. It looks like a Palindrone that fell apart in the middle. If you ingested an overdose of codeine cough syrup, you might have a shot at pronouncing it. Rumor has it there is a small religious sect in Northern Kyrgyzstan that believes if you chant Bamlanivimab for several hours, you will attain 'the state of the sheep'.

Bad name, promising treatment.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Eli Lilly for bamlanivimab (LY-CoV555), the company's investigational neutralizing antibody for the treatment of coronavirus disease 2019 (COVID-19).

Bamlanivimab is intended to treat adults and pediatric patients 12 years and older who have been recently diagnosed with mild to moderate COVID-19 and who are considered high-risk for developing severe infection that may require hospitalization, according to the company.

Delivered as a single, intravenous, 700-mg infusion, bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

The FDA's decision to grant an EUA is based on results from the randomized, double-blind, placebo-controlled phase 2 BLAZE-1 study, in which the treatment led to reduced viral loads and reduced rates of symptom progression and hospitalization in patents with mild to moderate COVID-19 in the outpatient setting.

"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," Lilly's chief scientific officer and president of Lilly Research Laboratories Daniel Skovronsky, MD, PhD, said in a statement.

The FDA included a warning for hypersensitivity, including anaphylaxis and infusion-related reactions, with its EUA. In BLAZE-1, adverse events were similar between the study and placebo arms, and were considered mild to moderate in severity.

Notably, bamlanivimab could be particularly beneficial for patients aged 65 years of age and older, with certain chronic comorbid medical conditions. According to the BLAZE-1 interim analysis, nearly three-quarters of the patients were found to have at least 1 risk factor for severe illness, including age of 65 years or older, a body mass index of 35 or more, or at least one relevant coexisting illness.

[Jersey Girl]

Without reading your entire post, MeDot. I'm guessing that is a monoclonal antibody. Just going from the name.

Ok. Now I get to see if I was right.