DawgTalkers.net Forums DawgTalk Palus Politicus Covid ~ Part 10

Hope he recovers quickly.

This new wave seems pretty wild, but I think everyone seems fatigued from the whole experience. WP AFB just went to HPCON Charlie, which means we all have to mask up on base if we have to go into the office.

Won't wish that on anyone. Hope JB recovers quickly and the symptoms remain mild.

Wife & I got boosted yesterday.
Slightly sore arm; no symptoms.

If I shop at a large venue with good circulation, I sometimes go without a mask. If it's a small place, I cover my face. No exceptions.

My mask wearing isn't a political statement at all. It's a by-product of being raised by parents who taught me (by example) how to exercise common sense.

Hopefully an effective booster that targets omicron will be available by then. Multiple companies have been working on them since last November.

First reports were they would be available by last March, but the trials fell flat on their faces and they proved ineffective. Now reports are "out by fall" with no news of any trials or possible efficacy.

My hope is that with each new variant, the lethality drops as transmissibility rises.
Maybe in a couple years, my immunocompromised azz can decide about CoVid shots they way I do about flu shots.

The efficacy trials were released in June, and are relatively positive -- though not a home-run (the efficacy of the omicron boosters is better than the original shots - but is less than the efficacy of the original vaccine against the original versions of Covid, for example):

https://investors.modernatx.com/new...dy-Response-Against-Omicron/default.aspx

https://www.pfizer.com/news/press-r...ontech-announce-omicron-adapted-covid-19

my hope as well.. I'm not getting the booster right now as I'm hoping that they will get one that targets the more recent variants this fall...

Agreed... we've seen that trend so far and I hope it continues...

As a note, the CDC has said that getting a 2nd booster right now won't prevent you from getting the updated booster in the fall (you have to scroll down a bit in this article, but you can find others):

https://www.cnn.com/2022/07/21/health/omicron-booster-vaccine-coronavirus-wellness/index.html

Thanks - still prefer to wait at this point... I've gotten the vaccine and have been exposed to covid frequently due to work or just in my personal life... so far haven't gotten it... I plan on getting the booster in the fall... but don't want it right now... glad though that for those who get the booster now that they can get the updated one in the fall as well if they choose.

My wife and mother-in-law got theirs, and I had mine scheduled but my wife got it and I was exposed. So I still need it and will do it this weekend hopefully.

Thanks for bringing your expertise and facts to the board on this subject.

I should note that I am not a doctor --- i just read a lot.

Also, should add for the vaccine efficacy trials above. They were tested on BA.1, and not BA.4/5 -- though it seems quite likely that a vaccine that is better against BA.1 will also be better against BA.4/5.

I'm sorry, I thought you were in the field. But you always show up with facts.

Agreed. Thanks for the info Luke!

I feel pretty sure it will get to that point. I hope so because I think people are getting tired of this whole deal.

I saw you just got a booster. Is that your 3rd? I got my 2nd maybe last Nov. I will look to get the 3rd maybe in the next several weeks. The 2nd had me fevered for a day. After that, I doubt I will just go get one every time someone says so. I will probably be pretty selective at that point.

J+J for the first.
Moderna for the 2nd.
This is now my 2nd boost after the first two.

That is where I am at. I am waiting for this newer shot that is said to be better for the new b variant. I think it is a b variant...lol...it's some variant. I think they say it should be available this fall.

I picked up some immunity the hard way back in May. I'm going to wait until about the holiday season to see what the situation is.

That's where I'm at, had it twice now. I'll keep my ear to the ground, but if the severity stays in the same neighborhood, I doubt if I'll get it.

J/C. Wright-Patt moved back into HPCON Charlie. We need to be all masked up when we go back in, which means most of us aren't going back in. I was in the office yesterday and forgot how much of a PITA it is to have that thing on all day. It's been long enough now where I stopped getting used to it.

I was a little confused here.

I had read both of these and the only thing I was seeing is a blanket statement that amounts to "these are better than the original".

I also read something on the Moderna link... buried in the longest sentence in the world... that amounts to saying phase three clinical trials should be scrapped in favor of "in real world data studies or in larger, more diverse populations following commercialization".


But one google search later revealed the rest of the story.

THE FDA HAS DECIDED CLINICAL TRIALS ARE NO LONGER NECESSARY.

https://www.reuters.com/legal/gover...ze-redesigned-covid-boosters-2022-06-30/


This “Future Framework” now allows reformulation to be pushed through where COVID is concerned, regardless of new molecular entity. Formal regulatory review and trials are now out the window.

From the June 28 meeting: "The manufacturers (Moderna, Pfizer, and Novavax) were asked what their production timelines are… and they said out loud, ‘So long as we don’t have to provide any clinical data, we’ll have them ready by fall.’ No one had a problem with that …"


So, if we follow the timeline...

Moderna and Pfizer work on "omicron specific" booster starting last fall.
After 5 months, clinical trials show the "reformulations" are ineffective.
The narrative changes to "now working on boosters effective for all strains"... which seemed strange considering they couldn't create one to battle omicron effectively.

Months later, the story reemerges that there will be "omicron specific boosters by fall".
Both Pfizer and Moderna release statements that say, basically, "yep, these ones are better".
The FDA says, "well then, we don't see any reason for clinical trials".

In other words, if the bar is too high, you can always lower the bar... or in this case, throw the bar away altogether.

Seems about right.

I think that is an oversimplification.

My understanding of the present situation:

1.) In early November 2021, both Moderna and Pfizer began working on Omicron-specific formulations of their vaccines. They had previously also developed delta-specific formulations, but those never made it to real-world tests both because omicron quickly replaced delta, and because the original vaccines were still pretty effective against delta (especially with a booster dose).

2.) At least one of these (Moderna, i believe), announced in late January/early-February that their first tests of the omicron specific booster hadn't worked. This formulation is different than the .214 formulation they are now using. Also, note that these are tested in situ -- meaning that people are given the vaccine, then the have their blood drawn, and then the effectiveness of the antibodies against tissue infected with the omicron virus is tested in the lab. It is a good way to test vaccines - and is much faster than the "give 10,000 people the vaccine and 10,000 people fake vaccines and see how many people get sick over time" approach.

3.) In June, both Moderna and Pfizer (over the course of a few weeks), released information showing that their updated omicron-specific vaccines do improve the immune response (again in situ, using a few different techniques) -- against omicron, compared to the original vaccines. However, this information is already a bit delayed -- because these vaccines were tested on BA.1 (the first omicron variant that came through in January 2022) -- and not on BA.4/BA.5 -- which are the versions currently spreading in the US. There was also a BA.2 wave in November, and a BA.2.12 wave that is currently moving through Africa and India.

4.) Moderna and Pfizer have both developed BA.4/BA.5 versions of the vaccine at present -- but they don't have any data on how these work compared to either the BA.1 version or the original version -- they are unlikely to have that information in time to start mass-producing vaccines by the fall (the physical process of making a tub of vaccine takes about 60 days).

**This is what the article you quoted was talking about, from that article:

"NEW YORK (Reuters) - The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to authorize those shots, a top FDA official said on Thursday."

5.) This leaves us with four options: (1) use the original vaccine, which has been tested on billions of people at present, but is not optimal at preventing omicron infections, (2) use the BA.1 version, which is proven to be better than the original vaccine in laboratory experiments, but has not been tested on large populations, (3) use a "bi-valent" vaccine, which is a fancy way of saying "give people half a dose of the new vaccine, and half a dose of the original vaccine as a backup in case the new one works less well.", (4) use the new BA.4/BA.5 formulations (possibly with a bivalent backup), which are based on the same science that made the successful BA.1 vaccine, but haven't been tested at all.

It seems to be that we are leaning towards option 3 -- though I've heard some more articles recommending a push towards option 4 in Europe.

It is worth noting that this is how influenza vaccines are produced every year. They do not do the large "10,000" person tests on the influenza vaccine every year. They use a well-established technique to change its formulation based on the new versions of influenza that appear to be spreading (it changes every year -- and around May/June scientists need to make a best-guess as to what the actual influenza strain is going to look like by the winter). This approach is much more successful than using the last years influenza as a template -- but the effectiveness does fluctuate from year to year.

We're likely to see something similar with Covid over the next few years -- variants will change rapidly, and we will become decently good at updating the vaccine to address those variances (with notable hits and misses).

I would imagine that they would have to prove equivalence to a certain threshold in order to be able to leverage the real world safety data that they already have on hand.

The press releases spend quite a bit of (in my opinion) unnecessary time showing that the omicron specific booster is just as good at shielding you against the original variants of Covid as the original formulations of the vaccines -- presumably because the agencies demand this information.

It's a bit silly in my opinion, because the original variants of the virus aren't spreading anymore -- it's much more likely that we get a "whatever comes after omicron" variant than we see a re-newed spread of the original virus (or even of alpha/delta).

That's hilarious trying to make it political. I had it twice. Hardly any symptoms once, really sick once. I'm fully vaccinated. Truth is, nobody knows who's going to get hit hard.

It seems everyone we know across the entire country has covid. In fact, I don't know a time in the last couple of years when we have known this many who have all had it at once.


I am really shocked that they haven't locked down the country.

That's exactly what many of us thought about the anti vaxxers.

That's what a lot of normal folks thought who were labeled "anti vaxxers" for not standing in line day one to get the jab.

#sciencematters

#apparentlynotasmuchasthepoliticsbehindit

When one side stands behind science and one side denies it, I can see why you would say that.

Wow! You've got memes! lmao

You win. But in order to secure that win, you'll have to post one more time... because... you know.

j/c:

Biden tests positive for Covid again, will restart isolation despite no new symptoms

https://www.cnbc.com/2022/07/30/bid...t-isolation-despite-no-new-symptoms.html

P.S. My doctor told me those testing kits are designed to test positive, so maybe that's it? Or he may still have some of the virus in his system.

If they are designed to test positive, we've got major problems. Major problems as in: why would I trust any thing going forward.