To Vaccinate or Not---The Rat Flu Odyssey Continues

[old goat]

The mRNA that essentially IS the vaccine doesn't stick around beyond getting into your dedritic cells and getting translated into virus protein for further processing and presentation on the surface where it can engage B and T-cells. Then it goes away. Your body will establish resident B and T cell population that arise from the process so that if you're ever infected by the virus, you can mount a quick response. The education of the B and T cells is called "adaptive immunity" and conservatively takes around 2 weeks to complete. Bottom line, by the time a booster comes around there will not be any remaining mRNA from the first shot.

The FDA has already told Moderna and Pfizer that they can skip phase I of the clinical trials process. Phase I is exclusively designed to check for early safety issues while establishing dose ranges that are hypothesized to be effective while not causing toxicity. Therefore, the variant-versions of the mRNA vaccines are already in Ph2 and will have data by end of summer. Whether we need a booster at all is a question that is still pending longer-term follow up data.

Will they require a Phase 3?

[huckbucket]

Will they require a Phase 3?

OK. I'm glad you asked, because it revealed to me that I answered CAJ's question about clinical trials from memory and clearly got it all wrong. Sorry everyone for the misinformation. The end result is essentially the same but there are important differences. Here's the real scoop;

In March, the trial of the Moderna vaccine covering the South African variant began. You can see all of the details here;
https://www.nih.gov/news-events/news...vaccine-begins

OG - It's a phase I trial that will complete enrollment this month and read out this summer. The primary endpoint is safety and the secondary endpoint (yet super important) is magitude and response rate of antibody generation (i.e. immunogenicity). There will be 60 people who were part of the original trial of the first Moderna vaccine and another 150 who are unvaccinated and never-infected. However, don't expect there to be a Ph2 or 3. In Feb, the FDA issued new policies for vaccine developers. You can find it here;
https://www.fda.gov/news-events/pres...dressing-virus

The important point is as follows;

"For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. Manufacturers are also encouraged to study the modified vaccine in both naïve (non-vaccinated) individuals and in individuals previously vaccinated with the authorized vaccine. Additionally, the guidance outlines the FDA’s recommendations for assessments of safety to support an EUA for a modified vaccine. Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may be authorized without the need for clinical studies."

As you can see in the bolded section, if Moderna demonstrate safety AND antibody reactivity in Ph1 it may already satisify these new FDA criteria to the extent it could earn them an EUA for the variant version. Notably, we may not need it and that is mentioned at length in that first article I linked. Time will tell.

[Thaleia]

Wow, booked for AZ this Wednesday, at a godamned Walmart of all places. I assume they have a pharmacy there, and it's not on the loading dock in the smoking area lol.

Every time-line and prediction for vaccinations up to this point in Ontario was for July, maybe September latest for my age group.

All it took was Trudeau to seriously troll our premier, and a reporter to point out that by concentrating on some reluctant 55+ folks, thousands of vaccines were about to expire.

Got booked. Got super excited. Then admittedly got angsty about it being AZ. Did some further reading and I'm back to beyond excited.

Really did not see this coming. Just this last Friday it was announced we were in a police enforced lock down. By Saturday afternoon all but two of our provinces forces made public statements to the effect of "yeah fuck that, we're not randomly stopping people to ask why they're out of their home".

Sunday the Prime Minister announces he's working with other provinces (specifically implying he's not bothering with our premier) to get help to Ontarians, plus the very public call out from the reporter, and boom, finally some action from the province. Roller coaster of a weekend.

Edited to ad, I do have once concern. Since this first shot of the vaccine is due to an unplanned surplus, I hope it doesn't imply there could be supply issues to receive the second dose. Maybe we'll be mixing and matching by then.

[billyk]

Got my second dose of Moderna on Saturday. I didn’t have any reaction to the first dose, but the second shot was another story. Sore arm, and just felt wiped out. Spent most of the last day and a half in bed. Certainly woke up my immune system, and hopefully created lots of antibodies.

To get my first shot required spending 4 hours waiting online to get the appointment, and another 2 hours waiting in line at the center. The second shot went a lot quicker, no line at all at the center. Maybe the talk about blood clots has scared people off, even though it’s a completely different vaccine than J&J..

[subtle plague]

Not defending out resident dipshit, but the answer to your question was right in the article. Examples include;

" ... population density of your area, your education level, and whether you have regular access to health care."

You forgot size of reproductive organs.

[Benny Profane]

Getting Covid after vax.

https://khn.org/news/article/the-sho...ng-vaccinated/

[jono]

Getting Covid after vax.

https://khn.org/news/article/the-sho...ng-vaccinated/

“I was shocked,” said Hauser. “I thought: ‘What the heck? How did that happen?’ I now tell everyone, including my colleagues, not to let their guard down after the vaccine.”

September still "fuck em all month" Benny?

[Benny Profane]

Yup. Look at the numbers. Millions poked, a few thousand sick, a handful dead, and I'd love to hear about pre existing conditions of the latter. You gonna stay inside with your mask on after September, scared little boy? Have fun.

[skifishbum]

coming from the guy whos scared to buy pots on the street
thats alinis morristte funny stuff bunners

[Benny Profane]

How much acid did you do as an adolescent?

[jono]

I'm still waiting to hear how you plan to screw over everyone, though. You have an inside source for the carrier-only vaccine? How's that gonna work?

And in the meantime you're hiding indoors?

[Bunion 2020]

Maybe you should have said yes to the tab Benny, you might not be such an unhappy asshole.

On another note, after both jabs in the left arm I had minor bruising on the inside of my bicep opposite of where I was stuck. Anyone else? Pfizer.

[skifishbum]

bunners dropped out fore
the turn on
tune in
part
let this be a lesson in doing it right kids
#dontbeabunners

[Benny Profane]

I'm still waiting to hear how you plan to screw over everyone, though. You have an inside source for the carrier-only vaccine? How's that gonna work?

And in the meantime you're hiding indoors?

Nope. First flight, May 8. Life goes on.

[Benny Profane]

Maybe you should have said yes to the tab Benny, you might not be such an unhappy asshole.

Sheeit, we had little orange barrels rolling around my neighborhood like candy.

[subtle plague]

So doing acid is like a vaccination? And you learn a second language. SFBish. Win win win situation!

[Cono Este]

Chinese Vaccination has been a dud in Chile. 50 % effective. Why am I not surprised.

https://www.cnbc.com/2021/04/19/covi...e-rollout.html


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[tetzen]

Then the government would be on the hook if something goes wrong. Right now it's maybe some weird clotting thing. There will be some other things. There always are. And really I don't think they really care that much. Seems it's the media and some regional governments that have gone nuts

The government is already on the hook if a vaccine goes wrong under the National Vaccine Injury Compensation Program.

[GoldMember]

Maybe you should have said yes to the tab Benny, you might not be such an unhappy asshole.

On another note, after both jabs in the left arm I had minor bruising on the inside of my bicep opposite of where I was stuck. Anyone else? Pfizer.

No but both of my shoulders, in the joint itself away from the vaccine site were achy for about a day. In your case, could just be where the blood settled internally after the shot. In my case, thought it was kind of weird that both shoulders would ache equally.

[KQ]

No but both of my shoulders, in the joint itself away from the vaccine site were achy for about a day. In your case, could just be where the blood settled internally after the shot. In my case, thought it was kind of weird that both shoulders would ache equally.

Tension. Shoulders creeping up to your ears without even realizing it I learned that from yoga.

Release those traps!

[GoldMember]

Tension. Shoulders creeping up to your ears without even realizing it I learned that from yoga.

Release those traps!

Yeah, I'm not sure a twelve hour, one-time event having occurred shortly after the shot qualifies under this scenario. If I tried yoga, pretty sure I would tear something and be hobbled... Whatcha got for lower backs? That's more chronic.

[jono]

OK. I'm glad you asked, because it revealed to me that I answered CAJ's question about clinical trials from memory and clearly got it all wrong. Sorry everyone for the misinformation. The end result is essentially the same but there are important differences. Here's the real scoop;

In March, the trial of the Moderna vaccine covering the South African variant began. You can see all of the details here;
https://www.nih.gov/news-events/news...vaccine-begins

OG - It's a phase I trial that will complete enrollment this month and read out this summer. The primary endpoint is safety and the secondary endpoint (yet super important) is magitude and response rate of antibody generation (i.e. immunogenicity). There will be 60 people who were part of the original trial of the first Moderna vaccine and another 150 who are unvaccinated and never-infected. However, don't expect there to be a Ph2 or 3. In Feb, the FDA issued new policies for vaccine developers. You can find it here;
https://www.fda.gov/news-events/pres...dressing-virus

The important point is as follows;

"For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. Manufacturers are also encouraged to study the modified vaccine in both naïve (non-vaccinated) individuals and in individuals previously vaccinated with the authorized vaccine. Additionally, the guidance outlines the FDA’s recommendations for assessments of safety to support an EUA for a modified vaccine. Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may be authorized without the need for clinical studies."

As you can see in the bolded section, if Moderna demonstrate safety AND antibody reactivity in Ph1 it may already satisify these new FDA criteria to the extent it could earn them an EUA for the variant version. Notably, we may not need it and that is mentioned at length in that first article I linked. Time will tell.

Thanks for that. Very encouraging to see that they're not necessarily going to have to prove effectiveness by placebo. Seems important if we actually make enough progress to significantly slow down exposure rates.

[KQ]

Yeah, I'm not sure a twelve hour, one-time event having occurred shortly after the shot qualifies under this scenario. If I tried yoga, pretty sure I would tear something and be hobbled... Whatcha got for lower backs? That's more chronic.

Child's pose is my favorite lower back stretch along with a reclined stretch with a strap:

Child's pose:


Reclined strap stretch:


Knees to chest with an optional side-to-side rock is great too (I'm not a fan of the forward/back rock but some people love it). From this pose you can also go to shoulder stand and plow which are nice for the back.

Knees to chest



Shoulder stand


Plow


You can also throw Bridge pose into the mix if you like. The hands clasped and stretched towards feet with shoulders rolled under really feels nice.



Also really like the restorative yoga pose "waterfall" of legs in the air with a block or up a wall. Putting the block edge right on my sacrum really helps and getting my legs up, reversing the flow feels wonderful. Here's an article on sacrum stretches.

[gravitylover]

I can't do that...

[The AD]

Moderna shot 1 now coursing through my veins. I went to the drive through site in Monroe, Washington. I was there approximately 16 minutes including the 15 minute after vax wait.