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No one who got Moderna's vaccine in trial developed severe Covid-19

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Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#371

Is COVID real? Yes! Is is really that bad as everyone makes it out to be? No! If it was that deadly of a virus, 9 out of 10 people would be dead by now. Do you need a vaccine? Nope, unless you want to take one and die. I have only been sick one time, and that was during Dec to Feb of 2019 when every human being was exposed to COVID. Have I wore a mask this entire time? No! Have I went and got tested? No! Will I go ge…

Is this GPT-3, trolling, or just honest stupidity? I'm having a hard time seeing the difference these days.

>Is this GPT-3, trolling, or just honest stupidity?

What if it is neither?

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#372
post #339

Earlier quoted context omitted.

No, mRNA is not DNA.

Not that I agree with the parent but isn't technically mRNA used to "hack" DNA to make it synthesize a specific protein?

no. DNA doesn't synthesize proteins.

Roughly: Protein descriptions are "read" from DNA into mRNA, which is then used by ribosomes to synthesize proteins. An mRNA vaccine adds additional mRNA with instructions to synthesize the vaccine-specific protein to the cells. So it uses some of the same mechanisms that are also used to generate proteins from DNA, but does not involve DNA itself.

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#373

Earlier quoted context omitted.

None of these trials have used a "challenge" design where people were deliberately exposed to the virus. Instead, they vaccinate a ton of people and then let them go about their lives. Participants' risk of getting COVID shouldn't go up, unless participating in the trial induces them to behave more riskily.

That wouldn’t be smart because they don’t get to know if they got the vaccine or the placebo.

No, definitely not!

Still, risk homeostasis is (sometimes) a thing: people reportedly ski faster when wearing a helmet, drive closer with ABS, and stuff like that. I was just trying to pre-empt that argument.

That said, if this were a factor, it would be small and would make the trial results most impressive, rather than less.

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#374

There a lot of comments that are being downvoted just for questioning different aspects of such a vaccine and other related issues. That's not what I have come to expect from a crowd of curious people carrying a scientific temper. C'mon HN. Let's answer the questions without downvoting someone to oblivion.

You're only allowed to have certain ideas about certain topics. Step outside those bounds and the thought police will attack you.

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#375

Earlier quoted context omitted.

There's a (blinded) control group so purely based on how deeply unethical it would be to purposefully expose them to the virus I'd wager they were 'natural' occurrences.

I understand how it could be unethical, though I'd be more confident in a study that had purposeful exposure - how can we say the vaccine really was the means of protection, and not just the current measures?

That's precisely why there is a control group.

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#376

Earlier quoted context omitted.

Can read all of them in their published protocol at https://www.modernatx.com/sites/default/files/mRNA-1273-P301... under section 5.2.

There is an additional question that opens the door to all sorts of hidden exclusions: Were study participants given medical advice prior to participation? If I ask my doctor whether it is a "good idea" for me to participate in an investigational study like this, there are all number of reasons he may advise against. Those reasons form a defacto hidden list of exclusions. Would a doctor advise a patient with diabetes…

As someone who volunteered for the AZD12222 trial and who has various "co-morbidities", I consulted with 2 of my doctors beforehand. Given that none of the vaccines being tested are live virus vaccines (meaning there is 100% no way to get COVID-19 from the vaccine, unlike say, the polio vaccine), and all had already passed Phase 1 safety trials, they both put it as (paraphrasing): "It's a personal choice, but if you do it, thank you for helping science."

I think COVID-19 is perhaps different than many other types of diseases in it's mainly-selective dangerousness to select groups of people. A healthy 30-something is unlikely (but possibly) to have severe, hospital-landing COVID. Someone with various co-morbidities, however is more than twice as likely to die than someone without. As such, I think that makes it much more likely that this group will volunteer, than "normal" people. It's certainly what drove me to do so.

The only issue they seemed to really care about during the intake was immunosuppression. As another comment pointed out, as long as other medical conditions were stable, you were eligible. From the vaccine makers point of view, I'd surmise this group is almost desired (my personal opinion), as you're less likely to a have asymptomatic COVID infection, which given how they are running the trial are unlikely to get noticed.

I take great solace in hearing that among the people who got COVID even when having received the vaccine (I'm talking about the AstraZeneca one, which is ~70% effective), there were no serious cases that required hospitalization. This indicates that even among the "not-effective" group, the vaccine confers some immunity. For me, that bring the personal risk factor from "possible death sentence" to "just like the flu...it'll suck for 2 weeks but I'll be fine".

Obviously I don't know if I got the vaccine or not (though given I felt crappy the next day, I'm fairly sure I did), which as another commenter points out is what makes these trials effective. Neither I, nor the doctors I met with (nor anyone at the clinic where I received it) has any idea if I got vaccine or placebo. In fact, they even had the vaccine couriered over from another hospital pharmacy using only a numeric identifier so really nobody knows what I got.

Coming back to the original question, I think many people, especially with co-morbities might seek out advice before enrolling, but at least in my case, two doctors were all for it.

I'm thankful I enrolled, and I'd encourage others, especially those who are more likely to get severe COVID to do so as well!

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#377

note there is not a claim this vaccine prevents infection, only lessens symptoms, meaning you are still contagious. "We all expect an effective vaccine to prevent serious illness if infected. Three of the vaccine protocols—Moderna, Pfizer, and AstraZeneca—do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache." "Prevention of infec…

It is true that for these initial protocols, they are only testing becoming symptomatic versus prevention of transmission. That said, all the trials (at least in phase 1/2) are also looking at antibody levels[1][2], which would indicate less likelihood of transmission.

Remember, all these vaccines aren't yet applying for full approval, but an EUA (Emergency Use Authorization). I fully expect that the FDA would want to see data on transmission before full approval; but that is harder to acquire, so it makes sense they wouldn't wait for that specific data.

As someone in the AZD12222 (AstraZeneca/Oxford) trial, I can confirm that they are following all participants for a full 2 years. In this time (versus the ~3 months each Phase 3 trial has run for), there will be much more time to see if these vaccines prevent transmission, not just prevent symptoms.

With all that said, many thousands of live will be saved by getting these vaccines out now, even if they are only partially effective. After all, someone who can't get sick can return to a more normal life, since they won't have issues if they were to get SARS-COV-2 infection later on.

[1] https://biology.mit.edu/undergraduate/current-students/subje... [Lecture 10, with a NIH researcher who worked on the Moderna vaccine]

[2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [Phase 2/3 study of AstraZeneca vaccine, figure shows neutralizing antibody levels]

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#378

Earlier quoted context omitted.

you can't completely predict who it's going to be mild for. 14-year olds with no known underlying issues have died, 25-year olds have lost their sense of smell and taste permanently or suffer from long covid months later.

Not to take away from the argument that we should vaccinate everyone (we should, at least adults. not sure if this vaccine will be approved for kids, which usually requires more stringent approvals), but your argument isn't a good one. Covid has killed 42 people from age 5-14 in the US according to the CDC, for example. That alone is really not something we should be making huge policy decisions around. It's sad, of…

I would expect that reopenings wouldn't be based on vaccinated percentage, but caseloads, just as they are now. Once more people are vaccinated, however, those will decrease.

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#379

How do they know that participants were exposed to Covid-19? Just simply through statistics?

They don't fullly know. They rely on statistics. I hope they at least ask subjects about exposure.

I'm in the AZD1222 (AstraZeneca) trial, and for the next two years, I need to fill out an online symptom questionnaire every single week. They also draw blood at the 6-month and 1-year mark, so presumably could test for antibodies.

Re: No one who got Moderna's vaccine in trial developed severe Covid-19

#380

Earlier quoted context omitted.

I understand how it could be unethical, though I'd be more confident in a study that had purposeful exposure - how can we say the vaccine really was the means of protection, and not just the current measures?

That's precisely why there is a control group.

And that's what I mean, the control group may be avoiding exposure altogether.
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