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FDA grants authorization to Moderna's Covid-19 vaccine

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Re: FDA grants authorization to Moderna's Covid-19 vaccine

#131
post #73

Earlier quoted context omitted.

Challenge trials don’t work when 40% of infected are asymptomatic. And challenge trials especially don’t work when 15% of cases require hospitalization and ICU beds are already maxed out.

Citation needed for that 15% number. Even if it’s true, it absolutely isn’t true for all age groups. Give to 20-29 year volunteers. There were hundreds of thousands who volunteered.

What our (Lithuania) officials say is that about 5% of the cases are hospitalized. We are close to the top by the number of new infections per 100000 pop.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#132

Earlier quoted context omitted.

According to NPR [1] > Moderna spokesperson Colleen Hussey explained to NPR in an email that its vaccine doesn't need to be kept so cold because of its particular "lipid nanoparticle properties and structure," and because the company has learned from experience — it's developed ten mRNA vaccine candidates already. "Now we don't need [ultra-cold conditions] as the quality of product has improved and [it] doesn't need…

Those LNPs have historically caused adverse reactions, per their 2018 SEC filing, hopefully their upgraded versions are improved and do not cause those reactions; I am hopeful.that they have, because of the reported results of their current clinical trials, but it is a data point: https://www.sec.gov/Archives/edgar/data/1682852/000119312518... "Most of our investigational medicines are formulated and administered in…

Good to be cautious but there’s a lot of CYA in those SEC risk disclosures.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#133
post #118

i'm surprised absolutely noone here talks about the fact that we have absolutely no idea what the long term consequences of this new tech are. We've all seen people advocating new wonderful technological solutions that fail because of unknown unknowns, in every field. That's just the rules of the R&D game. In that case we're seriously thinking about injecting a new kind of drug to the whole world population based on…

Ok, what the mechanism for the long term consequences would be? mRNA itself is gone in days. All what's left is antibodies and some immune memory which should be the same as if you had real COVID. Is that more dangerous than catching covid which may affect your body in many more ways than vaccine which makes your cells to produce a particular protein?

I do not know what the long term effects of the glass of water I just drunk will be.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#134
post #121

Earlier quoted context omitted.

It won't be taken by everyone in the world. There are countless vaccines being developed. The two mRNA based ones were the quickest to fulfil the criteria of their phase three trials. The AstraZeneca/Oxford vaccine and Sputnik V are based on more conventional methods (adenovirus vector) for example. Also: the implication of your statement about the "most fragile 1 percent" is that their lives are worth less than othe…

"inhumane attitude" could also be a good qualifier for using the population as lab rats. it's called a tradeof , and public policies is doing it all the time, including accepting people dying for the greater good of others. Otherwise we would have banned cars a long time ago.

So vaccine looks more dangerous to you than COVID, despite numbers showing that's not the case? 20 in 1000 dying from COVID-19 is somehow acceptable, but two in hundreds of thousands getting some allergic reaction is not? How does one even justify that logic?

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#135
post #119

Earlier quoted context omitted.

This video https://www.youtube.com/watch?v=eK0C5tFHze8 can answer yours and a lot of other questions about mRNA: Professor Shane Crotty, PhD answers a series of COVID 19 vaccine questions including what are the chances of long-term side effects? How safe is RNA vaccine (i.e. Pfizer / BioNTech an Moderna Vaccines) technology? How long does mRNA from a vaccine stay in our cells? What else goes in vaccines? How long doe…

I looked the video and he says that based on vaccine literature, for the past any important vaccine safety signature was clear within two months meaning two months is enough to conclude whether a vaccine is safe or not. However, I think his answer seems a little bit superficial. Isn't the most part of the vaccine literature based on traditional vaccines? Yes I know that mRNA is not that much new but is literature on…

Seems like people prefer to downvote rather than try to give a compelling answer to the question "is the literature on long term side effects of mRNA vaccines extensive".

If the argument towards this question is overwhelming, surely someone has made a lecture on it somewhere.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#136
post #119

Earlier quoted context omitted.

This video https://www.youtube.com/watch?v=eK0C5tFHze8 can answer yours and a lot of other questions about mRNA: Professor Shane Crotty, PhD answers a series of COVID 19 vaccine questions including what are the chances of long-term side effects? How safe is RNA vaccine (i.e. Pfizer / BioNTech an Moderna Vaccines) technology? How long does mRNA from a vaccine stay in our cells? What else goes in vaccines? How long doe…

I looked the video and he says that based on vaccine literature, for the past any important vaccine safety signature was clear within two months meaning two months is enough to conclude whether a vaccine is safe or not. However, I think his answer seems a little bit superficial. Isn't the most part of the vaccine literature based on traditional vaccines? Yes I know that mRNA is not that much new but is literature on…

I have noticed this sleight of hand being used in a few different mRNA explainers. The two month window which has usually been sufficient to establish the safety of traditional vaccines isn't really applicable here, unless we have some reason to believe this new type of vaccine will present side effects and complications in the same way over the long term. But we don't have a good reason to believe anything about them in the long term because it has never been studied.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#138
post #133
post #118

i'm surprised absolutely noone here talks about the fact that we have absolutely no idea what the long term consequences of this new tech are. We've all seen people advocating new wonderful technological solutions that fail because of unknown unknowns, in every field. That's just the rules of the R&D game. In that case we're seriously thinking about injecting a new kind of drug to the whole world population based on…

Ok, what the mechanism for the long term consequences would be? mRNA itself is gone in days. All what's left is antibodies and some immune memory which should be the same as if you had real COVID. Is that more dangerous than catching covid which may affect your body in many more ways than vaccine which makes your cells to produce a particular protein? I do not know what the long term effects of the glass of water I j…

This is not necessarily specific to the mRNA vaccines, but one potential consequence of population-wide deployment of a 90% effective vaccine might be to create selective pressure for a more virulent strain of Covid without actually eliminating it.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#139

Anyone knows why they insist on both doses given the limited supply of the vaccine and the marginal increase in effectiveness with the second dose? I would imagine every single day counts. https://www.lesswrong.com/posts/Rvzdi8RS9Bda5aLt2/covid-12-1...

If every single day counted, they would have done challenge trials. What counts is following the FDA's process, and the FDA's process says that you have to administer it in the same way as the trial. No one at the FDA is going to go out on a limb just to save a few thousand lives.

Are challenge trials for dearly diseases even legal?

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#140

Is CureVac still in the race? What other mRNA companies are there that are doing interesting work in the space (beyond COVID)?

They are, but very very slow. Their 2b/3 trial only started this week. Almost a year into the pandemic.

https://www.curevac.com/en/2020/12/14/curevac-commences-glob...

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