FDA grants authorization to Moderna's Covid-19 vaccine • Hacker News Board

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

#121

Post by bsaul » Sat, Dec 19, 2020, 10:25 AM UTC

_Microft wrote: post #120

bsaul wrote: 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…

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.

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

#122

Post by BillyTheKing » Sat, Dec 19, 2020, 10:32 AM UTC

IfOnlyYouKnew wrote: post #80

chromatin wrote: post #28

Earlier quoted context omitted.

And it turns out the cohort who received the half dose was on average younger than the total study population, this explaining the apparent improvement in efficacy

As far as I can tell, the virus is more prevalent among younger people. Since infection, not death, was the primary endpoint, and also because medicine hasn't used that sort of wishful reasoning for about a hundred years, the age difference doesn't explain anything.

it certainly does, younger people have stronger immune systems, and therefore generally react better to vaccines than older people. The stronger the immune system reacts to a vaccine the better, since that usually ensures that there will be an immune-response to the actual virus as well.

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

#123

Post by marvin » Sat, Dec 19, 2020, 10:32 AM UTC

bsaul wrote: 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…

Okay, we've researched mRNA medicine since the 90s. But have similar medicines been given to a million people? Have those been tracked for three decades? We're talking about scaling that up by a factor at 10-100+, and giving it to millions of healthy people with many decades of life ahead. What if some serious adverse reaction happens ten years later, to 0.1% of the 20-year olds who take it today? Worth it?

The efficacy of the new mRNA vaccines is fantastic. It's a no-brainer to give them to people with a high likelihood of having a serious covid case.

Maybe it's justified to also give it to everyone else, to mitigate the economic effects of the epidemic. But asking this question is qualitatively different than what you hear from people who are normally skeptical towards vaccines. This is a completely new type of prophylactic, there is potential of an unknown unknown.

I'm typing this contrarian comment mostly to document that I've thought about it, in case, heaven forbid, we make a horrible discovery about it in 2025.

Honestly - aren't there researchers working in the field thinking similar thoughts? Is it such a taboo interjection that they don't dare speak it out loud out of fear of being compared to antivaxxers? I don't believe that it's an excessively cautious concern.

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

#124

Post by herbst » Sat, Dec 19, 2020, 10:38 AM UTC

giantDinosaur wrote: post #115

Erlich_Bachman wrote: post #112

Earlier quoted context omitted.

There is a lot of real evidence that masks do work https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

My impression is that the consensus is reasonably strong that masks work in and of themselves, that is - they do act as a physical barrier against transmission, but , most infections are happening at e.g. family gatherings and in households, so the actual effects of masks writ large are more muted than proponents argue. Basically, it's like saying seat-belts work, which is obviously very true, but regarding them in a…

Could it be that most transmissions happen with family and not shopping simply because the majority wears masks?

In countries with actually working contact tracing you have regular cases from restaurants and doctor offices. For example

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

#125

Post by reader_1000 » Sat, Dec 19, 2020, 10:49 AM UTC

tkinom wrote: post #119

reader_1000 wrote: post #108

Are mRNA vaccines safer than traditional ones? In the long run, which one will have less side effects? As far as I know, Both US and Europe are only going with mRNA vaccines for COVID. Is it intentional or just because there is no traditional vaccine that completed Phase III trials?

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 long term side effects of mRNA vaccines extensive?

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

#126

Post by nojito » Sat, Dec 19, 2020, 11:37 AM UTC

cameldrv wrote: post #68

CyanLite4 wrote: post #66

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.

I don't see how the asymptomatic fraction makes a normal trial superior to a challenge trial. As for the hospitalization and ICU, those numbers are inflated, but regardless, in order to pass the trial, the same number of people need to be infected in the trial. The only difference is that while you're waiting for a few dozen people to be infected naturally because you gave them a placebo, millions are being infected…

I work in healthcare.

Where’s your source on them being inflated?

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

#127

Post by Slartie » Sat, Dec 19, 2020, 11:40 AM UTC

morsch wrote: post #83

tyre wrote: post #72

Earlier quoted context omitted.

It’s fun to shit on Big Pharma but this isn’t true. Pfizer specifically rejected government funding. It did so because it didn’t want to be dragged into bureaucracy.

Biontech, Pfizer's research partner, received 375 million Euro from the German government. https://www.bundesregierung.de/breg-de/themen/themenseite-fo...

That is true, and likely one of the reasons for that favorable EU deal.

But what's also correct is: neither Pfizer nor BioNTech did accept money from the Trump government (except as payment for the finished product once it was approved of course), which is what the OP probably meant. There's a huge difference regarding the potential for politicization between this particular government and any other sane government on this planet, and especially the German one that's currently being led by a trained physicist.

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

#128

Post by nojito » Sat, Dec 19, 2020, 11:41 AM UTC

bsaul wrote: 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…

That 1% have the ability to devastate the healthcare infrastructure.

ICU beds are dollar for dollar the most expensive resource in healthcare today.

Not to mention the rarity of qualified healthcare workers who are trained in working in the ICUs and the risk of losing them for 2+ weeks if they get infected.

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

#129

Post by rleigh » Sat, Dec 19, 2020, 11:50 AM UTC

zaroth wrote: post #55

throwaway201103 wrote: post #32

Earlier quoted context omitted.

Both of the mRNA vaccines (Pfizer and Moderna) require two doses. Don't know if the 2nd dose is the same as the first.

The actual study results show the vaccine is highly effective within 10 days of the first dose. Honestly a bit shocked based on the results and the number of lives that could be saved by effectively doubling the number of available doses that they didn’t try to get it modified to a single dose regimen. Seems to me like just another way the FDA has screwed up this whole rollout.

Two doses is very common for vaccines because this is based upon how the immune system responds to real infections. The first dose will initiate a primary immune response. The second dose will act as a "challenge" to trigger a secondary immune response.

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

#130

Post by refurb » Sat, Dec 19, 2020, 12:14 PM UTC

Retric wrote: post #63

maxerickson wrote: post #58

Earlier quoted context omitted.

In practice it seems the expiration dates on even boring drugs aren't real far into the future.

Yea, prescription drug manufacturers have little incentives to seek multi year shelf lives. Combined with the slow approval process real time testing is likely considered sufficient. https://www.pharmacytimes.com/news/some-medications-last-lon...

I think you summarized it well. There is little incentive to test the limits of stability as manufacturers typically control channel inventory quite tightly. I know my company targeted maybe 14 days on hand? So going much beyond 2 years stability didn’t make much sense as most product was consumed well before it expired.