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FDA grants authorization to Moderna's Covid-19 vaccine
- mchusma 6y agoIf they stopped banning Astrazeneca too, and stopped vaccinating people who already had COVID, we could be done within 60 days. Astrazeneca is well above the FDAs original safety and efficacy guidance and something I'd be glad to take and give my family.
- apsec112 6y agoThe AstraZeneca vaccine doesn't have enough supplies for that when you count all the countries that have ordered it, and isn't effective enough to create herd immunity by itself (most likely 60-70%).
- ganeshkrishnan 6y agoI don't think Astrazeneca is banned. maybe they dont have FBA approval. Also they illegally marketed their psychotic drugs to children under kickbacks from doctors https://abcnews.go.com/Politics/Health/astrazeneca-pay-520-million-illegally-marketing-seroquel-schizophrenia/story?id=10488647 https://abcnews.go.com/Politics/Health/astrazeneca-pay-520-m...
- eganist 6y ago> and stopped vaccinating people who already had COVID How would you propose doing this without drawing blood from every single person getting a vaccine?
- enchiridion 6y agoSeem like a good option. I'd imagine it's a parallel supply chain, so it would speed things up.
- eganist 6y agoit's most definitely not. The application and collection points aren't even the same because there's a time delay in antibody testing.
- blhack 6y agoThere are people I am personally acquainted with who have been PCR positive for COVID, who are now also receiving the vaccine.
- tertius 6y agoIf they haven't been proven to be infected why should it matter?
- blhack 6y agoWhat? They have been proven to be infected (PCR positive) and they are now receiving the vaccine.
- tertius 6y agoPCR positive doesn't mean infected. You'll need an high amount in PCR, i.e. low cycle threshold for the probability to be high. Antigen tests will show if there was/is an infection. PCR does not show infection only presence. (WHO has now put out guidance about this. They don't have to it's well known.) If you're European this may be strange to you but I'm the U.S. we don't receive the cycle count when the RNA for the virus is detected. Here's Fauci talking about it a little: https://youtu.be/a_Vy6fgaBPE&t=4m30s https://youtu.be/a_Vy6fgaBPE&t=4m30s
- throwaway201103 6y agoSimply tell people, "if you've had COVID, don't get the vaccine" or maybe "go to the end of the line"
- m-ee 6y agoThat’s terrible messaging given that reinfection is rare but possible and occasionally deadly. We want everyone to take it.
- throwaway201103 6y agoHard to imagine that infection and recovery from the actual virus confers less immunity than the vaccine, but even without knowing that, it seems reasonable that people who have already recovered should be a lower priority for vaccination than more at-risk groups.
- m-ee 6y agoIt’s not hard to imagine, it’s a well observed phenomenon in other diseases like HPV. Antibody titers were higher for the mRNA covid vaccines than convalescent plasma if I remember right. Most people probably are at lower risk, but some people are dying from reinfection. They certainly weren’t.
- IfOnlyYouKnew 6y agoNothing is "banned". AZ accidentally ran their first trial with only half the intended dose. For some reason, this turned out to work better than the intended regimen (90 % vs 60 % in the other trial). When they noticed the mistake, they pretended it had been their intention all along. That's one troubling error, one surprising result that doesn't fit expectations and could, therefore, indicate other, potentially dangerous, problems in thinking or execution, and one deliberate lie. Personally, I'd tend to agree with you and would probably take their vaccine if offered. But that's something entirely different than allowing it to be given to millions of people. Getting this wrong would lead to a total breakdown of trust in institutions, and, in due course, a few democracies as well. To insinuate some conspiracy given these circumstances is evidence for the mechanism of that breakdown, as well as irresponsible and, frankly, amateur populism.
- chromatin 6y agoAnd 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
- IfOnlyYouKnew 6y agoAs 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.
- BillyTheKing 6y agoit 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.
- SAI_Peregrinus 6y ago> For some reason, this turned out to work better than the intended regimen (90 % vs 60 % in the other trial). The difference isn't actually statistically significant. It's probably 60-70% effective overall.
- stjohnswarts 6y agoNone of what you said is true...
- FreakyT 6y agoGlad to hear it! One key advantage of the Moderna one versus the similar Pfizer/BioNTech vaccine is that it doesn't require deep freeze storage, only regular freezing temperatures. (-90º C for Pfizer/BioNTech vs -20º C for Moderna)
- lisper 6y agoDoes anyone here know the reason for the difference? They're both mRNA vaccines, right? So why does one need a deep freeze and the other one not?
- m-ee 6y agoDifferent lipid nano particles, or maybe just stability testing. The vaccines could be stable at lower temperatures but the companies haven’t had time to prove it by letting the vaccine sit in a fridge for months.
- bpodgursky 6y agoThe answer is "there is probably no difference, but Moderna has more experience with mRNA vaccines and felt good about the -20 requirement, but Pfizer is new to mRNA, and didn't": https://www.npr.org/sections/health-shots/2020/11/17/935563377/why-does-pfizers-covid-19-vaccine-need-to-be-kept-colder-than-antarctica https://www.npr.org/sections/health-shots/2020/11/17/9355633...
- refurb 6y agoAs someone who has been involved in stability testing before, I doubt this is really the case. In order to justify your stability, you need data to submit to the FDA (they don't take your word for it). When doing your initial stability studies, you try and collect data for the most ideal conditions - no refrigeration needed, stable for X years from room temperature to 30C (to account for conditions during shipment). No doubt Pfizer lined up a number of early stability studies testing -80C, -50C, -20C, 0C, etc. They recognize that needing a -70C cold chain is a logistics hurdle. If they could avoid it at all, they would have pushed for it and had data to back it up.
- roody15 6y agoHmm super expensive hard to transport Pfizer vaccine ... first to be approved. Next Moderna ... also super expensive second to be approved. After six months to a year ... and after making huge profits.... Then the AstraZeneca/Russian vaccine variants will be “found” to be also effective. We must first wait and let Pfizer make a few billion !!!
- maxerickson 6y agoIt's $40, not super expensive. 600 million doses would cost $25 billion, a trifle compared to how much the pandemic is costing.
- roody15 6y agoAstrazeneca believes their vaccine may soon be less than 1$ per dose. If we are serious about vaccination worldwide and quickly ... then this should already be approved IMO
- djsumdog 6y agoWell hundreds of millions have already flowed into every major pharma company for development costs, so the price for tax payers in every contributing country is substantially higher than $40/person. That's just the price an individual may see.
- maxerickson 6y agoNo, that's (roughly) the per dose price the US is paying for the vaccine (there's no individual fee here for the vaccine, I guess there can be an administrative fee, but that won't go to the manufacturer, it will go to the health provider doing the vaccination).
- graeme 6y agoDid you mean hundreds of billions? Hundreds of millions is a tiny amount relative to the billions of doses under production. Hundreds of billions is not accurate either though.
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- opendomain 6y agoI am concerned that the Pfizer vaccine was put on hold [1]. I am also concerned that Moderna has never produced ANY drug beyond the third stage before. [2] How could we research if the approval was politically motivated? How can I know if this is actually safe? (1) https://www.vanityfair.com/news/2020/12/white-house-delays-pfizer-vaccine-shipments/amp https://www.vanityfair.com/news/2020/12/white-house-delays-p... (2) https://www.wsj.com/articles/modernas-covid-19-vaccine-is-cleared-for-american-use-11608338496 https://www.wsj.com/articles/modernas-covid-19-vaccine-is-cl...
- stu2b50 6y agoIt was not "put on hold", rather as many experts expected, especially with the state of the current administration, mass distribution and coordination is a clusterfuck. Which, to be fair, is a very challenging problem with a lot of minutia and moving parts. But "your amazon product will take another day to ship" is very different from "your amazon product is broken". If you're worried that it was rushed by US politics: the "Pfizer" vaccine was made by Biontech, a German company, and has also been accepted (earlier, even) by regulators in Canada and the UK.
- kalnins 6y agoIt's also expected to be accepted in EU on 21st december. And, if approved, vacination would be started across the whole EU on 27th december.
- apsec112 6y agoShipping and distribution problems have nothing to do with safety. There's a lot of data on what side effects the trial participants got, how the vaccine compared to placebo, etc. which has been published by the FDA. With tens of thousands of trial participants, we can be pretty confident that serious side effects are rare.
- jrockway 6y ago> I am also concerned that Moderna has never produced ANY drug beyond the third stage before. Have there been a lot of disease outbreaks preventable with an mRNA vaccine before? To make a product, you need customers. Whatever research we did to deal with SARS and MERS became moot when people stopped spreading the diseases; maybe Moderna could have delivered a vaccine, but there would have been no customers because other containment measures limited the spread. My outsider impression of Moderna is that they had all the technology ready to deal with something like COVID-19, but there was no COVID-19 until now. The fact that Pfizer/BioNTech independently produced a similar product on a similar timeframe is a pretty good indication that the technology was ready, and was just waiting for a market.
- dang 6y agoWe changed the URL from https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us https://investors.modernatx.com/news-releases/news-release-d..., which is a corporate press release [1], to the most substantive non-paywalled article I could easily google. [1] https://hn.algolia.com/?dateRange=all&page=0&prefix=true&sort=byDate&type=comment&query=corporate%20press%20release%20by:dang https://hn.algolia.com/?dateRange=all&page=0&prefix=true&sor...
- finolex1 6y agoAnyone 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-12-17-the-first-dose https://www.lesswrong.com/posts/Rvzdi8RS9Bda5aLt2/covid-12-1...
- cameldrv 6y agoIf 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.
- CyanLite4 6y agoChallenge 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.
- cameldrv 6y agoI 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 and thousands are dying daily.
- nojito 6y agoI work in healthcare. Where’s your source on them being inflated?
- cwhiz 6y agoCitation 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.
- avocad 6y agoDoes anyone know how they manage to produce complex microstructures like that, RNA inside a lipid capsule, on such a large scale? Does these vaccines need an adjuvant to work, or is the change to the affected cells large enough to trigger an immune reaction?
- m-ee 6y agoThere’s no additional adjuvant. I have no idea how they’re produced, would love to learn more.
- blackbear_ 6y agoThis article [1] has a section with several references on that, with the most used technique [2] being depicted in fig. 3 (this is from 2016 so there might be a more recent technique around now). The basic principle is to mix a solution with lipids and one with the mRNA and pump it through a channel with herringbone-shaped incisions that generate turbulence in the fluid. Apparently, the turbulence makes lipids surround the mRNA and stick together to form the nano-particle. [1] http://www.future-science.com/doi/10.4155/tde-2016-0006 http://www.future-science.com/doi/10.4155/tde-2016-0006 [2] https://science.sciencemag.org/content/295/5555/647.full https://science.sciencemag.org/content/295/5555/647.full
- neuronic 6y agoSo to quickly summarize they use fluid dynamics and force and whatever sticks through this process will be useful. I wonder what the rate of lipid-surrounded mRNA is after the process. Say you fire 100 mRNAs through this construct, will 90 of them be surrounded by lipids afterwards? Or 30? Or 100?
- reader_1000 6y agoAre 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?
- andylynch 6y agoThe latter. Many countries have bought a mix of both, the advantage of mRNA tech was always its adaptability hence why these are coming out first. Oxford vaccine is reported likely to be approved for use in UK in less than two weeks’ time, for roll out first week of Jan
- tkinom 6y agoThis video https://www.youtube.com/watch?v=eK0C5tFHze8 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 does immunity last? Why are T-Cells so important? Why does Pfizer's vaccine need to stay SO cold?
- reader_1000 6y agoI 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?
- marvin 6y agoSeems 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.
- bsaul 6y agoi'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 a couple of short term trials, for a desease that is only lethal for far less than 1 percent of the population ( and in general, only the most fragile 1 percent). I'm just like everyone and i find this new arn cell transcription machinery hacking absolutely insanely great. And i also think it looks safe from what the expert are explaining. But is it safe enough to have it taken by everyone in the world ??
- _Microft 6y agoIt 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 others. I cannot begin to describe the disgust I am feeling towards such an inhumane attitude.
- bsaul 6y ago"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.
- rimliu 6y agoSo 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?
- dharma1 6y agoIs CureVac still in the race? What other mRNA companies are there that are doing interesting work in the space (beyond COVID)?
- ulfw 6y agoThey 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-global-pivotal-phase-2b-3-trial-for-covid-19-vaccine-candidate-cvncov/ https://www.curevac.com/en/2020/12/14/curevac-commences-glob...
- arrrg 6y agoThat’s not slow. That’s just not the fastest. They are solidly leading the mid field. Also, given current high incidences I suspect phase 3 might be quite quick, which means Q3 or Q2 approval.
- hannob 6y agoCurevac just very recently started with phase 3 studies. This means it'll be months before you can expect results. They may still play a role, as obviously the world won't be vaccinated within the next months. But they're also unlikely to play a role any time soon.