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FDA advisors unanimously vote to approve Moderna's mRNA after agency drama
- andy99 4mo agoFor context, it’s a seasonal flu vaccine, the title is a bit unclear.
- amanaplanacanal 4mo agoSounds like at least one step toward putting science back in charge.
- baggachipz 4mo ago> While unanimous support from the advisors is a positive sign for the vaccine’s fate, the FDA ultimately decides whether to grant approval. The agency has set a deadline for a decision by August 5. They'll just ban it again. Science got a temporary victory but I predict it won't matter.
- chrsw 4mo agoIt won't. Many people here in the US don't believe in science any more and they definitely think mRNA technology is some kind of conspiracy.
- deleted 4mo ago[deleted]
- jiddert8 4mo ago[dead]
- deathanatos 4mo agoThe Covid vaccines have saved an estimated 14 million to 20 million lives.[1] The trust was not eroded by scientists, it was eroded by politicians pushing lies. I'm still to this day hearing lies & misinformation repeated about the vaccines. [1]: https://en.wikipedia.org/wiki/COVID-19_vaccine https://en.wikipedia.org/wiki/COVID-19_vaccine
- ted_dunning 4mo agoPushing those vaccines saved hundreds of thousands of lives.
- stefantalpalaru 4mo ago[dead]
- epistasis 4mo agoThe subversion of scientific expertise to replace it with podcasters and political sycophants is one of the biggest disasters of the current years. The very concept of merit has been destroyed and replaced with judgement calls on celebrity (necessary for leadership role) and subservience to the political whims of the last 15 minutes (and you had better switch in the next 15 minutes or you're out).
- mmooss 4mo ago> The subversion of scientific expertise to replace it with podcasters and political sycophants > The very concept of merit has been destroyed ... It's the subversion of truth. I think that way of saying it is more accurate, addresses the consequences, and is less occluded by jargon: People care about truth; 'scientific expertise' may seem esoteric to most people. I think HN is frequently part of that process: Merit - expertise, actual trials and evidence - is replaced both by sensational too-clever hot takes / takedowns, and by political/social advocacy. Most threads begin with a takedown, a 2 minute drive-by from an amatuer, often of years of research by someone spending their life studying the matter. For some issues, we all know what side many will take before you know any facts or evidence. These comments are normalized and given greater credibility than the OP and than valuable comments. How is that any different than the things we criticize (other than the FDA's subversion of truth [EDIT:] is far more consequential [sorry, I didn't finish that sentence!]) There are valuable comments to be found; maybe that's one difference, but I'm wonder how the signal-to-noise compares with other forums.
- rho138 4mo agoSo you don’t agree with their point and saw fit to draw out a response that fingerpoints at the the side that’s over the intolerance of the non-scientifically bound members of society? Great high horse fam.
- epistasis 4mo agoHow is discussion on HN different from the leadership levels at FDA? Very different. Decisions with enormous health implications, enormous financial implications, are made at FDA. At HN, most people are here to learn, here to understand more. Vinay Prasad is a fraud, completely unfit for the leadership role he was placed into, making baffling and arbitrary decisions on his own, overturning those with far more experience, knowledge and expertise. If a HN comment gets things wrong, a few people might be misinformed, if they are credulous enough to not double check things. When the FDA makes decisions like they have been making, thousands to millions of peoples' lives are worse off, and billions in capital is wasted. Discussion forums of all sorts are incredibly valuable, even when they get things wrong. I have lots of complaints about the overhyping of, say, CRISPR, especially on HN, but whatever, it's a far far higher signal-to-noise than a random person I meet around town. Mention you work on drug development for big pharma to the random person and they think you're evil, at least HN is less likely to have that basic misconception.
- comrade1234 4mo agoIs this the one that's a flu/Covid combo? I live in Europe and have been looking forward to it - especially since the flu part covers way more variants than traditionally - no longer a need to depend on flawed predictions as to what variants will be predominant. Also no longer a need for two sore arms.
- duskwuff 4mo agoNo, this one is just flu.
- shusaku 4mo agoInteresting. I wonder if the variant limits us now capped by how much you can pack in the vaccine, or how good a on the body does priming for a bunch of stuff at once.
- amluto 4mo agoIn the US, until very recently, there were four variants in the vaccine: two Influenza A and two Influenza B. But one of the B variants seems to have gone extinct during the COVID pandemic, and now the vaccine is just two A and one B.
- arjie 4mo agoThis would be a much more useful headline if it said "vote to approve Moderna's mRNA flu vaccine".
- 2OEH8eoCRo0 4mo agoIs this good because flu vaccines are an educated guess as to what will be circulating because it takes so long to culture them all and this will shorten the manufacturing time so the educated guess can take place later in the process (and be more accurate)?
- consensus1 4mo ago> Prasad was also behind the rejection of a closely watched gene therapy for Huntington’s disease made by UniQure This guy is a disaster. But really it's not just him. It's the entire organizational structure that puts him, or any other one person, in the position that they have the power to do this. There is simply no one qualified. We need to have expert scientists to set up trials and review the design of the trials and conduct the analysis of the data. This is something that is generally objective and not able to be done without skills and experience. But then you have to make a decision based on those results. And the decision is some sort of risk reward trade off. While science can quantify what that tradeoff is, which path to take is fundamentally outside of the scope of science. Trade offs are not objective determinations at all because they are based on subjective preferences. And therefore it makes no sense to force it into a one size fits all approval or denial by some centralized body. The only rational approach to such a trade off is to allow each individual to choose for themselves. The only person's opinion on whether the risk justifies the reward for the experimental Huntington's disease treatment is the patient's. The best we can do with science is to use it for its intended purpose to produce good data for him to make his choice.
- chmorgan_ 4mo agoIf Prasad thought this needed more research then it needed more research. He and the people he works with have written dozens, maybe hundreds now, of reports that expose studies that lack the rigor for definitive results, have misleading endpoints, have imbalanced arms etc. I get that anything that would slow vaccines down has somehow become political and lots of people would gladly accept the pharmaceutical companies word on things. This is a blindness due to political leanings and not evidence based. If Prasad says it needs more and better data I'd put money on it needing it.
- kelnos 4mo ago> This is a blindness due to political leanings and not evidence based. Your comment reeks of that as well.
- JSR_FDED 4mo agoHow much death and suffering does this guy have on his conscience? I’m so curious how someone goes from being a professor to a science denier? I simply can’t imagine that journey.
- pwarner 4mo agoThe suffering is the point.
- api 4mo agoDeath and suffering are “natural.” These people are all delusional ideologues. If reality does not match the ideology, reality must be wrong.
- bickfordb 4mo agoResults are fuzzy. He has a nice Malibu compound to go to after this lived experience
- dboreham 4mo agoAlso interesting that there can be a giant asshole running a federal agency into the ground and I've never heard of him until now. Gives some scale to the problem. I also wonder what else is going on in government that falls below the widely reportable threshold.
- idiotsecant 4mo agoIt's like saying that one of the seagulls at the beach is particularly noisy.
- blindriver 4mo ago[flagged]
- awakeasleep 4mo agoIs there a similar story behind that huntingtons therapy?
- ConanRus 4mo ago[dead]
- willmadden 4mo agoFlu vaccines aren't immunizing vaccines. They protect against specific strains, and half the time they immunize against a strain that doesn't become widespread and do very little or nothing to protect you. They have side effects which vary widely in severity depending on the specific vaccine. This article has no data about why mRNA flu vaccines will improve these outcomes, and has no data about the risk/benefit ratio or how it was calculated. It doesn't even cite the "studies" it mentions. It's a remarkably bad article written for low information readers by a low information author. Hard pass until I see some hard data.
- ted_dunning 4mo agoWhat do you mean by "immunizing vaccines"? In the first sentence, you say that flu vaccines are not and in the second you admit they are. Maybe you meant that their coverage is not comprehensive. If so, that's what you should say. mRNA flu vaccines have substantial potential advantages in terms of the ability to target a wider spectrum of variants and faster time to manufacture.
- willmadden 4mo ago[dead]
- jancsika 4mo ago> faster time to manufacture. In other words: improved responsiveness when loading a flu season.
- ted_dunning 4mo agoWow... that took me several, uh, seconds to find. https://www.nejm.org/doi/full/10.1056/NEJMoa2516491 https://www.nejm.org/doi/full/10.1056/NEJMoa2516491 There's your hard data.
- willmadden 4mo agoThanks. 10 our of 13 of the researchers work for Moderna or another pharma company. That "study" might as well be a marketing brochure.
- queeshonda 4mo ago[flagged]
- queeshonda 4mo ago[flagged]
- queeshonda 4mo ago[flagged]
- queeshonda 4mo ago[flagged]
- boxed 4mo agoBetter medicine is better.
- queeshonda 4mo ago[dead]
- pu_pe 4mo agoSo in at least two fields in which the US still leads (biomedical research, AI), government action is actively harming their ability to compete because of ideological or political reasons.
- tim333 4mo agoThey seem to be doing some interesting things to their reputation as military superpower peace keeper too.
- linuxftw 4mo agoMore deaths in the new study group for this product. More overall adverse reactions for the new product. Here's the top-line comparison: Healthcare encounter: new: 80 (0.4) existing: 120 (0.6) Each group had roughly 20k participants, mostly white. No actual control group, no independent third party study. Junk.
- s1artibartfast 4mo agoWhat is the baseline?
- DennisP 4mo agoSo we need CDC approval for the vaccine to be provided to everyone at no cost. But it sounds like if only the FDA approves, the vaccine will be available to anyone willing to pay. Is that correct?
- ivraatiems 4mo agoSomething I have never understood about the "big pharma makes fake/unnecessary/harmful vaccines" narrative is how folks who believe in it (including those in this comment section) understand these companies' incentives. In the United States, pharma companies make money when insurance companies (and the government, but less so than in many other nations) buy their product to give to patients. In practice, very few people are paying for vaccines out of pocket. Insurance companies in particular hate, hate, hate giving anybody money for any reason. They will not pay for something unless you beat them over the head with how well it works. And if they don't believe you, they'll do their own analyses. Better to blow a few million on a study than spend a few billion on unnecessary treatments. (This is the same reason that there's a car-insurance funded highway safety institute crash-testing cars.) And yet, every year, they insist on making the flu and COVID vaccines free and pushing it on as many people as possible! I guarantee you if you call your insurance company and ask if they think you should get a flu or COVID vaccine, or any vaccine, really, they'll say, yes please. Why would they do that if these vaccines were going to cost them money by a) being useless or b) being harmful? There is simply no incentive! The reason everybody wants you to get the damn shot is that the shots work, and the downside risks of them are smaller and cheaper than the downside risks of the things they prevent. Capitalism would make it very difficult to repeatedly sell vaccines that don't work, or hurt you; you might get away with it once, but after that, the reward's just not there. I don't know how one responds to that, if one distrusts vaccines, other than to suggest a much larger and more complex evil conspiracy than is plausible to most people.
- b0rtb0rt 4mo ago“it’s been 5 years since i’ve taken up smoking and i didn’t die yet, therefore cigarettes are perfectly safe and anyone who disagrees with me doesn’t understand science” - average educated internet science expert
- sajithdilshan 4mo agoI thought mRNA vaccine was approved by FDA as an emergency measure for Covid. Doesn't it usually take around 10 years of assessment long term effects to approve a vaccine for general use? Especially for a new family of vaccines like mRNA?