FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

How 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.

Is 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.

The 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).

Sounds like at least one step toward putting science back in charge.

> 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.

For context, it’s a seasonal flu vaccine, the title is a bit unclear.

This would be a much more useful headline if it said "vote to approve Moderna's mRNA flu vaccine".

Is 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)?

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Flu 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.

If 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.