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Comment by cactus2093 | Hacker News Reader

cactus2093

What's the issue with the safety profile?

Probably referring to the fact the majority had fairly noticeable side effects especially with the second dose.

One person taking the highest dose had a 103+ fever with the second...

If this is happening in healthy young people, what will the side effects look like for older or more vulnerable people who actually need it the most?

They already eliminated the highest dose given the lower dose also produced significant antibodies.

yeah, and I don't see fever as a significant negative symptom. It's really just an indication that the immune system is working.

Fever is very common in vaccines, especially in children.

103 degree fevers is nothing to sneeze at.

It may not be significant to you, but to an epidemiologist this means a certain fraction of the overall population is going to die.

As others have mentioned, the highest dose did have some adverse events, and has been withdrawn from consideration. Here's his own words on twitter.

https://twitter.com/ichaydon/status/1265275383798050819

Here is an article going over the person with the adverse reaction [1]. Its a pretty scary read as the patient was 29 and seemed healthy. Like others have said this dose will not be used going forward. And these phase 1 trials are meant to find cases like that so the correct dose can be found.

[1] - https://www.statnews.com/2020/05/26/moderna-vaccine-candidat...

> If this is happening in healthy young people, what will the side effects look like for older or more vulnerable people who actually need it the most?

May be better on that axis (only way to know is to do the trial). Efficacy, on the other hand, is likely to be lower. Both sides of the same coin: you probably get less of a response from the old.

The <45years of age US population in 2010 accounted for 60% of the total. Depending on what the threshold for herd immunity actually is, it could be "enough" to have everybody outside risk groups vaccinated. Even if we don't achieve herd immunity then, it does put us closer to it, meaning fewer people in the risk population would die.

https://www.census.gov/prod/cen2010/briefs/c2010br-03.pdf

> Probably referring to the fact the majority had fairly noticeable side effects especially with the second dose.

Did anyone look at the actual data? [1, Table S1-S3]

At the 100 μg 2nd dose, the most frequent moderate symptoms were fatigue (40%, "some interference with activity"), chills (26.7%, "some interference with activity"), and headache (26.7%, "repeated use of non-narcotic pain reliever > 24 hours or some interference with activity"), with no severe events reported.

In other words, pretty much what you'd expect if you asked your immune system to floor it. I wouldn't characterize these as concerning.

In all probability, we won't see sufficiently numerous cohorts until Phase II is published, Phase III is in process. Remember, this was n=15 for most arms.

> One person taking the highest dose had a 103+ fever with the second...

That's why they standardized on the 100 μg dose for Phase III [2], as a result of Phase I/II safety profile and efficacy.

[1] https://www.nejm.org/doi/suppl/10.1056/NEJMoa2022483/suppl_f...

[2] https://investors.modernatx.com/news-releases/news-release-d...

Test subjects were 18-55 — I guess I wouldn't say that's exclusively "healthy young people" other than in comparison to the 80+ group which is most in danger. But we are mostly on the same page — is the cure worse (or equally bad) as the disease for the 60-70, 70-80, 80+ populations?

Even if the vaccine is not suitable for the older groups, high vaccination rates in younger people may be enough to drop the rate of infection significantly below 1.0, eventually conferring herd immunity for the immunocompromised.

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