Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

Johnson and Johnson single-shot vaccine appears 66% effective in global trial

cbc.ca

Post reply on HN
Print view View original

81–90 of 274 posts

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#81

Post by boulos »

I find the Johnson and Johnson Press Release [1] more informative. It gives a lot more detail on the study, including linking to their protocol [2].

It’s unfortunate, but the different vaccine trials all have different demographics and different measures of efficacy. IIRC, the Moderna “95%” is not “only 5% developed COVID” but rather “95% didn’t end up showing any symptoms” while AstraZeneca was doing weekly testing (again this is from memory). With so many people being asymptomatic, the difference between “95%” and “66%” is in the details (which is definitely why Johnson and Johnson also highlight their 72% in the US, and 85% against hospitalization/death).

tl;dr: each vaccine group made reasonable, independent choices for their effectiveness metrics, but they’re not the same metric.

[1] https://www.jnj.com/johnson-johnson-announces-single-shot-ja...

[2] https://www.jnj.com/coronavirus/covid-19-phase-3-study-clini...

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#82

Post by sradman »

The NIH news release Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released [1]:

> An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.

> The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant.

[1] https://www.nih.gov/news-events/news-releases/janssen-invest...

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#83

Post by JamesBarney »

_Understated_ wrote: post #42
JamesBarney wrote: post #3

66% protection against getting moderate to severe Covid but 100% protection against death and hospitalization. I have no idea how the FDA can hold back these vaccines in good conscience while peoples are dying by the thousands on a daily basis.

Sorry, but I take issue with that statement: 100% protection against death and hospitalization for a tiny minority that are susceptible. Your statement makes it sound like everyone that gets it will die when that is absolutely not true. In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually die…

1. I've never met anyone in the last year who thought Covid had a 100% death rate. Do you know anyone who believes this?

> In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID.

Over 10,000 people under age 70 have died from covid, why does it matter if they have underlying symptoms?

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#84

Post by zug_zug »

jdhn wrote: post #76
5440 wrote: post #52

Earlier quoted context omitted.

I can give you a laundry list right now. For example, millions of vials are cracking around the rim, several of the filling rooms have mold issues, one of the vial hoppers is leaving metal particulates in the vials, weekly OOS for manufacturing impurities..I think the public would freak out if they knew what was happening in the supply chain.

If this is in any way true, you need to contact a journalist ASAP. Alex Berenson would love to hear from you. If this isn't true, then you should delete this immediately.

>> If this is in any way true, you need to contact a journalist ASAP.

??? It sounds like he's saying the supply chain is working out normal issues, and the FDA is rightly holding it back until they are resolved. I don't see anything newsworthy about that. Certainly could be misquoted/smudged for some great clickbait though.

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#85

Post by abfan1127 »

mmmrtl wrote: post #61
abfan1127 wrote: post #36

Earlier quoted context omitted.

I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device perfo…

Do you realize the irony in providing a list of FDA recalls while bemoaning their lack of rigor? Lots of these "drugs" were unapproved dietary supplements that the FDA found to actually contain drugs, or drugs that failed QC while on the market, not the pristine batches and data that would have gotten the drug approved in the first place. To me, it's similar to having more trust for media outlets that post correction…

The irony is specifically why I posted it. FDA approval is treated as a "gold standard" yet we have lots of evidence that it isn't. Companies lie, make non-intentional mistakes not caught by the FDA, there's all sorts of issues with it. The FDA review process is more like an editor checking spelling than actual rigorous analysis.

I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy.

I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example:

Gold is independent labs find similar results to internal labs (verified) Silver is only internal labs produced results, not reproduced elsewhere etc.

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#86

Post by abfan1127 »

jpeloquin wrote: post #75
abfan1127 wrote: post #36

Earlier quoted context omitted.

I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device perfo…

> I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.

Its been 10 years since that employment so I don't recall the details. We would get annual "FDA training" on how to report, document, etc. my particular employer always stressed on being accurate and doing what was right for the patient. But "over-reporting" was discouraged... I always related it to a police investigation. Don't give them any more information than asked, you never know what rabbit hole they will go down, risking rejection.

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#87

Post by jdhn »

zug_zug wrote: post #84
jdhn wrote: post #76

Earlier quoted context omitted.

If this is in any way true, you need to contact a journalist ASAP. Alex Berenson would love to hear from you. If this isn't true, then you should delete this immediately.

>> If this is in any way true, you need to contact a journalist ASAP. ??? It sounds like he's saying the supply chain is working out normal issues, and the FDA is rightly holding it back until they are resolved. I don't see anything newsworthy about that. Certainly could be misquoted/smudged for some great clickbait though.

The way I'm interpreting the statement is that these issues are happening today during the production of Covid vaccines that have already been approved and are being sent out.

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#88

Post by azinman2 »

Bloomberg quoted “No severe allergic reactions,” to the J&J, yet my cousin-in-law is in the hospital right now with Guillain–Barré syndrome following the J&J clinical trial shot. Granted this is rare and can happen with any vaccine (I believe?), but it’s pretty strange to read about the lack of negative reactions when I personally know someone who has been affected.

NB: I’m not advocating there is anything largely wrong or unsafe about it.

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#89

Post by _Understated_ »

JamesBarney wrote: post #83
_Understated_ wrote: post #42

Earlier quoted context omitted.

Sorry, but I take issue with that statement: 100% protection against death and hospitalization for a tiny minority that are susceptible. Your statement makes it sound like everyone that gets it will die when that is absolutely not true. In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually die…

1. I've never met anyone in the last year who thought Covid had a 100% death rate. Do you know anyone who believes this? > In fact, the statistics show the exact opposite: here in the UK, for example, only around 400 people under the age of 70 (I think!) that have no underlying symptoms, have actually died from COVID. Over 10,000 people under age 70 have died from covid, why does it matter if they have underlying sym…

I meant "underlying conditions", not underlying symptoms... that's my fault.

So, basically, if you are healthy, your chances are absolutely tiny that you will die if you catch it.

So, yeah, it matters a whole lot actually.

Re: Johnson and Johnson single-shot vaccine appears 66% effective in global trial

#90

Post by _Understated_ »

jfengel wrote: post #69
_Understated_ wrote: post #58

Earlier quoted context omitted.

> exhibited a severe chest X-ray 70%-80% of the time With a sample size of what? That's a nonsense statement that can't be scrutinised. Edit, found this: The finding is promising but will require further research given the small size of the study with only 82 patients, mostly male and average age over 50 82 people over the age of 50. It also doesn't mention how healthy these people were. This is typical of pretty muc…

The "70-80%" figure is based on thousands of the doctor's own patients. https://observer.com/2021/01/covid-long-term-health-impacts-... It's not a peer reviewed study, and it includes only the people whose situations were severe enough to be sent to a radiologist. But it's enough to conclude that it's more than just a dismissably small number of cases.

Sorry, it says nothing of the sort. All the evidence, including government statistics, tell is it is precisely that, a dismissably small number outside known vulnerable groups.
Post reply on HN