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

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

#41
post #27

The contrast between the response to Astrazeneca and J&J is striking. Similar efficacy numbers, but Astrazeneca is still banned and got terrible headlines. J&J has all positive headlines. I don't know if this is just because more time has passed and people realize it was dumb to not approve Astrazeneca? Is "Supercovid" just making people realize we can't wait around? I think J&J, Astrazeneca, and Novavax all easily s…

Germany is approving Astrazeneca with some sort of limitation.

It was just approved by the EU and is already being distributed in the UK.

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

#42

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 died from COVID.

Edit: Oh here we go again... drive-by downvotes. Care to state your reasons?

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

#43

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.

Why do you believe that the FDA is holding them back?

So far the process appears to be approval after the minimum of safety and effectiveness testing. This means that people won’t waste time or be harmed by a failed vaccine candidate. I don’t work in medicine and am just a bystander like most. Is there something I am missing?

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

#44

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.

Unpopular opinion: the FDA has to justify their existence. If vaccines can be developed safely and deployed quickly, inexpensively, and in large quantities all without FDA then people would realize how bloated our government really is.

This is unfortunately an ignorant statement.

During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.

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

#45

Earlier quoted context omitted.

The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously…

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…

Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.

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

#46
post #27

The contrast between the response to Astrazeneca and J&J is striking. Similar efficacy numbers, but Astrazeneca is still banned and got terrible headlines. J&J has all positive headlines. I don't know if this is just because more time has passed and people realize it was dumb to not approve Astrazeneca? Is "Supercovid" just making people realize we can't wait around? I think J&J, Astrazeneca, and Novavax all easily s…

> In the US, this would allow us to end this thing within 90 days. It... would not. We need half a million (edit: billion of course, oops) doses to "end this thing", and those just aren't going to be there from any combination of manufacturers. If that kind of result was really on the table, a new administration and congressional leadership would be moving mountains to get that win. But yes: AZ should probably be app…

i think you mean half a billion (or milliard).

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

#47
post #8

66% effectiveness in one shot is better than 50% - 1/2 shots where there is not enough vaccines to go around. In some places people are not getting both shots of vaccines. FDA approved two different shots of 2 shot vaccines. At this time they should just immunize everybody with one shot at least.

Would a partial or half immunized population not end up culturing a more resistant strain?

This isn't like antibiotics. The 66% is how many people are provided some level of immunity, just reducing the infectible population; it doesn't directly cause issues for the virus the way an antibiotic interferes with the functioning of a bacterium. It might culture a strain that's better at infecting folks for whom the vaccine doesn't prove effective, if there's a common factor there and the virus can use it.

It is not yet known if any of the vaccines completely prevent infection; there are concerns the vaccinated might still be able to be asymptomatic carriers.

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

#48
post #27

The contrast between the response to Astrazeneca and J&J is striking. Similar efficacy numbers, but Astrazeneca is still banned and got terrible headlines. J&J has all positive headlines. I don't know if this is just because more time has passed and people realize it was dumb to not approve Astrazeneca? Is "Supercovid" just making people realize we can't wait around? I think J&J, Astrazeneca, and Novavax all easily s…

The issue with Astrazeneca is that they messed up part of their clinical trials.

The results weren’t even negative. A subset of their trial group received a different amount of vaccine which seemed to show greater efficacy later.

The issue, and thus the “mistrust”, is that if they messed up that rather critical part of their clinical trials then what else could they have messed up?

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

#49
post #27

The contrast between the response to Astrazeneca and J&J is striking. Similar efficacy numbers, but Astrazeneca is still banned and got terrible headlines. J&J has all positive headlines. I don't know if this is just because more time has passed and people realize it was dumb to not approve Astrazeneca? Is "Supercovid" just making people realize we can't wait around? I think J&J, Astrazeneca, and Novavax all easily s…

Yeah, I don't get why the Astrazeneca vaccine approval in the US is being delayed till (reportedly) March. Is it because Pfizer and Moderna are US companies charging a lot more money vs. Oxford/Astrazeneca being UK and not making any money on their vaccine?

I think it's because of the transverse myelitis scare during AZ's Phase 3 tests, combined with AZ's dosage quality control issues making it really hard to interpret efficacy data.

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

#50

Earlier quoted context omitted.

The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously…

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 suggest you read up on the history of medicine prior to creation of the FDA, and similar agencies world wide.
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