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Because this is a phase 3 trial, which has not been completed by any other vaccine.


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It appears that phase 3 trials haven’t started yet in that vaccine. I would expect it to be several months before it is ready to submit.

There are 6 vaccines undergoing phase 3 trials at the moment. There are no results yet because this is the final stage.

We don't really know because the even the phase 2 trials for these vaccines have not been done..

Does this mean the vaccine has passed FDA Phase 3 trials? What comes next?

Oh wow! Thanks for this. I didn't know there were candidates in Phase III already or that there's already a vaccine that's been approved.

It's great news, though at first I thought they had released Phase 3 results, which would be earth-shattering news. They are still the leading vaccine candidate and the one most likely to get approval this year (though the US press tends to ignore it in favor of covering the various US-originated vaccines that are also in Phase 3 trials).

Great so why is exploritory stuff being published without being completed? This isn't a known to work vaccine or equivalent.

Not sure why everyone keeps saying the trials completed, or which link you mean, because we can go right to the primary source (clinicaltrials.gov) and see that all the vaccines are still in Phase 3 of FDA trials. Here are the links.

Please stop spreading misinformation during a deadly pandemic.

Moderna's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04470427 Estimated Study Completion Date: October 27, 2022

Pfizer's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04368728 Estimated Study Completion Date: May 2, 2023

JnJ's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04505722 Estimated Study Completion Date: January 2, 2023


There's already been large scale phase 3 trials, and we've deal with vaccines for decades, they're not entirely novel and unknown each time.

The 3-5 year clinical trial like all of the previous vaccines.

Phase 3 is basically the definitive clinical trial. Phase 4 is essentially keeping track of what happens after your drug comes onto market. Once all of the results are in, that paper will likely become the definitive paper on this particular drug (again, it's a bit weird that they did this prelim analysis without a clearly stated reason). So Phase 3 is the real deal in terms of winning approval to market the drug.

Regarding efficacy, it is definitely low compared to many modern vaccines which are in the 90+ range. But my understanding is that this is much higher than previous malaria vaccines. If the numbers are really true, then they could possibly save hundreds of thousands of lives per year despite the relatively low efficacy. And it should be a first foothold in terms of making immunologic progress against Plasmodium.


Phase 3 trials were concluded last year. That's why the vaccines are available.

https://www.pfizer.com/news/press-release/press-release-deta...

Did you mean that you were waiting for the regular use authorization rather than the emergency use authorization? OK, that's expected early next month:

https://www.reuters.com/business/healthcare-pharmaceuticals/...

You might want to make your reservation early, since I hear a lot of people claiming that they're waiting for that. Of course it's the very same vaccine that's available today; it's just a matter of going over the paperwork to make sure all of the i's are dotted and t's crossed.


These projects are cool and do contribute to our understanding, but they are not part of the critical path of fighting this pandemic.

The vaccine(s) are already in phase one clinical trial testing, as are some important anti-viral treatments which are in phase three clinical trial testing.

There is no potential output from this folding project that can accelerate those timelines.


So, this is Phase 3 trials which are due to start on 12th as per the site. The "Clinical Trials" [0] page has some more info. As far as I can see, no published articles in any peer reviewed journals on the efficacy they saw in Phases 1&2.

"Phase 3 clinical trial involving more than 2,000 people in Russia, a number of Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico) will start on August 12.....Mass production of the vaccine is expected to start in September 2020"

[0]https://sputnikvaccine.com/about-vaccine/clinical-trials/


There are over 100 vaccines in development, several have completed phase 1 trials, and one is actually in production already so it will be available when it completes phase 3.

We didn't need vaccines for SARS or MERS because they were both gone pretty quickly and the number of affected individuals was never high enough to warrant completing the expensive testing required to get approval for a vaccine.


Phase IV trials are only undertaken after formal approval by FDA and EDA; they are not relevant in the current context. The current vaccins (including Pfizer, moderna which clearly use a novel mechanism for delivery) also don't have phase IV data yet. Thank God they have been approved though, they are currently clearly the way out of a pandemic that so far has claimed 3.4 million deaths. I really don't understand what you on about, sorry.

> New vaccines usually take 6-7 years to complete clinical trials

Not necessarily. The yearly updated flu shot doesn’t for example. This case is similar, the novel technique itself was in development for a decade now with different parts having been clinically tested.


Title should (IMO) contain "human challenge". Most vaccine trials have involved humans, but none have involved deliberate exposure, i.e. "challenge".

Seems crazy this took so long. Why didn't this happen last summer?


The is/was several SARS vaccines. They never got to phase 3 trials, because of various problems. We learned enough from them to skip all the issues this time around.
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