OT(ish?) COVID vaccine is 90% effective

Submitted by Malarkey on November 9th, 2020 at 10:33 AM
  • Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
  • Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
  • Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
  • Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
  • Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

 

Yay for good news for a change

johnnywalkerblue

November 9th, 2020 at 12:51 PM ^

Mask usage/mandates are through the roof.

States preventing gatherings, etc.

Covid cases on the RISE despite all of the precautions - to RECORD levels.

Hmmm..."Getting the cases under control asap..." is a pipe dream.  These methods don't work.

Denarded

November 9th, 2020 at 10:44 AM ^

General curiosity, let's say this gets rolled out beginning of 2021. Does Crisler go back to being full? The state of Indiana has already been allowing Colts games at decent capacity, do they allow 100% for the Final Four at Lucas Oil Stadium? With these athletic departments hurting and NCAA always money hungry I feel they will have a quick trigger to open. 

mgobaran

November 9th, 2020 at 11:30 AM ^

 Also, are places going to ask if you've gotten a vaccine?  Are they even allowed to ask?  It'll be interesting.

I don't think anyone will ask. If a vaccine is available, it's on the population to use it. If you get covid at a Pistons game because you didn't get the vaccine, that's on you. Not on the Pistons, LCA, or the NBA for allowing fans. The liability is shifted to the individual. 

njvictor

November 9th, 2020 at 12:05 PM ^

People do realize it's going to take probably 6 months to a year to get the vaccine to an even somewhat substantial number of people, right? There is 100% going to be a huge surge in cases right after the vaccine is officially announced because of people like you who think that because a vaccine exists that means people are all of the sudden immune

mackbru

November 9th, 2020 at 10:45 AM ^

OP is deceptive. It’s preliminary data based on limited testing. Drug companies constantly announce “promising” preliminary data only to run into walls later. It’s encouraging but that’s all it is right now. 

Sopwith

November 9th, 2020 at 11:07 AM ^

It's technically "preliminary" in that it's not final, sure, but this is an interim evaluation where the endpoint of 32 positive cases (i.e., wait until you have 32 positive cases then make an interim report) was pushed back to 62 cases and, by the time of the release, had gone to 94 cases. 

What that means is that you've actually got substantially more data than in a typical interim release. This is a good thing.

The most salient bit of the release:

”After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary.

This is Phase III study of over 43,000 participants. This is not your typical Phase I "it worked in 7 out of 8 chimps" or Phase II "25/30 people look good." This is a big deal.

As far as being rolled out to the public, they're projecting (maybe a tad optimistically): 

Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

If everyone needs two doses the best case scenario would be 650 million in 2021, probably ramping up as we go along. That first 50 million, covering 25 million people, is likely for front line medical workers in various global hotspots.

At that point, the biggest question is going to be... how long does it last? If you can get 6 months at 90% effectiveness, that's fairly amazing. Obviously a year or more would be a lot better and release some of the pressure on production speed. At that point it becomes a manufacturing/distribution/logistical problem, but that's better than a biological problem.

Still waiting on some of the other big Phase III trials like Moderna and Oxford/AZ but I'll roll those into the next Neck Sharpies on vaccines when it happens.

 

blue in dc

November 9th, 2020 at 11:32 AM ^

Will your neck sharpies het into how efficacy is calculated?    Is it along the lines of half the 43,000 got the vaccine and half didn’t.  They them take the number who got covid with the vaccine divided by the number who didn’t?   Something like 85 got it who didn’t and 9 got it who did?

I imagine it is at least a bit more complicated than that since people from both the vaccinated and  the control dropped out at various points?    So if my general understanding above is right you actually calculate the per capita cases in each group and use that to get to the 90% effectiveness?

jmblue

November 9th, 2020 at 10:47 AM ^

Great news if true.  We should await independent confirmation of this news though, rather than take it from a press release from the involved company.

4godkingandwol…

November 9th, 2020 at 10:48 AM ^

Fauci gave an interview hinting towards this recently. Said he was hopeful we could return to normal by second half of next year. That’s nearly 2 years from when the red flags started going off in the medical community. And is consistent with the amount of time experts said is the fastest they could see a vaccine being developed and distributed. 
 

still work to do, but this is hopeful news. 

bronxblue

November 9th, 2020 at 10:55 AM ^

Really good news; obviously we'll want to see more testing results like this but way more promising than the 40-50% coverage that was being thrown around earlier.

Michigan Arrogance

November 9th, 2020 at 11:00 AM ^

Good news, but it is still early, and at best, once final approval happens it will take several months before the vaccine is widely distributed to the average American. Military, first responders, etc will get it in (hopefully early) spring and maybe the general public will be able to get it by late summer or early fall of 2021 with the flu shots.

Michigan Arrogance

November 9th, 2020 at 12:13 PM ^

Agree there at the beginning - AFAIK, the other vacs are using the same protein so odds are good that this level of efficacy could hold up.

The logisitics of distribution are what I'm worried about. From what I've seen, this (and likely most other) vacs require 2 doses AND require low temp storage (below 0C? IDK). That's a tough logisitical challenge to distribute this vac by 7/1/21.

Njia

November 9th, 2020 at 12:33 PM ^

I can't speak for the Pfizer approach, but Operation Warp Speed money was used, among other things, to start ramping up production of a number of the most promising vaccine candidates even before approval in order to get it to points of use as quickly as possible. That still means we'll have to find a whole bunch of needles, syringes, glass bottles, etc. But I've got an old turkey baster and some old canning jars if it helps.

johnnywalkerblue

November 9th, 2020 at 12:40 PM ^

I think he means "COVID is about to disappear because Biden said he would take care of it..." and BAM!  Here's a vaccine!  By not 1...not 2...not 3...but 4 (FOUR!!!) companies are rushing to the finish line to deliver!

It's like magic!

Njia

November 9th, 2020 at 11:47 AM ^

More than anything, what news of an effective vaccine will do is give people the intestinal fortitude to endure the next few months. This also shows the power of modern chemistry and computer science. The chattering classes said back in the spring that there was "no chance" we would be close to a vaccine by now. This isn't the 1950s. The ability to model molecular interactions in software doubles every few years, and the impact can't be overstated.

M-Dog

November 9th, 2020 at 12:10 PM ^

I have been reading a number of articles about this.  They all wind up inevitably comparing the 90% effectiveness rate to the flu vaccine's 40% - 60% effectiveness rate.

OMG, I never knew the flu vaccine's effectiveness rate was that dismally bad.  

That's the last time I will ever say "Even though I have flu symptoms, it can't be the flu. I had a flu shot."  

 

 

Perkis-Size Me

November 9th, 2020 at 12:24 PM ^

Even if this vaccine is the one, we’ve got to remember that it’s going to be a long time before it gets trickled down to the general population. I have to imagine gov’t employees, military, hospital workers, other truly essential workers, and those who can buy their way into getting the vaccine will all be getting it first. 

Don’t get me wrong, this is definitely encouraging news. But until I hear it’s available at my local CVS and I’m not waiting weeks for an appointment, I’m still gonna be taking the same precautions that I take every day.

ndscott50

November 9th, 2020 at 5:41 PM ^

They supposedly have a domestic production capacity of 50 million per month – so 25 million vaccinated per month. J&J, which requires only one dose, says it can produce a billion doses in 2021 and the US is contracted for 100 million doses. The US should get a good share of those.  The US has a contracts with Moderna for 100 million doses and 300 million doses of the AstraZeneca vaccine.  If 3 or 4 of these are ready to go by the first of the year, we could be vaccinating 50 million people a month or more by February or March in the US. We could have most of the population done pretty quickly.