Not sure if this has been posted, so posting just in case. IgGs are short lived (duh!), but… Don’t discount B cells and T cells…
Ok, I’m sure you knew I’d be here to pipe in with Pfizer’s news this morning. They now have their full data set (170 cases of the 44,000 participants), and will be applying for FDA emergency use authorization in the next couple of days. Here’s the new info:
170 cases. 162 in placebo arm, 8 on vaccine.
95% effective!!! (Ha ha, that was actually my guess when they said OVER 90%)
Importantly, 94% effective in people 65+
There were 10 severe cases of the 170. 9 of them in placebo arm, only 1 in vaccine arm.
Well tolerated, no serious safety concerns. After 2nd dose, some headaches and fatigue for a day or so is possible (likely?)
They have enough safety data to apply (they needed half of the 44,000 people to be 2 months past their 2nd dose, and they are past that). I think I heard if things go well, FDA assessment would take approximately 2 weeks or so. Oh, just saw on the news there are expected to be key FDA meetings on Dec 8-10th. Not sure of final timing.
This continual string of good vaccine news definitely is what I need to keep motivated/uplifted during this awful surge. Like having people cheer on marathon runners at mile 21, “you’re almost there!”
As a caution, a physician friend, who thinks he was part of the group to get the vaccine (not a placebo) in the Moderna trial, posted:
"Pfizer initially announced last week and Moderna on Monday.
Regardless, the news is incredibly premature. We are only three months into their Phase 3 trials, only fewer than 100 cases out of tens of thousands inoculated vaccine or placebo. The confidence intervals around the estimates of effectiveness are still way too wide to make anything of this news. We know this is true because if the evidence were definitive, the trials would be ethically obliged to stop (i.e., that is, to stop withholding effective vaccine in favor of giving placebo), but the external data safety monitoring boards for both trials have not stopped them. This is really just an attention grab that has successfully shot stock prices up.
Further, with this news, people in the trial may behave less safely. Those who believe to have received the actual vaccine rather than placebo will now march around thinking they have 95% protection and start going to bars and partying. Well, that will only increase cases artificially and muck up the findings."
Of course, I’m as hopeful as the next person. But every scientist I know is falling back on scientific principles when discussing the vaccine- which boils down to: one step at a time, waiting to see, and cautiously reading the “news” for some take on what’s the spin and what’s the reality. One, who works digesting “news” for the govt and for state agencies, said they won’t even refer to claims made via corporate PR as evidence or fact, until further proofs are in.
I have a lot of faith in the scientists- think of it, years of work, maybe their project hits gold, maybe they don’t. But they keep dedicated to playing their roles, learning more, testing. That’s where my trust is, right now. I’m grateful to them, all those bio majors out there doing the work.
I’m thankful for my physician friend’s updates, because my current experience with journalism has destroyed my trust in reporters.
Party pooper.
I don’t know how much your comments really matter though. The vaccines will go into production and it seems be distributed and presumably accepted by some people in the first round. Things will chug ahead. I guess you’re saying that the testing will continue and we have to see if the good news continues with these initial volunteers? Of course but these numbers are real numbers and I just can’t believe that extrapolating is completely off the mark.
And wouldn’t it be good if the people in the trial “march around and start going to bars”? Don’t we need them to be exposed to get data? No sense in having a trial with people who sit at home all day.
The only silver lining I can see with the recent surge of cases across our country is that it rapidly sped up the number of exposures that trial participants had, so we can get to results. In just a week Pfizer participants went from 94 cases (as your friend referred to “fewer than 100 cases”) to its FULL 170 cases. The scientists and statisticians did the work on the confidence intervals needed to estimate efficacy, and that was less than 170. So this 95% efficacy is highly statistically significant. But any layperson, non-statistician can tell that 162 vs. 8 does not happen by chance ;-).
His concern about the 22,000 participants who might believe they got the vaccine due to side effects, now acting more reckless, may be true, but two things about that. 1). Who cares? 22,000 people in our country acting recklessly for a few extra weeks is not even a drop in the bucket of the reckless people in our country acting recklessly all year. But 2). People who get the vaccine acting more reckless than people who think they got the placebo, if there really was a notable difference in their behaviors, would really mean the vaccine was MORE than 95% effective…the people in the vaccine arm would have been even MORE exposed to the virus, so that gave the vaccine an even harder test than the placebo was exposed to, and still only 8 cases among the 22,000 participants vs 162 in the placebo arm.
The trial does essentially stop with these numbers. For ethical reasons, that is why they are now seeking emergency use authorization. They have statistical proof that they have an extraordinarily effective vaccine, that should not be denied to the populace. The data was analyzed by an outside monitoring board of experts before they revealed the info to Pfizer. The peer-reviewed articles will take months to come, and some people won’t be satisfied until those articles are published, but by that time, millions of people will be vaccinated with the blessing of the FDA and outside scientists/monitors.
Be happy, and take your friend out for a sounds-like-much-needed (socially distanced, outdoor) drink or cup of coffee to enjoy this great news) ;-). (I’d do a winky face but can’t figure out how to get my emojis working on here).
A member of my family is a senior physician/practice head with one of the hospital systems which participated in the phase 2-3 global Pfizer/BioNTech study. Hospital management is saying they will start administering the vaccine to its medical workers within a matter of weeks. Perhaps there is a mechanism already set up for distribution to those hospitals which participated in the study as soon as the emergency approval goes through? I don’t know, but I found the news encouraging. My 17 year old is set to receive the Pfizer vaccine (or a placebo) this weekend at the same hospital, as part of another study focused on children.
"The only silver lining I can see with the recent surge of cases across our country is that it rapidly sped up the number of exposures that trial participants had, so we can get to results. "
“people in the vaccine arm would have been even MORE exposed to the virus, so that gave the vaccine an even harder test than the placebo was exposed to…”
I don’t think we know any testee is being “more” exposed. I do think it’s a leap to say, over here, we have these test subjects, over there are the reckless individuals, so they meet.
We don’t know any participant went out and threw caution to the wind. We don’t know how any of them (anyone) actually got covid (other than by some association- which could be anything.) Most of us do not have positive results. And we range from the more isolated (self quarantined) to those who cautiously go about their daily business. None of us are, like, “Let’s go to Branson.”
But ML’s doc friend has a point. There have been comments that a vaccine can let us get back to our old ways. If that’s one’s goal- and with some blinders on, yes, that’s risky. On so many levels.
As an absolute number, 22k may seem small. But we have to accept this virus grows geometrically. Nothing says it stops at 22k.
Again, these vaccines being statistically effective, at this point, is only for the sort of testing done to-date and conditions. I see it as the tip of the iceberg.
Typically, when a product is approved (I know EUA is not a regular approval) trial participants who received the placebo would get the real vaccine. Probably will happen here too (companies can’t stop that from happening).
Retaining participants in the other ongoing vaccine studies will be problematic with available approved vaccines because people will want to get the approved vaccines and drop out of the study they are in (and many probably should).
Future Phase III studies won’t be able to have a placebo arm, they will have to have a standard of care arm (approved vaccine). But that’s complicated because of supply issues that will persist for a while. We are fortunate that the first two vaccines have such high efficacy rates.
Last thought…no mention if Pfizer will seek EUA for ages 18+ or 12+…they had just added under 18’s 4-6 weeks ago, so may not have a large enough sample size in that age group to be approved.
@vistajay That is what I am also hearing about hospital workers in my hometown. They are anticipating doses for hospital workers in December. It can’t come soon enough as it’s a place with lots of mobile morgues right now and few people wearing masks.
A big thank you to your son.
I want to start by saying I’m glad the initial news is continuing to be positive and I hope it stays that way for both Pfizer and Moderna and any others coming through the pipeline.
Otherwise though, as a math teacher, it bugs me when people believe sentences like the one I quoted from your post.
A layperson might (incorrectly) believe that. Someone who knows stats knows that you have to look deeper at those numbers. eg Were they across regions or localized? What outliers do we see, if any? Numbers without context are meaningless.
I haven’t looked, so I can’t tell you one way or another, though I’m hopeful people making decisions have thoroughly looked at everything.
In an emergency one presses forward on good news hoping it holds true. It only becomes true after we have a lot more info. There’s nothing wrong at all with anyone reminding people of that fact. Being careful and cautious as we go forward on (hopefully solid) hopes makes sense to anyone if they reason it out.
And who cares about the 22,000? Do you seriously think they don’t have family, friends, people they meet, etc, who could have bad effects if they get sick and/or spread it? These are folks who are trying to help us advance medical knowledge. I care about them - and their families, etc. One has to be really callous not to care.
I can’t repeat the whole series but listened to a lecture about how the Chinese have been studying this since like 2013 indof
First off… No… Secondly… University of Michigan had a town hall yesterday. Head of public health said even if this vaccine is perfect we will all be wearing masks to some extent till 2022. They all think there will be variations of viruses in the next few years. Getting this vaccine is great but the first small step. She also thinks it will be very accessible to students next fall 2021.
I think her timelines are realistic and will find the recorded townhall and post on the college site.
I can definitely see where science/math education in our schools has major gaps. It’s easy to “believe” what one wants to be true, esp if it’s in headlines. It’s harder to be cautious and look at what’s really true.
And some will read my caution and assume I mean nothing is true about the news. That’s as wrong as believing we definitely have the golden ticket.
My posts are meant to say proceed on possible good news and stay vigilant until we have more data.
We will have that in a few months, because the masses have given up caring. At least polls say 58% are willing to give a vax a chance vs just 50% a month ago.
Are you implying (or really, saying) I’m callous? It’s pretty hard to not be offended by that. I don’t think over the course of this thread I’ve given any evidence that I am anything other than a pretty compassionate person, who is thrilled about a vaccine to help save humanity and prevent needless death, physical suffering, and economic/mental/other suffering caused by this pandemic. I’m pretty sure a careful reader would have understood that I didn’t mean I didn’t care about bad things happening to the trial participants and their friends, but merely that in terms of whether the small possibility of changed behavior in a subgroup of the trial was going to have an impact on the analysis of whether the vaccine is effective or not, their behavior shift was not going to have a significant impact. Unless they were intentionally not giving benefit of the doubt, if the wording is slightly awkward. But if you want to accuse me of being callous, I guess, go ahead. Nothing is taking the smile off my face today, with such continued good news ;-).
It definitely came across as callous to me TBH. Glad to know you didn’t mean it that way even though it reads that way.
My mind could be colored by many around me (not family, but where I live) who often say things like, “only the older folks and fat people die, so go out and live life” as if it’s ok that “only” older/overweight folks are mainly at risk of death. They totally ignore people who end up as long haulers and others who draw the short straw for who knows what reason.
Sorry, to be clearer, you omitted my “IF” when you quoted me. I did not say that people in the vaccine arm ARE running around recklessly and getting disproportionately exposed. I was responding to the physician friend’s concern that that could happen. I was then saying that IF that occurred and there was a notable difference in the 2 groups’ behaviors, and the people who felt side effects (presumably more in the vaccine arm) went out and about more than the people who didn’t (presumably more in the placebo arm), while that might “muck” with the numbers as he suggested, it would only do so in the direction of making it an even tougher hurdle for the vaccine.
The study described in this article seems to confirm what virology experts have been talking about: viral loads are indicative of prognosis.
My daughter (RN in Seattle) is part of the Moderna trial. She thinks she got the real vaccine because of strong side effects, but they won’t be told for two years. Participants are free to take any available vaccine in the meanwhile but must notify the study. Her boyfriend also volunteered, but wasn’t chosen. Based on two data points, their conclusion was that the study wanted plenty of volunteers who were going to have exposure vs the WFH crowd.
Definitely they were not looking for WFH people.