Originally published at: Pfizer/BioNTech reports COVID-19 vaccine is "100% effective" in adolescents | Boing Boing
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My Dear Wife and I get the 1st jab next Tuesday. It’s been nothing less than a slog through the red tape & wonky websites that support the Vaccine Roll-out…
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Congrats! I signed us up for the mass vax site in the stadium The Lions lose at, but haven’t been contacted to schedule jabs yet.
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Further context for anyone like me who wanted to know more about what this statement means.
From their announcement:
So obviously good news.
I felt the need to look this up because I’ve repeatedly seen a claim in press reports that the Johnson & Johnson vaccine was 100% effective in preventing death in their study, which is a somewhat misleading statement since no deaths occurred in their placebo control group either.
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Well, at least you’re getting it so congratulations. Our government here in Austria fucked up the vaccine orders and didn’t take additional doses when offered and is now on a begging tour across Europe for more doses. Which we won’t get because everyone else also has too few of them. But after keeping everything open through the whole winter while the weather was shit for five months straight, they have now had the epiphany to go into a new lockdown as spring has started. Yup, stable geniuses are not a US exclusive.
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Bleib dran, Kumpel, der Frühling liegt in der Luft.
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I’m slated for my second dose of Pfizer next week. The sign-up process was way more complicated than it should have been, but I’m glad it’s being distributed and is effective. I have 2 kids in this age range and will sign them up as soon as we are able to do so.
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That just shows how awesome it is! /s
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It’s not the same type of study done with adults. Fewer subjects are needed for a shorter time. For the kids, they can draw blood to see how well their immune response compares to adults. Apparently the response indicates 100% effective. No placebo testing was needed.
The safety side does need placebos. Safety will still be monitored up to 2 years, but acute negative responses (sore arm, fever, etc) have also be similar enough to adults to feel comfortable with the results.
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I suppose that depends on what you’re trying to learn. Regardless, they did specifically state that they had a placebo group, so we do have that information.
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The Pfizer report indicates 100% efficacy within the bounds of the study. Also, efficacy and effectiveness are not the same.
This one brief sentence in the disclosure notice indicates how and why numbers might change:
“Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data (including the data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use authorization) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.”
Placebo group is needed to confirm that a treatment has statistically better outcome than doing nothing. That was proven in the adult study. Getting the shot correlated with an type of immune response that correlated to reduction in mortality/morbidity.
The assumption is a positive correlation (not necessarily the same one) between immune response and reduction in mortality/morbidity holds for adolescents. So all that’s needed is to establish what sort of immune response is seen in adolescents.
What most people might not realize is that 100% effective doesn’t necessarily mean perfection. It means that there is a positive effect 100% of the time. In this case, it may mean that 100% of adolescents had an immune response as oppose to the 95% you hear about for adults. Bagoombah says it well.
But back to your point, the adults would be the proxy placebo group for the adolescent immune response study.
Ugh. Maryland is the same way. Not to mention having their priorities FUBAR regarding eligibility for the vaccine. Still, I’m getting my first jab this Wednesday, so there’s a light at the end…
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Here in California, still ain’t nowhere to go, nothing is really open. So being vaccinated is great, but you’re still a prisoner of your home & bubble friends if you have them…
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That’s most of what I’m looking forward to now. Zoom got reeeeal old months ago.
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Yeah, Zoom Happy Hours went South for me. I just put the phone on speaker and chat to whomever is there, or not there.
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Experts anticipate Covid-19 vaccines won’t be available for children 11 and younger in time for the upcoming school year.
So if your district has middle school that encompasses grades 6-8, the 6th graders (~age 11) will not be vaccinated, but the 7th and 8th graders age (~12+) can/will? Is there a physiological basis for the age cutoffs or are they arbitrary?
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Kiddo turns 12 this fall. I would hope the EUA is approved before then. Finding a vaccination appointment for her is going to be part of her birthday.
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i heard an interview with a kid who said he didn’t know if he was getting the placebo or not. so i think you’re wrong here. im not sure if ive ever heard of valid studies that mix and match groups from different trials
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Bring it on. My 11 year old is desperate to be with his friends, and he already has all the makings of a ‘difficult’ teen period. At the very least when he sneaks out and smokes weed with his friends I’d like him not to get covid in the process.
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