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FDA authorizes Pfizer vaccine for kids age 12 to 15
- vmception 5y agoGo USA! What is the current standard of review for these authorizations since complete clinical trials are not possible, and a convenient point of contention for people that opt-out of taking the vaccine (most of them would move the goal post to something else even with successful clinical trials with a relatable list of side effects, but I was wondering about this process)
- vecplane 5y agoIsn't it reasonable to have the option to opt-out of taking these vaccines, in the absence of more complete data and longer-term trials?
- happytoexplain 5y agoSure - but the parent didn't criticize the existence of the option. They criticized the decision making that many (not all) people use when exercising that option.
- kurthr 5y agoYes, I think that at this point putting your own life at risk is acceptable. You'll probably have to wear a mask since you could make other people sick (who could then pass it on to someone immunocompromised). Of course you could face a civil suit, if someone get's sick or dies, and you can be shown as the proximate cause of illness. Your employer may choose not to take that risk. If you're licensed in many states (e.g. medical, etc.) you're already required to be vaccinated against flu/TB. With EUA they've put this off, but with full authorization, why treat it differently? One question, what long term effect of the vaccines are you concerned about, that wouldn't be far less severe than actually being infected?
- vmception 5y agoMany people are wary of the newness of mRNA technology. They think a long term affect has been overlooked or is unknown. Although some people make up long term effects, many other people are just acknowledging the absence of history to tell, and thats valid. (Very few of the people opting out are distinguishing between any vaccine technology though. But some are.)
- Pfhreak 5y agoIsn't "the mRNA technology" decades old at this point? Yes, this might be the first wide spread human deployment, but they've been researching the technique in animals for over thirty years. What's the bar for when a technology is no longer "new"?
- symlinkk 5y agoYou’re joking right? This reads like a parody
- Pfhreak 5y agoNo? The first mRNA tests were conducted in 1990 in mice -- https://pubmed.ncbi.nlm.nih.gov/1690918/ https://pubmed.ncbi.nlm.nih.gov/1690918/ We figured out the basics in 2005, specifically two scientists Karikó and Weissman. A decade ago there were discussions about how to develop more complex vaccines -- https://www.tandfonline.com/doi/full/10.4161/rna.22269 https://www.tandfonline.com/doi/full/10.4161/rna.22269 Given the immense potential to address everything from parasites (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963228/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963228/) to cancer (https://pubmed.ncbi.nlm.nih.gov/28101688/ https://pubmed.ncbi.nlm.nih.gov/28101688/) to allergies (https://pubmed.ncbi.nlm.nih.gov/30063806/ https://pubmed.ncbi.nlm.nih.gov/30063806/), tons of research is being done on this technology. Scientists have been working on and reporting on dosing strategies, managing immune responses, monitoring long term effects on animals, etc. for a long time now. Which part is parody? Just because something is new to you doesn't mean it's new.
- sithadmin 5y agoIn the absence of legitimate health concerns preventing one from safely receiving the vaccines, it's increasingly unreasonable and arguably unethical to opt-out of taking the vaccines.
- deleted 5y ago[deleted]
- bongobingos 5y agoFortunately, America isn't an autocratic dictatorship.
- xwolfi 5y agoAs long as it's still legal, my wife wont budge. Some people are just scared and want nothing to do with it until it's mandatory.
- vecplane 5y agoIt's unreasonable to want more data and longer term studies before making a decision to take one of these vaccines? It's barely been a year. We all hope they're great, but it should remain a choice.
- kurthr 5y agoThe clinical trials are actually the same (statistical power) as previous vaccine trials. They've simply enrolled more people faster and had a higher infection rate to evaluate safety and efficacy. It is likely in the next month that Pfizer will get a standard (non Emergency Use) Authorization. https://www.biospace.com/article/pfizer-biontech-and-moderna-aim-for-full-fda-approval-of-covid-19-vaccines/ https://www.biospace.com/article/pfizer-biontech-and-moderna... The reason for EUA was that so many people were dying that some more limited (<1yr clinical safety) data was accepted. Now that many of the original subjects are falling past 1yr post inoculation (and variants have been evaluated) a full authorization in eminent. Previously, people worried that once one vaccine was authorized other EUA (NovaVax, AZ/ChadOx, etc) wouldn't happened, has also been resolved since the FDA realizes people want choice.
- maxerickson 5y agoThey are currently submitting their application for full regulatory approval: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics https://www.pfizer.com/news/press-release/press-release-deta...
- mixmastamyk 5y agoI've recently heard a few parents talking about getting their kids these shots. So I decided to take a look at the CDC numbers again. There's a graph where you can select death counts per age group: https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#SexAndAge https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#Se... Given that death rates for the elderly are in the thousands per week, while those for kids jump around two to four or so, is this a good idea? Typically you want the benefits of a vaccine to outweigh the risks. I certainly could be missing something, but it doesn't look like this is the case for healthy kids.
- uniformlyrandom 5y agoCOVID has many other long-term side-effects besides death (fatigue, muscle and joint pain, respiratory problems, etc). These side-effects are present in younger people as well. For me, mere possibility of these side-effects outweigh the risks, which are negligible for MRNA vaccines.
- splittingTimes 5y agoVaccines help to reduce risk of hospitalisation and death, But are there studies that show that vaccination prevents long covid, too?
- Gh0stRAT 5y agoBesides nearly eliminating the risk of hospitalization and death, the vaccines also greatly reduce the odds of contracting COVID-19 in the first place which logically would lead to a reduction in long covid. (contracting covid is a prerequisite for experiencing long-covid)
- lthornberry 5y agoLong covid is also more likely to result from more severe initial cases.
- stevefrench93 5y agoDoes anyone know the case fatality rate for children in this age range?
- pragmatic8 5y agoYeah. Nil.
- williw 5y agonot nil https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#SexAndAge https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#Se...
- stevefrench93 5y ago282 deaths according to CDC.
- rel2thr 5y ago282 for all of 0-17 ages
- beagle3 5y agoIn context, Israel had 9 (for 1/40 of US population - similar rate) and a reporter that actually inquired about each case, reported that every single one of them died while PCR positive but corona was not implicated in death (e.g. one had terminal cancer at a “dying any day” stage and in fact recovered from corona before dying; another was a traffic accident casualty, etc) Also 40 cases of MIS-C; corona isn’t benign, but by all counts it’s less harmful than the flu at ages 0-19, though much more harmful for older people. And a couple of cases of heart attacks and life threatening thrombosis at 16 associated and almost surely resulting from the vaccine. It’s safe, but not perfectly safe as many believe. In such small numbers, it is incredibly hard to compare short term safety of disease and of vaccine. (And of course impossible to assess long term effects of either as well)
- jdlshore 5y ago
- randomopining 5y agoDoubters are like “you don’t know the long term effects!” But you also don’t know the long term effects of covid lol. At least this has been clinically studied for a year.
- abfan1127 5y agowe have year old results for Covid too.
- acchow 5y agoMayo Clinic has an article about COVID's long term effects https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-effects/art-20490351 https://www.mayoclinic.org/diseases-conditions/coronavirus/i...
- abfan1127 5y agodo you know if they break these long term affects into age groups or other demographics?
- deleted 5y ago[deleted]
- joshjdr 5y agoI think that was the point
- randomopining 5y agoYeah exactly my point lol. So the 5-10-15 year impact of both is unknown. Thus it’s a mute point of consideration for a logical person.
- timr 5y agoThe approval letter and supporting data is here: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use https://www.fda.gov/news-events/press-announcements/coronavi... (EDIT: side-effect data for 12-15yo are pages 25-27 in this: https://www.fda.gov/media/144413/download https://www.fda.gov/media/144413/download) I have to be honest...this strikes me as poor risk analysis by the FDA. This approval is based on a study of ~1100 children over two months, of which the absolute risk reduction was ~1.6% (16 cases -> 0). However, about 2% of kids had severe reactions to the vaccine itself. (EDIT 2: a further 0.4% had life-threatening reactions, which are labeled as "severe adverse events") They don't report the number of severe infections, but I'm guessing that the number is zero, based on what we know about Covid in children.
- sbelskie 5y agoI’m having trouble finding where the numbers for severe reactions are given. Can you point me in the right direction?
- timr 5y agoPage 26 in this: https://www.fda.gov/media/144413/download https://www.fda.gov/media/144413/download
- sbelskie 5y agoThanks! I appreciate it
- lthornberry 5y agoIt’s important to be clear here—these “severe” side effects are not life-threatening. We’re talking about a really bad headache or bout of diarrhea. Unpleasant, for sure, but not likely to have any long-term consequences. As a parent, I’m ok with those odds even if my kids don’t get much direct benefit. Contributing to reduced community transmission is worth it.
- stevefrench93 5y agoAccording to this paper published recently in Nature Immunology, around 4 out of 5 people already have pre-existing immunity to SARS-COV-2. > Of the SARS donors, 100% showed T cell responses to cross-reactive and/or specific ECs (HLA class I 86%, HLA-DR 100%; Fig. 5d,e), whereas 81% of PRE donors showed HLA class I (16%) and/or HLA-DR (77%) T cell responses to cross-reactive ECs (Fig. 5d). https://www.nature.com/articles/s41590-020-00808-x.pdf https://www.nature.com/articles/s41590-020-00808-x.pdf
- maxerickson 5y agoHaving reactive antibodies isn't the same thing as immunity.
- ttesttom 5y agoPre-print for that paper was published 7 months ago and the sample collection date was from April-May 2020. Obviously there have been huge spikes in cases across the world since May 2020 with majority of infections occurring after that timeframe. > Sample collection date Apr–May 2020
- rel2thr 5y ago1.6% of the placebo group getting symptomatic covid seems crazy high for this age group in a short period of time, kind of unclear but it sounded like a 2 week a period Was there a super-spreader event in the placebo group?
- lthornberry 5y agoIt’s over a much longer period than that.
- deleted 5y ago[deleted]