The editors of the Washington Post have what appears to me to be a very measured commentary on whether children younger than 5 should be vaccinated against COVID-19. Here’s the meat of their remarks:
Pfizer said Dec. 17 that a two-dose vaccine worked well to stimulate antibodies in children from 6 months to 2 years old in a clinical trial, but did not work in children from 2 years old to under 5. The company said it would attempt a clinical trial with a third dose, to see if that got better results, and if successful, it would seek an emergency-use authorization from the FDA for a three-dose regimen. At issue is not vaccine safety or tolerance but whether it is effective.
On Tuesday, Pfizer announced the FDA has requested that it submit information for an emergency-use authorization of the first two doses, leaving the third for later. This raises the question: What has changed since the December announcement that those two didn’t work? We might learn more when the matter comes before an FDA advisory committee soon. Pfizer said results on the third dose would only be available in “the coming months.â€
In statements, the FDA and Pfizer both pointed to the omicron surge as the reason for the unusual process. An FDA spokesperson said the new variant “has rapidly facilitated the collection of important additional clinical data impacting the potential benefit-risk profile of a vaccine for the youngest children.†FDA officials felt it was “prudent†to get the data from Pfizer now instead of waiting, especially because of “notable increase in reports of children experiencing covid-19 long haul symptoms, including in some cases children developing autoimmune diseases and Type 1 diabetes after having had covid-19.â€
The company and the FDA are right to feel a sense of urgency. But parents will be asking: Should they start with two doses, given Pfizer’s statement that in the earlier trial, they didn’t work for children from 2 to under 5? Should parents be comfortable starting a vaccine series — which Pfizer calls “a planned three-dose primary series†— without knowing anything about the effectiveness of the third dose?
The context for these measures may be that recent studies of the prevalence of COVID-19 among children younger than 5 have suggested that it may be greater than had previously been thought. Shorter: kids under 5 get COVID-19.
My own view is that the FDA should have high confidence that the vaccine is effective among children 2-5 before granting emergency use authorization for that age group. At this point there is still a lot we don’t know.
Poor Pfizer and FDA cant win can they. First they didnt act fast enough to get initial approval. Now they are acting too fast this time.
Link goes to Beckers report on docs being disciplined over Covid misinformation. There were 8 in total for 2021 out of about 1 million total doctors in the US. In response some states are passing laws/regs so that state boards cannot discipline docs.
https://www.beckershospitalreview.com/hospital-physician-relationships/medical-boards-disciplined-8-physicians-in-1-year-over-misinformation.html
Steve
Also, nice study on effects of masking for young kids. It suggests, not definitively, that masking helps. What is really nice about it is the level of detail it goes into when discussing the strengths and limitations of the study admitting that it does have weaknesses. It also acknowledges and addresses concerns over the perceived negative effects of masking kids.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788457
Steve
Thanks for the link to the masking study, steve.
https://www.justfacts.com/news_face_masks_deadly_falsehoods
Thanks jan. A real treasure trove to show medical students examples of bad studies and arguments.
Did you ever look up Brownian motion?
Steve
I have a question about the effectiveness of masks at childcare centers.
Are closures the right measurement endpoint? Because closures in response to cases in childcare centers are themselves a government edict. If governments stated that childcare centers do not need to close due to cases; I could foresee the benefit being only 1-2% less risk of closure instead of 14%.
If we are talking about traditional measures of benefit/harm, like morbidity/mortality, the absolute benefit among children would be small since children’s risk is smaller than even a vaccinated + boosted healthy 20 year old.
And this is even through I think the cost / benefit ratio still weigh towards masks.
As for the FDA, have they lost the plot? Here’s a fact, only approximately 25-30% of children 5-11 have been vaccinated (and the rate has flatlined). My belief is he surprisingly low rate is due to parents caution on the unknown risk of long term side effects coupled with the known risks of infection. Whether justified or not, that caution will be even stronger for parents in 2-5 crowd.
Let me state it this way, even if parents trust the FDA, they are going to let real world experience and time prove the vaccine is safe.
Now the FDA is going to approve a vaccine where there’s no direct clinical data of its effectiveness in the target population, and it failed even the proxy measurement of effectiveness? That’s going to build trust with parents?
Would the good Doctor inject it into his own grandchild?
That was my point. I think they’re tone-deaf.
IMO there are multiple motivations for pressing the issue of inoculating children under 5. One of them is sincere concern for their health and well-being but it’s not the only motivation. Another possible motivation is that as long as you expand the number of individuals eligible to be inoculated, it leaves open the possibility of blaming people who won’t allow themselves (or their children) to be inoculated.
If 100% of the population were inoculated against COVID-19 and the disease continued occur at high rates, who or what would they blame?
Shorter: I think that the vaccines are being oversold. I’ve been inoculated and boosted so, obviously, I’m not opposed to the idea. That was based on my own risk analysis. I think that others may reasonably come up with different answers in their own distinct cases.
I think the weaknesses section pretty much tells it all on steve’s citation. No control over the subjects, and as the teachers unions have shown us, those doing the reporting have obvious reasons for bias. Its almost like they said “yeah, the study is crap, but it tells us what we want so we’re going with it.”
As for brownian motion, that’s a hoot. Although brownian motion exists, one of the transport phenomena surely dominates: gravity and drift velocity effects on fluid flow.
” Shorter: I think that the vaccines are being oversold. I’ve been inoculated and boosted so, obviously, I’m not opposed to the idea. That was based on my own risk analysis. I think that others may reasonably come up with different answers in their own distinct cases. ”
And this is the whole issue. The vilification of those reaching a different conclusion is the attitude adopted mostly by the hysterical and the authoritarians. Does anyone doubt that every single year there are people out and about with the flu who infect people who in turn die of the disease. When do we start calling for lockdowns for that?
I’m sure most people here have seen the point system for susceptibility to severe disease from covid. At the top and by a wide margin are diabetes and obesity. We are perfectly prepared to impose all kinds of costs on the general population related to covid, but I see no emerging movement to do anything about the epidemic of obesity and diabetes (or heart disease, or orthopedic issues…..). Why not? Politics. Not science or pubic health considerations.
The adamant thinking surrounding universal vaccination pushes, and the mitigating protocols surrounding this virus seem to ignore weighing the risk/benefit to each individual and group, based on age, ethnicity, immunity status, and co-morbidities. Like so many esteemed virologists have stated, vaccination should be targeted to the most vulnerable, not the masses. And, once infected there is no need to vaccinate at all.
Masking, shutting down economies, social distancing has done more harm than good, as indicated by the latest John Hopkins study that has been underreported by the dishonest media. The real science, the more authentic data all point to major screw-ups in the misinterpretation of data and inappropriate remedies promoted by the pharma-financed CDC, FDA, and Fauci-followers.
Finally, the wholesale masking and vaccination of all children, IMO, is horrific. The social and developmental damage to these youngsters is impossible to assess. However, once long term studies are done politicians, the medical industry and others will be carrying huge amounts of guilt around for what they have demanded of the people to sacrifice for a virus having such a low mortality rate – their livelihoods, childhoods, mental and physical health and sometimes even their lives.
Or is this an example of the everything is a nail when you only have a hammer.
For these young children seems sensible to wait for the full approval process to unroll. Injecting folks with something of unproven effectiveness sounds wrong. Wonder political factors are in play.
Btw, any one seen any research on how Covid has affected Amish, Mennonite, Christian Science etc communities? About all I could find was a study of obits in a Amish newspaper, suggesting a peak then a fall to near baseline death rate.
“Why not”
Because you cant cure obesity or diabetes with 2 essentially risk free shots. On the mask study this is what we should be looking for. One that notes its weaknesses as well as strengths. Note that the Hopkins study jan cited doesnt really do that. Takes kind of a weak stab at it but carefully avoids saying the study has any weaknesses. While it has weaknesses it also has strengths. It is prospective and it is large.
Mask studies are hard since compliance is always an issue that is hard to measure. You have to find other ways to measure effectiveness that might get around that. This study has found a way.
The Hopkins study is a meta analysis. It sets exclusion criteria so that it ends picking studies that will give them the result they want to have. It seems to consider any kind fo NPI the same as a lockdown. It hand waves at timing but timing is a big issue. Finally, it claims there have been huge losses due to lockdowns but just makes that claim without any support or quantification. Guess we should expect that since eat the start of their study they say that since they are economists (social scientists) they are better than other people.
Steve
“Poor Pfizer and FDA cant win can they. First they didnt act fast enough to get initial approval. Now they are acting too fast this time.”
I think the situations are different.
Speedy approval was necessary at the beginning for vulnerable populations because they were dying in droves. Speedy approval for the 2-5 age a year later isn’t necessary because children are not dying in droves – they’re barely affected. I just looked up the CDC statistics and they don’t break it out by the 2-5 age group, but in the 1-4 age group, 87 kids have reportedly died from Covid in the last two years. That’s out of a total of around 7,500 deaths in that age group total in those two years.
Also, I think things would be much different if the vaccine prevented transmission. Vaccinating kids to achieve herd immunity makes sense.
Plus it seems likely that efficacy will wane in kids just as it does in adults, which could mean boosters once or twice a year.
As it stands, parents would have the difficult choice of weighing the risk between two very low-probability events – long covid problems after an infection, or problems with the vaccine and boosters down the line. It seems to me that both of those are so small that the decision doesn’t really matter much one way or the other. Parents ought to worry more about accidents and driving.
And I’m also pro-vaccine – my whole family is “fully” vaccinated including my youngest who is 11. If I had a kid in the 2-5 group, given what we know, I’d probably wait until the vaccine was fully approved and not just under an EUA.
Stop doing the moonwalk, steve. The mask study was horseshit. And now you are trying to poke holes in Jans citation? The simple fact of the matter is that the evidence is so problematic that to impose such draconian costs on society is borderline evil. Authoritarians run wild. Group think run wild. Public Health (snicker) officials run wild.
I have no idea why Dave made the decisions he made, and its none of my business. Mine were based on cardiac arrhythmias. Garden variety Afib and a left bundle branch block, which each give one point in the risk grid. Add age and its that simple. I find Jan’s rationale perfectly rational. I think she is younger, and perhaps there are other factors. This just shouldn’t be controversial. Jan doesn’t need a quasi-criminal like Fauci telling her what to do.
I note that Dave has decided to not comment on the Johns Hopkins survey study. I remind people I have a friend at Hopkins in the belly of the beast. She is not surprised. And I don’t make my commentary up out of whole cloth. NPR, MSNBC, The Atlantic etc will surely attempt to bury this. It should be the subject of scrutiny every damned day for the next two months. But I dream of honesty………….
The data captured from the DOD, by 3 protected whistleblowers, is devastating. The increased percentages of adverse effects and disease states following vaccination should reverse the “safety†memes that are being circulated, curtesy of the CDC, FDA, media, Pfizer and other pharmaceuticals. Also, the red flags being raised by people like me are not the result of having an anti vaccine posture. Rather, it’s addressing the superficiality of the clinical trials, the hiding of data in those trials, no animal testing, which is why people are calling us humans pharma’s “lab rats.†I don’t understand how people can be so incurious, supporting taking something that has had so little testing and analysis, regarding both it’s short term and long term safety. And, then to expose children to this charade of a vaccine, to address a non-virulent virus in basically people under 40, is simply mind-boggling.
“Finally, it claims there have been huge losses due to lockdowns but just makes that claim without any support or quantification.”
LOL You just couldn’t make this shit up. Yes, steve, things are just hunky dory out there. Go with it. Please, just go with it. 2 more seats, 4 more seats, 6 more seats………..
Drew,
I agree Steve’s mask study was so narrow, as to be irrelevant in the bigger picture of mask efficacy versus mask madness. IMO, the masking of especially young children is not only pointless but cruel. For those who want to look beyond COVID hysteria, it would raise their covers of awareness to see how speech therapists have had an overwhelming spike in business dealing with speech impediments, delayed speech and social interaction difficulties.
Also, I so enjoy the pragmatism and common sense employed in your posts. They are like a blast of fresh air realism!
Basically, age, my wife’s age, and my wife’s health. We’re in a higher risk group due to age and I wouldn’t want my contracting COVID-19 to have an adverse effect on my wife’s health.
Since the beginning I thought the lockdowns were marginally acceptable for a few weeks at the outset but since then, at least in Illinois, were not particularly useful, illegal, authoritarian, and only enforced capriciously.
Andy:
As usual I largely agree with your reasoning. That said
Even if the vaccines prevented transmission that would potentially present ethical problems. The ethics of treating Person A to reduce the risk to Person B is ethically quite questionable, particularly if the treatment poses any risk at all to Person A.
https://www.foxnews.com/media/johns-hopkins-university-study-lockdowns-media-blackout
â€However, the Johns Hopkins study received no mention on any of the five liberal networks this week. According to Grabien transcripts, CNN, MSNBC, ABC, CBS and NBC all ignored the anti-lockdown findings after having spent much of the pandemic shaming red states with minimal restrictions and events deemed by critics as “superspreaders.”
It wasn’t just the networks avoiding the study. The New York Times, The Washington Post, The Associated Press, Reuters, USA Today, Axios, Politico among other outlets also turned a blind eye to the findings, according to search resultsâ€
The importance of why the above was posted was as an example of the enormous filter our news media has had over this entire pandemic. In the case of the Hopkins Study, the media deliberately ignored it’s findings because it didn’t fit the pandemic protocols that were devised and implemented by the powers that be for nearly 2 years.
To think that the ineffectiveness of lock-downs was the only misstep taken, and summarily ignored or underreported, by the MSM, is unicorn thinking. The effectiveness of readily available, been in use for decades, and relatively inexpensive antivirals is another aspect of this pandemic that has been scurrilously panned by the media, in their attempts to only showcase ill-prepared, “leaky†vaccine products, put out by pharmaceutical companies (for massive profit) as the only approved and viable way out of COVID.
So when a mask study is not perfect you dont want any part of it. But when suggested you ought to have some studies on the supposed costs of masks and lockdowns you dont care that they do not exist. One of the problems is that people voluntarily change their behaviors when surges peak. We dont know how much behavior change is due to voluntary behavior vs lockdowns. This is not addressed in the Hopkins paper.
I asked, I know you want answer, but just exactly how do you plan to accept for compliance with masks? Ideally I guess we have little drones following everyone to see if they are really being worn, but that’s not happening. I think this study is fairly clever way to account fro compliance. One in a series of studies that try to find ways around the compliance issue. Also, prospective is pretty important. Note that the studies in the Hopkins paper are all retrospective I believe. (Been a while since I read some of the original studies so could be wrong.)
“The ethics of treating Person A to reduce the risk to Person B is ethically quite questionable, particularly if the treatment poses any risk at all to Person A.”
Haven’t had time to read the studies yet, but the risks for everyone else have been so low that when you do risk/benefit analysis it favors vaccines at all ages. If this is similar then it would favor vaccinating younger kids. Except, while the Risk/benefit ration is very good the absolute risk is also very low. For my grandson, a fair amount of care is provided by his other grandparents and some older aunts. If they have covid it could have a major impact on his care. Kind of think trauma of grandmother dying might be worse than occasionally having to wear a mask. Let me quickly say there is no study for that but the cost of wearing a mask is close to zero as fares I can tell based upon current literature.
Steve
â€Haven’t had time to read the studies yet, but the risks for everyone else have been so low that when you do risk/benefit analysis it favors vaccines at all agesâ€
It only favors vaccinations for all ages if one totally dismisses all the estimates done of injury and death, off the VAERS data, of being at least 20 fold over the numbers actually submitted.
Also, rarely taken into consideration is the higher immunity young children innately have, as well as the small viral load they are able to carry, making infectious transmission much lower. Studies done in countries, where children have attended schools unmasked, have proved that contagion was no higher than how colds/flues were treated in normal-times school settings.
Does the following constitute a “vaccine†that is safe? When you add how short-lived and iffy it’s efficacy is, do these injections even meet the criteria of an actual vaccine?
â€VAERS data released Friday by the Centers for Disease Control and Prevention included a total of 1,088,560 reports of adverse events from all age groups following COVID vaccines, including 23,149 deaths and 183,311 serious injuries between Dec. 14, 2020, and Jan. 28, 2022.â€
I have been aware of VAERS and what it is for many years. This is not something that I suddenly have an interest in because of my political ideology. So no, the VAERS numbers do not concern me.
Steve
VAERS was a somewhat incidental government site collecting, voluntarily, adverse effects of vaccines. Up until the mRNA technology the adverse effects were marginal, not posing an abundance of red flags. With the current jabs, just within the first few months of people being injected, there was an enormous spike in deaths (well over a thousand) and injuries. Furthermore, this gene therapy vaccine has had way more deaths and injuries than all modern day vaccines combined. Consequently, it’s not “ideology†that has so many physicians, virologists, epidemiologists concerned, but the data showing the toxicity inherent in these mandated jabs.
Again, I know what VAERS does so I am not worried. There have always been doctors who have advocated for quack cures and “natural” cures that dont work. Laetrile, the entire supplements industry, healing touch, etc. Now they are opposing vaccines and people believe them.
Another interesting mask study. Again note that they lay bare possible limitations. Some of their numbers are too small to be significant but again like nearly all studies of decent quality it points to masks having positive effects. This one is interesting since it looks only at the issue of wearing mask in indoors public places.
https://www.cdc.gov/mmwr/volumes/71/wr/mm7106e1.htm?s_cid=mm7106e1_w%20%5Bcdc.gov%5D#contribAff
Steve