French health authority advises against Moderna Covid-19 vaccine for under 30s
reuters.com
reuters.com
"However, according to the EMA, the benefits of both mRNA shots in preventing COVID-19 continue to outweigh the risks, the regulator said, echoing similar views expressed by U.S. regulators and the World Health Organization."
"France's public health authority has recommended people under 30 be given Pfizer's Comirnaty COVID-19 vaccine when available instead of Moderna Inc's Spikevax jab, which carried comparatively higher risks of heart-related problems."
"Researchers find a higher than expected risk of myocarditis in young men after full vaccination."
https://www.nytimes.com/2021/10/09/health/researchers-find-a...
Particularly this one from article above:
"...Boys between 16 and 19 years of age had the highest incidence of myocarditis after the second dose, according to a second study in the journal. The risk of heart problems in boys of that age was about nine times higher than in unvaccinated boys of the same age..."
Edit: The article above has a quote that I find fascinating
"Myocarditis is among the concerns that may have led the Food and Drug Administration to ask Pfizer-BioNTech and Moderna to enroll more children in their vaccine trials. Potential side effects are likely to dominate the discussion when agency advisers meet next week to review the evidence for a vaccine in children aged 5 to 11 years."
What kind of person voluntarily enrolls their children in vaccine "trials"?
People who want the pandemic to end and everyone’s children to be safe?
In the US, since the start of the pandemic, the total number of deaths "involving COVID-19" in children aged 17 or younger is 595. During the same period, total deaths in this age group amount to 61,523.[1]
The vaccine does not provide sterilizing immunity. Fully vaccinated individuals can become infected and transmit the virus to others.
Based on these facts, can you explain how vaccinating children will "end" the pandemic and make children significantly more safe?
[1] https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#Se...
I've come to believe that it's all political and ideological at this point. There is indeed a contingent of crazy people who don't think COVID is real, believe in wild conspiracy theories about COVID, oppose any preventative measure (be it masking, social distancing or vaccination), etc.
And then there is another, larger contingent of people who believe that if they acknowledge any limitations of the vaccines, the minimal utility of rushing to vaccinate children, etc., they are letting the crazies win.
So now we're stuck in a Twilight Zone where the vaccinated have to be protected from the unvaccinated, vaccinating the group least likely to be affected by COVID is promoted as the latest key to ending the pandemic, "natural immunity" has gone from being accepted as basic science to treated like pseudoscience, and everybody who is vaccinated will probably be pressured to boost every 6 months no matter how much protection they continue to be told they have against hospitalization and death.
Children absolutely get flu shots. It's recommended annually for anyone over six months old.
"We have something that might cause heart inflammation in children...Might be true or not. We would like to find out more as we have seen a few cases...Would you mind send your toddler in Monday morning please? We are going to give him this product"
We did so in part because my kids benefited from other people making that same decision years ago - to participate in clinical trials that might benefit future children like mine.
I would then it would then look beyond the benefit to the self and take into account civic duty. If your own personal probability of mortality is exactly the same with the vaccine and without, then we need to ask, what is then best for the system within which I live? (Remember, never send to know for whom the bell tolls.)
myocarditis isn't contagious, but covid is, and if left unchecked, might (will?) mutate into something that might be a lot more than 1% deadly to you. So you expected value of taking the covid vaccine will be higher than not.
I really think we should encourage people to be willing to think objectively like this. There IS a set of efficacy and risk numbers that would make the vaccines not worth it. They're just obviously not the numbers we have (which make it very worth it). It's just unfortunate that such an astonishingly large portion of the populace apparently can't do the math right enough or objectively enough to come to the same conclusion.
It isn't.
Even if it were an identical 1% and 1%, the answer to:
> which risk should I take?
would then involve other variables, like the fact "that vaccinated people infected with the delta variant are 63 per cent less likely to infect people who are unvaccinated". https://www.newscientist.com/article/2294250-how-much-less-l...
"Viral loads of Delta-variant SARS-CoV-2 breakthrough infections after vaccination and booster with BNT162b2"
https://www.nature.com/articles/s41591-021-01575-4
"...By analyzing viral loads of over 16,000 infections during the current, Delta-variant-dominated pandemic wave in Israel, we found that BTIs in recently fully vaccinated individuals have lower viral loads than infections in unvaccinated individuals. However, this effect starts to decline 2 months after vaccination and ultimately vanishes 6 months or longer after vaccination..."
If vaccines and their boosters infer temporary immunity, there's a certain level of rapid vaccine production and administration that can leverage that temporary immunity. Whether we can reach it is somewhat of a political problem.
"As of June 11, 2021, approximately 296 million doses of mRNA COVID-19 vaccines had been administered in the United States, with 52 million administered to persons aged 12–29 years; of these, 30 million were first and 22 million were second doses. Within the Vaccine Adverse Event Reporting System (VAERS) (4), the national vaccine safety passive monitoring system, 1,226 reports of myocarditis after mRNA vaccination were received during December 29, 2020–June 11, 2021."
Second, the risk of death is much lower:
"Of the 323 persons meeting CDC’s case definitions, 309 (96%) were hospitalized. Acute clinical courses were generally mild; among 304 hospitalized patients with known clinical outcomes, 95% had been discharged at time of review, and none had died."
(Many, but not all--from the EU data, IIRC, excess myocarditis events were in the range of about 1 in 100,000, not 1 in 10,000.)
[1] https://www.cidrap.umn.edu/news-perspective/2021/10/covid-va...
Okay, I'll bite.
Exactly how do you propose demonstrating the safety and effectiveness of a vaccine (or any drug) in children without running clinical trials where you test it on actual, you know, children?
"This Article explores the flaws inherent in this ethics of pediatric research. Specifically, it challenges the view from ethics that the law permits parents to consent to their children's inclusion in harmful or risky research to the extent that related invasions would meet legal maltreatment standards. More broadly, it challenges the movement to increase access to healthy children for harmful and risky research on the ground that it risks two important regressions: First, in its willingness to risk harm to individual children in the interests of the group, it threatens the progress the law has made in its development of the concept of the child as an individual worthy of respect in his or her own right, a concept that imagines parents as fiduciaries and that includes strong protections against invasions of bodily integrity. Second, in its failure to assure that the burdens of non-therapeutic research are not placed disproportionately on children of lower socioeconomic and minority status, it violates the antidiscrimination principle, which has only begun to make good on its promise of equal treatment for all children."
How do you vet a new therapy for use on children without actually trying it on children at some point?
At some point you do have to use it on an actual child, right?
> The myocarditis risk difference between the first and second dose was 1.76 cases per 100,000 people (95% confidence interval [CI], 1.33 to 2.19), or less than a 0.002% incidence. The largest difference was among male recipients 16 to 19 years, who had 13.73 cases per 100,000 people (95% CIs, 8.11 to 19.46)—but even that level amounts to only a 0.014% incidence.
> In other words, compared with unvaccinated people, vaccinated people had a 2.35 rate ratio of myocarditis 30 days after the second dose (95% CI, 1.10 to 5.02). Vaccinated young males had an 8.96 rate ratio (95% CI, 4.50 to 17.83).
[1] https://www.cidrap.umn.edu/news-perspective/2021/10/covid-va...
"Covid: Children's extremely low risk confirmed by study" https://www.bbc.com/news/health-57766717
What needs to be compared is "expected negative effects from the vaccine to children" to "expected negative effects from Covid to children as well as everyone they are likely to infect".
Kids don't die from covid often, but they sure spread it all over to people who do.
https://www.nature.com/articles/d41586-021-02689-y
https://www.businessinsider.com/delta-variant-made-herd-immu...
https://www.thelancet.com/journals/laninf/article/PIIS1473-3...
A vaccinated person is less likely to become infected at all, so even if vaccination did not reduce transmission in infected people, it would still reduce transmission in the whole population because fewer people were infected.
"Dr. Fauci answers questions about children and COVID-19 vaccines"
https://www.npr.org/2021/10/27/1049546323/dr-fauci-answers-q...
Above, you compared "risk of death" to "risk of myocarditis" and noticed the latter is higher. But Dr. Fauci is comparing "risk of death and other non-fatal negative effects from covid" to "risk of myocarditis and other negative effects from vaccination", and that tips the scales the other way.
https://www.gov.uk/government/news/jcvi-issues-updated-advic...
> A recent study found that vaccinated people infected with the delta variant are 63 per cent less likely to infect people who are unvaccinated.
> What is important to realise, de Gier says, is that the full effect of vaccines on reducing transmission is even higher than 63 per cent, because most vaccinated people don’t become infected in the first place.
It's not perfect, but it's not nothing either.
1) This would be true only if the magnitude of spreading was equal. But the data suggests that the vaccinated spread covid less than unvaccinated, especially soon after vaccination.
2) Even if an infected vaccinated person spread the disease an equal amount as an unvaccinated person, they are less likely to be infected at all, thus resulting in a reduction in total disease spread.
> Almost 95% of vaccine-linked myocarditis cases were mild, but one fulminant (sudden and quickly escalating) case was fatal. Surveillance occurred from the vaccine's market introduction, Dec 20, 2020, to May 31, 2021.
[0] https://en.wikipedia.org/wiki/Myocarditis
[1] https://books.google.nl/books?id=-nIpAgAAQBAJ&pg=PA135&redir...
We don't even yet know for sure the mechanism by which the vaccine can cause myocarditis. There are various theories, a number of them related to the spike protein itself.
Figuring this out should be of the highest priority given that public health officials around the world are basically moving towards a boost every 6 for the foreseeable future position.
Myocarditis is inflammation of the heart and is believed to be caused by the immune system's response to the virus. It maybe that it's less likely to happen in 30+ because their immune response tend be more muted.
The serum is meant to be administered at an intramuscular site, but injections have a chance of hitting a blood vessel upon insertion.
I am not a medical professional, but the advice I've read is that practitioners should "aspirate" the needle (pull back on the plunger) before delivering the vaccine, to see if they've hit a blood vessel.
https://www.youtube.com/watch?v=KgVsd6qoyU4
This theory somewhat matches the observations because young people are likely to have more, larger blood vessels in their arms compared to older demographics.
This also explains why men experience myocarditis more than women.
"How Aging Affects Your Immune System" https://www.webmd.com/healthy-aging/guide/seniors-boost-immu...
It was a balance of the risks of the vaccine pretty much in general versus the risks of Covid by age range.
So basically if the risk of Covid is high it makes to get any vaccine available. But if the risk of Covid is very, very low then you may start considering what the risks of getting the vaccine are.
In other words, if you have a medicine with both risks and benefits increasing with dose, the optimal dose will generally be larger for people who stand to benefit more.
>For persons aged over 30, however, the authority explicitly recommended the use of the Moderna vaccine, saying its effectiveness was slightly superior.
I think what people are missing is that getting covid is inevitable, it's not a choice we can make anymore, whereas getting vaccinated is. That throws a monkey wrench into this risk/reward equation where even if the vaccination benefits outweigh the risks, people are worried about the possibility of an own-goal and how stupid they would feel knowing their personal risk profile to covid is basically zero. It's this notion of the possibility - no matter how remote - of self-inflicted harm juxtaposed with the unavoidable outcome of getting covid that messes up the equation, and I don't think it's really that irrational for many people.
I am amazed at the people who are afraid to go outside and exercise, while putting on weight while sitting on couch being scared by TV news and ordering meal delivery.
Look at the graphs of covid deaths overlayed over infections in time per country.
You will clearly see the two waves and now the third with deaths tracing up for each.
Now in countries with high % vaccinations there is barely a bump in deaths. Then look at russia or romania, their deaths are tracking first and second wave pattern.
I dunno how one can make case vaccines have no effect.
Covid might be staying and it sucks, but so far its much more dangerous than flu, I will be vaccinating myself for it as it looks like the best bet.
Lockdowns are probably not going to happen as EVERY single country would have to introduce them and that kind of global coordination is a pipe dream.
Are you sure you know how vaccination works?
Well, yeah, you're vaccinated.
We've known since the original EUA submission data for the Pfizer vaccine that they're highly effective at preventing severe disease.
It's a little odd to go "welp, vaccine didn't work" when it probably did.
> Well, yeah, you're vaccinated.
While we're sharing anecdotes, I was unvaccinated when i got Covid and my experience was also that of a mild Flu. Contrasted with my brother in-law who was vaccinated and got Covid at the same time, our symptoms were on par. Same severity and duration.
This is why we collect data across tens of thousands of people in clinical trials, rather than hoping for anecdotes to be submitted.
Some people get mild COVID. Some get severe. Statistically, the vaccinated are a lot less likely to get the severe sort.
Long covid and hearth problems can appear even after mild disease.
There are many ways you can go from healthy 43 old to chronically ill 43 year old.
You made a right decision to get vaccinated.
> However, according to the EMA, the benefits of both mRNA shots in preventing COVID-19 continue to outweigh the risks, the regulator said, echoing similar views expressed by U.S. regulators and the World Health Organization.
"Take Pfizer over Moderna if you're under 30" isn't the anti-vax position.
Only idiots, rational people would say
for sure the risk for vaccine A is not exactly equal with B for each individual, and that person would ask for real data and not some speculation for a youtubger that bearly finished high-school or some fake news website shared on Facebook.
Just to remind people, the risk for X complication is just a number , you always need to remember that the risk might be smaller for you (or larger) but it might be much larger for someone in your family/friends so don't forget the otehrs when you try to pretend you know how to calculate your own risks,
If you want to blame something for the unhealthy state of public discourse around vaccines, blame anti vaxxers. It is their anti science stance during a health crisis that is both irrational and has removed all nuance from healthcare discussions.
I'm not so sure about that. I think there's valid healthy skepticism about the mRNA shots but the loudest people protesting are firebreathers with no coherent argument or thought
When did we have discussions and thoughts and reasoned policy change on the _time_ aspect of safety testing? While some things like asbestos have uses, safety concerns can take years to be discovered.
Once you get to the point of doing the large phase 3 trial the timeline for these vaccines was much less compressed. Also much easier to test a vaccine when the virus is spreading all over the place quickly.
Also there just aren’t historical examples of vaccines having “hidden” long term effects. All side effects that happen after 6 weeks also happen much more frequently before 6 weeks.
1. I can't speak for others, but my skepticism stems from one idea: it's foolish to tamper with your immune system unless absolutely necessary or there's absolutely no risk, because you can't undo it later. At this point we can safely say the covid vaccine poses some risk relative to other vaccines.
That being said, for some individuals the vaccine is absolutely necessary. For other's such as children and young people whose bodies are still developing, the cost-benefit tradeoff is dubious.
2. "safe and effective" has proven to be a false statement. It might be fair to instead phrase it as "better than nothing, for most people". That's what the tens of billions of data points tell us so far.
Yet this is undermined further by reports such as "Aaron Rodgers, unvaccinated, sick with COVID, has mild symptoms and is doing fine" and "Fully Vaccinated NFL player hospitalized with COVID-19".
https://www.washingtonexaminer.com/news/vaccinated-nfl-playe...
3. We don't have a good way of tracking and reporting adverse events. VAERS has a lot of systemic problems -- self-reporting isn't 100% reliable in scientific terms, but simultaneously studies show vaccine related adverse events are typically under reported.
"and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported." https://digital.ahrq.gov/sites/default/files/docs/publicatio...
4. By extension of VAERS, we don't have a good way of relating the vaccine to adverse event. ex. If someone gets vaccinated, and a month later dies of a blood clot, how do we prove or disprove the correlation? With food, drugs, and medicine, the only useful way is long term clinical trials.
I don't think we even have a causal relationship between the vaccine and myocarditis at this point, but rather an undeniable correlation. This says something about our scientific ability to measure safety.
5. There have been whistleblower reports about the honesty and reliability of the original vaccine trials. I take this with a grain of salt, but it highlights the lack of transparency and forced compliance endemic in the medical industry.
6. As time goes on, more articles and studies are released that cast doubt on the safety of the vaccine. This recent study shows (in vitro) that the mRNA induced spike protein is observed to cause damage at the cellular level in a way that hinders DNA repair and antibody creation. (Published: 13 October 2021)
https://www.mdpi.com/1999-4915/13/10/2056
To be clear, I don't want to forecast "vaccine doom" because everyone I know and love has the vaccine. I truly hope the science disproves any doubts about safety.
But until then I reserve the right to speculate and make my own risk assessment.
But yes, my concern is with apoptosis and whether or not it happens correctly in both scenarios.
My impression is that viruses thoroughly destroy cells, but the mRNA method naively exposes the nucleus to the spike protein without doing all the other things viruses do.
Maybe the spike protein does the same damage in both scenarios
Maybe apoptosis correctly resolves all the risk
But people with wild imaginations like myself are wondering if between the virus and the vaccine if we didn't just drastically increase the risk of cancer and auto immune deficiencies across the whole world. Something we won't observe for years to come.
Prove it. You won't be able to because no such relative measurements exist.
Also any “whistleblower” complaints about the studies are ridiculous at this point. Billions of people have taken the vaccines, we are overflowing in data about how safe and effective they are. There isn’t a coverup that half the human population is in on.
Further, it comes off as tone deaf to care about long term COVID effects but not that of vaccines.
I agree we're overflowing with data, my stance is data-driven.
I think it's wrong to discount whistleblowers, but you can pick and choose who you think is worth listening too.
I think it's fair to challenge my _ability_ as an interpreter more than bias, but rarely do we have the opportunity to defer important life altering decisions to others and still retain confidence they will prioritize what's best for us over themselves.
The problem with risks and probability is that human brain does not process probability numbers well, so it is all or nothing.
Anti-vaxxers point of view: I do not understand what 0.0001 is, round it up to 0.5 - OMG vaccines kill.
Vaxxers point of view: I do not understand what 0.0001 is, let us round it down to 0. Vaccines are harmless.
Second point is way more rational, although of course also incorrect.
That's quite different. Most people are not Bayesian thinkers. They mostly react based on how they feel about things.
I think what people fail to understand is that this isn't a one time problem. It's not bad math being done. It's one of the first major displays of an on going collapse of trust in Western institutions.
These are the same people who said two weeks to slow the spread, then proceeded to lockdown for months and put your business into flip-a-coin odds for insolvency.
It doesn’t matter how many credentials are next to their names - you are never listening to them ever again.
And neither will your family who depended on your business or saw you lose your business.
Someone did a computer simulation of this, showing that just 1-2% running around and spreding the virus was enough to undo the effects.
So here we are now, almost 2 years later and the family business you pretend to protect have lost costumers, their business and maybe also few family members. Things would have gone so much better if we didn't have these "freedom lovers" dragging their feet, damaging the economy and in the end filling up ICU beds while waiting for their Herman Cardon award.
It certainly isn't the fault of freedom lovers or any single group. This is blaming the other team and basic tribalism.
What also comes to mind the Randal Munroe's "What if - Could we eliminate the common cold if we all self isolated long enough?"
In theory yes, but the severe degree of isolation and spreading required would likely not parse well with supply chain economics .. which given not everyone grows their own food, is also required to live.
edit: there's also news now of COVID spreading to deer and possibly other animals, making this scenario even less viable.
Virtually no accurate, trustworthy and useful information about the safety or effectiveness of the vaccines is available. The public health and media establishment is far too biased in favour of vaccines and far too biased against anything that might discourage people from taking it. In such an environment it doesn't matter whether you understand Bayes theorem or not. You can't just do some calculations and understand the risks.
I’m not sure where you are getting this characterization of people who are pro vaccines but it doesn’t apply to anyone I know who took the vaccine. Yes, there’s some risk of side effect as with most medicines. But you still take them because the benefits far outweigh the risks. Pretty sure the average person who took the vaccine is able to wrap their head around that concept.
Analysing all angles and making informed decisions is sort of the exact opposite of pushing your head in the sand.