The phenomenal safety of the Covid-19 vaccines

Hear, hear, folks.

I've just learned from a foreign language news site, that as of today, 12,623,018 people have been vaccinated against Covid-19 around the world. This uses official data and I happen to know that due to a lag in reporting, here in the United States we have had about 700,000 additional doses that went into people's arms but haven't been counted yet. So, 13,323,018, roughly.

Vaccines that have been delivered into people's arms around the world: Pfizer/BioNTech, Moderna/NIH, Sinopharm/Beijing, Sinopharm/Wuhan, Cansino, CoronaVac, Sputinik V, and Oxford/AstraZeneca. Two mRNA vaccines, 4 inactivated virus vaccines, and 2 adenovirus vector vaccines, so, 3 different platforms, varying in efficacy from 62% to 95% for the infection, and practically 100% protection against severe disease (in all trials of all vaccines so far, only ONE person - in the Pfizer trial - developed severe Covid-19 - but did not die).

Severe reactions to the vaccines, that I know of:

Four in the United Kingdom (two of which in trials - Oxford/AstraZeneca (transverse myelitis), and Janssen (stroke), leading to a temporary stop in trials - two post-marketing cases of anaphylaxis in Scotland)
Six anaphylaxis cases in the United States
One case of encephalomyelitis in Mexico (today)

Eleven people, none of whom have died so far, ten of whom have fully recovered; even the stroke case was mild and recovered nicely - the only pending case is the Mexican one; I do not know yet how the woman in Mexico is faring, she's been admitted to an ICU).

That's one serious but non-fatal reaction for each 1,211,183 doses. Even if the woman in Mexico dies (not a given), then it's 1 fatality in 13,323,018 cases.

I'd say, pre and post-marketing experience is showing that the the vaccines are safe.

Let's put this into perspective. Let's apply to these 13,323,018 people, the American current case-fatality rate (to be conservative; other countries have had numbers even higher) of 1.8%.

So, if these 13,323,018 people contracted the virus, we'd expect at least 238,814 deaths.

As for severe reactions, the virus steadily causes 20% of severe cases needing hospitalization. This number also matches the current estimates in sequelae. One in five.

So, for these 13,323,018 people, 2,664,603.

Do you guys realize the enormity of this? Without the vaccines, 238,814 deaths. With the vaccines, 0 or 1 deaths (in case the Mexican woman dies which is far from a given). Without the vaccines, 2,664,603 severe issues. With the vaccines, 11.

Anybody who's been saying that he/she doesn't want the vaccines; care to reconsider?

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PS - I do acknowledge two caveats:

1) Maybe these 13 million people wouldn't have a CFR of 1.8%, could be lower, as low as a third of that, 0.65%, due to asymptomatic and undiagnosed cases bringing down the actual IFR a(infection-fatality rate) s opposed to the CFR (confirmed case-fatality rate). But the 20% of estimated sequelae remain valid even for asymptomatic cases, like recent studies show (for example, 15% of heart damage in asymptomatic college athletes).

2) Maybe there's been more serious reactions in less transparent countries that we don't know of, like Russia and China.

Still, even with the caveats above, the benefits of the vaccines far outweigh the risks, but HUGE numbers.

 

India has just approved the Oxford/AstraZeneca vaccine. So, in this very populous country, soon we'll have a lot more people vaccinated.

 

Yay, a 1/2% reduction in absolute risk over placebo in developing mild illness, if you're young and healthy.

 

Wrong. Like I said, young and healthy persons are getting 15% of myocarditis even in asymptomatic college athletes, in a study by the University of Ohio (and an additional 30% with evidence of past myocarditis). This virus is much more dangerous than its death toll indicates. Given that the heart is just one organ and many others get permanent damage from a bout of Covid-19, most notably lung fibrosis, but also cognitive deficits, chronic fatigue, clots, strokes, and kidney insufficiency, at least 20% of survivors come out of it with some sort of damage INCLUDING young and healthy people.

Minimize it at your own risk.

https://jamanetwork.com/journals/jamacardiology/fullarticle/2770645

 

Hey, I found an English version for the application. It's in real time! You can see the numbers growing. With the 700,000 unreported by the CDC, we are at almost 14 million, now (obviously the news I read were a bit older).

Also, one of the goals of the application, which is from Brazil, is to mock their president Jair Bolsonaro who said the vaccine would turn people into alligators (!!! LOL!!!), and his administration hasn't approved any vaccine yet, falling behind other Latin American countries like Argentina, Chile, Costa Rica, and Mexico.

Check it out:

https://jacare-tracker.org/en

 

The freshest details I could find about the Mexican female doctor in a local website in Spanish: she is stable, being treated with steroids and anticonvulsants. She has a history of severe allergies. Another symptom, not previously reported, was muscle weakness, in addition to the rash, shortness of breath, and seizures (several). From the article it seems like she is expected to recover but her state is still delicate. She had encephalitis and transverse myelitis (the latter, the same problem seen in a British patient who took the Oxford/AstraZeneca vaccine).
Her name: Karla Cecilia Pérez Osorio. 32 years old, internal medicine specialist. Works at Hospital General de Zona número 7, in Monclova, state of Coahuila. She took the vaccine on 12/30, so it's been 3 days and she remains stable, which is good. But yes, very scary.
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Another detail about reactions:
The six cases of anaphylaxis in the United States were all to the Pfizer vaccine. There was 1 case of allergy to the Moderna vaccine, a doctor in Boston. I didn't include it above because it wasn't very serious; he had a history of seafood allergy and carried an epi-pen, he had a rash and some dizziness, he self-administered the epi-pen, was fine in minutes, and went back to work with no other symptoms. So I wouldn't call it a severe reaction.

 

Maybe you should look at the vaccine studies

 

Me, I should look at the vaccine studies? I'm a scientist with expertise in this area, dear, with 40 years of experience (MD/PhD). I know all that there is to know about this. I've read all the phase 1/2 studies, and the phase 3 that have been released. I followed the whole process of FDA and CDC approval for the Moderna and Pfizer EUAs and read the documents, and posted them here. Look up my thread State of the Vaccines and take a good guess if I'm in need of learning more about it, LOL.

http://www.politicalforum.com/index.php?threads/the-state-of-the-vaccines.576983/

 

Then you would know the miniscule reduction in absolute risk and know the participants were ASA 1 and 2 young people, dear.

 

Fantastic news!
What is so hard about understanding risk versus benefit? Australia has been slow to start vaccinating but we are in a better place than many countries so it is only fair to get the vaccines to where they are needed most first.

Still with the Sydney and now Melbourne outbreaks there is talk of doing “ring” vaccination strategy and just targeting those areas where people have shown positive results. I would like to see this happen if only to establish if it is feasible

 

Here is the demographic table for the Pfizer vaccine phase 3 trial:



What exactly is your point? ASA 1 and 2 only? What about the 18,592 subjects with comorbidities? Or the 14,027 with obesity? What about the 8,613 older than 65? Where in the hell did you get the idea that the subjects were ASA 1 or ASA 2 only??? Are you mixing up phases 1 and 2 that are supposed to have younger and healthier subjects, with phase 3??? FYI, phase 3 is supposed to include sicker and older subjects too, and in the case of Pfizer and Moderna, did.

Now, yes, if you are ASA 1 your risk of dying from Covid-19 is very small. ASA 1 will exclude obesity, requires a BMI lower than 30, and supposes a normal and healthy status (non-smoking to boot). The mortality from Covid-19 in this population if you are a teenager or a young adult, can be as low as 0.02%.

But what you are not considering is morbidity. Like the study I showed to you above demonstrates, extremely young, fit, and healthy people, college athletes which by definition are almost guaranteed to be ASA 1 (except some linebackers, haha), had 15% of them with continuous myocarditis and 30% additional ones with evidence of past myocarditis despite having mild or asymptomatic Covid-19, only. That is, Covid-19 carries a significant risk, beyond mortality.

Here is the Frankfurt study I had mentioned too, with older subjects but also with much larger percentage of cardiac damage (78% cardiac involvement, 60% continuous myocarditis), also published in the JAMA Cardiology and also looking at cardiac MRI and troponin; so the Ohio State study was a replication attempt:

https://jamanetwork.com/journals/jamacardiology/fullarticle/2768916

My point is, EVEN young and healthy subjects are exposed to very significant risks from Covid-19, way beyond the low case-fatality rate.

Care to reconsider?

 

And here is the co-morbidity data for the Moderna trial:

https://www.fda.gov/media/144585/download

Go to page 18. See the bottom of the page. 6,191 subjects with one high risk condition, and 1,115 with two or more high risk conditions. 7,026 subjects older than 65.

Come again? Only ASA 1 and 2 subjects?

LOL. Where in the hell do you get your information???

By the way, absolute risk as compared to the full population in the study is NOT the way you calculate efficacy of a vaccine because you don't even know if these people who didn't get infected got exposed to the virus or not, since this trial is not a Human Challenge trial. The way to calculate is to compare the real events (infections) in the placebo arm and the active arm. You can see on page 20 that the Moderna vaccine went in subjects 18 to 65, from an incidence of infection of 1.5% in the placebo arm to less than 0.1% in the active arm. So the risk got reduced more than 15 times. It actually went from 156 events to 7. That's 22 times smaller. If you don't think that this is a significant risk reduction, you clearly don't know what you are saying. Efficacy in this group, 95.6%.

Absolute risk is not the best indicator because of not knowing who got exposed (it would have been the best indicator in a Human Challenge trial in which all subjects got equally exposed, and actually all of them got exposed, period - since they would have been inoculated with the virus). Relative risk is more meaningful in this case of a non-Human Challenge RCT.

Of course, Covid-19 being a dangerous disease without a rescue treatment, we couldn't run a Human Challenge trial (although actually one is being prepared in the UK, but over here, our IRBs will never agree to that).

 

The OP many times comes across as a sales rep for the vaccine manufacturers.

 

Center Field, please ignore the distractors, you will never change their minds.
The information you give us is more than outstanding. Very professional, high quality.
The vaccines have been a huge success of science and the results of the vaccinations reflect the Phase 1, 2, 3 tests.

I am rather impressed how well the mRNA are doing. That is a major breakthrough for science.
Considering what they were researching before Covid, cancer, HIV and so on, we will probably sea a revolution with those and many other diseases coming. My guess it is like the first chip, it changed our lives for ever.
mRNA will change our lives for ever.
Sahi, bioNtech, thinks they can adjust the vaccine with in 6 weeks to what ever the virus mutates, because of how they attack the virus.
Proteins.
That is rather amazing.
Curevac with their 40F vaccine has given Moderna and bioNtech some homework. They are working on their next generation, to match that temp.
We will see a giant leap, when it comes to vaccines against the most brutal and common diseases in the next 10 years.

Stay healthy, your second shot will be coming in 2-3 weeks and than hold on for one more week.
I wish I had my first one.

 

Thanks. Yes, the mRNA vaccines are amazing and a great breakthrough, and will advance cancer research, etc., like you said.
Yes, they can be tweaked in 6 weeks to target mutations. The problem, though, is to produce more, get enough ingredients, get them in vials, get syringes, distribute them, and get them into people's arms if we have to redo everything again due to mutations. The new South African strain, the 501.V2, seems to have drifted even more than the B.1.1.7. I'm concerned.

 

I am not concerned at all. Besides staying healthy for the next 4 month.
I have no high school degree, or college, but have educated myself rather nicely over the decades. Love science, as long as somebody can explain it to me. Have a nack for physics. I find some logic in it. Chemistry, rough, you need more math.
100% dyslectic, math, give me a break. That prevented me from finishing high school and than to college. English is not my mother language.
A lot of the fancy words I have to get my books out, dictionaries.

All they have to do, find out what makes the outer shell of that virus tick. What is it made of, what is the proteins of it. You know that, you can design the mRNA accordingly.
If you look at it from the tech guys side, that's what I am, you just change one bolt from grade 7 to 8 or to 6. Every thing else stay the same.

It is not about the virus, it is just about the protein of the fatty shell around it that protects it.
Yes I know you, know it, all of it, you have the science papers and so on and so on.

But in a simple nutshell, that's what it is all about.
That is the nuts and bolts of it.

 

Production of this new tech is the greatest challenge we face.
Ain't just mixing a chemical cocktail of dead or live or benign viruses.
Producing the mRNA is so very different, needs special tools, bio reactors, the ingrediencies, at a quality and volume never produced.
I think most people have hugely underestimated the challenge we face, producing, distributing and and actually giving the shot, to hundreds of million and billions of people.

 

Or, you know, if you'd rather not pass it on to other people and care about something more than just your own health and safety.

 

One of my daughters is a nurse and she got her first shot today of Moderna. No side effects yet.

 

The poster you are replying to doesn't know what he is saying. I've debunked all his claims already in posts #11 and especially #12.

 

Or, you know, someone who actually cares about public health more than fringe conspiracy theories, as alien as that may be to some.

 

People who care about public health emphasize good nutrition and supporting the individual immune system.

People with special interests emphasize Big Pharma's narratives and products.