Coronavirus

[MrCrowesGarden]

The first night after my Pfizer booster, I had pretty severe chills, and I stayed home the next day because I felt tired and under the weather.

But today, everything's back to normal.

I'm glad you're doing good, sigh. I've been fortunate to have practically no symptoms, just a sore arm like I get with all vaccinations.

[ghostrunner]

Taking the 11 year old to get vaxxed today. Apparently this is about a third of the adult dosage.

On the treatment side, sounds like good news:

Another bit of context on the trial:

[mikechamp]

Now there's a pill. Discuss:

Pfizer says antiviral pill 89% effective in high-risk cases

A pill to treat Covid developed by the US company Pfizer cuts the risk of hospitalisation or death by 89% in vulnerable adults, clinical trial results suggest. The drug - Paxlovid - is intended for use soon after symptoms develop in people at high risk of severe disease.

It comes a day after the UK medicines regulator approved a similar treatment from Merck Sharp and Dohme (MSD). The UK has already ordered 250,000 courses of the new Pfizer treatment, which has not yet been approved, along with another 480,000 courses of MSD's molnupiravir pill.

The Pfizer drug, known as a protease inhibitor, is designed to block an enzyme the virus needs in order to multiply. When taken alongside a low dose of another antiviral pill called ritonavir, it stays in the body for longer. Three pills are taken twice a day for five days.

The combination treatment, which is still experimental because trials haven't finished, works slightly differently to the Merck pill which introduces errors into the genetic code of the virus.

https://www.bbc.com/news/health-59178291

[AdmiralKird]

Booster study out of Israel on Pfizer reveals not only does it reset your efficacy against infection back to 95%, it has a ~20 times reduction from severe illness that stacks on top of your first two doses' reduction.

[Socnorb11]

Booster study out of Israel on Pfizer reveals not only does it reset your efficacy against infection back to 95%, it has a ~20 times reduction from severe illness that stacks on top of your first two doses' reduction.

This seems like very very good news.

[heyzeus]

Took Zeus Jr and Zeus Jr Jr to get their shots yesterday. They both glow faintly in the dark and claim they can see gravitational fields, but otherwise, both are doing pretty great.

[mikechamp]

Took Zeus Jr and Zeus Jr Jr to get their shots yesterday. They both glow faintly in the dark and claim they can see gravitational fields, but otherwise, both are doing pretty great.

Far out, man! Sounds like it's going to be a:

[AWvsCBsteeeerike3]

https://www.statnews.com/2021/10/23/fda ... s-5-to-11/

FDA scientists say benefits of Pfizer Covid-19 vaccine ‘clearly outweigh’ the risks for children ages 5 to 11

Scientists at the Food and Drug Administration presented an analysis late Friday showing that the protection offered to children between the ages of 5 and 11 by the Covid vaccine developed by Pfizer and BioNTech “would clearly outweigh” the risk of myocarditis, a heart-related side effect, that the vaccine appears to cause.

Then there's the actual study which kind of says that.

https://www.fda.gov/media/153447/download

The results of the benefit-risk assessment AW added (for 5-11 year olds) are summarized in Table 14 below. The results
predict that under Scenarios 1 (Sept 11, 2021 Incidence), 2 (Delta surge peak incidence), 4
(high efficacy), and 5 (higher COVID-19 death rate, per the CDC COVID-19 Data Tracker), the
benefits of the Pfizer-BioNTech COVID-19 Vaccine 2-dose primary series clearly outweigh the
risks for ages 5-11 years. Under Scenario 3 (lowest incidence), the model predicts more excess
hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented
hospitalizations due to COVID-19 in males and in both sexes combined. However, in
consideration of the different clinical implications of hospitalization for COVID-19 versus
hospitalization for vaccine-associated myocarditis/pericarditis, and benefits related to prevention
of non-hospitalized cases of COVID-19 with significant morbidity, the overall benefits of the
vaccine may still outweigh the risks under this lowest incidence scenario. If the
myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in
the model, the benefit-risk balance would be even more favorable.

The study notes they use the same incidence of myocarditis as is seen in 12-15 year olds to predict what will happen with the 5-11 year olds and note the dose is less for the 5-11 year olds so it's a conservative approximation. But, is it? And, what is the rate?

Again, from the study:

Safety data from a total of 2,260 adolescents 12-15 years of age randomized to receive vaccine
(N=1,131) or placebo (N=1,129) with a median of greater than 2 months of follow-up after the
second dose suggest a favorable safety profile, with no specific safety concerns identified that
would preclude issuance of an EUA.

A male participant who was randomized to blinded placebo group at age 15 years and
subsequently unblinded and crossed over to open label BNT162b2 at age 16 years was
diagnosed with myopericarditis beginning 2 days after Dose 2 of BNT162b2. He was
hospitalized on Day 3 and treated with IVIG, non-steroidal anti-inflammatory medications
and steroids, and discharged the following day. He was followed by a cardiologist and
seen for follow-up 2 months after vaccination. At that time the cardiologist recommended
limited activity. The investigator concluded that the there was a reasonable possibility
that the myopericarditis was related to vaccine administration due to the plausible
temporal relationship. FDA agrees with this assessment.

...

In an FDA analysis of the Optum healthcare
claims database, the estimated excess risk of myocarditis/pericarditis approached 200 cases
per million fully vaccinated males 16-17 years of age and 180 cases per million fully vaccinated
males 12-15 years of age.44 Although some cases of vaccine-associated myocarditis/pericarditis
have required intensive care support, available data from short-term follow-up suggest that most
individuals have had resolution of symptoms with conservative management. Information is not
yet available about potential long-term sequelae and outcomes in affected individuals, or
whether the vaccine might be associated initially with subclinical myocarditis (and if so, what are
the long-term sequelae). A mechanism of action by which the vaccine could cause myocarditis
and pericarditis has not been established.

Should be noted "some"/"most" are not quantified and should be. It's a medical analysis, not a guesstimating game.

So, there's that. For young males the risk of hospitalization from myocarditis associated with the vaccine is somewhere between 1:550 (the BNT162b2 data wasn't available but of the 1131 that received the vax, I'm assuming it's about half/half male/female) and 1:5,000.

Back calcing the numbers in table 14 from the benefit analysis, they're presuming about 1 out of every 220 infections/cases will result in a hospitalization best I can tell with 1 out of every ~50K cases resulting in death.

From what I understand, there's the recap of what the FDA actually says.

Now, having gone through that mental exercise, it brings me to little AW who is an 8 year old boy.

It seems pretty clear that the data above suggests the benefits outweigh the risks.

But, here are my concerns.

1. As noted above, the mechanism of action causing myocarditis is not known, which is troublesome. (There's probably more than just myocarditis, but whatever, we'll completely ignore that) The best theory out there, not that this is true - just the best guess I've seen at the moment, is that vaccines are inadvertently being injected intravenously at some (I don't have the quantities because I rely on the FDA/CDC to provide these numbers, which they haven't) rate. It should be noted Pfizer/Moderna both specifically say the vax has to be given intramuscularly. If IV injections are the cause, this would explain the increased prevalence in boys as their veins are less protected by fat from my very limited understanding of biology. And, little AW has about zero fat and tiny muscles which would lead to an increased chance of an inadvertent IV injection, again from my very limited understanding of biology. Even if not the cause of myocarditis, it increases the risk of an incorrect vaccination. Sure, most of this is pure speculation which is stupid, but it brings me to this point.

2. What are the risks from a natural infection to a healthy, fit 8 year old boy? *Shrugs* Not much. From the FDA link above, apparently 1:220 risk of hospitalization for all cases in kids under 18 and he'd fall heavily on the less risk side of even that bell curve.

3. What effect does prior exposure play? Mrs. AW tested positive back in March and littlest AW (4 yo girl) had a fever for about a day at the same time and never missed a beat. They slept in the same bed, continued to play together/wrestle, and eat/drink after each other for all but that one day she had a fever. It's almost impossible he wasn't exposed to the virus at that point. Which brings me to my last point.

4. In adults, we know that a single dose of the mrna vax boosts antibodies in those that have been naturally infected. But, antibodies are mostly irrelevant in kids because kids innate arms do a great job fighint off the virus so antibodies which are part of the slower to react adaptive arm don't even do anything. The vaccines just speeds up the adaptive arm in the event of an infection. If the innate arm fights it off, what's the point of training the adaptive arm via vaccine and accept any risk, rather its 1:50 or 1:5 million? And, doubly, what's the point of accepting that risk if his adaptive arm is already trained via natural infection?

When the risks are so minimal either way, I have a real tough time parsing through all the data, especially with the unknowns, to come to a conclusion. And, lean towards avoiding any known risk associated with the vaccine.

tl;dr: There isn't one. It's a nuanced subject.

[G. Keenan]

No matter how you slice it, the health risks of getting Covid are much higher than vaccine side effects. The risk of myocarditis from the vaccine is much LESS than the risk of myocarditis from a Covid infection. And for the kids that do get that side effect from vaccination, it's very treatable.

There simply is not a risk calculation of vaccinate vs. get infected (which is virtually inevitable for unvaccinated individuals at this point) that does not yield vaccination as the logical course of action.

[AWvsCBsteeeerike3]

No matter how you slice it, the health risks of getting Covid are much higher than vaccine side effects. The risk of myocarditis from the vaccine is much LESS than the risk of myocarditis from a Covid infection. And for the kids that do get that side effect from vaccination, it's very treatable.

There simply is not a risk calculation of vaccinate vs. get infected (which is virtually inevitable for unvaccinated individuals at this point) that does not yield vaccination as the logical course of action.

That sounds good and all, but the numbers don't bear it out.