[merged] Pfizer says low dose vax works on kids 5-11. Will seek EAU this month.

[Passepartout]

Pfizer Says COVID-19 Vaccine Works In Kids Ages 5 To 11 | HuffPost
This could be a game changer.

 

[DannyTS]

Where is the study if they are so confident in the data? How long was the study? Around 2000 kids?
This must be a bad joke.

“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.” What does it mean consistent with those observed in older population? I would rather see the numbers than the PR BS

Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years | Pfizer

Results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses Companies plan to submit these data to the FDA, EMA and other...

www.pfizer.com

 

[emeryjre]

Is the study available to the public?

 

[MULTIZ321]

Pfizer says its Covid vaccine is safe and generates
robust immune response in kids ages 5 to I I.

Pfizer says its Covid vaccine is safe and generates robust immune response in kids ages 5 to 11

Pfizer and BioNTech tested a two-dose regimen of 10 micrograms — about a third the dosage used for teens and adults — administered three weeks apart.

www.cnbc.com

.


Richard

 

[DannyTS]

WSJ: "The Flimsy Evidence Behind the CDC’s Push to Vaccinate Children
The agency overcounts Covid hospitalizations and deaths and won’t consider if one shot is sufficient."

"A tremendous number of government and private policies affecting kids are based on one number: 335. That is how many children under 18 have died with a Covid diagnosis code in their record, according to the Centers for Disease Control and Prevention. Yet the CDC, which has 21,000 employees, hasn’t researched each death to find out whether Covid caused it or if it involved a pre-existing medical condition.

Without these data, the CDC Advisory Committee on Immunization Practices decided in May that the benefits of two-dose vaccination outweigh the risks for all kids 12 to 15. I’ve written hundreds of peer-reviewed medical studies, and I can think of no journal editor who would accept the claim that 335 deaths resulted from a virus without data to indicate if the virus was incidental or causal, and without an analysis of relevant risk factors such as obesity.

My research team at Johns Hopkins worked with the nonprofit FAIR Health to analyze approximately 48,000 children under 18 diagnosed with Covid in health-insurance data from April to August 2020. Our report found a mortality rate of zero among children without a pre-existing medical condition such as leukemia. If that trend holds, it has significant implications for healthy kids and whether they need two vaccine doses. The National Education Association has been debating whether to urge schools to require vaccination before returning to school in person. How can they or anyone debate the issue without the right data?"

Opinion | The Flimsy Evidence Behind the CDC’s Push to Vaccinate Children

The agency overcounts Covid hospitalizations and deaths and won’t consider if one shot is sufficient.

www.wsj.com

 

[DeniseM]

DannyTS - Do you have a background (career/education) in medicine, science, research, or any field related to this topic?

 

[DannyTS]

DannyTS - Do you have a background (career/education) in medicine, science, research, or any field related to this topic?

Did you see the quotation marks? This is an article written by Martin Adel "Marty" Makary who, according to Wikipedia is "an American surgeon, professor, and author. He practices surgical oncology and gastrointestinal laparoscopic surgery at the Johns Hopkins Hospital, is Mark Ravitch Chair in Gastrointestinal Surgery at Johns Hopkins School of Medicine, and teaches public health policy as Professor of Surgery and Public Health at the Johns Hopkins Bloomberg School of Public Health. Makary is an advocate for disruptive innovation in medicine and physician-led initiatives such as The Surgical Checklist, which he developed at Johns Hopkins, and was later popularized in Atul Gawande's best-selling book The Checklist Manifesto.[1] Makary was named one of the most influential people in healthcare by Health magazine.[2] In 2018, Makary was elected to the National Academy of Medicine.[3] "

 

[DeniseM]

Yes, I saw the quotation marks. What I'm curious about is your background. (It's no secret that my background is education, but certainly not medicine or science or research or any related field.)

 

[DannyTS]

Yes, I saw the quotation marks. What I'm curious about is your background.

What I noticed during this pandemic, the qualifications actually do not matter. We have another thread where a journalist calls "fringe" a doctor who is the second most published critical care doctor in the world. Those that defended the doctors on that tread were "loons" and "clowns", a wise person explained. The inventor of the mRNA vaccine has been "debunked" by the media (and by few TUGgers as well). Scientific research is not good if it does not fit the official narrative. On Tug, whole threads are so uncomfortable that they have been trolled, those commenting have been called names, and eventually the treads were closed, not because they were not legit discussions but because of the cognitive dissonance of certain people. They knew exactly what they were doing: drive the heat up than ask the moderators to close the tread.
As you and me both know the qualifications do not really matter, or only matter when it comes to those that are not part of the "consensus".

 

[DeniseM]

I think that qualifications matter a great deal when it comes to analyzing the science and the studies. I know I'm not qualified.

 

[TravelTime]

Finally!
——————————

A lower dose of the Pfizer-BioNTech coronavirus vaccine — one-third the amount given to adults and teens — is safe and triggered a robust immune response in children as young as 5 years old, the drug companies announced in a news release Monday.

The finding, eagerly anticipated by many parents and pediatricians, is a crucial step toward the two-shot coronavirus vaccine regimen becoming available for younger school-aged children, perhaps close to Halloween…….

Read more here:

https://www.washingtonpost.com/health/2021/09/20/covid-vaccine-for-children/?itid=hp_pandemic

 

[MrockStar]

This could make teachers happy, not so sure about the kids/parents.

 

[PigsDad]

This could make teachers happy, not so sure about the kids/parents.

Almost all parents I have talked to about this have been waiting for a vaccine for their kids. But then, I live in a state that is ranked high in quality of education. Could be a factor.

Kurt

 

[MrockStar]

I hope so.

 

[MrockStar]

As long as the kids can ditch the masks in school after they get vaccinated Ian all for it on the name of getting a quality education.

 

[Passepartout]

As long as the kids can ditch the masks in school after they get vaccinated Ian all for it on the name of getting a quality education.

Kids can get an education masked. They're flexible.

 

[MrockStar]

I hope you have kids/grandkids in School so you can hear their complaints then.

 

[davidvel]

I hope you have kids/grandkids in School so you can hear their complaints then.

I do, and they are all fine. They go to school, they cheer and play sports just fine. It's just those that have made it political and convinced their kids to complain to support their ideological leanings. I had to wear a mask for months upwards of 9-10 hours a day. It's uncomfortable, but so are lots of things. Too many complainer snowflakes these days.

 

[TravelTime]

As a parent, I think the government should make the vaccine available for children and let parents decide. I am fine with so called “flimsy” data. There is enough data on the vaccine for adults that could translate to children that I think it is worth getting for my kids at least.

 

[amycurl]

My daughter and her friends have never once complained about wearing masks. They do, however, complain when they are in public spaces indoors and people *aren't* wearing a mask (or not wearing one properly.)

 

[hurnik]

I'll note that these studies aren't peer reviewed (to my knowledge) yet, and the VAERS isn't verified data.

However, a big concern I have is that some of the new data *seems* to indicate (and other studies say otherwise as well, so there's that) the incidence of myocarditis among certain (young males apparently) is higher than COVID-related myocarditis now.

My big concern is the all-or-nothing approach that seems to be happening (you will get 2-dose vaccination or single dose J&J, regardless).

IF the studies hold true (increased myocarditis risk) AND you have a young male child who already had COVID, I'd be concerned about an increased risk (I notice the studies don't seem to factor that in, but then again the Pfizer mRNA hasn't been approved until just recently).

This one says increased risk, but less than if you get COVID itself (if I'm reading things correctly):

Heart Problem More Common After Covid-19 Than After Vaccination, Study Finds (Published 2021)

The research did not assess the risks specifically for young males, who are the most likely to develop the rare side effect.

www.nytimes.com

This one may or may not be paywalled (I clicked "support" and then went back to the original page and it loaded the article):
This one says the opposite of the first one (I believe). "Their analysis of medical data suggests that boys aged 12 to 15, with no underlying medical conditions, are four to six times more likely to be diagnosed with vaccine-related myocarditis than ending up in hospital with Covid over a four-month period. "

Boys more at risk from Pfizer jab side-effect than Covid, suggests study

US researchers say teenagers are more likely to get vaccine-related myocarditis than end up in hospital with Covid

www.theguardian.com

and then this one:

SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis

Objectives Establishing the rate of post-vaccination cardiac myocarditis in the 12-15 and 16-17-year-old population in the context of their COVID-19 hospitalization risk is critical for developing a vaccination recommendation framework that balances harms with benefits for this patient...

www.medrxiv.org

Yes, I think vaccinations (generally speaking) are good, but I want more studies on those with previous infections ("natural immunity"). I don't have kids, but my sister has two and I'd be a bit concerned about my newphew who is in the age range of the possibly affected group (they had COVID already). In other words, could a young male who had COVID already, and then be subject to the new vaccine regime have an even greater risk of myocarditis than what the studies (may) show? That, to me, would give me pause. But again, I'm not a parent. Sorry for blabbing on, hopefully I explained the situation/concern correctly.

 

[cman]

This is welcome news for a lot of parents. Since age verification is not required for children, some have been vaccinating their 11 year olds. Let's hope all goes well.

 

[bluehende]

I'll note that these studies aren't peer reviewed (to my knowledge) yet, and the VAERS isn't verified data.

However, a big concern I have is that some of the new data *seems* to indicate (and other studies say otherwise as well, so there's that) the incidence of myocarditis among certain (young males apparently) is higher than COVID-related myocarditis now.

My big concern is the all-or-nothing approach that seems to be happening (you will get 2-dose vaccination or single dose J&J, regardless).

IF the studies hold true (increased myocarditis risk) AND you have a young male child who already had COVID, I'd be concerned about an increased risk (I notice the studies don't seem to factor that in, but then again the Pfizer mRNA hasn't been approved until just recently).

This one says increased risk, but less than if you get COVID itself (if I'm reading things correctly):

Heart Problem More Common After Covid-19 Than After Vaccination, Study Finds (Published 2021)

The research did not assess the risks specifically for young males, who are the most likely to develop the rare side effect.

www.nytimes.com

This one may or may not be paywalled (I clicked "support" and then went back to the original page and it loaded the article):
This one says the opposite of the first one (I believe). "Their analysis of medical data suggests that boys aged 12 to 15, with no underlying medical conditions, are four to six times more likely to be diagnosed with vaccine-related myocarditis than ending up in hospital with Covid over a four-month period. "

Boys more at risk from Pfizer jab side-effect than Covid, suggests study

US researchers say teenagers are more likely to get vaccine-related myocarditis than end up in hospital with Covid

www.theguardian.com

and then this one:

SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis

Objectives Establishing the rate of post-vaccination cardiac myocarditis in the 12-15 and 16-17-year-old population in the context of their COVID-19 hospitalization risk is critical for developing a vaccination recommendation framework that balances harms with benefits for this patient...

www.medrxiv.org

Yes, I think vaccinations (generally speaking) are good, but I want more studies on those with previous infections ("natural immunity"). I don't have kids, but my sister has two and I'd be a bit concerned about my newphew who is in the age range of the possibly affected group (they had COVID already). In other words, could a young male who had COVID already, and then be subject to the new vaccine regime have an even greater risk of myocarditis than what the studies (may) show? That, to me, would give me pause. But again, I'm not a parent. Sorry for blabbing on, hopefully I explained the situation/concern correctly.

For the guardian study

Their analysis of medical data suggests that boys aged 12 to 15, with no underlying medical conditions, are four to six times more likely to be diagnosed with vaccine-related myocarditis than ending up in hospital with Covid over a four-month period.

This is an apples to oranges comparison. We know hospitalization is rare and myocarditis is rarely serious enough for hospitalization. Why would they not compare hospitalization rate to hospitalization rate. That would be the true comparison of risk.

From the article about myocarditis

The cases tended to be mild and the vast majority recovered with simple treatment and rest,” they added.

 

[DannyTS]

I think that qualifications matter a great deal when it comes to analyzing the science and the studies. I know I'm not qualified.

I think you should give yourself more credit. For example look at this study and make your own determination about the CO2 concentration when wearing a mask. There are several studies that link poor academic performance and the quality of air. Now connect the two and draw your own conclusion if the masks are beneficial for the health and development of the kids, when they have to wear them in school for 6 hours straight.


"The results demonstrated that a respirator caused excessive CO2 inhalation by approximately 7 greater per breath compared with normal breathing. Furthermore, heat and mass
transfer in the nasal cavity was reduced, which influences the perception of nasal patency. It is suggested that wearers of high-efficiency
masks that have minimal porosity and low air exchange for CO2 regulation should consider the amount of time they wear the mask"

"V. CONCLUSION
CFD simulations were performed over eight respiration cycles
for normal and respirator breathing. The nasal airflow and temperature were compared between the two different simulations. The
assessed variables for normal breathing were consistent with each
breath cycle. For respirator breathing, the mucosal wall temperature
increased compared with normal breathing. The breathing flow field
with and without a respirator showed that the N95 respirator significantly affected the flow properties, including CO2 concentration, temperature, and humidity of the inhaled air.
The effect of breathing through a respirator has increased the
time-averaged inhaled air temperature by 8%; H2O mass fraction by
150%; and CO2 concentration by 555% during the first inhalation
cycle. Throughout eight breaths, the maximum change as a ratio to
normal breathing was temperature increased by 1.13 times; H2O mass
fraction increased by 2.46 times; and CO2 concentration increased by
7.3 times. The increase in the inhaled temperature and humidity
decreased the cooling effect on the mucosal surface, which is thought
to affect the physiological sensation of full breathing. Furthermore, the
continual inhalation of excessive CO2 concentrations can lead to detrimental health effects on the subject."

Cookie Absent

 

[DrQ]

I think that qualifications matter a great deal when it comes to analyzing the science and the studies. I know I'm not qualified.

There have always been quackery. Google Patent Medicine, Black Salve, Radithor and homeopathy and you will see how some have perpetuated junk to the public.

We have had pandemics before, they will evolve into endemic. Our bodies will adapt to the virus.

The question is how much suffering will we endure?

If it were just to the unvaxxed, most would say let them twist in the wind -- Freedumb.

Where do we go from here? Do we set up wards and provide a best effort while providing a reserve for others with ailments which have a higher favorable outcome? Do we let them know, they are "on the bubble" because of a choice?

'Unmasked, unmuzzled, unvaccinated' mother-of-four dies of COVID

Kristen Lowery, 40, from Escalon, California, died on September 15th. She leaves behind four school-age children. She had been outspoken against vaccines and masks.

www.dailymail.co.uk