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BumRushDaShow

(127,301 posts)
Mon Sep 20, 2021, 07:00 AM Sep 2021

Low dose of Pfizer-BioNTech vaccine is safe and effective in children ages 5 to 11

Source: Washington Post

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 morning. 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. The companies still must prepare and submit the data to the Food and Drug Administration, a process they expect to complete by the end of September. Then, the data — not yet published or peer reviewed — will be scrutinized by regulators to ascertain that the vaccine is safe and effective. That could take weeks, or up to a month.

Regulators have made clear they are as working as fast as possible, but also need to ensure the vaccine meets the highest standards — especially because a rare, but concerning vaccine side effect of heart muscle inflammation has been identified, most frequently in 12- to 15- year old males, the youngest group eligible for the vaccines. With the school year in full swing and cases soaring among children, pediatricians have been inundated with requests to bend the rules and give children a shot now. The new data seems likely to intensify the pressure, even though the existing vaccine is triple the dose tested in the trial. Younger children’s immune systems are not the same as adults, and the companies tested and found a much smaller dose was safe and effective.

“No one should really be freelancing — they should wait for the appropriate approval and recommendations to decide how best to manage their own children’s circumstances,” said William C. Gruber, Pfizer’s senior vice president of vaccine clinical research and development, who explained that younger children tend to have more “exuberant” immune responses than older people, both to this vaccine and others. “Nature has equipped us, particularly when we are young, to respond very well to an assortment of things we will encounter in nature — and we will use vaccines to accelerate that process and really improve on nature,” Gruber said. Detailed data from the study in school-aged children was not immediately released Monday.

The step forward for a children’s vaccine may deepen the rift between families eager for the vaccine and parents who are hesitant. Hospitalizations among children have increased in the delta surge, but children have been far less likely to develop severe illness and death than older people throughout the pandemic, leading to a perception among some that the disease is not harmful to them. Among 12- to 17-year-olds eligible for the Pfizer-BioNTech shot since May, only about half have received at least one dose, according to the American Academy of Pediatrics. More than 5 million cases of covid-19, the illness caused by the coronavirus, have been reported among children and teens, causing 20,000 hospitalizations and 460 deaths since the start of the pandemic. Many families and schools have been navigating disruptive quarantines and at times divisive policies on use of masks.

Read more: https://www.washingtonpost.com/health/2021/09/20/covid-vaccine-for-children/



Full headline: Low dose of Pfizer-BioNTech vaccine is safe and effective in children ages 5 to 11, companies’ study finds

Note that this is based on "rolling data" that I expect they have been submitting to the relevant agencies.

One of the issues with children, aside from needing the reduced dose (if anything based on their still-forming immune systems and much lower body mass than adults) is their ability to still spread the virus in their households. I.e., as we have found, certain variants like Delta, are more "transmissible" than the earlier wild type variants. And Delta has apparently been found to reproduce itself much faster and at a greater quantity, due to its spike configuration. So regardless of the disease impact of Delta on children (which is being seen as a significant "signal" above the noise from the past by earlier variants), the potential for them to harbor it and pass it on to their families as there is little mitigation in those "home" situations, is real IMHO.

In schools with aggressive mitigation in place in locations where the R0/positivity rate is low, seems to forestall super-spreader events in schools. But where there is little mitigation in those school settings, the reports of positives and quarantines continue to pour in from around the country.

The other issue with this younger set that was brought up during last Friday's FDA approval meeting, was that very youngest of the demographic - and that pointed to that age 16, which is just above the cutoff of the 12-15 age that this OP is reporting about, and the potential for myocarditis for the youngest of demographic. Back during the original discussion regarding granting an EUA to these firms, the subject of approving this vaccine down to "age 16" vs "age 17" or "age 18" was significant, and there were arguments to raise the age for Pfizer's, but the EUA (and later BLA) was granted for 16+. Note that Moderna's EUA was submitted for approved for 18+ and they kept it at 18+.

Some additional info on that "age" issue from an article published this past March that provided a good summary of what happened with the original submissions and approvals -

Why can teens aged 16, 17 get the Pfizer vaccine but not Moderna or Johnson & Johnson?
Coronavirus

by: Justyn Melrose
Posted: Mar 24, 2021 / 02:06 PM EDT / Updated: Mar 25, 2021 / 06:12 AM EDT


As states open up COVID-19 vaccinations up to more and more people, some are beginning to wonder why the age requirement isn’t consistent across the three currently-approved vaccines.To get the Pfizer vaccine, you must be at least 16 years old, but you have to be at least 18 to get the Moderna vaccine and the Johnson & Johnson vaccine. Those age limits, set by the Food and Drug Administration, are based on how the three companies conducted their pharmaceutical trials.

Before getting emergency use authorization, both Moderna and Johnson & Johnson had limited their trials to people ages 18 and older, while Pfizer was testing with children as young as 12. According to the New York Times, both Pfizer and Moderna are now testing with children ages 12 and older but it may take until summer before the vaccines receive approval for this younger age group. Johnson & Johnson also plans to test its vaccine with younger patients but is further behind.

(snip)

Moderna was the second COVID-19 vaccine to receive emergency use authorization on Dec. 18. after testing its vaccine with 15,419 participants aged 18 years and older across three clinical trials. According to the emergency use authorization, “Safety and effectiveness have not been assessed in persons less than 18 years of age. Emergency Use Authorization of Moderna COVID-19 Vaccine does not include use in individuals younger than 18 years of age. ”On Feb. 27, the FDA approved the Johnson & Johnson vaccine after testing with 43,783 participants. Similarly to Moderna, Johnson & Johnson also only tested its vaccine with people ages 18 and older.

https://myfox8.com/news/coronavirus/why-can-16-17-year-olds-get-the-pfizer-vaccine-but-not-the-moderna-johnson-johnson-vaccines/


So lots of things to consider and weigh with respect to risk/benefit...
13 replies = new reply since forum marked as read
Highlight: NoneDon't highlight anything 5 newestHighlight 5 most recent replies
Low dose of Pfizer-BioNTech vaccine is safe and effective in children ages 5 to 11 (Original Post) BumRushDaShow Sep 2021 OP
re: "side effect of heart muscle inflammation...most frequently in 12- to 15- year old males" thesquanderer Sep 2021 #1
I just edited the OP with a bit pile of stuff for consideration BumRushDaShow Sep 2021 #3
And that's temporary... SergeStorms Sep 2021 #8
Heart inflammation is never temporary - the heart doesn't repair itself - it scars womanofthehills Sep 2021 #13
So emergency authorization in a few months. Good news! mucifer Sep 2021 #2
Weeks. SergeStorms Sep 2021 #9
Great news! SheltieLover Sep 2021 #4
This is just awesome! FakeNoose Sep 2021 #5
I wonder DownriverDem Sep 2021 #6
I'm sure quite a few BumRushDaShow Sep 2021 #7
I just left the MSN... SergeStorms Sep 2021 #11
It will be emergency authorization I'm sure. At least everyone will have the option ! mucifer Sep 2021 #12
Promising news. Good to hear...nt Wounded Bear Sep 2021 #10

thesquanderer

(11,954 posts)
1. re: "side effect of heart muscle inflammation...most frequently in 12- to 15- year old males"
Mon Sep 20, 2021, 07:22 AM
Sep 2021

Maybe ultimately the answer will be something like, 1/3 dose for children 5 to 11, 2/3 dose for those 12 to 15, full dose for 16 and up.

womanofthehills

(8,579 posts)
13. Heart inflammation is never temporary - the heart doesn't repair itself - it scars
Mon Sep 20, 2021, 10:52 AM
Sep 2021
Understanding Myocarditis

In simple terms, myocarditis is a disease that causes inflammation of the heart muscle. This inflammation enlarges and weakens the heart, creates scar tissue and forces it to work harder to circulate blood and oxygen throughout the body.

https://www.myocarditisfoundation.org/about-myocarditis/

FakeNoose

(32,349 posts)
5. This is just awesome!
Mon Sep 20, 2021, 09:03 AM
Sep 2021

Start giving the school kids their vaccine as soon as possible.
Maybe we'll get back to "normal" by next year.



BumRushDaShow

(127,301 posts)
7. I'm sure quite a few
Mon Sep 20, 2021, 09:23 AM
Sep 2021

The "news" always reports about the loud-mouthed anti-vaxxers but parents who already readily give their children the typical childhood series of vaccines for MMR, Polio, Chicken Pox, DtaP, etc., I expect would most likely do so for this too whenever it is officially approved (at least as an EUA) - especially if their pedis can do it during a visit.

SergeStorms

(18,893 posts)
11. I just left the MSN...
Mon Sep 20, 2021, 09:33 AM
Sep 2021

(Microsoft News) message board. The number of conspiracy theorists and anti-vaxers is mind boggling.

I had to leave, because the stupid hurt soooooooo much!

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