Sep 20, 2021

COVID-19 Update

First, of course - Fuck you, Google.

Now some good(ish) news via WaPo: (this one's a freebie)

Low dose of Pfizer-
BioNTech vaccine is safe and effective in children ages 5 to 11, companies’ study find
s

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 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 the younger males eligible for the vaccines. An FDA analysis estimated that among 16- to 17- year old males, the risk was close to one in 5,000.

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.


- more -




No comments:

Post a Comment